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Ultra-processed food significantly raises the risk of high blood pressure, heart disease, heart attacks and strokes, according to two studies that one expert says should serve as a wake-up call for governments worldwide.
Global consumption of heavily processed items such as cereals, protein bars, fizzy drinks, ready meals and fast food has soared in recent years. In the UK and US, well over half the average diet now consists of ultra-processed food (UPF). For some, especially people who are younger, poorer or from disadvantaged areas, a diet comprising as much as 80% UPF is typical.
Stark new research adds to a growing body of evidence that experts say exposes a “tidal wave of harm” being caused directly by UPF. Two large studies presented at the world’s largest heart conference showed the devastating impact UPF is having on cardiovascular health.
The first study, which tracked 10,000 women for 15 years, found that those with the highest proportion of UPF in their diet were 39% more likely to develop high blood pressure than those with the lowest. This was the case even after academics adjusted for the effect of salt, sugar and fat.
High blood pressure, or hypertension, increases the risk of serious heart conditions including heart disease, peripheral arterial disease, aortic aneurysms, kidney disease and vascular dementia.
The second study, a gold-standard meta-analysis of more than 325,000 men and women, showed those who ate the most UPF were 24% more likely to have cardiovascular events including heart attacks, strokes and angina.
Increasing daily UPF consumption in calorie intake by 10% was associated with a 6% increased risk of heart disease. And those with UPF making up less than 15% of their diet were least at risk of any heart problems, according to the research led by the Fourth Military Medical University in Xi’an, China.
The findings were revealed at the annual meeting of the European Society of Cardiology in Amsterdam, where thousands of the world’s leading heart doctors, scientists and researchers were briefed on the studies. The results prompted calls from experts for urgent action.
Ultra-processed foods are products that have gone through multiple processes during manufacturing. They are often high in salt and sugar and may contain additives and preservatives. Often, the foods are low in fibre and lacking the nutrients present in fresh or minimally processed foods, such as fresh fruit and vegetables, plain yoghurt and homemade bread.
Previous studies have linked eating high levels of ultra-processed foods with a range of health problems including obesity, type 2 diabetes and cancer.
Speaking to reporters in Amsterdam, one of the researchers behind the first study, Anushriya Pant, of the University of Sydney, said many people were unaware that food they assume is healthy, such as shop-bought sandwiches, wraps, soups and low-fat yoghurts, were in fact UPF. “It could be that foods you think are healthy are actually contributing to you developing high blood pressure,” she said.
Women typically eat more UPF than men, Pant added. Further research is needed to establish whether this is driven by the marketing of ultra-processed diet and low-fat foods at women.
Dr Chris van Tulleken, one of the world’s leading UPF experts and the author of the bestselling book Ultra Processed People, said: “The findings of these new papers are entirely consistent with a large and growing body of work showing that increasing consumption of UPF is associated with an increased risk of cardiovascular disease.
“Much of it will be familiar as ‘junk food’, but there’s plenty of organic, free-range, ‘ethical’ UPF which might be sold as healthy, nutritious, environmentally friendly or useful for weight loss. Almost every food that comes with a health claim on the packet is UPF.
“There is now significant evidence that these products inflame the gut, disrupt appetite regulation, alter hormone levels and cause myriad other effects which likely increase the risk of cardiovascular and other disease much in the same way that smoking does.”
Van Tulleken called for black warning labels to be added to UPF packaging, as is already the case in Chile and Mexico, and said there should be a clampdown on marketing of UPF, and in particular adverts aimed at children.
The UK Department of Health and Social Care said it had already introduced legislation to restrict the placement and promotion of certain products in supermarkets to discourage unhealthy food choices.
Henry Dimbleby, the government’s former food tsar, said the studies presented in Amsterdam were among the first to suggest that the harm caused by UPF may be more than just because of the high fat, sugar and salt content of the products.
“This indicates there is something else going on,” he said. “Given that UPF represents 55% of our diet, that should be a wake-up call. If there is something inherent in the processing of foods that is harmful, then that is a disaster.
“Britain is particularly bad for ultra-processed food. It is storing up problems for the future. If we do nothing, a tidal wave of harm is going to hit the NHS.”
Dr Sonya Babu-Narayan, an associate medical director at the British Heart Foundation, said more research was needed to understand the links between ultra-processed foods and cardiovascular disease.
“For example, we don’t know to what degree this is driven by artificial additives or the high levels of salt, sugar and fat that these foods tend to contain,” she said.
“We do know that the world around us doesn’t always make it easy for the healthy option to be the accessible and affordable option. On the contrary, less healthy foods often take centre stage. To address this, we need a comprehensive strategy that creates an environment that can support people to live long and healthy lives.”
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Nutrition Research
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The government in England should increase its use of the private sector to tackle the NHS backlog, Labour says.
It said as many as 300,000 patients have missed out on treatment since it called for greater use of private clinics in January 2022.
And the party said it was unjust that the lack of action meant only those who could afford to pay for treatment themselves were being seen on time.
The government said it was delivering by cutting long waits.
However, data published by NHS England last week showed key targets to tackle the backlogs in cancer care and routine treatment had been missed.
Overall, there are now a record 7.3 million people on a hospital waiting list, which is nearly three million higher than it was before the pandemic started.
Health minister Will Quince said: "The Conservatives have virtually eliminated waits of over two years, and cut 18-month waits by 91%."
He said Labour politicians were split over use of the private sector in the NHS, adding: "While Labour fight with themselves over how to deliver care, we are cutting waiting lists and delivering for patients."
However, Labour shadow health secretary Wes Streeting said: "It's completely unjust that only those who can afford to pay to go private are being treated on time, while everyone else is left behind.
"Labour would use the spare capacity in the private sector to get patients seen faster.
"If the Conservatives had got their skates on, almost 300,000 patients could have been treated, off the waiting list and back to living their lives to the full. Rishi Sunak's dither and delay is costing patients dear."
'Cross-party consensus'
That figure is based on the fact the independent sector has said it has capacity to do an extra 30% of the work it was doing for the NHS before the pandemic.
So instead of carrying out the 1.8 million treatments it has for the NHS between January 2022 and March 2023, the private sector could have done 2.1 million, Labour said.
It urged the government to get on and publish the conclusions of the elective recovery taskforce that has been looking at how to make better use of the private sector.
The taskforce finished its work in March, but its findings have yet to be published - although election rules meant it could not be released in the weeks leading up to the local elections at the start of May.
Under the arrangements in place, the private sector carries out NHS work at the same rates received by NHS hospitals.
The criticism by Labour is being seen as another sign of the party's renewed interest in getting the private sector more involved in NHS care.
Labour's last two leaders, Jeremy Corbyn and Ed Miliband, focused their election campaigns on protecting the NHS in England from privatisation.
But under the New Labour government of the late 1990s and 2000s, the role of the private sector increased in the health service.
David Hare, chief executive of the Independent Healthcare Providers Network, said he was pleased to see the "cross-party consensus" on the role the private sector could play in the NHS.
"We look forward to publication of the taskforce report," he added.
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Health Policy
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What to know about aspartame following the WHO’s assessment
The World Health Organization’s (WHO) new assessment of the safety of the common artificial sweetener aspartame has ignited a debate over just what consumers should do.
Two groups tied to the WHO — the International Agency for Research on Cancer (IARC) and the Joint Expert Committee on Food Additives (JECFA) — issued somewhat diverging conclusions on Thursday in regard to aspartame, an extremely popular additive most often associated with diet foods.
IARC determined that the sweetener was “possibly carcinogenic,” while JECFA said it found “no convincing evidence from experimental animal or human data that aspartame has adverse effects after ingestion.”
The studies did not produce a change in the recommended daily intake of aspartame for humans.
A food safety official for the WHO said that the consumption of aspartame is “not a major concern at the doses which are commonly used.”
The amount of aspartame that was indicated as being potentially harmful would be the equivalent of drinking a dozen or more cans of diet soda every day.
With all this attention focused on aspartame but little in terms of a concrete conclusion, it remains unclear what the WHO sought to achieve by publicizing its risk assessments.
Here’s what to know:
US groups still say it’s safe
The Food and Drug Administration (FDA) publicly split with the WHO’s assessment.
“The FDA disagrees with IARC’s conclusion that these studies support classifying aspartame as a possible carcinogen to humans,” said the agency. “FDA scientists reviewed the scientific information included in IARC’s review in 2021 when it was first made available and identified significant shortcomings in the studies on which IARC relied.”
The food and beverage industry was also quick to issue reassuring statements.
The American Beverage Association on Thursday stated plainly: “Aspartame is safe.”
“People all around the world can be confident in consuming food and beverages with aspartame,” the organization added. “The safety of our products is the highest priority for our industry.”
WHO report offers little for consumers
Marion Nestle, author and Paulette Goddard professor of nutrition, food studies, and public health emerita at New York University, took issue with how the WHO reports were released.
“So, the IARC came out and said based on limited evidence, aspartame is possibly a carcinogen. What on Earth are you supposed to do with that?” Nestle asked. “IARC says that there’s tons of evidence that aspartame induces metabolic problems. But I don’t see the evidence because they haven’t published it.”
As Nestle noted, aspartame has been at the center of controversy for decades.
The sweetener was first approved by the FDA for use in some foods and beverages in 1974 before its approval was suspended due to objections and conflicting studies. Aspartame ultimately entered the U.S. market in 1981.
Why we still don’t know for sure
Despite frustration with the vague, diverging report on aspartame’s safety, health experts acknowledge the difficulty in conducting a thorough study of the additive.
“People use aspartame in very, very small quantities. And they eat lots of other things and behave in lots of other ways. So, it’s very hard to parse out,” said Nestle, who is not associated with the multinational food conglomerate of the same name. “You can’t do the kind of science that you’d want to do, which is to put one group of people on aspartame and the other group without and follow them for 30 or 40 years. But you can’t do that, so everything is inferential.”
Allison Sylvetsky, associate professor of exercise and nutrition sciences at the George Washington University Milken Institute School of Public Health, noted that many studies looking into aspartame also include a variety of other artificial sweeteners, making it difficult to pin down the potential effects of just aspartame.
Why the renewed attention
Even after decades of studies and availability on the market, there is still no broad consensus on aspartame. But the increasing amount of research into the additive and its expanded use in food products likely played a part in the WHO’s focus.
“There’s just more use of these sweeteners. There’s more consumption of these sweeteners, and that’s part of why it’s kind of resurfaced as an important issue,” Sylvetsky said, noting the growth in global efforts to cut down on added sugars in food that has coincided with the ubiquity of artificial sweeteners.
“They’re increasingly used for products aimed at children,” said Nestle. “So there’s increasing concern about what they do, particularly to kids.”
What the experts say
In light of all this attention and concern over the artificial food additive, the long-held advice remains the same in the end: moderation.
“Foods and beverages that are usually ultra-processed, that contain low-calorie sweeteners, you know, are not desirable in excess,” Sylvetsky said.
Nestle, who personally does not consume products with aspartame because of the taste and the complicated science surrounding it, advised that people should generally try to limit sweetened drinks to “only once in a while and in very small amounts.”
“But I have been accused of being totally out of touch with reality,” she added with a laugh. “I won’t argue that.”
Copyright 2023 Nexstar Media Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
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Nutrition Research
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This story discusses suicide. If you or someone you know is having thoughts of suicide, please contact the Suicide & Crisis Lifeline at 988 or 1-800-273-TALK (8255).
The popular medications Ozempic and Saxenda — both made by Novo Nordisk in Denmark — are under investigation after a small number of users experienced an increase in thoughts of suicide and self-harm, the European Medicines Agency (EMA) reported.
Three people reported the symptoms in Iceland — two linked to Ozempic, one to Saxenda — which sparked the EU’s safety review, according to multiple reports.
Both drugs are glucagon-like peptide 1 (GLP-1) agonists, which have the dual effect of controlling blood sugar and aiding in weight loss.
Ozempic, an injectable semaglutide, is marketed for the management of type 2 diabetes.
Saxenda, which contains liraglutide, is intended as a weight-loss medication.
The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) will also look into whether other GLP-1 medications should be investigated, per reports.
Dr. Marc Siegel, professor of medicine at NYU Langone Medical Center and a Fox News medical contributor, noted that "an association doesn't prove causality."
"It could have more to do with people who are requesting these drugs in the first place — their obesity or other medical or psychological issues could be occurring at the same time and could be independent," he told Fox News Digital.
"Having said that, this does need to be carefully addressed because these drugs (semaglutides) do affect hormones in the brain, and the impact on nutrition can also impact brain function," Siegel added.
"These drugs do affect hormones in the brain."
The increased risk of suicidal ideation associated with GLP-1 drugs has been known since the clinical trials, according to Dr. Angela Fitch, co-founder and chief medical officer of knownwell, an in-person and telehealth "weight-inclusive" health care company based in Boston.
"This risk is very small, but increased above placebo," Fitch told Fox News Digital.
"This data is available in the trials, and suicidal ideation is a listed side effect of many of our obesity medications."
The effect is also complicated by a patient's relationship with food — particularly if the patient tends to use food as a coping mechanism for emotions, Fitch said.
"If you take away the desire to eat and some of the satisfaction of eating, this can be emotionally challenging," she said.
In light of this risk, Fitch emphasized the importance of taking these medications as part of a comprehensive chronic disease management plan in a supportive clinic model, so that health care professionals can monitor for side effects, make adjustments in the treatment plan and provide emotional support.
A Novo Nordisk representative released the following statement.
"GLP-1 receptor agonists have been used to treat type-2 diabetes for more than 15 years and for treatment of obesity for eight years, including Novo Nordisk products such as semaglutide and liraglutide that have been in the U.K. market since 2018 and 2009 respectively."
"The safety data collected from large clinical-trial programs and post-marketing surveillance have not demonstrated a causal association between semaglutide or liraglutide and suicidal and self-harming thoughts."
Fox News Digital reached out to the company for further comment.
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Drug Discoveries
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Up to 9,000 cases of lung cancer could be caught sooner or prevented under a new screening programme set to be rolled out acroos the country.
The scheme could provide almost one million scans and earlier treatment.
It is set to cost £270m annually once fully established and will use patients' GP records for those aged 55 to 74 to identify current or former smokers.
Prime Minister Rishi Sunak suggests the scheme could provide "a lifeline to thousands of families across the country".
Under the programme, backed by a recommendation from the UK National Screening Committee, patients will have their risk of cancer assessed based on their smoking history and other factors - and those considered high risk will be invited for specialist scans every two years.
It is estimated the rollout will mean 325,000 people will be newly eligible for a first scan each year, with 992,000 scans expected per year in total.
The Department of Health and Social Care said the first phase of the scheme will reach 40% of the eligible population by March 2025, with the aim of 100% coverage by March 2030 following the rollout.
The rollout comes after a successful earlier phase which saw approximately 70% of the screenings take place in mobile units parked in convenient sites such as supermarket car parks.
This helped ensure easy access and focused on more deprived areas, where people are four times more likely to smoke.
The first phase of the targeted lung health check scheme by NHS England resulted in more than 2,000 people being detected as having cancer, while 76% were found at an earlier stage compared to 29% in 2019 outside the programme.
In total, during the initial phase almost 900,000 people were invited for checks, 375,000 risk assessments made and 200,000 scans were carried out.
Smoking causes 72% of lung cancers, around 35,000 people die and 48,000 people are diagnosed with lung cancer each year.
Read more:
Australia to ban recreational vaping in crackdown on e-cigarettes
Disposable vapes face ban as Scotland launches urgent review
Future generations banned from ever being able to buy tobacco in New Zealand
It has one of the lowest survival rates of all cancers, which is largely attributed to lung cancer being diagnosed at a late stage when treatment is much less likely to be effective.
Anyone assessed as being at high risk of lung cancer will be referred to have a low dose Computed Tomography (LDCT) scan, with a diagnosis and treatment to follow if needed.
Anyone whose scans are negative will be reinvited for further scans every 24 months, until they pass the upper age limit.
NHS chief executive Amanda Pritchard said: "Identifying lung cancer early saves lives, and the expansion of the NHS's targeted lung health check programme is another landmark step forward in our drive to find and treat more people living with this devastating disease at the earliest stage.
"The NHS lung trucks programme is already delivering life-changing results, with people living in the most deprived areas now more likely to be diagnosed at an earlier stage, giving them a better chance of successful treatment."
Hazel Cheeseman, the deputy chief executive of Action on Smoking and Health, said: "Targeted lung cancer screening with support to stop smoking at its heart will help prevent as well as treat lung cancer, still the leading cause of cancer deaths."
But Labour accused the government of "disarming" the health service.
Shadow health secretary Wes Streeting said: "We need a war on cancer, but the Conservatives have spent a decade disarming the NHS."
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Disease Research
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Justin Bieber shared an update about his health after revealing he had been diagnosed with Ramsay Hunt syndrome, causing him to have facial paralysis. The 28-year-old performer posted on Instagram Monday, telling fans that while he continues to experience discomfort, each day is getting better, and he is finding solace in “the one who designed me and knows me.” "I’m reminded he knows all of me,” Bieber wrote, referencing God. “He know[s] the darkest parts of me that I want no one to know about and he constantly welcomes me into his loving arms. This perspective has given me peace during this horrific storm that I’m facing." Justin Bieber updates fans on his health in an Instagram post, June 13, 2022. (Screencapture, @justinbieber Instagram) Bieber said he is leaning into his faith, adding: “I know this storm will pass but in the meantime JESUS IS WITH ME.” OZZY OSBOURNE TO UNDERGO ‘MAJOR OPERATION’ TO ‘DETERMINE THE REST OF HIS LIFE’ In the caption, the Grammy Award-winning pop star reminded fans that no matter the storm or difficulties of life, they are not alone. “By this point in my life I realize storms come and go,” Bieber wrote. “Jesus continues to remind me that he is with me in the midst of the storm. It’s not about the storm. It’s that we are NEVER ALONE AND HE UNDERSTANDS.” On Friday, Bieber revealed he is taking a break from performing due to his diagnosis of Ramsay Hunt syndrome. “It is from this virus that attacks the nerve in my ear and my facial nerves and has caused my face to have paralysis,” Bieber explained in an Instagram video. “As you can see, this eye is not blinking. I can’t smile on this side of my face. This nostril will not move. So there’s full paralysis on this side of my face.” CLICK HERE TO READ MORE FROM THE WASHINGTON EXAMINER Ramsay Hunt syndrome stems from a shingles outbreak caused by a reactivation of the same virus that causes chickenpox, called the varicella-zoster virus. With RHS, the virus infects the nerves in the face or near the ear, according to the Mayo Clinic. It can result in a painful rash, partial paralysis, and hearing loss in the affected ear.
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Disease Research
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NASHVILLE, Tenn. -- For months, Carlton Clemons endured crippling pain from a rotting wisdom tooth. He couldn’t sleep, barely ate and relied on painkillers to get by.
The 67-year-old from Nashville, Tennessee, could not afford to see a dentist on the $1,300-a-month his family gets in Social Security and disability payments. So he waited for the state to roll out a program this year that offers dental care to the more than 650,000 Medicaid recipients like him who are 21 and older. Tennessee is spending about $75 million annually on the program.
“Man, I thought I had made it heaven because the pain was over,” he said after the tooth was pulled in July at the Meharry Medical College School of Dentistry. “When they did pull it out, I was so happy. I was so glad. Everything just changed after that.”
His wife, Cindy, who also is on Medicaid, has had her teeth pulled at the clinic.
Medicaid, the federal and state health insurance program for the poor, requires states to provide dental coverage for children but not adults. But with a growing recognition of the economic and health costs of poor dental health and an influx of federal pandemic dollars, six states began or expanded their Medicaid programs this year to provide coverage for adults.
Access remains difficult in many of those states with some dentists refusing to treat Medicaid patients. Even those who want to expand their practice are finding themselves caught up in red tape.
Dr. Victor Wu, the chief medical officer for Tennessee’s Medicaid program, said he was pleased with the rollout of Medicaid dental benefits that started in January, but he acknowledges the state needs to build out its network and increase the participation rate among dentists.
While dental care often is seen as routine, the poor often go without any care for years or even decades. Doing so has significant costs, both to taxpayers and to those who cannot afford treatment.
One study from Texas A&M University found that treatment for preventable dental conditions represents up to 2.5% of emergency room visits, at a cost of $2 billion a year. An additional $45 billion is lost year in productivity in the United States annually from untreated oral disease, according to the federal Centers for Disease Control and Prevention.
“You put off care and you get sicker and then it becomes a crisis where you’re missing work or you end up going to the emergency department where you get a big bill and you don’t get the tooth actually taken care of,” said Dr. Rhonda Switzer-Nadasdi, the chief executive officer of Interfaith Dental Clinic which has offices in Nashville and Murfreesboro, Tennessee.
“You need good teeth to have good employment,” Switzer-Nadasdi said.
All states provide some Medicaid dental benefits for adults, but some limit it to only specific segments of the population, like pregnant women or those who have intellectual disabilities, or cover only emergency care, according to CareQuest Institute for Oral Health, a nonprofit that advocates for expanded dental care.
Hawaii, Tennessee, Kentucky, Michigan, Maryland and New Hampshire were the latest to begin or expand their dental coverage; they did so this year.
In New Hampshire, the state is spending $33.4 million over 12 months to provide dental care to its 88,000 Medicaid recipients.
“There is an increasing understanding that oral health is inseparable from health care,” said New Hampshire Democratic Rep. Joe Schapiro, who was the prime sponsor of the expanded dental benefits bill. “The amount of money spent on other health care problems that are related to oral health and the amount of money spent on emergency care when people can’t get any kind of preventive or restorative care is not only unfortunate for those people’s health but cost a tremendous amount of money.”
In Kentucky, Democratic Gov. Andy Beshear pressed ahead with emergency regulations ensuring that about 900,000 Kentuckians would continue having access to dental care after the Republican-led legislature rejected his proposal.
“We are focused on removing roadblocks that prevent people from getting back into the workforce, and this program does just that,” he said.
Virginia expanded its Medicaid program in 2021, budgeting $282 million for the 2022 and 2023 fiscal years to cover dental procedures for more than a million recipients. Last year, Kansas gave dental access to nearly 137,000 Medicaid recipients at a cost of $3.5 million in 2022 and $1.2 million in 2023.
While advocates are welcoming these changes, Texas, Alabama, Mississippi, Utah and Louisiana still only offer limited benefits.
Even as states add dental coverage, millions of beneficiaries are being culled from the Medicaid program nationwide as part of a review of eligibility, something states were prohibited from doing during the pandemic.
There are also plenty of hiccups in states that have expanded care, including Tennessee. Among the biggest is that too few dentists, especially in rural areas, are taking Medicaid patients, resulting in long waiting times and hours-long drives in search of care. Only about 15% of dentist take Medicaid in New Hampshire, 24% in Tennessee and 27% in Virginia.
Many dentists and groups advocating for expanded care blame Medicaid reimbursement rates. New Jersey only covers 13.3% of what a dentists normally charge, Michigan covers 17% and Rhode Island 22.4%, according to 2022 data analyzed by the American Dental Association. Illinois, New York, Ohio and Oregon each cover a little more than 28%.
Most states, though, cover between 30% and 50% with Alaska and North Dakota covering at least 55% and Delaware, 76.9%.
Dr. Heather Taylor, an assistant professor at the Richard M. Fairbanks School of Public Health at Indiana University, said some of Indiana’s Medicaid reimbursement rates for dental have not increased since 1998.
“It’s almost like we’re incentivizing our dentists not to treat the ones that are in need, because we don’t pay them even half of what they could get from private insurers,” she said.
Tennessee Family Dental, which has four clinics in the state, has experienced overwhelming demand from Medicaid patients. Dr. Ryan O’Neill, a dentist who owns the business, said he got some 300 calls on the first day and that some of his patients have traveled from 30 minutes away or more.
He wants to hire more dentists but said it can take upward of four months to get one certified under Medicaid. He also is struggling with a Medicaid billing system that routinely rejects some claims and he said there is “a lot of inconsistency over what is approved and what is denied.”
“Offices are hesitant to go in network because there’s a lot of unknowns,” O'Neill said. “We’re still learning what the rules are and, you know, trial and error in terms of how we’re supposed to deal with a particular situation.”
Danielle Wilkes, a 26-year-old mother of five from Ashland, Tennessee, drove 90 minutes to see O’Neill after calling dozens of dentists in her area and finding none who takes Medicaid. Her cousin, June Renee Pentecost, also came with her for treatment.
For the past five years, Wilkes had been waiting to see a dentist after getting several teeth knocked out in a car wreck. She was told it would cost her thousands of dollars for multiple crowns, which she could not afford.
“I was mad at first but I was like there nothing she could do. I’m just going to have to wait until my kids are grown up,” she said, adding that the pain often brought her to tears.
But here she was in a dental chair, her pink hair standing out against O’Neill and dental assistant Jasmine Webb in black scrubs. Afterward, the soft-spoken Wilkes said she was “just happy” to finally get the work done, even if she had to pay $400 that Medicaid did not cover.
In a different room, Pentecost was getting examined for a root canal. It had been more than a decade since she last saw a dentist because she was deterred by the cost despite years of pain. A mother of five, she figured dental care would take away from spending on her children.
“I couldn’t play with my kids because my head was hurting," she said.
The 30-year-old was relieved to get the work done but wondered why the state had not offered the benefit sooner.
“I’m hoping my pain would ease up and quit once I get my teeth fixed and then I won’t have so many headaches and feel so bad,” she said.
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Associated Press writer Bruce Schreiner in Frankfort, Kentucky, contributed to this report.
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The Associated Press Health and Science Department receives support from the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
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Health Policy
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TAMPA, Fla. — When a hemp dispensary in this Florida city started to stock edibles with certain mushroom extracts last year, state regulators quickly ordered it to stop selling the items.
The shop had been advertising fruit-flavored gummies and other products containing tiny doses of mood-altering chemicals from the mushroom Amanita muscaria. The red-capped, white-spotted fungus — rooted in popular culture through the Super Mario Nintendo game franchise, “The Smurfs,” and “Alice’s Adventures in Wonderland” — is legal for consumers to possess and eat in every state except Louisiana, according to a review of state laws.
Products with the mushroom’s extracts have cropped up at stores and online retailers from Florida to Minnesota and Nebraska to Pennsylvania. Businesses advertise a milder high compared with psilocybin, the Schedule 1 psychedelic that remains illegal at the national level, to people hoping to ease anxiety, depression, or joint pain.
But federal officials and fungi experts have urged caution, and Florida regulators have clamped down on sales in at least five counties. Some uses of the mushroom and its chemicals have led to serious side effects, including delirium with sleepiness and coma, according to Courtney Rhodes, an FDA spokesperson.
No human clinical trials have evaluated the products’ safety and effectiveness, said Heather Hallen-Adams, a faculty member at the University of Nebraska-Lincoln, who researches fungi in food.
Chillum, a hemp dispensary in the Ybor City neighborhood, stopped selling the edibles in December after regulators from the Florida Department of Agriculture and Consumer Services ordered it to do so, calling A. muscaria a dangerous ingredient. The shop returned $30,000 worth of merchandise to Psilo Mart, a Las Vegas-area supplier that says it imports the mushroom from Lithuania. The agriculture department, which regulates shops that sell products like hemp vapes, then lifted its restrictions on the dispensary.
Drew Gennuso, president of Psilo Mart, said he hasn’t heard of any “major issues” with the edibles. Chillum’s owner, Carlos Hermida, said he believes the products are safe.
“It’s so mild,” he said of the fungus’s effects. “It’s not anything where you’re going to smell the color purple.”
Hermida recently began selling the products again for between $20 and $55 — but, attempting to avoid another state order, he said Chillum added labels warning they are solely for “educational” or “spiritual” purposes and not human consumption.
Federal officials haven’t approved the fungus and its chemicals to be sold as food additives or to treat medical conditions.
The Tampa case highlights the gaps in oversight of this nascent national market despite concerns from federal officials.
“The companies are moving faster than the research,” said John Michelotti, who heads the medicinal mushrooms committee of the North American Mycological Association and founded Catskill Fungi, an upstate New York business that sells mushroom extracts.
“It’s the wild West.”
The crackdown at Chillum began in October. The Florida agriculture department collected samples of products for lab testing. Returning in December, the agency said a Psilo Mart hemp joint with A. muscaria powder had elevated levels of toxic heavy metals, department records show.
Hermida threw out his inventory of the mushroom joints, he said, and regulators ordered him to stop selling the other fungus products. They cited a state law that says food is “adulterated” if it “bears or contains any poisonous or deleterious substance which may render it injurious to health.”
The gummies with the extracts elicit a feeling of “being high and drunk,” Hermida said, while the capsules cause a “tingly body sensation” and throw off depth perception.
The Florida Poison Information Center in Tampa gets one report a week, on average, of a hallucinogenic mushroom poisoning, but many callers don’t explain what kind they ate, and doctors don’t have a quick way to verify, said Alexandra Funk, its managing director. She said A. muscaria products should be kept away from children.
In the Tampa Bay area, medical examiners haven’t recorded any recent deaths from the mushroom. Johns Hopkins All Children’s Hospital in St. Petersburg and local AdventHealth emergency rooms haven’t seen poisonings, according to spokespeople. But there appears to be a lack of routine testing for the fungus.
The edibles sold at Chillum appealed to Antwan Towner, a 40-year-old Ybor City magician who said he struggles with anxiety. He eats half a gummy when having a bad day, he said, and it produces euphoria that lasts about four hours, then peace of mind for a week. He said he hasn’t experienced a negative reaction or hallucinations.
“It was never about getting high,” he said. “It was just about trying something that may be effective.”
There’s a “lot of anecdotal evidence” that low doses of the mushroom may be useful therapeutically, said Hallen-Adams, who chairs the toxicology committee of the North American Mycological Association.
But more data is needed to prove if it helps those with various medical conditions or if it’s simply a placebo, she said.
The Toronto company, Psyched Wellness, conducted preclinical studies on its “Calm” extract, a sleep aid, said CEO Jeffrey Stevens.
Other businesses, Stevens said, haven’t invested in such research. “We have so many cowboys right now who are just saying, ‘Oh, this is a legal psychedelic mushroom, let’s just put product into the market.’”
Since early February, Florida regulators have cited five businesses in Daytona Beach, Largo, Plant City, Tallahassee, and Tamarac for selling merchandise containing A. muscaria, according to state agriculture department records. Because federal officials haven’t approved the mushroom to be used in food, the Florida agency orders businesses to stop selling these products when its inspectors find them, Aaron Keller, a spokesperson for the state agriculture department, wrote in an email.
In this emerging market with many unknowns, Hallen-Adams urged consumers to “be careful if this is something you’re going to experiment with.”
Under Chillum’s new labeling, consuming the edibles it sells is an “abuse of product,” Hermida said.
“If you want to study it, or if you want to pray to it, that’s fine with me.”
This article was produced in partnership with the Tampa Bay Times.
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Drug Discoveries
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Spent coffee grounds may protect brain from neurodegenerative disease
With around six million tons of spent coffee grounds discarded each year, much of that dumped into landfills, there's growing interest in repurposing the everyday by-product for other uses, such as creating new sustainable materials.
University of Texas El Paso (UTEP) researchers have ventured down an entirely different path, deriving caffeic-acid Carbon Quantum Dots (CACQDs) from the grounds, which may have the potential to shield brain cells from the microbiological attacks that can lay the foundations of neurodegenerative disease.
“Caffeic-acid based Carbon Quantum Dots have the potential to be transformative in the treatment of neurodegenerative disorders,” said lead researcher Jyotish Kumar. “This is because none of the current treatments resolve the diseases; they only help manage the symptoms. Our aim is to find a cure by addressing the atomic and molecular underpinnings that drive these conditions.”
While genetics play a major role in neurodegenerative disease, lifestyle and environmental factors can hugely contribute to the loss of neurons in specific areas of the brain that then develop into conditions such as Alzheimer’s and Parkinson’s.
Those factors include overactivity of free radicals, the harmful molecules that also have a hand in cancer and heart disease, and the aggregation of amyloid-forming protein fragments. These can form plaques in the brain, which are a hallmark of Alzheimer's progression.
In cell samples, the researchers found that CACQDs removed free radicals or blocked them from having an influence, and inhibited the aggregation of amyloid-forming proteins. Importantly, CACQDs did not appear to have any negative impacts on the cells.
If this benefit could translate to preventative treatment, it could keep patients away from the tipping point of disease progression.
“It is critical to address these disorders before they reach the clinical stage,” said Mahesh Narayan, a professor at UTEP. “At that point, it is likely too late. Any current treatments that can address advanced symptoms of neurodegenerative disease are simply beyond the means of most people. Our aim is to come up with a solution that can prevent most cases of these conditions at a cost that is manageable for as many patients as possible.”
Caffeic acid is a polyphenol compound, which has known antioxidant properties. It can also penetrate the all-important blood-brain barrier, which is key to delivering cellular protection to the very site that requires it.
As well as the spent coffee grounds being a sustainable source of caffeic acid, the CACQDs are produced via environmentally friendly ‘green chemistry.’ Coffee grounds are ‘cooked’ at 200 °F (93 °C) for four hours, in order to reorient the caffeic acid carbon structure for the CACQDs. And given the amount of coffee grounds discarded annually, the source material offers sustainability and scalability.
While still early days, the team are hopeful that further research will confirm early testing and that, one day, something as simple as a CACQDs pill could provide the human brain with an invisible shield to protect against non-genetic neurodegenerative disease.
This is the second study in recent months to find a surprising brain-health benefit from coffee products. In September, researchers identified a compound in green coffee beans, trigonelline, which shows promise in helping to maintain memory and cognitive function in aging brains.
The study was published in the journal Environmental Research.
Source: University of Texas El Paso
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Disease Research
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Brian Hurley, left, and Niall Hickey are two bar owners in different areas of the province who have been focused on training their staff on how to use naloxone kits. (Melissa Tobin/CBC News)
For Brian Hurley, co-owner of Iron Rock Brewery in Labrador City, training his staff on how to use naloxone is just one piece in making sure all his customers are safe inside his business.
"There's a lot of working professionals that do partake [in drug use]," Hurley said. "To have something as accessible as naloxone and be able to train our staff so that they're prepared or or have access to it, that's the approach we've taken."
He said having easily accessible naloxone in rural and remote parts of the province is especially important, given that healthcare services are often harder to access in these regions.
"Harm reduction is so much more important that you really do need to provide that access," Hurley said.
"Whether that's having test strips to be able to test something for fentanyl or any of those items, to be able to have those tools on site are real tangible ways that places can help."
As well, Hurley said a lot of drug users would be hesitant to pick up naloxone kits form healthcare facilities.
"I understand the ease and reason for that, but a lot of people do not want to approach a healthcare scenario for that," he said.
As such, it's important to have naloxone available where people will likely do drugs, like in a bar, he added.
Hurley was first introduced to the idea of having naloxone at his bar during last year's Canadian Brewery Awards.
Naloxone kits help reverse the effects of an overdose from opioids. (Paula Gale/CBC)
"Myself and my co-owner, my brother, were in Halifax and we caught up with a lab in Calgary that had assisted us with some testing of hand sanitizer in aluminum cans," Hurley said.
The lab offered him his first naloxone kit and by early June this year, Hurley was working on having his staff trained.
He said the Labrador West Status Of Women Council was a big help and even just opening the conversation about naloxone with people makes a difference.
As a business owner, he said he's worried that having naloxone on site could give people the wrong impression of his business.
However, he said it's all about safety.
"It does potentially stigmatise your community that you're talking about it," Hurley said. "I can understand people's resistance, but it's such a prevalent thing and we need to talk about it, prompting people to have conversations with their children or brother or loved one. We all have struggles. But it's what we don't talk about that can really lead to some really negative outcomes."
Another key point that Hurley thinks should be more well know is the Good Samaritan Act, which protects people from conviction if they're charged as a result of seeking assistance for, or having remained at the scene with someone suffering from a medical emergency.
"You can't be prosecuted for any possession offences should you be caught in the act of overdosing," Hurley said. "If you are a user yourself, I think that's really important to understand that you're protected and that at the end of the day the most important thing is that person's life."
Niall Hickey, the co-owner of the Newfoundland Embassy pub in downtown St. John's, says harm reduction is a necessary response to growing fears about overdoses and addiction. (Malone Mullin/CBC)
Hurley's comments come in the wake of naloxone training efforts led by Niall Hickey, co-owner of The Newfoundland Embassy in St. John's.
Hickey's efforts surrounding naloxone began after a young man died of a fatal overdose near his establishment. Since then, Hickey has worked with Thrive — a youth and young adult support group — to get more bars trained.
"Practically every single bar welcomed us in with open arms," Hickey said. "It was a really welcoming sight to see."
So far, around 25 bars have been trained in St. John's.
Hickey would also like to see a safe injection site set up in St. John's as he believes the crisis is increasing.
"Right now, it's every single day," Hickey said. "It doesn't matter if it's a Monday, Tuesday, Friday, Saturday. You can walk out the door and see everyone downtown — a lot of zombie-looking people," he said.
"We do have customers coming in that just want to use the bathroom and you can tell they're going to use the bathroom just to try to use [drugs]."
Hickey said the focus needs to be on harm reduction.
"Drugs aren't going to go anywhere and they've been around for hundreds of years and they're not going to stop," he said.
"[We need to] just keep speaking about it, talk about harm reduction, get safe injection sites. It will help the community as a whole."
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Drug Discoveries
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The UK had one of the worst increases in death rates of major European economies during the Covid pandemic, BBC analysis has found.
Death rates in the UK were more than 5% higher on average each year of the pandemic than in the years just before it, largely driven by a huge death toll in the first year.
That was above the increase seen in France, Spain or Germany, but below Italy and significantly lower than the US.
Comparing death rates across countries
Back in April and May 2020, the UK was seeing one of the worst waves of Covid deaths in the world.
But Prof Sir Chris Whitty, England's chief medical officer, warned against international comparisons of Covid deaths too early in the pandemic.
Instead, he recommended looking at deaths for any reason, since they do not depend on what a country calls a Covid death.
And he said analyses should take account of the age profile of each country, which can explain a lot of differences in death rates.
We have built a database of those figures, collecting data for the last eight years from a range of European countries, as well as the US and New Zealand.
Now the UK's long-awaited Covid inquiry is under way and Sir Chris is about to give evidence for the first time.
And as the World Health Organization has declared an end to the global health emergency, we have looked back at three years of pandemic deaths, starting in March 2020.
We compared countries by measuring how much their death rates rose from those seen in the five years before the pandemic.
Over the three years to February 2023, the UK's death rates went up by more than 5%, which is more than France, Germany and Spain (all up between 3% and 4.5%), but by less than Italy's (up more than 6%).
The US and Eastern European countries like Poland were even harder hit, with death rates more than 10% above their pre-pandemic levels over the three years to February 2023.
In contrast, death rates fell in countries like Sweden and Norway and also New Zealand, who contained the virus successfully before its vaccination programme took off.
The year-by-year figures tell different stories for each country.
For the UK, they point to early losses followed by significant success in 2022.
How do the UK's deaths compare each year?
The UK was one of the worst-hit countries in the first year of the pandemic, with death rates running 15% above those before it started.
The combination of a terrible first wave and the rapid spread of the alpha (or Kent) variant just as the vaccine rollout was getting going contributed to a huge death toll.
Many eastern European countries like Poland avoided the spring 2020 wave but overtook the UK in numbers of deaths in the winter of 2020-21.
The US continued to have steadily increasing death rates during the summer of 2020 and by the end of the year, it passed the UK's total.
Death rates fell in many European nations in the second year of the pandemic as vaccine programmes got under way.
The UK's vaccine rollout is regarded as a "global exemplar", says Prof Devi Sridhar of University of Edinburgh.
That is not just number of doses, it was also getting them to the people most at risk.
And the UK looked better than any major European economy bar Spain in that second year - with death rates below historical averages.
In the third year, death rates rose in many countries as they opened up again.
Some of the largest rebounds we found were in countries like Germany, New Zealand and Norway, who had fared better in the first two years of the pandemic (and well overall).
Norway had far fewer deaths than Sweden in the first year of the pandemic but over the three years the two countries look more similar.
It is hard to read straight across from Scandinavian countries to the UK, cautions Prof Sridhar, arguing "we'd never look like either Sweden or Norway", and describing them as "healthier, wealthier and more equal" countries that are very different to the UK.
Lessons for the UK
It would take many inquiries to tease apart the effect of all the possible reasons behind every nation's pandemic outcomes: preparedness, population health, lockdown timing and severity, social support, vaccine rollout and health care provision and others.
But some argue that there are lessons for the UK that need to be learned even before we think about future pandemics.
The UK's heavy pandemic death toll "built on a decade of lacklustre performance on life expectancy" says Veena Raleigh, of the King's Fund, a health think tank. She argues that government action to improve population health and turn that around has "never been more urgent".
Methods
We collected data on deaths in five-year age groups and population estimates/projections from Eurostat, the Office for National Statistics, National Records of Scotland, the Northern Ireland Statistics Research Agency, the Centre for Disease Control, United States Census Bureau and Stats NZ.
We calculated the death rate in each age group and combined them to form an age-adjusted death rate using the 2013 European Standard Population.
Some nations did not have the full set of age bands. For example, US figures used 10-year age bands between five and 24 and above 55. Broader age bands can exaggerate excess mortality figures like the ones we calculated, in the order of a percentage point.
Additional journalism by Callum Thomson, Isabella Worth, Jana Tauschinski, Liana Bravo and Wesley Stephenson
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Epidemics & Outbreaks
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For people who have previously had a heart attack, taking a daily aspirin could reduce their risk of a repeat cardiac event or stroke, according to a recent Danish study.
The findings were presented at the ESC Congress 2023 in Amsterdam this week.
"Our findings support current clinical guidelines on aspirin therapy following myocardial infarction (heart attack)," said study author Dr. Anna Meta Kristensen of Bispebjerg and Frederiksberg Hospital in Denmark, in a statement provided to Fox News Digital.
"The key takeaway of our study is that patients who are non-adherent to aspirin therapy following myocardial infarction have an increased risk of a composite outcome consisting of recurrent myocardial infarction, stroke or death compared with adherent patients," she went on.
"However, the protective effect of aspirin appeared to decrease slightly over time from four years after myocardial infarction and onwards."
The researchers also found that among women or individuals older than 65, failure to take aspirin was not associated with adverse outcomes.
"We recommend that all patients who have had a heart attack stay adherent to their aspirin in accordance with guidelines until randomized controlled trials have proven otherwise and clinical guidelines have been changed," said Kristensen.
Aspirin is generally recommended for use after a heart attack because it prevents the formation of blood clots.
It does pose a risk of bleeding, however.
Researchers analyzed data from 40,114 patients who were 40 years of age and older, who had their first heart attack between 2004 and 2017, who had a stent placed — and who then took aspirin for the following year.
Patients who were taking anticoagulants or P2Y12 inhibitors, both of which prevent blood clotting — as well as those who had another heart attack or stroke during that first year — were excluded from the study.
Every two years after the initial heart attack, the researchers determined which patients were still taking daily aspirin and then compared the rate of recurrent heart attacks.
Those who did not continue taking the aspirin had a 29% higher risk of a recurrent heart attack, stroke or death at two years.
The risk increased to 40% at four years, to 31% at six years and 20% after eight years, the study found.
Study had some limitations
"Our results should be interpreted with caution because they show an association but do not establish causality," Kristensen told Fox News Digital.
Also, those who didn’t adhere to daily aspirin-taking might have already been predisposed to have poor health outcomes — which she called the "healthy adherer effect."
"For decades, cardiologists have recommended daily low-dose aspirin — which is usually 81 mg in the U.S."
"Yet we have made efforts to counteract this possible bias," she noted. "Our participant selection was limited to individuals who sustained adherence throughout the initial year following their heart attack."
Because the researchers drew the data from a national registry, they were not able to determine the specific reasons that some patients did not take their aspirin, Kristensen added.
"Furthermore, our findings cannot be generalized to all patients who experience a heart attack," she went on, "as our study specifically focused on those who received treatment with a coronary stent and were not taking other medications to prevent blood clot formation."
"With that in mind, the results support current guidelines recommending long-term aspirin after a heart attack."
Cardiologist Dr. Ernst von Schwarz, who practices in Culver City, California, was not involved in the study but offered his input on the findings.
"For decades, cardiologists have recommended daily low-dose aspirin — which is usually 81 mg in the U.S.," he told Fox News Digital. "This has resulted in a reduction of subsequent heart attacks or any cardiovascular events."
What did change in the revised guidelines a few years ago was that aspirin is no longer recommended as "primary prevention."
The American Heart Association recommends low-dose daily aspirin for people who have underlying vascular diseases, such as coronary artery disease or peripheral artery disease, or who have had a stroke or heart attack.
"This guidance is called ‘secondary prevention,’ and it has never changed," von Schwarz said.
"If someone had a heart attack or a stent placed in the past, this patient should stay on daily low-dose aspirin lifelong."
What did change in the revised guidelines a few years ago was that aspirin is no longer recommended as "primary prevention," he said.
"This means we no longer give aspirin to individuals just because they have risk factors for cardiovascular diseases — such as a combination of diabetes, high blood pressure and high cholesterol," the doctor noted.
The guidelines changed due to the risk of bleeding in the gastrointestinal tract as a result of aspirin use, von Schwarz pointed out.
"This risk can be reduced by taking aspirin with food but not on an empty stomach, preferably at dinner time, which is supposed to reduce the risk of heart attacks and strokes that oftentimes occur in the early morning hours," he said.
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Disease Research
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Cheap medicines prevented migraine as well as expensive ones
A new study sheds light on what works best to prevent migraine attacks, and surprisingly, cheaper medicines worked as well as the expensive ones.
Main content
Migraine is more than just a headache. Often the pain is accompanied by nausea, vomiting, light sensitivity, and sound sensitivity. Chronic migraine can be disabling and may prevent many, especially women, from contributing to working life.
Still, it often takes a long time for migraine patients to find a treatment that works well for them. Researchers at the Norwegian Center for Headache Research (NorHead) have used data from the Norwegian Prescription Register to look at which medicines best prevent migraine in people in Norway:
"There has now been done a lot of research on this subject before. This may weaken the quality of the treatment and increase the cost of treatment for this patient group", says the leader of the study, Professor Marte-Helene Bjørk at the Department of Clinical Medicine, University of Bergen.
Three medicines had better effect than the first choice of medicines.
The researchers used national register data from 2010 to 2020 to estimate treatment effect. They measured this by looking at the consumption of acute migraine medicines before and after starting preventive treatment, and investigated how long the people with migraine used the different preventive treatments. A total of over one hundred thousand migraine patients were in the study.
“When the withdrawal of acute migraine medicines changed little after starting preventive medicines, or people stopped quickly on the preventive medicines, the preventive medicine was interpreted as having little effect. If the preventive medicine was used on long, uninterrupted periods, and we saw a decrease in the consumption of acute medicines, we interpreted the preventive medicine as having good effect”, Bjørk explains.
As a rule, so-called beta blockers are used as the first choice to prevent migraine attacks, but the researchers found that especially three medicines had better preventive effect than these: CGRP inhibitors, amitriptyline and simvastatin.
"The latter two medicines are also established medicines used for depression, chronic pain and high cholesterol, respectively, while CGRP inhibitors are developed and used specifically for chronic migraine", says the professor.
Can have great significance for the cost of health care.
CGRP inhibitors are more expensive than the other medicines. In 2021 their reimbursement amounted to 500 million NOK (not including discounts given by pharma companies).
"Our analysis shows that some established and cheaper medicines can have a similar treatment effect as the more expensive ones. This may be of great significance both for the patient group and Norwegian health care", says Bjørk.
The researchers at NorHead have already started work on a large clinical study to measure the effect of established cholesterol-lowering medicines as a preventive measure against chronic and episodic migraine.
Link to article:
Bjørk MH, Borkenhagen S, Oteiza F, Dueland AN, Sørgaard FE, Saether EM, Bugge C. Comparative retention and effectiveness of migraine preventive treatments: A nationwide registry-based cohort study. Eur J Neurol. 2023 Sep 27. doi: 10.1111/ene.16062. Epub ahead of print. PMID: 37754544
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Drug Discoveries
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The move, if completed, would have major implications for the marijuana industry and, potentially, for Biden's reelection bid.
Biden announced the schedule review along with a series of marijuana-related pardons last October, in time for the midterm elections. Industry advocates say the rescheduling could be finalized roughly one year from now, which means it would happen in time for the presidential contest.
"I think the administration wanted this to be done before the presidential election so they can see it through and it couldn't be derailed by a new administration," said Kris Krane, director of cannabis development for KCSA strategic communications. "And I think this will be quite a popular move."
The timing indicates that President Joe Biden thinks it will be a popular move too.
Biden has historically taken a strong anti-weed stance. As a senator, he helped pass the 1994 crime bill that included mandatory minimum sentences for marijuana possession. Reports surfaced in March 2021 that he had fired five White House staffers over their marijuana use, which was later confirmed by press secretary Jen Psaki.
But he's since changed to a position more in line with the modern Democratic Party as 23 have legalized recreational marijuana and 38 allow it for medical use.
The impact of such a change on young voters was apparent last year when Biden visited the University of Pennsylvania campus days after announcing the schedule review. A crowd gathered as he was strolling the campus, and two men repeatedly yelled out, "Yo Joe! Legalize that weed!"
Moving to Schedule III would not legalize the drug at the federal level but would make it easier to own and operate a marijuana-based business and to conduct cannabis research. Businesses could deduct expenses on their taxes, for example, and could find it easier to use traditional banking and lending services. It could also pave the way to a future move toward full descheduling.
"It's absolutely better than schedule I," Krane said. "The federal government is officially recognizing that cannabis has medicinal value and does not have a high potential for abuse."
Cannabis company stocks posted enormous gains following the news.
The agencies involved are being tight-lipped so far. White House press secretary Karine Jean-Pierre was asked about the move and pointed back to the HHS and DOJ.
"The administrative process is an independent process, led by HHS, led by the Department of Justice, and guided by evidence," she said. "I'm not going to comment on that."
HHS did not respond to a request for comment from the Washington Examiner. An unnamed DEA spokesperson acknowledged receiving a letter from HHS and said the agency "will now initiate its review."
A Pew Research poll conducted last year found that 88% of respondents support legalizing marijuana for medicinal use, along with 59% who support full legalization. Fully 73% of Democrats support full legalization, compared to 45% of Republicans.
Some GOPers responded to last year's moves by calling it a naked ploy to secure votes.
"This move maybe makes sense in individual cases," Ohio Attorney General Dave Yost posted on X, formerly Twitter. "But Biden’s blanket pardon 34 days before an election is the most political, cynical abuse of the pardon power in history."
Those complaints could be repeated this time around.
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Drug Discoveries
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These doctors are trying to lower hospitals' carbon footprintAround the country, health care workers continue to grapple with their industry's massive carbon footprint. In Pittsburgh, doctors formed Clinicians for Climate Action to address the problem.
The University of Pittsburgh Medical Center campus. Doctors at UPMC have been trying to reduce carbon pollution.
Kevin Lorenzi/Bloomberg via Getty Images
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Kevin Lorenzi/Bloomberg via Getty Images
The University of Pittsburgh Medical Center campus. Doctors at UPMC have been trying to reduce carbon pollution.
Kevin Lorenzi/Bloomberg via Getty Images
Inside an operating room at Magee Women's Hospital in Pittsburgh, Noe Woods stands in her blue scrubs next to a black operating table.
Woods, an Ob-Gyn, knows this room well.
"I've operated in this room many times over the last 14 years. I've probably taken out uteruses, polyps, ovaries, ectopic pregnancies," Woods said.
Operating rooms are central to what hospitals do, but they're also at the root of a problem Woods and others at the University of Pittsburgh Medical Center (UPMC) are trying to solve: how to reduce carbon pollution.
"Operating rooms are a pretty small part of the physical footprint of a hospital, but they produce an outsized amount of the waste," Woods said.
Hospitals are some of the biggest carbon polluters almost no one thinks about. The American health care system accounts for an estimated 8.5% of the country's carbon footprint. This sector emits climate warming pollution through a variety of sources including energy used to run facilities, transportation, products and what gets disposed of.
I've known Woods for 20 years, but only recently found out about her climate work at UPMC, western Pennsylvania's largest hospital system.
Pete Adams, director of operations and surgical services at Magee Women's Hospital, and Noe Woods, Ob-gyn at Magee Women's Hospital, are both members of Clinicians for Climate Action.
Reid Frazier/The Allegheny Front
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Reid Frazier/The Allegheny Front
Pete Adams, director of operations and surgical services at Magee Women's Hospital, and Noe Woods, Ob-gyn at Magee Women's Hospital, are both members of Clinicians for Climate Action.
Reid Frazier/The Allegheny Front
Woods struggled for years to get her colleagues to focus on human-driven climate change. "In the beginning it was just so slow, it was so weird and alternative," she said. "A lot of people gave me a pat on the back like, 'Oh, I'm so glad you're doing that.' "
Woods eventually burned out. But two years ago she found a handful of other doctors at UPMC also interested in climate change. They formed Clinicians for Climate Action, which quickly grew to over 500 doctors, nurses and others inside UPMC's 40-hospital system.
"Everyone now, because the world is on fire, everybody's sort of looking at each other saying, OK, now we really do have to do something," Woods said.
For example, UPMC Children's Hospital of Pittsburgh switched to reusable fingertip sensors to measure blood oxygen levels. That idea came from Isabela Angelelli, a pediatrician at Children's Hospital and a co-chair of the climate group.
"Children's Hospital goes through 180,000 of them a year. That's $1 million that goes in the trash," she said. In the months since switching to reusable sensors, they've decreased their consumption of sensors by 63%, Angelelli said. "We're saving in the thousands every month."
Angelelli said it's been easy to get hospital staff to buy into the idea of reducing waste. "It comes all from people at the bedside coming to us and saying, 'My heart hurts when I throw all these things in the trash,'" Angelelli said. "The nurses would come and tell me, 'Count me in, I'm totally in.' Everyone wants to be part of this."
Hospitals are some of the biggest carbon polluters almost no one thinks about. The American health care system accounts for an estimated 8.5% of the country's carbon footprint.
Reid Frazier/The Allegheny Front
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Reid Frazier/The Allegheny Front
Hospitals are some of the biggest carbon polluters almost no one thinks about. The American health care system accounts for an estimated 8.5% of the country's carbon footprint.
Reid Frazier/The Allegheny Front
Around the country, health care workers continue to grapple with their industry's massive carbon footprint.
Jodi Sherman, associate professor of anesthesiology and epidemiology at Yale School of Medicine, said unnecessary procedures are a part of the problem. She said they improve hospitals' bottom lines but not patient health.
Sherman said hospitals have also gone overboard on using disposable items to meet mandates to prevent infections.
"We're at a point where we're throwing away complex robotic surgical instruments," Sherman said.
High-end scalpels get trashed, but also blood pressure cuffs, bed linens, pillows and patient gowns. Each requires energy to make, package and ship, most of which still comes from fossil fuels — the main cause of global warming.
"These are all becoming single-use disposable," Sherman said. "We're dripping in waste."
"Operating rooms are a pretty small part of the physical footprint of a hospital, but they produce an outsized amount of the waste," said Noe Woods, an Ob-gyn at Magee Women's Hospital.
Reid Frazier/The Allegheny Front
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Reid Frazier/The Allegheny Front
"Operating rooms are a pretty small part of the physical footprint of a hospital, but they produce an outsized amount of the waste," said Noe Woods, an Ob-gyn at Magee Women's Hospital.
Reid Frazier/The Allegheny Front
The group also asked UPMC to establish a sustainability office to measure and then reduce its greenhouse gas footprint. Woods said she was surprised when UPMC agreed and then actually created the Center for Sustainability.
"It [the center] has names on the doors. It has employees," Woods said. "They are calculating things. It's unbelievable."
The office's latest hire is an energy engineer who will help figure out how to lower UPMC's energy use and source more of it from renewables.
Woods said the momentum to push for climate action has gained quickly among her peers.
"You don't find doctors very often volunteering their time for a cause consistently, persistently, meeting after meeting. Showing up with new ideas, and then another person who's interested (comes) and then another," Woods said. "Everybody cares."
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Global Health
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When she prescribes the popular weight-loss drug Wegovy, Dr. Angela Fitch sends patients on a quest she likens to “The Hunger Games."
They will have to call drugstores over several days to find one with the properly sized first dose. Then they'll do that again for their second dose, and probably the third. And that’s only if the patient has insurance or the means to afford a drug that can cost more than $1,300 a month.
“This is not for the weak-willed,” said Fitch, who is president of the Obesity Medicine Association and also consults for drugmakers.
Supply problems and insurance complications have made it difficult for people to start — and stay on — Wegovy and similar medications that are transforming obesity treatment, according to doctors and patients around the country. They say getting the high-demand, injectable drugs requires persistence and a fair amount of luck.
People starting on Wegovy have to take injections of gradually increasing strength before they reach the so-called maintenance dose that they stay on.
The drug's maker, Novo Nordisk, says that demand has forced it to restrict the supply of those smaller, initial doses in the U.S. The company also is warning those taking another weight-loss drug, Saxenda, to expect difficulty filling prescriptions “for the remainder of 2023 and beyond.”
Another drugmaker, Eli Lilly, has said it expects tight supplies until year's end for its diabetes treatment Mounjaro, which also is prescribed for weight loss.
Finding Wegovy can become a part-time job for patients, said Dr. Diana Thiara, medical director of the weight management clinic at the University of California, San Francisco.
Thiara said some wind up driving 45 minutes or more to get prescriptions filled, a barrier for hourly workers who can’t leave their job and for people without cars.
“It’s usually patients who are a little bit more privileged, able to take off from work to go make those drives,” Thiara said.
One of Fitch's patients, Mike Bouboulis, has taken Saxenda, Mounjaro or Ozempic, a Novo diabetes drug with the same active ingredient as Wegovy, since around 2019. It became much harder for him to find the drugs in the past year, after their popularity exploded.
Refilling a prescription involved calling five to seven pharmacies.
“They all know what you’re calling for, and they all have the same answer: ‘I don’t know. We’ll see tomorrow,’" said the 35-year-old small business owner who lives outside Boston.
Pharmacy technician Lizzy Nielsen used insider knowledge to start Wegovy earlier this year.
She regularly checked drug wholesalers' supply lists, refreshing her screen each morning, and then ordering Wegovy for her pharmacy as soon as she saw it in stock.
“I was really lucky ... because that’s when it was like starting to be constantly back-ordered,” the 42-year-old West Springfield, Massachusetts, resident said.
While patients have had to deal with shortages of many medications in the past year, those taking weight-loss drugs can face coverage complications too.
The federal Medicare program for people age 65 and older doesn’t cover obesity medicines, but some privately run Medicare Advantage or Medigap plans do, according to Novo. Coverage from Medicaid programs for people with low incomes varies.
Doctors and patients say many insurers have stopped covering Ozempic and Mounjaro outside their approved use for diabetes. Some insurers and employers don't pay for Wegovy.
Novo Nordisk even offers a form letter on its Wegovy website to help doctors request coverage.
Bouboulis, the Boston-area resident, said his insurer stopped covering Mounjaro earlier this year. He then tried switching back to Ozempic but found that also was no longer covered.
He’s taking low doses of leftover Ozempic until he can find coverage.
“I know the insurance companies don’t want to pay, but between (them) and the pharmaceutical industry, they need to find some kind of nice middle ground because these medications, they can save people’s lives,” said Bouboulis, who has lost around 80 pounds since he started taking them.
Employers and insurers that do pay for the weight-loss treatments often require patients to get pre-approval or to first try other strategies like diet and exercise.
Some require patients to show they’ve lost 5% of their body weight after six months on the drugs in order to continue coverage. Supply problems make that hard, Thiara noted.
“A lot of patients are not staying on it consistently because they can’t get it,” she said.
Dr. Laura Davisson estimates that less than 30% of her patients with insurance through an employer or an individual plan have obesity medicine coverage.
Davisson directs a weight-loss program in West Virginia, a state that consistently ranks as having one of the highest obesity rates in the country. The state's Medicaid program doesn't cover Wegovy, but neighboring Pennsylvania's does.
“For me, it’s either they have coverage through insurance, or they’re not taking it,” she said. “No one can afford it.”
Coverage may improve over time, as it has with other obesity treatments like bariatric surgery.
About 46% of large U.S. employers cover obesity medicines like Wegovy, according to the benefits consultant Mercer. Another 18% are considering it. Mercer’s experts say employers are still trying to learn about how the added cost will affect them and what other support patients may need.
Dr. Deborah Horn says she thinks supply problems and coverage will eventually smooth out, but it may take a couple years. She noted that the FDA may soon approve Mounjaro to treat obesity, which could improve coverage.
Drugmakers also are developing other weight-loss medications, including easier-to-take pills.
In the meantime, more patients are realizing that they can get medical help for their disease and don't have to manage it on their own, said Horn, an obesity medicine expert at UTHealth Houston.
“I feel like this is the beginning of the change in obesity care, where we will see every year better and better medications coming to market and people getting their disease under control,” she said. “We're just in the hard part ... right now.”
___
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.
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Drug Discoveries
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The White House launched a plan Tuesday to counter the so-called "zombie drug" that is growing in popularity across the country, but stopped short of mandating a new classification of the substance that would subject it to stricter regulations.
Instead, the Office of National Drug Control Policy plan emphasized the importance of increased research and testing to identify the prevalence of the animal tranquilizer drug, xylazine, which can be laced with fentanyl to create a substance commonly referred to as "tranq." Federal agencies will explore how to limit supply and "assess regulatory options," but an official scheduling of the drug is not yet required.
Xylazine is used primarily for sedation and anesthesia of animals. It is not approved for human use, is not a controlled substance, and has no antidote. Several states this year have classified it as a Schedule III drug.
Rahul Gupta, director of the White House National Drug Control Policy, said his team has focused on the growing prevalence of xylazine this year and is working to discover the best course of action to limit its exposure.
"As a doctor, I have seen the devastating consequences of xylazine combined with fentanyl firsthand," Gupta said. "And as President Biden’s drug policy adviser, I am laser-focused on finding every tool we have and following the best evidence-based practices to take on this new challenge. This will be an all-hands-on-deck effort – but I am confident we can take action together and eradicate this emerging threat."
The Drug Enforcement Agency said in March that it found "tranq" in 48 states. This increased presence in illegal substances is believed to be a tactic by suppliers to save money. The drug can only be prescribed by a veterinarian, so it is unclear how these suppliers obtain it to lace with opioids.
The monthly percentage of fentanyl-involved deaths in illegal drugs with xylazine increased from 2.9% in January 2019 to 10.9% in June 2022, according to the Centers for Disease Control and Prevention. Viral videos this year of drug users with rotting flesh believed to be from the "zombie drug" could mean the percentage of overdoses may be increasing.
The White House plan calls for research on how to apply prevention and harm reduction tactics to drug addicts who use tranq. It also calls for a more effective identification and elimination of its illegal supply chain.
Several state governments have taken action to classify xylazine as a scheduled drug, which allows for further regulation depending on the exact classification. Delaware, Pennsylvania and Ohio moved this year to classify xylazine as a Schedule III drug. West Virginia this year made it a Schedule IV drug.
Gupta announced in April that the White House National Drug Control Policy named xylazine an "emerging threat." Several federal agencies have issued statements and warnings this year on the rise of the drug, but no official regulatory change has been made.
A group of bipartisan lawmakers in both chambers of Congress introduced legislation this year to classify xylazine as a Schedule III drug under the Controlled Substances Act.
"Drug traffickers are going to great lengths to pad their profits with dangerous drugs like tranq, and we need to empower law enforcement to crack down on its spread in our communities," Sen. Catherine Cortez Masto, D-Nev., said in March when the bill was introduced.
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Drug Discoveries
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Covid’s Back. Who’s Most Likely to Get It Again?
A new study of prison populations shows vaccination can ward off infection — up to a point. Masks and ventilation could make the difference.
(Bloomberg Opinion) -- A new study is offering data to back one of the core assumptions about the spread of Covid: The intensity of exposure to the virus matters, and vaccines and prior infections can only help so much — but they do indeed help.
The research, led by scientists at the Yale School of Public Health and published in Nature Communications, also reinforces the common-sense notion that masks and air filtration can augment the protection provided by a vaccine and lower the risk of getting the virus. Anyone watching Covid cases bubble back up in their community should take that to heart: Infections aren’t unavoidable, and the tools we’ve been using to protect ourselves are not just intuitive — and certainly shouldn’t be controversial. They’re increasingly backed up by evidence.
While real-world data has given scientists a reasonable sense of Covid vaccines’ ability to protect against the worst outcomes of the virus, understanding their effectiveness at preventing transmission has been difficult.
A team of researchers struck upon a smart way of trying to show the vaccines are “leaky” — that is, they can protect against transmission, but only up to a certain level of exposure to the virus. They looked at infections in Connecticut prisons.
A correctional facility provides a unique opportunity to consider the vaccines’ effectiveness. Rarely do researchers have such complete information on who a person is directly and intensely exposed to (a cellmate), is likely in regular close contact with (others in a cell block), or is potentially exposed to in more transient situations (in the broader community). Researchers meanwhile also knew how many times everyone had been previously infected or vaccinated. Even better, testing was conducted often and according to a set of rules, rather than personal inclinations.
By tracking infections during the delta and omicron waves, the researchers found that hybrid immunity — or having been both vaccinated and previously infected — did the best job at protecting people from getting Covid, even when in close quarters with someone with the virus. Immunity acquired from vaccination or previous infections alone was leakier — they conferred reasonable protection from infection when exposure to the virus was low, but much less when exposure was high.
There are, of course, limitations to the research. The study is observational, meaning it draws conclusions by looking back at the available data rather than actively testing a hypothesis. And the scientists could only assess the number of infections, not their severity. And of course, the prison population skews heavily male and young; I’d like to see this study repeated in settings where similarly frequent, rules-based testing occurred among an older population — say, at retirement homes.
Still, the paper suggests what shouldn’t be controversial by now: Avoiding a prolonged exposure to Covid, even after vaccination and prior infection, is a good way to avoid getting infected. “We’re not telling anyone anything that seems illogical based on what we’ve just gone through over the past few years,” says Margaret Lind, an epidemiologist at Yale Medical School who helped lead the study.
But it adds nuance to the conversation. The study suggests that masks and ventilation matter, not only as their own form of protection, but because lowering your exposure to the virus seems to improve the effectiveness of the immunity conferred by your vaccines and previous infections, Lind says.
And there are clear takeaways for the public. For starters, anyone still dragging their heels on getting boosted should reconsider when the updated shots arrive in a few weeks. A mere 20% of adults in the US got the last booster, so there’s a lot of room for improvement. The data have long been abundantly clear that the current crop of vaccines is critical for saving lives and keeping the most vulnerable out of the hospital, and now there’s good reason to think keeping up to date on your boosters can help you also avoid some infections.
That’s a reasonable goal. After all, we still don’t have a good handle on the potential long-term health consequences of repeated infections with Covid, so using a tool to try to minimize that risk seems like a no-brainer.
As cases climb, it’s also worth revisiting tried-and-true ways of lowering your exposure to the virus. That could mean pulling out a mask in situations where the risk might be high. And it should mean continuing to invest in improving the quality of indoor air we breathe, whether that’s at home, school or work. At the very least, throw open a window while the weather is still warm.
More From Bloomberg Opinion:
- Pregnant Women Aren’t Getting the Vaccines They Need: Lisa Jarvis
- Covid’s Summer Resurgence Resists Easy Answers: F.D. Flam
- Not All Covid ‘Misinformation’ Is Equal — or Even Misinformation: F.D. Flam
This column does not necessarily reflect the opinion of the editorial board or Bloomberg LP and its owners.
Lisa Jarvis is a Bloomberg Opinion columnist covering biotech, health care and the pharmaceutical industry. Previously, she was executive editor of Chemical & Engineering News.
More stories like this are available on bloomberg.com/opinion
©2023 Bloomberg L.P.
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Epidemics & Outbreaks
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In a sharp reversal, U.S. intelligence agencies now say none of the hundreds of mysterious illnesses that afflicted and in some cases incapacitated U.S. personnel around the globe can be linked to the use of a weapon by a U.S. adversary.
An assessment released Wednesday, based on what intelligence officials said was an exhaustive and detailed investigation, concluded it was "very unlikely" a foreign adversary was behind the anomalous health incidents (AHIs) plaguing U.S. workers both overseas and at home.
"Symptoms reported by U.S. personnel were probably the result of factors that did not involve a foreign adversary, such as preexisting conditions, conventional illnesses and environmental factors," said the National Intelligence Council assessment.
"Confidence in this explanation is bolstered by the fact that we identified medical, environmental and social factors that plausibly explain many AHIs reported by U.S. officials," the report added.
AHIs, also commonly known as Havana Syndrome, were first reported in 2016 among diplomats and other employees at the U.S. Embassy in Havana, Cuba.
Since then, hundreds of cases have been reported in Russia, China, Poland, Austria and the United States, with symptoms ranging from nausea and dizziness to debilitating headaches and memory problems.
Reasonable explanations
U.S. intelligence agencies had previously ruled out the likelihood that the mystery illnesses were the result of any sustained campaign by any of America's adversaries, with the CIA saying last year that it appeared most of the cases "can be reasonably explained" by medical conditions or environmental and technical factors.
But a February 2022 report by a panel of experts had warned that the core symptoms in a small number of cases were "distinctly unusual and unreported elsewhere in the medical literature" and suggested some sort of device must be responsible.
"Pulsed electromagnetic energy, particularly in the radiofrequency range, plausibly explains the core characteristics," the 2022 report said.
But in releasing the latest assessment, U.S. intelligence officials argued that despite extensive research and intelligence gathering, there was no evidence to indicate that such a weapon was in use or even existed.
"There's no credible evidence that a foreign adversary has a weapon or a collection system that caused AHIs," said a U.S. intelligence official who was familiar with the assessment's findings.
Instead, the official, who briefed reporters on the condition of anonymity under ground rules set by the Office of the Director of National Intelligence, said all the intelligence and the data gathered during the investigation "point against the involvement of a foreign adversary."
"We have a lot of evidence that points the other way," the official said. "There were leads, but every time we followed them, they dissipated."
Adversaries baffled
Some of the countries initially suspected of being behind the health incidents appeared to be caught off guard by the assessment.
"What you tend to see among key adversaries is confusion. Many of them thought this is a U.S. plot," the official added.
A second official, who also briefed on the condition of anonymity, said the intelligence officers investigating the reported cases tracked down multiple possible causes of the symptoms and searched for evidence that a foreign adversary was inflicting damage with some sort of device.
But in the end, the investigators were forced to reevaluate the notion of a device.
"We weren't finding what we expected to find," the official said. "We weren't finding anything that was validating those assumptions."
Instead, the hundreds of intelligence officials tracking down the approximately 1,500 reported cases of Havana Syndrome found multiple other factors that could have affected those who came down with symptoms or reported not feeling well.
Officials told reporters that in some cases, a malfunctioning heating, ventilation or air-conditioning system might have been causing a perceptible change to the air pressure.
Investigators also had to track down and rule out other potential causes, such as optical sensors on computer mice that were emitting signals that "looked very suspicious."
Many explanations
Ultimately, they said, the answer is complex.
"There are many, many explanations," the second official said, adding one key takeaway: "We need a greater attention to resourcing the health and well-being of our workforce."
U.S. intelligence officials also said that the report should not be seen as an attempt to minimize or dismiss the impact the incidents have had or are still having on the health of U.S. personnel.
"These findings do not call into question the very real experiences and symptoms that our colleagues and their family members have reported," Director of National Intelligence Avril Haines said in a statement.
"Officers did exactly what we asked them to do: to take our guidance seriously and report suspicious experiences and symptoms," she said. "We are sincerely grateful to those who came forward as it helped to not only shape our response, but identify areas where we need to improve our medical and counterintelligence protocols, which remains an ongoing process."
CIA Director William Burns likewise promised to continue to address the health concerns "with honesty and compassion."
"We will continue to remain alert to any risks to the health and well-being of agency officers, to ensure access to care, and to provide officers the compassion and respect they deserve," he said in a statement.
Separately, the State Department on Wednesday said its personnel would continue to be given access to timely medical care and receive compensation as part of the HAVANA Act, signed into law in 2021.
Such assurances, however, are doing little to allay the concerns of some affected by Havana Syndrome.
"The new report does not track with our lived experiences, nor does it account for what many medical professionals across multiple institutions have found in working with us," said Robyn Garfield, an advocate who suffered Havana Syndrome symptoms while working for the Commerce Department in Shanghai, China, in 2018.
"Our doctors have determined that environmental or preexisting medical issues did not cause the symptoms and traumatic injuries to our neurological systems that many of us have been diagnosed with," he said, alleging the latest assessment reflected the views "of a subset of officials interested in deflection and closure."
The assessment acknowledged there was still a degree of disagreement among the seven intelligence agencies regarding the conclusion that Havana Syndrome is not caused by U.S. adversaries.
Two of the seven agencies expressed moderate to high confidence in the findings, while three had only moderate confidence.
The final two intelligence agencies called the involvement of a U.S. adversary unlikely but expressed low confidence in the conclusion based on what they described as collection gaps.
U.S. intelligence officials Wednesday acknowledged that the latest findings would likely disappoint some.
"I understand it won't be persuasive to any number of officers," said one of the officials briefing reporters, adding that they would continue to investigate as cases trickled in.
The official also said they would continue to investigate whether someone, somehow had overcome technical obstacles to develop a weapon that could cause many of the symptoms.
"We're pursuing it because there are a lot of implications if a foreign adversary has a weapon like this," the official said.
The officials, however, emphasized that such a scenario was unlikely, not just because of the technological hurdles but because no U.S. allies or partners have seen any indications of such a weapon being used to inflict Havana Syndrome symptoms on their personnel, even in conflict zones.
Patsy Widakuswara and Nike Ching contributed to this report.
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Epidemics & Outbreaks
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Patients have been left waiting up to 65 hours for an ambulance in England - while one patient waited in the back of an ambulance for 40 hours outside A&E.
Data collected by Labour from Freedom of Information requests show long waits for ambulances and people waiting hours outside hospitals waiting to be admitted to A&E this winter.
Half of NHS ambulance trusts in England responded to the request, and worst waiting times included:
A patient in the North West who waited 65 hours, 38 minutes and 13 seconds in December for a response to a category 3 call - urgent but not immediately life-threatening and should be reached within two hours in 90% of cases
Waits after category 2 calls - which can include heart attack and stroke victims - in the West Midlands and Yorkshire included patients left waiting for more than 21 hours instead of the 18-minute target
A category 2 in the East Midlands was more than 26 hours in December - the longest wait for such serious symptoms
One patient who waited 40 hours in the back of an ambulance outside a hospital in the South West due to staff and bed shortages
A patient in the East of England with an almost 36-hour wait
Another in the West Midlands who had to wait for 32 hours in the back of an ambulance
Shadow health secretary Wes Streeting said: "Patients can no longer trust that an ambulance will reach them in an emergency.
"Stroke and heart attack victims are left waiting for hours, when every second counts."
NHS Providers, which represents NHS trusts, said the figures show last winter was "one of the toughest on record for the NHS" and the government's long-term workforce plan "cannot come a minute too soon".
On average, people waiting for a category 2 response in December waited one hour, 32 minutes and 54 seconds, the NHS England data showed.
Meanwhile, 36,000 category 2 patients waited for ambulances for more than three and a half hours in December.
January saw a big improvement, with the average response time reducing to 39 minutes and 33 seconds - but that was still much higher than the 18-minute target.
But from 1 December to 28 February, 129,023 people waited more than an hour in ambulances outside hospitals.
Mr Streeting added: "This is the terrifying reality after 13 years of Conservative understaffing of our NHS.
"Patients should be able to phone 999, safe in the knowledge that they will get an answer and an ambulance when they need it. The longer we keep the Conservatives in office, the longer patients will wait.
"Labour will launch the biggest expansion of the NHS workforce in history, training the staff needed to reach patients on time, paid for by abolishing the non-dom tax status. We will ensure the NHS is there for us when we need it once again."
Read more:
NHS waiting lists hit 7.3 million
Care delayed for three years as backlog increases
NHS Providers chief executive Sir Julian Hartley said: "Trust leaders will be very concerned by these wait times as ensuring timely, high-quality care for patients is their top priority.
"The causes of long ambulance waits are complex. High demand - always at its worst in winter - along with overstretched capacity and vast workforce shortages all contribute."
A Conservative Party spokesman accused Labour of "throwing stones in glass houses" and said the party should "start fixing the mess they have made in Wales".
A Department of Health and Social Care spokeswoman said: "No one should have to wait longer than necessary to access urgent and emergency care and we are working hard to improve ambulance waiting times, which have substantially reduced from the peak of winter pressures in December 2022.
"Our Urgent and Emergency Care Recovery Plan will allow people to be seen quicker by scaling up community teams, expanding virtual wards, and getting 800 new ambulances on the road.
"This is on top of £750m we have provided this winter to speed up hospital discharge and free up beds."
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Health Policy
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There is a pond in the park near Emily Barley’s home in Wentworth, South Yorkshire where, when she was pregnant, Barley used to imagine bringing her daughter to play.
“I’d picture her as a baby on a blanket, gazing up at the sky,” says Barley, 34. “I could see her as a toddler, splashing round in her wellies and giggling as I ran after her.” Now, almost two years later, Barley still visits the pond – but she is alone.
For her daughter, who she named Beatrice, was stillborn last May, after a series of catastrophic failings at Barnsley Hospital. After Beatrice’s heart stopped beating during labour, Barley had to endure another three hours of contractions before delivering her daughter in a birthing pool.
“She was so beautiful,” says Barley. “I didn’t really believe she was gone until that point. I had that same joy every new mother gets when they see their baby, but it was also the worst moment of my life because she was dead.”
The NHS hospital trust has since apologised to Barley, with an independent investigation making eight safety recommendations – “that’s eight opportunities they had to save her,” she explains – for future maternity care as a result.
But for Barley, and for countless others like her, this is simply not enough.
Brand new research from the Care Quality Commission stated that 67 per cent of NHS maternity units are not safe enough. Alongside worrying reviews into neonatal and maternity care up and down the country – involving scandals uncovered at Shrewsbury and Telford Hospital NHS Trust, East Kent Hospitals University NHS Foundation Trust, and an ongoing review of failings at Nottingham University Hospitals – a bleak pattern is emerging.
Claims against the NHS for maternity negligence have risen by over a third in three years, with almost 1,400 cases last year. Total spending on negligence payouts hit a record high last year at £2.64m.
And a report last November found that almost a fifth of NHS trusts have been rated “red” for neonatal mortality – another record high.
Maternity care in this country has, it seems, reached crisis point.
Last month, the Maternity Safety Alliance, a campaign group set up by Barley and other bereaved parents, wrote to the then health secretary Steve Barclay, calling for a statutory public inquiry into maternity safety in England.
They are seeking fundamental reform, rather than piecemeal reviews of substandard NHS trusts – and say urgent overhauls are required to stop yet more women and their babies dying and suffering in vain.
So what has gone so very badly wrong? While a raft of issues, from lack of funding to staffing problems, have been singled out over the years, experts say something more endemic lies at the heart of the crisis: a clash of cultures between doctors and midwives.
Unlike any other medical field, maternity care is a shared discipline. On one hand are midwives, who handle so-called “straightforward” pregnancies, labour and postnatal care, while on the other are obstetricians, who take charge when complications arise during either pregnancy or delivery.
The system has operated this way since the Eighties, when the natural childbirth movement emerged, leading to the establishment of independent midwifery-led units within hospitals, charged with primary responsibility for antenatal care and labour management.
In theory, their overlap should be seamless and their shared work cohesive, broadening women’s choices about how and where to give birth. But in reality, in the past four decades, the two factions have grown further apart, the space between them rife with tension, hierarchy and alleged attitude clashes.
Midwife Donna Ockenden’s review of the Shrewsbury maternity scandal in March last year found evidence of a “them and us” culture between obstetricians and midwives, while the East Kent review last October found escalating tensions over who was “in charge”.
In Barley’s case, she can point to several instances where a doctor should have been involved in her care, but nobody raised the alarm.
“I was having between five and seven contractions every 10 minutes,” she says. “If you have more than four it’s a medical emergency, but this wasn’t recognised. The midwives decided I was a dramatic first-time mum. I felt like I was losing my mind.”
As her pregnancy was high risk (due to a high BMI and Crohn’s disease), and she had been due to have a home birth, Barley should have been seen by a consultant immediately on her arrival at hospital. Instead, it took four hours.
When the CTG, the machine monitoring Beatrice’s heart, showed a sustained low heart rate for six minutes, Barley should have been rushed to theatre for an emergency caesarean section. Instead, health professionals erroneously monitored Barley’s heartbeat and not her daughter’s – and gave her false hope.
“There were clear signs she was struggling. I have a black and white printout from the machine that shows Beatrice dying. But they stayed in the mindset that everything was fine, nothing would shake it.
“There was a clear lack of communication between the doctors and the midwives – they weren’t working as one team.”
Anne Henderson, a specialist gynaecologist and former consultant obstetrician who left the NHS after 17 years in 2016, says this experience is sadly commonplace.
“Until relatively recently, the vast majority of consultants in the specialism were men and the midwives were predominantly women – and that created an atmosphere of ‘them’ and ‘us’.
“Many of the male consultants who went into the field weren’t remotely interested in the obstetrics side of obs and gynae: they didn’t want to be up at night, yanking babies out.”
Though she says women have started coming through the ranks as senior obstetricians, Henderson fears it’s too late to offset the “toxic culture” that now exists.
“I worked in units where consultants would refuse to come in to help during the night, even once in a case where a woman nearly haemorrhaged to death.
“I’ve been called a ‘glorified b----y midwife’ by a male consultant, just for wearing my scrubs and getting stuck in on the labour ward.
“I’ve been in a room where I’ve seen consultants shouting at and abusing midwives in front of patients. It’s appalling and it shouldn’t be tolerated for even five minutes, but in some trusts it’s become an everyday occurrence,” says Henderson.
It’s an experience Jessica Doman-Lees, a nurse from Dudley, West Midlands, had first-hand.
In May this year, Doman-Lees, 27, found herself lying on an operating table while doctors and midwives argued above her head about whether to deliver her baby, who had fallen critically ill just 30 weeks into her pregnancy.
“I had an oxygen mask on my face and all of a sudden an argument erupted around me,” Doman-Lees recalls. “The doctor said he didn’t want to do the caesarean section, and the three midwives in the room were pleading with him, saying my baby was just alive and he needed to deliver her so they could resuscitate her.
“He kept saying, ‘There’s no FH’, which I now know to mean ‘foetal heart rate’. Twenty-five minutes passed while they were arguing.”
Doman-Lees’s daughter Pippa was eventually delivered stillborn, almost three hours after she arrived at hospital complaining that she couldn’t feel her moving.
Dudley Group NHS Foundation Trust have apologised to Doman-Lees and her husband Charlie, who have added their voices to calls for an inquiry – and launched a formal complaint against the hospital for the errors that led to Pippa’s death.
“The report from the paediatric neonatal consultant who was trying to resuscitate her says she was a ‘fresh stillborn’, which means she had only just died,” says Doman-Lees, whose “world crumbled” that day.
“It’s evidence to us that had that argument not happened, there would have been a better chance of resuscitating Pippa – or of her being born alive.”
In Doman-Lees’s case, as in most, the faults lie not just with one individual, but with the system itself, and how it fails to accommodate two very different cultures of care.
“The minute you get a hierarchy developing, or consultants not getting on with midwives, or dumping on their juniors and not pulling their weight, the whole system unravels,” explains Henderson.
“Somehow, there has never been a single overarching body that manages to pull all these issues together and get the different staff members to work as a team,” she says.
Both the Royal College of Midwives and Royal College of Obstetricians and Gynaecologists have lent their support to calls for a public inquiry – but those on labour wards fear the problem goes deeper than superficial change.
The default in this country is for midwives to take the lead on maternity care, unless a woman’s pregnancy or labour is, at any point, deemed “high risk”.
The Lancet Series on Midwifery found that midwives can dispense 87 per cent of the necessary care mothers and newborns require, while the National Institute for Health and Care Excellence (NICE) has argued that giving birth at home or in a midwife-led centre is preferable for up to 45 per cent of mothers.
Why the emphasis on midwife-led care? For the woman and her unborn child, the benefits can be multiple: a 2019 study of over 23,000 births, published in the journal Obstetric Gynaecology, found that, compared with obstetrician-led births, midwifery patients had significantly lower intervention rates, including a 40 per cent lower risk of caesarean.
Minimising intervention decreases birth trauma for both mother and infant, and aids recovery time. Other benefits of a midwifery birth can include emphasis on maternal bonding, hands-on help with breastfeeding and postnatal care – and a focus on patient-led labour: from private rooms and ambient lighting to the use of a birthing pool.
A midwife in the south of England, who spoke to the Telegraph anonymously, says it’s important not to discount midwives’ role in advocating for the mother – and combatting the “Hollywood” version of labour, replete with screams and agony.
“A lot of doctors practise defensively, so if a woman is giving birth and not progressing as well as she should, they’ll cut their losses and do a C-section, even if it’s not in the best interests of the patient,” she explains.
“As midwives, we often have a fight on our hands to advocate for the woman. We’ve been trained very differently: doctors concentrate on the abnormal, so they’re always looking for the problem. It’s no wonder our heads can butt.”
Jacqui Tomkins, chair of Independent Midwives UK, agrees, adding that midwives’ “autonomy is severely hampered” at times.
“Less experienced, newer midwives find it difficult to advocate for their profession,” she says. “More experienced and confident midwifery staff have been managed out of the workforce as they are more expensive, leaving the way open to the power imbalances, patriarchy and disrespectful attitudes of some doctors to midwives.”
While such a culture should never be tolerated or allowed to thrive, this doesn’t mean a midwife-led birth is right for every woman.
Indeed, in 2017 the RCM abandoned its official “Normal Birth” campaign in favour of a policy for “Better Birth”, acknowledging that some midwives were too focused on promoting vaginal births at the expense of ignoring potentially damaging or even fatal complications.
Alex Barr, a mother-of-two from Christchurch, Dorset, lost her daughter Marnie in April 2020 after she was sent home following a bleed in hospital.
It was during the pandemic and, feeling anxious as she reached 40 weeks, she asked her community midwife for a “stretch and sweep”, a procedure that can kick-start labour.
“She said: ‘No, you should carry on for a natural delivery,’” recalls Barr, 35, who has since left her job as an NHS nurse. “They seemed to have this natural birth ideology.”
Her waters broke 12 days later and, in hospital after an examination, Barr noticed she was bleeding – a sign her baby was in distress.
“The midwife was at the sink and she glanced over and said, ‘Don’t worry, that’s just your show.’ I really wasn’t sure but I took her word for it.”
Barr was told to return home but less than an hour later, in the car outside her house, she started bleeding again – this time profusely. “I called 999 and I was blue-lighted back to the same hospital. They told me there was no heartbeat and that Marnie had died.”
Had Barr been seen by a consultant or examined when she started bleeding, she believes the outcome – and her life – would have been very different.
There are, after all, cases in which an obstetrician-led birth is not only beneficial but necessary. Not only does it put labouring mothers in an environment where high-dose pain relief drugs are readily on hand, but blood loss and other complications can be dealt with swiftly – and, crucially, operating theatres are mere minutes away.
With much midwife-led care taking place in independent units, often located outside the main hospital building, this isn’t always the case – something maternity campaigner Catherine Roy says is a concerning flaw in the system.
“If you have a woman giving birth in a birth centre across the car park from the hospital, this can mean the difference between life and death for her baby,” she explains.
“In an emergency, you may only have a few minutes to act, but if you can’t get to the labour ward in time, that can be fatal. I’m not sure women are made aware of these risks.
“If there is a bad culture in a [hospital] trust, having freestanding units can make this worse. Suddenly there is a line: ‘This is my birth centre’ or ‘This is my labour ward’ – and that can mean a lack of joined-up care.”
A male consultant obstetrician, who spoke to the Telegraph anonymously, underlined the importance of having a tier of doctors on the maternity ward – especially when things take a turn for the worse.
“The role midwives play is incredibly important and I would hate to understate that,” he says. “But they can’t make life or death calls when a baby is in distress or a woman is losing a lot of blood and needs an immediate, life-saving procedure. Sometimes we have no choice but to intervene, and sometimes we have to overrule midwives or junior colleagues, because we’ve seen what can happen if we don’t.
“That’s not to say those decisions are always the right ones, but we do our best. Everyone on a maternity ward is doing their best, on that day, in that moment.”
But these systemic problems and instances of mistrust between doctors and midwives, says Dr Shazia Malik, a leading consultant obstetrician and gynaecologist in London, are exacerbated by a “chronic lack of funding, chronic lack of capacity and chronic lack of staff” in the maternity sector.
“You have an NHS where everyone is overworked, tired and suffering from poor morale. This adds up to not providing the care that we all want to,” she says.
Better training and leadership is needed, argues Malik, to “nurture a culture in organisations where people aren’t afraid to blow the whistle”.
“I really welcome a public inquiry. It’s about spreading good practice from one unit across the whole country, allowing for open discussion and meaningful change.”
Looking abroad – to the US, perhaps, where all maternity care is doctor-led, or across Europe, where homebirths have to be privately funded – may prompt some ideas for change, but for midwives like Tomkins and Ockenden, it’s all about funding.
“Scrutiny is not a magic plaster,” says Ockenden. “We need funding and we need it urgently. In June 2021, the Health Scrutiny Committee said that maternity services in England needed an immediate sum of up to £350m, recurring annually. So far NHS England have spent £180 million, but more is needed.”
Tomkins suggests giving women a “maternity budget voucher” to spend on their care, echoing calls made back in 2016 by the National Maternity Review, which pledged £3,000 to every pregnant woman for private healthcare and treatment leading up to her birth.
In addition, she adds, midwives should be given “GP-style contracts” to streamline their cases, prioritise care and clearly demarcate their roles from obstetricians’.
“Let them set up group practices and provide the services that their communities want,” she says. “Until we can see and accept that the mainstream maternity services are lacking the element of service, women and their babies will continue to pay the highest of prices.”
It’s a warning women like Barley, Doman-Lees and Barr know only too well.
“I think about Beatrice every day,” says Barley, who has had to give up her job as a local councillor because her mental health declined so dramatically after her daughter’s death.
“I wake up in the middle of the night and think I can hear her crying, even though she never cried. I picture her perfect little face. I imagine what we’d be doing together and what she’d be like as she gets older. Most days, I want to live in that world, not this one.”
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Women’s Health
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UK Healthcare Horror: After over 6,500 rapes, sexual assaults in hospitals since 2019, nurses to wear body cams
The Department of Health will work closely with National Health Service (NHS) to deploy the measure. Other steps that will be put in place to reduce the cases of sexual abuse in hospitals include AI data processors to improve prosecution rates and the launching of a national violence prevention hub
London: Nurses working in UK hospitals will now be required to wear body cameras as part of the government’s efforts to crack down on sexual assaults in health institutions.
The move comes after a shocking report emerged last week which revealed that there have been more than 6,500 reports of rape and sexual assault in hospitals since 2019.
Health Secretary Steve Barclay introduced the rule of giving healthcare workers body-cams similar to those worn by paramedics and police.
The Department of Health will work closely with National Health Service (NHS) to deploy the measure. Other steps that will be put in place to reduce the cases of sexual abuse in hospitals include AI data processors to improve prosecution rates and launching a national violence prevention hub, according to The Telegraph.
6,500 cases of sexual abuse in hospitals in 3 years
Last week, the Women’s Rights Network – a feminist group in the UK – published statistics revealing that sexual assaults take place in the country every week.
In just the last three years, Britain reported 6,500 cases of rape and sexual assault in hospitals.
Heather Binning, the founder of Women’s Rights said that the numbers are “just the tip of the iceberg.”
“Hospitals are places where everyone – patients, staff and visitors – should feel completely safe but rapes and violent assaults are taking place in hospitals every week,” she said.
Binning added, “The figures show hospitals are just not safe places. They are almost a market for sexual offenders. It’s absolutely terrifying.”
Among the horrific crimes faced by patients, staff and visitors include gang rapes and assaults on children.
What is more shocking is that only 4.1 per cent of the perpetrators involved in these cases have faced charges.
NHS vows to prevent attacks
The NHS director of sexual assault services commissioning, Kate Davies said, “We will work with the Government and other partners to ensure the NHS is a safe space for all staff and patients. Local services must not tolerate sexual misconduct, violence, harassment, or abuse – it is totally unacceptable.”
“Preventing these attacks from occurring in the first place is a priority and we have a programme of work dedicated to this and have appointed our first national clinical lead to drive forward action – together we must do all we can to keep staff and patients in our services safe,” she added.
She further said that it is of utmost importance that all NHS Trusts and Organisations must have “robust measures in place to ensure immediate action is taken in any cases reported to them.”
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Health Policy
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Newhave accelerated for a fourth straight week, Centers for Disease Control and Prevention data now shows.
A total of 10,320 patients in the U.S. were newly hospitalized with COVID-19 for the week ending August 5, according to the figures published Monday, an increase of 14.3% from the week before.
Levels remain far below the summer peak that strained hospitals at this time last year, when 42,813 admissions were reported for the week of August 6, 2022.
Where are COVID hospital trends worst?
Hospitals across the Southeast are continuing to report the nation's highest rate of COVID-19 admissions. In the region spanning Alabama, Florida, Georgia, Kentucky, Mississippi, North Carolina, South Carolina and Tennessee, 4.58 new patients were reported per 100,000 residents.
The Southeast has also been reporting the highest rate of COVID-19 cases among nursing home residents. Weekly infections are now close to the worst rates seen during 2021's summer wave in the region, but below more recent peaks.
Nationwide, data collected from emergency rooms suggests COVID-19 levels have been highest in recent weeks among seniors ages 75 and older, similar to what was seen during last winter's peak.
Emergency room visits for children ages 0 to 11 years old have also climbed steeply. Measured as a percentage of all visits in the age group, nationwide COVID-19 rates in these kids are now tied with seniors for the first time in a year. Other CDC data suggests visits from the youngest kids, ages 0 to 1 year old, are seeing the steepest increase.
In some parts of the country — like the region spanning Arkansas, Louisiana, New Mexico, Oklahoma and Texas — the share of COVID-19 ER visits involving children ages 0 to 11 have already far surpassed older adults.
It is unclear what has driven the steep increase in ER visits from kids. A CDC spokesperson did not immediately respond to a request for comment.
Is the EG.5 variant to blame?
Authorities say, has not been driving an increase in severe disease any different from previous strains.
EG.5 made up 17.3% of infections nationwide in a CDC estimate earlier this month. New estimates are expected to be published Friday.
Despite its "low" public health risk relative to other recent Omicron descendants, the World Health Organization said on August 9 that the strain could be on track to outcompete its XBB variant siblings.
"EG.5 may cause a rise in case incidence and become dominant in some countries or even globally," the U.N. agency said.
Health officials say theexpected to roll out this September are targeted to XBB-related strains of the virus, and will likely boost protection for EG.5 as well.
for more features.
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Epidemics & Outbreaks
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- It's been 10 months since the Food and Drug Administration first announced a nationwide shortage of Adderall — and the supply strain could potentially worsen in the months ahead.
- Some experts noted they're concerned about market conditions as children, who are commonly affected by ADHD, head back to school.
- It's nearly impossible to know when the shortages will end — or what exactly can be done to resolve them — because of the lack of transparency in the pharmaceutical industry.
It's been 10 months since the Food and Drug Administration first announced a nationwide shortage of Adderall — one of the most widely used medications for attention deficit hyperactivity disorder — and the supply strain could potentially worsen in the months ahead.
While some supply issues have improved, many Americans are still struggling to find and fill prescriptions for the drug and other medications for ADHD that they often rely on to stay focused and complete daily tasks.
Drug-shortage experts told CNBC that it's extremely difficult to forecast how much longer the shortages will last because of the lack of transparency in the pharmaceutical industry — and some are concerned about market conditions as children, who are commonly affected by ADHD, head back to school.
"Unfortunately, we might see the shortage worsen. We are heading into back-to-school time, so I am worried about it worsening as we go into that season," Erin Fox, a pharmacist at the University of Utah and leading expert on U.S. drug shortages, told CNBC.
Adderall is one of more than 300 drugs in short supply in the U.S. as of June, according to a list from the American Society of Health-System Pharmacists, which represents pharmacists in a variety of health-care settings. That list also includes Adderall alternatives like methylphenidate, which is commonly known under the brand names Ritalin or Concerta.
Adderall and alternative ADHD medications apart from other drugs are Schedule 2 controlled substances.
That means the federal government regulates how those drugs are made, prescribed and dispensed because they've been deemed to have a high potential for abuse and could potentially lead to severe psychological or physical dependence. The designation also means that patients need to get new prescriptions for those drugs every one to three months.
Millions of Americans in the U.S. use the drugs to help them concentrate, control their impulses and manage their schoolwork, employment or relationships with others. ADHD is usually diagnosed in childhood and often lasts into adulthood.
An estimated 6 million children have been diagnosed with ADHD, and 60% were being treated with medication as of 2016, according to the Centers for Disease Control and Prevention. Meanwhile, around 8 million adults have been diagnosed with the condition, but only about a quarter of that number are getting treatment for it.
Many children and young adults with ADHD often take the summer off medication and primarily rely on it during the school year. That could lead to even more demand in the months ahead that may not be met.
Historically, prescriptions for ADHD medications increase as the school semester starts around the U.S. — and "there is no indication this year will be different," according to David Margraf, a pharmaceutical research scientist at the University of Minnesota's Center for Infectious Disease Research and Policy.
Some drugmakers have said they expect to resupply a few ADHD products in August or September, according to an FDA database on shortages. But Margraf said "we need to be cautiously optimistic" because drugmakers don't disclose exact numbers of how much stock they'll have available by then.
That reflects a bigger issue with the ongoing shortages. It's nearly impossible to know when they will end — or what exactly can be done to resolve them — because of the lack of transparency in the pharmaceutical industry.
"Very little factual information is out there. I think this is one of the biggest issues," says Ozlem Ergun, a mechanical- and industrial-engineering professor at Northeastern University and an expert in pharmaceutical supply chains. "When you don't have transparency or information sharing, how can you understand and resolve a problem that is complex?"
"This really, really hurts the users and the hospitals and the health-care system. They have pretty much no vision of what the future looks like," Ergun added.
Teva Pharmaceuticals, Amneal Pharmaceuticals, Novartis's planned spinoff Sandoz and Purdue Pharma subsidiary Rhodes Pharmaceuticals, which all manufacture drugs targeting ADHD, don't need to publicly share information about where they manufacture medications, how much of them they make, where ingredients are sourced and their overall production capacities.
And the Drug Enforcement Administration — the federal agency that regulates controlled substances — shares little information about the production quotas it sets for each manufacturer of Adderall and other ADHD medications.
The DEA specifically limits the amount of raw ingredients, such as amphetamine, a drugmaker can get to manufacture those drugs.
"We don't have the quota amount that each company is given. And we also don't have the amount that each company is actually producing and if they're meeting those quotas," said Fox of the University of Utah. "There's no way to understand which company maybe isn't doing the job and which companies are, so we just don't know exactly what's going on."
Ending the shortages of Adderall and other ADHD medications is no easy task.
"It's not as simple as a free market where you just boost up production and meet demand," said Michael Ganio, the senior director of pharmacy practice at the American Society of Health-System Pharmacists.
Many manufacturing plants operate at or near capacity and create multiple drug products. That means increasing the production of one drug could potentially require reducing production — and potentially impacting supply — of another drug, according to Ergun.
"In general, it is difficult to increase the manufacturing capacity for a drug," she said. "There isn't much unutilized capacity anywhere."
It's even harder to scale up the production of tightly controlled ADHD medications.
Drugmakers can request for the DEA to increase their production quotas if necessary, but it takes "a lot of push" for the agency to actually approve that, according to Margraf.
And even if the DEA does approve a quote change, it could take months to do so: "It's not just flipping a switch and boosting your output by 20%," ASHP's Ganio said.
Some drugmakers have suggested that DEA quotas are contributing to the ADHD medication shortages or making it harder to alleviate them. That includes Aytu BioPharma, which makes an ADHD drug that used to be in shortage.
In a CNBC op-ed in February, Aytu CEO Josh Disbrow said the DEA could potentially cause widespread drug shortages if it underestimates demand and fails to increase quotas in a "timely manner in response to new information."
However, the DEA and FDA pointed to a different problem in a joint letter released earlier this month.
The agencies said an internal analysis found that drugmakers fell 30% short of meeting the full quota for amphetamine medications in 2022, leaving about 1 billion potential drug doses on the table. They added that there's a "similar trend" occurring this year.
The DEA and FDA said they called on manufacturers to confirm they are working to increase production to meet their allotted quotas.
"There's obviously a lot of finger-pointing going on here between the agencies and manufacturers," Fox said.
The shortages of Adderall and generic versions of the drug kicked off last August, when major manufacturers reported that their medications were on back-order.
Manufacturers are required to notify the FDA of a shortage, but not the cause of the interruption. However, the FDA pointed to "ongoing intermittent manufacturing delays" at Teva when it first announced the Adderall shortage.
Teva previously said the manufacturing slowdown was partly tied to a labor shortage, which was quickly resolved. Teva did not immediately respond to CNBC's request for comment about the state of its Adderall manufacturing.
A surge in demand for Adderall and other ADHD medications seems to have played a significant role, too.
U.S. prescriptions for Adderall rocketed to 41.4 million in 2021, a more than 10% increase from 2020, according to IQVIA, a health industry analytics firm.
One possible factor sending demand up, according to experts, was the increased use of telehealth services during the Covid public health emergency that may have allowed for more relaxed prescribing standards for ADHD medications.
The pandemic also created a perfect storm of distractions — such as the shift to remote work and a thrum of anxiety, stress and grief over the uncertainty of Covid — that may have exacerbated some ADHD patients' symptoms or convinced more people that they have the condition, prompting them to seek treatment.
The increased demand for Adderall amid shortages of the drug likely resulted in a domino effect, too, with health-care providers and patients being driven to turn to alternative medications, triggering shortages of those drugs as well.
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Drug Discoveries
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When you think of stress, it probably brings negative emotions to mind. But some stress is good for you, like the anticipation you feel when you start a new relationship or job. It can fuel excitement and make you want to do and achieve more. Stress can also help you be prepared to face challenges or respond to dangerous situations.
Good stress doesnât stick around. It boosts your mood to meet the moment, then goes away. If youâre under stress for long periods of time, it can become overwhelming and affect you both physically and emotionally.
âOur stress response does pretty good in the short term, but it doesnât do very good if you activate it in the long term,â says David Prescott, PhD, associate professor of Health Administration and Public Health at Husson University in Bangor, ME.
âIf we stay under chronic stress, our physiological stress response is taxed beyond what itâs designed to do, and it starts to impair us.â
The effects of chronic, or long-term, stress can be harmful on their own, but they also can contribute to depression, a mood disorder that makes you feel sad and disinterested in things you usually enjoy. Depression can affect your appetite, your sleep habits, and your ability to concentrate.
âThe impact of stress on depression, and vice versa, is one of the most important problems of our times,â says Carol Landau, PhD, clinical professor at Brown University.
The Stress-Depression Connection
âWe think that the causal relationship between stress and depression is whatâs called âbidirectional,ââ Prescott says. âOne can cause the other, and the other can cause the first, and both can make each other worse.â
The ways depression can lead to stress are pretty clear.
âDepression disrupts your life, so you often are more isolated,â Prescott says. âSometimes you shrink your interpersonal network and stop doing a lot of activities, like work or school or things that you enjoy. We know that kind of isolation makes your perceived stress level go up, so we know that depression can cause stress.â
Thereâs good evidence that the reverse is true as well.
âA severe stress, like a divorce or a huge financial change, is a major stressor, and it sends the psyche sort of out of equilibrium. If you keep raising levels of stress, somethingâs going to happen, and often it is depression,â Landau says.
But the reasons stress contributes to depression are less obvious.
âItâs pretty clear that chronic stress raises the incidence level of depression,â Prescott says. According to The Mental Health Survey Report from The Mental Health Institution, levels of depression among members of Gen Z went up about 4% or 5% between pre- and post-pandemic.
âWe think the social isolation, the disruption in normal activities, and the general stress of having your college or work disrupted appeared to increase levels of depression. But I would say we donât know, causally, exactly how that happened.â
Make Lifestyle Changes
Sometimes a few small changes can break the stress-depression cycle, beginning with a more positive mindset.
âIf youâre stressed and feel like youâre starting to become depressed, the biggest thing is to get a little more active coping strategy in the way youâre going to deal with your stress,â Prescott says. âDonât just think that youâre going to have to âsuck it up and take it.â"
A more active coping strategy can include:
- Exercise. Just 30 minutes of physical activity 5 days a week is enough to make a difference. Activities like yoga and tai chi, which slow things down and help you relax, are good for reducing stress.
- Avoid binge-eating or drinking. These may make you feel better temporarily, but theyâre not helpful. In addition to being physically harmful, they can make you feel guilty and worse about yourself. Overdoing alcohol can affect your sleep and make you sluggish the next day.
- Limit caffeine. Too much can wind you up and make stress even more intense. Try to cut down on coffee, soda, and other caffeinated drinks.
- Quit smoking. The idea that smoking cigarettes can help you handle stress is a popular myth. While nicotine does help relax you right away, that feeling is short-lived and can create more stress through cravings or withdrawal.
- Make time for yourself. Do things you like to do or that make you feel good. Go easy on yourself and focus on the things you do well.
- Steer clear of stressors. If you know something or someone sets you off, do what you can to avoid that situation or person.
- Sleep well. Making sure your mind and body get enough rest can go a long way toward easing stress. The National Sleep Foundation recommends 7 to 9 hours for adults every night.
âIf youâre depressed and youâre trying to minimize the impact of stress on your life, itâs important to overcome that belief that ânothing I do is really going to matter,ââ Prescott says. âItâs just not true in most cases. It may not change everything, but itâs a big thing to overcome that kind of hopeless belief.â
Find Support
âDepression is a state of disconnection,â Landau says. âSo one of the most important things would be to find a way to connect. Adding a couple of people who youâve known from the past and finding a way to connect is extremely important.â
Talking with friends and family can help you better understand whatâs causing your stress, which can be a big step forward.
âIf stress and depression are playing off each other, it can help to kind of articulate and pinpoint the stressors in your life that are causing the most impairment,â Prescott says. âWe ultimately all feel âIâm stressed,â in general, but itâs really helpful to sort of pinpoint down what specific things are getting to you.
âItâs helpful to have someone say things like, âHow are you doing dealing with your stress?â or âTell me about how your mood is holding up?â or âHow are your spirits?â Then just listen.
âA lot of times, what helps people is not specific advice like, âDo this or do that,â but just a chance to talk it out with somebody who pays attention. Ask an open-ended question like that and then bite your bottom lip and listen for a while.â
If talking to friends or family doesnât work well enough, you can talk with a professional. Cognitive-behavioral therapy (CBT) is one way to change your perspective and approach.
âCognitive behavior therapy is important because we want to be able to get control back,â Landau says. âCBT helps you focus on what small thing you can accomplish today, how you can implement it, how you can evaluate it. So itâs a great educational tool as well as a therapy tool.â
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Stress and Wellness
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She was dressed in a cartoon-spangled onesie, while he wore a tiny denim jacket and wide-legged pants. It was a bluebird day in Williamsburg, Brooklyn, and I was eavesdropping on the couple at a crosswalk.“Sobriety is a big thing these days,” she said.“Yeah,” he said. “For babies.”This article appears in the June 2022 issue. Subscribe to WIREDIllustration: Patrick SavileBabies are sober, and adults drunk. Browsing in a cavernous thrift store, I rolled the idea around. It’s true I sometimes feel remedial and juice-boxy holding a Sprite at a cocktail party, as I often have over the past 10 years. But I also remember someone sharing in a 12-step meeting that she used to think she was a cold, calloused femme fatale when she was blackout drunk—the soul of sophistication. I used to think the same thing. Later, she realized that she drank because she couldn’t bear one electron of pain. Some alcoholics call this Queen Baby Syndrome. She self-soothed, she said, by sucking on a bottle of Georgi. (I’ve changed some details here to protect privacy.)This person hit bottom, she said, when she woke up on a deflated air mattress spooning with a drag queen who looked like Ted Cruz. I’ve never forgotten that.Though I still describe myself as an alcoholic, the word has fallen out of favor with marquee nondrinkers, and for good reasons. Above all, it’s a coarse portmanteau, one that has set off its share of linguistic crises, notably “chocoholic.” But “alcoholic” also confounds because it designates not an ordinary person with a problem (cf. “diabetic,” “asthmatic”) but a problem person whose intractable nature somehow includes an eccentric orientation toward an otherwise benign if flammable organic compound, ethanol. Ethanol is not as ubiquitous as (say) gluten, but, as desperate alcoholics know, it can be found not just in whiskey sours but in perfume, mouthwash, and windshield-wiper fluid.In traditional 12-step treatments for alcohol addiction, as opposed to the beguiling new ones that I’m now curious about, inveterate boozers are also represented as having an eccentric orientation to lying, cheating, stealing, boasting, and mean-spiritedness. But are these eccentricities measured in numbers, divined by introspection, or evaluated with respect to cultural norms? Maybe none—or all three. In 1633, the English poet and priest George Herbert brilliantly tried his hand at alcoholism analysis in “The Church-porch.” He warned that drinkers court shame, and perhaps emesis, if they don’t dump excess booze:Drink not the third glasse, which thou canst not tame,When once it is within thee; but beforeMayst rule it, as thou list; and poure the shame,Which it would poure on thee, upon the floore.Herbert’s special worry about the shame brought by the third drink brings to mind another three-stage adage about the progression of alcoholism: “The man takes a drink, the drink takes a drink, the drink takes the man.” Herbert then switches to the personal pronoun and imagines that the third drink would cast him on the floor, where he would literally hit bottom.It is most just to throw that on the ground,Which would throw me there, if I keep the round.Herbert, of course, wrote centuries before the habit of consuming more than a third of a six-pack was considered a pathology rather than a failure of will. But the 20th-century disease model, often associated with Alcoholics Anonymous, brings more confusion. Why does the affliction that’s said to define the alcoholic—“alcoholism”—lack clear biological markers? Finally, it’s “ism,” not “itis.” Is alcoholism a disease or an ideology?If etymology is any help, “alcohol” comes from the Arabic al-kuhl, referring to kohl, the black eyeliner powder dating back to the fourth millennium BC; kohl was made of a refined mineral, and then it came to be used for anything distilled. I Googled this once when I was drunk. Another spelling of the word, in Latin, is alcool. All cool.ILLUSTRATION: GENIE ESPINOSASobriety is a big thing these days.The hip crosswalk woman was right. And she was especially right if sobriety has something to do with “changing your relationship to drinking,” talking about it all the time, and exploiting sobriety’s market potential. Instagram is fully awash in pastel George Herberts—dancing soberfluencers who soberglow while soberaf. The 21st century has been a boon to young abstainers who reject the word alcoholic, and to anyone who wants to quit drinking without becoming a sad sack or a prig.It’s hard to know when AA lost its luster. One starting point is the early aughts. Since then, an increasingly robust swath of people testing the zero-proof waters of sobriety has sworn off drink and joined the international reverse-rave known as Dry January. In 2013, Dry January launched as a branded public-health initiative in the UK, attracting some 4,000 people. By 2021, that number had jumped to 130,000. The fever for abstemiousness also caught on in the US, which will forever be known as both puritanical and hedonistic; the challenge of refraining from drinking for 31 days has seemed to energize those eager to observe secular Lents. Last January, nearly one in five American adults tried Dry January.For years, too, there’s been a stampede of self-help books by alcohol skeptics, most of them women, many of whom once had trouble drinking not the third bottle. These books have included My Unfurling, by Lisa May Bennett; Her Best-Kept Secret, by Gabrielle Glaser; This Naked Mind, by Annie Grace; The Unexpected Joy of Being Sober, by Catherine Gray; Mindful Drinking, by Rosamund Dean; Drink?, by David Nutt; Sober Curious, by Ruby Warrington; and Quit Like a Woman, by Holly Whitaker. The subtitles run together, but they make big promises. If they follow the instructions, readers of these books—and listeners to adjacent and spin-off podcasts, including Recovery Happy Hour and Edit Podcast—will break up with alcohol, emerge from the grip of anxiety, radically defy patriarchy and capitalism, and become happy, healthy, and even wealthy. As 12-steppers will tell you, traditional recovery from alcoholism guarantees none of these marvels.Some of the intoxication with nonintoxication may be more than a pose. People really do seem to be cutting back on drinking. According to Gallup, in 2019, 65 percent of American adults drank alcohol; in 2021, even after the claustrophobia and worry of the plague years, that number went down to 60 percent. What’s more, Americans went from (an avowed) four alcoholic drinks weekly in 2019 to 3.6 in 2021.To cater to these newly temperate types—that is, to get those who decline to consume to keep consuming—sober-friendly bars have shot up like crocuses in New York, Denver, Miami, Austin, and San Francisco. Some of these places serve no booze at all. Others feature extravagant mocktails alongside full bars. At these places, someone with a drink the color of rust or algae can generally pass as a habitué. Amid chic decor, mixologists lace soft drinks with sophistication-signifiers and wallet-declutterers like orgeat, tobacco syrup, and chinotto orange.In the last year, household-name mocktail moguls including Blake Lively, Bella Hadid, and Katy Perry have introduced their nonalcoholic beverages in collectible, high-design containers. The promises made by these drinks, which are largely water and tea plus high style, complement the ones made on the covers of sobriety books. Several available on Amazon, including Tranquini and Recess, come with herbal adaptogens, the latest wide-spectrum panacea for stress, in place of alcohol, the best wide-spectrum panacea for stress. Töst, one sober beverage brand, offers a “grown-up, complex” fake wine, while another called Seedlip distills plants to make a “flavorful, sophisticated, adult option.” Maybe sobers do fear being perceived as babies.Just the way Big Food engendered Big Diet, Big Alcohol seems well on its way to engendering a new market sector with Big Sobriety. That could mean hefty payouts for opportunists who are more entrepreneurial than sober. Already, an 8-ounce can of Katy Perry’s De Soi Purple Lune drink, a fizzy tea with rose and myrrh that comes with outlandish health claims about balance and stress relief, can be yours for $6. This is nearly five times the price of a can of Bud.All the better, I guess, to toast the charismatic influencers who inhabit the highly nonanonymous sobriety … space. (There’s always a space.) You might think there would be an oligopoly in neo-sobriety superstardom, but no, it’s a thousand points of light, and each soberfluencer has staked out a niche approach or at least some trademark design elements. Many also sit in Venn patches with lifestyle masters in apparently related realms: exercise, spirituality, prosperity, productivity, and even conspiracy. From what I’ve divined from a heady three-day scrolling bender, the biggest influencers in the sobriety space fall pretty clearly into three categories: mystical gurus who ground their sobriety in rococo superstitions, professional habit-breakers who regard sobriety as a happiness hack, and reps from the managerial class who advocate for medical interventions and cognitive science to treat a brain malfunction they now refer to as alcohol use disorder.On the ground floor of sober influence is of course Russell Brand (Perry’s ex-husband), the flamboyant one-time heroin user who swapped drugs for the sober papacy in 2002. He now calls himself prophetic, dresses like the Lizard King, and flaunts a crucifix tattoo and rudraksha mala beads. His florid self-promotion and orientalist affectations (including zeal for dime-store Hare Krishnaism) are at odds with both the anti-mysticism of science-based sobriety and the imperative to humility of traditional 12-step sobriety. Lately, Brand has espoused so-far-left-it’s-right politics that confuse the principles of liberal humanism with the market-driven neoliberalism he naturally despises, and occasionally he seems determined to consign the whole liberal project—including science and voting—to the trash heap of history. On YouTube, Brand-branded sobriety comes packaged with his ideology of rad individualism, conspirituality, and kitchen-sink disinformation about vaccines, Russia, and Hillary Clinton.On the softer side of gurudom is Ruby Warrington, a lifestyle influencer in the so-called Now Age and creator of an astrology “tool” called the Numinous Astro Deck. “Little old middle-class me,” as Warrington describes her pre-franchise self in her memoir, used to overconsume chardonnay and cosmopolitans. She then found herself #sobercurious, as she has tirelessly memed it. In 2016 she helped launch an event series called Club Söda NYC—the sober umlaut strikes again—and she now hosts other happenings for people who are kind of thinking about quitting drinking, or thinking about kind of quitting drinking.Before the pandemic, these events featured “plant-based family-style brunch” meals, TED-style sermons-on-the-mount, and high hopes—the usual aesthetic comforts of the WeWork/Obama era. From the photos, Warrington’s events are also abuzz with Instagram-farm vibes. At Club Söda (“sober or debating abstinence”), quitting drinking is not styled as a last-ditch way to address “incomprehensible demoralization,” as the soul’s dark night is known in AA, but as the royal road to bliss, focus, and deep connection. Sex and productivity, it sounds like. Good gig if you can get it; the 12 steps tend to scare away dates more than they spike libido.A less astral influencer is Holly Whitaker, a social-justice optimizer and author of the 2019 bestseller Quit Like a Woman. In 2013, Whitaker, a San Francisco Bay Area rise-and-grinder, decided that drinking was a drag on her girlboss well-being. One year later she founded an online alcohol-counseling startup called Hip Sobriety (now Tempest) that offers its paid services to help people, yes, “change [their] relationship with alcohol.” Whitaker’s programs use techniques like coaching and online communities, and with fewer fireworks and less insight than Russell Brand, she connects patriarchy and capitalism to boozing, because those things kindle overconsumption. At the same time, she describes her online business as a product and a business model: “a for-profit, consumer-focused, design-forward thing … geared toward people like me.” In 2020, she gave an interview to How I Raised It about how to get venture capital in Silicon Valley as shrewdly as she did, having raised $15.4 million for Tempest in three investment rounds. By contrast, the only venture money in 12-step programs, which have no dues or fees, is crumpled singles dropped into a hat during meeting breaks.Gabrielle Glaser, a distinguished health journalist who has never had a drinking problem, is committed to data over all spiritual folklore, from AA’s “higher powers” to Warrington’s astrology cards. But she’s not a personal brand; she has no recovery story of her own. In 2013, her densely researched book Her Best-Kept Secret: Why Women Drink—and How They Can Regain Control had 12-step programs squarely in its sights. As Glaser underscores, AA doesn’t have much science backing it up. The anonymous program is notoriously hard to track, and Glaser is right that it’s tricky to prove empirically that it works.What Glaser recommends instead is a less absolutist approach, notably touting naltrexone, an opiate antagonist, as a way to cut back on booze. When you take opiate antagonists, alcohol stops bringing pleasure to the brain, which reduces cravings. John David Sinclair, the psychologist who created this regimen for addiction and died in 2015, published his discoveries in peer-reviewed journals over four decades. Glaser cites a 2001 study by Sinclair in the journal Alcohol and Alcoholism that shows a 78 percent success rate of naltrexone alone in helping patients cut their drinking down to 10 drinks a week.Oh … OK. So 78 percent sounds like a good chunk, but holy smokers: Ten drinks a week, which easily could still fuel my old weekend blackouts and hangovers, plus a new pill that antagonizes my brain’s own pleasure systems? That’s success?Leafing through thousands of influencer posts, a hundred ads for top-shelf celebrity soft drinks, and a dozen journal studies of brain receptors doesn’t, blessedly, make me want to drink. But all of this does make me want to drop my last name, grab a steel folding chair, and indulge in some old-time AA, complete with sloganeering in a musty church undercroft. Keep it simple, stupid. Or my favorite: Easy does it. I’ve decided these new abstainers have an entirely different goal than the anonymous alcoholics of yesteryear.ILLUSTRATION: GENIE ESPINOSAFor every culture that includes fermented drink among its sacraments or refreshments, there is a unique perspective on drunkenness. Over a century ago, the French poet Charles Baudelaire counseled, “Be always drunk”; the Nigerian Afropop singer Joeboy advocates wine as a break from troubles in his 2021 hit "Sip (Alcohol).” Among the European colonizers of North America, drunkenness became a religious issue, a lapse from Christian virtue. In the 1870s, Protestant women, long before they could vote, centered their politics on the temperance movement as a way to keep their men in line and keep the rowdies away. By 1900, nativism had crept into the temperance discourse, as immigrants from Ireland and Italy were associated with drunkenness and moral turpitude. Some proponents of temperance required that churchgoers keep pledges of abstinence, on pain of damnation.Later, after Prohibition ended in 1933 as a failed experiment, public-heath officials tried a new approach, condemning drunkenness less as a sin, like adultery, or an unhealthy lifestyle choice, like smoking, and more as a threat to public safety, like brawling. The states made laws to curb drunk driving, and programs sprang up to educate students about how drunkenness can lead to every kind of violence. Public health as a framework for alcoholism is Janus-faced. On the one hand, when drunkenness is framed as a shared public problem with social remedies, hard drinkers might be faulted less often for personal failure. On the other, when law enforcement gets involved, some people get stopped for speeding or frisked for drugs far, far more than others. Twelve-step groups are filled with white drunks marveling at how often they got away with driving drunk while people of color describe being jailed for far lesser offenses.In parallel with the post-Prohibition approaches to hard drinking, Alcoholics Anonymous, which was formed by a doctor and a stock broker in 1935, evolved as a project of moral betterment. Yes, you’re expected to stop drinking in the program. But the longer you sit in the rooms the clearer it becomes that AA doesn’t see abstinence from alcohol as an end in itself but as a baseline precondition for a life of honesty, faith, and service to others.A therapist once told me that people don’t come to therapy to change; they come to get out of pain. You have to coax them into changing. The same is true in 12-step programs. People come into the rooms heartbroken, bruised, unemployable, and in dire need of comfort (and, often, money). Within days, even if they’re trembling with withdrawal symptoms, they’re urged to help others, if only by mopping the floor and stacking chairs. Soon after, they’re encouraged to seek a “power greater than ourselves” in which to invest their faith. The so-called “God stuff” has turned people off from the start, although atheists have cooked up plenty of higher power workarounds, like ”the universe” or “nature.” The self-important but amusing AA manual known as the Big Book even offers a chapter called “We Agnostics,” which tries to allay fears that sobriety requires specific pieties. Some sober nonbelievers find the chapter disingenuous.Still, if you stick around, the helping-others part almost always sinks in. As does the imperative to self-examination. It also becomes a source of wry humor. Some months in, while most drunks are fuming about the garbage people who’ve done them wrong, you’re encouraged to write out an inventory of the people you, the original garbage person, have harmed. If you’ve ever once padded your expenses or faked an orgasm, a guide to the program—your sponsor—might make you add it to an inventory. You’re a thief. You’re a liar. It stings.One of my favorite stories from the rooms was told by a 12-stepper who noticed a friend reading The Art of Happiness, by the Dalai Lama.“I doubt I’ll read it,” the guy said, morosely. “Can you just tell me the secret?”“You’re not going to like it,” his friend replied.“Oh no. It’s not—”“Yep.”“Please say it’s not.”“It is.”“It’s ‘help other people,’ isn’t it?”“Uh-huh.”“Fuuuuck.”When I came into a 12-step program, I hated the idea that helping others was supposed to take the place of screw-top wine and benzos. Helping others is the key to happiness? What do you know. I really thought it was money.This old-fashioned parable of sobriety, in which the untreated drunk is a scoundrel and not a wellness entrepreneur, showed up in an unexpected place this year: a sitcom on Hulu called Single Drunk Female. Created by TV writer Simone Finch, who is herself a recovering alcoholic, this extremely charming show, which premiered in January, stars Sofia Black-D’Elia as Sam, a blackout drunk who is remanded to 12-step meetings after an assault charge.To my surprise, scenes of meetings and deep cuts of AA jargon in Single Drunk Female don’t exist entirely to set up exciting relapses, as they do in many shows that feature problem drinkers. In fact, Sam’s recovery with the 12 steps was so spot-on and moving to me that I wondered if someone else might see the whole show as merely AA propaganda, like that run of Archie comics that had an unnerving undertow of Christianity. Archie and his crew would be having normal fun in a convertible, facing midcentury temptations like cigarettes or making out, and one would say something like, “You know, Jughead, read John 14:6! God has a perfect plan for us!” My partner assured me that Single Drunk Female was not like this. But I noticed he didn’t choke up like I did when Sam got her 30-day chip. And when she finally realized the world doesn’t owe her a living and started coming through for other people? Forget about it. I cried.A big criticism of AA is that the hair-shirting—AITA? Yes and always—can tilt into moral masochism. Though the bracing inventories of my own “defects of character” seem to keep me honest, some in the program who suffer with trauma see AA’s insistence that alcoholics are all sinners as victim-blaming. Searching for your part in your life’s low ebbs might lead you to repress your own suffering or, worse, compound it.There’s plenty more to dislike. Though the rooms are more socially heterogeneous than just about anywhere I’ve been on earth, talking about politics is essentially forbidden in the program’s loose guidelines, which are called its “traditions.” (I was once kicked out of a meeting for complaining about Brett Kavanaugh.) What’s more, the sexism in parts of the Big Book is preposterous. In the horrifying chapter “To Wives,” the ideal handmaidens of boozers are instructed to forgive their drunken men everything from profligacy (“the checking account melted like snow in June”) to violence (“they struck the children”) to bad company (“the sheriffs, the policemen, the bums, the pals, and even the ladies they sometimes brought home”).But, though some 12-step members are textual fundamentalists and cultural conservatives (the tenor of meetings is highly regional), the programs live less in scripture than in the eclectic lore and aphorisms accumulated in the rooms over the past 80-plus years. This never-ending document includes “qualifications” and “shares.” Through these ritual forms of storytelling, alcoholics discuss their experience, the perspective they’ve gained, and the hope they cultivate. The bulk of the Big Book is also not gospel from midcentury white men. Instead, after the opening chapters that explain the program, it contains mini-memoirs by diverse alcoholics, including queer drunks, indigenous drunks, doctor drunks, and hobo drunks who rode the rails. In many meetings, members read from these stories, sometimes taking the “I” pronoun into their own mouths, embodying identities foreign to them; when an elderly auntie drunk reads the words of a young felon drunk, there are ironies—but also the supreme sweetness that comes from acknowledging the expansiveness of other minds and the universality of suffering. Good sponsors also keep sponsees from zeal, and help you laugh at the program’s dogma, contradictions, and anachronisms.Less pleasantly, a sponsor will also remind you that you don’t get sober in order to win “cash and prizes.” These are things like cars, sex, fame, dough, or even physical health—the super things sober influencers model, and even offer. Nor do sponsors countenance drinking “in moderation,” much less 10 drinks/week. A hazard of drinking for a traditional alcoholic is that it invariably leads to dishonesty. A formidable matriarch in the room once warned me not to “get cute with this disease” when I asked whether I could taste a dessert with a touch of cooked-off Grand Marnier. She definitely doesn’t mess with near beer or Katy Perry’s $6 mocktails.ILLUSTRATION: GENIE ESPINOSAPart of why I can’t take too seriously the scientific rejections of AA like Glaser’s is that researchers seem to use a vision of success that, in 12-step programs, would not count as sobriety, which the fellowship generally sees as a moral and spiritual state that only starts with “putting down the drink.” In the end, AA makes an extremely modest set of promises. According to a list called the Ninth Step Promises, recovering alcoholics who make amends to people they’ve hurt can expect only a few vague dividends. By not drinking and by helping others, you get a measure of peace, renewed interest in others, keener intuition, and freedom from regrets, self-pity, bafflement, and fear of economic insecurity. (nb: Freedom from fear of economic insecurity ≠ money.)So much of the new sobriety flex is anathema to the captious alcoholics of 12-step groups. But carping that others aren’t doing sobriety right is such a common mistake among recovering alcoholics that Bill W., the founder of AA, came up with excellent slang for the carpers: “bleeding deacons.” God knows where that phrase comes from, but I imagine gaunt figures in black pope hats with open, oozing stigmata. According to popular interpretation in the rooms, bleeding deacons insist that if you stray from their narrow path—failing to pray, say, or arranging coffee cups wrong—you’ll literally die.I have no authority at all when it comes to quitting drinking. It took me till I was 41 to quit. (Russell Brand was 27; yes, I compare-and-despair about that.) Very little love or light informed my pissed-off cold-turkey detox. Quitting with the use of opiate antagonists, hot yoga, and nonalcoholic tequila seems every bit as righteous—and evidently more effective—than sweating it out in the rooms.But the way I learned it, to get sober is not to stop drinking. It’s to undertake a program that is chronically uncool in the quaint hope that it will make you a better person. People in the rooms talk less about drinking than about yielding to other drivers, feeding a stranger’s meter, buying a sandwich for a panhandler. The new sober influencers have convinced me that this cornball 12-step stuff isn’t for everyone. Certainly, its benefits can’t be tabulated by science. In my experience, they are indeed beyond measure.This article appears in the June 2022 issue. Subscribe now.Let us know what you think about this article. Submit a letter to the editor at mail@wired.com.More Great WIRED Stories📩 The latest on tech, science, and more: Get our newsletters!The infinite reach of Facebook's man in WashingtonTech can fix the climate mess—but not without helpPeloton is betting big on body tracking tech15 books you need to read this summerWhat Twitter is really planning for crypto👁️ Explore AI like never before with our new database🎧 Things not sounding right? Check out our favorite wireless headphones, soundbars, and Bluetooth speakers
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Mental Health Treatments
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Image source, Sophie KitcherImage caption, Sophie says that she couldn't be more proud of her baby son Ralphie The mother of a three-month-old baby with blood cancer said the way he has coped with chemotherapy has been inspirational.Sophie Kitcher, from Ware, Hertfordshire, said Ralphie was being "incredibly strong".The 34-year-old's first child Huxley died at three days old in 2021."Ralphie you are loved beyond words, you are our inspiration, hero, world and our strength that keeps us going," she said.Image source, Sophie KitcherImage caption, Sophie said she was "the proudest and luckiest Mummy in the world" to be able to call Ralphie hersRalphie, who was born on 5 October at the Princess Alexandra Hospital in Harlow, has had two rounds of chemotherapy so far to treat his acute myeloid leukaemia.He is about to start a third round, where he will be hooked up to a machine for eight hours a day.Image source, Sophie KitcherImage caption, Sophie and Luke are spending all of their time with their son at Great Ormond Street Hospital"My heart is still breaking each day seeing him go through all this and I'm still struggling to accept the fact that my baby boy has cancer but at the same time it has been the most magical time spending each and every minute with him and his Daddy. "We've shared the most precious moments and made the best memories that we will cherish forever," she said.Her son Huxley was diagnosed with Down's syndrome at birth and died three days later in July 2021 during surgery to repair a hole in his intestine.Image source, Sophie KitcherImage caption, Baby Huxley died at three days old during an operationRalphie was given the middle name Leo in memory of his big brother, who was born under the star sign.Mrs Kitcher said at the time she felt Ralphie had arrived to "help heal Mummy and Daddy's broken hearts" and he had made them smile again.Image source, Sophie KitcherImage caption, Sophie and Luke felt it was a new chapter for their family when Ralphie was bornFriends have set up a GoFundMe page for the family, which has raised more than £82,000 so far, to help pay for their accommodation while Ralphie has chemotherapy at Great Ormond Street Hospital in London."Thank you so much for everyone's continued support," Mrs Kitcher said. "It really does make this journey so much easier for us to all be together as a family."Please all keep praying for us, we may be half way there but we still have a long long way to go. Keep kicking cancer's butt my baby, you've got this," she added.If you need help and support following a bereavement or cancer diagnosis, there is information available at BBC Action Line.Find BBC News: East of England on Facebook, Instagram and Twitter. If you have a story suggestion email eastofenglandnews@bbc.co.ukRelated Internet LinksThe BBC is not responsible for the content of external sites.
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Disease Research
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It was a moment Meagan James never expected to witness.
A surgical team at NYU Langone Health in New York had performed the world’s first successful whole-eye transplant in a living person: her husband, Aaron James.
After an accident at work led to the loss of his left eye and part of his face, Aaron was given a new window to his soul, as well as a partial face transplant.
When Meagan peered into her husband’s new eye for the first time, she noticed the post-surgery swelling and saw that the eye was brown. Aaron naturally has ocean-blue eyes.
She also saw his new nose, lips and cheek, which already had some beard stubble growing. She saw a face filled with gratitude, and that’s when the emotion set in.
She was happy for her husband of 20 years.
“It was a crazy, great, weird, strange, ecstatic, happy feeling,” Meagan said. “I was just happy he made it through, and everything was good in the moment.”
On that day in late May, a team of more than 140 surgeons at NYU Langone Health completed Aaron’s transplantation procedure, which lasted about 21 hours. The surgery included transplanting the entire left eye and parts of the face from a single donor. It was a medical first.
Aaron’s eye is now showing “remarkable” signs of health, according to his medical team. Although he can’t see out of the eye, he remains hopeful that vision might come with time — and that his first-of-its-kind procedure may help advance transplant medicine.
“That’s really my biggest hope,” Aaron said. “If I can see out of it, that’s great. But if it’ll kick-start the next path in the medical field, then I’m all for it.”
A life-changing accident
Seeing Aaron’s new eye and face “wasn’t as big of a shock” as seeing him the night of his accident, Meagan said.
Aaron, a 46-year-old military veteran based in Arkansas, worked as a high-voltage power lineman, and that night in June 2021, he was working with his colleagues in Mississippi when his face accidentally touched a live wire.
The deadly 7,200-volt electric shock caused extensive injuries to Aaron’s face: his left eye, his entire nose and lips, his left cheek area and chin, as well as his left arm.
Back in Arkansas, Meagan and their daughter, Allie, who was in high school, were driving home from the grocery store when Meagan’s phone rang. She didn’t recognize the number, but she still answered. She heard the words “Aaron,” “accident” and “serious.”
Meagan immediately packed a bag when she got home and then drove about four and a half hours to Mississippi, where Aaron was being cared for at a local hospital. During the drive, her phone rang again. This time, it was a doctor. The doctor described Aaron’s condition and explained that he had been electrocuted.
“Is he OK? Is he going to be OK?” Meagan asked. She recalls the doctor responding, “The only thing that I can promise you is that he won’t die before you get here.”
Meagan remembers that she would tell Aaron to “be careful” every morning before work. She still thinks back to the morning of his accident and wonders whether she told him to “be careful” that day.
‘Oh, my goodness, his face is gone’
Meagan remained by Aaron’s side as he was transported to different medical centers for more intensive care, for reconstructive surgeries and to have his left arm amputated.
After he was flown to a burn unit in Dallas, Allie, who was staying with her grandmother at the time, was able to visit him.
“When I saw him, his chinbone was exposed,” Allie said.
“I could see his eye socket and everything. I was seeing his skull, and I think that’s the part that was kind of freaky for me. I was like ‘Oh, my goodness, his face is gone,’” she said. “Most of my worries was just how he was going to be when he was awake and aware.”
Aaron said he doesn’t remember the accident at all.
“Basically, I got up, went to work and woke up six weeks later in Dallas, Texas,” he said. “It’s a weird feeling when you just all of a sudden wake up in a hospital.”
The first time Aaron saw himself after the accident was from his hospital bed in Dallas. He asked Meagan to take a photo, but she hesitated.
“She said, ‘Are you sure?’ I said, ‘Yeah, it’ll be fine,’” Aaron said.
“She took a picture, and she spun the phone around, and I was just like, ‘Oh, my goodness, this is a bad deal right here,’” he recalled. “I mean, I felt OK, so I knew I was going to be OK. We were just going to have a long road ahead of us.”
Aaron’s medical care team had mentioned the option of a face transplant to Meagan. When she then brought it up to Aaron, he said he was “all for it.”
“As soon as the face transplant got talked about, that’s when I thought, ‘Man, this is a big deal,’ because they just don’t do those every day,” he said.
In New York, Dr. Eduardo Rodriguez, director of the Face Transplant Program at NYU Langone Health — who had performed four face transplants before — and his colleagues were introduced to Aaron’s case by specialists in Texas.
After learning more about Aaron’s accident and subsequent injuries, Rodriguez said that it was “remarkable” that Aaron had survived.
“To see him walking when he was completely down for the count in the hospital — multiorgan system failure, breathing tube, is he going to make it, is he going to have neurological injury — to see him without any of those sequelae, it’s very impressive,” Rodriguez said.
“It’s a testament to modern medicine,” he said. “It’s a testament to this patient and his family. And it’s also a testament that, in these cases, there’s some celestial involvement where it wasn’t his time to go.”
‘You have to have a patient zero’
Discussions around the possibility of a transplant continued even after Aaron’s medical team in Texas had removed his left eye due to severe pain. Rodriguez and his colleagues in New York asked the Texas team to preserve as much of the optic nerve as possible in hopes of a potential eye transplant.
As Rodriguez talked with Aaron about the possibility of doing not just a partial face transplant but a whole-eye transplant, he warned that the donor eye might not restore vision. For there to be sight, there will have to be some communication between the transplanted eye and the brain.
“But I said ‘even if it don’t work, I’ll have an eye, and it will be at least normal-looking, and then you all could learn something off of this,’ ” Aaron said. “You have to have a patient zero.”
Aaron was listed as a potential recipient in February 2023. The opportunity to perform the whole-eye and partial facial transplant came just a few months later, in May.
It was a “risky” operation for Rodriguez and his colleagues. No medical team in the world had previously performed a successful human eye transplant in a living patient.
“It’s completely uncharted territory,” Rodriguez said.
The surgery involved two operating rooms. Aaron was in one room, where surgeons removed the parts of his face that would be replaced with donor tissue. Rodriguez was in the other room, dissecting the donor face and eyeball.
“That part of the operation took about 12 hours,” Rodriguez said.
“Now I have to ensure that Aaron’s room is ready to receive the face,” he said. “We cut the blood vessels, we disconnect it from the donor, and the race begins. At this point, the face and the eye are not receiving any blood supply.”
Rodriguez and his colleagues then began connecting the donor face and eyeball to Aaron. For the eye transplant, the team combined the donor eye with adult stem cells derived from the donor’s bone marrow by injecting the adult stem cells into the optic nerve during the transplant. Those stem cells may help enhance nerve regeneration.
“We were able to define a specific cell, a CD34, which is an adult stem cell that has some potential benefits — not only in immune modulation, because it is a transplant — but also neuro regeneration,” Rodriguez said. “At the connection of the optic nerve from the donor to the recipient, right at that site, we injected those CD34 stem cells.”
A key step in the whole-eye transplant surgery was reconnecting Aaron’s optic nerve to the donor eye, said Dr. José-Alain Sahel, clinical spokesperson for the American Academy of Ophthalmology. He was not involved in the procedure but is chair of the Department of Ophthalmology at the University of Pittsburgh School of Medicine and has been involved in related experimental research.
“It was very smart that they didn’t cut the optic nerve too far from the eyeball when the eye was removed in the recipient,” said Sahel, who has been following the NYU Langone Health team’s work.
“I think what remains to be done — which is a major, major undertaking — will be how to regrow the optic nerve, guide its fibers or axons to the appropriate targets, as well as making sure that the corneal nerves are well-preserved,” he said. “What we learn from this is that potentially the surgery can work, and then we should promote more research, more investment into research on corneal and optic nerve regeneration.”
When the surgery was complete and Aaron looked at his new face in a mirror for the first time, he was thrilled, Rodriguez said. Aaron continues to be closely monitored and must continue taking medications to reduce the risk of his body rejecting the transplant. His medical team notes that the eye has shown signs of health, such as having direct blood flow to the retina, the layer of tissue at the back of the eyeball associated with visual processing.
Looking ahead, Aaron, Meagan and their daughter, Allie, who recently graduated from high school, are preparing to celebrate Thanksgiving together in a couple of weeks. Aaron can now smell and taste — and looks forward to the Turkey Day meal. He also remains hopeful that on one miraculous day, he may be able to see out of his donor eye.
“As far as whether he will see or not, that’s the question that remains unanswered,” Rodriguez said.
“A transplant of this kind has never been done, and transplants have a unique way to work, and even in face transplants, things have occurred that we would not have imagined,” he said. “So, I’m hopeful.”
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The procedure marks a major step for the field of transplant medicine, Dr. Oren Tepper, plastic and reconstructive surgeon and director of the Craniofacial Surgery Program at Montefiore Health System, said in an email.
“This highly technical and complex surgery represents a significant advancement in the field of face transplantation,” wrote Tepper, who was not involved in Aaron’s care.
“Ultimately, if transplanting an eye proves to be successful at restoring any form of nerve function or visual signals, this would be a tremendous breakthrough in medicine for patients who have suffered loss of the eye due to trauma or cancer.”
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Medical Innovations
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People from minority ethnic backgrounds no longer have a significantly higher risk of death from Covid-19 than white Britons, for the first time in the pandemic.
Figures from the Office of National Statistics (ONS) show rates of deaths involving Covid-19 are now substantially lower for all ethnic groups compared with earlier in the pandemic.
Experts suggest this could be down to changes in exposure to the virus, vaccination, levels of natural immunity, and the severity of Covid variants.
During the first and second wave of the pandemic, between January 2020 and January 2021, minority ethnic groups had a significantly higher Covid-19 mortality rate than white Britons.
“In the first wave and the second wave, the differences in mortality were largely due to social demographic factors. The main reason for the differences was differences in the risk of infection,” said Vahé Nafilyan, a senior statistician at the ONS.
During the period of successive lockdowns, people from minority ethnic backgrounds were more likely to be exposed to the virus as they were more likely to be key workers or live in multi-generational households. Covid mortality rates were highest for Bangladeshi, Pakistani, black African, and black Caribbean groups, ONS figures show.
Deaths from Covid decreased by the third and fourth waves, known as the Alpha and Delta waves, but ethnic disparities remained.
“The Delta wave coincided with the rollout of the vaccination campaign, where the uptake of vaccine was much lower in some groups, such as the black Caribbean and black African groups, compared to the white British group,” Nafilyan said. “One of our studies found that to a large extent these differences in vaccinations explained the differences in mortality.”
Research showed that the Omicron variant caused less severe disease than Delta.
“In addition to that, you’ve got the fact that more and more people have got immunity because they’ve been infected previously. So what hasn’t changed in the Omicron period is the gap in vaccination uptake. It has reduced slightly between groups, but it’s still there,” Nafilyan said. “You would expect a group that is less vaccinated to have the highest mortality rates, and what we find is it’s not the case. So why is that? We can’t say for sure from the data.”
He added: “I don’t think we can do anything but speculate, but I think it’s good news because the rate of death has gone down substantially.” He said further research was needed to look into the level of immunity in different groups, and see whether groups with lower vaccination levels had higher level of infection
Kit Yates, the director of the Centre for Mathematical Biology at the University of Bath, said it was unclear what driving factors were behind the latest figures. “My best guess would be that there were disparities in terms of exposure levels for different ethnic groups earlier on in the pandemic, when we were actively trying to control transmission. I suspect that these have now largely dissipated given the unmitigated spread situation in which we have found ourselves for the last year or so.”
He said another possibility was that the impact of vaccines was diminishing. “We know that there are disparities in vaccine uptake by ethnic groups. However, combination of vaccine protection waning and the majority of people now being over a year out from their last vaccine may have levelled that playing field.”
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Epidemics & Outbreaks
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LONDON, May 5 (Reuters) - The World Health Organization ended the global emergency status for COVID-19 on Friday more than three years after its original declaration, and said countries should now manage the virus that killed more than 6.9 million people along with other infectious diseases.
The global health agency's Emergency Committee met on Thursday and recommended the UN organization declare an end to the coronavirus crisis as a "public health emergency of international concern" - its highest level of alert - which has been in place since Jan. 30, 2020.
"It is therefore with great hope that I declare COVID-19 over as a global health emergency," said WHO Director-General Tedros Adhanom Ghebreyesus, adding that the end of the emergency did not mean COVID was over as a global health threat.
During a lengthy conference call to brief the press on the decision, some WHO members became emotional as they urged countries to reflect on lessons learned during the pandemic.
"We can't forget those fire pyres. We can't forget the graves that were dug. None of us up here will forget them," said WHO's technical lead on COVID-19 Maria Van Kerkhove.
The COVID death rate has slowed from a peak of more than 100,000 people per week in January 2021 to just over 3,500 in the week to April 24, 2023, according to WHO data, reflecting widespread vaccination, availability of better treatments and a level of population immunity from prior infections.
Ending the emergency could mean that international collaboration or funding efforts are also brought to an end or shift in focus, although many have already adapted as the pandemic receded in different regions.
"The battle is not over. We still have weaknesses and those weaknesses that we still have in our system will be exposed by this virus or another virus. And it needs to be fixed," said the WHO's emergencies director Michael Ryan.
The WHO does not declare the beginning or end of pandemics, although it did start using the term for COVID in March 2020.
"In most cases, pandemics truly end when the next pandemic begins," Ryan said.
Last year, U.S. President Joe Biden said the pandemic was over. Like a number of other countries, the world's biggest economy has begun dismantling its domestic state of emergency for COVID, which officially ends May 11, meaning it will stop paying for vaccines and testing for many people and shift responsibility to the commercial market.
The European Union also said in April last year that the emergency phase of the pandemic was over, and other regions have taken similar steps.
'SIGNIFICANT PUBLIC HEALTH PROBLEM'
The WHO's declaration comes just four months after China ended its prolonged severe COVID restrictions and was ravaged by a big surge in infections.
The decision also suggests that WHO advisers believe a new more dangerous coronavirus variant is unlikely to emerge in the coming months, although the virus remains unpredictable.
"I will not hesitate to convene another emergency committee should COVID-19 once again put our world in peril", WHO chief Tedros said.
In many parts of the world, testing has dwindled dramatically, and people have largely stopped wearing masks. In some countries, mask-wearing mandates have resumed during COVID outbreaks. The WHO published a plan this week advising countries on how to live with COVID long-term.
COVID will continue to challenge health systems worldwide long term, including long COVID, infectious disease experts say. "No one should take (this) to mean COVID-19 is no longer a problem," said Mark Woolhouse, an epidemiologist at the University of Edinburgh.
"It is still a significant public health problem and looks likely to remain one for the foreseeable future."
Our Standards: The Thomson Reuters Trust Principles.
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Global Health
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Roughly 14 percent of the global population has been infected with Lyme disease, and its prevalence is only growing, according to a study published Monday. Researchers said the study, which was published in the journal BMJ Global Health, is a first-of-its-kind analysis that examined more than three decades worth of studies on the tick-borne disease. Researchers parsed through thousands of potentially applicable studies from three databases, eventually analyzing 89 studies conducted between 1984 and 2021 that involved a total of 158,287 participants. But the study found research that didn’t utilize a certain laboratory technique that separates and identifies proteins to confirm results, called western blotting, increased the risk of reporting false positives. So researchers looked at just 58 of those studies that used the confirmation technique when assessing potential risk factors for the disease. The group found a higher prevalence of the bacteria that is the most common cause of Lyme disease, in groups including people aged 50 years or older, those located in Central Europe and men. The researchers noted more recent studies are finding a higher prevalence of the bacteria, increasing from 8.1 percent between 2001-2010 to 12.2 percent in the following decade. The study also suggests the prevalence in Europe is nearly 50 percent higher than in the Americas, with the prevalence in Asia clocking in even lower. Central Europe, Eastern Asia and Western Europe presented the highest prevalence out of the regions analyzed. Nearly 19 percent who had a tick bite history were found to test positive for the virus, compared to 10.5 percent for those not tick bitten. Lyme disease can cause symptoms like fever, headache, fatigue and a bullseye skin rash, according to the Centers for Disease Control and Prevention (CDC). Most cases can be treated successfully in a few weeks with antibiotics. Although it is rarely life threatening, Lyme disease can spread to joints, the heart and the nervous system and leave permanent damage if left untreated, according to the agency. Federal regulators made a Lyme disease vaccine called LYMErix available to people older than 15 in the 1990s. The vaccine, which required multiple injections and was linked to harmful side effects, was pulled from the market in 2002. Valneva, a French biotech company, and Pfizer are collaborating to develop a new vaccine for the disease, dubbed VLA15. The Food and Drug Administration (FDA) in 2017 granted the product fast-track status. The companies announced in April they plan to begin a phase 3 trial of the vaccine later this year, including with pediatric participants.
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Disease Research
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Will robots rule the world? Maybe.
But right now I'm watching one carry out orthopaedic surgery, and it's not frightening - it's fascinating.
Scrubbed in and masked up, Sky News was invited to see a robotic arm assist with a full knee replacement at Walsall Manor Hospital.
It's the first time that this type of technology has been used at an NHS district general hospital, and leading today's pioneering surgery is clinical director, Thomas Moores.
"Has it been quite nerve-wracking, getting ready for this?" I ask him, ahead of the procedure.
"No, it's exciting," he says.
"The robotic technology helps us plan in advance, so there's actually a lot less stress in terms of the surgery itself."
Today's patient is Jess Sansara who is in his 60s.
He has severe arthritis in his right knee and, for months, it's been too painful for him to walk.
'We used to be offering 18-week waits' but now it's 'a backlog of one to two years'
"Patients have had to wait far too long for their joint replacements," Mr Moores says.
"We used to be offering 18-week waits. COVID unfortunately had given us a backlog of one to two years."
That's where doctors hope robotic-assisted operation can help (and where, if you're squeamish about saws, bones or surgery you might need to skip to the end).
First, the preparation is different.
Using the robot's technology, a 3D computer image of the joint is made ahead of the operation.
The parts of the deformed bone that need to be removed are marked on this image.
It is those parts that will need to be cut off before the new, artificial knee joint can be fitted.
The robotic arm is mounted on a large mobile platform and gets wheeled in, next to the operating table.
The "hand" end of the robotic arm is securely attached to the orthopaedic bone-saw that'll be used in surgery.
The surgeon also holds the saw, and can start and stop it.
Now, this is where the plan comes in.
The margin for error is tiny
With the saw now on, the surgeon starts to cut the bone under guidance from the robotic arm.
The robot's sensors limit the surgeon's saw movements, restricting any cuts to the bone beyond the planned excisions marked on the 3D image.
The margin for error is tiny.
The robot automatically stops the saw if the surgeon strays more than half a millimetre outside the marked area.
We see it doing just that, as Mr Moores - surrounded by colleagues both robot and human - starts to operate.
In front of the surgical team is a large computer screen featuring the 3D image of Mr Sansara's right knee.
The real-time movement of the saw is tracked on the screen, which also indicates the lines beyond which the saw should not cross.
'It means that every day is the best day in surgery'
On the, admittedly, rare occasions that Mr Moores moves beyond those lines, the screen flashes red, the robot steps in and immediately switches off the saw.
"With the robot-assist, really it means that every day is the best day in surgery," Mr Moores says, "[and] it's really safe for patients, with less soft tissue damage for some, for others, greater bone preservation."
In patient-speak, that can mean less pain and a quicker recovery.
For the hospital, it means an ability to free up beds faster.
"Early evidence shows it will probably translate into reduced length of [patient] stay," says Fahad Hossain, the hospital's director of research and development.
"The quicker we can get our patients out, the sooner we can get the ones that have been waiting longer in."
'The future of this type of surgery for all patients'
The hospital's trust has made an £1.8m investment here, using grant money earmarked specifically for innovation.
At a time when NHS spending and staff salaries are under intense scrutiny, it's a hefty spend on a piece of equipment with the relatively narrow operational application of hip and knee replacements.
But its backers believe it will help relieve pressure on the health service almost immediately.
"A lot of the strain is coming from a bottleneck of patients in beds," Mr Hossain says.
"We're really proud to be able to bring this technology to the community here for use at an NHS district hospital.
"Normally this would be the domain of the private sector, but we believe it's the future of this type of surgery for all patients."
Around two hours after he went under general anaesthetic, Mr Sansara's operation is complete.
He's been fitted with a new artificial knee joint, his mobility looks good and he's off to recovery.
"If he passes all our physio assessments, we'll have him home tomorrow afternoon," Mr Moores says, "and I think that's what this robot technology is going to give us - help reduce those lengths of stays, help get us better patient outcomes."
The next morning, the hospital messages to let us know that Mr Sansara is up and doing well.
Forget man versus machine: this robot is here to help.
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Medical Innovations
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A gene mutation which increases the risk of breast and ovarian cancer has been linked to people with Orkney heritage.
Scientists from the universities of Aberdeen and Edinburgh have found that one in one hundred people with grandparents from the islands off the north-eastern coast of Scotland, have a mutation of the gene BRCA1.
It is likely the gene variant came from one of the founding members of Westray - an Orkney island which has a population of under 600 people - at least 250 years ago, according to the research.
The gene mutation was repeatedly spotted in women from Orkney who have the cancers, most of whom could also trace their family ancestry back to the small island of Westray.
As a result of the findings, planning is under way to offer free testing for the gene variant to anyone living on the Scottish islands with a Westray-born grandparent, regardless of their family history with the disease.
Professor Zosia Miedzybrodzka, director of NHS North of Scotland Genetic Service, made it clear that developing cancer is not solely down to carrying the BRCA1 variant alone.
Genes are found in every cell in our body. They enable bodies to grow and function correctly. BRCA1 is a tumour suppressor gene that helps to protect us from developing cancer, according to the NHS. A variation can affect the function of the gene. This can increase the chance of developing breast, ovarian or prostate cancer, which is more likely to occur at a younger age. A person's genes can be examined from a blood sample. However, currently, it is usually only offered to families with a strong history of cancers.
Everyone has the BRCA genes, but not everyone has mutations in them.
"There are many complex factors, and some people with gene alterations will not get cancer," Prof Miedzybrodzka said. "However, we know that testing and the right follow-up can save lives."
Read more:
NHS unions reach pay deal after government offers 5% rise
Gonorrhoea cases rise by over a fifth
Family receives payout after baby burned at Aberdeen nursery
She recommended things like risk-reducing surgery, breast screening with MRI from the age of 30 and lifestyle advice to improve the health of women with the gene mutation.
Awareness of the faulty gene was raised when Hollywood actress Angelina Jolie underwent a double mastectomy a decade ago, after losing her mother to ovarian cancer and then discovering she had a BRCA1 variant.
The NHS recommends talking to your GP if cancer runs in the family, or if you are worried about your own risk. They may refer you for a genetics test, which will tell you if you have inherited one of the cancer risk genes.
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Disease Research
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Staff sickness in the NHS in England has reached record levels.
Figures for 2022 show an absence rate - the proportion of days lost - of 5.6%, meaning the NHS lost the equivalent of nearly 75,000 staff to illness.
This is higher than during the peak pandemic years of 2020 and 2021 - and a 29% rise on the 2019 rate.
Mental health problems were the most common cause, responsible for nearly a quarter of absences, the Nuffield Trust analysis of official NHS data shows.
Big rises were also seen in cold, coughs, infections and respiratory problems, likely to be linked to the continued circulation of Covid as well as the return of flu last year.
There were three categories covering these types of illnesses. If combined, they would be responsible for more sickness than mental health.
Staff leavin
The think tank warned the NHS was stuck in a "seemingly unsustainable cycle" of increased work and burnout, which was contributing to staff leaving.
The analysis, exclusively for BBC News, comes ahead of the publication of the government and NHS England's long-awaited workforce plan.
Nuffield Trust senior fellow Dr Billy Palmer said: "The health service is grappling with a difficult new normal when it comes to staff sickness leave.
"There has been a lot of focus on recruitment but we need more endeavour to improve the working conditions of existing staff and protect them from illness.
"The workforce plan needs to have concrete support to enable employers to improve NHS staff experience if the service is to break this cycle of staff absences, sickness and leaving rates."
'Psychological strain'
The NHS sickness rate, the highest since records began, in 2010, is above the public sector average of 3.6%.
The Nuffield Trust warned it was likely to be an undercount of the true figure as not every absence would have been recorded.
And while recording systems differed in Wales and Scotland, it was clear those nations were also seeing increased levels of sickness in the NHS.
Miriam Deakin, of NHS Providers, which represents health managers, said the findings "laid bare the psychological strain on staff".
She said the absences came on top of 110,000 vacancies in the health service and warned the situation was having a "knock-on effect on patient care".
Unison head of health Sara Gorton said the rise in illness was due to the "unrelenting pressure" on the NHS.
"Until the NHS has sufficient employees to care for and treat all the people needing its help, absence levels will keep going through the roof. If there's to be a healthy NHS, it first needs a healthy workforce."
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Health Policy
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io9 is proud to present fiction from LIGHTSPEED MAGAZINE. Once a month, we feature a story from LIGHTSPEED’s current issue. This month’s selection is “The CRISPR Cookbook (Chapter Two): A Guide to Biohacking Your Own Eggs into Weapons of Destruction, to Be Forcibly Implanted into One Patriarchist at a Time” by MKRNYILGLD. You can read the story below or listen to the podcast on LIGHTSPEED’s website. Enjoy!
The CRISPR Cookbook (Chapter Two): A Guide to Biohacking Your Own Eggs into Weapons of Destruction, to Be Forcibly Implanted into One Patriarchist at a Time
If you’re reading this, in a self-destructing DM, on the reverse strand of a plasmid, in the recipe binder you found in a deported neighbor’s belongings dumped on the curb, you’re no longer angry.
You’re hungry.
Your last co-op got raided by the Department of Homeland Biosecurity, hunting for pharmaceuticals “dangerous” to those at risk of getting pregnant. Your lab mates are bloody stains being hosed off the sidewalk. You barely escaped, but even in your grimy motel room you can’t help but keep a hotplate, a few chipped beakers, and a trusty pipette.
You’re starving. Not for more regulation of your reproductive system, as if the reversal of Roe twenty-six years ago, as if every ticking clock and prohibition heaped on our bodies since then weren’t enough. Deep within you, where everyone thinks a maternal warmth should be, is a ravening. You want to sink teeth into those majority opinions, those judges that know what’s best, rend them, chew them into bloody giblets.
A highway howls outside. On your room’s flatscreen, a politician kills a clinic with a slash of his pen and smiles. You flash your canines back. Your life is different now. You made a choice. You altered your body; or the mere act of reading the first chapter of this Cookbook altered your mind. You turned your anger inward, allowing it to transform yourself, and now you are a kind of beast with wings and talons and gaping maws. You came to me again because you want to know what to do with them.
I can give you a few ideas.
Eggs. You really only need one thing in addition to the materials you collected in Chapter One. Oocytes, or egg cells, or the soul of the next generation, as the groups dedicated to saving concepts as nebulous as Life or America say. What you call them is up to you, not the savers. You have (or once had) a body capable of giving birth to another human being; now you have a body capable of giving birth to a new world—to change. You’ve always had this secret ingredient, nestled deep within. You only need to extract it.
Step 1: Ovulation. But you’re so young, the fertility doctor says. Surely your ovaries don’t need to be stimulated! Even the forged referral, the affidavit from your “partner” that they want the procedure, are barely enough to convince the doctor to administer the drugs. After the final shot, he tells you to come back in a few days for the next steps. He’ll be in hot water with the DHB if he loses track of the eggs maturing in your body. You nod sympathetically. You help yourself to one of his ultrasound probes and a box of his aspirating needles on your way out.
Step 2: Retrieval. It’s not difficult to find someone with the expertise you need. Even in the heartland, there are farming co-ops that aren’t just farms. Especially in the heartland, there are ex-physicians who never stopped practicing. A whole wave of them went into hiding after the In-Vitro Fertilization Clinic Raids of 2036, after the DHB took protective custody of the unborn: thousands of embryos “rescued” from freezers, even more embryos killed by the DHB’s improper handling, and thousands of embryos already implanted into the wombs of those deemed “unfit.” Those pregnancies weren’t terminated of course, our president at the time proclaimed, wiping a tear from his eye—they aren’t monsters, after all. The mothers were given the best of facilities, and the best of re-education, until the babies could be safely delivered and taken to “safe” homes.
That didn’t stop people who can’t ordinarily get pregnant from starting families, to be sure. It all just went underground. Drive your junker down the highway, stopping at roadside farm stalls. Look in particular for ones with chickens strutting around, pecking at the dusty grass. Direct your conversation toward eggs, the shortages, how difficult it is to even bake a birthday cake these days. Ask carefully—might there be a few cartons stashed in the back of a fridge, hidden from state-mandated purchasers, that you could buy? If you play it right, you’ll be on your back on a kitchen table, with an ultrasound probe inside you and a needle aspirating your ovarian follicles one by one. Anesthetic won’t be available. You’ll leave with a lot of abdominal pain—and hopefully at least twelve vials of egg cells.
Once you get your oocytes, you’ll need to handle them carefully. Transfer them into the highest quality cell culture media you can barter for. Keep them in an incubator under physiological conditions. Look at them under the microscope every day. Are they perfectly spherical? Is their cytoplasm homogeneous? Is their membrane thick, but not too thick, their polar body intact? Move the plate slowly. Don’t even breathe when you take off its lid. You have to be gentle. Eggs are fragile, so fragile. However, as our foremother once said, not fragile like a flower. Fragile like a bomb.
So make your bomb.
- Gene editing. Egg cells are surrounded by the “shell” of the Zona Pellucida, a stronger membrane than that of the cells you worked with in Chapter One. You’ll need access to a microinjection apparatus. Thanks to the labor shortages, that won’t be difficult to get. More and more cattle farms are using them, and looking for lab technicians to operate them too. You’ll get training on how to hold a cow oocyte with a micromanipulator, remove its nucleus, and replace it with one from a high-quality steer—-bam, cloned beef! Most meat these days, when you can get it, is.
On a slow day, load your own oocytes into the well and use the micropipette to insert your desired genetic material into the nucleus instead. Your egg cells are transcriptionally inactive at this point, so nothing will happen immediately. But don’t worry. The payload will go off when it’s time. Inject your trusty synCas-X vector along with guide RNAs targeted to the following genes: TP53 and PIK3CA to give your egg the extra growth push it needs. TET1 and KMT2D for the epigenetic malleability to adapt. Finally, you’ll want to make your eggs just a bit defective in DNA repair by targeting an ERCC gene or two. Just enough to scramble some of your germline variants. Just enough so that your egg can’t be traced back to you.
- Implantation. If I know you, you already have a candidate in mind. A certain district judge who brags red-faced at the bar every night: I’m the one who killed the pill. That pill, and that pill, and that one. A million babies saved! I’m practically their father. Or perhaps a senator? The one who nods and says, I’m just giving the people what they want; anyone who doesn’t want it isn’t a person. Or any of the dozens applauding around them, playing with fascism as with toy soldiers, and discarding the sex workers they hire as even less than that?
You’re always so attractive to them, for a reason they can’t quite put their finger on. It’s the hunger in your eyes that reflects their own. They’ve been warned about bioterrorists with needles, but most will still let you lance them in the heat of the moment (see Diagram A). You need only whisper the magic word in their ear: virility. Despite their preaching about biosecurity, about Big Pharma destroying the bodies of the birthing population, most of them will take any kind of drug to get it up. For the needle-shy, there are hydrogel microcapsules you can form around your oocytes instead. Your eggs will travel, shielded from digestion enzymes, and latch onto the wall of the intestinal tract. From there, it’s only a short hop to the target.
- Embryogenesis. Millions and millions of sperm in the epididymis, squirming so helplessly, suddenly find an oocyte among them. Of course they surge forward. Of course they penetrate. It’s only natural for a sperm to fertilize an egg—the most natural thing in the world. And at that exact moment, as the savers say, the miracle of life begins. For what forms at your injection site in the scrotum is an embryo, indistinguishable from one formed in a Petri dish, or even a womb. It’s so small as to be unnoticeable. But slowly, but surely, it grows. Only after you’re long gone does it become impossible to ignore. At that point, beautifully, it’s formed hair and teeth. It has a heartbeat. It has all three germ layers; it even has neurons, of a sort. It’s alive, as the savers cry, it’s alive! Never mind that the mass is almost certainly moribund, never mind that its environment has little to no possibility of sustaining development up to live birth. Even a one in a billion, a one in a trillion of a chance of survival is an absolute in the eyes of their God. It’s alive!
The host will have to let this thing run its course. That’s simply the morally right thing to do, according to their politicians, their preachers, their CEOs. After all, it’s an embryo—it’s practically a newborn baby! Who’s to say it doesn’t feel pain? Who’s to say, up until the moment its environment can no longer support it and it necroses, taking out all surrounding tissue with it, that it’s not viable? There’s a chance that the mass may instead become metastatic and grow out of all control, killing its host, but that’s no excuse either. It’s simply a matter of principle. For if the host shows weakness, if he submits to removal of this foreign growth with half his DNA and a theoretical possibility of becoming human—then what else might he have to submit to? Those with wombs doing the exact same thing? Or, horror of horrors, that such a procedure might be a basic human right?
Such cases have become more and more common lately. The scion of a prominent family, suddenly confessing to calling the DHB on a college girlfriend, as if that will stop his own mass’s growth. An award-winning actor and spokesman for the savers tearfully begging for an exception to the law, for medications to eliminate his own twelve-week-old case. Each time, the hydra they helped put into power rises around them. Its heads debate, deny. They writhe, they chop themselves into little pieces. If they would rather destroy themselves than yield—then let them.
You’ve heard the whispers, haven’t you? Despite the assurances of the DHB, the deportations, and arrests, the youth are afraid. A certain type of youth, now that willful carelessness is no longer their God-given right. This recipe is so easy, after all. Anyone with eggs could do it. More and more of them want to get their testes removed to avoid the issue. Avoid the bars, they whisper among themselves, the dating apps. Sick bitches lurk on those. If you refuse to wear a condom, they’ll force their egg into your drink, or their saliva; even a kiss will be enough.
Then the whispers will turn to you. They will say: you should not have this power. Fertilization is natural, beautiful, but in your hands it’s violent. It’s wrong, because you could use it to terrorize the innocent, to assault their bodies, to destroy their minds. Never mind that you’ve carefully considered all of that. Never mind that you would never waste your oocytes on such a base, senseless act. Never mind the countless spermatozoa those whisperers jack off daily, unpoliced. They’ll turn to you, at the dinner table, in the line outside the grocery store, and with wide eyes, you’ll respond: It’s terrible, it’s tragic, but that’s just the world we live in now, isn’t it? Of course, we don’t have to live in this world. We could live in a world where abortion is legal and accessible instead. Until then: Sperm will be sperm and eggs will be eggs!
Do you taste it? It’s the most forbidden of fruits dribbling down your lips, burning down your throat. Its warm flesh contains all the calories you’ve denied yourself over the years, all the fats and sugars you were told would twist you into a monstrosity beyond desire, and therefore beyond worth.
You would never deem a fellow human being worthless. You’ve been taught to eat only until full, or better yet less-than-full, or best of all to puke it all up after. But you can eat this forbidden fruit, and you can keep eating. As long as we live in this world where fellow humans deny us justice, you can feast. You can gorge yourself, or you can lie in wait. It’s up to you. I only have one request. When you finally swoop down on your prey, digging into tendon and bone, when he pleads he’ll give you anything save for the basic human rights you’re due:
Don’t. Let. Go.
MKRNYILGLD (Twitter: @MKRNYILGLD) is a biologist who has the choice to give birth—or not. Her first CRISPR Cookbook short story, previously published in Lightspeed, has been selected to appear in The Best American Science Fiction and Fantasy 2023.
Please visit LIGHTSPEED MAGAZINE to read more great science fiction and fantasy. This story first appeared in the November 2023 issue, which also features work by Bennett North, Osahon Ize-Iyamu, Lars Ahn, Winston Turnage, Regina Kanyu Wang (translated by Rebecca F. Kuang), Martin Cahill, Dominica Phetteplace, and more. You can wait for this month’s contents to be serialized online, or you can buy the whole issue right now in convenient ebook format for just $3.99, or subscribe to the ebook edition here.
Want more io9 news? Check out when to expect the latest Marvel, Star Wars, and Star Trek releases, what’s next for the DC Universe on film and TV, and everything you need to know about the future of Doctor Who.
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Medical Innovations
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The World Health Organization still does not have key data from China about the origins of the Covid-19 outbreak, putting the world in jeopardy, says Dr. Maria Van Kerkhove, the group’s Covid-19 technical lead and head of its program on emerging diseases.
“The lack of data disclosure is simply inexcusable,” Van Kerkhove wrote in an editorial in the journal Science on Thursday. “The longer it takes to understand the origins of the pandemic, the harder it becomes to answer the question, and the more unsafe the world becomes.”
Understanding how the disease emerged in Wuhan, China, in December 2019 would help prevent future outbreaks, Van Kerkhove said.
It was only this year, three years after the start of the pandemic, that WHO got access to certain data that Chinese scientists had gathered in early 2020 at the Huanan Seafood Market in Wuhan. The raw genetic sequences from the samples had recently been uploaded to the data-sharing site GISAID. They were soon removed, but quick-thinking researchers had already noticed them and downloaded them for further study.
An analysis of that material uncovered animal DNA in samples already known to be positive for SARS-CoV-2, the coronavirus that causes Covid-19. A significant amount of that DNA seemed to belong to animals known as raccoon dogs, which had been on sale at the market, WHO officials said in March.
Although the sequences showed that the animal could have been an intermediate host and that the market amplified the spread of the virus, the data did not show that people who interacted with those animals got sick through that exposure. In other words, the findings did not settle the question of how the pandemic started.
To do so, scientists would need to trace the animals to the source of the virus. WHO also needs access to test results from workers at the market.
Three years later, Van Kerkhove said, WHO still does not have access to the raw data China collected from early Covid-19 cases.
With China’s advanced technical capabilities, she firmly believes, it has more essential information that it is not sharing.
Van Kerkhove says China could have more unshared information about things like the wild and farmed animal trade, the testing of humans and animals in Wuhan and across China, the operations of labs in Wuhan that worked with coronaviruses, and the first cases.
The failure to share information, she said, only fuels politicization of the origin of the virus.
“The world needs to move away from the politics of blame and, instead, exploit all diplomatic and scientific approaches so that the global scientific community can do what it does best – collaborate, focus on this health crisis, and find evidence-based solutions to thwart future pandemics,” Van Kerkhove wrote.
It’s still not clear whether the Covid-19 pandemic began with a lab leak or with spillover from animals. Many scientists believe that the virus naturally moved from animals to humans. Intelligence agencies like the US Department of Energy’s Office of Intelligence and Counterintelligence and the FBI endorse the theory that that virus spread out of a Chinese lab. Without more data from China from early in the pandemic, it may never be proved.
This is not the first time Van Kerkhove has been vocal about China’s lack of transparency about Covid, nor is she the only world leader to call on China to be forthcoming about the beginnings of the pandemic.
In March, Van Kerkhove described to Science WHO’s late discovery of the Chinese data about the market as “beyond infuriating,” calling the lack of collaboration “scary as hell.”
Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota and a member of President Joe Biden’s Covid task force during the presidential transition, said Van Kerkhove’s editorial puts WHO on the record on the issue.
“Will that be a compelling incentive for China to share more? No. They’re going to do what they’re going to do,” Osterholm said.
“I am not optimistic,” he added.
It will never be fruitful to spend time and attention on getting data from China to pinpoint what happened with Covid, Osterholm said.
“My whole message is that we’ve got to prepare for lab leaks or spillover events,” he said.
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WHO plans to publish a status report about what it knows about the origins of Covid-19 this year.
In the meantime, it’s encouraging all countries, not just China, to share what they know to help solve the mystery and fight future pandemics. Collaboration is key, as is finding evidence-based solutions, Van Kerkhove believes.
“Time is running out,” she wrote.
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Epidemics & Outbreaks
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WASHINGTON — The COVID-19 pandemic may have originated with two separate leaks at Chinese labs doing risky “gain of function” research, a Republican senator stated Monday.
A report released by Sen. Roger Marshall (R-Kan.) raises the prospect that millions of lives worldwide could have been saved — including those of more than 1 million Americans — if not for an alleged “coverup” by the Chinese government while a much-theorized initial outbreak simmered.
“This report concludes most likely this was two leaks — the possibility of a lab leak in the September-October [2019] timeframe, even as early as July or August,” the medical doctor turned senator told a small group of journalists ahead of the release of the 301-page document.
“We’ve concluded that they [China] started vaccine development in November 2019. And then another lab leak seems to be most sensible explanation,” he said. “There are key data points that are being held back that could help us prove that.”
Dr. Robert Kadlec, the cofounder of the Operation Warp Speed program that rapidly developed US COVID-19 vaccines, drafted the report titled “Muddy Waters: The Origins of COVID-19 Report” with about a dozen staffers and additional outside consultants.
The theory that there were two lab leaks, with the first one’s effect going unrecognized by the global community as the Chinese government raced ahead with early vaccine development, is unproven and Marshall says he welcomes debate and the exploration of other possibilities.
The theory rests on scientific conjecture about previously reported details — including an assessment of the amount of work that would have had to predate a Feb. 24, 2020, vaccine patent filed by Dr. Zhou Yusen, a Chinese military scientist who later died under mysterious circumstances. Investigators concluded that the vaccine development would have had to start in November 2019, using the Operation Warp Speed timeframe as a benchmark.
A pre-November series of additional events adds weight to the theory, Marshall said, including the mysterious death of 11 Iranian athletes, publicly reported in 2020. Some of the athletes reportedly attended the Olympics-style World Military Games in held Wuhan, China, in October 2019.
There are additional scientific clues, according to the report.
“Epidemiological and genetic molecular analyses of the early published circulating Wuhan SARSCoV-2 strains supported the possibility of two spillover events two or more weeks apart,” the report says.
“This assessment was made based on minor genetic differences in early circulating strains suggesting that two lineages of the same virus may have emerged simultaneously and progressed on different paths or sequentially separated by some period of time. One lineage showing more mutations than the other implying it had been circulated longer than the other or had potentially passed through more individuals.”
The document goes on: “A recently published study analyzed data from existing WHO global influenza surveillance networks early in the COVID-19 pandemic. Their analysis could identify outliers in influenza-negative influenza-like illness (ILI) that served as potential early indicator of COVID-19 community
transmission.”
The Kadlec-led team reported “[a] noticeable increase of Wuhan adult ILI cases during week 46 (November 11-17, 2019) corresponded to negative influenza testing that same week. This occurrence is similar to the epidemiological outlier identified in the published study. It occurs approximately 13 weeks before the recorded surge of COVID-19 cases in Wuhan in late January, early February 2020.”
Further raising the suspicions of investigators, the Wuhan Institute of Virology, which was conducting risky US-funded gain of function research on coronaviruses, deleted an online database of virus samples on Sept. 12, 2019, which Marshall said likely would have shown “cousins” of COVID-19 if it was indeed from nature.
“There are a lot of events around this timeline, then it gets a little quiet, and then — boom, something else happens,” Marshall said.
But Marshall readily admits that there may be alternative explanations for the outbreak, which Chinese authorities first publicly acknowledged on Dec. 31, 2019.
Pressed by The Post on whether it was possible the vaccine patent was quickly filed because Chinese scientists were aware of COVID-19 in a lab without it necessarily leaking, the senator said, “I’m inviting that [possibility]. I think that’s the whole purpose of science, to shoot down those theories.”
Marshall said he hopes the report will build momentum to establish a 9/11 Commission-style investigation of the origins of the virus to understand the reason for the devastating pandemic and to prevent a recurrence.
“I don’t think anyone can conclude that this is a ‘get [Dr. Anthony] Fauci’ paper,” said Marshall, who has clashed with the former top US infectious disease expert at hearings focused on US funding for the Wuhan lab that modified viruses to make them more contagious.
Marshall said that he believes Democratic colleagues are warming to an investigation of the pandemic’s origins and “I’ll be curious as to how the White House responds.”
The senator also ridiculed an effort by what he called the “gain of function mafia” to push a theory that raccoon dogs farmed for their fur caused the pandemic, saying they would have been shipped around China — leading to outbreaks in geographically distinct areas, rather than concentrated in Wuhan, where no animal or animal handler responsible for its origin has been put forward by the Chinese government.
President Biden on March 20 signed a bipartisan bill that mandates the declassification of records on the pandemic’s origins, though it’s unclear what material will be redacted. Marshall said that he’s been unable to get his own hands on complete records, even though he has clearance to review the nation’s secrets.
But Marshall said the US government itself hasn’t yet been very forthcoming — and that he hopes especially to further investigate the money trail flowing to Wuhan for research that modified coronavirus.
“Every time I pick on China, we should look in the mirror because our own federal government has kept data from us, they wouldn’t show us information. They wouldn’t let us talk to the right people. So much of it is redacted,” said Marshall, who took on leadership of the Senate Health Committee’s GOP inquiry following the retirement in January of former Sen. Richard Burr (R-NC).
The Wall Street Journal in February revealed that the Energy Department now believes the pandemic began with a Chinese lab leak. The department operates the US National Laboratories, given the assessment additional weight.
FBI Director Christopher Wray confirmed after that revelation that the FBI also believes COVID-19 leaked from a lab.
“The FBI has for quite some time now assessed that the origins of the pandemic are most likely a potential lab incident in Wuhan,” Wray told Fox News at the time. “Here you are talking about a potential leak from a Chinese government-controlled lab.”
Under political pressure, Biden in May 2021 ordered a US intelligence community assessment of the origins of COVID-19, after previously saying the US would defer to the World Health Organization to get answers.
US spy agencies assessed in August 2021 that it was “plausible” that the virus came either from a lab release in Wuhan or from a natural origin via animal-to-human transmission.
At the time, a written statement attributed to Biden said: “The world deserves answers, and I will not rest until we get them.”
“Responsible nations do not shirk these kinds of responsibilities to the rest of the world,” the statement said. “Pandemics do not respect international borders, and we all must better understand how COVID-19 came to be in order to prevent further pandemics.”
But Biden, who campaigned heavily in 2020 on mourning pandemic deaths and slamming then-President Donald Trump’s management of the crisis, has hardly mentioned the origins question since then — even walking away from reporters on the White House lawn March 3 when asked about holding China accountable for the outbreak.
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Epidemics & Outbreaks
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NEW YORK -- Fed up with hundreds of bootleg pot shops, New York launched new inspections this month aimed at getting rid of the unlicensed stores that are troubling the state's fledgling legal marijuana market. “You will be caught,” the governor vowed.
But anyone who expects to see the stores shape up or shut down might need patience.
Two weeks after the enforcement push debuted with authorities issuing violation notices and confiscating contraband weed at 11 Manhattan storefronts, only two appeared to have closed when an Associated Press reporter visited, and two others were no longer selling marijuana products.
At the rest, it was business as usual.
In some shops, customers came and went right past the “ILLICIT CANNABIS SEIZED” notices inspectors had posted in the windows. Other retailers apparently took down the signs, ignoring their stated warnings of additional penalties for doing so. A couple of stores advertised marijuana products on sidewalk signs. And another was thick with pot smoke from customers enjoying their purchases in its “lounge.”
For all its new initiative, the state won't immediately shutter the illegal shops, which have been operating with relative impunity throughout New York City.
Inspections are just a first step toward hefty fines and, potentially, closure and even criminal prosecution. Still, regulators hope this will be a turning point in weeding out illegal sellers and giving authorized ones more room to flourish.
“To the citizens that want us to go out and padlock on day one: We do have to afford a due process system," explains state Office of Cannabis Management enforcement director Daniel Haughney. “As you see the process actually play out, step by step, it will get to a point where you’re not going to see these illicit shops out there any longer.”
A manager at one of the first 11 shops that were cited declined to discuss it. Managers and owners of those that hadn't shut down didn't respond to requests for comment.
Since New York legalized recreational marijuana use in March 2021, it has struggled to enforce the new regulations on sales.
The state limited the amount of pot someone can have for personal use and allowed for criminal charges, including felonies, for illegally possessing and selling larger amounts. But officials have stressed that they don't want to “recriminalize” the drug after striving to make up for decades of prosecutions.
New York set aside its first dispensary licenses for people who had pot convictions or relatives who did, planned to find and outfit storefronts for them to lease, and more. But those complexities helped slow the rollout. Just 15 approved retailers have opened in a state of nearly 20 million people, compared to the 25 dispensaries that opened in the first three months of legal sales in neighboring Vermont, which has only about 650,000 residents.
Unlicensed sellers rushed to fill the vacuum in New York. That has happened in some other states, but scale and density have made the problem especially visible in New York City, where shops have appeared every couple of blocks in some neighborhoods.
Their proliferation is irking lawmakers and licensees alike.
“The most frustrating part is that there’s just not a clear understanding within the public about the difference between a licensed dispensary and an unlicensed dispensary,” since the latter are operating so openly, said Arana Hankin-Biggers, president of a licensed Manhattan dispensary called Union Square Travel Agency.
She emphasizes that buying legal means that products have been tested at state-approved labs and follow labeling and other rules. She notes that half her dispensary's proceeds go to a nonprofit partner that helps formerly incarcerated people. Yet those selling points vie with the sheer abundance of unauthorized options nearby.
Price comparisons between the licensed and unlicensed sellers are difficult because of the range of products and stores; also, licensed sellers collect state taxes that illicit shops likely do not. Hankin-Biggers said Union Square Travel Agency's prices are competitive, and sometimes lower.
The state cannabis office started trying to oust unauthorized marijuana stores last year by sending warning letters. But at the time, it didn't have the clear authority that it now has for inspections, fines and other consequences.
Meanwhile, some local officials took action. New York City has towed trucks suspected of selling weed, sued shops, and, with the state's help, inspected over 600 smoke shops since November on suspicion of illegal sales of pot or other items. Those inspections have led to more than 1,000 violation notices, 100 arrests, $15 million in fines and millions of dollars' worth of seizures, Mayor Eric Adams' office said.
“New York City is doing everything in its power" to tackle the problem, mayoral spokesperson Kayla Mamelak said in a statement that commended the state's new efforts. Meanwhile, the city could levy new fines against illegal weed shops' landlords under a measure the City Council passed last week, and that Adams appears likely to support.
The state's new powers come from legislation that Gov. Kathy Hochul, a Democrat, signed into the state budget in May. It allows for inspections, seizures, fines that can reach $20,000 a day plus possible tax penalties, and, in some cases, closing shops and going after landlords.
After an inspection and seizure, retailers are entitled to an administrative hearing to determine whether they’ll be fined. In order to lock the doors, the state would have to go to court and demonstrate that “the public health, safety, or welfare immediately requires” such a step.
Arrests, while possible, are “not the focus point,” as the state hopes that fines and seizures will persuade illegal sellers to stop, Haughney said.
Hankin-Biggers said she's already seen an impact. The first inspections included several unauthorized shops near her licensed dispensary, and some then pivoted to other products or apparently closed.
“I’m super-hopeful,” she said. “It's going to take some time, but I think we’re starting to finally make progress."
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For more AP coverage of recreational marijuana: https://apnews.com/hub/recreational-marijuana
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Health Policy
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As if excess salt, fat and several types of sugar weren’t bad enough, the ingredient lists of much ultra-processed food often end with a befuddling number of additives. Either written as E numbers or given their full chemical names, this information is unsettlingly opaque to non-experts, prompting many of us to just refer to them derogatively as “chemicals”, even though, technically, everything is made of chemicals.
One category of these additives – emulsifiers – has hovered below the radar for many years. But as scientific understanding of the gut microbiome has grown, they have emerged as potential culprits in the modern western diet’s attack on gut health. And, as we now understand, gut health means general health because it governs everything from mood and metabolism to inflammation and immune response.
But emulsifiers are hard to avoid. “In the UK, there are 63 different types in the food supply,” says Kevin Whelan, head of nutritional science at King’s College London. “We’ve done a research study showing that more than 6,000 foods in the UK contain emulsifiers.” Some foods contain multiple emulsifiers, “three, sometimes four and up to 11”.
This is because emulsifiers are extremely useful. “They can be used for bread, chocolate, cakes, ice-cream, margarine and processed meats,” says food scientist Natalie Alibrandi, founder and CEO of Nali Consulting. They help products stay smooth and uniform in texture, and stop ingredients separating. “An emulsifier is used to combine water and oil,” says Alibrandi. “It is structured with a hydrophobic side, which does not like water, and a hydrophilic side, which does like water. So one side is helping bind to the oil or the fat in the product, and the other side is helping bind to the water.”
The ingredients list for Kingsmill’s Mighty White bread includes emulsifiers E471 (Mono- and diglycerides of fatty acids), E472e (diacetyl tartaric acid ester of mono- and diglycerides or DATEM) and E481, (sodium stearoyl lactylate or SSL). For bread, cakes and pastries, says Alibrandi, as well as helping keep the product consistent wherever it’s made, “they can help increase the shelf life, and make it softer, with less drying effects”. But particularly in baked goods with different components, from sponge and fillings to icings and chocolate drops on top, the various emulsifiers in the product can soon add up.
Emulsifiers are used in chocolate to delay the appearance of a white bloom that can happen if the sugar or fat rise to the surface. “With ice-cream,” says Alibrandi, “it’s so important to have the right amount of fat and air to create the ice structure [texture]. By adding an emulsifier, you’re helping combine the fat and water to create that structure. The same would go for margarine.”
Some brands, she says, are eschewing additives, with slogans like “separation is natural”. She gives the example of certain plant-based milk products. The downside for the consumer, she says, “is that when they add their non-dairy milk to their coffee, it separates. It doesn’t look good, it doesn’t taste good, it’s got a different texture. Whereas by adding emulsifiers, you can help make the product look and taste smooth.”
Alibrandi is comfortable eating them, noting that they’ve been used for more than 50 years in the industry and have long been deemed safe by the appropriate bodies. “Emulsifiers are ubiquitous,” she says. “They are in everything within the food and beverage industry, and we wouldn’t have the convenience and shelf life of products that we do without having these types of ingredients.”
Inflammatory bowel disease affects one in 200 people, and those who eat a more ultra-processed diet seem to be at higher risk
The trouble is, says Megan Rossi, research fellow at King’s College London and founder of The Gut Health Clinic, that the original food safety assessments were done before we knew much about the gut microbiome. She, and the other researchers who have turned their spotlight on emulsifiers, are primarily trying to help those with inflammatory bowel disease – incidences of which have steadily increased since food became industrialised. It is now rising in economically developing countries. “We’ve known for a long time that people who eat a more ultra-processed diet seem to be at higher risk,” says Rossi, “which we’ve been trying to get our heads around for decades. Inflammatory bowel disease affects one in 200 people. So it’s really quite common and there’s not really a cure for it at the moment.”
There are many elements in an ultra-processed diet that could play havoc with the gut microbiome, but in terms of emulsifiers, says Rossi, “if you think about how they combine water and oil together and turn into this kind of soap [emulsifiers are also used in detergents], we think that may make the gut lining more vulnerable to penetration of specific inflammatory microorganisms”.
Preliminary research has indicated this could well be the case, and it is this research that is now grabbing headlines. It began in earnest in 2015, says Whelan, when a paper was published by one of their collaborators, Benoit Chassaing at Université Paris Cité. He tested the effects in mice of two common emulsifiers: CMC (carboxymethyl cellulose), and P80 (polysorbate 80). “He fed them water containing either CMC, P80 or neither,” says Whelan, “and he found that the mice consuming the emulsifiers had dramatic changes to the diversity of their bacteria. They had a reduction in the number of different types of bacteria in the gut. We don’t think that is a good thing to happen to your gut microbiome.” Greater numbers of pro-inflammatory bacteria were present, too, but this wasn’t all.
In the mice that consumed emulsifiers, the mucus wall that protects their guts was much thinner. “The emulsifiers had emulsified the mucus, so some of it had been dissolved away,” says Whelan. “This meant the bacteria were much closer to the lining of the gut. What he also showed was that there was much more ‘leaky gut’ – the passage of bacteria, but also other molecules getting through the lining, causing more inflammation.” It looked as though these emulsifiers could be driving inflammatory disorders of the gut such as Crohn’s disease and ulcerative colitis. But these were mice, not humans.
The next step was to eradicate emulsifiers from people’s diets, and see if this helped ease their inflammatory conditions. This is where Whelan came in. “I spend all my time designing diets that are complex, and trying to work out how we might be able to get people to follow them,” he says.
His team started with a small feasibility study in 2020, in 20 people with Crohn’s disease, to see if they could manage to avoid emulsifiers for two weeks. “We found that compliance was really good,” says Whelan, “and actually, lots of people felt a little bit better. The problem is, you can’t take that as proof that the diet works, because when anybody gets a lot of support, and takes part in a study, they feel a little bit better.” That’s why the big trial they are currently undertaking includes a control group on a placebo.
Meanwhile, US researchers in 2017 had run another small study in which 12 patients with ulcerative colitis, the long-term inflammation of the colon and rectum, cut all emulsifiers from their diets for up to 12 months. Five took a daily capsule containing the emulsifier carrageenan, and the other seven participants took a placebo capsule. Three of the five taking carrageenan relapsed, while none of the placebo group did. The same year, the European Food Safety Authority identified food emulsifiers as an emerging risk.
Whelan’s new clinical trial is placebo-controlled, with 150 people with Crohn’s disease. For eight weeks, half will consume a normal diet, and half will move to a low-emulsifiers diet, to see if that will make their inflammation better. “We’re about two-thirds of the way through,” he says, “and we’re really excited to get more patients, so if you can mention that in the article that would be amazing for us.”
This work-in-progress situation leaves consumers in a tricky situation – should we be searching the back of every food packet for emulsifiers before buying? “I can understand that lots of people are concerned about what to eat,” says Whelan. “But my view is it’s too early to be saying we should not be adding emulsifiers to our foods. I also think it’s too early to be saying that everybody should stop eating any emulsifiers in foods.” But that doesn’t mean people shouldn’t start trying to eat a less processed diet. “We should be encouraging people to cook more from scratch, not rely so much on packaged ready meals and things like that – there’s certainly no harm in doing that.”
Among the many things we don’t know about emulsifiers is which, if any, are the most harmful. After his early mouse studies, Chassaing experimented with many more emulsifiers. “Some really didn’t have any effect at all,” says Whelan. “Soy lecithin [commonly used in chocolate] has not very much of an effect. But again, this is only in animals. Nutrition is so nuanced, so now is not the time to start advising people on which ones to avoid.” Eventually, when robust work is complete, there may be scope to work with the food industry to help them reformulate. “There are lots of opportunities and it’s a complex problem to solve.”
Complex indeed. Sarah Berry, chief scientist at Zoe, a personalised nutrition app based on research by gut health scientists, says that emulsifiers, in her opinion, “are only a fraction of the problem with ultra-processed foods, and I think where we go wrong is over-focusing on single ingredients”. It’s not that she doesn’t think emulsifiers aren’t a potential problem, but they’re just one of many ways in which ultra-processed foods affect health. They are more calorie-dense than minimally processed equivalents and we consume them 50% faster, she says, which means our fullness signals don’t have time to kick in. Normally, it would take “about 10 to 20 minutes” to feel full, Berry adds.
Ultra-processed foods tend to have less of the healthy ingredients such as fibre, high-quality proteins and healthy fats. And they tend to pack in more sugar and saturated fat. Added to all this is one of Berry’s recent research topics, which is how the structure of food is changed by industrial processing. She has found that products using commercially ground almonds are 30% more calorific than whole almonds, and eating powdered porridge oats results in a 30% higher sugar spike, simply because more cell walls have been broken, releasing more calories.
And when it comes to the additives, emulsifiers aren’t the only ones in question. There are also stabilisers, preservatives, colourants and sweeteners – all contributing, says Berry, “to this perfect storm”.
This isn’t about scaremongering: scientists are loth to trigger premature conclusions about individual ingredients, although in Rossi’s own clinical practice, she says, “when I’m talking to clients, or patients, I do say that we are investigating food additives that, if you have a predisposition, or if you do have Crohn’s disease, that it probably is smarter to try to limit the amount of these ultra-processed foods, many of which contain these food additives.”
Rossi says she understands why so many people struggle to kick the habit of consuming processed foods, despite their health impact. “I’m a busy mum,” she says, “and packaged foods – let’s face it – allow us to function, to work full-time and all that sort of stuff.” While she is conscious of how many different types of additives are in the foods she chooses, she advises we remember that they’re not all evil – and ill effects are dose dependent. Lecithin is a type of emulsifier, she says, but is found naturally in eggs. “So I think we need to be cautious of how obsessive people get with food additives – another common additive is ascorbic acid, which is vitamin C. We shouldn’t be demonising all additives, and a lot of them do ensure there’s a longer shelf life.”
Not all ultra-processed foods even contain emulsifiers, or any harmful additives, but will have some of the other unhealthy attributes that Berry listed. “We have probably been too reliant on these ultra-processed foods,” says Rossi. “We need to dig a little bit deeper into what we’re consuming. Certainly it’s not going to be toxic or cause cancer overnight, so we can still include them. But if most of your diet is coming from these ultra-processed packaged foods, then it probably is worth re-evaluating.”
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Nutrition Research
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Photography by Akhtar Soomro Reporting by Charlotte Greenfield and Gloria Dickie Filed June 14, 2022, 05:00 a.m. GMT Heavily pregnant Sonari toils under the burning sun in fields dotted with bright yellow melons in Jacobabad, which last month became the hottest city on Earth. Her 17-year-old neighbour Waderi, who gave birth a few weeks ago, is back working in temperatures that can exceed 50 Celsius (122 Fahrenheit), with her newborn lying on a blanket in the shade nearby so she can feed him when he cries. "When the heat is coming and we're pregnant, we feel stressed," said Sonari, who is in her mid-20s. These women in southern Pakistan and millions like them around the world are at the searing edge of climate change. Pregnant women exposed to heat for prolonged periods of time have a higher risk of suffering complications, an analysis of 70 studies conducted since the mid-1990s on the issue found. For every 1 degree Celsius in temperature rise, the number of stillbirths and premature deliveries increases by about 5%, according to the meta-analysis, which was carried out by several research institutions globally and published in the British Medical Journal in September 2020. Cecilia Sorensen, director of the Global Consortium on Climate and Health Education at Columbia University, said the unfolding impact of global warming on the health of women was "highly underdocumented", partly because extreme heat tended to exacerbate other conditions. "We're not associating health impacts on women and often times it's because we're not collecting data on it," she said. "And often women in poverty are not seeking medical care." "Heat is a super big deal for pregnant women." Sonari collects muskmelons, at a farm on the outskirts of Jacobabad, May 17, 2022. REUTERS/Akhtar Soomro Women are especially vulnerable to rising temperatures in poor countries on the frontlines of climate change because many have little choice but to work through their pregnancies and soon after giving birth, according to interviews with more than a dozen female residents in the Jacobabad area as well as half a dozen development and human rights experts. Further adding to the risks, women in socially conservative Pakistan - and many other places - typically cook the family meals over hot stoves or open fires, often in cramped rooms with no ventilation or cooling. "If you're inside cooking next to a hot open fire you have that burden of that heat in addition to the ambient heat which makes things that much more dangerous," Sorensen added. EXTREME HUMID HEAT EVENTS South Asia has suffered unseasonably hot temperatures in recent months. An extreme heatwave that scorched Pakistan and India in April was 30 times more likely to happen due to climate change, according to scientists at World Weather Attribution, an international research collaboration. Global temperatures have risen by about 1.2 degrees Celsius above pre-industrial levels. As temperatures continue rising, extreme heatwaves are only expected to increase. Jacobabad's roughly 200,000 residents are well aware of their reputation as one of the world's hottest cities. "If we go to hell, we'll take a blanket," is a common joke told in the area. Few places are more punishing. Last month, temperatures hit 51 Celsius (124 Fahrenheit) on May 14, which local meteorological officials was highly unusual for that time of year. Tropical rains can also conspire with warm winds from the Arabian Sea to drive up humidity later in the year. The more humid it is, the harder it is for people to cool down via sweating. Such conditions are measured by "wet bulb temperatures," taken by a thermometer wrapped in a wet cloth. Wet bulb temperatures of 35C or higher are considered the limit to human survival. Jacobabad has crossed that threshold at least twice since 2010, according to regional weather data. And, globally, such "extreme humid heat events" have more than doubled in frequency in the last four decades, according to a May 2020 study in the journal Science. Women and children wash themselves using a hand pump, after work at a muskmelon farm on the outskirts of Jacobabad, May 17, 2022. REUTERS/Akhtar Soomro Sonari, who is in her 20s, and Waderi work alongside about a dozen other women, several of them pregnant, in the melon fields about 10 km from Jacobabad's centre. They begin work each day at 6 a.m. with a short afternoon break for housework and cooking before returning to the field to work until sundown. They describe leg pains, fainting episodes and discomfort while breastfeeding. "It feels like no one sees them, no one cares about them," aid worker Liza Khan said more broadly about the plight facing many women in Jacobabad and the wider Sindh region which straddles the border of Pakistan and India. Khan's phone rings constantly as she drives to one of three heatstroke response centres she has helped set up in recent weeks as part of her work with a non-profit group called the Community Development Foundation. With a finance degree, Khan has lived in cooler cities across Pakistan but returned to her hometown because she wanted to be a voice for women in the conservative area. "Nowadays I'm working 24/7," said the 22-year-old, adding that her organization was finding the impact of extreme heat increasingly intertwining with other social and health issues affecting women. THE FRONTLINES OF SUFFERING The harsh conditions facing many women were brought into tragic focus on May 14, the day temperatures in Jacobabad hit 51 C, making it the world's hottest city at that time. Nazia, a young mother of five, was preparing lunch for her visiting cousins. But with no air conditioning or fan in her kitchen, she collapsed and was taken to a nearby hospital, where she was pronounced dead from a suspected heat stroke District health officials did not answer requests for comment about Jacobabad's record of heat-related deaths in recent years, or more specifically about Nazia's case. Her body was taken the following day to her ancestral village to be buried and her children, the youngest a one-year old who was still breastfeeding, regularly cry for their mother, a relative said. Widespread poverty and frequent power cuts mean many people can't afford or use air conditioning or at times even a fan to cool down. Potential strategies recommended by experts include providing clean-energy stoves to replace open-fire cooking, offering women's medical and social services during early morning or evening hours when it is cooler and replacing tin roofs with cooler material in white to reflect solar radiation away from the home. Climate Change Minister Sherry Rehman told Reuters that women were likely bear the brunt of rising temperatures as they continued to scorch the country, adding that climate change policies in the future needed to address the specific needs of women. "A megatrend like climate change ... poses a significant threat to the well-being of unempowered women in rural areas and urban slums," she added. "Pakistani women, especially on the margins, will be impacted the most." Some in Jacobabad find it galling that Pakistan is responsible for just a fraction of the greenhouse gases released in the industrial era and now warming the atmosphere. "We are not contributing to the worsening, but we are on the frontlines as far as suffering is concerned," said Hafeez Siyal, the city's deputy commissioner. Men sleep on charpoy rope beds on a roof,, early in the morning, May 15, 2022. REUTERS/Akhtar Soomro NO WATER, NO POWER, WE PRAY In a residential neighbourhood of the city, a donkey-drawn cart stacked with blue plastic jerrycans stops near the entrance to warren-like lanes leading to a cluster of homes. The cart's driver runs back and forth delivering 20-litre containers of water from one of a few dozen private pumps around the city. Most residents of Jacobabad rely on such water deliveries, which can cost between a fifth and an eighth of a household's meagre income. Still, it's often not enough, and some families are forced to ration. For young mother Razia, the sound of her six-month-old Tamanna crying in the afternoon heat was enough to persuade her to pour some of her precious water over the baby. She then sat Tamanna in front of a fan, and the child was visibly calmer, playing with her mother's scarf. Local officials said water shortages were partly due to electricity cuts, which mean water cannot be filtered and sent via pipes throughout the city. There are also severe water shortages across Sindh, with climate change minister Rehman flagging shortfalls of up to 60% of what is needed in the province's key dams and canals. Rubina, Razia's neighbour, fried onions and okra over an open fire, explaining she usually felt dizzy in the heat and tried to soak herself in water each time she cooked to prevent herself from fainting. There was not always enough water to do so, though. "Most of the time, it ends before it's time to buy more and we must wait," Rubina said as she closely supervised her children and grandchildren sharing a cup of water. "On the hot days with no water, no electricity we wake up and the only thing we do is pray to God." The Wider Image Photography by Akhtar Soomro Reporting by Charlotte Greenfield and Gloria Dickie Photo editing by Gabrielle Fonseca Johnson Text Editing by Mike Collett-White, Katy Daigle and Pravin Char Design by John Emerson and Kezia Levitas Parya, 42, a labourer, works in the sun during a heatwave at a brick kiln factory, May 14, 2022. REUTERS/Akhtar Soomro Follow Reuters Investigates
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Global Health
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WASHINGTON -- The leading decongestant used by millions of Americans looking for relief from a stuffy nose is likely no better than a dummy pill, according to government experts who reviewed the latest research on the long-questioned drug ingredient.
Advisers to the Food and Drug Administration voted unanimously on Tuesday against the effectiveness of the ingredient found in popular versions of Sudafed, Allegra, Dayquil and other medications sold on pharmacy shelves.
“Modern studies, when well conducted, are not showing any improvement in congestion with phenylephrine,” said Dr. Mark Dykewicz, an allergy specialist at the Saint Louis University School of Medicine.
The FDA assembled its outside advisers to take another look at phenylephrine, which became the main drug in over-the-counter decongestants when medicines with an older ingredient — pseudoephedrine — were moved behind pharmacy counters. A 2006 law had forced the move because pseudoephedrine can be illegally processed into methamphetamine.
Those original versions of Sudafed and other medicines remain available without a prescription, but they account for about one-fifth of the $2.2 billion market for oral decongestants. Phenylephrine versions — sometimes labeled “PE” on packaging — make up the rest.
If the FDA follows through on the panel’s recommendations, Johnson & Johnson, Bayer and other drugmakers could be required to pull their oral medications containing phenylephrine from store shelves. That would likely force consumers to switch to the behind-the-counter versions of the pills or to nasal sprays and drops that contain phenylephrine, which are not under review.
This week’s two-day meeting was prompted by researchers at the University of Florida, who petitioned the FDA to remove phenylephrine products based on recent studies showing they failed to outperform placebo pills in patients with cold and allergy congestion. The same researchers also challenged the drug’s effectiveness in 2007, but the FDA allowed the products to remain on the market pending additional research.
That was also the recommendation of FDA's outside experts at the time, who met for a similar meeting on the drug in 2007.
This time, the 16 members of the FDA panel unanimously agreed that current evidence doesn't show a benefit for the drug.
“I feel this drug in this oral dose should have been removed from the market a long time ago,” said Jennifer Schwartzott, the patient representative on the panel. “Patients require and deserve medications that treat their symptoms safely and effectively and I don’t believe that this medication does that.”
The advisers essentially backed the conclusions of an FDA scientific review published ahead of this week’s meeting, which found numerous flaws with the 1960s and 1970s studies originally used to support phenylephrine’s approval. The studies were “extremely small” and used statistical and research techniques no longer accepted by the agency, regulators said.
“The bottom line is that none of the original studies stand up to modern standards of study design or conduct,” said Dr. Peter Starke, the agency’s lead medical reviewer.
Additionally, three larger, rigorously conducted studies published since 2016 showed no difference between phenylephrine medications and placebos for relieving congestion. Those studies were conducted by Merck and Johnson & Johnson and enrolled hundreds of patients.
A trade group representing nonprescription drugmakers, the Consumer Healthcare Products Association, argued that the new studies had limitations and that consumers should continue to have “easy access” to phenylephrine.
Like many other over-the-counter ingredients, phenylephrine was essentially grandfathered into use during a sweeping FDA review begun in the 1972. It has been sold in various forms for more than 75 years, predating the agency's own regulations on drug effectiveness.
“Any time a product has been on the market that long, it’s human nature to make assumptions about what we think we know about the product,” said Dr. Theresa Michele, who leads the FDA’s office of nonprescription drugs.
But FDA reviewers said their latest assessment reflects new testing insights into how quickly phenylephrine is metabolized when taken by mouth, leaving only trace levels that reach nasal passages to relieve congestion. The drug appears more effective when applied directly to the nose, in sprays and drops.
There’s unlikely to be any immediate impact from Tuesday’s panel vote, which is not binding.
The group’s negative opinion opens the door for the FDA to pull phenylephrine from a federal list of decongestants deemed effective for over-the-counter pills and liquids. The FDA said removing the products would eliminate “unnecessary costs and delay in care of taking a drug that has no benefit.”
The FDA's nasal decongestants drug list, or monograph, has not been updated since 1995. The process for changing a monograph has traditionally taken years or decades, requiring multiple rounds of review and public comment. But a 2020 law passed by Congress streamlines the process, which should allow the FDA to accelerate the publication of new standards, doses and labeling for nonprescription ingredients.
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.
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Drug Discoveries
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COLUMBUS, Ohio -- At Cleveland's Urban Kutz Barbershop, customers can flip through magazines as they wait, or help themselves to drug screening tests left out in a box on a table with a somber message: “Your drugs could contain fentanyl. Please take free test strips.”
Owner Waverly Willis has given out strips for years at his barbershop, hoping to protect others from unwittingly being exposed to the highly potent synthetic opioid ravaging the U.S. and often secretly laced into other illegal drugs.
“When I put them out, they just fly out the door,” said Willis, who proudly hands out about 30 strips a week as part of The Urban Barber Association, a Cleveland organization that provides health education to the community via local barbershops.
Nearly 18 years into his own sobriety from drugs, Willis isn't shy about making the strips available. He figures he’d be dead if fentanyl were so widely prevalent when he was using.
Fentanyl has driven overdose deaths in the U.S. since 2016, and that isn't changing as the cheaper and deadlier synthetic opioid continues to be cut into the drug supply. Approximately 75,000 of the nearly 110,000 overdose deaths of 2022 could be linked to fentanyl, according to data from the U.S. Centers for Disease Control and Prevention. Legalizing test strips could bring those numbers down, advocates say, saving lives by helping more people understand just how deadly their drugs could be.
Until this spring, use of the strips was technically illegal in Ohio. It has joined at least 20 other states whose lawmakers formally decriminalized the strips since Rhode Island became the first in 2018. Pennsylvania, South Dakota, Kentucky and Mississippi also followed suit this year.
The CDC recommends fentanyl test strips as a low-cost means of helping prevent drug overdoses. They can detect fentanyl in cocaine, methamphetamine, heroin and many other drugs — whether in pills, powders or injectables.
Yet these small paper strips are still considered illegal in some states, outlawed under drug paraphernalia laws dating to the 1970s era war on drugs — long before fentanyl began seeping into the nation's drug supply. Every state but Alaska had an anti-paraphernalia law on the books by the mid-1980s, making materials used for testing and analyzing illicit substances illegal.
Increasingly, the strips are now being seen as potentially lifesaving.
Newark, Ohio, resident Rodney Olinger has used methamphetamines for eight years. The 45-year-old gets four to five fentanyl test strips weekly from the Newark Homeless Outreach, and calls them a “blessing.” He credits the strips with helping ensure he and his fiancée, who also uses, stay alive.
“It’s very scary,” Olinger said of fentanyl. “Just a little bit could kill you.”
While the strips may not prevent drug use overall, they allow testers to take a pause if a strip comes back positive, possibly encouraging them to reconsider drug use and seek help, said Sheila Vakharia with the national nonprofit Drug Policy Alliance, which seeks to shape U.S. drug policy.
“You never know if a fentanyl test strip can keep someone alive long enough so they can make that decision for themselves,” she said.
The CDC says any drug that dissolves in water can be tested. The strip is dipped in the solution for about 15 seconds, set out a few minutes, and is positive for fentanyl if a single pink line appears. Two pink lines is a negative result.
The strips can often be obtained from advocacy groups, local and state health departments, or purchased online.
Where strips are illegal, the push to change the law continues.
In Kansas, lawmakers debated until April whether to legalize the strips. But there was never any debate for Kansas mother Brandy Harris, who lost her 21-year-old son Sebastain Sheahan to a fentanyl overdose in April 2022. Addicted since age 13, he was first prescribed opioids after being hit by a truck.
Friends and family knew Sheahan as “big-hearted” and “goofy” with a soft spot for abused animals. He was open about his addiction issues and had been clean three years before he died after a relapse.
Harris believes her son would still be alive if he’d had test strips showing what he was ingesting. “I do believe that if these were available, that at least one person would be saved,” Harris said. “And that is the main goal -- at least one person.”
Kansas’ governor recently signed a bipartisan bill decriminalizing the strips starting July 1.
Montana and other states are considering similar legislation. Republican Gov. Greg Abbott of Texas recently dropped opposition to decriminalizing the strips, citing a “better understanding” of how they prevent opioid deaths.
And in Pennsylvania, Republican state Rep. Jim Struzzi lost his brother to a drug overdose in 2014 and lobbied colleagues for years to destigmatize the strips.
“Fentanyl isn’t going to ask you if you’re a Democrat or a Republican before it kills you,” said Struzzi, who sponsored state legislation making test strips legal in January.
The shift in how political leaders view the strips has advocacy groups, health departments and outreach programs optimistic. Increased legalization opens doors for more funding, including for strips themselves and for public education campaigns.
The SOAR Initiative, a Columbus, Ohio-based nonprofit fighting overdose deaths, distributes about 5,000 strips each month, according to executive director Jessica Warner.
SOAR sends out the strips via mail to anonymous recipients, both individuals and larger distributors. Handing them out never brought legal consequences in Ohio even before.
In fact, prosecution for possessing the strips doesn’t appear to be occurring anywhere in the U.S., according to Jonathan Woodruff of the Legislative Analysis and Public Policy Association, which tracks drug laws nationwide. He said drug paraphernalia possession is a minor offense in most states and law enforcement may now be more attuned to the strips' lifesaving benefits.
Northeast of Boston, police Lt. Sarko Gergerian of the Winthrop Police Department has boxes of them stacked in his office.
Legalized in Massachusetts in 2018, the strips go into “survival kits” that his department, as part of the Community and Law Enforcement Assisted Recovery Program, gives to those struggling with substance use — as well as to recovery coaches and social workers for distribution.
Gergerian calls it a “win” when a life is saved — not the arrest of someone struggling with addiction.
“Could you imagine if your kid was addicted to a substance and they weren’t ready to give it up?” Gergerian posed. “We need to keep them alive. Anything else is immoral.""
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Kantele Franko in Columbus, Ohio, and John Hanna in Topeka, Kansas, contributed to this report.
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Samantha Hendrickson is a corps member for the Associated Press/Report for America Statehouse News Initiative. Report for America is a nonprofit national service program that places journalists in local newsrooms to report on undercovered issues.
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Drug Discoveries
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Anxiety is when you feel tense and worried. It's natural to have these feelings from time to time. But if you feel this way often, it can be an anxiety disorder. It can cause intense attacks that speed up your heart rate, raise your blood pressure, and make you sweaty or dizzy. Anxiety can also affect your sleep.
Insomnia is when you have trouble falling or staying asleep. If this happens to you at least three times a week for more than 3 months, itâs called chronic insomnia. It can eventually make you more likely to have other health conditions, including an anxiety disorder.
The Link Between Anxiety and Insomnia
Constant worry during the day often carries over into night. That can cause âmental hyperarousal,â which can keep you from falling asleep.
Sleep disturbances such as these, like insomnia, can be a symptom of an anxiety disorder.
Once you do get to sleep, an anxiety disorder also can prevent you from staying asleep long enough to feel fully rested. Anxiety can be compared to your bodyâs alarm system -- it can help keep you safe and out of potentially dangerous situations. But if that alarm goes off all the time and for no real reason -- as it does with an anxiety disorder -- it can keep you from getting enough deep sleep.
Researchers have also found evidence that a chronic lack of sleep can also affect your emotional health. Studies show that people who have obstructive sleep apnea, which causes you to have episodes of pauses in your breathing and wake up continually through the night, are more likely to have mental health conditions like anxiety, panic disorder, and depression.
Could I Have Insomnia or an Anxiety Disorder?
Chronic insomnia is defined as when you have trouble falling or staying asleep for a specific time frame that can't be explained by another health concern. But an anxiety disorder is harder to diagnose.
In addition to ongoing tension, worry, and trouble with sleep, other signs of an anxiety disorder include:
- Steering clear of situations that trigger your fears
- Nervousness, restlessness
- A sense of impending danger
- Increased heart rate or breathing
- Sweating or trembling
- Trouble concentrating
- Digestion problems
- Having trouble controlling worry
See your doctor if you have these symptoms or your level of worry has drastically changed your lifestyle or is affecting work or school. Call 911 if you start having thoughts of hurting yourself or committing suicide.
Sleep Anxiety vs. Somniphobia
Anxiety about sleep can cause somniphobia. Somniphobia is an extreme fear of sleep that can stem from a variety of sources including previous trauma or fear of sleepwalking. If you have sleep anxiety, you may worry about getting enough sleep. But if you have somniphobia, your fear is more intense, you may be scared to sleep, and you may focus on what could happen when you fall asleep.Â
Symptoms of somniphobia
If you have somniphobia, you may experience distress when you think about sleep or try to go to sleep. Other symptoms can include feeling irritable, having a lack of focus because of thinking about sleeping, putting off going to bed as long as possible, and leaving the lights and/or TV on while trying to sleep.
Other physical symptoms of somniphobia include panic attacks, chest pain, hyperventilation, and heart palpitations.
Causes of somniphobia
Doctors are unsure as to what causes somniphobia but believe it can come from a few sources, including:
Tossing and turning (insomnia). Often, dreading sleep is the result of a sleep disorder.
One in three adults worldwide have symptoms of insomnia, which is the most common cause of this fear. When people donât get the sleep they need, they become concerned.
Chronic nightmares. Chronic nightmares are another troublesome sleep disorder that can cause fear. Children are especially vulnerable, but adults, especially those who have post-traumatic stress disorder, have nightmares, too.
Fear of dying while sleeping. You may worry about sleep because you have a health condition. If you have obstructive sleep apnea, for example, you may sometimes fear that youâll stop breathing in your sleep. While this fear is rare, it may occur when someone learns that they have sleep apnea and are waiting for a CPAP (continuous positive airway pressure) device to treat it. Once the apnea is under control, some people have increased alertness and less daytime sleepiness.
Fear of dying during sleep can also occur if you have heart issues such as sudden cardiac arrest, stroke, seizure, or sedative overdose. Your risk for sudden cardiac arrest during sleep is higher if you have heart disease, lung disease, or obstructive sleep apnea.
Repeated sleep paralysis. Sleep paralysis is when you are unable to move while falling asleep or waking up. This paralysis can sometimes occur with hallucinations and can be hereditary. It can create nervousness about falling asleep.
What You Can Do?
Sleep and anxiety disorders are treatable.
Some options that can help to eliminate the fear of sleep include:Â
Practicing good sleep hygiene.
- Go to bed at the same time every night and wake up at the same time every morning.
- Create a bedtime routine, including the same restful activities every night like playing soft music .
- Donât eat or drink any caffeinated or alcoholic beverages before bed.
- Steer away from napping during the day.
- Only go to bed when you feel sleepy.
- Get regular exercise.
- Avoid long-term use of sleep medications.
- Keep your bedroom cool and dark.
- Limit your bedroom activities to sleep and sex.
- Maintain a healthy weight.
Insomnia can be treated with cognitive behavioral therapy or sleep medications. Chronic nightmares may require imagery rehearsal therapy or similar treatments like exposure, relaxation, and rescripting therapy, which involves rewriting and rehearsing a new version of the nightmare during the day. It can also be treated with various prescription medications.Â
You should also talk to your doctor if you think you have sleep apnea or another condition thatâs disrupting your sleep.
If you have an anxiety disorder, your doctor may recommend options similar to those available for sleep concerns, including:Â
- Psychotherapy. A mental health specialist may suggest relaxation techniques. Cognitive behavioral therapy, which is the most effective form of psychotherapy for anxiety disorders, can also be used to effectively treat anxiety by helping you understand and better control your emotions and behavior.
- Medication. A doctor may also recommend medications, including certain antidepressants and anti-anxiety medications, or short-term use of sedatives or beta-blockers.
You can also do a few things to help break the cycle between anxiety and insomnia:
- Practice meditation.
- Prioritize and delegate your to-do list.
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Mental Health Treatments
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Within the last two months, four locally acquired cases of malaria were, according to the Centers for Disease Control and Prevention, marking the first time in 20 years that the potentially fatal mosquito-borne disease has been transmitted within the United States.
"Locally acquired cases" mean the infections were not linked to foreign travel and appear to have been spread by mosquitoes in the U.S. carrying the parasite that causes the illness.
"Malaria is a medical emergency and should be treated accordingly," the CDC wrote in a Health Alert Network Health Advisory. "Patients suspected of having malaria should be urgently evaluated in a facility that is able to provide rapid diagnosis and treatment, within 24 hours of presentation."
Here's what else to know about the disease.
How is malaria transmitted?
People typically get malaria by being bitten by an infective female Anopheles mosquito.
"This means that we have had malaria spread into the mosquito population here, which means that the risk for getting malaria here in this country is higher than it used to be... and that is really concerning," said Dr. Céline Gounder, a CBS News contributor and editor-at-large for public health at KFF Health News.
The disease is most common in tropical climates, putting nearly half the global population at risk, according to the World Health Organization. WHO estimates there were about 247 million cases of malaria worldwide in 2021, and 691,000 deaths. The vast majority of cases and deaths occurred in Africa.
Less commonly, "Malaria can also be transmitted through blood transfusion, organ transplant or the shared use of needles or syringes contaminated with blood," the CDC's website reads. "Malaria may also be transmitted from a mother to her unborn infant before or during delivery."
The diease is not contagious between humans, meaning it can't be spread from person to person like a cold.
"It cannot be sexually transmitted, (and) you cannot get malaria from casual contact with malaria-infected people, such as sitting next to someone who has malaria," the CDC says.
What are malaria symptoms in humans?
Mild symptoms may include headache, fever and muscle aches, Gounder told CBS News.
Symptoms may also include nausea and vomiting, diarrhea, abdominal pain, fatigue, rapid breathing, rapid heart rate and cough, according to the Mayo Clinic.
More severe symptoms include change in mental status as well as lung and kidney failure. And if not promptly treated, the infection can also cause seizures, coma and death.
"Severe malaria can be deadly and it is a medical emergency," Gounder said. "So people who have signs and symptoms of malaria should get checked out as quickly as possible."
Symptoms typically begin about 10 days to 4 weeks after a person was infected, "although a person may feel ill as early as 7 days or as late as one year later," the CDC notes.
Is malaria fatal?
Yes, severe malaria can be deadly — but there are treatments available. Gounder advises people who have signs and symptoms of malaria to get checked by a doctor as quickly as possible.
Is there a cure for malaria?
The illness can be treated and cured with prescription medications.
Several factors go into determining the best treatment plan, according to the CDC, including the patient's clinical status, the type of infecting parasite, where the infection was acquired as well as any potential drug allergies and other medications taken.
Timing of treatment is key and should be initiated as soon as possible, the CDC says.
Malaria prevention
While most malaria cases are connected to people who have traveled out of the country, the CDC advises the public to take steps to prevent mosquito bites and control mosquitoes at home.
To prevent bites, experts advise usingand wearing loose-fitting, long-sleeved shirts and pants. The CDC and WHO recommend insect repellents with active ingredients that include:
- DEET
- IR3535
- Oil of lemon eucalyptus (OLE)
- Picaridin (KBR 3023)
some repellents are not suitable for children: DEET is not recommended for children younger than 2 months old, while lemon eucalyptus oil should not be used on children under 3 years old.
At home, use screens on windows and doors to help keep mosquitoes out, and use air conditioning if it's available. You can also help stop mosquitoes from laying eggs by reducing any standing water near where you live.
"Once a week, empty and scrub, turn over, cover or throw out items that hold water, such as tires, buckets, planters, toys, pools, birdbaths, flowerpots or trash containers," the CDC suggests.
Aliza Chasan contributed to this report.
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Epidemics & Outbreaks
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Findings from a recent study suggest that mindfulness meditation may reduce interference from emotional distractions, particularly positive emotional distractions, in various perceptual load conditions. In the study, which was published in the Journal of Cognitive Enhancement, meditators showed improved attentional control and reduced emotional distraction compared to non-meditators.
Mindfulness meditation is a practice that involves training your mind to stay present and fully engaged with the here and now. It’s all about paying attention to your thoughts and feelings without judgment, helping you become more aware of your surroundings and experiences.
Mindfulness meditation has gained popularity in recent years for its potential to enhance mental well-being. Previous studies have shown that mindfulness can improve our attention and help us process emotions more effectively. However, until now, little research had examined how mindfulness affects our attention in the presence of emotional distractions and varying levels of available focus.
The new study delves into uncharted territory by exploring the combined effects of mindfulness and perceptual load on attention. Perceptual load refers to the amount of attention required for a task, and understanding how mindfulness interacts with it can be incredibly valuable for individuals seeking to improve their focus and emotional control.
“Lately, mindfulness-associated practices have gained substantial popularity among the mainstream population as a means to well-being and are also receiving ample attention from researchers as a subject of psychological investigations. Through this study, we wanted to advance the scientific investigation by understanding the mechanisms by which mindfulness meditation influence behaviours in a goal-oriented tasks,” said study author Rashmi Gupta, an associate professor at the Indian Institute of Technology Bombay.
To investigate this, the researchers conducted two experiments. In the first, they compared the effects of emotional distractions (happy and angry faces) on individuals with mindfulness meditation experience and those without it. Participants engaged in a letter search task while emotional stimuli vied for their attention. The researchers measured how these emotional distractions impacted their performance.
In the second experiment, they replicated the study with emotionally evocative images (pleasurable erotica and unpleasurable gore), aiming to understand how mindfulness and perceptual load interacted with emotions of varying intensity.
The participants were recruited from a community sample through emails, posters, and word of mouth. They were required to meet specific inclusion criteria, such as age between 18 and 45, right-handedness, normal or corrected-to-normal vision, and either having at least one month of regular mindfulness meditation practice or no experience in any form of meditation. Importantly, both groups (meditators and non-meditators) were age-matched to ensure that any differences in the results were not due to age-related factors. The final sample included 154 individuals.
In the first experiment, the researchers found participants without mindfulness experience were significantly affected by both positive and negative emotional distractions, particularly in low perceptual load conditions. This suggests that emotional distractions could impair their task performance.
However, individuals who practiced mindfulness meditation displayed better attentional control, especially in high perceptual load conditions. They could effectively manage their attention even when resources were limited, distinguishing them from non-meditators.
In the second experiment, the researchers found that mindfulness meditators exhibited higher interference from negative distractors than positive distractors in high perceptual load conditions. However, their overall task performance remained unaffected, suggesting that mindfulness practitioners were better at managing their attentional resources.
These findings suggest that by training the mind to be present and attentive, individuals may improve their ability to manage distractions and process emotions more efficiently. Additionally, mindfulness might reduce the need to seek satisfaction from external pleasurable distractions. This could mean that those who practice mindfulness meditation find greater contentment in their internal states, rather than relying on external stimuli for happiness.
“Simply put, practicing mindfulness might provide an effective remedy to the problems of modern life,” Gupta told PsyPost. Quoting from the research article, she added that “today, we are bombarded with information ‘like countless work emails, social media notifications, food offerings, and innumerable online series, hooks our attention and distracts us from the task at hand. For example, while driving on a bustling highway, an individual might get distracted by a billboard advertisement displaying sales of his favourite clothing brand. The pleasurable feelings associated with it might make him lose his focus. Mindful awareness could help quickly shift the attention from the advertisement and pay attention to the road.'”
While these findings are promising, the study does have some limitations. It cannot definitively establish causation between mindfulness practice and improved attentional control. Individual differences, personality factors, and self-selection biases may have influenced the results.
Future research could address these limitations by conducting longitudinal studies with active control groups. These studies would help determine whether mindfulness meditation genuinely causes the observed differences in attentional control.
“We cannot assuredly attribute the observed results to mindfulness meditation because there was no mindfulness training given,” Gupta said. “Questions regarding the length and intensity (dose) of practice needed to see the changes needs to be addressed.”
The study, “Are You Distracted by Pleasure? Practice Mindfulness Meditation“, was authored by Surabhi Lodha and Rashmi Gupta.
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Mental Health Treatments
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A study spearheaded by Oregon State University has shown why certain polyunsaturated fatty acids work to combat a dangerous liver condition, opening a new avenue of drug research for a disease that currently has no FDA-approved medications.
Scientists led by Oregon State's Natalia Shulzhenko, Andrey Morgun and Donald Jump used a technique known as multi-omic network analysis to identify the mechanism through which dietary omega 3 supplements alleviated nonalcoholic steatohepatitis, usually abbreviated to NASH.
The mechanism involves betacellulin, a protein growth factor that plays multiple positive roles in the body but also contributes to liver fibrosis, or scarring, and the progression to cirrhosis and liver cancer.
"We only succeeded in finding these surprising results because we implemented an entirely unbiased approach that incorporated a diverse type of big data analysis ranging from lipids and metabolites to whole tissue and single-cell RNA sequences," said Morgun, a researcher in the OSU College of Pharmacy.
Findings were published in EMBO Molecular Medicine.
NASH is associated with a disorder known as metabolic syndrome. It develops when fat in the liver becomes toxic, killing liver cells, inflaming the organ and promoting fibrosis. The disease can lead to permanent scarring (cirrhosis), liver failure and possibly death.
People are considered to have metabolic syndrome if they have at least two of the following conditions: abdominal obesity, high blood pressure, high blood sugar, low blood levels of "good" cholesterol and high levels of bad cholesterol and triglycerides.
A diet high in saturated fat and refined sugars causes chronic low-grade inflammation that contributes to the development of metabolic syndrome. Metabolic syndrome is also associated with cognitive dysfunction and dementia as well as being a major risk factor for cardiovascular disease, Type 2 diabetes and NASH.
An estimated 35% of U.S. adults have metabolic syndrome, the researchers note.
In this study, scientists used both a mouse model and human liver transcriptome data -- the total of all the messenger RNA molecules expressed from the genes -- to uncover betacellulin as the target of omega-3 polyunsaturated fatty acids, often abbreviated as omega 3 PUFA.
"Via large meta-analysis, we found betacellulin is consistently up-regulated in livers of cancer patients -- there's more of it than there should be," Morgun said. "And omega 3 PUFA lower, or down-regulate, betacellulin in both mice and humans with NASH. Targeting betacellulin expression is one of the mechanisms for omega 3 PUFA reduction of western-diet-induced NASH."
Beyond greatly advancing the understanding of how NASH starts and progresses, the findings open a new door for pharmaceutical research, he added.
"We found a novel drug target, and our results may aid in the quest for a precision-medicine approach to NASH treatment and liver cancer prevention by using specific omega 3 PUFA," Morgun said. "One thought is that patients' betacellulin could be monitored during treatment to determine optimal dosages for each patient."
In addition to dietary supplements, omega 3 PUFA, such as docosahexaenoic acid, are found in cold-water fatty fish such as salmon and mackerel and in some nuts, seeds and plant oils.
Omega 3 PUFAs are not manufactured by the body but are essential fatty acids that must be acquired from the diet. These fatty acids are involved in a wide range of bodily processes including cognitive function, vision, cell growth, regulation of multiple metabolic processes and cardiovascular function.
Jyothi Padiadpu, a postdoctoral researcher in the OSU College of Pharmacy, was the lead first author on the study. Other Oregon State researchers contributing to the paper were Nolan Newman, Richard Rodrigues, Sehhajvir Singh, Manuel Garcia-Jaramillo, Jacob Pederson, Zhipeng Li, Philip Monnier and Kevin Brown.
The collaboration included scientists from the National Institutes of Health's National Cancer Institute.
The research was supported by grants from the National Institute of Diabetes and Digestive Kidney Diseases, part of the National Institutes of Health.
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Disease Research
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The Busted musician tells the BBC the "ripple effect of addiction is huge" on families and loved ones.
When Matt Willis is going through a relapse, he describes it as a "complete loss of control".
Something switches in his brain when he drinks alcohol or takes drugs - and his only priority is consuming more. "Something else takes over," he says. "I can't turn that switch off."
He then finds himself inside a cycle of unhappiness and shame that he can't escape.
There have been times when he couldn't get to midday without getting drunk - and he was taking six grams of cocaine a day. By his 20s, he was completely addicted to alcohol and drugs.
Addiction is "exhausting, tiring, all-consuming," Matt says. "It's not an easy way out. It's really hard and horrible."
The Busted musician speaks about his experience with addiction in the BBC One documentary Matt Willis: Fighting Addiction. In it, he also explores the impact on the people around him.
"When I'm in active addiction, all I care about is me," he says, adding that his mindset becomes "selfish and self-absorbed".
Matt says his addiction has left emotional scars on his wife, TV presenter Emma Willis. "I loved her with all my heart but I couldn't stop," he says, "and nothing she could say or do would make me stop."
'Incredibly heavy'
Matt and Emma met while Busted - a pop-punk band with hits including What I Go to School For, Year 3000 and Air Hostess - was appearing on the music channel MTV.
Emma interviewed the band and the couple eventually started dating.
When they first met, Matt was a lot of fun to be around, Emma remembers, but his issues with alcohol and drugs became apparent even before they got married. He was in rehab just five weeks before their wedding day.
Matt, who started drinking in his early teens after a difficult childhood, has been to rehab four times.
Emma recalls times when she'd drive around local pubs trying to find him after he didn't return home at night.
She says living with Matt could be unpredictable and anxiety-inducing - and she feared he might die.
"It's not easy," Emma says. "It's been incredibly heavy at times."
Matt, who has now been sober for more than five years, describes the impact on loved ones as a "forgotten piece of the puzzle" when it comes to addiction.
"It's so much bigger than just the addict," he says.
Family and friends can often face things like stress, abuse, isolation, mental health difficulties and financial strain, says Vivienne Evans, chief executive of Adfam, a national charity tackling the effects of drugs and alcohol an addict's wider circle.
She adds that, too often, attention and support is given to those with the drug or alcohol problem while the needs of family members, "the ones bearing the brunt of it all, are forgotten".
"Many families suffer in silence," she says.
Adfam research from 2021, that sampled more than 2,000 people, suggests four million adults in the UK are dealing with the negative impacts of a friend or family member's drinking - while one and a half million are negatively affected by drug use.
The Busted singer opens up about his struggles with addiction and the pressure it puts on his family, as well as looking into what helps him and others stay clean.
Matt says reflecting on how his addiction has affected Emma has, at points, left him "in pieces".
"She was so focussed on keeping me clean that she neglected her care, and I did too," he says.
Emma and Matt have three children - and when he describes how he's nervous about his eldest child watching the documentary, his voice breaks and tears come to his eyes.
"It's going to be really hard to see her dad like that and what her mum had to deal with.
"But I think nothing should be swept under the carpet. We have to be as honest and open as possible."
'Fun had gone'
The Busted trio - Matt together with fellow band members James Bourne and Charlie Simpson - secured four number one hits, won two Brit awards and performed around the world.
But it was on tour that Matt's addiction would often get out of control. And it wasn't glamorous or rock 'n' roll, he says. "The fun had gone for a long time."
Looking back, Charlie says he never saw the "darker undercurrents" of Matt's addiction. "I was not aware at all of how bad things were," he says.
Matt, 40, says ideas around masculinity stopped him from talking about his emotions and what he was going through.
"There is a real problem with the mentality that you've just got to 'man up'. Those kinds of sayings really play into the psyche of boys when they're growing up."
Busted are going back on tour in September but Matt says he's confident things will be different this time.
"I've been really honest with the band and everyone knows what I'm dealing with. Everyone wants to help."
His rider for this tour, for example, is decidedly health-conscious: protein powder, nuts, berries and protein bars.
Matt, who has attended therapy, says journalling and writing a daily gratitude list has been helpful for his sobriety.
And Matt describes music as a way to escape, too. Until now, he hasn't written many songs about addiction, "because it's not very Busted," he laughs. "But who knows what's going to happen now?"
How to support a loved one dealing with addiction
Adfam's Vivienne Evans says there isn't enough specific support for families and friends of people dealing with addiction.
But she says, despite the stigma that often surrounds addiction, there are some things people can do, including:
- Making sure you're putting yourself first, by setting boundaries and taking care of your own mental health needs.
- Getting information on the nature of addiction, from addiction-specific charities.
- Seeking support from GPs, drug and alcohol treatment services and peer support groups, such as Al-Anon. Informal support can be helpful, too, like finding a friend in the same position and meeting for a coffee.
If you, or someone you know, have been affected by addiction, the following organisations via the BBC Action Line may be able to help.
Watch Matt Willis: Fighting Addiction on Wednesday 17 May, 21:00 on BBC One and on BBC iPlayer.
BBC images courtesy: Twofour / Phil Sharp
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Mental Health Treatments
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Doctors are cautiously hopeful about a new multiple sclerosis therapy after finding that injecting stem cells into patients’ brains was safe and potentially protective against further damage from the disease.
The small, early stage trial was only able to assess whether injecting cells directly into the brain was well tolerated by patients, but in tests carried out in the year after treatment, researchers found hints that the cells may have a long-lasting, beneficial impact.
“We don’t know yet whether this is the beginning of a fantastic journey or not, but the results are very strong and very consistent,” said Prof Stefano Pluchino at the University of Cambridge.
More than 2 million people worldwide live with multiple sclerosis. While most existing drugs target the early, relapsing remitting phase of the disease, two-thirds of patients still move on to the secondary, progressive and increasingly debilitating stage within 30 years of diagnosis.
The disease occurs when the body’s immune system attacks the protective myelin sheaths that wrap around nerve fibres, causing damage that disrupts how electric signals are beamed around the nervous system.
For the first in-human trial of the therapy, researchers injected between 5m and 24m neural stem cells directly into the brains of 15 patients with secondary progressive MS. Rather than rebuilding damaged tissues, the stem cells are thought to reduce the inflammation that drives the disease.
Some patients on the trial experienced side-effects, with one developing a tremor and another steroid-induced psychosis, but all recovered with treatment.
Tests on the patients over the following year found that none reported any worsening symptoms or increased disability, though most were using wheelchairs before the study and may not have deteriorated anyway. Brain scans revealed that patients who received higher doses of stem cells experienced less brain shrinkage, perhaps because the stem cells were dampening inflammation.
What intrigued the scientists most were tests on the cerebrospinal fluid that bathes the brain and spinal cord. These revealed that patients who received more stem cells had higher levels of compounds called carnitines, which are thought to protect neurons from damage. “What does it mean? I have no idea. But it is incredibly exciting,” said Pluchino. Details are published in Cell Stem Cell.
The researchers are now keen to run a larger trial to confirm whether or not the injections are changing the course of the disease. One factor they need to rule out is any effect from the immunosuppressive drugs patients took to prevent rejection of the stem cells.
Prof Paolo Muraro, an expert in neuroimmunology at Imperial College London, who was not involved in the study, said the trial set a benchmark for the manufacture and quality control of the cell-based drug. Further challenges remain, however. One is scaling up the therapy and making it affordable for large trials to investigate how effective the treatment is. “It is a long journey for hope, but certainly a worthy one,” Muraro said.
Caitlin Astbury at the MS Society said it was “a really exciting study” that built on previous research funded by charity. “These results show that special stem cells injected into the brain were safe and well-tolerated by people with secondary progressive MS,” she said. “They also suggest this treatment approach might even stabilise disability progression. We’ve known for some time that this method has the potential to help protect the brain from progression in MS.
“This was a very small, early-stage study and we need further clinical trials to find out if this treatment has a beneficial effect on the condition. But this is an encouraging step towards a new way of treating some people with MS.”
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Medical Innovations
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We may live in a largely secular society, but the Protestant work ethic is still alive and strong. The “lazy” and “entitled” millennials, we have been told, are workshy and self-indulgent. They spend too much and save too little – behaviour that is not only harming their future prospects, but those of the world economy.
We should have the grit of our elders, apparently – who weren’t scared to suffer some hardship with the promise of a better life ahead. Except they too are coming under criticism for enjoying the life that they struggled to earn. According to the UK chancellor, Jeremy Hunt, it is time for the over-50s to put away their golf clubs and start contributing to the economy again.
The gospel of self-restraint clearly runs very deep in the cultural psyche and, until recently, psychological research had seemed to confirm that delayed gratification was indeed the secret to long-term success. Yet some recent research has come to question these ideas. While moderate levels of willpower are almost certainly beneficial, people who attempt to avoid all kinds of indulgences are neither happier, nor healthier. They are not even more successful at achieving their goals.
By embracing rather than shunning our short-term desires, and knowing when and how to indulge them, we may enjoy greater wellbeing with no cost to our productivity.
The long and the short of it
By definition, delayed gratification is the idea that putting off temporary pleasure in the moment will lead to greater contentment once we have met our longer-term targets.
The research may be best represented by the famous “marshmallow test”, in which children were asked to resist eating one marshmallow immediately with the promise of enjoying two marshmallows a quarter of an hour later. Years later, those who had succeeded in the marshmallow test got better grades at school and progressed more quickly in their careers.
The finding proved to be so influential that it inspired education programmes devoted to building character; the idea even infiltrated Sesame Street, as the Cookie Monster learned to deal with his cravings – and taught viewers to do the same. “Me want it but me wait,” he sang in the accompanying electropop pastiche.
But does delayed gratification always lead to better wellbeing? Signs that this might not be the case were already apparent in the 1990s. Analysing the state of the evidence, Prof David Funder at the University of California, Riverside found that children who scored well on self-control also grew up to be overly reserved and lacked curiosity. He also pointed to research showing that women with very high levels of self-control tend to be at greater risk of depression, for instance. “The correlates of delay of gratification are definitely a mixed bag,” he concluded.
Later research suggested that people with the highest levels of self-control may suffer from feelings of regret. They can struggle to appreciate the present moment, and when looking back over their lives, they come to resent the sacrifices they have made.
To investigate this possibility, Prof Ran Kivetz of Columbia University and his doctoral student Anat Keinan asked university alumni to reflect on their winter breaks from 40 years previously. The researchers found that the ageing graduates were much more likely to lament having had too much self-control than too little at this key moment in their youth. Their regret over the pleasures that they had missed from being too sensible, such as turning down the chance to travel, was much greater than any guilt over their moments of indulgence – the times they had skipped their studies, spent too much and acted irresponsibly.
Interestingly, the researchers found exactly the opposite views among current undergraduates: these students were much more likely to endorse the standard view that self-control was preferable to indulgence. It was only with the perspective of a lifetime that the alumni could recognise how much richer their life might have been if they had practised a little less self-denial.
People with low self-control are often said to have a kind of psychological myopia, but Kivetz and Keinan proposed that many suffer the opposite problem – a psychological longsightedness that leaves them so deeply focused on their future goals, they cannot enjoy all the delicious distractions of the present moment.
Strategic indulgence
Besides ignoring these long-term regrets, historical psychological research might have overstated the short-term consequences of momentary indulgences. According to one prominent theory, any lapse would only encourage more slip-ups, as we find ourselves falling for further temptations.
If you are on a diet, for instance, one slice of cake may soon lead to another, until all your good intentions are in tatters. Similarly, once you start watching videos on YouTube, you may find that the whole morning has passed by without you getting any work done. For this reason, indulgences were seen as “failures” that should be avoided.
This idea also has religious origins. “This abstinence idea has its roots in Christianity,” says Prof Lile Jia at the National University of Singapore. Yet recent research shows that intermittently giving in to our desires can often be better for our wellbeing, without putting us on a slippery slope to failure. The trick, it seems, is to plan the indulgences in advance.
Consider a study of dieters, aptly titled The Benefits of Behaving Badly on Occasion, conducted by Prof Rita Coelho do Vale at the Católica Lisbon School of Business and Economics in Portugal and colleagues at Tilburg University in the Netherlands. All the participants wished to lose weight and aimed to consume an average of 1,500 calories a day. For those in the control condition, there was no opportunity for variation. Those in the “behaving badly” condition, however, were asked to eat just 1,300 calories on six days of the week; they could then enjoy a blowout of 2,700 calories on the seventh. Over the first two weeks, the researchers tracked the participants’ feelings of motivation and their general mood. They then followed up again one month later to find how much progress they had made.
As you might expect of people on calorie-restricted diets, the participants in both conditions lost a few kilos. On average, their body mass index dropped from about 25, which is considered overweight, to about 24, which is just within the “normal” category. There were, however, significant differences in their experiences of the diet: the people who had planned those days of indulgence reported more positive feelings and remained more motivated throughout. The participants who simply cut their calories without the treat days, in contrast, seemed to find it much harder work to maintain their self-control and stick to the diet. That could be crucial for a dieter’s long-term success.
Jia has noted similar phenomena in his research comparing the habits of students with high and low grade point averages (GPAs) at US universities. He was interested in the ways that they responded to big-time collegiate sports games – American football, basketball and baseball. These are an important part of student life in the US, but also a huge distraction from their studies. If successful self-control simply involves avoiding short-term pleasures in the pursuit of long-term goals, then you would expect the high-GPA students to have shunned the matches in the run-up to their exams.
To find out if this was the case, Jia and a colleague at Indiana University Bloomington asked 409 students to take an online questionnaire a week before a home basketball game against a long-standing rival team. They reported their general attitudes to basketball, and then gave an hour-by-hour plan for their studies on the day before the game, the day itself and the day afterwards.
Overall, the low- and high-GPA students hoped to devote roughly the same amount of time to studying over those three days; the big difference lay in the way they distributed those studies. The more successful students planned to take much more time off on the day of the game, but compensated for that with a few extra hours on the days either side of the match. The low-GPA students, in contrast, planned to skip the game entirely.
Crucially, a follow-up study confirmed that the more academically successful students were much more likely to have actively participated in watching the collegiate games and celebrating afterwards – and this brought significant pleasure. “They were enjoying the activities more,” says Jia. That would have then put them in a better psychological state to continue their studies the next day.
Jia’s latest research suggests that the advantages of “strategic indulgence” may come from an increased sense of autonomy – a finding that may be useful for anyone hoping to avoid procrastination at work.
Avoiding guilt
There are many ways that we could incorporate this new view of self-control by including a few strategic indulgences into our own lives. We can set up pleasant diversions in a long working day or schedule regular treats during our health kicks. If we’re saving money, we may set a date each month to enjoy the odd luxury as a reward for our frugal living.
Just as importantly, this research should teach us to look a little more kindly upon those unplanned indulgences that may accidentally take us a step away from our long-term goals. You may think that guilt and self-criticism will help you to learn from your mistakes, but recent psychological literature shows that they are often counterproductive. By increasing our stress levels, and reducing our sense of self-efficacy, these emotions can impair our motivation. You would do much better to treat yourself with a little self-compassion, relishing the pleasure before looking for practical means to get back on track.
As the study of university alumni showed, balance is the key – we should aim to weigh up the needs of our present or future selves to ensure that we are serving the health and happiness of each. And contrary to the self-help puritans, a little bit of hedonism is sometimes exactly what you need.
David Robson is the author of The Expectation Effect: How Your Mindset Can Transform Your Life (Canongate, £10.99). To support the Guardian and Observer order your copy at guardianbookshop.com. Delivery charges may apply
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Stress and Wellness
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A 14-year-old boy has been named America's Top Young Scientist for developing an affordable bar of soap that treats skin cancer.
Heman Bekele, a ninth grader at W.T. Woodson High School in Annandale, Virginia went head-to-head with nine other finalists in the 2023 3M Young Scientists Challenge and took home the $25,000 grand prize.
Bekele made the cancer-fighting soap by infusing medicinal soap with salicylic acid, glycolic acid and tretinoin, which have been found to reactivate dendritic cells that generate an immune response to combat cancer.
Not only does his soap help fight skin cancer, but Bekele found that each bar costs just $0.50, compared to the more than $40,000 needed for current medical treatments.
'Skin cancer is mostly found in people living in developing countries,' Bekele told Farifax County Public Schools.
'But the average price for an operation is $40,000.
'I was devastated by the idea of people choosing between treatment and putting food on the table for their families. There are so many preventable deaths.'
The teen started researching skin cancer and learning about dendritic cells, which he said help protect the skin by boosting immune response.
Bekele's video submission for the competition explains that the three ingredients are keratolytic agents that break down the skin's outer layers.
This allows toll-like receptors, proteins that play a key role in the innate immune system, to be released into the skin that latch on to and reactivate dendritic cells.
The dendritic cells join with white blood cells to fight the infected cells.
Over the next five years, Bekele hopes to refine this novel innovation and create a nonprofit organization to distribute this low-cost solution to needy communities.
Bekele calls the product skin cancer-treating soap or SCTS, which he said can be applied to the skin every couple of days after a prescription.
Along with his title comes a $25,000 prize, which Bekele hopes to put toward securing a patent and college.
He has dreams of becoming an electrical engineer when he grows up.
'I envision myself leading a team of professionals in the development of innovative electrical systems that will shape the future of technology,' Bekele said.
'Alongside my professional success, I hope to have a fulfilling personal life with a loving family and a strong network of friends.
'I also hope to have given back to my community by mentoring aspiring engineers and supporting initiatives that promote STEM education.
'Ultimately, in 15 years, I hope to have positively impacted the world through my work and personal endeavors.'
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Medical Innovations
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Americans who have a tooth pulled or another painful dental procedure in the United States today are far less likely to get opioid painkillers than they were just a few years ago, a new study shows.
That's good news, since research shows that opioids are not necessary for most dental procedures.
But the COVID-19 pandemic seems to have thrown a wrench into the effort to reduce opioid use in dental care -- and not just in the few months after dentists and oral surgeons started providing routine care again after a pause in spring 2020.
The decline in opioid prescriptions filled by dental patients was much faster in the pre-pandemic years 2016 through 2019, compared with the rate of decline from June 2020 to December 2022, the study shows.
In all, dental opioids dispensed to U.S. patients of all ages declined 45% from 2016 to the end of 2022, according to the new findings published in PLoS One by a team from the University of Michigan Medical School and School of Dentistry.
But even with the decline, 7.4 million dental patients of all ages filled opioid prescriptions in 2022.
Fortunately, opioid prescriptions to teens and young adults -- who face especially high risks related to opioids -- kept declining at a rapid rate after the pandemic pause in dental care, the study finds. But for other groups, the rate of decline slowed after June 2020.
In all, the researchers estimate, 6.1 million more dental opioid prescriptions were dispensed between June 2020 and December 2022 than would have been if pre-pandemic trends had continued.
And American dentists and oral surgeons were still prescribing opioids in late 2022 at four times the rate that another study showed British dentists were in 2016.
"These data suggest the dental profession has made major strides in reducing opioid prescribing, but also suggest that progress is slowing," said Kao-Ping Chua, M.D., Ph.D., the senior author of the new study and an assistant professor of pediatrics at U-M. He worked with first author and former U-M research assistant Jason Zhang, who is now in medical school at Northwestern University.
"We know from research that dental pain in most patients can be controlled with non-opioid medications, avoiding the risks of opioids," said co-author Romesh Nalliah, D.D.S., M.H.C.M., professor and associate dean for clinical affairs at the U-M School of Dentistry. "While it's reassuring that dental opioid prescribing is declining, the recent slowing in the decline suggests the dental profession must redouble its efforts to reduce unnecessary opioid prescribing."
The researchers couldn't determine the procedure that led to each opioid prescription, nor could they determine the exact reason for the slowing of the decline in dental opioid prescribing during the pandemic. However, there are some likely culprits.
"One reason for the slowing might be that dentists were more likely to prescribe opioids just in case they were necessary, out of concerns that patients couldn't easily follow up with their dentist during the pandemic," said Zhang.
Right-sizing prescribing
Chua, Nalliah and their colleagues have studied dental opioid prescribing multiple times, and worked with the Michigan Opioid Prescribing Engagement Network (OPEN) to develop prescribing guidelines for dental and oral surgery care (available at https://michigan-open.org/dentistry/).
Reducing the number of opioids dispensed to dental patients, especially young ones, is thought to reduce the risk of opioid misuse and diversion of pills to other people besides the patient.
Poisoning of others in the household, and interactions between opioids and other substances including alcohol and prescription drugs, are other reasons to focus on non-opioid dental pain care.
But no studies have examined dental opioid prescribing trends using pandemic-era data.
Differences by provider type, insurance type and region
The new study is based on data from a company called IQVIA that tracks prescriptions dispensed at 92% of U.S. pharmacies. The researchers excluded data from March through May of 2020, when routine dental care in the U.S. stopped temporarily.
The study revealed pandemic-associated changes in dental opioid prescribing varied widely. For instance, the rate of decline in opioid prescribing by oral and maxillofacial surgeons -- who perform more complex procedures on people with advanced dental conditions -- slowed during the pandemic to a lesser degree than for general dentists and dental subspecialists.
For low-income patients covered by the Medicaid program, the number of dental opioid prescriptions during June 2020-December 2022 was 57% higher than predicted than if pre-pandemic trends had continued. For privately insured patients, this percentage was 30% higher than predicted.
The authors speculated that worsened access to dental care in Medicaid patients -- who have already have poor access to begin with -- may have increased the number of painful dental emergencies and the need for opioids.
People living in the Southern U.S. made up nearly 46% of all people with dental opioid prescriptions in 2022, higher than any other region. But the researchers found that the decline in dental opioid prescribing to people in the Northeast slowed to a greater degree than in other regions. This meant that by the end of 2022, dental opioid prescribing was 69% higher in the Northeast than it would have been if declines had continued at pre-pandemic rates, compared with 23.8% in the South.
Additional authors:
In addition to Chua, Zhang and Nalliah, the study's authors include OPEN co-directors Jennifer Waljee, M.D., M.P.H., M.S. and Chad Brummett, M.D. All except Zhang are members of the U-M Institute for Healthcare Policy and Innovation, and Brummett co-directs the U-M Opioid Research Institute.
Chua is a member of the Susan B. Meister Child Health Evaluation and Research Center in the Department of Pediatrics, which also provided some of the funding for the study.
The study was also funded by the Benter Foundation and the Michigan Department of Health and Human Services.
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Drug Discoveries
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The U.S. Department of Health and Human Services (HHS) has recommended easing restrictions on marijuana, a department spokesperson said on Wednesday, following a review request from the Biden Administration last year. Reuters reports: The scheduling recommendation for marijuana was provided to the Drug Enforcement Agency (DEA) on Tuesday as part of President Biden's directive to HHS, the spokesperson said. "As part of this process, HHS conducted a scientific and medical evaluation for consideration by DEA. DEA has the final authority to schedule or reschedule a drug under the Controlled Substances Act. DEA will now initiate its review," a DEA spokesperson said.
Marijuana is currently classified as a schedule I drug under the Controlled Substances Act, meaning it has a high potential for abuse and no accepted medical use, along with drugs like heroin and LSD. HHS is recommending reclassifying marijuana to say it has a moderate to low potential for dependence and a lower abuse potential, which would put it in a class with ketamine and testosterone. "If marijuana classification were to ease at the federal level, that could allow major stock exchanges to list businesses that are in the cannabis trade, and potentially allow foreign companies to begin selling their products in the United States," notes Reuters.
While marijuana remains illegal on the federal level, nearly 40 U.S. states have legalized it in some form. According to a survey last year from the Pew Research Center, "an overwhelming share of U.S. adults (88%) say either that marijuana should be legal for medical and recreational use by adults (59%) or that it should be legal for medical use only (30%)."
Marijuana is currently classified as a schedule I drug under the Controlled Substances Act, meaning it has a high potential for abuse and no accepted medical use, along with drugs like heroin and LSD. HHS is recommending reclassifying marijuana to say it has a moderate to low potential for dependence and a lower abuse potential, which would put it in a class with ketamine and testosterone. "If marijuana classification were to ease at the federal level, that could allow major stock exchanges to list businesses that are in the cannabis trade, and potentially allow foreign companies to begin selling their products in the United States," notes Reuters.
While marijuana remains illegal on the federal level, nearly 40 U.S. states have legalized it in some form. According to a survey last year from the Pew Research Center, "an overwhelming share of U.S. adults (88%) say either that marijuana should be legal for medical and recreational use by adults (59%) or that it should be legal for medical use only (30%)."
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Drug Discoveries
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Sometimes there is a bleakly effective logic to underinvesting in public services. If they survive, then great, the money was saved. If they fail, then even better, because privatisation is here and ready to pick up the pieces. A classic example of this strategy is the NHS.
Junior doctors are working longer and harder, being paid next to nothing for it, and then blamed when things go wrong. There may soon be future strikes as their requests have not yet been met. Even though it is primarily about pay restoration, there is a wider context. They are now expected to put in extra shifts, compromise their career progression, and do work above their pay grade with no training or reward. This is by design.
Whenever the government reduces funding but maintains the service it is defunding, there is an undeclared expectation: the shortfall will be plugged by additional unpaid work and professional sacrifice. Staff are forced to crash course their training and dig deep into their moral and psychological reserves in order to make decisions they have not been adequately prepared for. The added salt in the wound is that the targets of patients’ distress are the staff right in front of them, not an abstract criminal history of a lack of investment.
This is also part of the design of underfunding, to shift responsibility on to those on the scene of the tattered service – slash and run, leaving the knife in the hands of those left behind. Our experiences with the NHS can happen at the sharp end of physical pain and emotional distress, and so the blame for its failures is understandably directed towards the institution and those who staff it: doctors who make mistakes or don’t show up, nurses who seem listless and unresponsive, or GPs who dispatch you after a five-minute consultation or cannot escalate your case quickly enough. Verbal and physical abuse of NHS staff is now a hazard of the job. They simply brace themselves before going to work.
And if you’re going to deny better conditions and pay for anyone, doctors are the easiest to justify. They are white collar, have high earning potential as their careers progress, and enjoy a professional prestige that makes it easy to target them as greedy or irresponsible – as the rightwing press has not wasted a moment in doing.
It is a testament to the enduring popularity of myths about the entitlement and poor work ethic of NHS staff, and striking workers in general, that just 54% support for the junior doctors’ strike is considered high. The government can still count on this bias, and the propaganda that sustains it, in its refusal to negotiate. The narrative focuses on the challenge that another strike will bring to a struggling system just so that doctors can get paid more at a time when everyone else is facing a cost of living crisis.
But it’s not about pay. It’s more existential than that. It’s about the limits of what humans can do when governments abdicate. What is asked of junior doctors now makes the entire practice and purpose of medicine questionable, let alone the viability of the NHS. A junior doctors’ strike is about commitment to a model of healthcare that, when properly resourced, provides free treatment to patients while also enabling doctors to receive the sort of wide-ranging medical training, research opportunities and academic specialisation support that they would never receive in the private sector.
As it stands, junior doctors pay hefty sums towards their own training and exams and they have to compete fiercely for a small number of senior positions. If they are from overseas, they have to pay huge, escalating sums for work permits and the residences of their dependents. Once junior doctors are consultants, they are too few in number, so have to lead, as much as is feasible, those junior doctors below them to do the work they cannot.
To expect junior doctors to continue like this is nothing short of holding them hostage to their choice of vocation and ambition to be the best doctors they can be. The government is asking them to take it or walk away. Increasingly, many across the NHS hierarchy are giving up. Almost 13,000 doctors gave up their medical licences last year, up almost 10% from the year before. They cite burnout, mental distress and impossible workloads. Nearly half of junior doctors are considering leaving the profession altogether.
Those who stay face a circular firing squad that compromises their ability to provide free, good quality healthcare and thwarts their ambition. Even an increase in junior staffing would be a drop in the ocean when there is no increase in bed capacity, no upgrades to administrative infrastructure, and no progression in a career that is founded on increasing specialisation. Junior doctors’ ability to continue to underwrite the government’s failures is not infinite, but the risk is that this state of affairs is normalised. The NHS has been under stress for so long that we have become desensitised to the toll of the crisis on both doctors and patients, and to the fact that it will, if nothing changes, inevitably reach a disastrous climax. I don’t know what that would look like, but I don’t want to find out.
Nesrine Malik is a Guardian columnist
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Health Policy
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Production of biological substances for medicine using genetically engineered yeast cells shows new promising results in basic research from an international team of researchers. In 2022, the researchers attracted international attention by programming the longest-ever biosynthetic pathway -- or 'assembly line' -- into a microbial cell factory and designing it to produce biological substances for cancer drugs.
In an article published in the scientific journal Nature Chemical Biology, Biosynthesis of natural and halogenated plant monoterpene indole alkaloids in yeast, the researchers now present results with the artificial production of the naturally occurring substance, alstonine, which has shown promising results for use in treating mental disorders.
"Development of medicines from natural plant substances is widely used. However, since plants do not produce these substances to fight human diseases, there is often a need to modify them to make them more effective and safe," says Michael Krogh Jensen, a senior researcher at DTU Biosustain and co-founder of the biotech company Biomia.
The researchers hope that the yeast platform can play a prominent role in discovering and developing plant-based medicine.
Fewer side effects for patients
The new research results prove that the engineered yeast cells can make other substances in the group of alkaloids than the substance vinblastine, for which the researchers presented results in 2022. In addition to producing the two new natural plant substances, alstonine and serpentine, the researchers have further developed the method to make 19 new derived variants of the two substances through a chemical process called halogenation, often used in medicine development. Today, up to 40 percent of the substances tested in human trials are produced by halogenation.
"We have found a method to make yeast cells use enzymes and carry out the same chemical process that takes place in halogenation. Plants generally can't naturally carry out halogenation. Therefore, our versatile biotechnological platform is a possible method for optimizing and developing plant-based alkaloids that may then be used to make medicines against, for example, schizophrenia, for which there are many negative side effects such as insomnia, weight gain and reduced immunity, when using existing medicines" says Michael Krogh Jensen.
The researchers created the yeast-based cell factories by inserting a large number of genes from plants that can generate biosynthesis of natural plant substances. In addition, they inserted enzymes from bacteria to halogenate these natural substances and tested the production in yeast. Following the conversion into serpentine and alstonine, the substances were purified. The researchers then tested their structure -- using an NMR analysis (Nuclear Magnetic Resonance spectroscopy), which looks at the composition of atoms -- and investigated their bioactivity in a cell line from monkeys.
Tested in human trials
The researchers have filed a patent application for the manufacture of the chemistry involved and established the company Biomia, which has a license to the patent portfolio that protects the manufacturing method. For drug discovery within part of the chemistry that the researchers presented in their Nature article from 2022 and this new study, Biomia raised 3 million USD in September 2023.
The research into the new yeast-based production of the halogenated plant-inspired natural substances and the 19 variants is still in an early phase, where the researchers are now finding the best candidates to use in treating mental disorders. The candidates must then be prepared for testing in clinical studies. At best, Michael Krogh Jensen expects to be able to send substances derived from alstonine to clinical trials in 2026.
Even if the clinical studies show promising results against schizophrenia or other mental disorders, it will still be at least ten years before the research may lead to new medicines for purchase at pharmacies.
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Drug Discoveries
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A Texas woman who nearly lost her life after giving birth was reunited at home this month with her now-4-month-old daughter and 2-year-old son.
Krystina Pacheco, 29, of Pleasanton, Texas, gave birth to her daughter Amelia on Oct. 24, 2022, in what she described as an uneventful C-section delivery.
Two days later, on the day she was discharged from the hospital, Pacheco said she started feeling feverish but assumed it was just part of her recovery post-C-section and was given ibuprofen by a nurse.
When she continued to feel unwell at home, Pacheco said she went to see a doctor, who sent her to a local emergency room.
From there, Pacheco was airlifted to a hospital in San Antonio, where doctors discovered her body was in septic shock.
"I just remember I couldn't breathe anymore and I couldn't see anymore and I just started slowly fading out," Pacheco told ABC News. "My husband, I could just hear him saying, 'Please come back to us, please, your babies need you. I need you. I need you to be here and help me with our babies,' and that's the last thing I remember."
Septic shock is the most dangerous stage of sepsis, which occurs when your body has an extreme response to infection. According to the National Institutes of Health, "without quick treatment, it can lead to tissue damage, organ failure, and even death."
In septic shock, the body has dangerously low blood pressure. Risk factors include recent infection or surgical procedure.
In Pacheco's case, the condition began to affect her heart, lungs and kidneys, according to her husband, Jacob Pacheco.
Jacob Pacheco said his wife was simultaneously put on dialysis to help her kidneys and on an ECMO machine, a lifesaving device that removes carbon dioxide from the blood and sends back blood with oxygen to the body, allowing the heart and lungs time to rest and heal.
"They didn't want to tell us how close she was [to death] but you could see it in their faces every time I asked," Jacob Pacheco said, adding that doctors at the time gave his wife a 20% survival rate. "It was scary."
Jacob Pacheco, a coach and teacher, who met Krystina because they both work in the special education field, said he relied on family and friends for support as he stayed by his wife's bedside while also needing to care for their newborn daughter and young son.
"We would bring them to the hospital and our families would meet there and we would take care of them in the lobby," he said of their children, Amelia and Owen. "It was, you know ... living just day by day, just trying to take care of Krystina."
For the two weeks Krystina Pacheco remained in the intensive care unit and on dialysis and the ECMO machine, Jacob Pacheco said he and his mother-in-law and father-in-law took turns sitting by her bedside.
In mid-November, Krystina Pacheco began to turn a corner and improved enough that doctors were able to take out her breathing tube so she could speak.
"The first thing she said to me was, 'What happened to me? Did I almost die?,'" Jacob Pacheco recalled. " And we had a moment of tears -- tears of sadness, tears of joy, just a bunch of emotions coming over us."
Though Krystina Pacheco was now awake, she still had to face what she now describes as the "hardest thing" she's been through.
Just before Thanksgiving, she said doctors told her they would need to amputate both of her feet and hands because of the damage they had sustained while she was in intensive care.
One of the risk factors of an ECMO machine is poor blood flow to the limbs, which can result in the need for amputation, according to the Cleveland Clinic, which was not involved in Krystina Pacheco's medical care.
"My hands and feet were black. They looked like a person who had gotten frostbite," she said, adding that her medical team "tried to do everything they could" to avoid having to amputate.
"I was just breaking down and being absolutely crushed that that's where we were at, at that point," Krystina Pacheco said of learning amputations were necessary. "And crying with my family, crying with Jacob, and just being sad that my life would no longer be the same."
In addition to undergoing an initial surgery to amputate both arms below the elbows followed by a second surgery days later to amputate both legs below the knees, Krystina Pacheco said she underwent nearly one dozen skin grafts over the next several weeks because the skin around her amputations was so damaged.
"Every day I woke up and thought about my babies and every time I went into a surgery, my thought was, I have to get home to be with my babies, so if that means going through one more surgery, then ultimately I have to go through another surgery," she said. "They were my number one motivation, hands down."
In late January, three months after she was admitted, Krystina Pacheco was discharged from the hospital and moved to TIRR Memorial Hermann, a rehabilitation center in Houston.
There, Krystina Pacheco, who previously taught group fitness classes outside of her full-time job, spent several weeks healing her amputation wounds and learning to live as a double amputee, while also rebuilding her strength after a three-month hospital stay.
"Any task, any exercise, I tried it and I gave it my 100%," she said, adding that she started applying the motivation she had taught in group fitness to herself. "I would self-talk to myself, like, 'Come on. You've got this. Just get this,' so I would push a little. I even surprised myself some of the time."
Dr. Vinay Vanodia, medical director of the amputee and limb loss rehabilitation program at TIRR Memorial Herman, said Krystina Pacheco's self-motivation helped her progress really quickly in rehab.
"When she first came in, I had received a message about this young patient who came in with these unfortunate amputations after pregnancy and her baby was at home while she was here," Vanodia told ABC News. "But when we went to see her, she was such a bright light and it just changed the whole mood."
He continued, "Any challenge we put in front of her, she was able to accomplish. She just gave 100% and was able to make a lot of progress while she was with us."
On Feb. 11 -- more than 100 days after she was hospitalized and away from her newborn daughter and son -- Krystina Pacheco was able to return home.
"I cried," she said of the moment she arrived home. "I hugged [Jacob] really right. He knew I was overcome with emotions."
Krystina Pacheco said she has no lingering medical complications from her septic shock scare beyond her amputations. She is currently doing workouts at home to rebuild her strength and will start outpatient rehabilitation soon so she can get stronger and be self-sufficient in tasks like transferring herself from her bed to a chair and the shower.
The Pachecos said they have been overwhelmed with the help they've received from friends, family and their community over the past several months, from helping to take care of their children to raising money to help them cover medical costs and costs associated with making their home wheelchair-friendly.
Jacob Pacheco said that new challenges have arisen as his wife has settled in at home, but they are moving forward, looking at each new challenge as a new "chapter" in their story.
"It's not easy, and it's not going to be easy," he said. "We were definitely crying yesterday and ... it's okay to feel those things. It's not easy, but if we're sticking together, it makes it that much better."
Krystina Pacheco said she plans to return to work as a licensed specialist in school psychology, and wants to share her story to inspire other people and raise awareness of limb differences. She will soon be able to use state-of-the-art prosthetics for both her hands and feet, according to Vanodia.
When it comes to her kids, she described them as "resilient" and said her 2-year-old son Owen is always by her side and willing to help his mom with everyday tasks like pushing up her sleeves and opening her makeup.
Her 4-month-old daughter Amelia is now catching up on the bonding time she missed with her mom in the very first months of her life.
"That's one of the things that does break my heart a little bit still and that I'm working through is that mommy guilt of not being able to be with my baby every day for her first three months of her life," Krystina Pacheco said. "But you know, I'm home now and we're making those adaptations as we go and we're adjusting and being a little family again."
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Medical Innovations
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If you've just been diagnosed with psoriasis, you may have a few questions about it. Here are answers to some of the more common ones people ask.
What's the difference between psoriasis and eczema?
To an untrained eye, these conditions may seem alike. But while they're both skin diseases, they're not the same. In fact, "They're 100 percent different," says Whitney High, MD, an associate professor of dermatology and the director of the Dermatopathology Laboratory at the University of Colorado Anschutz Medical Campus.
Psoriasis doesn't usually affect children, High says. But eczema, or atopic dermatitis, is a childhood disease. Eczema also tends to be itchier than psoriasis. Only about a third of people who have psoriasis say they have itchiness.
And the conditions are likely to appear in different places. Eczema often shows up on kids' faces and buttocks and the inside of their knees and elbows. Psoriasis isn't typically found in those places.
Plus, "The same person that has childhood eczema doesn't get psoriasis. And the person who has psoriasis as a young adult usually didn't have childhood eczema," High says.
What causes psoriasis?
Doctors arenât exactly sure. âI get that a lot of times; âWhy do I have it?ââ says Melvin Chiu, a doctor of dermatology at the David Geffen Medical Center at the University of California, Los Angeles. âI donât really ⦠have a good answer for that. Itâs a big mystery, I think, right now.â
Chiu says researchers believe the two main culprits behind psoriasis are your genes and your environment. Scientists are still tracking down which genes are to blame, but they think that about 1 out of every 10 people got at least one of the genes that can lead to psoriasis from their parents. But only about 3% of people who have those genes get psoriasis. That's where the environment comes into play.
Researchers think things like infection (especially strep throat), an injury to the skin, certain medications, smoking, and other things may trigger the condition.
What's the cure?
"There is no cure at this point," Chiu says. "It's a chronic condition. ⦠You may have times when it'll be worse, and there may be times when it'll get better." He also says there may be some lucky people in whom it's very minimal. Or it gets better and doesn't get worse again. But, he says, most people "can expect it will be persistent." Treating it can make it better. But when treatments stop, it often comes back.
"There are some really excellent treatments," he says. "There are newer treatments in the pipeline, and many treatments [that] are available currently ⦠work very well." Those treatments don't cure the disease, he says. "But they significantly improve the disease and make [people] feel better."
What are the treatments?
The most common ones are medicines prescribed by your doctor. They include foams, solutions, ointments, or creams, called topicals, that you put on your skin, along with drugs you take that affect your whole body. Your doctor also may recommend light therapy.
"Consult with a board-certified dermatologist, and they'll be happy to discuss any and all of these options, including over-the-counter options when they're appropriate," High says.
What works for one person may not work for another. That's why you and your doctor need to talk about what your treatment plan should be.
Chiu says that with the treatments available now, "we can get skin a lot better." He says that 20 to 30 years ago, psoriasis patients had much worse options and many fewer ones than people do now. "I tell people, it's kind of an exciting time in psoriasis."
Can the sun help?
Some research says a little every day can help with your symptoms. But, as always, you have to be careful not to overdo it. A sunburn may lead to a flare-up.
Is psoriasis contagious?
You can't "give" it to anyone, and no one can "catch" it from you.
"You can touch psoriasis all day long," High says. "As a dermatologist ⦠I see at least one person if not a few people with psoriasis [every work day], and I don't have it." High adds, "My wife doesn't have it. I didn't bring it home. I don't do special laundry. I don't undress in the garage or anything like that."
What is psoriatic arthritis?
Up to 30% of people who have psoriasis get this condition as well. It causes inflammation and swelling in your joints that can lead to pain and stiffness.
If you have psoriasis and feel any discomfort in your joints, tell your doctor. It's important to treat it quickly so your joints don't get damaged. Â
Are any other conditions linked to psoriasis?
Research is still under way, but scientists think people with psoriasis and psoriatic arthritis may be more likely to have other serious diseases.
"There's an increasing appreciation that psoriasis can manifest in other ways: increased risk of cardiovascular disease, increased risk for obesity ⦠a natural risk for diabetes," High says. "It might impact your life in ways that you can't even really fully predict now."
Besides cardiovascular diseases and obesity, psoriasis also has been linked to cancer, Crohn's disease, depression, and liver disease, among others.
That's even more reason to stay in touch with your doctor and make sure you have a plan.
Show Sources
SOURCES:
American Academy of Dermatology: âPsoriasis,â âWho Gets and Causes.â
National Psoriasis Foundation: âAbout Psoriasis,â âThe Immune System and Psoriatic Disease.â
CDC: âPrevalence of Psoriasis Among Adults in the U.S.â
Whitney High, MD, associate professor of dermatology, University of Colorado; Dermatopathology Laboratory director, University of Colorado.
Melvin Chiu, MD, director, Psoriasis and Phototherapy Center, David Geffen School of Medicine, University of California, Los Angeles; assistant professor of medicine, David Geffen School of Medicine, UCLA; health sciences assistant clinical professor, dermatology, David Geffen School of Medicine, UCLA.
American Academy of Dermatology: âWhatâs the difference between eczema and psoriasis?â
National Psoriasis Foundation: âAbout Psoriatic Arthritis,â âCauses and Triggers,â âComorbidities Associated with Psoriatic Disease,â âGenes and Psoriasis,â âModerate to Severe Psoriasis and Psoriatic Arthritis: Biologic Drugs,â âPsoriasis Treatments,â âWhy early diagnosis is critical for psoriatic arthritis.â
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Disease Research
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Press release -
Swap red meat for Quorn protein to improve heart health and reduce waist circumference, study finds
People looking to reduce their cholesterol and trim fat from around their waist could try swapping meat for Quorn protein, according to the findings from a new study by Northumbria University, Newcastle, published in the European Journal of Nutrition, which saw positive effects in both areas in just two weeks.
Researchers from the University found that participants who ate Quorn products – the popular mycoprotein-based meat substitute - over just a two-week period, saw a significant 12% drop in ‘bad’ LDL cholesterol and a 7% fall in total cholesterol, compared to those who ate similar products made from red and processed meat. In addition, they also reduced their waist circumference by close to 1cm (0.95cm) on average over the 14 days.
Such a drop in total cholesterol levels could, according to medical research, reduce a person’s risk of dying from a cardiovascular disease, such as a stroke or coronary heart disease, by as much as 9% . Waist circumference is a good measure of abdominal fat and a key marker of cardiovascular health, with a near 1cm reduction in the mycoprotein group, achieved within a short period, suggesting potential benefits for heart health and body composition.
The investigator-blind trial - which involved 20 healthy male adults who were randomly assigned to consume 240 grams per day of red and processed meat or an equivalent amount of Quorn over two 14-day periods – also revealed further heart health benefits from consuming mycoprotein, the unique ingredient in all Quorn products. Researchers identified a clinically meaningful trend toward lower systolic and diastolic blood pressure in the mycoprotein group, potentially contributing to improved cardiovascular health.
The findings come after the latest annual Health Survey for England estimated that well over half (59%) of adults suffer from raised cholesterol , almost two-thirds (64%) are overweight or living with obesity and almost a third (30%) have high blood pressure . All three are known to cause cardiovascular disease – meaning millions of people could be at risk of a potentially fatal heart attack or stroke.
High cholesterol is mainly caused by diets high in saturated fat, carrying excess fat around your waist and not exercising enough, and is described, alongside high blood pressure, as one of the ‘silent killers’ that are often symptomless and only identified through a medical emergency.
Elevated levels of low-density lipoprotein (LDL) cholesterol, often referred to as ‘bad’ cholesterol, can lead to the build-up of fatty plaques in a person’s arteries, which restrict blood flow and increase their risk of a heart attack or stroke. Currently, high LDL cholesterol is associated with a quarter (115) of the 460 heart and circulatory disease deaths recorded in the UK every day.
Almost eight million people in the UK rely on statins to lower their cholesterol, but there is growing concern, following shortages, about the affordability of these drugs, with the most prescribed statin, atorvastatin, recently increasing in price from 49p to £5.30 over a six-week period .
Maintaining a healthy waist circumference is also known to be important for preventing future heart attacks and strokes. A larger waist typically indicates that there’s excess fat around and inside organs and when this happens in the liver, for example, it pushes out too much fat and sugar into the blood, increasing the risk of coronary heart disease and type 2 diabetes. This is a particular risk when excess fat is carried around the lower torso in the abdominal area.
Commenting on the study findings, lead researcher Dr Daniel Commane, Associate Professor in Nutritional Sciences at Northumbria University, said:
“At a time when millions of people have high cholesterol and excess tummy fat, this study is the latest of several human dietary intervention trials where mycoprotein has demonstrated significant cardiovascular benefits.
“It’s important as it highlights how making a simple dietary change to consume mycoprotein can deliver impressive heart health benefits in a very short period of time, cutting the risk of a person dying from cardiovascular disease by as much as nine per cent according to some models. It also demonstrates how mycoprotein could play a key role in supporting weight loss and long-term weight management - which is hugely important when we consider the health risks of obesity and that almost two in three people in England are clinically overweight.
“This latest study builds on previous research we conducted, which revealed that Quorn mycoprotein significantly reduces the presence of cancer biomarkers and improves gut health.”
Fungi-based proteins like Quorn’s mycoprotein are a separate kingdom of food, distinct from plant-based foods, and they are increasingly being recognised for their distinct nutritional attributes. Cultivated via the age-old process of fermentation, mycoprotein is a ‘complete protein’ that’s low in saturated fat, contains no cholesterol, and is recognised as a healthy source of protein and fibre. Quorn mycoprotein forms part of a healthy and sustainable diet, with mycoprotein included in the Eatwell Guide , the UK Government’s healthy eating guidelines.
Tim Finnigan, Scientific Advisor for Quorn Foods and Visiting Professor at Northumbria University, said:
“While many millions of people have been diagnosed with raised cholesterol or high blood pressure, there are millions more who remain undiagnosed, and tackling these silent killers should remain an absolute priority.
“There’s a myriad of solutions to these challenges, some costing more than others, but what is clear from this research and other recent studies, is that people can make a huge difference to their heart health just by adding mycoprotein to their diet.
“Made by fermenting a naturally occurring fungus, it replicates the taste and texture of meat incredibly well and is supported by a rich evidence base of more than 20 published studies showing its health benefits as a quality protein.”
You can learn more about the study findings in the European Journal of Nutrition.
Topics
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Nutrition Research
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- The U.S. Food and Drug Administration approved a birth control pill for use without a prescription for the first time in U.S. history this week.
- Opill will be available in major stores and online in early 2024, according to the manufacturer Perrigo.
- Women could face barriers to obtain Opill because health insurance is not currently required to cover birth control without a prescription.
The first birth control pill sold without a prescription in the U.S. could remain out of reach for some women and girls because health insurance plans are not required to cover the medication in its over-the-counter form.
The U.S. Food and Drug Administration on Thursday approved the sale of the oral contraceptive Opill without a prescription, a historic decision that should make birth control pills easier to obtain by eliminating the need to visit a doctor's office and refill prescriptions.
One-third of adult women who have ever tried to obtain prescription contraception have faced barriers to access, according to a survey published in the Journal of Women's Health in 2016.
Opill's manufacturer Perrigo expects the pill to be available in major stores and online in early 2024. Perrigo will announce the price of Opill in a couple months before the pill is in stores, said Frederique Welgryn, a Perrigo executive, during a call with journalists Thursday.
Welgryn said the company is committed to ensuring Opill is affordable. Perrigo is setting up a patient assistance program so the cost of the pill is not a barrier for women struggling to make ends meet.
But some women and girls could still face barriers to obtain Opill. The Affordable Care Act does not require private health insurance to cover the cost of the pill when used without a prescription. Most health insurers are required to offer birth control for free when prescribed by a doctor.
State Medicaid programs are also generally not required to cover drugs sold without prescription, according to the federal Centers for Medicare & Medicaid Services.
Welgryn said Perrigo is working to enlist private insurance and state Medicaid programs to offer over-the-counter Opill to women and girls for free. But she said the Affordable Care Act needs to be tweaked to guarantee that health insurance pays for birth control without a prescription.
Welgryn said it is unclear whether insurance coverage for Opill will be in place when the pill is available in stores early next year. "We have some work to do to make that happen. It's going to take time," she said.
Democrats in Congress and President Joe Biden are pushing to expand access to contraception.
Sen. Patty Murray, D-WA, reintroduced legislation called Affordability is Access in the Senate in May that would require health insurers to offer oral contraceptives without a prescription for free.
Biden ordered the U.S. Department of Health and Human Services in June to ensure all contraceptives approved by the FDA are available without out-of-pocket costs.
CMS is encouraging health insurance to cover over-the-counter contraceptive products for free, an agency spokesperson said Friday. The agency is working on ways to ensure contraceptives approved by the FDA for use without a prescription are available without cost sharing, the spokesperson said.
Opill is 93% effective at preventing pregnancy. It is the most effective form of over-the-counter contraception in the U.S. Opill should be taken at the same every day to ensure its effectiveness.
Welgryn said 15 million women in the U.S. who are sexually active and don't want to get pregnant are using a form of contraception that is less effective than Opill or no contraception at all.
Nearly half the six million pregnancies in the U.S. every year are unintended, according to the FDA. Unintended pregnancy is linked to preterm delivery, which can result in poor health outcomes for newborns, according to the agency.
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Women’s Health
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Paxlovid is Pfizer's antiviral medication to treat COVID-19. (Reuters/Wolfgang Rattay/Illustration)When the antiviral medication Paxlovid was approved in 2021 to treat COVID-19, doctors began noticing a perplexing trend among some of the patients who took the medication: a rebound case of the virus. After treatment, some people would recover and test negative for the virus, only to test positive or have symptoms come back a few days later. “Paxlovid rebound,” as it’s known, received a lot of media attention when President Biden, first lady Jill Biden, as well as Drs. Anthony Fauci and Rochelle Walensky, director of the Centers for Disease Control and Prevention, all experienced it last year after taking the medication.Scientists are not sure why this rebound effect occurs when taking Paxlovid, but here are a few things we do know.What is Paxlovid? How does it work?Paxlovid is an oral antiviral pill that can be prescribed to people who come down with COVID-19 and are at risk for developing severe disease. This can be individuals who are unvaccinated, the elderly or people with other medical conditions, such as cancer or diabetes. The drug, developed by Pfizer, can protect these high-risk patients from needing hospitalization. Those who are vaccinated but who are at risk for severe outcomes of COVID-19 can also benefit from taking Paxlovid.U.S. regulators granted emergency use authorization for Paxlovid in December 2021. Today the drug is available by prescription only, from a physician or pharmacist. Anyone ages 12 and older who weighs at least 88 pounds and who is at high risk for severe disease is eligible for the medication. Patients with severe kidney disease — or who are on dialysis — or people with severe liver disease, however, should not take Paxlovid. The drug can also interact with other medications such as those that treat high cholesterol, high blood pressure and migraines, so patients taking these drugs should avoid taking Paxlovid.Like many antivirals, Paxlovid works best when taken early in the course of illness. The CDC recommends treatment begin within the first five days of experiencing symptoms. Once a person is prescribed the medication, they will take three Paxlovid pills twice a day for five days for a full course that adds up to 30 pills.The antiviral therapy consists of a combination of two oral antiviral drugs — nirmatrelvir and ritonavir — which work together to stop the viral replication process. By reducing a person’s viral load, the medication lessens the severity of their symptoms.In clinical trials, which were conducted when the Delta variant was predominant, Paxlovid was found to reduce the risk of hospitalization or death by 89% in high-risk people. Since its approval, many clinical studies that have been conducted around the world have also confirmed the drug’s high level of protection against hospitalization and death.With Omicron being a highly immune-evasive variant that has rendered many antibody treatments ineffective, vaccine experts worried that Paxlovid would lose its effectiveness too. Fortunately, that doesn’t seem to be the case. According to recent research, the drug continues to offer significant protection against hospitalization and death and can also offer a substantial benefit even to vaccinated patients diagnosed with COVID-19.Other studies, however, have found no evidence of Paxlovid benefiting people younger than age 65.“I don’t think we need to push Paxlovid in every 20-year-old who comes down with COVID or 35-year-old who’s healthy,” Dr. Bruce Farber, chief of public health and epidemiology at Northwell Health, the largest health care system in New York state, told Yahoo News. “But in those who are at high risk, those who are elderly, who have not been vaccinated, those who have comorbidities, those who are immunosuppressed, [for] those people [it] can make a significant difference,” he added.In addition to keeping high-risk patients from getting very sick, Paxlovid can reduce the risk of symptoms of long COVID, a November study conducted by the Department of Veterans Affairs found.What is Paxlovid rebound?The CDC defines Paxlovid rebound as when, after completing the full five-day course of treatment, a person experiences either a reemergence of symptoms or tests positive after having tested negative for COVID-19. According to the CDC, this rebound effect tends to occur between two and eight days after initial recovery. But experiencing a rebound, the agency said, doesn’t mean that a person was resistant to Paxlovid, nor does it mean they were reinfected with the virus. Additionally, the CDC has said Paxlovid rebound cases are typically mild, resolve within a few days, and there’s no evidence that additional treatments are needed for these patients.Despite Paxlovid’s efficacy even in the setting of Omicron, the medication is being underutilized in the U.S. and other parts of the world. According to a report by the London-based health analytics firm Airfinity, U.S. physicians have prescribed the drug in only about 13% of new COVID-19 cases, Nature recently reported. Experts have said concerns about suffering from potential Paxlovid rebound is one of the reasons this may be happening.Farber also said that another reason Paxlovid is being underutilized has to do with the virus itself.“This virus is much less virulent even though it’s more contagious,” he said, adding that the need for Paxlovid “became less.”Scientists are still studying why this rebound effect occurs when taking Paxlovid, as well as who is more likely to experience it. However, recent research has found that rebound can also happen to people who develop COVID-19 and don’t take Paxlovid. Studies are underway to understand why this happens, Farber said.“More recent data suggests that rebound also occurs in people who recover from COVID who have not gotten Paxlovid, and it occurs at probably similar rates, whether you take Paxlovid or not,” Farber said, adding that rebound cases after taking the drug were initially thought to occur in roughly 5% of cases but that research has shown it may happen more often than initially thought. “More recent articles say it may be as common as 10 or 15% of cases,” he said.What to do if you experience Paxlovid reboundIf someone’s symptoms return or they test positive after Paxlovid treatment, the CDC advises following its isolation guidance and quarantining again for five days. Isolation can end after this period if a person is fever-free for 24 hours without the use of fever-reducing medications. The agency also recommends wearing a mask for 10 days after rebound symptoms start.The CDC encourages doctors and patients to report Paxlovid rebound cases to Pfizer’s portal for adverse events associated with the drug.Finally, Farber said that Paxlovid rebound is still fairly uncommon and that it shouldn’t deter people and their doctors from using the life-saving medication when needed.“In theory, it could prolong their isolation. But I think [people] should realize that this can occur even without Paxlovid. So it becomes really not an important distinguisher, of whether they get it or not,” he said.
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Drug Discoveries
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Scientists whose work on mRNA paved the way for first COVID-19 vaccines win Nobel Prize
Katalin Karikó and Dr. Drew Weissman, American scientists whose long collaboration has revolutionized the making of vaccines and raised the prospect of new treatments for a range of afflictions, were awarded the Nobel Prize in physiology or medicine Monday for their work on messenger RNA.
Hungarian-born biochemist Karikó, 68, spent nearly a decade at BioNTech, the German pharmaceutical firm that collaborated with drug giant Pfizer to produce the pandemic’s first vaccine against the virus that causes COVID-19. Physician-scientist Weissman, 64, is a professor of vaccine research at the University of Pennsylvania’s Perelman School of Medicine.
Their work has armed scientists and drug companies with the means to turn the body’s cells into manufacturers of its own medicine.
Though mRNA rose to public prominence for its use in COVID-19 vaccines, the technology is expected to become a major basis for flu vaccines, allowing shorter lead times and more accurate matching between circulating influenza strains and yearly shots.
Beyond that, it could play a key role in treating sickle-cell disease and shows promise for the autoimmune disorder multiple sclerosis. Its potential use in treating cancers is also opening new avenues for arming the immune system against malignancy.
A new COVID-19 vaccine is coming, and health officials are recommending most everyone get it. But how many people are willing to roll up their sleeves again?
HIV could be the next target. Three new experimental vaccines to protect against HIV infection, all based on an mRNA design similar to that used in the COVID-19 jab, are now undergoing early human clinical trials.
The techniques pioneered by Karikó and Weissman have allowed scientists to nimbly customize the proteins targeted by vaccines, a key for thwarting shape-shifting viruses like the coronavirus and HIV.
Such capabilities more than proved their worth during the pandemic. The mRNA vaccines made by Pfizer-BioNTech and Moderna were both designed within weeks of the release of the SARS-CoV-2 coronavirus genome, and first to come off manufacturing lines for worldwide use. Today, the two COVID-19 vaccines are in use in at least 164 countries, and roughly 270 million Americans have received at least one dose.
That “impressive success story” alone would make recognition of Karikó and Weissman by the Nobel Committee “proper and appropriate,” said Dr. Anthony Fauci, former director of the National Institute of Allergy and Infectious Diseases and chief medical advisor to President Biden. But advances the pair made in the use of mRNA have only begun to be felt in medicine, he added.
Karikó was first introduced to ribonucleic acid, or RNA, in 1978 and said she’s been “passionate about this fragile molecule ever since.” She was exploring DNA’s use of messenger RNA to deliver specific work orders to cells when she met Weissman over a photocopy machine at the University of Pennsylvania in 1997.
Antiretroviral medications were just entering wide use against HIV/AIDS at the time, and Weissman was trying to design a vaccine against a disease that was killing hundreds of thousands of Americans each year. He had been intrigued by the possibility that mRNA could induce cells to produce proteins that the body was missing or that it needed to heal itself. But he knew that efforts to repurpose this delicate nucleic acid for medical purposes had hit a host of stumbling blocks.
Svante Paabo’s discoveries on human evolution provided key insights into our immune system and what makes us unique compared with our extinct cousins.
Karikó was intimately familiar with the obstacles to mRNA’s use. And she was well aware of the skepticism directed its way by the scientific community. After earning a PhD in biochemistry at Hungary’s University of Szeged and emigrating to the United States in 1985, she had been determined to find ways to harness mRNA for treatments.
By the time she met Weissman, Karikó had been an itinerant postdoctoral researcher for more than a decade. At Temple University in Philadelphia, the Uniformed Services University of the Health Sciences in Bethesda, Md., and the University of Pennsylvania, she had tried to drum up support for work on mRNA’s biomedical uses. She had a drawer full of rejected grant proposals to show for it.
Weissman’s research pedigree was more promising. A biochemistry major at Brandeis University, Weissman earned his medical degree and a PhD at Boston University and was awarded a postdoctoral fellowship in Fauci’s lab at the National Institutes of Health. While there, he studied a key node of the mammalian immune system — dendritic cells — and their perturbation in HIV/AIDS.
Weissman knew that messenger RNA had an incidental effect on dendritic cells: Their interaction touched off an immune response that ignited dangerous inflammation across the body.
Weissman and Karikó both realized that until that problem could be fixed, mRNA would be of limited biomedical use, and no use at all in making vaccines. There was also the problem of mRNA’s fragility outside of cells: Unpackaged, it was easily chewed up by enzymes, and getting it through cells’ outer walls was no picnic either.
The two scientists formed a partnership of grit and grace. Over more than two decades, Karikó’s and Weissman’s experiments shed more light on how mRNA could be repurposed to enter cells and safely order up the production of certain proteins. They watched how other nucleic acids snuck past the immune system unnoticed and devised a fix that allowed mRNA to ferry new work orders into cells without causing flares of inflammation.
Two Americans and one Briton share the Nobel Prize in medicine for their discovery of the hepatitis C virus.
“Each spark of something interesting, whether a finding we expected — or even more exciting, the ones we didn’t — motivated us to continue,” Weissman said in a speech accepting the 2021 Lasker Award, one of several prestigious scientific honors the pair have won in recent years.
“Together we designed and conducted experiments, often trading emails into the early hours — unable to wait until the next day to share particular findings or ideas,” Weissman said. “We just kept at it.”
By 2004, the two had produced a paper that detailed their success at reengineering mRNA for use in mammals. In an interview with the journal Cell, the two recalled that their first paper together was rejected by the three premier science journals — Cell, Science and Nature. One reviewer dismissed the work as a mere “incremental improvement” over existing research in the area.
Karikó said she had to look up “incremental” in the dictionary. Undeterred, the pair got their paper published in a specialty journal, Immunity, in 2005. Then they waited for the conference invitations to pour in.
“We sat and stared at the phone, and nothing happened,” Weissman said. After presenting the paper at one conference, Karikó said a fellow scientist came up and asked who had supervised her work — the kind of question no one would ask a man of her age.
Not until 2010, after the pair published findings that further improved the prospects for mRNA’s use, did the medical establishment start to take notice. By 2012, Weismann and Karikó led a team that showed that mRNA, introduced into mice, could prompt the temporary production of red blood cells.
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“They had to do some really fancy manipulation to allow it to persist long enough” inside the body to ferry genetic instructions into cells, Fauci said. “They were persistent, resilient, and they stuck to it,” he added. “It’s a great example of the scientific process.”
In 2013, Karikó left the University of Pennsylvania to join BioNTech, reasoning that pharmaceutical companies would eclipse universities in devising treatments using mRNA technology.
When the SARS-CoV-2 virus emerged in China in 2019, BioNTech had already used mRNA technology to design a vaccine against the Zika virus, which had infected hundreds of thousands of pregnant women and caused grievous birth defects across the world. Moderna, too, had been working on a Zika vaccine, as well as vaccines against cytomegalovirus infection and cancers.
Within two weeks of the publication of the SARS-CoV-2 virus’ genetic sequence, both companies had what they needed to build a vaccine. They used different formulations for the delivery of mRNA, but once inside a human cell, the vaccines provided the genetic specifications for producing harmless replicas of the coronavirus’ spike proteins. The human immune system would take it from there.
When health officials in the U.S. and United Kingdom ordered up a new crop of COVID-19 booster shots that targeted the Omicron variant, all Pfizer-BioNTech and Moderna had to do was insert a key piece of genetic code that matched the desired strains. The updated shots were ready in mere months.
Weissman has established laboratories in Thailand, South Africa and other low- and middle-income countries to devise COVID-19 vaccines that can be produced locally. His research continues to explore ways for mRNA vaccines to provide more enduring protection against COVID-19 by training the immune system to recognize pieces of the virus that are much less prone to mutation.
The 2019 Nobel Prize in physiology or medicine was awarded to William Kaelin Jr., Peter Ratcliffe and Gregg Semenza for work on how cells use oxygen.
He remains at the University of Pennsylvania, and is married to Mary Ellen Weissman. They have two daughters, Rachel and Allison.
Karikó is married to Béla Francia. The couple and their daughter, Zsuzsanna “Susan” Francia, arrived in the United States in 1985 with their life savings — about $1,000 — sewn into the stuffing of a teddy bear. (Susan Francia grew up to become a decorated rower, winning two Olympic gold medals for the United States.)
Through it all, Karikó has said she was not deterred by her lack of funding, the lack of interest from the medical establishment or the slow pace at which she and Weissman uncovered mRNA’s secrets.
“I am so glad it helped humanity,” Karikó told a University of Pennsylvania interviewer. But for decades, the process of scientific discovery was its own reward, she added.
“So many enigmatic things about RNA I find very, very exciting,” Karikó said. She and Weissman would ask questions and then design experiments to answer them.
“And of course, instead of the answer, we got 100 more questions,” she added. “It was very enjoyable. I would like to emphasize that to be a scientist is a joy.”
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Vaccine Development
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‘Go after it’: GOP strategists say Republicans need to hit Biden on drug pricing
Republicans are working to persuade Americans that the Biden plan will stifle innovation and lead to price controls.
As President Joe Biden touts the first 10 drugs subject to Medicare price talks, Republicans are searching for their own message that would resonate with voters on the downsides of his signature domestic achievement.
Piggybacking on the pharmaceutical industry’s strategy, Republicans are working to persuade Americans that the Biden plan will stifle innovation and lead to price controls, several strategists say.
“The price control is a huge departure from where we have been as a country,” said Joel White, a Republican health care strategist. “It gets politicians and bureaucrats right into your medicine cabinet.”
However, the effort to reframe the drug price debate comes as Democrats prepare to run on the issue up and down the ballot next year against a Republican Party unlikely to cede any ground with campaign attacks and more likely to focus on the border and inflation.
A new poll from nonprofit KFF shows that 58 percent of independent voters trust Democrats to lower drug costs compared with 39 percent of Republicans.
“If they want to run their campaigns based on keeping the profits of the drug companies high, welcome,” Sen. Amy Klobuchar (D-Minn.) told POLITICO. “Why don’t they go for it and see how well President Biden does because people are going to understand that seniors want to see less expensive drugs.”
Nevertheless, Republicans are strategizing the best message to counter the first Medicare drug price negotiations.
“Republicans have to figure out how to go after it,” said Joe Grogan, a Republican strategist who served as a domestic policy adviser for former President Donald Trump. “They go after it by taking it head on: it is killing clinical programs, fundamentally restricting the amount of treatments.”
Grogan said the negotiations process can stifle innovation by demanding makers of the selected drugs accept a final negotiated rate or leave Medicare and Medicaid, which can amount to 40 percent of total revenue depending on the drugmaker.
“Company after company is making changes to commercial strategy due to the fact they have to anticipate government price-setting and basically [the] extortion that price dictates,” Grogan said.
Some companies have said they are pulling back funding for certain clinical programs. Eli Lilly, for example, blamed the IRA for nixing a $40 million cancer drug due to the negotiations program, according to a November report in Endpoints News.
Grogan added that drug companies could decide to no longer fund clinical trials that search for new uses for a drug already on the market.
“It is not negotiating the prices, it is price-setting and companies are responding to kill programs that are no longer going to be profitable in a high-risk business to bring to market,” he said.
But the question is “what do Republicans want and [what is] the alternative here?” asked White.
Congressional Republicans slammed Biden’s Tuesday drug price announcement, saying they will impose crippling price controls.
“I hope that our colleagues on both sides of the aisle can come together to mitigate these devastating effects and advance consensus-based, market-driven solutions to access and affordability challenges,” said Sen. Mike Crapo (R-Idaho), the top Republican on the Senate Finance Committee.
But White conceded that right now Republicans “don’t have a plan that cuts with voters or resonates with voters and stands as a clear contrast to what Democrats are offering.”
The Republican-led House is working on bills to reform pharmacy benefit managers, which some GOP lawmakers say act as middlemen that do not pass on discounts negotiated with drugmakers to patients.
Florida Gov. Ron DeSantis, who is running second behind Trump in most polls, signed into law his own bill to regulate PBMs in the state. The DeSantis campaign did not return a request for comment on Tuesday’s announcement.
“That is a gimme, it seems to me. PBMs are everybody’s favorite villain these days,” said Joe Antos, senior fellow with think tank American Enterprise Institute.
So far, most 2024 campaigns have not put forth detailed health care policy plans and have been largely mum on drug prices specifically.
One of the exceptions is the frontrunner: Trump.
He promises to revive an executive order he issued while in office that mandated the federal government pay the same price for pharmaceuticals as countries overseas. The Biden administration pulled the order in 2021 after a federal judge struck it down.
“We’ve been ripped off by everybody for so many decades. We are tired of it. Not going to happen,” Trump said in a video on his campaign website.
Former Vice President Mike Pence has made general statements on improving transparency and competition to lower costs. He also proposed reviving Operation Warp Speed, the federal program created to expedite Covid-19 vaccines, but for new drugs.
Strategists say that candidates will need to explain their vision for health care as the campaign shifts into high gear. Except for abortion, health care was largely missing from the first GOP presidential candidate debate in Milwaukee, Wis., last week.
“There is an opportunity and an obligation on the presidential campaign,” Grogan said. “The Trump indictments have dominated so much of the debate, but there will be a necessity to flesh out economic visions.”
David Lim contributed to this report.
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Health Policy
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A man left with life-changing injuries after being crushed by a horse while driving was only recognisable to family via his nose.
Ian Tilston was driving on the M56 from his home in Hawarden to Nantwich, Cheshire, when his car was crushed by a horse as he exited at junction 10.
As he drove down the slip road a car in front hit a horse which had escaped from a nearby field. The horse then hit the 34-year-old’s car, crushing him and his car.
Ian was rushed to Salford Royal Hospital where he had life-saving brain surgery before a number of other procedures, one of which involved reconstructing his face.
Speaking more than a year on from the accident on January 10, 2022, Ian's brother, Adam, told the Liverpool Echo: "He was put in an induced coma for a few weeks and when he woke up they moved him to The Walton Centre.
"He had a number of surgeries and they even rebuilt his face. His entire face was crushed in the crash and he had to have a piece of his skull removed for surgery. He looked an absolute mess after the accident and we only knew it was him through his nose.
"He's been at the Walton Centre for a year now. He's had life-changing injuries as a result of this. He's lost his vision and can't walk so he needs 24-hour care.
"They're looking to discharge him but we need somewhere for him to go. We're trying to transform our mum's house now. We want him home to be able to enjoy some quality of life.
"We just want to get something in place for him. Police at the time said it was a freak accident and the fences were in fine condition but horses had since escaped."
Adam explained that Salford Royal told him the bleed on his younger brother's brain was the worst they had seen. However, Ian can now speak and is also able to partially move his right arm, something that seemed a million miles away 12 months ago.
However, despite his overwhelming progress, Ian is still cognitively challenged as a result of the damage done to his brain and has days where he thinks it's 2010.
Adam, a dad of one, said: "I was in work and around 9.30am my grandad rang me, it was the first time in my life I'd heard him cry. I thought the worst and thought he had died.
"I went to see my grandparents and we waited for news. Since then our entire lives have changed. At the start, we were preparing our lives for the worst.
"We could only recognise him through his nose. The turning point was when he was in ICU and he put his thumbs up to us."
Now the family are raising money to try and pay for the work to be done at Adam and Ian's mum's home in order for Ian to be discharged from The Walton Centre. To read more or donate, click here.
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Medical Innovations
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Reports of chemical attacks on Iranian school girls are once again on the rise after a hiatus, leaving hundreds of young girls unable to breathe and hospitalized.
The unknown substance continues to impact girls while in class, according to The Foundation for Defense of Democracies (FDD) who is tracking and mapping the attacks, which the group says are deliberate.
Hundreds of schoolgirls have been hospitalized as a result of these "targeted chemical attacks," United Nations officials said in a statement last month.
"We are deeply concerned about the physical and mental well-being of these schoolgirls, their parents and the ability of the girls to enjoy their fundamental right to education," the UN statement said.
At the same time, students at several Iranian universities have organized sit-in protests against the country’s violent behavior in enforcing mandatory hijab and covering of female students.
One such protest is slated for April 27 at Tehran University and was planned by students of the Faculty of Psychology and Educational Sciences.
Poisoning of schoolgirls continues in Iran; schools targeted with toxic gas in several cities today again. “Our pupils have been poisoned,” says girl in video from ‘Qasem Soleimani’ school in Karaj (L); ambulance near ‘Meraj’ school in Ardabil (R). #IranChemicalAttacks @UNICEF pic.twitter.com/u4QpGy7QF6— Ali Javanmardi (@Javanmardi75) April 16, 2023
Iranian schoolgirls have been frequently poisoned for months
Poison gas attacks on schoolgirls in Iran have shocked the world for months, from the first reports in November, at the height of the protests against the regime triggered by the suspicious death of 22-year-old Mahsa Amini who died in the custody of morality police in September after allegedly wear a hijab incorrectly. Reportedly the chemical attacks peaked in March and then briefly ceased during the Persian New Year holidays because children were out of class for two weeks.
More than 1,000 schoolgirls at more than 26 schools in 25 of Iran’s 31 provinces have now been hit by the poison gas since the first attacks in the city of Qom in November, when 15 schools were targeted. The victims reported a smell akin to rotten oranges, followed by nausea, headaches, and finally, shortness of breath left them urgently seeking medical attention.
Attacks have been reported in schools for girls in many major cities, and Tehran, Ardabil, Isfahan, Shahin Shahr, Karaj and Kermanshah were even all targeted on the same day.
Videos from ‘Toloo Eslam’ girls school in Tehran today show parents, pupils and emergency vehicles outside the school after chemical attack left many students sick, several requiring transfer to hospital. #IranChemicalAttacks @UNICEF @AmnestyIran @JavaidRehman @hrw @SkyNews @CNN pic.twitter.com/xybca09aAx— Ali Javanmardi (@Javanmardi75) April 16, 2023
Several Iranian politicians have accused religious groups that oppose girls’ education of carrying out the poisonings, and a little-known group from Qom calling itself Fadayeen-e Velayat has claimed responsibility.
The group said that allowing girls to receive an education was a violation of Islam, and threatened to step up the attacks if the authorities continue to allow female students in the classroom.
A number of people have been arrested for allegedly carrying out the attacks. A statement by the Iranian Interior Ministry released in March said that some of the suspects had links to "foreign-based dissident media" and to the unrest that began in September following the death of Amini.
The MediaLine/Felice Friedson contributed to this report.
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Epidemics & Outbreaks
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A new mother has said she hopes to raise awareness of a flesh-eating disease that nearly killed her.
Charleigh Chatterton, 27, gave birth to her daughter Alessia in Colchester on 22 April with no complications.
But six days later she was rushed back to hospital after developing a rash on her stomach.
Doctors diagnosed the finance administrator with necrotising fasciitis and warned her family she might not survive.
"The doctors said my chances of survival were slim. I think I got diagnosed just in time," she said.
Miss Chatterton, from Harwich, Essex, had a rash that was "as hot to touch as a boiled kettle" and severe flu symptoms.
Her fiance Liam Boyne called midwives at Colchester hospital who recommended she go in to be checked.
Doctors carried out multiple tests which came back clear but her condition was rapidly declining and she was struggling to remain conscious.
After a scan revealed pockets of gas underneath her tissue, they realised it could be necrotising fasciitis. Doctors said she needed immediate surgery to remove a large amount of dead tissue to stop the flesh-eating bacteria from spreading.
Miss Chatterton was kept sedated for three days and woke up to two large wounds on her stomach, which had to left open for six days to help her body recover until they were able to fit a vacuum pump.
What is necrotising fasciitis?
Necrotising fasciitis is an uncommon although not rare medical and surgical emergency, with an estimated 500 cases presenting each year in the UK.
The infection affects tissue beneath the skin and can lead to a minor injury becoming life-threatening if not treated quickly.
Early flu-like symptoms can quickly develop into a rash, vomiting and swelling of affected areas, before it spreads through the body causing dizziness and confusion.
It can progress very quickly and lead to serious problems such as blood poisoning (sepsis) and organ failure.
Source: NHS/Royal College of Surgeons
She was able to leave hospital after two weeks and return to her new-born baby.
"I'm still finding it quite difficult psychologically, but physically I'm doing really well. I've got some big scars and some nerve damage but I feel so lucky. I'm here and that's all that matters.
"I just want to get the message out because most people have never heard of it and early diagnosis can be the difference between life and death," she said.
A 20-year-old amateur footballer from Northampton died from the disease earlier this year, having had his leg amputated in an effort to save his life.
Doctors told Miss Chatterton it was unusual there was no obvious entry point for the bacteria - she had a natural delivery and did not have any obvious cuts, grazes or insect bites or any breakage of the skin.
Martin Mansfield, deputy chief medical officer at East Suffolk and North Essex Foundation Trust, which runs Colchester Hospital, said: "We're so glad to have been able to help Charleigh and very pleased to know that she is doing so well.
"Necrotising fasciitis is a bacterial infection that can be very serious and life-threatening if not caught early and it's testament to the knowledge and expertise of our staff that they spotted what was happening and were able to take action very quickly."
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Disease Research
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Glaucoma is one of the leading causes of blindness worldwide, and vision loss, due to the loss of retinal ganglion cells (RGCs), cannot currently be reversed with any treatment. Some studies have looked at replacing RGCs through cell transplants, but this process is still in the research and development stage and fraught with limitations that highlight a need for a more precise manner of effectively repopulating these cells in the retina. Now, a multidisciplinary team led by researchers at the Schepens Eye Research Institute of Mass Eye and Ear has identified a promising new strategy for glaucoma cell replacement therapy.
In their new study, researchers changed the microenvironment in the eye in a way that enabled them to take stem cells from blood and turn them into retinal ganglion cells that were capable of migrating and surviving into the eye's retina. They conducted their study on the adult mouse retina, but the work's implications could one day be applied to human retina, according to the researchers who published their findings November 6th in Proceedings of the National Academy of Sciences.
One limitation that prevents the success of current stem cell transplantation strategies in retina studies is that the majority of donor cells remain at the site of injection and do not migrate where they are most needed. To identify an improved solution, the researchers created RGCs out of stem cells, then tested the ability of various signaling molecules known as chemokines to guide these new neurons to their correct positions within the retina. The research team utilized a "big data" approach and examined hundreds of such molecules and receptors to find 12 unique to RGCs. They found stromal derived factor 1 was the best performing molecule for both migration and transplantation.
"This method of using chemokines to guide donor cell movement and integration represents a promising approach to restoring vision in glaucoma patients," said senior author Petr Baranov, MD, PhD, of Mass Eye and Ear, who is also an assistant professor of Ophthalmology at Harvard Medical School. "It was an exciting journey to work with a team of talented scientists with unique expertise to develop novel techniques in this study to modify the local environment to guide cell behavior -- techniques that potentially be applied to treat other neurodegenerative conditions."
The study was co-led by members of Baranov's lab at Mass Eye and Ear including bioengineer and lead study author Jonathan R Soucy, PhD, and lead bioinformatician Emil Kriukov, MD.
In addition to Baranov, Soucy and Kriukov, co-authors of the study include Levi Todd, Monichan Phay, Volha V. Malechka, John Dayron Rivera and Thomas A Reh.
The study was funded by several National Eye Institute (NEI) of the National Institutes of Health (NIH) grants -- a complete list can be found in the paper -- and grants from the Bright Focus Foundation and Gilbert Family Foundation.
The University of Washington discloses a patent incorporating the endogenous reprogramming technology described in this report with inventors LT and TAR.
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Medical Innovations
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The chances of a person developing type 2 diabetes can increase even if they eat red meat just two times a week instead of an alternative option, researchers have said.
Replacing red meat with plant-based protein sources, such as nuts and legumes, may reduce the chances of developing the condition and would also help reduce greenhouse gas emissions and tackle climate change, according to experts at Harvard University.
Type 2 diabetes is one of the world’s fastest growing major health threats. Its prevalence has risen dramatically everywhere in the last three decades, according to the World Health Organization.
More than 400 million people have been diagnosed, but millions more are estimated to be in the dark about the fact they have the condition. It is a major cause of blindness, kidney failure, heart attacks, stroke and lower limb amputation.
Research increasingly suggests that one of the main things you can to do lower your risk of type 2 diabetes, as well maintaining a healthy weight, is improve your diet.
Previous studies have indicated a link between red meat consumption and type 2 diabetes risk, but researchers say new research by Harvard adds a greater level of certainty about the association.
In the study published in the American Journal of Clinical Nutrition, researchers looked at health data from 216,695 people from the Nurses’ Health Study, Nurses’ Health Study II, and Health Professionals Follow-up Study (HPFS) in the US.
People were asked to complete questionnaires about their diet every two to four years, for up to 36 years. During this time, more than 22,000 of them developed type 2 diabetes.
Those who ate the most red meat had a 62% higher risk of developing the condition compared with those who ate the least.
The research suggests that every additional daily serving of processed red meat was associated with a 46% greater chance of developing type 2 diabetes. Every additional daily serving of unprocessed red meat was associated with a 24% greater risk, the study found.
First author Xiao Gu, postdoctoral research fellow in the department of nutrition at Harvard T H Chan School of Public Health, said: “Our findings strongly support dietary guidelines that recommend limiting the consumption of red meat, and this applies to both processed and unprocessed red meat.”
Estimating the potential effects of replacing one daily serving of red meat for another protein source, researchers found substituting for nuts and legumes was associated with a 30% lower risk of type 2 diabetes. Substituting a serving of dairy products was linked to a 22% lower risk.
Senior author Walter Willett, professor of epidemiology and nutrition, said: “Given our findings and previous work by others, a limit of about one serving a week of red meat would be reasonable for people wishing to optimise their health and wellbeing.”
The scientists added that swapping red meat for healthy plant protein sources would also help reduce greenhouse gas emissions and tackle climate change, and provide other environmental benefits.
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Nutrition Research
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When White House press secretary Karine Jean-Pierre faced questions recently about calls for an administration office to tackle gun violence, she had an answer: Susan Rice is in charge. Rice, she said, is already leading a 12-person team from her perch atop the Domestic Policy Council to execute a government-wide effort to reduce gun violence that also brings in mental health and workforce development. “There’s no one who is better at bringing stakeholders to the table to drive progress,” Jean-Pierre told reporters. The announcement served as a reminder that Rice is at the center of major and contentious policy debates and decisions on everything from gun violence to immigration to criminal justice reform to student loan debt forgiveness to the stymied talks around President Biden’s signature domestic legislative effort. “I’d say that the Domestic Policy Council has the broadest and also the most diffuse agenda,” said Bill Galston, chair of the Brookings Institution’s governance studies program and a former domestic policy aide to then-President Clinton. But Rice is leading on these issues quietly. While she has headlined a handful of roundtables from the White House on issues including racial equity and eviction prevention, she has appeared at only one press briefing to field reporter questions — six days after Biden took office — and rarely does media interviews. Brian Deese, chair of the National Economic Council, has attended eight briefings. Jake Sullivan, Biden’s national security adviser, has participated in 11, not counting informal gaggles aboard Air Force One. “She has kept herself outside of the limelight,” Galston said. “Keeping your head down and doing your job is a pretty good formula, and I think it’s the formula she’s been following.” The position of domestic policy adviser is decidedly lower-profile than others in presidential administrations. It’s a change for Rice, who cut her teeth in foreign policy and served as ambassador to the United Nations and national security adviser under then-President Obama. Still, some believe that the administration should be putting Rice out there more, even if it’s not part of the traditional job description. “I expected her to be a little more public-facing if I’m being honest,” said one Democratic strategist. “She’s such a powerful force. She could have been vice president or secretary of State and I don’t think they’re utilizing her in a way that creates maximum impact for the administration.” “Some might say that’s not her role, but why shouldn’t it be?” the strategist added. A White House official countered on Monday that Rice speaks publicly with various groups every few days, adding that she is focused on the work itself, and when an opportunity arises for her to explain that work to the American public, she takes it. “She’s done a fair amount of public engagement, it’s just not necessarily always through the press channel,” the official said. Behind the scenes, though, Rice has wielded her power. She was intimately involved in the crafting of the long-awaited executive order on policing that Biden signed on the second anniversary of George Floyd’s murder last month. Jim Pasco, executive director of the Fraternal Order of Police, recalled receiving a call from Rice on a Sunday night while he was watching a football game not long after a leaked draft version of the order irked police groups. Rice, Pasco said in an interview, told him the administration wanted to do a “reset.” “She and [White House counsel] Dana Remus were right in the middle of things from there on out along with other senior staff,” he said. The White House worked with law enforcement groups to negotiate aspects of the final order so that ultimately it would be acceptable to police organizations as well as civil rights groups. “She’s a tough negotiator,” Pasco said of Rice, who noted she was up front about where the administration’s “red lines” were. “That said, she was a fair negotiator.” Rice has also been at the center of contentious debates over immigration policy amid a surge of migrants at the southern border. Rice and Biden chief of staff Ron Klain worried last summer that lifting Title 42 would encourage more migrants to flow to the southern border, The New York Times reported in April. She was also reportedly among a group of officials who blocked a plan to give COVID-19 vaccines to migrants out of concern it would encourage more border crossings. “They didn’t want to create a new crisis on their hands,” said one Democrat close to the White House. “I think that was what she and other White House officials were trying to stress.” Last year, Rice was a regular fixture on Capitol Hill as Biden’s team tried, and failed, to get senators to agree on a compromise version of his Build Back Better bill that could pass the upper chamber with only Democratic votes. “She carries a certain clout and gravitas and that’s not lost on folks who sit at the table with her,” said one Biden ally. “She’s a brilliant, hardworking and thoughtful person, period. She’s someone you walk away from saying ‘Damn, she’s smart.’” The White House official noted that Rice put her own mark on the domestic policy office by tapping four deputies to head four pillars — rather than the traditional organization of one director, one deputy and experts underneath — so that the administration could push forward on all of its focus areas at once. “That speaks to her desire to ensure that we can continue to put points on the board, or the president [can], despite what might be going on at any given moment,” the official said. Rice is among a cadre of Obama-era officials who joined Biden’s administration early on. She, Klain, deputy chief of staff Bruce Reed and other officials are said to brief Biden in the Oval Office several times a week. “There is a reason that Susan is the only person in American history to have led both the White House’s National Security Council and its Domestic Policy Council: she has unique talents, intellect, and determination to get results,” Klain said in a statement to The Hill on Monday. “Thanks to Susan and the Domestic Policy Council team in the Biden Administration, we have achieved historic wins: health care coverage for over 5 million more Americans, student loan relief for 1.3 million borrowers, and historic executive orders to advance equity and public safety. Most impressive is her tireless work to save American lives on essential gun reform, spearheading the White House’s efforts.” Rice was initially rumored to be a candidate for secretary of State, but Biden ultimately chose longtime adviser Antony Blinken for the role amid Democratic concerns that Rice would lack the votes to be confirmed in the Senate. She has long been a popular target for criticism among Republicans due to her involvement in the response to the 2012 Benghazi attack. During that response, Rice appeared on a round of Sunday shows and said the attack on the consulate in Libya was the result of a protest that turned violent instead of a planned terrorist attack. The administration later announced it was a terrorist attack. Benghazi became a leading talking point against then-Secretary of State Hillary Clinton, Obama and Rice for years. Many Democrats say it was one of the reasons she was passed over for the vice presidential nomination. “The White House says ‘no one better’ than Susan Rice to lead their gun control messaging,” Rep. Darrell Issa (R-Calif.), who headed a House panel investigating the Benghazi attack almost a decade ago, tweeted in late May. “The architect of the Benghazi cover-up? I can’t think of anyone worse.” But gun control advocates have been happy with Rice’s work, though some have advocated for a devoted office to focus on the issue more than the Domestic Policy Council can muster given its competing priorities. Under Rice’s leadership, the council “is certainly more engaged on gun safety than it was under the Obama administration,” said Peter Ambler, executive director at the gun control advocacy group Giffords. “I think Rice has advanced the ball on some important initiatives like expanding the administration’s focus on violence intervention strategies and funding.” The White House official said that Rice’s office has taken a broad approach to addressing gun violence by connecting it to other policy areas, such as mental health and health care. “We view it as a comparative advantage to have our gun policy agenda connected to so many of our other critical policy agendas, so we’re not looking at it narrowly,” the official said. Randi Weingarten, the president of the American Federation of Teachers who said she has met with Rice over Zoom on issues such as student debt and civics education, described her as someone who “looks around corners” and really engages people from the outside as the administration weighs policy decisions. “Before you have a meeting with Susan Rice, you have to do your homework. Because she’s going to ask you — even if you do your homework — a question that you don’t know the answer to,” Weingarten said. —Updated at 3:08 p.m.
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Mental Health Treatments
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Circadian Clock Study Shows Why Jet Lag Wipes Us Out
Research has modeled the interactions between circadian clocks to investigate why jet lag leaves us fatigued.
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New research has modeled the interactions between our body’s circadian clocks to investigate why jet lag leaves us so fatigued.
Tuning the body’s clocks
A long-distance flight can herald the start of an adventure, a new life or a well-earned break. It will also likely precede a period of drowsiness, fatigue and sleepless nights. Jet lag can ruin a vacation.
This exhausting condition is caused by a disconnect between our surroundings and our body’s internal circadian clocks. When in our home time zone, our body clocks are set in a careful balance. While it was originally thought that our bodies were set to a single circadian rhythm, research conducted at the turn of the century showed that our body has multiple clocks in tissues throughout the body, set in different rhythms that can each become disrupted by jet lag. These clocks are individually cued. The brain’s internal clock is set by sunlight, whereas clocks in the peripheral organs are set by eating times. The body becomes more vulnerable to disruption as we age.
The new research, published in the journal Chaos, developed a model that maps the links between these clocks and shows how events like jet lag interfere with these careful calibrations.
Yitong Huang, a postdoctoral researcher in the Braun lab at Northwestern University and study co-author, said, “Conflicting signals, such as warm weather during a short photoperiod or nighttime eating — eating when your brain is about to rest — can confuse internal clocks and cause desynchrony.”
“Most studies primarily focus on one particular time cue or a single clock,” Huang added. “Important gaps remain in our understanding of the synchronization of multiple clocks under conflicting time cues.”
To address this gap, Huang and the team built a model that considered the interplay between different clocks. Within the model, two oscillators are linked together, mimicking circadian clock rhythms.
Better sleep through the stomach
The team was then able to explore how this type of linked system would be altered by various external cues. The data suggested that targeting the circadian clock in the gut might be a handy way to accelerate jet lag recovery. “Having a larger meal in the early morning of the new time zone can help overcome jet lag,” says Huang. “Constantly shifting meal schedules or having a meal at night is discouraged, as it can lead to misalignment between internal clocks.”
The team also noted that effects linked to aging, like weakened signaling between clocks and reduced responsiveness to sunlight, made for a more vulnerable circadian system that was slower to recover from disruption.
The team says their next step is to use their model to investigate the factors that stabilize the circadian system. They hope these findings can help develop preventive techniques to stop jetlag and therapies to keep our circadian clocks on time throughout life.
Reference: Huang Y, Zhang Y and Braun R. A minimal model of peripheral clocks reveals differential circadian re-entrainment in aging. Chaos. 2023. doi: 10.1063/5.0157524
This article is a rework of a press release issued by the American Institute of Physics. Material has been edited for length and content.
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Medical Innovations
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- The European Union's drug regulator said it has broadened an investigation into the risk of suicidal thoughts among patients taking Novo Nordisk's Ozempic, Wegovy and Saxenda drugs to include other weight loss and diabetes medications.
- The agency didn't specify which additional drugs, known as GLP-1 agonists, are now included in the investigation.
- But it could potentially include Eli Lilly's diabetes Mounjaro. Other companies like Pfizer and Amgen are developing similar products.
The European Union's drug regulator on Tuesday said it has broadened an investigation into the risk of suicidal thoughts and self-injury among patients taking Novo Nordisk's Ozempic, Wegovy and Saxenda drugs to include other weight loss and diabetes medications.
The European Medicines Agency didn't specify which additional drugs are now included in the investigation. But it could potentially include Eli Lilly's diabetes drug Mounjaro, which is approved in the EU. Other companies such as Pfizer and Amgen are developing similar products.
The EMA said it is now evaluating about 150 reports of possible cases of self-injury and suicidal thoughts in patients taking weight loss and diabetes drugs. It's still unclear if the medicines caused the events or whether they are linked to patients' underlying conditions or other factors, the statement said.
The EMA expects to finish its probe in November, according to a statement.
On Monday, the agency told CNBC it launched an investigation into the matter after the Icelandic Medicines Agency flagged three cases of suicidal thoughts and self-injury in patients taking drugs containing liraglutide and semaglutide.
Liraglutide is the active ingredient in Novo Nordisk's weight loss drug Saxenda. Semaglutide is the active ingredient in the Danish company's weight loss injection, Wegovy, and its diabetes counterpart, Ozempic.
Liraglutide and semaglutide are part of a class of highly popular drugs called GLP-1 receptor agonists.
They mimic a hormone produced in the gut called GLP-1 to suppress a person's appetite and ultimately aid with weight loss. Those drugs can also help people manage Type 2 diabetes because they encourage insulin release from the pancreas, lowering blood sugar levels.
Novo Nordisk said in a statement to CNBC on Monday that "safety data collected from large clinical trial programs and post marketing surveillance have not demonstrated a causal association between semaglutide or liraglutide and suicidal and self-harming thoughts."
The company said it is "continuously performing surveillance of the data from ongoing clinical trials and real-world use of its products and collaborates closely with the authorities to ensure patient safety and adequate information to healthcare professionals."
The EMA's investigation could potentially establish new side effects associated with blockbuster drugs like Wegovy and Ozempic, which are already known to cause nausea, vomiting and diarrhea.
Suicidal behavior is not currently listed as a side effect in the EU product information for any GLP-1 receptor agonists.
The U.S. prescribing information for Novo Nordisk's Saxenda, approved by the Food and Drug Administration, also does not list suicidal thoughts or self-injury as side effects. But it does include a recommendation to monitor patients for depression or suicidal thoughts and to discontinue the drug if symptoms develop.
Clinical trials in adults found that nine out of 3,300 people on Saxenda reported suicidal ideation. That's compared with two out of more than 1,900 people on a placebo. The prescribing information says "there was insufficient information to establish a causal relationship to Saxenda."
There is no similar warning in the U.S. prescribing information for Ozempic.
Wegovy's U.S. prescribing information notes that suicidal ideation and behavior have been reported in clinical trials for other weight management products. Patients on Wegovy should be monitored for depression and suicidal thoughts or behavior, the information says.
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Drug Discoveries
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Millions of people enter later life carrying an extra 10 to 15 pounds, weight they’ve gained after having children, developing joint problems, becoming less active, or making meals the center of their social lives.
Should they lose this modest extra weight to optimize their health? This question has come to the fore with a new category of diabetes and weight loss drugs giving people hope they can shed excess pounds.
For years, experts have debated what to advise older adults in this situation. On one hand, weight gain is associated with the accumulation of fat. And that can have serious adverse health consequences, contributing to heart disease, diabetes, arthritis, and a host of other medical conditions.
On the other hand, numerous studies suggest that carrying some extra weight can sometimes be protective in later life. For people who fall, fat can serve as padding, guarding against fractures. And for people who become seriously ill with conditions such as cancer or advanced kidney disease, that padding can be a source of energy, helping them tolerate demanding therapies.
Of course, it depends on how heavy someone is to begin with. People who are already obese (with a body mass index of 30 or over) and who put on extra pounds are at greater risk than those who weigh less. And rapid weight gain in later life is always a cause for concern.
Making sense of scientific evidence and expert opinion surrounding weight issues in older adults isn’t easy. Here’s what I learned from reviewing dozens of studies and talking with nearly two dozen obesity physicians and researchers.
Our bodies change with age. As we grow older, our body composition changes. We lose muscle mass — a process that starts in our 30s and accelerates in our 60s and beyond — and gain fat. This is true even when our weight remains constant.
Also, less fat accumulates under the skin while more is distributed within the middle of the body. This abdominal fat is associated with inflammation and insulin resistance and a higher risk of cardiovascular disease, diabetes, and stroke, among other medical conditions.
“The distribution of fat plays a major role in determining how deleterious added weight in the form of fat is,” said Mitchell Lazar, director of the Institute for Diabetes, Obesity and Metabolism at the University of Pennsylvania’s Perelman School of Medicine. “It’s visceral [abdominal] fat [around the waist], rather than peripheral fat [in the hips and buttocks] that we’re really concerned about.”
Activity levels diminish with age. Also, with advancing age, people tend to become less active. When older adults maintain the same eating habits (energy intake) while cutting back on activity (energy expenditure), they’re going to gain weight.
According to the Centers for Disease Control and Prevention, 27% of 65- to 74-year-olds are physically inactive outside of work; that rises to 35% for people 75 or older. For older adults, the health agency recommends at least 150 minutes a week of moderately intense activity, such as brisk walking, as well as muscle-strengthening activities such as lifting weights at least twice weekly. Only 27% to 44% of older adults meet these guidelines, according to various surveys.
Concerns about muscle mass. Experts are more concerned about a lack of activity in older adults who are overweight or mildly obese (a body mass index in the low 30s) than about weight loss. With minimal or no activity, muscle mass deteriorates and strength decreases, which “raises the risk of developing a disability or a functional impairment” that can interfere with independence, said John Batsis, an obesity researcher and associate professor of medicine at the University of North Carolina School of Medicine in Chapel Hill.
Weight loss contributes to inadequate muscle mass insofar as muscle is lost along with fat. For every pound shed, 25% comes from muscle and 75% from fat, on average.
Since older adults have less muscle to begin with, “if they want to lose weight, they need to be willing at the same time to increase physical activity.” said Anne Newman, director of the Center for Aging and Population Health at the University of Pittsburgh School of Public Health.
Ideal body weight may be higher. Epidemiologic research suggests that the ideal body mass index (BMI) might be higher for older adults than younger adults. (BMI is a measure of a person’s weight, in kilograms or pounds, divided by the square of their height, in meters or feet.)
One large, well-regarded study found that older adults at either end of the BMI spectrum — those with low BMIs (under 22) and those with high BMIs (over 33) — were at greater risk of dying earlier than those with BMIs in the middle range (22 to 32.9).
Older adults with the lowest risk of earlier deaths had BMIs of 27 to 27.9. According to World Health Organization standards, this falls in the “overweight” range (25 to 29.9) and above the “healthy weight” BMI range (18.5 to 24.9). Also, many older adults whom the study found to be at highest mortality risk — those with BMIs under 22 — would be classified as having “healthy weight” by the WHO.
The study’s conclusion: “The WHO healthy weight range may not be suitable for older adults.” Instead, being overweight may be beneficial for older adults, while being notably thin can be problematic, contributing to the potential for frailty.
Indeed, an optimal BMI for older adults may be in the range of 24 to 29, Carl Lavie, a well-known obesity researcher, suggested in a separate study reviewing the evidence surrounding obesity in older adults. Lavie is the medical director of cardiac rehabilitation and prevention at Ochsner Health, a large health care system based in New Orleans, and author of “The Obesity Paradox,” a book that explores weight issues in older adults.
Expert recommendations. Obesity physicians and researchers offered several important recommendations during our conversations:
- Maintaining fitness and muscle mass is more important than losing weight for overweight older adults (those with BMIs of 25 to 29.9). “Is losing a few extra pounds going to dramatically improve their health? I don’t think the evidence shows that,” Lavie said.
- Unintentional weight loss is associated with several serious illnesses and is a danger signal that should always be attended to. “See your doctor if you’re losing weight without trying to,” said Newman of the University of Pittsburgh. She’s the co-author of a new paper finding that “unanticipated weight loss even among adults with obesity is associated with increased mortality” risk.
- Ensuring diet quality is essential. “Older adults are at risk for vitamin deficiencies and other nutritional deficits, and if you’re not consuming enough protein, that’s a problem,” said Batsis of the University of North Carolina. “I tell all my older patients to take a multivitamin,” said Dinesh Edem, director of the Medical Weight Management program at the University of Arkansas for Medical Sciences.
- Losing weight is more important for older adults who have a lot of fat around their middle (an apple shape) than it is for people who are heavier lower down (a pear shape). “For patients with a high waist circumference, we’re more aggressive in reducing calories or increasing exercise,” said Dennis Kerrigan, director of weight management at Henry Ford Health in Michigan.
- Maintaining weight stability is a good goal for healthy older adults who are carrying extra weight but who don’t have moderate or severe obesity (BMIs of 35 or higher). By definition, “healthy” means people don’t have serious metabolic issues (overly high cholesterol, blood sugar, blood pressure, and triglycerides), obesity-related disabilities (problems with mobility are common), or serious obesity-related illnesses such as diabetes or heart disease. “No great gains and no great losses — that’s what I recommend,” said Katie Dodd, a geriatric dietitian who writes a blog about nutrition.
We’re eager to hear from readers about questions you’d like answered, problems you’ve been having with your care, and advice you need in dealing with the health care system. Visit kffhealthnews.org/columnists to submit your requests or tips.
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Nutrition Research
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A Washington woman who refused to treat her tuberculosis for at least two years has finally been taken into custody, local health officials reported this week. The woman repeatedly ignored court orders to seek treatment and stay away from others, even visiting a casino earlier this year. She is now being detained in a jail room specially equipped for isolation and treatment and will remain there for at least 45 days.
The case first became public knowledge in January 2023, when the Tacoma-Pierce County Health Department announced that a resident was experiencing a case of acute tuberculosis. Officials noted at the time that the woman had declined to complete the standard antibiotic treatment for TB. Local reporting soon revealed that she had refused to do so for over a year and that the health department had started to win court orders demanding that the women stay isolated and/or receive treatment until she was no longer a public health threat.
The woman reportedly continued to flout these orders over the next year, at times potentially exposing others to her infection. In February 2023, Pierce County Judge Philip Sorenson issued a civil arrest warrant for the woman. But she still managed to evade authorities for months, at one point taking public transportation to visit a local casino. This past Thursday, however, the Pierce County Sheriff’s Department reportedly finally caught up with her. According to health officials, she has since been transferred to the Pierce County Jail.
Most people who catch TB never develop illness, but symptoms can emerge years or even decades after the initial infection. People with acute TB are contagious to others and without treatment can develop severe or deadly complications. Though TB is now rare in the U.S. it remains a major killer worldwide, with an estimated 1.6 million deaths in 2021. Some cases of TB are also antibiotic-resistant, making treatment even harder. One major risk factor for the emergence of resistant TB is people starting but failing to finish their treatment, much as the woman in this case reportedly did.
The woman, identified only as V.N. in court documents, will not be charged criminally, according to the Pierce County Sheriff’s Department. But she will be mandated to stay in jail for at least 45 days. She’ll be staying in a negative pressure room, which is often used in hospitals and other medical settings to keep airborne germs from escaping elsewhere.
Health officials have previously said that this is only the third time in the past 20 years that they’ve had to seek a court order to detain someone who has refused TB treatment. At this point, it’s not certain whether the woman will decide to go through with treatment.
“We are hopeful she will choose to get the life-saving treatment she needs to treat her tuberculosis,” the Tacoma-Pierce County Health Department said in a statement released Thursday.
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Epidemics & Outbreaks
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COVID-19 infections in the UK have climbed to their highest level since the beginning of the year, final official estimates of the prevalence of the virus have revealed.
While the trend is uncertain in Scotland, Wales and Northern Ireland, there are signs the virus is continuing to spread.
It marks the last time that regular estimates of COVID-19 are being published, as the long-running infection survey - dubbed "the envy of the world" due to its success in tracking the virus, has been halted.
The UK Health Security Agency said that any further monitoring of the virus will be announced after a review to ensure it is "cost-effective".
The data showed that in the week ending 13 March, an estimated 1.5 million people in private households in England were likely to have had coronavirus.
It is the highest total of COVID cases in England since the week to 3 January, when the total stood at around 2.2 million.
Due to a low number of samples received by the ONS there is greater uncertainty in the latest figures for Scotland and Wales, while too few samples were returned in Northern Ireland to produce a new estimate.
Around 136,200 people in Scotland were likely to have the virus in the week to 13 March, or around one in 40, compared with 105,100 or one in 50 the week before.
For Wales, the latest estimate is 74,500 COVID cases, or one in 40, compared with 68,200 or one in 45 the week prior.
Michelle Bowen, ONS head of health surveillance dissemination, said: "This week's data show infections are rising in England; however, the trend is uncertain across the rest of the UK.
"In England, positivity increased in children and those aged 50 and over.
"The North West, East Midlands and South East of England all saw infections increase, though the trend is uncertain in all other regions."
The infection survey has run for nearly three years, providing valuable weekly data on levels of the virus across the UK, allowing successive waves to be identified and tracked.
Read more:
Chinese COVID data from animal market gives clues on origins of virus, scientists say
Biden vows US will 'declassify' information about COVID's origins
It has also provided vital information on the emergence of new variants, antibody levels and long COVID.
Sir David Spiegelhalter, emeritus professor of statistics at Cambridge University and chairman of the advisory board for the survey, told the PA news agency it had been an "extraordinary achievement" which has provided "vital evidence of great value both to national policy and international scientific understanding".
He continued: "There is a general consensus that the survey has been a world-leading demonstration of how health surveillance can best be done. It is expensive, and this has led to it being paused, but the participant group is not being disbanded and a survey should be able to ramp up when necessary.
"Meanwhile there are important lessons to be learned for future emergencies, both by us and every other country. The survey has been the envy of the world and is a jewel in the crown of UK science."
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Epidemics & Outbreaks
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As a version of COVID-19’s omicron variant —the XBB.1.5 subvariant — grows more prevalent in some parts of the U.S., health experts say it likely escapes immune protection better than previous mutations, though it is still unclear whether it causes more severe illness. More than 80 percent of coronavirus cases in the Northeast are now due to XBB.1.5. According to health authorities, XBB.1.5 appears to be the most transmissible subvariant of omicron that has been detected yet. The bivalent COVID-19 vaccine and antiviral treatments like Paxlovid and molnupiravir are still believed to be effective at treating the strain, though they may not be as effective when compared to previous mutations. Physicians from across the Northeast who spoke with The Hill said they have not noticed a marked difference in disease severity among their recent COVID-19 patients. Bernard Camins, medical director for infection prevention at the Mount Sinai Health System in New York, said the proportion of patients with illness severe enough to require an intensive care unit stay is the same as with previous variants. Camins said a recent labor dispute with nurses in the Mount Sinai Health System presented more of a disruption to his hospital than the increase in COVID-19 cases that occurred after the holidays. “The presentation is for the most part the same. Maybe they’re not presenting as ill, but we are still seeing plenty of ill patients and we are still certainly seeing patients that die,” Ulysses Wu, chief epidemiologist for Hartford Healthcare in Connecticut, said. Wu said XBB.1.5 does not appear to be more lethal and noted that any time more cases of COVID-19 are seen, morbidity and mortality will increase in turn. “The reality is, [people] shouldn’t be any more concerned about the new variants because they should be just as concerned about this variant as they were about the previous variant. They’re all equally dangerous to a certain extent,” said Wu. Shira Doron, chief infection control officer for Tufts Medicine in Boston, said the new dominant strain was “not really such a big deal” in her area. According to Doron, her hospital has seen a “modest” increase in new admissions, though she noted that most of the patients who test positive for coronavirus are not being admitted due to a COVID-19 infection but because of another ailment. “I do feel like we’re in a really good place. I want to make sure that we don’t lose access to testing, we don’t lose access to treatment,” Doron said, adding that there is still work to be done when it comes to ensuring access to effective medications to treat COVID-19. At the start of January, the Food and Drug Administration said it did not anticipate Evusheld, the preventative coronavirus monoclonal antibody treatment, to be effective against XBB subvariants. The treatment was authorized for people who likely would not have developed strong enough immune responses from the COVID-19 vaccines. Jo-Anne Passalacqua, an infectious disease specialist at St. Vincent’s Medical Center in Connecticut, said she doesn’t think there is any reason to believe XBB.1.5 represents a change in disease severity. “The folks that we’re seeing that are very ill with COVID are similar to the people that were very ill with COVID before. They’re either frail elderly or they’re people with underlying heart or lung disease, you know, or some or some underlying immune compromise,” she said. While severity does not seem to be worsening, Passalacqua cited some concerns when it came to the newest mutation. Recent studies, such as one conducted by researchers at the University of Texas, found the bivalent COVID-19 booster had a reduced efficacy against omicron subvariants like BQ.1.1 and XBB.1, from which the strain widely circulating in the Northeast descends. “I think that information is very concerning because the public, the world, has returned in many respects to life as we knew it,” she said, noting families gathered and people traveled over the holidays as they did in pre-COVID times. “And that might be OK if you’re a reasonably healthy person who, if they get COVID and it becomes a little more severe, can call your doctor and get some Paxlovid. But that’s not going to be OK for somebody who has heart disease, lung disease, is frail and elderly. For those folks, that infection may result in death.” Health care providers who spoke with The Hill all encouraged people to get vaccinated if they aren’t already. Frederic Bushman, who oversees the Bushman Lab, a microbiology research lab at the University of Pennsylvania’s Perelman School of Medicine, said that even though vaccines may be less effective against a particular subvariant, people are still better off immunized. “Our countermeasures are getting better and better. Vaccines still work. Go out and get vaccinated. Maybe they work a little less well with the new variant, but they still work.” Passalacqua emphasized that regardless of what variant is circulating, people should get “back to some basics” when it comes to limiting the spread of infectious illnesses. She urged people to make use of simple measures like hand washing, wearing masks in crowded spaces and staying home if you are feeling ill.
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Epidemics & Outbreaks
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How 3 Black women took on breast cancer in our failed health care system
More than 1,000 hours. That’s how long the two of us — both Black women doctors in Los Angeles — have spent in the chair of our friend and hairstylist Sharone.
It’s not easy to find a good stylist who understands Black hair, but Sharone has a gift. When Medell met Sharone 17 years ago, she knew she’d met a kindred spirit, and she has styled her ever since.
When Medell came to work with Elaine at MLK Community Healthcare, Elaine knew she was an outstanding physician who would be critical to her hospital’s mission of bringing quality care to South Los Angeles. But she needed to know one thing: Who did Medell’s hair? She wanted to lean into the natural texture of her hair and thought Medell’s looked amazing. It wasn’t long before she was in Sharone’s chair, too.
Over years, a couple of hours at a time every two weeks, the three of us became friends. We trusted and confided in Sharone — a mother and grandmother, and a model of grace and professionalism. Curly highlights one year, sleek blow-outs the next. Sharone understood that in a world that judges Black women harshly, appearance has meaning. She took care of us.
Then, a couple of years ago, Sharone found a lump in her breast. It was our turn to care for her.
As doctors working to change America’s separate and unequal health care system, we know how serious breast cancer can be for Black women. Although prevalence is slightly lower, outcomes are much worse, with a 41 percent higher mortality rate than for white women. We had to intervene.
We also understand the legitimate reasons Black Americans distrust the health care system, and how that can interfere with treatment. A recent study shows that 30 percent of Black women reported mistreatment during maternity care, and earlier research associates experiences of racial discrimination with pregnancy complications.
The earliest appointment Sharone could get to see a primary care doctor was weeks away. A few weeks can mean the difference between life and death; delays in diagnosis are a huge factor in breast cancer outcome disparities.
Elaine arranged for Sharone to see a physician in her medical group right away. The doctor, a man of color, listened to Sharone’s concerns and took action. He immediately ordered a mammogram, and within a few days, she had a biopsy referral.
The biopsy didn’t go as smoothly. After a long drive, Sharone’s experience was less than ideal. The specialist told Sharone she would place a metal marker in her breast that couldn’t be removed. Sharone wasn’t comfortable and had questions. A metal marker? What was that for? The doctor became combative and told her she needed to do what she was told.
Sharone agreed to the biopsy; she knew she needed a speedy diagnosis. But she did not consent to the marker. She left that experience feeling guarded, dismissed and unheard.
“I was facing death and felt like I was losing my choices,” she told us. “I needed to be treated like a person with opinions and feelings. I had to trust other people with my life, and the only thing I could hold on to was my ability to choose.”
Trust in health care is often one-sided. As doctors we expect our expertise to be trusted and revered. Too often doctors dismiss the patient’s expertise, perspective and preferences.
Sharone calls this an issue not of trust but of positioning. What worked for her was when doctor and patient could come together as human beings, with mutual respect for one another’s expertise: the doctor as an expert in medicine and the patient as the expert on their experience.
Ideal doctor-patient positioning is about respectfully listening to patients and gaining their trust, by centering their concerns and preferences. It helps when doctors look like the patients they serve, with doctors who have themselves experienced the unique pressures and biases people of color encounter in a white-dominated culture. But the lesson applies to all of us.
Shortly after Sharone’s biopsy, we got heartbreaking news: She had triple negative breast cancer, among the most aggressive and difficult to treat. Her tumor was in stage two, but it had not yet spread to other parts of her body. It was critical for Sharone to get into treatment as quickly as possible.
Within a week, Medell helped Sharone get into treatment at UCLA Health.
Medell joined Sharone for several medical appointments, serving as mediator and supporter. “They were excellent doctors,” Sharone later told us. “Each doctor came in and explained the process. They were very professional.”
But there were setbacks.
Sharone had an allergic reaction to the initial medical treatment. “That first day of chemo, it almost killed me,” she said. “After that, I didn’t want to continue, but I knew I had to continue. I knew as long as I had breath, I would continue to fight for my life and for my family.”
Then Sharone’s treatment plan changed. Her body wasn’t responding fast enough. Her doctor recommended two additional rounds of treatment. Chemotherapy is tough on the body and mind, and Sharone wasn’t sure she needed all of it. We gently encouraged her. Sharone finished the treatments.
Today, two years after her initial diagnosis, Sharone is healthy. She caught the cancer before it spread and got effective treatment quickly.
Our counsel also helped her stick with her treatment. Having friends guide her through the challenging mazes of the health care system helped ensure Sharone did not become one of thousands of Black women lost too soon to breast cancer each year.
But the fact that we had to intervene is a sign that our system is broken and needs to change.
Everyone deserves access to high-quality care, empathetic physicians and a supportive community. Without these things, we will continue to see health inequities among Black women and other people of color.
“If the two of you hadn’t been there to support me and speed things up, I probably would’ve received care,” Sharone told us. “But, I don’t think I would have survived.”
Dr. Medell Briggs-Malonson is chief of Health Equity, Diversity and Inclusion for the UCLA Health System and associate professor of emergency medicine at the David Geffen School of Medicine at UCLA.
Copyright 2023 Nexstar Media Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
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Women’s Health
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At least 400 women are in the second week of a hunger strike in a high-security prison in Iraq's capital Baghdad, the BBC has learned.
They are in prison for being part of the Islamic State group, after what they say were unfair trials.
The group is said to include foreign nationals from Russia, Turkey, Azerbaijan, Ukraine, Syria, France, Germany and the US.
It is thought about 100 children are also being held at the facility.
The Islamic State group, also known as ISIS, waged a brutal campaign to establish a self-declared caliphate - an Islamic nation - across Syria and Iraq, killing and enslaving thousands across a five-year period.
After its fall in 2017, tens of thousands of former members were rounded up. It is alleged many of the men were summarily executed, but thousands of women and children were taken into detention. Some were repatriated to their home nations, but many remain in Syrian and Iraqi jails.
Videos sent to BBC Arabic from inside the Baghdad facility show emaciated women lying motionless on hard stone floors. It is thought the group have not eaten since 24 April.
The BBC has been told that at the start of the hunger strike, participants were consuming just half a glass of water per day. Some women have now stopped drinking altogether.
Young children can also be seen in the video footage - many reportedly born inside the facility.
The women's sentences range from 15 years to life imprisonment. Some have been sentenced to death, but no executions have been carried out, the BBC understands.
The hunger strike is a protest against both their convictions and the conditions they are being held in.
Speaking on an illegally-held mobile phone, one Russian woman said she would not eat anything until she was released. She said she was given a 15-year sentence after a 10-minute trial, based on a confession she was forced to sign.
The document was written in Arabic, a language she cannot read, and stated she was arrested in Mosul whilst carrying weapons, both of which she denies.
It has not been possible to verify most of her claims.
The women said they had had no contact with their embassies, and diplomatic representatives had not been present at many of their trials.
The women we spoke to claimed around 60 adult inmates had died inside Rusafa prison over the last six years, along with up to 30 children. One woman said the last child to die was three years old.
The facility is located east of Baghdad, and holds women serving sentences for various crimes - not all terror-related. The inmates said they were held 40 to a cell, and were often subjected to beatings and inhumane treatment.
Last April, the Iraqi ministry of justice announced the dismissal of the director of the prison, citing "leaked audio" from the facility. The ministry also acknowledged that Rusafa prison was four times over its capacity.
Iraq's criminal justice system has long been criticised over allegations that trials are unfair and abuse is widespread.
The Iraqi government declined to answer the BBC's questions about the hunger strike or conditions in the prison. Previously, it has said it wants to help those who are innocent of any crime to return to their home countries.
Amnesty International, however, has reported that long prison terms and death sentences have been imposed in IS-linked cases "following convictions based primarily on torture-tainted 'confessions'".
The Human Rights Committee of the Iraqi parliament recently urged the authorities to speed up the process of repatriation of IS-linked foreign prisoners.
While some women have admitted to willingly joining IS, often participating in their crimes, others claim they were tricked or coerced into joining the group. Some insist they were forced to marry fighters and were threatened with death if they refused.
One of the most high-profile is Shamima Begum, a British schoolgirl who travelled to Syria in 2015. She is still being held in a detention camp in the north of the country.
Additional reporting by Joe Inwood and Peter Ball.
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Epidemics & Outbreaks
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On a typical day, Eve* would wake up and start prodding at her body while still in bed. She would avoid catching sight of herself while showering, or while trying to find an outfit to best hide her body.
“The day would usually be spent at work thinking about what to eat or not to eat and worrying about how I appeared to others, making sure I was holding in my stomach or standing or sitting behind something. I would check myself in every reflective surface I passed during my entire waking moments: shop windows, bathrooms, cars, mirrors.”
She would then go home alone to cook, which she dreaded, eating as quickly as possible to get it out of the way. She would then spend about an hour looking at her body, pinching and squeezing it.
“I would usually go to bed sad and angry about my appearance, hating it – wishing I would morph into another body and [thinking] my life would be so much easier.”
For Eve, body dysmorphic disorder (BDD) has been a shadow attached to every thought since childhood. She was often praised for being “pretty” as a child, but the compliments became backhanded as she got older, with suggestions from boys at school, and later men, that she would be more attractive if she were thinner.
“Then I went through puberty and I felt like I changed, like I became a kind of monster.”
Convinced there was something wrong with most of her body – particularly her stomach, thighs and bottom – she embarked on extreme exercise regimes in a bid to change her naturally “hourglass” shape. At 16, Eve became bulimic.
She was driven by “shame, self-loathing and wishful thinking – if I can just change this, I can do all the things I want”.
Now in her 50s, Eve says she had a couple of relationships, but the disorder ultimately led her to push people away; over the years she socialised less to avoid the anxiety of being looked at.
“It’s a hard one because I really longed for connection … but if people told me I was beautiful, I’d think there was something wrong with them: ‘Why would you find me attractive when I’m so revolting?’
“I believed I’d never allow myself to be intimate again as my body was too repulsive, and if a partner saw me naked, they would reject me. I resigned myself to a life of being single.”
What Eve didn’t know then was that no amount of exercise, or even surgery, could change what she saw.
Extreme body dissatisfaction
Although BDD is becoming better known, experts say it is often still confused with poor self-esteem or narcissism, sometimes with devastating results. The disorder involves preoccupation with perceived – but nonexistent or minor – flaws, causing enormous distress and varying repetitive behaviours to hide or “fix” the flaw.
Eighty per cent of sufferers consider suicide and roughly a quarter attempt it.
It is widely cited as affecting about 2% of the general population, making it more prevalent than anorexia and schizophrenia combined. Experts say the true figure could be higher – and rising.
Susan Rossell, an internationally recognised BDD expert, is running a survey to understand its extent in Australia.
“Those prevalence figures are very old and based on [data from] other countries,” says Rossell, a professor of cognitive neuropsychiatry at Swinburne University.
“We’ve noticed a general trend over the last 10 years of an increase in people reporting extreme body image dissatisfaction leading to BDD. But particularly during the pandemic, a range of things there to support us with our everyday lives – we know now are quite triggering for people who have a potential to develop BDD.”
An example is “the Zoom effect”. Rossell and colleagues found one-third of 335 adult surveyed who used video calls during the pandemic reported new concerns about their appearance; they also expressed greater interest in seeking aesthetic procedures.
Dr Katharine Phillips, a professor of psychiatry at New York-Presbyterian and Weill Cornell Medical Center in the US, notes genetics and the environment contribute to BDD’s development.
Phillips says the last nationally representative US prevalence survey, conducted in 2015, found it to be higher than in any previous study – at 2.9%.
“But I suspect BDD is becoming more common, perhaps because of widespread use of image-centric social media, which can promote unrealistic beauty standards, enables morphing of one’s appearance and can encourage people to compare themselves with very attractive people such as celebrities.”
‘We had no treatments’
During her medical residency, Phillips became interested in some severely ill patients – they could not work or socialise and some had attempted suicide because they believed they were so ugly. She had never heard of BDD, nor had her supervisors.
“It had fallen through the cracks of modern-day psychiatry,” Phillips says.
“Even though BDD had been described for more than 100 years, the field knew almost nothing about the disorder … We had no scales or assessments to diagnose it or assess its severity and we had no treatments. So I started on a quest to learn these things.”
BDD was first mentioned in the widely used Diagnostic and Statistical Manual of Mental Disorders in 1980. Phillips, whose research influenced diagnostic criteria and descriptions in several later editions, says recognition has improved compared with when she began research in the 1990s, but more is needed.
“BDD has been much less studied than many other severe psychiatric disorders and we need more research studies on virtually every aspect of the disorder. We especially need data from diverse populations and in children and adolescents.
“It tends to be considered less important than other severe mental disorders, even though it’s more highly associated with suicidal ideation and suicide attempts than most other serious mental illnesses.”
It often occurs alongside other mental health issues, but many sufferers avoid discussing their symptoms out of shame.
Perceived ugliness
Studies by Rossell and colleagues including David Castle, a psychiatrist and professor of psychiatry at the University of Tasmania, show changes in brain structure and connectivity among BDD patients.
Castle says while obsessive-compulsive disorder (OCD) and BDD both involve obsessional thinking and ritualised behaviours, BDD is distinct in important ways.
“Most people with OCD recognise their concerns are excessive, but in BDD, about half … have delusional convictions about their perceived ugliness: they completely believe it.”
There are also differences in visual processing: BDD sufferers tend to misinterpret facial expressions, being more likely to rate the expressions of onlookers as contemptuous or angry.
Rossell says unlike the brains of healthy people, which switch between looking at fine detail and at the big picture, the brains of people with BDD get stuck in detail mode. If anyone stares at one part of their appearance for a long time, it becomes distorted – which is thought to be at play in BDD.
Cosmetic quests
The Melbourne-based clinical psychologist Dr Toni Pikoos says about three-quarters of BDD sufferers seek cosmetic or dermatology procedures. But, she says, these are unlikely to help and often present increased risks to patients and providers.
“They can be vulnerable consumers. Often they’re quite desperate, so they’re willing to pay the money to feel better … Unfortunately in up to 90% of cases of people with BDD, they don’t experience any change in their symptoms afterwards.”
Pikoos often sees clients who were initially satisfied with a cosmetic surgery, but months or years later feel the “flaw” has come back or become worse.
“They can become quite depressed and fixated on that area of their appearance, which can sometimes lead to getting really angry at the surgeon … There’s a [US] statistic that 29% of people with BDD have complained or taken out litigation against their cosmetic practitioner.”
Following an inquiry into the cosmetic industry, in July 2023 Australia’s medical regulator, Ahpra, tightened guidelines for doctors providing cosmetic procedures, with further changes expected for providers of non-surgical procedures – including nurses, dentists and Chinese medicine practitioners.
The changes require doctors performing cosmetic surgery or prescribing cosmetic injectables (such as the botulinum toxin and dermal fillers) to screen patients for BDD and refer at-risk patients for external assessment.
Pikoos, who co-founded an organisation to help cosmetic practitioners with psychological assessments and consulted on the Ahpra review, says there has been an uptick in referrals for assessment since July, some of which have needed further treatment or support.
Access to treatment
BDD symptoms are unlikely to improve without targeted treatment, Castle says: usually involving high doses of SSRI antidepressants combined with cognitive behaviour therapy focusing on avoidance and safety behaviours, including work with mirrors.
“You can change people’s lives completely. The tragedy is, often people are coming to us very late and having gone through a lot of cosmetic procedures.”
Rossell estimates there is a dozen mental health professionals in Australia trained to treat BDD, many of whom she trained, but laments that there is no specialist focus.
BDD is not a searchable issue in the Royal Australian and New Zealand Royal College of Psychiatrists (RANZCP) or the Australian Psychological Society (APS) clinician directories, although APS includes body image as a subcategory of “personal” issues. Rossell says improving searchability is “crucial”.
She is concerned patients – and those who want to refer them – struggle to find the existing specialists and she urges any practitioners with experience in BDD to notify RANZCP and APS, since they rely on information provided by practitioners.
The RANZCP president, Dr Elizabeth Moore, says research shows the disorder is poorly understood and that prevalence could be higher due to underdiagnosis.
“Amongst health professionals, there are concerns around missing symptoms associated with BDD in patients, or misdiagnosing BDD patients for depression, social anxiety or OCD.”
Eve estimates she saw 10 psychologists or psychiatrists before being diagnosed with BDD three years ago. She has been receiving specialist treatment for almost a year, which has been transformative.
“I wake up feeling positive and the focus on my physical appearance has become less intense.”
It is also bittersweet.
“It’s almost surreal to have someone who understands it. It’s validating, but it also made me a little angry that it had taken so long to get help and that I’ve spent most of my life grappling with it myself – the shame and stigma and being dismissed.”
However, she believes this progress is the reason she is now in a supportive relationship – marking the first time she has told a romantic partner about her BDD.
“Things have changed drastically … and I am in love. I have opened myself up to the most caring and understanding person I have ever met.”
Eve is now studying psychology, with plans to specialise in the treatment of BDD.
*Name has been changed.
Prof Susan Rossell invites anyone with concerns about body dysmorphic disorder to contact her at Swinburne University’s Centre for Mental Health at bodyimage@swin.edu.au.
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Mental Health Treatments
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Montreal health authority investigating after surgery patient was left 'abandoned' in empty hospital ward
Health minister calls the incident 'unacceptable and disturbing'
A succession of errors led to a patient, who was still recovering from anesthesia and surgery, being abandoned on an empty floor without supervision or medical assistance for hours, Radio-Canada has learned.
The incident occured at Fleury Hospital, in Montreal's north end, on the night of Feb. 3, several Radio-Canada sources learned.
The patient, a firefighter, was supposed to be sent to the eighth floor for overnight observation after an evening surgery. However, the orderly erroneously took him to the third floor — intended for day surgeries — which is closed at night.
According to sources, the orderly saw someone in the hallway and assumed it was a nurse, when it was in fact a maintenance worker. The worker didn't see the patient and then closed the door on their way out.
For hours, none of the medical staff noticed the patient was missing. It wasn't until his wife, who was waiting for him on the eighth floor, started asking questions around 1 a.m. that a staff member went to investigate.
A co-ordinator went to the operating room but was unable to find the patient there. Still, no one activated a code yellow to signal that the man was missing.
The patient, who was recovering from anesthesia, woke up about two hours later, around 3 a.m., with no one around. In a gown, without a cell phone, he found the strength to go to the nurses' station, but no one was there.
He then picked up a phone and called security, who reportedly hung up on him.
The man then called his wife to come get him, and the couple decided to leave the hospital. The patient's vital signs and pain were assessed before he was discharged, and he refused further treatment.
'He could have died 100 times'
Hospital and health authority staff say the case raises concerns about the quality of care being provided. (Radio-Canada has agreed not to name them, as they are not authorized to speak to the media.)
"He could have died 100 times," said a source who is not authorized to speak to the media.
"Everyone was shocked," said another source. "It shouldn't happen."
The regional health authority, the CIUSSS du Nord-de-l'Île-de-Montréal, confirmed that a patient was taken to the wrong floor of Fleury Hospital on Feb. 3. It said that after realizing the patient had disappeared, the medical team called the patient, who was able to speak with his surgeon.
"Our priority was to continue caring for the patient at home," said CIUSSS spokesperson Marie-Hélène Giguère.
What type of operation the patient underwent is not yet known, but the CIUSSS said the surgery was related to the upper body.
Paul Brunet, a patient advocate and president of the Conseil pour la protection des malades, says patients are usually in much more vulnerable positions, which could have made this case "much more serious."
"It's hard to believe that, once admitted, once registered, once operated, a patient is abandoned, as if he didn't exist," Brunet said. "He was literally written off. It sends shivers down the spine."
Ongoing investigation and reinforced measures
The risk management team is currently investigating the incident with the patient's co-operation, according to the CIUSSS.
"Labour relations are also involved in the investigation to understand the role and responsibilities of each of the employees and managers who intervened during this evening," the regional health board said. "The teams have all been interviewed."
"This type of incident hardly ever occurs and we will do everything necessary to prevent it from happening again," Giguère said.
She said additional measures have already been put in place to correct the situation, such as indicating where the patient is headed in their file, as well as transmitting that information verbally to employees in charge of transfers. The day surgery unit will also receive more monitoring rounds, even outside its operating hours.
The CIUSSS confirms that this incident is considered a "sentinel event," which the Health Ministry defines as an event that requires in-depth analysis, because it reveals flaws in a process that have led or could have led to serious consequences. Such incidents are announced to the entire health network.
Health Minister Christian Dubé said in a statement that the incident was "unacceptable and disturbing."
"It does not in any way represent the care that Quebecers deserve, and that they must have," Dubé said. "A situation like this should never happen."
Based on reporting by Radio-Canada's Thomas Gerbet
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Health Policy
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By Judith Goldstein, OD, as told to Keri WigintonÂ
Geographic atrophy (GA) can be visually confusing.Â
People often tell me that one minute they see something, and the next minute they donât. For example, the word youâre reading might be âshe,â but you see only the âheâ part. Or $129 might look like $12 and then $129 when you glance back.Â
That leaves people wondering: Well, then, whatâs the price?
In more advanced stages of the disease, your central vision may seemingly âwhite outâ or go grey when you look straight at things or people.Â
Itâs easy to get scared or upset when the visual information you take in comes and goes or isnât clear. And for some, these sight setbacks can lead to feelings of depression or anxiety.Â
But what I see most often is that people with GA get really frustrated -- everything takes longer; everything is slower. And sometimes they may need to rely on other people for everyday things, like paying bills or driving to the store. I find itâs this loss of independence that bothers people the most.Â
As an optometrist who specializes in low vision, I help people manage the individual mental, emotional, and physical impacts of their disease. What I emphasize to folks is that no matter what degree of vision loss they have, there are ways to adapt. Itâs just a matter of finding the right solution for you.Â
The Confusion That May Come With Geographic Atrophy
I often explain to people that their lived experience may not match up with what they hear from their retina specialist. For instance, your visual acuity according to the eye chart may seem really good, yet you still read really slowly or have trouble spotting uneven pavement when you walk down the street.Â
To get to the source of this disconnect, itâs important to understand how this disease affects vision.Â
GA causes progressive and irreversible loss of the cells of the macula/central vision and can lead to vision loss. This is the light-sensitive part of your eye that sees and transmits details and colors when you look straight at things.Â
But the disease may also cause a âdoughnutâ of damage around the macula in the early stages. And you lose pockets of your visual field around the center. This can make simple tasks like shopping or reading labels more difficult. You may have to go back and reread things a lot, and numbers are often harder to read than words.
This happens because we donât read one character at a time. We see a whole visual span. For instance, you may read three characters to the left and maybe seven characters to the right every time the center of your eye looks straight at a letter or number in a sentence.Â
Sometimes this leads to frustration from family members. People will say they donât understand how their mom can see a really small thread on the floor, but she canât read anything. And I try to explain to them that when she drops something on the floor, she sees it out of the side part of her eye. But if she looked at directly at it, it would seemingly disappear.Â
People with GA also have trouble with contrast sensitivity, which is rarely measured outside of a low vision evaluation, but contrast sensitivity is important when it comes to peopleâs faces. My skin may appear the same color as my lips, for example.Â
Tips to Avoid Social IsolationÂ
A loss of central vision can affect socialization in a couple of big ways. For starters, you may not be able to drive to parties or events, especially if they happen at night. And when you do go out, you may not be able to spot friendly faces from across the room.Â
Now imagine that youâre older and transitioning into community living. You may worry that people will think youâre snubbing them if you donât say hi or you reintroduce yourself because youâre not sure if youâve met before. You may be too embarrassed to go out and meet new people or try new things.Â
But there are ways to boost your social life and well-being while living with GA.Â
Some key things you can do are:Â
Go to low-vision rehab. As low vision specialists, we donât make your vision better. Instead, we tackle all kinds of activities and teach you to adapt to them with low vision. Some of these modifications may take time to learn, but they can make everyday life with GA a lot easier.Â
Get your best corrective glasses. This might sound simple, but itâs actually not. Because it may seem like you should get stronger reading glasses as your vision gets worse. But that can magnify the good as well as the bad parts of your vision. As your GA progresses, less magnification may help you see better up close.Â
Control lighting. Consider wearing a wide-brimmed hat or a cool pair of custom-tinted glasses to a party or event. You may see better if you control how light hits your eyes.
Ask friends and family for support. If you go to the grocery store or a social event, ask whoever youâre with to give you a heads-up about whoâs coming your way. Ask your spouse to say, âHey, thatâs Sally coming down the aisle,â for example.Â
Call a car. GA can make it unsafe to drive on your own. But the good news is there are lots of rideshare services and apps you can use with your smartphone, and some are geared toward older adults. There may also be community ride options available if you ask your doctor or check with your local health department.Â
Find new ways to socialize. Weâll connect people with activities organized by local senior or community centers, or in some cases, we can connect them to volunteer groups who might come read to them or arrange other activities.Â
Connect online. The beauty of technology is that almost everyone I treat has a smartphone. And lots of people play online games like Words with Friends. Maybe their gaming partner isnât right in front of them, but theyâre still spending time socializing.
Finding the Right Solutions
If you have GA, there are lots of ways to improve your ability to see and do things, but itâs key that you grasp what is and isnât possible.Â
For instance, you can use specialized devices to keep up your stamp collection or see paintings in a museum. And lots of folks with GA get back into reading when they switch from printed material to electronic tablets.Â
But you may need to let go of the idea that youâll still be able to drive cross-country at night in the dark while itâs raining.Â
Often, the key to well-being for older folks isnât taking up new hobbies or socializing. Itâs little things like maintaining control over their administration. For some, that may mean we set you up with a tablet to do online banking or we help you find new ways to manage your medication.Â
If you have GA, whatâs most important is to think about what you actually like to do and how you want to stay connected. There are low-vision modifications you can do for pretty much everything. Even if itâs difficult, we can usually make it work if itâs something important to you.Â
How to Spot Depression in Your Loved OneÂ
Many people with vision loss tell me they have ups and downs but overall, theyâre doing OK. When the balance tips toward more bad days than good days and there are other symptoms of depression (like sleeping too much or eating a lot less), then that can be a cause for concern.Â
The median age of the people I treat is about 77, and I donât find that GA triggers depression in most folks, but it can be enough of a driver when you add it to the physical losses that come with age.Â
Though we have to be careful about labeling certain behaviors as depression in older adults.
For instance, your loved one may not go out as much as they did when they were younger. But that may not be a sign that something is wrong. Many folks in their 70s, 80s, and 90s may be very pleased just enjoying time at home.Â
Whatâs important is to take a look at your loved oneâs baseline. What was this person like before they started to have trouble with their vision?Â
Really talk to your loved one who has GA. Whether theyâre your spouse, friend, or family member, itâs important to check in and have those conversations about mental and emotional health.Â
Show Sources
Photo Credit: shapecharge / Getty Images
SOURCE:Â
Judith Goldstein, OD, director, Lions Vision Research & Rehabilitation Center; associate professor of ophthalmology, Johns Hopkins Wilmer Eye Institute, Johns Hopkins University School of Medicine.Â
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Disease Research
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"No leg, no excuse" - those are the words which will be on Matt Edwards' T-shirt when he climbs the highest mountain in Wales this weekend.
The amputee will scale Mount Snowdon (Yr Wyddfa) with his friend Jack Sharpe on Saturday, and wants to show people that you can achieve success in the face of adversity.
Mr Edwards, 24, faces the added challenge of doing the hike on crutches after he lost his left leg below the knee five years ago.
After a traffic collision while travelling on his motorbike, Mr Edwards was put in an induced coma before waking up on Christmas Eve without his left leg at the age of 19.
He said that it was "physically and mentally hard" to process and due to a lack of support at the time, he turned to alcohol and drugs before spending a few weeks in rehab in early 2019.
"At one point, I was drinking every day for about six months and became addicted to cocaine and that's when I got sectioned in mid-February 2019 for drug-induced psychosis," Mr Edwards said.
"Even before that, I was homeless and was just being a scrounger."
After that, Mr Edwards turned his life around with a newly-discovered love of keeping fit and helping others.
He added: "I created a charity called Boxing for the Brain before the pandemic and I help people who have low self-esteem, no confidence.
"When I got out of rehab they told me I needed a hobby to keep my mind away from drugs and alcohol and when I found boxing and punched the bag for the first time, it was an instant stress reliever.
"I knew instantly that I could help a lot of people through this and have helped a lot of people get clean, sober and even housed and even just act as a shoulder to cry on.
"I believe God gave me the accident to get me to change my life around."
Mr Edwards says that he always wanted to climb Snowdon and he aims to complete the hike in under six hours.
He will be raising money for the Stillbirth and Neonatal Death Charity (SANDS).
He said: "Last year, my brother-in-law Callum went through a stillbirth and it broke him dramatically - it really, really affected him.
"That's why I chose SANDS to raise money for - it is in remembrance of Vienna Bowden, his baby girl.
"I also wanted the challenge to have a charity aspect because when you get half way and you feel like giving up - your arms are dead and your ankles are hurting, you're soaking wet and slipping and sliding - that gives you the push to the top.
"I have an abscess on my leg at the moment so cannot use my prosthetic leg, so I will crutch myself all the way to the summit."
The support Mr Edwards has received in donations and messages has given him more motivation ahead of the hike.
"It's nice to know that people out there are following my journey," he said.
"I also want to show that I don't have a disability, I have a different ability."
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Mental Health Treatments
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The arms race over the next generation of obesity drugs is continuing to heat up. This week, pharmaceutical company Eli Lilly announced it was suing several pharmacies, spas, and wellness centers in the U.S. for allegedly selling unauthorized copycats of its blockbuster drug tirzepatide, which is expected to be formally approved for treating obesity soon. The Food and Drug Administration has previously warned the public to stay away from sketchy sources of the similar drug semaglutide, sold under the brand names Ozempic and Wegovy.
Tirzepatide is the active ingredient in Eli Lilly’s injectable drug Mounjaro, which is currently approved for type 2 diabetes. It’s the latest in an emerging class of medicines that act as synthetic versions of hormones key to controlling our hunger and metabolism. Like semaglutide, tirzepatide mimics the hormone GLP-1, but it also mimics the hormone GIP. The combination is intended to boost its potency, a strategy that seems to have paid off. In large-scale clinical trials of tirzepatide for obesity, people have lost an average of 20% to 25% of their baseline weight, noticeably above the 15% or so average weight loss seen with semaglutide in similar trials (itself far above the success seen with past weight loss drugs). Both drugs have appeared to be generally safe, though they do commonly cause gastrointestinal symptoms that can be very intense for some people.
With the release of its positive Phase III data this spring and summer, Eli Lilly is expected to win approval for tirzepatide as an obesity drug as early as late 2023. However, doctors have already been prescribing Mounjaro off-label to some of their patients. And some people have been desperate enough to seek out tirzepatide and semaglutide from less scrupulous places. Spas, wellness centers, and some doctors have relied on compounding pharmacies—pharmacies typically used to create custom-made medications for patients with special needs—to produce off-brand, usually cheaper versions of these drugs.
Earlier this May, the FDA announced that it had received adverse event reports from people using compounded semaglutide. The agency also warned the public to stay away from these unregulated medications, noting that some pharmacies may be using wholly unapproved formulations. Novo Nordisk, the makers of Wegovy and Ozempic, has already begun to sue specific companies for producing or selling compounded versions of their products. And now Eli Lilly has joined the fray.
“Lilly cannot validate the safety or effectiveness of products claiming to contain tirzepatide that are not our own branded product,” the company said in a statement released Tuesday. “Because of this, Lilly filed lawsuits to protect patient safety and stop the unlawful marketing and sale of non-FDA approved compounded products fraudulently claiming to be Mounjaro® (tirzepatide) by medical spas, wellness centers and compounding pharmacies.”
While some of the interest in black market semaglutide and tirzepatide might be fueled by customers otherwise not eligible for these drugs, there are other important factors. Both Eli Lilly and Novo Nordisk have faced supply shortages at various points, which has also impacted diabetes patients. In the U.S. specifically, both drugs are pricey and often not covered by insurance, costing upwards of $1,000 a month without coverage.
The future of weight loss treatment isn’t looking to get any less tangled anytime soon either. There are dozens of other potential obesity drugs coming down the pipeline, from Eli Lilly, Novo Nordisk, and many other competitors. Some of these treatments may be even more effective than tirzepatide, while others might provide more convenience, such as being available in a pill.
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Drug Discoveries
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A Biotech Slump Is Emptying Labs And Threatening Research On New Drugs
Sangamo Therapeutics Inc.’s cost cuts didn’t hurt just the roughly 162 US workers who lost their jobs this month. It’s also a blow to Jerry Walter, who’s lost five family members and suffered kidney, lung, hearing and heart damage from a rare disease.
(Bloomberg) -- Sangamo Therapeutics Inc.’s cost cuts didn’t hurt just the roughly 162 US workers who lost their jobs this month. It’s also a blow to Jerry Walter, who’s lost five family members and suffered kidney, lung, hearing and heart damage from a rare disease.
Citing the “challenging economic environment” that’s sending shock waves through the biotech industry, Sangamo paused research on an experimental gene therapy — possibly a cure — for Fabry disease. Walter, a 69-year-old retired US Army colonel who’s already had a heart transplant due to the inherited enzyme deficiency, said it’s disappointing to see work stop on yet another potential new medicine.
“The promise of a better treatment keeps getting pushed down the road,” he said.
Sangamo will finish a current Fabry trial as planned and is seeking funding or a partner for help with moving its studies to the final stage, a spokesperson said. Yet it’s been another bleak year for biotech companies as a closely watched index of stocks, often called the XBI, just passed 1,000 days from its early 2021 peak. The number of companies exploring strategic options — typically a sign of desperation — just hit a record high, according to analysts from Stifel.
“Nobody knows where the bottom of this is,” said Sam Fazeli, an analyst at Bloomberg Intelligence.
Money for research is getting harder to find: New flows into biotech venture funds are estimated to fall to $23 billion this year from about $31 billion in 2021, the Stifel analysts said. Rising interest rates, threats to prices of new drugs and a post-pandemic letdown have forced biotechs to pull back on research and development.
Last year, global pharma R&D spending fell 2.2% to $244 billion, the first drop in a decade, according to Evaluate Pharma, and slowed growth is expected in the coming years. It was just the fourth such decline in almost four decades, according to the PhRMA industry group.
The sector has seen “serious slimming down of pipelines at the small end,” Evaluate said in its August report.
Crucial Work
Big drugmakers have increasingly moved into areas that used to be biotech’s domain — like cancer and rare diseases — seeking profits from drugs that aren’t easily replaced by competitors. French drugmaker Sanofi is boosting R&D spending, while Eli Lilly & Co., maker of blockbuster weight-loss drugs, increased this year’s R&D budget by $600 million.
But the industry giants can’t replace the crucial work done by smaller biotech companies, said Derek Lowe, a longtime drug researcher who writes the industry blog “In the Pipeline.” In many cases, biotech companies handle risky early-stage research that big drugmakers may invest in if it shows promise.
Biotech companies often take on challenges that are a bit “out there,” Lowe said. Big manufacturers “let the little companies take a crack at it and see how it goes.”
Gone is the pandemic enthusiasm that drove Covid shot-maker Moderna Inc.’s 12-month trailing price as high as 188 times diluted earnings per share from continuing operations in June 2021. Now the company is expected to report losses on an adjusted basis over the next year, and more than half the analysts covering it don’t recommend buying shares.
An industry slowdown was inevitable, Fazeli said. Firms are shifting their strategies in response. Unable to find investors who can provide more funds, small biotechs are skipping the long shots to focus on sure bets that are more likely to generate income soon or attract a deal with a bigger drug company, said John LaMattina, a former head of R&D at Pfizer Inc.
That means less creativity in the sector that gave rise to Covid shots, life-saving gene therapies and other treatments for once-fatal diseases. Those include Merck & Co.’s Keytruda, which first took shape about two decades ago at biotech company Organon & Co. Today the drug has treated more than 1 million patients with more than 20 different cancers, generating some $21 billion in sales last year.
Medicine Paucity
“The concern is that in three or four years from now there will be a paucity of innovative medicines,” said Jeff Jonas, former chief executive officer of the biotech company Sage Therapeutics Inc. “There is potential for the early ecosystem to suffer.”
The impact is hitting companies like Charles River Laboratories International Inc. that does work including early safety research on rats that precedes human testing. The firm has been involved in studying more than 80% of all US-approved drugs in the past three years.
Biotech companies that once investigated four or five products at a time now just have enough funding for two, said Jim Foster, Charles River’s chief executive officer. The result: organic revenue is expected to grow about 6% this year, roughly half its 2022 level.
“People are reprioritizing, being more judicious,” Foster said in an interview. “We are a canary in the coal mine.”
Lab space vacancies in the Boston biotech industry hub have hit a 10-year high, according to the real estate firm Colliers. For the first time, there’s about 5 million square feet of space on the market, up from 300,000 two years ago.
IRA Fears
Biotech’s woes could be a problem for big drugmakers, said Lowe, the pharma blogger: a smaller crop of candidates for big drug companies to buy later on. Those drugmakers need new products to make up for older ones that will be facing competition when their exclusivity runs out.
Aging drugs are also eligible for Medicare price negotiations under the Inflation Reduction Act, President Joe Biden’s signature legislation. Drugmakers have said that the law effectively shortens their products’ most profitable period, and that some early development programs will have to be sacrificed.
All that is bad news for Walter, the former colonel who founded the National Fabry Disease Foundation. Twice a month, the Hillsborough, North Carolina, resident sits for three hours getting enzyme replacement through an IV.
Before running short of money, Sangamo was pursuing a one-time treatment aimed at fixing the gene flaw responsible for the disease, meaning Fabry patients wouldn’t need those twice-monthly infusions. Those who got it in a trial “continue to report improvements in their quality of life,” the company said.
“We believe this is an important potential medicine and are doing everything in our power to still get this to patients in need,” the Sangamo spokesperson said in an email.
The treatment could have been “revolutionary,” had work on it continued, Walter said, adding he hopes that Sangamo can resolve its funding issues.
(Updates with company comment in final section. A previous version of this story corrected the frequency of patient’s infusions.)
©2023 Bloomberg L.P.
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Drug Discoveries
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Image source, Jim McCallumImage caption, Retired headteacher Jim McCallum, pictured with his wife Margaret, said he felt 'incredibly lucky' to have been part of a medical trialCancer centres in Scotland are to receive £4m funding to help develop new experimental treatments.Glasgow's Experimental Cancer Medicine Centre (ECMC) and paediatric ECMC will receive about £2.3m and Edinburgh ECMC will receive £1.8m over five years.Cancer Research UK and the Scottish government provided funds, with a contribution from The Little Princess Trust for children's cancer treatments.They said the money would help develop "cancer treatments of the future".Glasgow and Edinburgh ECMCs are part of a network of 17 UK centres funded by Cancer Research UK, which delivers clinical trials of new treatments. Since the network was established in 2007 about 30,000 patients have taken part in 2,100 clinical trials.The investment has been welcomed by retired headteacher Jim McCallum, from Paisley, who was diagnosed with Non Hodgkin Lymphoma in 2017.His lymphoma didn't respond to standard treatment, but after taking part in a cell therapy clinical trial at Glasgow ECMC in 2020 he is now free of cancer.The new funding will allow new treatments, including immunotherapies and cell therapies, to be developed for a range of cancers, especially those that particularly affect the Scottish population. It also aims to improve existing treatments - especially by targeting therapies more precisely to the patient's tumour - and support trials from innovative drug therapies to the latest advances in radiotherapy treatment. ECMCs work with local NHS facilities to provide access to medical trials and treatments to help find new ways to detect, monitor and treat cancer.Glasgow and Edinburgh ECMCs said they were "delighted" to secure the funding. Professor Jeff Evans, who leads the Glasgow centre, said: "Thousands of patients have kindly participated in these trials through the Glasgow and Edinburgh ECMCs and this funding, in partnership with other cancer centres in Scotland and throughout the UK, will benefit people with cancer in Scotland and beyond." 'They can't find any trace of cancer now'Image source, Jim McCallumA cancer diagnosis in 2017 shook Jim McCallum "to the core".The 76-year-old retired secondary school headteacher from Paisley visited his GP with a lump in his neck and was referred to hospital for tests. "I think I had known but you always hope that they tell you it's just a harmless lump," he said, recalling the diagnosis of Non Hodgkin lymphoma."That was the worst day, being told I had cancer."Chemotherapy treatment in 2018 was not successful - the cancer had spread.The father of two admitted: "After that first shock of diagnosis I tried never to get too high about progress or too low about the lack of progress."Cancer is such an insidious disease, you can never be sure where you are with it, and you do start to wonder how many treatment options are left to you."In 2020, just before the country was to go into Covid lockdown, he stepped forward for a clinical trial at Glasgow's ECMC and was given a new type of immunotherapy - chimeric antigen receptor T cell (CAR-T) therapy. This involves making a change to a patient's T cells, which are part of the immune system, to better recognise and attack cancer cells. The adapted T cells are then multiplied in a laboratory and returned to the blood stream via a drip. Jim was monitored in hospital for a week after the treatment and returned home just as the pandemic forced people to stay at home."I had already been in a lockdown as they had stopped visitors to the hospital including my wife Margaret," he said. "But I was incredibly lucky with the timing, being able take part in the trial before the full impact of Covid-19 struck the UK."Since completing the trial nearly three years ago, Jim has been closely monitored by medical staff and remained cancer-free despite not taking any further treatment for the disease.He said: "They can't find any trace of the cancer now. After the CAR T-cell therapy trial, there was only one small tumour but they gave me another treatment for that and it has also gone."I was just so glad they had a treatment I could try and taking part in a trial also has the potential to help others as well, it's all about gathering information."Jim has been able to spend time with family, including his three granddaughters, playing golf and his guitar, and praised the medical staff at the hospitals where he was treated. "I can't say just how good the hospitals have been and that is a huge element of going through cancer treatment," he said. "I feel I have been incredibly lucky."Cancer Research UK, which has helped develop many new cancer treatments that are used in clinical practice around the world, is hoping the ECMC funding will bring together "vast medical and scientific expertise" to take scientific discoveries from the lab into clinics for many types of cancer. Its executive director of research and innovation, Dr Iain Foulkes, said: "The trials taking place today will give the next generation the best possible chance of beating cancer. "Researchers will be working to find new treatments and tackle the unique challenges presented by cancers in children and young people."Phil Brace, chief executive of the Little Princess Trust, said cancer was the leading cause of death amongst children and young people in the UK and their charity was funding research to with the hope of finding "more targeted and less toxic treatments" for youngsters."We've made some good progress, but we want to do so much more," he added.
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Medical Innovations
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The number of different electronic cigarette devices sold in the U.S. has nearly tripled to over 9,000 since 2020, driven almost entirely by a wave of unauthorized disposable vapes from China, according to tightly controlled sales data obtained by The Associated Press.
The numbers demonstrate the Food and Drug Administration's inability to control the tumultuous vaping market more than three years after declaring a crackdown on kid-friendly flavors.
Most disposables e-cigarettes, which are thrown away when they're used up, come in sweet, fruity flavors like pink lemonade, gummy bear and watermelon that have made them the favorite tobacco product among teenagers. All of them are technically illegal because they haven't been authorized by the FDA.
Once a niche market, cheaper disposables made up 40% of the roughly $7 billion retail market for e-cigarettes last year, according to data from analytics firm IRI obtained by the AP. The company's proprietary data collects barcode scanner sales from convenience stores, gas stations and other retailers.
More than 5,800 unique disposable products are now being sold in numerous flavors and formulations, according to IRI's data, up 1,500% from 365 in early 2020. That's when the FDA effectively banned all flavors except menthol and tobacco from cartridge-based e-cigarettes like Juul, the rechargeable device blamed for sparking a nationwide surge in underage vaping.
But the FDA's policy — formulated under President Donald Trump — excluded disposables, prompting many teens to switch from Juul to the newer flavored products.
"The FDA moves at a ponderous pace and the industry knows that and exploits it," said Dr. Robert Jackler of Stanford University, who has studied the rise of disposables. "Time and again, the vaping industry has innovated around efforts to remove its youth-appealing products from the market."
Adding to the challenge, FDA has little visibility into a sprawling industry centered in China's Shenzhen manufacturing hub. Agency records show that FDA inspectors have only conducted a tiny handful of inspections in China, despite the fact that it produces nearly all e-cigarettes used in the U.S. today.
"FDA theoretically has the authority to inspect foreign manufacturing facilities," said Patricia Kovacevic, an attorney specializing in tobacco regulation. "But practically speaking, the inspection program that the FDA has in place only happens in the U.S."
Most disposables mirror a few major brands, such as Elf Bar or Puff Bar, but hundreds of new varieties appear each month. Companies copy each other's designs, blurring the line between the real and counterfeit. Entrepreneurs can launch a new product by simply sending their logo and flavor requests to Chinese manufacturers, who promise to deliver tens of thousands of devices within weeks.
Under pressure from politicians, parents and major vaping companies, the FDA recently sent warning letters to more than 200 stores selling popular disposables, including Elf Bar, Esco Bar and Breeze. The agency also issued orders blocking imports of those three brands. But IRI data shows those companies accounted for just 14% of disposable sales last year, leaving dozens of other brands untouched, including Air Bar, Mr. Fog, Fume and Kangvape.
FDA's tobacco director, Brian King, said the agency is "unwavering" in its commitment against illegal e-cigarettes.
"I don't think there's any panacea here," King said. "We follow a comprehensive approach and that involves addressing all entities across the supply chain, from manufacturers to importers to distributors to retailers."
IRI restricts access to its data, which it sells to companies, investment firms and researchers. A person not authorized to share the information gave access to the AP on condition of anonymity.
IRI declined to comment on or confirm the data, saying the company doesn't offer such details to news organizations.
To be sure, the FDA has made progress in a mammoth task: processing nearly 26 million product applications submitted by manufacturers hoping to enter or stay on the market. And King said the agency hopes to get back to "true premarket review" once it finishes plowing through that mountain of applications.
Meanwhile, parents, health groups and major vaping companies essentially agree: The FDA must clear the market of flavored disposables.
But lobbying by tobacco giant Reynolds American, maker of Vuse e-cigarettes, has made some advocates wary about pushing the issue. The company petitioned the FDA earlier this year to restrict flavors in all disposable vaping products.
FDA's King says the agency already has ample authority to regulate disposables.
"There's no loophole to close," King said, pointing to FDA's recent actions against disposable makers.
But King's predecessor at the FDA says the current situation could have been avoided but for a decision by Trump's White House to exclude disposables from the 2020 flavor ban.
"It was preventable," said Mitch Zeller, who retired from the FDA last year. "But I was told there was no appeal."
In September 2019, Trump announced at a news conference a plan to ban non-tobacco flavors from all e-cigarettes — both reloadable devices and disposables. But his political advisers worried that could alienate voters.
Zeller said he was subsequently informed in December 2019 that the flavor restrictions wouldn't apply to disposables.
"I told them: 'It doesn't take a crystal ball to predict that kids will migrate to the disposable products that are unaffected by this, and you ultimately won't solve the problem,'" Zeller said.
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Epidemics & Outbreaks
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Research on long-term memories has largely focused on the role of neurons -- the brain's nerve cells. However, in recent years, scientists are discovering that other cell types are also vital in memory formation and storage.
A new study, published in the journal Neuron, reveals the crucial role of vascular system cells -- known as pericytes -- in the formation of long-term memories of life events -- memories that are lost in diseases such as Alzheimer's disease. The research, conducted by New York University neuroscientists, shows that pericytes, which wrap around the capillaries -- the body's small blood vessels -- work in concert with neurons to help ensure that long-term memories are formed.
"We now have a firmer understanding of the cellular mechanisms that allow memories to be both formed and stored," says Cristina Alberini, a professor in New York University's Center for Neural Science and the paper's senior author. "It's important because understanding the cooperation among different cell types will help us advance therapeutics aimed at addressing memory-related afflictions."
"This work connects important dots between the newly discovered function of pericytes in memory and previous studies showing that pericytes are either lost or malfunction in several neurodegenerative diseases, including Alzheimer's disease and other dementia," explains author Benjamin Bessières, a postdoctoral researcher in NYU's Center for Neural Science.
Pericytes help maintain the structural integrity of the capillaries. Specifically, they control the amount of blood flowing in the brain and play a key role in maintaining the barrier that stops pathogens and toxic substances from leaking out of the capillaries and into brain tissue.
The discovery, reported in the new Neuron article, of the pericytes' significance in long-term memory emerged because Alberini, Bessières, Kiran Pandey, and their colleagues examined the role of insulin-like growth factor 2 (IGF2) -- a protein that was known to increase following learning in brain regions, such as the hippocampus, and to play a critical role in the formation and storage of memories.
They found that IGF2's highest levels in the brain cells of the hippocampus do not come from neurons or glial cells, or other vascular cells, but, rather, from pericytes.
IGF2's presence in pericytes, then, raises the following question: How is this linked to memory?
The scientists conducted a series of cognitive experiments using mice, comparing behaviors of those with pericytes that produced IGF2 and those that did not. By removing IGF2-producing capacity in some, the researchers could isolate the significance of both pericytes and IGF2 in neurological processes.
In these experiments, the mice were subjected to a series of memory tests -- learning to associate a mild foot shock to a specific context or learning to identify objects placed in a new location.
Their results showed that production of IGF2 by pericytes in the hippocampus was enhanced by the learning event. More specifically, this increase in pericytic IGF2 took place in response to activity of neurons, revealing a concerted, neuron-pericytic action. In addition, IGF2 produced by pericytes were shown to circle back to influence biological responses of neurons that are critical for memory.
"IGF2 produced from pericytes and acting on neurons support the idea that a neurovascular unit regulates neuronal responses as well as functions of the blood barrier and may have repercussions on brain injury and inflammation," notes Pandey, a postdoctoral researcher in NYU's Center for Neural Science.
"Cooperation between neurons and pericytes is necessary to assure that long-term memories are formed," observes Alberini. "Our study provides a new view of the biology of memory -- though more research is needed to further understand the roles of pericytes and the vascular system in memory and its diseases."
The research of this study also included scientists from Cold Spring Harbor Laboratory and the University of Cambridge.
The research was supported by grants from the National Institutes of Health (MH065635), the United Kingdom's Biotechnology and Biological Sciences Research Council (BB/H003312/1) and Medical Research Council (MRC MC_UU_00014/4, MRC_MC_UU_12012/5).
Alberini is a founder and equity holder of Ritrova Therapeutics, Inc, a company exploring new treatments for neurodegenerative diseases and neurodevelopmental disorders. The company did not fund this study.
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Disease Research
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Image source, CHSSImage caption, Greig Brown has not worked and has struggled since he caught Covid in January 2021Health boards are avoiding publicising their long Covid services to avoid a rush of patients, an expert has claimed.Edward Duncan, a professor of applied health research, has been evaluating rehabilitation services in Scotland for the past eight months.The University of Stirling academic examined four health boards for a Scottish government-funded project.The latest ONS figures showed 155,000 Scots had long lasting Covid symptoms.Prof Duncan said the current situation was contributing to a "trickle" of patients accessing treatment in some regions.He is working with Robert Gordon University, the University of Dundee and long Covid sufferers to work out the best way to maximise recovery and quality of life for patients.It comes after patient groups accused the health service and government ministers of pretending the illness has disappeared.'Won't meet demand'Prof Duncan said: "Staff in some health boards have said to us that they are purposely not publicising the pathway, because they fear that if they do, they will have so many referrals that they will not be able to meet demand."There is a lack of proactive publicity, despite the fact that in late 2020 every health board said that these services were there for patients who need them."We know from other research that patients are going to primary care and being told by their GP that they don't know where to send them."Image caption, Prof Edward Duncan said health boards were afraid of being overwhelmed by demand for Long Covid supportProf Duncan and his team have followed four health boards across Scotland to see what the Covid rehabilitation pathway looks like. One had a dedicated team and the others were integrating long Covid rehab into existing services.They found that in the area with the dedicated team, where the pathway was well-publicised, hundreds of referrals were made and there have been challenges meeting patient demand.However, where long Covid rehab has been delivered within existing services, that pathway has not been publicised, meaning GPs don't know where to send people. Prof Duncan said that as a consequence, referrals to those services were in single figures - between four and eight - over an eight-month period.'Turf protection'He added: "Not everybody will need access to rehabilitation. But if you imagine, conservatively, that 10% will need it, then we are talking about 15,000 people across Scotland."With 14 regional health boards, we should be expecting in the region of 1,000 people in each, and we are not seeing anything like that."There is a phenomenon known as turf protection, where services will not publicise pathways because they know if they do they can't meet demand."The Scottish government said it had allocated £3m this year to allow NHS boards to deliver models of care appropriate for local needs.Chest Heart & Stroke Scotland (CHSS) has called for a digital pilot scheme that automatically connects GP's with long Covid support services to be rolled out across the country.The scheme, involving more than 30 GP surgeries in NHS Lothian, was set up in response to concerns that thousands of long Covid patients were missing out on support.The charity created an online platform called My Tailored Talks which allows GPs and other clinicians to refer patients automatically to its support services and provide self-management information to patients.Lesley Macniven, of the Long Covid support group, said the role of patients in treatment options should not be overlooked. She said: "As patient groups we've been the mainstay of support for people living with the illness while the relevant services haven't been in place. "Omitting this wealth of knowledge will only delay action to reverse this spiral of despair, lost careers and lost lives."'I want to be fit and healthy again'Image source, CHSSImage caption, Greig Brown's GP put him in touch with a Covid pilot groupGreig Brown, 44, from Armadale, West Lothian, found vital help in the CHSS support groups. He caught Covid in January 2021 and has not been able to return to his job as a joiner at St John's Hospital in Livingston.His long Covid symptoms include brain fog, breathing difficulties, extreme fatigue, loss of smell and taste. He relies on inhalers and steroids, which have led to him gaining weight.Previously Greig enjoyed running, cycling, golf and walking his dogs. Not being able to do those things, plus financial worries from not working, led to some dark moments.Greig said: "I was worrying about money, was my life going to get better? It wasn't, it was getting worse."It was a real struggle last Christmas. I thought there was nothing else and I tried to take my own life which was really silly."I thought at the time it was doing the right thing, my mortgage would be cleared, my partner and my son would have a better life. That's not the case. My son and my partner want me here. It was really, really silly of me."Greig's GP put him in touch with the Covid pilot group and found its support groups helpful. But he feels more could be done by the NHS to help people in his situation get their lives back.He said: "I want to be able to get up for work and being fit and healthy again. I get angry and think to myself, I can't accept being like this for the rest of my life."Adapting to needsHealth Secretary Humza Yousaf welcomed Chest Heart & Stroke Scotland's long Covid support service.He said: "This kind of digital innovation is just one example of the flexible way in which our NHS boards across Scotland are adapting to meet the needs of people with long Covid."I look forward to seeing the full results of the pilot exercise and considering how digital solutions can help healthcare professionals to access information and resources to support the identification, assessment and management of people with long Covid."Mr Yousaf said given the range of symptoms, there was no "one-size fits all" response to long Covid and his aim was for patients to access care and support in a setting as close to their home as practicable.
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Epidemics & Outbreaks
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New research in Scientific Reports provides evidence that the way people think and feel during their waking hours strongly related to the content and characteristics of their dreams during sleep. Specifically, dreams are most similar to thoughts that are unrelated to ongoing tasks (e.g. mind wandering), supporting the idea that our daytime experiences are psychologically intertwined with our dreams at night.
Despite advancements in scientific understanding, the reasons behind why we dream remain elusive. Previous research has drawn parallels between the content of dreams and waking thoughts, hinting at possible connections. However, most studies have been limited by small sample sizes and a lack of exploration into which types of waking thoughts are most similar to dreams. This study aimed to address these gaps and gain insights into the underlying mechanisms of dreaming.
“My doctoral work revolved around the topic of the thoughts that emerge in contexts when environmental demands are minimal,” explained study author Quentin Raffaelli, a PhD in Psychology affiliated with the Neuroscience of Emotion and Thought Lab at the University of Arizona.
“In daily life, this includes situations when one performs a task that is extremely easy, based on rote memory (e.g., doing the dishes), or passive (e.g., waiting for the bus). These situations demand very little cognitively from us. What’s fascinating is that in these situations the mind has a tendency to produce a lot of unrelated content, what is usually called mind wandering. An extreme form of such a situation is dreaming, when the mind generates content that is available to consciousness in a situation where the body is (almost) entirely decoupled from the environment and has no task to perform beyond the recuperative and maintenance activities that require sleep.”
“A lot of work suggest some sort of continuity between ‘day-dreams’ (i.e., mind wandering as defined by task-unrelated thought) and dreams, a theory known as the Continuity Hypothesis. Our goal with this study was to demonstrate with a large and diverse sample that this continuity includes the phenomenological characteristics of such experiences, that is, that the way we daydream is predictive of the way we dream.”
To explore the relationship between dreams and waking thoughts, the researchers conducted a study involving 719 young adults. Participants were recruited from the University of Arizona’s undergraduate student pool. They were required to download a smartphone app called “Mind Window,” which prompted them to answer questions about their thoughts and feelings throughout the day. This ecological momentary assessment was conducted over a period of one week.
The researchers categorized waking thoughts into four distinct categories:
- Stimulus-Independent Task-Unrelated Thoughts: These are thoughts that spontaneously arise in your mind without any connection to external events and are not related to the task you are currently doing.
- Stimulus-Dependent Task-Unrelated Thoughts: These thoughts are triggered by external stimuli or events but do not pertain to the task you are engaged in, often serving as distractions.
- Stimulus-Independent Task-Related Thoughts: These thoughts are generated independently of external influences and are focused on the specific task or activity you are currently performing, representing spontaneous insight.
- Stimulus-Dependent Task-Related Thoughts: These thoughts are both influenced by external stimuli and directly related to the task you are currently working on, indicating full engagement in the task and responsiveness to the environment.
Additionally, participants were asked to complete a self-report questionnaire about their typical dreams, covering various characteristics such as intentionality, awareness, vividness, valence, and more.
The most striking finding of the study was the significant similarity between dreams and task-unrelated thoughts, particularly those that were stimulus-independent. Participants perceived their dreams as resembling these thoughts in terms of valence, vividness, self-focus, and social content.
Furthermore, the researchers discovered that task-unrelated thoughts, especially those that were emotionally charged, correlated positively with dream characteristics at the individual level. This suggests that individuals with more emotionally significant concerns in their waking life tended to experience similar emotional content in both their dreams and daytime thoughts.
Another intriguing aspect of the study revealed that individuals who engaged in rumination, a repetitive and passive focus on distressing thoughts, exhibited more negative and unconstructive dreams. This trait rumination was found to be linked to both negative dream characteristics and the degree of concern individuals had about the COVID-19 pandemic. The study demonstrated that those prone to rumination were more likely to experience distressing dreams, particularly when they were highly concerned about global issues like the pandemic.
“The main take-away from our study is that there is a relationship between the characteristics of mind wandering and dreams,” Raffaelli told PsyPost. “We found that the phenomenological profile of participants’ daydreams was predictive of the phenomenological profiles of their dreams. In simpler words, the way we daydream is the way we dream.”
“Our results also suggest it may be related to the way one deals with their current concerns or unfinished businesses, all the short and long-term problems and worries that seem to make up a lot of what we think about when we mind wander. Individuals that were more worried about the COVID-19 pandemic experienced more negative dreams, and this tendency was worsen for individuals who tend to ruminate, a maladaptive approach to dealing with one’s problems and worries.”
The findings of the study are in line with the Continuity Hypothesis of dreams, which posits that there is a fundamental relationship between waking cognitive processes and dreaming, implying that the thoughts, concerns, and experiences people have during their waking hours are often reflected in their dreams during sleep.
“What I learned about dreams in preparation to this project was fascinating,” Raffaelli said. “The work on the Continuity Hypothesis in particular, which suggests various sorts of similarities between waking life and dreams, was very interesting. Multiple lines of works for example show that individuals with particular mental health conditions have dreams that reflect their wakeful idiosyncratic way of thinking and that one can see the characteristics of dreams evolve as mental health status improves or worsens.”
While this study provides valuable insights into the connections between dreams and waking thoughts, it is not without limitations. One limitation is that participants’ self-reporting of their dreams may be influenced by their personality traits, potentially skewing the results. Moreover, the study focused on a specific age group (young adults), limiting the generalizability of the findings.
“No research design is perfect, and ours is no exception,” Raffaelli told PsyPost. “It is difficult to get very precise assessment of dreams and here we add to make a compromise between having a very large sample and precision of assessment, favoring the former over the latter. It would be necessary to strengthen our results with a follow-up that captures more carefully the characteristics of dreams in particular.”
“People interested in the topic may consider the book ‘When Brains Dream: Exploring the Science and Mystery of Sleep’ by Zadra and Stickgold,” Raffaelli added. “Chapter 8 in particular proposes an explanation as to why mind wandering and dreams appear to share so much and was an important inspiration of this work.”
The study, “Dreams share phenomenological similarities with task-unrelated thoughts and relate to variation in trait rumination and COVID-19 concern“, was authored by Quentin Raffaelli, Eric S. Andrews, Caitlin C. Cegavske, Freya F. Abraham, Jamie O. Edgin, and Jessica R. Andrews-Hanna.
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Mental Health Treatments
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You can choose for the lamp to follow the natural sunrise and sunset times based on your location, which in most of the world changes a little day by day. Or you can set custom times in the app. I didn't want the lamp's sunset actually to begin at 7:30 pm every day, so I set my sunset to 9:30 pm. As night fell each day, the lamp would slowly reduce its blue light, just as a normal sunset does. It signals your body to start winding down and readying for sleep.You can also set how gradually the lights fade in and out, respectively—up to an hour—and the brightness and temperature of the light. The lamp can be connected to Amazon Alexa and Google Assistant if you'd like to integrate it into your smart home, but it isn't required.I did have some issues. Sometimes the light routine got stuck when I plugged in the lamp or turned it on, and I had to toggle one of the four “schedule override” settings on and off to get the lamp to enter its preprogrammed routine. These overrides let you set the light for a specific task, including sleeping, reading, relaxing, and working.Using it outside your bedroom is also odd. Assuming you don't live in a dorm room or a studio apartment, you'll have to carry the Skyview 2 into your bedroom each night and plug it into a wall so that the sunrise function wakes you up in the morning. It won't do you any good if it's going through its sunrise routine in some other part of the house where you're not sleeping. But then you'll have to pick it up and move it into another room—an office, the living room, or wherever you spend much of your day—to benefit from its all-day light-shifting pattern and sunset routine. If you find yourself annoyed or slowed down by small tasks like that, it's something to keep in mind.The lamp itself is built well. The wide, metal base prevents it from tipping over from anything less than a good whack, and the light enclosure is so thick you could probably knock down bowling pins with it. The lens is frosted enough that I could look right at it without blinding myself. It also stayed cool to the touch, no matter how long it'd been on 100 percent brightness.So, Did It Light Up My Life?Photograph: Biological Innovation and Optimization SystemsI enjoyed the effect throughout the day. It's difficult to say if I'm experiencing a placebo effect or the light really is helping, but emotionally, it was nice to have a bit of light variety throughout my day between sun-up and sundown.Cooping yourself up indoors all day under the same flavor of unchanging light from dawn to dusk is weird and unnatural. For folks in a room without a window, the Skyview 2 could be a godsend.But at $449, it's a pricey godsend. A Philips Hue A19 White Ambiance Smart Light Bulb costs $26 and you can screw it into any lamp and program it via the intuitive Hue app to mimic sunrise routines, sunset routines, and the shifting light through the day. And you can buy more than one of them. For this sort of money, the Skyview 2 should do more. For example, if it were bright enough to negate the need for other lamps in my living room, then I'd have a slightly easier time justifying the price.You pay a premium for the Skyview 2. Does it work? Yes. You can create a similar effect with smart bulbs. But for a plug-and-go solution, it sure was a novel way of pretending that I lived in a bright and sunny apartment, if only until my time with the Skyview 2 came to an end.
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Stress and Wellness
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Giving birth to child who is unresponsive or struggling to breathe is a harrowing experience. The medical team must quickly cut the umbilical cord and then rush the baby to aid. But taking a few seconds to squeeze blood from the cord into an infant’s abdomen before cutting the cord could help with the infant’s recovery, two recent studies suggest.
The practice, known as umbilical cord milking, is relatively unknown and not without some controversy. But if its promise holds up, it may help protect some of the most at-risk newborns, researchers say.
During fetal development, the umbilical cord brings nutrients from the placenta, which also serves as a reservoir for blood, iron and stem cells (SN: 4/4/18). At birth, the infant is still connected to this reservoir, and the standard recommendation is to wait at least 30 seconds to a minute before clipping that connection, allowing the baby to take in more of those essential nutrients.
For babies born with urgent health problems, however, there’s no time to wait. In these cases, quickly milking the cord might provide similar benefits as delayed cord clamping. But the jury is still out on if or when to use the technique. The American College of Obstetricians and Gynecologists, for example, said that there is “insufficient evidence to support or refute umbilical cord milking” in its 2020 guidelines, which the group reaffirmed earlier this year.
In one of the new studies, researchers randomly assigned 10 medical centers in three countries to one of two groups. If an infant was born limp, with difficulty breathing or bluish skin, the cord was immediately clamped and cut in one group. In the other, the umbilical cord was milked four times before being cut. The hospitals then switched practices halfway through the study.
After analyzing outcomes for over 1,700 infants, researchers found that babies who had had their umbilical cords milked were less likely to need extra oxygen or other breathing assistance. The newborns were also less likely to suffer from a brain injury called hypoxic encephalopathy that’s caused by a lack of oxygen to the brain before or shortly after birth, the team reported in the February American Journal of Obstetrics and Gynecology.
In a follow-up analysis of blood flow in over 200 of the infants, published in the June Journal of Pediatrics, the researchers found that these improved outcomes were probably due in part to increased blood volume and blood flow to the heart, lungs and brain in the infants who received the cord milking. These newborns also had slightly higher levels of hemoglobin, the protein which carries oxygen in human blood, than babies whose cords were quickly cut.
“We saw dramatic differences in the babies that have this extra blood,” says Anup Katheria, a neonatologist at Sharp Mary Birch Hospital for Women & Newborns in San Diego.
The new research adds key evidence in favor of umbilical cord milking, says Heike Rabe, a neonatologist at Brighton and Sussex Medical School in England who has collaborated with Katheria but wasn’t involved in the two studies. The findings offer important assurance to obstetricians who might be hesitant to adopt the practice, she says. “It should really be getting into standard of care.”
The intervention is quick, simple and does not require equipment, meaning it might be readily adopted in places with limited medical resources.
But the practice could harm some infants’ health. Another study lead by Katheria ended early in 2019 after it found that umbilical cord milking increased the likelihood of brain bleeding in very preterm infants, those born at less than 32 weeks of pregnancy.
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Based on the recent studies, umbilical cord milking “shows promise” in infants born in poor health at or near term, says Sarah McDonald, a maternal-fetal medicine specialist at McMaster University in Hamilton, Canada, who wasn’t involved in the studies. But more research is needed before the practice is recommended for use, even in emergency situations. And for most infants, she and Katheria agree, delayed cord clamping will likely remain the best course of action.
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Medical Innovations
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A measles outbreak among dozens of unvaccinated children in Ohio has local health officials concerned about a deepening distrust of vaccines among some parents. With vaccination rates slipping around the country, more Americans are beginning to question the value of vaccine requirements for kids ― putting at risk a growing group of young children with no immunity to the virus.Decades-old wariness of the measles vaccine ― based on well-funded false claims about a nonexistent link to autism ― has combined with the backlash against COVID vaccination rules and other pandemic-related hurdles to result in a slowdown in childhood vaccination rates.Taken together, these factors increase the risk of outbreaks like the one in Ohio. There have been 82 diagnosed measles cases in the state, almost all in the Columbus area, and the vast majority in patients 5 years old or younger. Most of the cases have occurred in the past two months, leading to the hospitalization of 33 children, primarily for dehydration, diarrhea and pneumonia.Seventy-five of the 82 kids were completely unvaccinated and four were partially vaccinated, having received one of two measles, mumps and rubella, or MMR, shots. Measles is remarkably contagious, infecting up to 90% of unimmunized people who come close to an infected person.Nearly two dozen of the Ohio patients were too young to be protected. According to state data, there have been 23 measles cases among children younger than 1 year. Children typically receive their first measles shot when they’re between 12 and 16 months old. When measles came to town, those infants ― and other children too immunocompromised to handle certain vaccines ― had to rely on protection from their neighbors and classmates.“When a parent makes a decision not to have their child vaccinated, they’re not realizing the implications of that decision. If their child can get that infection, it doesn’t just have an impact on their child or their household, but it can impact their school, it can impact their community,” Mysheika Roberts, who leads Columbus’s public health department, told HuffPost.The Ohio outbreak is a case in point: Between June and October, the first four measles cases since 2019 emerged in the state, all of them among unvaccinated, unrelated people who’d traveled to a measles-endemic country and returned to the U.S. By early November, four cases in children with no travel history were linked to a local day care. By the end of that month, there were 46 confirmed cases, and the exposure sites had multiplied, too, including a mall, a church and a supermarket.At this point, the total number of cases has stayed the same for several days. But holiday travel and measles’ long incubation period ― up to 21 days ― means the virus may well still be spreading undetected.“We’ve got a ways to go,” Roberts said. “Anything could happen.” The COVID Vaccine DipMeasles was technically declared eliminated in the U.S. in 2000. But outbreaks have popped up over the last two decades. The worst one hit hundreds of people in New York and New Jersey in 2019, just a few months before COVID-19 spread through the area. The measles outbreak occurred largely among the Orthodox Jewish community; other outbreaks have similarly occurred within close-knit communities, such as the Amish. And nationwide, vaccine trends have taken a troubling turn since the COVID-19 pandemic began. During the 2020-21 school year, the estimated rate of kindergarteners who met state-level vaccine requirements ― MMR, chicken pox and DTaP, the vaccine for diphtheria, tetanus and whooping cough ― fell by roughly a percentage point across the board, according to the Centers for Disease Control and Prevention. The percentage of kindergartners with two doses of the measles vaccine fell from 95.2% the year before to 93.9%.But the top-line numbers belie the pockets of low coverage across the country. On top of the 2.2% of kindergartners nationwide who had at least one vaccination exemption ― 86% of which were classified as non-medical ― an additional 3.9% without an exemption weren’t up to date on their measles shots, according to the CDC data.“This means there are 35,000 more children in the United States during this time period without documentation of complete vaccination against common diseases,” Georgina Peacock, the immunization services director at the CDC, said at a news briefing in April.And that’s not counting an approximately 10% drop in kindergarten enrollment that year ― representing roughly 400,000 kids, including an unknown number who were behind on their vaccines.Several things could factor into the nationwide dip in MMR vaccination rates. But it appears the backlash to COVID-19 public health measures ― particularly vaccine mandates ― played a significant role. As COVID vaccines arrived on the scene, so did fear-mongering: Social media and online forums were full of erroneous claims about the vaccines not being properly vetted and containing microchips that could track individuals. One Ohio doctor is currently under investigation by the state’s medical board after speculating that the vaccine had magnetized its recipients.Dr. Sherri Tenpenny, a Cleveland-based osteopathic doctor, is now under state medical board investigation after making false claims about COVID-19 vaccines.The Ohio Channel via via Associated PressPolling by the Kaiser Family Foundation last month found that 26% of adults who have not gotten vaccinated against COVID-19 think the risks of the MMR vaccine outweigh the benefits. And while adults overall still overwhelmingly think the MMR vaccine’s benefits outweigh its risks (85% to 12%), a striking number have changed their minds about vaccine requirements in the past three years. Twenty-eight percent of adults agree with the sentiment “Parents should be able to decide not to vaccinate their children, even if that may create health risks for other children and adults,” up 12% from the findings of a 2019 Pew Research Center poll, Kaiser Family Foundation noted.Stephanie Stock, president of the anti-vaccine-mandate group Ohio Advocates for Medical Freedom, told HuffPost in an email that various COVID-related claims by health authorities, such as changing guidance on masks, “certainly led people to question the level of trust to place in them.”“Many Ohioans came to OAMF during the pandemic to find out what medical choice rights they have and how to become politically involved in fighting to protect those rights,” Stock said. Asked whether the anti-vaccine movement is responsible for an increased risk to kids who can’t get vaccinated because they are too young or immunocompromised, Stock wrote that her group “believes parents, not communities, are responsible for a child’s health, and that those parents are best suited to make the health decisions they feel are in the best interest of that child.” It’s too early to say how much of an overlap there is between Americans who have hesitated to get vaccinated for COVID and those who have delayed or skipped their kids’ MMR shots. But according to Michael Osterholm, director of the Center for Infectious Disease Research and Policy, “there is this sense right now that much of the negative energy that has grown up around COVID vaccines is now spilling over substantially to childhood immunizations.” “We’re seeing in more and more counties around the country lower levels of immunization for routine childhood vaccines that really parallels the same lack of support for COVID vaccines,” Osterholm told HuffPost.“There is this sense right now that much of the negative energy that has grown up around COVID vaccines is now spilling over substantially to childhood immunizations.”- Michael Osterholm, director of the Center for Infectious Disease Research and PolicyOhio doesn’t require vaccination reporting statewide, so it’s difficult to know the state’s actual vaccination rates for measles or other viruses. But Ohio schools do keep data on students’ required vaccinations. Data provided to HuffPost by the Ohio Department of Health show a noticeable drop in vaccination among kindergartners since the COVID pandemic began. From the 2019-2020 school year to the 2021-22 school year, the rate of kindergarten students up to date on their MMR, polio and DTaP vaccines fell from over 92% to under 89% for all three vaccines. Kindergarteners with up-to-date chickenpox vaccines fell from 91.9% to 87.8%. And hepatitis B vaccination rates fell from 94.9% to 92.7% over the same period.“This [outbreak] is something that’s a direct consequence of being behind in vaccinations,” said Alexandria Jones, assistant health commissioner and director of prevention & wellness at Franklin County Public Health. Much of measles vaccine hesitancy in the U.S. comes down to a single word: autism.There is no evidence ― none ― of a link between the measles vaccine and autism spectrum disorder. But the myth has been around since Andrew Wakefield, a since-discredited British physician, claimed in a 1998 study that such a connection existed. That study was later retracted by The Lancet and the editor called statements in the paper “utterly false.” Several large studies around the world have refuted Wakefield’s claimed findings, and Wakefield was ultimately struck from the British medical register.Nonetheless, concerns about vaccine-induced autism have persisted for decades, churning on social media and by word of mouth, and accelerated in the COVID era by the backlash against coronavirus vaccine mandates. Scott Jensen, the recently unsuccessful Republican candidate for governor in Minnesota, headlined an anti-vaccine-mandate rally in that state’s capitol building despite his state seeing a troubling 22 reported measles cases between June and November last year.“When I was a child measles was a [rite] of passage, or childhood illness, as was chicken pox,” Scott Shoemaker, president of the anti-vaccine-mandate group Health Freedom Ohio, told HuffPost in an email, adding: “When the vaccine was released, it became a ‘deadly disease.’” That’s false: Thousands of Civil War soldiers perished of measles, and in the first decade of nationwide tracking, in the early 20th century, there were 6,000 measles-related deaths per year on average, according to a CDC history. According to the same history, in the decade before the vaccine was introduced, an estimated 400 to 500 people died annually of the virus, on top of 1,000 estimated encephalitis cases and 48,000 hospitalizations. Measles, mumps and rubella vaccination rates have fallen across the country during the COVID-19 pandemic.Eric Risberg/Associated Press‘He Just Made Up A Story’In Minnesota, anti-vaccine groups, “skeptics” and others opposed to vaccine mandates for school children ― including Wakefield ― have made their presence known at community events for years. They played in particular to anxieties in the Somali community about autism. One University of Minnesota study found that 1 in 32 Somali children in Minneapolis had autism spectrum disorder ― comparable to the rate among white children, for whom the prevalence was 1 in 36, but more than Black and Hispanic children. (The study was small and had major limitations, its lead researcher said.)“They are everywhere. Like, every event, every forum,” Fatuma Ishtar, a community outreach worker, told Stat News of anti-vaccine activists in 2017, as a measles outbreak swept through the community. “They continue to push the community. I feel offended by this group.”That same year, as the outbreak was ongoing in Minnesota, Columbus public health officials held forums to answer questions about vaccines from Somali Ohioans. They discussed the University of Minnesota study and emphasized the lack of any evidence of a link between autism and vaccination.Attendees’ concerns nonetheless echoed those of millions of Americans worried about their kids’ development: “A lot of people believe the vaccination ― the MMR ― is causing autism, because when we were back home, we never had autism. So why do we have now more than zero back home?” one man asked at a forum. At another event, an attendee noted that he was concerned for his young children: “Autism is a lifetime disease.” The health officials were clear about the existing uncertainty surrounding autism spectrum disorder. But they also stressed the lack of any evidence tying it to vaccines.“Let me clarify about the British doctor who started it all: He lied. He just made up a story, and so we cannot trust whatever he said, because it was proven, he lied,” Tatyana Karakay, a pediatrician at Nationwide Children’s Hospital, told community members at one forum. Studies of thousands of children, she said, had failed to find a connection between the vaccine and autism. “We don’t know what causes it, and it makes all of us worried, but we know what does not.” “When autism was first discovered, the first theory was it was bad mothers who caused it,” Karakay added. “I’m sure all of you will agree that’s not true. So we know a lot of things that don’t cause it. MMR is one of them.” The current Ohio outbreak is not contained to one particular community, both Jones and Roberts told HuffPost ― it’s a diverse group of patients united, primarily, by being unvaccinated. And on that front, there’s some good news: Vaccination sites run by both the city of Columbus and Franklin County saw noticeable increases in MMR vaccination visits last year.But the troubling trends in the state and nationwide have health officials worried that parents are delaying vaccines. Given that signs of autism spectrum disorder may begin to appear in early childhood, some parents wait to have their kids take the MMR shots. Rather than following the advised schedule ― one shot each at 12-15 months and 4-6 years ― some parents wait for their kids’ first shot until it’s required for school. That leaves infants and immunocompromised children vulnerable. And even if most kids can survive a case of measles with moderate symptoms, there’s no way to know who could have more severe consequences, including encephalitis or other severe effects. “We don’t know who is going to get really, really sick,” Jones said. “I don’t want any parent to take that chance.”
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Epidemics & Outbreaks
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58-year-old Lawrence Faucette has become a medical milestone this month, being only the second living person in the world to have received a heart transplant from a genetically modified pig.
His doctors at the University at Maryland School of Medicine say that Faucette appears to be doing well and that his new heart is functioning as expected. However, time will tell whether the team has avoided the stumbles that might have contributed to the death of their first patient last year, David Bennett, just two months after he received his transplant.
Animal-to-human transplantation, or xenotransplantation, has been a long-sought-after goal in the transplant medicine field. Given the constant shortage of human organ donors, safe and effective xenotransplantation would likely save many lives who otherwise would die on the waiting list. The trouble is that our immune systems are already naturally hostile to donated organs and tissues from other people, and we’re even less compatible with other animals.
In recent years, however, some scientists believe that they’ve made a giant leap forward in making xenotransplantation a viable reality. By tweaking a few genes in pigs, they theorize that it’s possible to make their organs human-like enough for transplantation to work. Perhaps the most important change is the knocking out of a gene responsible for producing alpha-gal, a sugar found in the muscles of most mammals, but not humans (this same quirk is why people can rarely develop an allergy to red meat caused by the bite of certain ticks). These modified pigs have been developed by United Therapeutics Corporation, through its division Revivicor.
So far, researchers have largely relied on using brain dead patients (with the permission of their families) to test out this technology. These experiments have shown that these pig organs can avoid immediate rejection by the body and function for up to several months, and have set the stage for larger clinical trials in the near future. But researchers at UMSOM were granted permission by the Food and Drug Administration in January 2022 to perform such a transplant with 57-year-old David Bennett as an experimental treatment of last resort—a treatment that has once again been approved for Lawrence Faucette.
Like Bennett, Faucette has been diagnosed with terminal heart disease and is not considered eligible to receive a traditional heart transplant. Despite the possible risks, Faucette agreed to undergo the procedure, which took place on September 20. As of the middle of last week, his doctors say Faucette has been breathing on his own and that his new heart is working well without the need for supportive devices.
“We are once again offering a dying patient a shot at a longer life, and we are incredibly grateful to Mr. Faucette for his bravery and willingness to help advance our knowledge of this field,” said Bartley Griffith, who has performed both transplants and is the clinical director of the cardiac xenotransplantation program at UMSOM, in a statement from the university. “We are hopeful that he will get home soon to enjoy more time with his wife and the rest of his loving family.”
The team notes that there are several lessons they have learned from their experiences with David Bennett, who appeared to be doing well at first but rapidly declined in health and died in March 2022.
An investigation into his death found that his new heart unknowingly carried a latent pig virus called porcine cytomegalovirus (PCMV). The virus didn’t appear to directly infect Bennett, but it may have reactivated and damaged the heart after his antiviral treatment was reduced to address other health issues. Bennett was also severely immunocompromised to begin with, which might have affected the expected success (based on animal studies) of the drug regimen he was given to avoid organ rejection. And the team gave Bennett doses of intravenous immunoglobulin to help prevent infection that might have triggered an immune response to the pig heart.
The UNSOM team and other researchers now perform a more extensive screening of latent viruses in transplanted pig organs. They’re also testing out an experimental antibody treatment designed to prevent rejection alongside conventional transplant drugs this time around. Ultimately, though, it’s still possible that Faucette’s new heart may not last long for any number of reasons.
The average five-year survival rate for heart transplant recipients nowadays is around 70%, but was much worse when the technology first emerged. And many experts believe that it will take quite some time before xenotransplantation could be expected to reach this standard. For his part, Faucette is willing to accept the unknowns.
“My only real hope left is to go with the pig heart, the xenotransplant,” said Faucette in an interview given a few days before his surgery. “Dr. Griffith, Dr. Mohiuddin and their entire staff have been incredible, but nobody knows from this point forward. At least now I have hope, and I have a chance.”
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Medical Innovations
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A woman who was illegally sold a weight loss drug on social media told the BBC she ended up in A&E vomiting blood.
Maddy, 32, fell seriously ill after using an unlicensed version of semaglutide - the active ingredient in Ozempic - from Instagram.
A BBC investigation found unregulated sellers offering semaglutide as a medicine, without prescription, online.
It also found the drug being offered in beauty salons in Manchester and Liverpool.
Doctors say drugs bought from unregulated sources are dangerous and could contain potentially toxic ingredients.
Demand for Ozempic, a type 2 diabetes medication, spiralled last year after it hit the headlines for being Hollywood's secret weight loss drug - nicknamed the skinny jab.
The drug works by lowering blood-sugar levels and slowing down food leaving the stomach.
Its soaring popularity led to a rise in off-label prescriptions for weight loss, which triggered global supply issues and created a shortage for diabetes patients in the UK.
As pharmacies across the UK struggled to get hold of the medication, an illicit black market selling semaglutide "diet kits" began to flourish online.
Delivered by post, these usually contain needles and two vials - one containing a white powder and the other a liquid - which have to be mixed together before the drug can be injected.
That's what came through Maddy's letterbox after she searched for a "quick fix" on Instagram to help her lose weight ahead of an event.
"I struggle in general with losing weight. I'm just not one of those people that can shift it easily," she says.
Maddy came across The Lip King, a company run by Jordan Parke. The Lip King's Instagram feed was flooded with before-and-after transformation photos of women with newly slimmed physiques and screenshots of text messages from customers raving about his product. Maddy wanted in.
After a brief message exchange with Mr Parke and a £200 bank transfer, Maddy was sold 10mg of semaglutide with no questions asked.
She also received a video from him on WhatsApp instructing her how to mix and inject the drug, along with dangerous guidance advising her to take a higher dose than what health officials would recommend.
After her first injection, Maddy was instantly "extremely ill, bed-bound, vomiting".
She says Mr Parke told her over text that vomiting was normal and to take anti-sickness tablets.
A few weeks later, when the nausea had passed, Maddy tried the drug again - this time before bed.
"I was woken up by the vomiting," Maddy says.
"It was bad. I was throwing up all night, to the point where I was throwing up stomach acid, blood, white foam."
She went to A&E the following afternoon, where she was put on a drip.
"I can be a bit of a drama queen, but I thought I was dying. I was literally crunched over, bawling my eyes out to my mum. I was so angry, as well, because I was like, no-one told me that this was going to be a side effect," she says.
"I did my own research, but I didn't see anywhere that anyone was suffering to this level."
The BBC made several attempts to contact Mr Parke, but he did not respond.
Removing websites
Mr Parke is one of many illicit sellers peddling semaglutide through social media. To find out what is actually in the drugs, the BBC bought unlicensed semaglutide from several sellers and had them tested in the lab.
The results showed inconsistencies in what was in each sample. Although most of the products contained semaglutide, vials from two different sellers had no semaglutide in them at all, and nearly all of them, including the one bought from the Lip King, did not contain the full dose that had been paid for.
Ozempic is available on the NHS strictly for type 2 diabetes patients. Wegovy, another semaglutide drug prescribed specifically to treat obesity, will be offered on the NHS to those with a body mass index (BMI) of at least 35, and exceptionally, some people with a BMI of 30 and a weight-related health problem.
Under UK law, it is illegal to sell semaglutide as a medicine without a prescription.
Drugs manufacturer Novo Nordisk is the only company approved to sell and market semaglutide, branded as Ozempic and Wegovy, in the UK, but it is now battling against knock-off online sales.
The firm says it is working with a third party to "proactively identify and remove websites, ads or social-media accounts selling counterfeit semaglutide", and has been carrying out "in-depth investigations into copyright infringement, criminal networks and sellers illegally diverting our products".
But the BBC has discovered sellers that are closed down one day usually return the next under a new name.
Online sellers attempt to get around the law by placing "not fit for human consumption" or "for research purposes only" on their product.
Gerard Hanratty, a public law expert, says: "You can put lots of different things on a label. It doesn't mean to say that it is then legal and you are compliant with the regulations."
He says sellers would need to be able to prove they are supplying the product for research purposes and not for human use in order for the warnings to be valid.
Salon sales
A BBC Three documentary The Skinny Jab Uncovered found the unapproved versions of the drug advertised in beauty salons on British high streets. Undercover investigators visited four salons in Manchester and Liverpool and received dangerous advice about mixing and dosages in some about how to use the drug.
In one salon, a reporter was told: "Well, if you have too much, you just wouldn't want to eat anything, and you might feel sick. It's not going to be dangerous."
The Medicines and Healthcare products Regulatory Agency (MHRA) says it has received reports of people ending up in hospital after using fake Ozempic pens, which are also flooding the market, with more than 300 seized since January.
Prof Barbara McGowan, a consultant endocrinologist who co-authored a Novo Nordisk-funded study which trialled semaglutide to treat obesity, says licensed medications - like Ozempic and Wegovy - go through "very strict" quality controls before they are approved for use.
She warns that buyers using semaglutide sourced outside the legal supply chain "could be injecting anything".
"We don't know what the excipients are - that is the other ingredients, which come with the medication, which could be potentially toxic and harmful, [or] cause an anaphylactic reaction, allergies and I guess at worse, significant health problems and perhaps even death," she says.
Prof McGowan says that drugs like semaglutide can cause "significant side effects", such as nausea, for some patients, which is why proper medical support is needed.
"The important thing to understand is not just about the prescription. It's about... all the wraparound care that one gets from senior health-care professionals," she adds.
'Huge health risks'
Dale Dennis, a personal trainer from East Yorkshire, sells 10mg vials of the unofficial drug and pre-mixed pens.
Mr Dennis sells the unlicensed drug on social media, encouraging buyers to message him on WhatsApp to place an order.
His company, Raw Peptides Limited, is listed as a business involved in the sale of "new cars and light motor vehicles".
The BBC contacted Mr Dennis for comment, but after initially agreeing to speak to us, he cancelled our call and sent a text using an expletive, adding: "I definitely make your yearly salary weekly".
Dr Simon Cork, senior lecturer in physiology at Anglia Ruskin University, stresses that semaglutide is not a short-term weight loss solution and is suitable only for people with obesity.
"That might be seen as being kind of selfish, because those people quite understandably want to lose some weight, but the drug is not tested or designed to help people in that position."
He says mixing and injecting weight loss drugs at home comes with "huge risks".
"The vast majority of the population are not qualified or trained to administer injectable drugs themselves. And the drugs you buy if you're prescribed Wegovy or Ozempic, or one of the licensed drugs, those come in predefined amounts," he says.
"So you press a button and you get the correct dose of the medication. You're not drawing up an amount into a needle that you're then injecting into yourself."
The vials of semaglutide sold illegally online do not have the safeguards the official medication comes with to prevent patients from overdosing.
Tilly, 22, decided to stop using semaglutide she bought on TikTok after she accidentally injected double the amount she was supposed to.
"When it came, it didn't have any instructions, which completely confused me⦠I messaged the company after being like 'what am I meant to do with this?' And she was like, 'well, join a Facebook group'," she says.
"It felt like the worst hangover ever. I felt like I had a really bad headache. I felt sick, and I felt stressed about the fact that I'd taken too much," she says.
The medicines regulator says it will use its powers to protect the public by taking "appropriate enforcement action, including, where necessary, prosecuting those who put your health at risk".
The Medicines and Healthcare products Regulatory Agency's chief safety officer, Dr Alison Cave, warns that buying semaglutide from illegal suppliers "means there are no safeguards to ensure products meet our quality and safety standards, and taking such medicines may put your health at risk".
BBC Three investigates the black market in cut price 'skinny jabs' and asks: are they what they claim to be? And are they safe?
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Drug Discoveries
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Gonorrhoea cases in England have resurged since the easing of Covid restrictions, health officials are warning people who are sexually active.
Condoms can stop the spread of this and other sexually transmitted infections.
Provisional data shows diagnoses in the first nine months of 2022 hit 56,327 - 21% higher than for the same 2019 period.
People should practise safe sex and get tested regularly if having sex with new or casual partners, experts say.
Typical symptoms of gonorrhoea include a thick green or yellow discharge from the vagina or penis.
But some people will have no symptoms, especially for infections in the throat, vagina or rectum.
Experts say people should practise safe sex and get tested regularly if they are having sex with new or casual partners.
Testing is simple, free and discreet, they advise.
What is gonorrhoea?
The disease is caused by the bacterium Neisseria gonorrhoeae.
The infection is spread by unprotected vaginal, oral and anal sex.
Symptoms can include a thick green or yellow discharge from sexual organs, pain when urinating and bleeding between periods.
However, vaginal and rectal infections often have no symptoms.
An untreated infection can lead to infertility, pelvic inflammatory disease and can be passed on to a child during pregnancy.
Dr Claire Dewsnap, from the British Association for Sexual Health and HIV, said: "The rise in gonorrhoea cases provides an important reminder of the importance of testing for sexually transmitted infections (STIs) and wearing a condom every time you have sex.
"By getting tested at least once a year, regardless of whether you're showing symptoms, you can help minimise the risk of catching or passing on STIs when having sex.
"Delaying access to the right care and treatment also risks developing longer term problems which can be more difficult to address. If you are concerned about STI transmission, sexual health clinics are on hand to help."
How to get tested
There are several different places you can go to be tested for gonorrhoea:
- a sexual health clinic (sometimes also called a GUM clinic)
- your GP surgery
- a contraceptive and young people's clinic
- a private clinic
It is possible to buy a gonorrhoea test from a pharmacy to do yourself at home. However, these tests vary in accuracy, so it is recommended that you go to your local sexual health service.
All tests are free through the NHS, but you will have to pay if you go to a private clinic.
Dr Katy Sinka, head of the STI section at UK Health Security Agency, reminded people: "You can get free condoms at your local sexual health clinic and if you're under 25, you can also get them online."
Scotland has seen a similar rise in gonorrhoea cases.
Experts are also concerned that gonorrhoea has been developing resistance to certain antibiotic treatments, with some cases of so-called "super-gonorrhoea" being seen in recent years around the world. These remain rare at the moment.
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Epidemics & Outbreaks
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Scotland's record on drugs is shameful and the latest figures once again lay bare the huge human toll.
It is a familiar and devastating rhythm for such a small country. The annual drumbeat of the lives lost to a preventable overdose.
This year was no different - 1,051 people killed.
Scotland drug deaths decrease - but rate still higher than rest of Europe
The reality is this is a nation with a stubborn addiction problem in a world where out-of-control street drugs are flooding communities.
Each time the authorities make small progress, new narcotics threaten to unravel life-saving developments.
We witnessed for ourselves the pain and suffering substance abuse is causing in poverty-stricken communities.
The users who will do anything for their next hit. Those who get their hands on a packet of pills for less than fast food takeaway. Street valium can be five times as strong as the prescription version and people are swallowing 25 in one go.
Ruthless dealers are taking advantage of a rampant market and charities are battling a war-like challenge.
It is likely some of the government and third-sector initiatives are helping to reduce overall deaths, but the reality is they remain stubbornly high. Despite a decrease two years on the bounce, experts say it's still far too early to suggest fortunes are turning around.
The question is whether the Scottish government is tackling the issue head on.
Read more:
'I lost my leg to £15 heroin hit' - on the frontline of Scotland's drug epidemic
Some experts suggest the current approach is "scattergun" and ministers are attempting to keep all parts of the drugs recovery movement happy. There is a feeling the crisis needs to be more targeted and bespoke.
Scottish and UK government officials continue to clash on the path ahead. Edinburgh wants more control over drugs policy, but Westminster claims the devolved powers are sufficient.
People are dying every day the politicians talk.
It is legitimate to ask when Scotland will return to an average rate of death after such a prolonged period of horror. Will it ever?
Who knows? There is still a very long way to go.
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Drug Discoveries
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Image source, BBC BreakfastImage caption, Tony Christie said he had chosen to speak about his diagnosis to reassure othersSinger Tony Christie has spoken of his positive approach to life following his dementia diagnosis.In an interview with BBC Breakfast, Christie, whose real name is Anthony Fitzgerald, said he was determined to carry on making music and touring."If you start worrying about it, you're finished. Ignore it, carry on and do what you do," he said.The 79-year-old, born in Conisbrough, South Yorkshire, is best known for his 1971 hit (Is This The Way To) Amarillo.Christie, whose other hits include I Did What I Did For Maria and Avenues And Alleyways, said he realised something was wrong when he found it difficult to complete a crossword."I've always been, for 50 years, a fanatic at doing crosswords and things, and suddenly I started finding it very hard," he said.After his wife suggested he get checked out, Christie said he was told "you've got the oncoming of dementia"."I ignored it. I just said carry on - and I just did carry on, and worked," he said."The main thing was, and why I've come out about it, is a lot of people I've met and who have got it, they're worried about it."And I'm not worried about it. I went to specialists and they gave me tablets and they've gradually worked."Image caption, The singer is best known for his 1971 hit (Is This The Way To) AmarilloAccording to the NHS. dementia is most commonly associated with memory loss, but can also affect the way people speak, think, feel and behave.Christie, who was diagnosed with dementia about two years ago, said he was hopeful a cure was not too far away."I've got a feeling that, within a few years, there will be tablets that will cure it. So I just carry on working."In November, the entertainer released his latest album, Essential Tony Christie, and is also set to perform a special show in celebration of his 80th birthday."I'm starting a big, big tour this year. It's going to be very busy but I'm looking forward to it."And music, actually, I found out is part of a cure for dementia, so every time I go on stage and work it's helping me," he said.On performing with dementia, Christie said he now had his song lyrics displayed on a monitor."Most of the time it's there like insurance, but I manage to get through my shows, it's great," he said."But, don't forget, I've been singing for 60 years or whatever, and I've got an album out. It's 70 songs... going back to 1967 - a lot of songs."Follow BBC Yorkshire on Facebook, Twitter and Instagram. Send your story ideas to yorkslincs.news@bbc.co.uk.Related Internet LinksThe BBC is not responsible for the content of external sites.
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Disease Research
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ST. PAUL, Minn. -- Minnesota has officially become the 23rd state to legalize recreational cannabis use -- but don't light up just yet.
Gov. Tim Walz signed the bill into law Tuesday. The 300-page bill allows adults 21 and older to use recreational marijuana and transforms a black market into regulated, state-licensed businesses throughout the state. It also expunges low-level cannabis convictions.
authorizing the growth, manufacturing, and lawful sale of cannabis products. Minnesota joins 22 states plus Washington, D.C., where marijuana is legal.
Possession for adults 21 and older will be legal starting Aug. 1, with limits. Minnesotans will be permitted to have up to two pounds of marijuana at home and two ounces while in public. Sale of the drug will still be illegal without a state license.
The bill also createsthat would cultivate, manufacture, and sell marijuana at retail dispensaries. There are 12 different business licenses a person can apply for in the adult-use market, and there are additional licenses for medical cannabis.
Rep. Zack Stephenson, DFL-Coon Rapids, who was a co-author of the bill, told WCCO he anticipates it will be 12 to 18 months before someone can go into a store and purchase new, regulated marijuana products.
Under the new law, non-felony cannabis offense will be automatically expunged and a board will be established to review more serious crimes involving cannabis. The Bureau of Criminal Apprehension on Aug. 1 will start the process of automatically clearing records, according to the bill.
Marijuana is still classified as a Schedule I drug, not legal at the federal level.
Note: The video above first aired May 20, 2023, before the bill was signed into law.
for more features.
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Health Policy
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More than 196,000 NHS appointments had to be cancelled because of the junior doctor strike in England last week, figures show.
It includes people who were waiting for operations and other treatments as well as scans and follow-up appointments.
The number of cancellations is the greatest so far in the NHS pay dispute.
And the true scale of the disruption is likely to be higher as some hospitals had cut back ahead of the strike to minimise last-minute postponements.
Some hospitals reported they were not carrying out up to half of their planned work so consultants could be redeployed to emergency care to cover for striking junior doctors.
The total included more than 20,000 operations and treatments. The rest were appointments, tests and check-ups.
NHS national medical director Prof Sir Stephen Powis said: "Today's figures lay bare the colossal impact of industrial action on planned care in the NHS.
"Each of the appointments postponed has an impact on the lives of individuals and their families and creates further pressure on services and on a tired workforce - and this is likely to be an underestimate of the impact as some areas provisionally avoided scheduling appointments for these strike days.
"Our staff now have an immense amount of work to catch up on.
"We have now seen nearly half a million appointments rescheduled over the last five months, and with each strike, it becomes harder."
'Severe impact'
It comes amid mounting concern about more industrial action across the NHS, with one hospital boss saying the planned walkout by nurses over the first May bank holiday weekend threatens the ability to staff emergency services.
On Friday the Royal College of Nursing announced a strike from 20:00 BST on 30 April to 20:00 on 2 May after its members rejected the pay offer from government.
It also said it would ballot members about taking more strike action over the course of the year.
Its mandate runs out after the bank holiday. The result of that new ballot is due mid June and unlike the last one which was organised by individual workplaces this is national ballot, which could mean nurses from across the country could walkout.
Currently, it only has a mandate for half of services in England as the other half did not reach the required threshold for the vote to count.
Unite, one of the smaller health unions which represents NHS staff such as support workers, admin staff and paramedics, also said members at London's Guy's and St Thomas' Hospital and Yorkshire Ambulance Service would walk out on 1 May.
It said the industrial action was likely to be followed by members in other services later that week.
Its ballot of members over the pay offer - a 5% increase this year along with a one-off payment of at least £1,655 - is not yet closed, but the union said it was acting as it was clear many of their members were rejecting the deal.
Unite general secretary Sharon Graham says: "All along we have said this offer is nowhere near good enough for NHS workers. The government needs to return to negotiations and put more money on the table."
Speaking to the BBC, University College London Hospitals chief executive David Probert said the spate of industrial action over recent months had left staff exhausted.
He warned the nurses' strike, which for the first time will involve staff in critical areas such as intensive care, will have a "severe impact".
He predicted planned care would "almost disappear".
And he added: "It's possible that elements of our emergency care will not be open during the strike."
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Health Policy
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Why is there a tampon shortage?Though Redditors have noted the tampon shortage for months, the issue flew largely under the radar until Time first wrote about the “great tampon shortage” earlier in June.Of course, tampons are not the only commodity in short supply. Global supply chains have been under stress since the beginning of the pandemic, disrupting consumers’ access to a variety of goods, among them toilet paper, baby formula, cars and kitchen appliances.Andre Schulten, chief financial officer of Procter & Gamble — which manufactures Tampax, the tampon giant that sells 4.5 billion boxes globally each year — said on a recent earnings call that it had been “costly and highly volatile” to acquire the raw materials needed for production, such as cotton and plastic.Inflation is also making other popular menstrual products more expensive. Bloomberg reported that the average price for a package of menstrual pads increased by just over 8% from the start of this year through the end of May, while the price of tampons increased by nearly 10%.Manufacturers and major retailers say they are trying to remedy the shortage.A representative for Procter & Gamble told The New York Times that the company knew how frustrating it was for consumers who could not find what they needed and said that it was working with retailers to maximize availability. “We can assure you this is a temporary situation,” the manufacturer said, though it did not offer a more specific timeline. Representatives for CVS and Walgreens also confirmed that the retailers had experienced shortages in recent weeks.Can I use an old stash of tampons?Some brands of tampons come with a date stamped on the package, but that is not an expiration date mandated by the Food and Drug Administration, like you’d find on, say, latex condoms.Tampax brand tampons, for instance, are marked with a “shelf life” date of three or five years, which Procter & Gamble describes as the “time period during which a product is expected to meet our high standards for quality” — when stored in a cool, dry place.But according to medical providers, that doesn’t mean tampons are necessarily unsafe or ineffective beyond that date. In theory, cotton could absorb some bacteria or mold, said Dr. Barbara Wilkinson, an OB-GYN with New York’s Brigham and Women’s Hospital and an instructor at Harvard Medical School, but there is no scientific data behind shelf-life dates.“I would say if you’re digging back into an old stash of tampons, just check to make sure the tampon wrapper is intact and that the tampon looks like it is still well protected,” she said.What should I do if I run out of tampons?First and foremost: If you are running low, do not try to extend your supply by wearing a tampon for longer stretches of time, Wilkinson cautioned. Toxic shock syndrome is a rare but potentially life-threatening condition that can occur when you leave a tampon in for more than eight hours or use one with too much absorbency.And while the tampon shortage may be a source of stress, Dr. Jessica Atrio, an OB-GYN at Montefiore Health System in New York, said it can also be a chance for women and others who use tampons to reexamine the products they use and whether they are in line with their values.“People should be assured that they have agency in these decisions,” she said, noting, for example, the possibility of switching from tampons to reusable options for environmental reasons. And these days, there are more alternatives to tampons available than ever.PadsMany women already use menstrual pads — sometimes called sanitary napkins — in conjunction with tampons, said Dr. Lauren Streicher, a clinical professor of obstetrics and gynecology at Northwestern University’s Feinberg School of Medicine, either on days when their flow is particularly heavy or perhaps when they are sleeping.There are disposable and reusable options. But Streicher acknowledged that pads aren’t for everyone: Some users don’t like the sensation of wetness they can cause, while those with vulvar conditions, such as genital psoriasis or vulvodynia, can experience significant discomfort and irritation. Pads can also keep women from engaging in certain activities, like swimming or intense exercise.Period underwearPeriod underwear use absorbent materials, like microfiber polyester, to soak up menstrual blood. “I’m seeing more and more women, especially my younger patients, really embracing this option,” Wilkinson said.There are many reusable brands on the market, most of which indicate their capacity by how many tampons’ worth of menstrual blood they can hold, she explained.But Wilkinson also noted that period underwear can be cost prohibitive (some popular bands are $30 to $40 per pair) and cannot be put in the dryer.Menstrual cups and discsMenstrual cups and discs — flexible, reusable devices made from medical-grade silicone or latex and inserted into the vagina to collect menstrual blood — have exploded in popularity in recent years. Research suggests leakage with menstrual cups is similar to or lower than what women experience with pads or tampons.“You place the menstrual cup over your cervix, and it collects menstrual blood for about 12 hours,” Streicher said. Cups and discs tend to fall in the $25 to $35 range.Every expert interviewed for this story noted that finding the right menstrual cup can take some trial and error, and that there may be a learning curve with insertion.This article originally appeared in The New York Times.
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Women’s Health
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A "fun-loving" woman took her own life following the breakdown of her relationship and a dispute over who would look after the dog, an inquest has heard.
Caroline Forte, a successful graphic designer, hanged herself at her elderly parents' home with her mental health having deteriorated since the break up with her partner who didn't want them to have a baby.
The 35-year-old had been sectioned under the Mental Health Act at a hospital psychiatric unit but had been allowed to go home for a night - a fateful decision which ended in her tragic death.
Caroline, who was privately educated at Brighton Girls School, was "hit hard" when her relationship with partner, Barry Wickens, broke down during lockdown in 2020. The couple had bought and renovated their first home together but difficulties arose when they disagreed over having a baby.
A five-day inquest into Caroline's death in Brighton, heard how Caroline struggled with her mental health following the end of the relationship, before eventually being admitted under the Mental Health Act to a psychiatric ward in Eastbourne District General Hospital.
Despite family insisting it was "unsafe" for her to come home for an overnight stay, the hospital allowed her release and she was found dead shortly afterwards, on February 20 last year, after hanging herself at her parents' home.
Penelope Schofield, acting senior coroner for Brighton and Hove, told the inquest jury that "facts needed to be established" around Caroline's death and that the family had waited over a year for answers. She said: "The family have indicated that they weren't given any advice on how best to support Caroline."
Attending the inquest were Caroline's parents, Gillian and Anthony Forte, her older sisters, Liz and Sandra and older brother, Chris.
In her witness statement, her sister Liz said: "We have lost a vibrant, clever, kind, loving and much-adored member of our family whose 35 years are certainly not defined by this relatively short illness.
"Caro - as she was known to us - was a happy, fun-loving person, the baby of the family. She was an extremely talented and very successful graphic designer with an infectious giggle and strong family values.
"She had been with her partner, Barry, for a few years and they had bought a house together which they did up. It was a planned family home because Caro was very keen to start a family. Barry then decided he was unsure whether he wanted to try for a baby and so they had couple counselling.
"However the relationship continued to deteriorate and Barry eventually left in May 2020."
The inquest heard how Caroline - the youngest of four children who lived in Brighton - was "hit hard" by his departure and was very up and down during the months following.
Liz recalled how her sister had turned up at her house late one night, very upset.
"Barry wanted shared custody of their dog, Doris, and there had been aggression and harassment with the police being involved," she told the jury.
"She asked if she could come and stay with me because she 'didn't feel right'."
The coroner heard how Caroline began to show signs of psychosis in November 2021, believing that her phone had been tapped and she was becoming paranoid about her devices. The family sought medical help and Caroline's condition stabilised enough for her to go on a planned holiday to Costa Rica over Christmas.
However, on her return in January 2022, things took a turn for the worse, the jury was told.
The sister's statement continued: "She wasn't okay. She kept asking for help in changing passwords on all her accounts and she talked continuously about being hacked."
The family agreed that Caroline should stay in Leeds with her other sister, Sandra, who was on maternity leave and who would therefore be able to look after her and keep her company.
The coroner heard that while in Leeds, Caroline attempted, twice, to kill herself with an overdose.
She received emergency psychiatric care under the Leeds and Yorkshire NHS Partnership Trust and was then transferred back down to Sussex where she was admitted under the Mental Health Act to the psychiatric ward of Eastbourne District General Hospital. She hanged herself less than a month later.
The inquest heard that her family believed there have been serious failures by both the Sussex Partnership Foundation Trust and Leeds and Yorkshire NHS Partnership Trust resulting in Caroline's death.
Liz claimed: "They didn't care for her. They released her when she wasn't safe and under a mental health section and they released her to the home of my parents who are in their 70's. It is absolutely shocking."
The inquest will conclude next week.
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Mental Health Treatments
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The mysterious incidents may have been deliberate attacks designed to prevent girls from seeking an education, officials said in recent days, after previously downplaying the issue. Girls and young women have played a prominent role in the protests that have rocked the Islamic Republic.
According to the Parliament's news agency, Khane Mellat, MP Alireza Monadi said after an investigation that nitrogen gas had appeared during testing at the schools.
Local media reports suggest the poisonings have been going on for months and involved dozens of schools in a range of cities, forcing young students to be taken to the hospital.
Iran’s police chief, Ahmad Reza Radan, said Tuesday that no one had yet been arrested.
"Our priority is to find the origin of the poisoning of the students, and until then, we will not judge whether it was intentional or unintentional,” he said in an interview with the semiofficial ISNA news agency.
But Deputy Health Minister Younes Panahi said Sunday the poisoning of schoolgirls in the holy city of Qom — one of Iran’s larger cities south of Tehran — and the western city of Borujerd, was not accidental and was down to people wanting to shut girls’ schools.
“What is clear is that both in Qom and Borujerd, it is a deliberate issue,” he said at a news conference, according to Iranian state broadcaster IRIB. “The poisoning of students of Qom was intentional and caused by available chemical compounds. Some people wanted all schools to be closed, especially girls’ schools.”
Panahi added that the poisoning was due to a chemical compound which has not yet been identified, according to IRIB. “The poisoning caused to the students was very mild, and did not cause any complications to anyone,” he was reported as saying. “They had symptoms of lethargy and weakness for several hours.”
“It has been revealed that the chemical compounds used to poison students are not war chemicals … the poisoned students do not need aggressive treatment and a large percentage of the chemical agents used are treatable.”
A special committee had been appointed to investigate the poisonings, and toxicology experts had been consulted, Panahi added.
Monadi, who sits on the Parliament’s education committee, also said the poisonings were “intentional,” according to the state-run news agency IRNA.
The “existence of the devil’s will to prevent girls from education is a serious danger, and it is considered a very bad news,” he said, according to IRNA.
Schools in at least 10 to 15 cities had been struggling to cope with poisoned students, MP Abdolali Rahimi Mozafari said, Khane Mellat reported. Meanwhile, Poisoning cases were reported at some 30 schools across the country, according to The Associated Press, which cited local media reports.
The first cases emerged in late November in Qom, according to the news agency, with students at the Noor Yazdanshahr Conservatory falling ill, and then falling ill again a month later. Parents in the city have pulled their children from classes in recent weeks, the AP reported, citing Shargh, a reformist news website based in Tehran.
Some critics of Iran’s government have have said without providing evidence that the recent spate of poisonings may be an act of “revenge” for the unrest that erupted across the country when 22-year-old Mahsa Amini died in a hospital after she was detained by the morality police, who accused her of breaking Iran’s strict dress code.
Female students in schoolyards and classrooms were at the forefront of Iran’s protests, as they stood up to strict sartorial codes by removing their headscarves and confronting officials.
“The poisoning of school girls is revenge by the terrorist Iranian regime against brave women that made the compulsory hijab the flag, and shook the Berlin wall of Khomeini,” the Iranian activist and journalist Masih Alinejad tweeted Sunday.
Another activist, Hossein Ronaghi, said on Twitter that: “In a structure where a citizen is beaten and detained by an army of privates for writing a story or graffiti against the government, it cannot be said that the deliberate and organized poisoning of Iranian girls is arbitrary and without information.”
“Attacking female students and harassing them is an attack on the future of all Iranian people,” said Ronaghi, who said he was released on bail in November after being imprisoned during the authorities’ crackdown on the protests.
Others drew different parallels but nonetheless expressed concern about the apparent trend.
Masoumeh Ebtekar, who was the country’s first female vice president after the Islamic Revolution and who has been supportive of the recent protests, said on Twitter on Monday that the poisonings had been going on for at least a month.
“Everyone is waiting for the law enforcement and judicial departments to act immediately. Why so much delay?” she said of the Iranian authorities.
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Epidemics & Outbreaks
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Billionaire Bill Gates revealed he would sleep as little as possible while building his Microsoft fortune, calling the need for shuteye lazy and “unnecessary.”
The tech titan said he realized the folly of his thinking while discussing brain health during a podcast with comedian Seth Rogan and his wife, Lauren Miller Rogan.
“In my 30s and 40s when there would be a conversation about sleep, it would be like: ‘Oh I only sleep six hours, and the other guys like: ‘No I only sleep five’ and ‘Well sometimes I don’t sleep at all,’ and I’d be like: ‘Wow those guys are so good. I have to try harder because sleep is laziness and unnecessary,” Gates said during the first episode of the couple’s podcast, “Unconfuse Me,” last month.
However, since Gates’ father passed away in 2020 of Alzheimer’s, the Microsoft co-founder said he’s reversed his opinion on the need for proper sleep.
“Now what we know is that to maintain brain health, getting good sleep even back to teen years is super important,” Gates said on the episode, which centered around Alzheimer’s disease.
“One of the most predictive factors of any dementia, including Alzheimer’s, is whether you’re getting good sleep.”
Rogan agreed, recalling that “when I was young, the convention was ‘you’ll sleep when you’re dead.'”
He added that the shift in cultural attitudes towards sleeping have shifted similarly to attitudes towards smoking cigarettes.
“They used to think smoking is healthy. It is similar. That’s where we are culturally — the things people think and understand about their own brains are where they were in the 1950s and 1960s. It’s so far off from what actual science is reflective of,” the Canadian actor said.
Gates has started tracking his daily “sleep score,” which monitors the length and quality of sleep, he said.
Representatives for Gates didn’t immediately respond to The Post’s request for comment.
This wasn’t the first time Gates confessed that he had unhealthy sleeping habits while serving as the chief software architect, then chairman, of Microsoft — roles he held up until 2014, when he transitioned away from the tech behemoth to focus on his philanthropic work with the Bill and Melinda Gates Foundation.
“I felt that sleeping a lot was lazy,” he wrote in a 2019 review of the book “Why We Sleep,” which was posted to his blog, GatesNotes.
He described the book as “an expert explaining the benefit of a good night’s rest,” starting the blog post with another memory: “Back in my early Microsoft days, I routinely pulled all-nighters when we had to deliver a piece of software.”
“I knew I wasn’t as sharp when I was operating mostly on caffeine and adrenaline, but I was obsessed with my work, and I felt that sleeping a lot was lazy.”
However, after reading the Matthew Walker novel, “I realize that my all-nighters, combined with almost never getting eight hours of sleep, took a big toll,” the billionaire penned.
And though he admitted to not buying into all of Walker’s reporting, “such as the strong link he claims between not getting enough sleep and developing Alzheimer’s,” he recognized that “neglecting sleep undercuts your creativity, problem solving, decision-making, learning, memory, heart health, brain health, mental health, emotional well-being, immune system and even your life span.”
Gates went on to share takeaways from the book on how to improve sleep hygiene.
Tips, according to Walker, included replacing LED lightbulbs in your bedroom, keeping the room’s temperature to a cool 65 degrees, limiting alcohol intake and taking a short midday nap sometime before 3 p.m.
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Stress and Wellness
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Subsets and Splits
List Unique Topics
Simple retrieval of unique topics from the dataset, useful for basic exploration but lacks deeper insights.