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and the methods for doing so were all well-known and well-published. Grunenthal didn’t bother, and led licensees in other countries to believe the testing had been done, misrepresented the conclusions of its own internal researchers, many of whom said that |
more testing was needed, and ignored how one of its own employees had given birth to a child without ears. The company, Sir Evans concludes, “covered up a crime against humanity for more than 60 years.” Journalist Geoff Adams-Spink, himself |
a victim of thalidomide, notes that Gruenthal hasn’t promised any compensation along with its “apology.” In essence, we’re sorry, not that we did anything wrong, and not like we’re going to help. The silver-lining of the Thalidomide disaster was, just |
like with Elixir sulfanilamide, improved regulation of pharmaceutical drugs. The Kefauver Harris Amendment or “Drug Efficacy Amendment” in 1962 required drug manufacturers provide proof of the claimed efficacy and safety of their drugs. The new laws more strictly regulated how |
drug manufacturers could describe their products; no more “completely safe” and “completely atoxic” branding without some proof. Unfortunately, in the two generations since Thalidomide, many of those safeguards have been weakened. I have already talked about the dangers of Pradaxa |
before. Just this month the Journal of the American Medical Association published an article questioning the “Expedited Drug Development Pathway,” raising an example the disturbing tale of Pradaxa: Dabigatran, the first new oral anticoagulant approved in 56 years, benefited from |
3 different FDA policies promoting innovation. This drug received both Fast Track and Priority Reviews and was studied in a single large phase 3 trial rather than in at least 2 pivotal trials, as normally requested. Dabigatran was considered significantly |
easier to use than warfarin for reducing the risk of stroke in patients with atrial fibrillation, because regular monitoring is not recommended. In the phase 3 trial of dabigatran, the risk of serious bleeding was similar for the 2 drugs. |
The FDA approved only a single primary dose of 150 mg. Unlike regulatory agencies in Canada, Japan, and Europe, the FDA did not approve a lower 110 mg dose and commented that the drug might be usefully studied at a |
dose higher than 150 mg. The limitations of a one-size-fits-all strategy for a treatment as inherently risky as anticoagulation in elderly patients soon became apparent. Within less than a year of approval, 1 survey showed that dabigatran accounted for more |
serious adverse drug events reported to the FDA during the second quarter of 2011 than any other regularly monitored drug. Risk of hemorrhage was prominent in older patients (median age, 80 years), a subgroup for whom declining kidney function or |
other factors may have increased bleeding risk. Both a manufacturer package insert revision and the European Medicines Agency have called for closer monitoring of kidney function, a needed step because even moderate kidney impairment increases dabigatran levels more than 2-fold. |
In addition, unlike warfarin, no antidote is available for use in bleeding emergencies related to dabigatran. Evidence was beginning to emerge that dabigatran-related bleeding – whether from trauma or as an adverse effect – may be more difficult to treat |
than warfarin-related bleeding. Every week, I talk with the children and spouses of Pradaxa victims, and they all end up telling me roughly the same story: their loved one was on Coumadin, their doctor recommended switching to Pradaxa because it |
was more convenient (not because it was safer or more effective) and because “the doctor said it could be stopped at any time.” After a couple days or weeks on Pradaxa, their loved one started vomiting blood or passing it |
in their stool and so were taken to hospital, where baffled doctors tried a couple variations of standard bleeding treatments that didn’t work. At that point, after 10 or more transfusions over the next 48 hours, the patient either got |
better, needed surgery, or passed away. The patient’s primary care physician or cardiologist then tells the family that they had no idea of the problem, and that they’ll never prescribe it again. I’m not exaggerating; I had that same conversation |
with three different families last week. The part that shocks me is that, like thalidomide, nobody needs Pradaxa. It doesn’t cure cancer. It doesn’t treat heart attacks. It’s not even unique. It’s a drug of convenience, a medication that’s supposed |
to be easier to use (but not more effective) than Coumadin for preventing strokes. That’s it. All of which makes me wonder what’s going on at the FDA, and if we as a society need to take a closer look |
at the way we rush into novel treatments. In The Cost of Hope, Amanda Bennett made a powerful argument in favor of insurers and Medicare paying for novel treatments of fatal diseases, even treatments where the benefit was doubtful and |
cost extraordinary, because the benefits extended far beyond merely adding time to a terminally ill patient’s life by giving that person and everyone around them hope. But we need to be honest about Pradaxa and other medicines like it that |
are not unique life-extending drugs, but instead are different modalities of existing treatments. When a drug offers marginal or similar efficacy to existing treatments, safety, not expediency, should be paramount. |
Liver Disease Information In Your Area American Liver Foundation 39 Broadway, Suite 2700 New York, New York 10006 >>The American Liver Foundation joins the World Hepatitis Alliance on July 28th as part of World Hepatitis Day to raise awareness of the serious implications of hepatitis B and C. The theme of the day, “Know It, Confront It and Get Tested” speaks to the need |
to increase knowledge of hepatitis, to remove the stigma of the disease, and take down barriers from seeking treatment. It is estimated there are 12 million people in the world with hepatitis. Hepatitis C is often called the silent killer as there may be no symptoms for 20-30 years after the person is infected. The disease is transmitted when infected blood enters the body. |
The most common ways of infection are sharing needles with IV drug use or having received infected blood in a blood transfusion prior to 1992. Recently the Centers for Disease Control and Prevention (CDC)’s issued draft guidelines recommending a one-time hepatitis C test for everyone born from 1945 to 1965 (the baby boomer generation). One in thirty people in this generation has been infected |
with hepatitis C and the overwhelming majority don’t know it. Left untreated, hepatitis C causes serious liver diseases, including liver cancer, the fastest rising cause of cancer-related deaths, and is the leading cause of liver transplants in the United States. Hepatitis B virus is highly infectious and about 50-100 times more infectious than HIV. In nine out of ten adults, acute hepatitis B infection |
will go away on its own in the first six months. However, if the virus becomes chronic, it may cause liver cirrhosis and liver cancer after up to 40 years, but in some cases as little as five years after diagnosis. The hepatitis B virus is transmitted between people through contact with the blood or other body fluids (i.e. saliva, semen and vaginal fluid) |
New Material Offers Safer Breast Implants, Integrates Cancer Treatment Puskas with new implant shell (left hand) and current silicone gel implant (right hand). CREDIT: Gabor Kaszas This Behind the Scenes article was provided to LiveScience in partnership with the National Science Foundation. According to the National Cancer Institute at the |
National Institutes of Health, an estimated one in eight American women will develop breast cancer during her lifetime. Out of those women who develop breast cancer, many will have mastectomies and will undergo breast reconstruction. A report from the America Society of Plastic Surgeons says that 96,277 women had breast |
reconstruction in 2011. The materials used for breast reconstruction, such as silicone, have improved over time, but according to a 2011 report from the FDA, “as many as ... 1 in 2 primary reconstruction patients — meaning those who have reconstruction performed at the same time as a mastectomy — |
require implant removal within 10 years of implantation” due to complications or poor outcomes. What if there was a way to create safer breast implants and also fight cancer? A team of researchers from the University of Akron bridged materials science and medicine to develop a new type of rubber |
material that can be used as the shell of a breast implant. Diagnostic agents that help reveal the presence of cancer cells, as well as cancer-fighting drugs, can be embedded into the shell and released into the body. “We are trying to integrate breast reconstruction with cancer treatment,” said Judit |
elastomers, or polymers with elasticity and the potential to become pliable and moldable above a certain temperature, as well as the ability to return to their initial state upon cooling. This material is lighter and stronger than silicone rubber. Compared to other rubbers, it is especially impermeable, preventing liquids from |
seeping through — essential for prevention of gel leakage in an implant. The material is also environmentally friendly and can be reprocessed. A previously developed PIB-based material — a predecessor to the new biorubber — has successfully been used as the coating on drug-eluting coronary stents. These are tubes placed |
in coronary arteries that slowly release a drug to block cell proliferation that can block arteries. This material is currently used in clinical practice, with over 6 million stents implanted. “Drug eluting stents reduced the incidence of [repetitive] blocking of the artery from 30 to 8 percent,” said Puskas. Puskas |
and her team worked to improve the properties of this PIB-based material, and came up with the new biorubber. The unique qualities of this material offer a vehicle to fight and treat cancer, reduce the risk of inflammation, and transmit painkillers. The polymer in the new material can be spun |
into a fiber mat; the fibers, which can be attached to the implant, encapsulate various cancer-fighting drugs. Over time, the drugs slowly release into the body. Delivering drugs directly to the cancer cells by embedding them into the fiber mat coating could reduce the amount of drugs needed for treatment, |
and thus lessen side effects. Researchers can also encapsulate a diagnostic agent to reveal the presence of cancer cells and their location as well as help determine the efficiency of the drugs. Then, drugs could be administered to fight the cancer cells. In addition, the implant can be coated with |
drugs that help reduce the risk of inflammation in the tissue surrounding the implant. Such an inflammation could result in tissue contraction, the shortening or other distortion of tissue, or even a ruptured implant. In addition to breast prostheses, the new material has other applications, such as vascular grafts, which |
are transplanted or prosthetic blood vessels used in surgery. The material can also be used with implantable devices incorporating antimicrobials to kill or inhibit the growth of microorganisms, steroids and analgesics or painkillers. In March, Puskas and her team received international recognition for their new material. It was one of |
the five winners of the General Electric healthymagination Breast Cancer Challenge. Their research was selected among 500 entries from 40 countries. Each winner received a $100,000 seed award and will be given access to additional funding for further research and development. Editor's Note: The researchers depicted in Behind the Scenes |
articles have been supported by the National Science Foundation, the federal agency charged with funding basic research and education across all fields of science and engineering. Any opinions, findings, and conclusions or recommendations expressed in this material are those of the author and do not necessarily reflect the views of |
White-lipped deer gain their name from the white markings visible beneath the mouth and down the throat. The species has a brown coat that gets thicker during winter to provide added warmth. One of the largest deer species, the white-lipped deer can reach six feet in length and six hundred |
pounds. Males possess an imposing set of antlers, which can be as large as four feet in size. These antlers are shed and regrown each mating season. ARKive is creating the ultimate multimedia guide to the world's endangered species. Visit ARKive for thousands more films, photos and fact-files! |
Click any word in a definition or example to find the entry for that word The force of the explosion had twisted the metal. She sat there twisting her handkerchief |
into a knot. He twisted vines round the logs to make a raft. This is the British English definition of twist. View American English definition of twist. to learn small |
What is Environmental Engineering? Environmental engineers are concerned with protecting the environment by assessing the impact a project has on the air, water, soil and noise levels in its vicinity. Their work may involve removing problems caused by past activity, such as cleaning contaminated industrial land so it can be used for housing; planning and designing equipment and processes for |
the treatment and safe disposal of waste material; and directing the conservation and wise use of natural resources. They are also involved in the research and development of alternative energy sources, water reclamation, waste treatment and recycling. Are you an engineer?Upload your profile IN Environmental ENGINEERING FREQUENTLY ASKED QUESTIONS BLOG ENTRY More October 3, 2012 The launch of Engineering Week |
was hosted by Her Honour, Sally Thomas the Administrator of the Northern Territory at Government House on Tuesday 7 August 2012. Over 50 members joined in the Division’s official launch of the week’s activities which included a Women in Engineering lunch and a cocktail function at the Defence of Darwin Experience at East Point Museum. September 21, 2012 A ‘Discover |
Engineering’ information evening aimed at secondary school students, parents and teachers was held at Division Office on Tuesday 7th August. Students were enlightened to see some of the many ways engineers influence their everyday lives and hear how to achieve a rewarding career in engineering... Engineers Australia is proud to announce that 2011 is the Year of Humanitarian Engineering |
YOU DON'T NEED a calendar to know that spring is right around the corner. Signs of the season abound as bulbs pierce the ground with vibrant bouquets and trees and shrubs begin to strut their floral finery. New foliage erupts from the bare branches and slender stems of your prized fruit trees, creating visions of bountiful crops, fresh peach pie, |
baked pears or fruit plucked warm off the tree. But your daydreams might be squelched when you instead see blistered, bumpy, puckered, twisted leaves on your peach tree or pear tree branches that look like they've been torched. What's up with that? As spring unfolds, so do a couple of common fruit tree maladies. Peach leaf curl is a fungal |
disease that affects only peach and nectarine trees, potentially weakening them and reducing yield. Left untreated, it can result in the demise of the tree. Fire blight is a nasty infection by a destructive bacterium. It most frequently affects apples, pears and related plants — crabapple, ornamental pear, Pyracantha and quince. Peach leaf curl produces malformed, thickened and often pink |
to reddish green leaves that punctuate healthy foliage and in severe cases, affect twigs and branches of the entire tree. The sadly deformed and discolored leaves turn brown and die. During cool rainy weather, the infecting agent increases in number, eventually forming a film on the tree's surface. The good news is that While it's admittedly not pretty to look |
at, peach leaf curl is generally not difficult to control. Selecting varieties resistant to the disease is the easiest preventive measure. "Frost," "Indian Free," "Muir" and "Q-1-8" are some resistant peach varieties; "Kreibich" is one of the few resistant nectarine varieties. Keeping trees healthy and vigorous, providing adequate water to reduce drought stress, and thinning fruit help to reduce demands |
on peach and nectarine trees. Along with good garden sanitation — removing diseased leaves, twigs and branches from the garden — these measures go a long way in fending off the disease. An annual application of a fungicide is usually sufficient to protect the tree from peach leaf curl, and timing is everything. Apply after leaves fall, usually in late |
November. If it's a very wet winter and early spring, a second application just before buds swell may be beneficial. Treatment after symptoms appear won't have any effect in controlling the disease. A fungicide containing copper ammonium is the easiest to use, and you can improve its effectiveness by adding a 1 percent horticultural spray oil to the application mix. |
Bordeaux mixture is another option — it is a copper sulfate and lime mixture that should be prepared just prior to use. The synthetic fungicide chlorothalonil is currently the only other noncopper fungicide available to the home gardener for managing this fungal disease. The telltale "scorched" look of fire blight may appear scattered throughout the crown of the plant and |
is usually seen first on blossoms and stems, turning them brown or black. It can spread from the point of entry (blooms, stems and branches, limbs, trunk or roots) and may severely disfigure or kill individual limbs or the entire plant. Mild temperatures (65 to 85 degrees) with some intermittent rain provide perfect conditions for the pathogen to develop. As |
trees resume growth in the spring, the bacteria become active and are spread by insects — aphids, flies, leafhoppers and honeybees, pruning tools, wind and splashing rains. As long as the warm, wet conditions exist, the disease can continue to spread and infect new sites. The most effective means of managing the disease is to plant varieties that are not |
susceptible, and as most infections originate in the flowers, avoid varieties that bloom late or throughout the season. Most pear tree varieties are very susceptible as are "Fuji," "Gala," "Gravenstein" and "Jonathan" apples. Keep plants vigorous and healthy through good cultural care and promptly remove and destroy any portions that appear infected. Prune diseased branches, cutting at least 8 to |
12 inches away from the visible injury or canker, or until you see healthy tissue. Sanitize tools between each cut, to prevent spreading the pathogen. Treatment with a very weak (about 0.5 percent) Bordeaux mixture or other copper product applied several times as blossoms open might reduce new infections but won't eliminate them or those already existing in wood. Apply |
spray to open blossoms; repeat applications every four to five days during the bloom period. Don't let those forlorn looking leaves deter you; the scrumptious orbs of summer and fall are worth the little extra effort that may be needed to keep your fruit trees healthy and productive. The University of California Marin Master Gardeners are sponsored by UC Cooperative |
Extension. For questions about gardening, plant pests or diseases, call 473-4204 from 9 a.m. to noon, and 1 to 4 p.m. weekdays, or bring in samples or pictures to 1682 Novato Blvd., Suite 150B, Novato. |
setchellii has a rather unusual body form for a green alga. Unlike most familiar green algae, C. setchellii is a crustose species, forming a thick mat on rocks in the low intertidal zone. This green crust comes in a variety |
of shades; most often the crust is brilliant green, but in some areas of Monterey Bay the crust is dark green, almost black in color. Crustose C. setchellii usually forms individual round clusters on the substrate. These amorphous "blobs" in |
the intertidal are often velvety in texture, varying from deep, dark green to lighter shades of green in some individuals. The "cushion" of the alga can reach a diameter of 25 centimeters, though individual algae may coalesce into larger crusts |
over the substrate (Abbott and Hollenberg 1976). The thallus of C. setchellii crusts is typically 6 to 15 millimeters thick, forming a tight association with the substrate to which it is attached (Abbott and Hollenberg 1976). Figure 1: Codium setchellii |
occurring as a solitary round colony in the low intertidal (Point Pinos, Pacific Grove, CA, USA) unusual morphology appeared in individuals observed and collected from Carmel (CA). Here, C. setchellii completely encrusted some rocks. This unusual form had a velvet |
texture and formed thick and thin mats over the rock. In some areas, the crust actually formed projections off the main form; the function of these projections remains unknown, but may be related to increasing surface area of nutrient uptake |
and Figure 2: Unusual crust formation by C. observed at Carmel Beach (Carmel, CA, USA) dominates the low intertidal Similar to Codium setchellii other organisms that live in the intertidal zone closely resemble Codium setchellii. Some algae are similar in |
appearance to C. setchellii from a distance, but only when examined up-close do the differences some areas of Monterey Bay, the filamentous green alga Cladophora columbiana often looks like C. setchellii. Both species are green and have a similar globular |
appearance when wet. However, the texture of Cladophora is clearly comprised of large filaments which can be teased apart, a feature not seen in C. setchellii. Figure 3: Tufts of the filamentous alga Cladophora columbiana in the intertidal zone may |
resemble C. setchellii from a distance "Petrocelis" form (tetrasporophyte) of Mastocarpus papillatus superficially resembles C. setchellii. Both form crusts in the intertidal zone, but the crust of Mastocarpus is dark brown in color and is much thinner than C. setchellii |
Figure 4: The black crust of the tetrasporophyte papillatus (sometimes called the "Petrocelis" morph) one of the following links to learn more about Codium setchellii: 2005 Raúl Nava. Text and images freely available for personal, educational use (please credit). e-mail |
For More Information INQUIRY IDEA H - FIGHTING FATHERS:THE PEOPLE BEHIND CONFEDERATION Consult these excerpts linked to the Web activity Inquiry Idea H "Fighting fathers: the people behind Confederation." - How did Dorion argue against Confederation during the 1864 debates? - What model of federation did Macdonald favour? - What was Brown’s view on the separation of church and state? - Why did Cartier’s |
defend? Why promote a customs union between colonies which had no trade ties? What good were bold promises that union would bring intercolonial railways if confederation was, as Dorion put it, only “another haul at the public purse for the Grand Trunk,” which would bankrupt all the colonies together?” Moore, Christopher. 1867: How the Fathers Made a Deal, Toronto, Christopher Moore Editorial Ltd., 1997, |
p. 147. “One of the immediate, fundamental questions was what the balance of power should be between the federal and provincial governments. Macdonald must have realized at once, the moment the word “federal” was used, that it could cover a great deal of ground. There were many different kinds of “federal”. At one end of the scale was a constitution like that of New |
Zealand in 1852, where the provinces were barely above municipalities; at the other, a constitution like the first American confederation of 1777-1789, where the states had virtually all the power. Macdonald had one distinct and unequivocal aim – to combat that which the American Civil War had writ so large: the inherent tendency of federal systems to fly apart. It was the result of |
too much weakness at the center. He therefore set out to centralize as much control in Ottawa as he could, save only the irreducible minimum which of necessity went to all the provinces.” Waite, Peter. “Between Three Oceans: Challenges of a Continental Destiny (1840-1900)”, in Illustrated History of Canada, Craig Brown (ed.), Toronto, Key Porter Books Ltd., 1997, p. 326. “Brown believed fiercely in |
the separation of church and state. Not because he was irreligious or anti-religious. Brown was a devout, God-fearing Scots Presbyterian, an heir to those early Protestants who had first condemned the worldly power and worldly corruption of the Church of Rome… It was Catholics, however, not Protestants, who felt most threatened by...Brown’s religion and his politics.” Moore, Christopher. 1867: How the Fathers Made a |
Deal, Toronto, Christopher Moore Editorial Ltd., 1997, p. 10. “Cartier, whose credentials as a defender of tradition were secure, could consider the leap to accepting rep-by-pop. The rouges no longer could. In the conservative Quebec of the 1860s, it was radical enough for rouges to question clerical authority by defending freethinking intellectuals and secular education. […] When Brown and Cartier began talking about federalism |
in the spring of 1864, Brown hoped to bring rouges leaders into the coalition. Instead, the rouges took up the traditional bleu repudiation of rep-by-pop, proposing that the sectional equality of Canada East and Canada West should be entrenched forever. The rouges stayed out of the coalition of 1864 and declared themselves opposed to its federal policy.” Moore, Christopher. 1867: How the Fathers Made |
a Deal, Toronto, Christopher Moore Editorial Ltd., 1997, p. 145-6. “Macdonald was the only member of the triumvirate [Great Coalition] who may have felt some momentary doubts [about the federal system]. Like his colleagues, he believed that the only possible federation was a federal union of the whole of British North America. But he saw union chiefly as strength and as expansion; and now |
he was full of unhappy doubts that expansion by means of federation would never give a transcontinental British American union the strength he craved for it. […] Macdonald lived for the action of practical politics; and he knew as well as Cartier, and better than Brown, that practical politics is the art of the possible.” Creighton, Donald. The Road to Confederation, The Emergence of |
Health systems around the world are under increasing strain because of the rising prevalence of chronic conditions, including diabetes, heart disease, and asthma. For more than 15 years, disease-management programs |
(DMPs) have been promoted as a solution to this problem. By carefully coordinating the delivery of high-quality care to patients with chronic conditions, the programs are supposed to enhance the |
patients’ health, reduce hospitalization rates, and lower treatment costs. Unfortunately, initial experience with DMPs was often disappointing. Many of them produced, at best, only modest improvements in health outcomes, and |
few were able to decrease health care spending. Thus, many payor, provider, and health system executives have questioned whether the programs are worth their cost. More recently, however, some DMPs |
have produced much better results. Germany’s diabetes program, for example, has reduced the incidence of some complications and has lowered the overall cost of care by 13 percent. Germany is |
also achieving good results with its programs for coronary artery disease (CAD) and chronic obstructive pulmonary disease (COPD). Several other countries have also begun to achieve good results with DMPs. |
Why have some DMPs achieved some or all of their goals while others have failed? To answer this question, we analyzed successful and unsuccessful programs to identify the differences between |
them. The key, we discovered, lies in the programs’ design; five characteristics markedly increase the likelihood that a DMP can both improve health outcomes and lower costs. Based on our |
results, we have developed a checklist that payor, provider, and health system executives can use to determine whether a DMP they are considering or are already sponsoring is likely to |
be successful—and what they can do if they spot problems. In most developed countries, three-quarters or more of all health care spending is now devoted to patients with chronic conditions, |
and a large portion of that money is spent only on a small number of diseases (Exhibit 1). Thus, well-designed DMPs could do much to meet the current need to |
control health care spending while improving patient care. The term “disease management” has often been used loosely to refer to general public-health campaigns (to promote regular exercise or influenza vaccination, |
for example), as well as to case-management programs tailored to individual patients. DMPs are neither of these. They are programs geared to specific groups of patients who all suffer from |
the same chronic condition. The patients receive a standardized, coordinated set of evidence-based interventions whose goals are to enhance the patients’ health and quality of life, reduce the need for |
hospitalization and other costly treatments, and thereby lower health care spending. Ideally, the savings obtained should exceed the programs’ cost. The need for effective DMPs has been clear for at |
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