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An announcement of the Government scientists' finding and recommendations on which course women with a Meme or Replicon implant should now pursue, is not expected from the F.D.A. for days, or even weeks. |
A spokeswoman for the agency, Susan Cruzan, would neither confirm nor deny the finding. She said data from the F.D.A.'s experiments were being urgently reviewed to determine whether the implant should be withdrawn from the market. |
But scientists familiar with those experiments said it appeared from preliminary calculations that the implant might cause cancer at the rate of 200 to 400 cases a year for every million women in whom it is inserted. |
Researchers who have worked on the dangers of breast implants, both for the Government and privately, said that the best course for women who have a Meme or Replicon implant was probably to do nothing until the F.D.A. issues recommendations. |
Word of the Government scientists' finding comes only days after the F.D.A. took other action against breast implants. In a directive issued this week, the agency gave makers of all breast implants 90 days to demonstrate that the products are safe or remove them from the market. |
One issue in that directive is evidence that silicon seeping from the implant can make its way into the lymph nodes and disrupt the immune system. |
Another is that if the silicon is not coated, breast tissue can grow around it, leading to muscle contracture that creates a painful lump. |
Government experiments with the Surgitek implants followed findings by private doctors that some of the coating had dissolved when the implants were removed from patients. The F.D.A. scientists, whose work on the matter lasted for months, found similar dissolution when the implants were placed in a liquid at body tempe... |
The F.D.A. data show that the dissolution of the polyurethane begins immediately after implantation and that in some cases, depending on factors not fully understood, the coating may dissolve almost completely within five years. The greater the rate of dissolution, the greater the cancer risk, the scientists said they ... |
But the Surgitek spokeswoman, Karen Garoukian Ferraro, said the company's studies had brought far different results. |
She said that doctors working for the company had examined 10 of the implants after they were removed from patients and that the doctors had found that the "structural integrity of the polyurethane remains intact." |
Microscopic examination, she said, showed that some of the polyurethane had dissolved in the body. But she said this process had been a very slow one. |
Mrs. Ferraro also said that from other Surgitek studies, which examined dissolution of the coating in a laboratory, the company had calculated that the number of cancers caused by the release of TDA into the body would be "one in several million implants," a far lower rate than found by the F.D.A. |
The story of spammer Edward “Eddie” Davidson, who escaped from a federal prison at the weekend, has a tragic ending. |
According to the Associated Press, the dead bodies of Davidson, his wife Amy Hill, and his three-year-old daughter, have been discovered by police, having suffered from fatal gunshot wounds. |
A teenage girl, believed to be the child of Davidson or Hill, has been taken to hospital with a gunshot wound to her neck. Edward Davidson’s infant son, about 7 to 8 months old, was found unharmed in the back of the Toyota car used for the convicted spammer’s escape from jail on Sunday. |
More information can be found in reports from 9news.com and Fox News, Colorado. |
Our sincere condolences to the family and friends of those concerned at this very difficult time. |
Even though 2015 was a better year for Nintendo than some of the years before it, many fans are looking forward to 2016. It seemed that almost everything in the company's pipeline would come to fruition once the calendar switched over and all of those "We'll talk about it next year" promises would finally be kept. |
Now that 2016 is finally here, fans still have to wait a little longer to find out what they want to know about things like the NX platform and Zelda U. To help tide them over, Nintendo president Tatsumi Kimishima recently spoke to Japanese newspaper Mainichi Shimbun and offered up a few teases of what the year would h... |
2) Kimishima says Nintendo wants to surprise fans with new ideas - not build on old ones. Nintendo will in 2016 release “details” on the NX. |
Note the emphasis on the word "details"; this seems to suggest that there won't be an NX release in 2016. It's important to keep in mind that this is all that Nintendo has promised in the past, despite analyst and fan speculation that the NX would see a release this year. |
3) Kimishima claims the expansion to smartphones and theme parks, but also to movies and TV animes (via character licensing) is progressing. |
There were a lot of rumors last year about movies or television shows, including a Legend of Zelda Netflix show that Nintendo denied at the time. Hopefully this means that projects like those will become real moving forward, especially for properties such as the Legend of Zelda series and Metroid. |
5) Kimishima promises smartphone apps with Nintendo’s famous characters in 2016. He wants to bring the company’s financials to a new level. |
New business models could be big for Nintendo, but it's important to remember that these will likely still be classic Nintendo through and through. Smartphone apps and other original content starring major Nintendo characters will be big, but you probably shouldn't hold your breath for classic Mario games on the PS4. |
Nintendo has a lot of money to help pad it against the lackluster sales that the Wii U experienced on launch, but profit is still the goal at the end of the day. It's good to see that Nintendo has a definite plan to increase its profits, and that it's not overpromising but is instead seeing a rise in profits over the n... |
It remains to be seen just how well Nintendo will be able to pull off its plans, but hopefully its new business models will embrace the modern world without straying too far from its roots. While Nintendo lags behind Sony and Microsoft in sales, the Wii U and 3DS are a different kind of console that delivers a largely ... |
Screen Rant will keep you updated with more news regarding Nintendo as it is made available. |
Five years ago, I bought a safe for my son’s doctor to store drugs. It was blue, about three feet square, and weighed 965 pounds—like the Acme safes Wile E. Coyote used to try to drop on Road Runner. My family and I had evidence the drugs might cure our 11-year-old son of his relentless seizures. But because the drugs ... |
The medicine did help our son, and a whole lot more. Sam’s seizures dropped from 100 a day to about five a day—and GW Pharmaceuticals, the manufacturer, was so encouraged by his response that it started talking to epilepsy doctors about clinical trials. On Monday, the Food and Drug Administration approved the drug, now... |
Like any new drug, we won’t know whether it lives up to its hype for a while. What’s clear is that it will permanently change the way we talk about cannabis in America. Cannabis is as legal as alcohol in Washington, DC and eight states, including the entire West Coast. But doctors, scientists, and hospital administrato... |
Early evidence suggests CBD could be useful not just for epilepsy, but a broad spectrum of neurological diseases like Parkinson's, Alzheimer's, multiple sclerosis, and some brain cancers. “There are neuroscientists who are drooling to work on this,” said Elizabeth Thiele, director of the pediatric epilepsy program at M... |
The approval also enables GW itself to accelerate its own internal cannabis research. GW is already testing Epidiolex for the treatment of tuberous sclerosis, a disease other than epilepsy that often causes seizures. Beyond that, GW now has political capital with US regulators that it plans to use to get approval for S... |
For the moment, the biggest unknown is how insurance companies will decide to cover Epidiolex. The double blind, placebo-controlled trials required for FDA approval only covered two rare brain-destroying pediatric types of epilepsy—Dravet Syndrome and Lennox Gastaut Syndrome. About 50,000 patients are affected by these... |
Indeed, two-thirds of the 1,756 patients who have tried Epidiolex in the past five years didn’t have Dravet or LGS—including Sam. Demand for Epidiolex was so high among drug-unresponsive patients like Sam that GW allowed neurologists at more than four dozen hospitals that weren’t part of the formal trials to conduct th... |
That parallel research should make it easier for doctors to prescribe the drug for other illnesses, a practice known as “prescribing off label.” It just means that in a doctor’s professional opinion a certain drug is worth trying, and it happens a lot with epilepsy drugs, Thiele says. |
The reason that pharmaceutical firms focus on rare diseases like Dravet and LGS—at least for seizure drugs—is driven as much by business and bureaucratic considerations as medical ones, doctors and pharmaceutical executives have told me. It’s difficult to get permission to do drug trials in children unless those kids h... |
What all this means is that GW will need to ensure that patients already taking Epidiolex for other forms of epilepsy don’t suddenly wake up in the fall and become compelled to pay full price for medications that work for them. It also means that doctors will need to marshal their expertise and the data that already ex... |
Thiele says that insurance companies eventually decide to cover epilepsy drugs for many more kinds of seizures than they were originally prescribed. The only question in her mind is how long that will take. The one thing she does know is that the public pressure for insurance companies to cover Epidiolex broadly will b... |
As for Sam, he wants to be a neurologist when he grows up. Two and a half years ago, when we combined Epidiolex with another drug, Sam’s seizures stopped completely. Sam, now 17, has medical permission to drive a car, something along with—well, everything—that seemed impossible to imagine five years ago. |
North East La Penitence, Albouystown-B, California Square and Kingston were among the winning teams when the Stag Beer Easter Futsal Championship continued on Thursday at the National Gymnasium, Mandela Avenue. |
North East La Penitence battled past Tiger Bay 3-2. Calvin Moore, Kevin Mullin and Joel Yhap scored in the ninth, 12th and 14th minute respectively. |
For Tiger Bay, Orin Moore and Deon Alfred netted in the sixth and eighth minute apiece. Similarly, California Square edged Ol Skool 3-2….. |
Tassie Cameron wrote ABC’s Ten Days in the Valley based on a recurring nightmare she was having. |
In the nightmare – and the series – a female showrunner is working late at night in her writing shed outside her house and when she tries to return to the house the back door is locked, she breaks in, and her young child is gone. |
Kyra Sedgwick plays Jane Sadler, the overworked television producer/single mom in the middle of a fractious separation, whose world, and controversial police series, implode. |
The series addresses the “archetypal guilt women have from the minute we give birth” that any moment not spent with your child “is a reason to loathe yourself,” Sedgwick said. “Society is happy to tell you those things as well,” she said. |
The first season’s 10 episodes will have a satisfying ending to the missing-child story, but also will include “bombshells” that create reason for a second season, Cameron said. |
The picture Cameron paints of her work is not very pleasant, one TV critic noted, asking if it’s true to life and is the intention that people feel sorry for her. |
“I never set out to make them feel sorry for her,” Cameron said of the character, who she described as a “truth-telling documentarian in over her head,” showrunning her first cop show. |
What Can Brown Do for Nickelodeon? |
Nickelodeon has elevated Brown Johnson to the newly created position of executive creative director of preschool television for Nickelodeon Television. |
Johnson -- previously executive vice president of Nick Jr., where she was responsible for such preschool staples as Blue’s Clues and Dora the Explorer, as well as recent series including LazyTown and The Backyardigans -- will now oversee development for all preschool programming on Nick Jr. and Noggin, the latter of wh... |
“Brown Johnson’s vision of preschool programming has changed the way kids watch TV,” Nickelodeon president Cyma Zarghami said in a prepared statement. |
What Can Browne Do for Telemundo? |
A paper and packaging company that is complemented by a North American merchant distribution system, with primary markets and manufacturing operations in the United States, Europe, South America and Asia. |
The Fool has written over 200 articles on International Paper. |
The paper company recovered after an awful December and then proved Wall Street wrong with full-year 2018 operating results. |
IP earnings call for the period ending December 31, 2018. |
The paper business was on fire last quarter. |
A fertilizer producer turning things around, America's leading aluminum company, and a paper manufacturer look too good to pass up right now. |
A low-cost cardboard manufacturer down on its luck, the newest fertilizer stock, and an energy leader are all worth a closer look this month. |
Does This Blue Chip-Dividend Stock Have a Cash Flow Problem? |
International Paper has averaged $1.9 billion in free cash flow in the last five years (sort of). |
International Paper is quietly crushing it -- and paying you a 3.2% yield to join in the fun. |
Industry, sector and description for International Paper. |
Leading global pharmaceutical companies have started to view their vast portfolios of older, established prescription drugs as vehicles for raising large sums of cash to fuel development of new medicines with far higher profit margins. |
France’s Sanofi and United States drugmakers Merck & Company and Abbott Laboratories are exploring selling off their mature drugs that have lost patent protection, Reuters reported this week, citing people familiar with the plans. Officials at the three companies declined to comment. |
The divestments could bring in more than $7-billion for Sanofi, north of $15-billion for Merck and over $5-billion for Abbott, the sources said, giving them considerable firepower to develop, or buy, promising experimental medicines. |
Such a shift would also remove a source of pricing pressure, since many of the older medicines are sold in emerging markets, where governments are increasingly demanding lower prices. |
“It makes sense to sell your low-growth assets that drag down profit margins and to redeploy that cash to higher-value innovative biotech assets,” said John Boris, an analyst with SunTrust Robinson Humphrey. |
The trickier part, according to some people familiar with the processes, is finding a buyer, particularly if many of these assets reach the market around the same time. Suitors could include generic or specialty drugmakers looking to widen their product line, or private equity firms content to milk the cash flow from t... |
The Merck products in particular could attract the interest of Valeant Pharmaceuticals, which derives a quarter of its revenue from branded generics sold in emerging markets, said Alex Arfaei, an analyst with BMO Capital Markets. |
Valeant’s chief executive Michael Pearson has said he favors established products over pumping cash into risky research and development projects. |
Once companies divest their mature drugs, good-selling patent-protected drugs can have a bigger impact on financial results, said Len Yaffe, portfolio manager of the healthcare fund at StockDoc Partners in San Francisco. |
Patent protection for a new drug is generally 20 years from the time the patent was approved, but it can then take a medicine 10 or more years to be developed and reach the market, giving a limited window for exclusivity. |
“From a smaller revenue base, it’s easier to grow revenue and earnings faster,” Yaffe said, especially as new drugs are approved and make contributions. |
The interest in unloading these older assets represents a shift for Big Pharma, which has relied on them as cash generators to cushion steep revenue declines from more recent drug patent expiries. |
Almost all are sold outside the United States, where governments are increasingly demanding lower prices. |
The divestments would also feed into a larger shakeout of the pharma industry, whose major players are in the midst of a series of asset sales and swaps to better focus on the types of medicines that will bring them the most growth. That logic has fueled Pfizer Inc’s $106-billion unsolicited takeover bid for AstraZenec... |
Merck drugs likely to be sold include blood pressure treatments Cozaar and Hyzaar, with combined sales of $1-billion last year; cholesterol fighter Zocor, with sales of $301-million, and hair growth drug Propecia, with sales of $283-million. |
Sales of Abbott’s aging drugs, which it calls “established pharmaceuticals,” fell 3% last year to $4.97-billion, irking many investors. |
When GSK reported quarterly financial results on Wednesday, it announced separate results for its established products division. Pfizer on Monday is expected to do the same, as a possible prelude to eventually divesting its mature drugs. |
GSK last September sold two blood clot medicines that are branded generics, Arixtra and Fraxiparine, and a related factory, to South Africa’s Aspen Pharmacare for $1.1-billion, as part of its strategy to focus on growth products. |
Pfizer, which recently spun off its animal health and infant formula businesses, is considering whether to divest its own established products unit, which includes hundreds of off-patent drugs and ones that will soon lose patent protection. |
Some analysts say an AstraZeneca purchase would allow Pfizer to combine the mature drugs divisions of both for a more significant sale or spin-off. |
But Pfizer has said it would not be able to divest the unit until 2017, following a review of its financial performance. It is one of the company’s three main businesses, and with revenue of $9.46-billion last year, it generated 18% of total Pfizer sales. |
There are clear risks for Merck, Sanofi and others, however, in concentrating their bets so much more heavily on the success of new medicines. |
FORMER Bank of England governor Lord King has blasted Theresa May’s Brexit preparations as “incompetent”. |
Dealing a fresh blow to the PM, he condemned her lack of planning for a no deal Brexit and said it “beggared belief” that the world’s sixth biggest economy had to stockpile food and medicines. |
And in an astonishing attack, he said “a government that cannot take action to prevent some of these catastrophic outcomes illustrates a whole lack of preparation”. |
He also laid the blame on Parliament and dithering on Whitehall. |
Last month Brexit Secretary Dominic Raab finally unveiled the first tranche of planning documents to prepare citizens and businesses for leaving the EU next March without a deal. |
Lord King was head of the central bank between 2003 and 2013 and backed Leave during the referendum campaign. And last year he urged Mrs May to make a clean break from the EU. |
But he PM’s Chequers proposals - which would keep the UK closely tied to Brussels - will leave us with the “worst of both worlds,” he said. |
BOULDER, CO—Claiming that anyone with even a little bit of pride in their company would have dismissed such a terrible employee by now, telemarketer David Baker, 29, said Tuesday that he was losing respect for the “obviously incompetent” boss who continues not to fire him. “He called me into his office about a month ag... |
ATLANTA, Ga., Nov. 19 (SEND2PRESS NEWSWIRE) — The Georgia Humanities Council and the Digital Library of Georgia won the Helen and Martin Schwartz Prize for their partnership on the Civil Rights Digital Library (CRDL). This marks the second time the Georgia Humanities Council has won the Schwartz Prize. Their first priz... |
The Federation of State Humanities Councils offers the Helen and Martin Schwartz Prize to recognize outstanding work in the public humanities that is supported or conducted by state humanities councils. The CRDL (civilrightslibrary.org) was selected for its unique contribution to the humanities and for its impact on th... |
The CRDL offers a digital video archive of historical news footage, a portal connecting users to civil rights movement content from libraries worldwide, and instructional materials for educators to use in the classroom. The Georgia Humanities Council, via the New Georgia Encyclopedia, developed original articles to sup... |
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