Current Events

Medicare will pay the costs of brain imaging that uses a Eli Lilly & Co. (LLY) drug to help diagnose Alzheimer’s disease only for patients participating in approved clinical studies, regulators proposed.

There isn’t enough evidence to show the scan will benefit all people with dementia, though in some cases it may help diagnose whether a patient has Alzheimer’s, the most common form of dementia, the Centers for Medicare & Medicaid Services said today in its proposed coverage decision. Medicare, the U.S. health plan for the elderly and disabled, will reimburse patients for a scan if they are part of an approved clinical trial for the prevention, treatment or better diagnosis of Alzheimer’s, the agency said. 

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The Food and Drug Administration on Wednesday signaled its intention to permit generic drug makers to make changes to their safety labels, a move that could open the door to lawsuits against generic drug companies for the first time since a Supreme Court decision barred such suits two years ago.

Consumer advocates applauded the development, calling it a necessary fix for a system that they say is unfair to patients who take generic medicines.

“It’s common sense,” said Dr. Sidney M. Wolfe, a senior adviser to the Health Research Group at Public Citizen, which in 2011 petitioned the F.D.A. to pass just such a rule. “It will obviously end this situation where people are being harmed physically and yet, although they are harmed, they have no right to go into court and get redress for serious damages.”

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(Reuters) - U.S. health regulators warned on Wednesday that Daiichi Sankyo Inc's blood pressure drugs Benicar, Benicar HCT, Azor and Tribenzor can cause severe, chronic diarrhea and substantial weight loss, sometimes requiring hospitalization.

The Food and Drug Administration said the intestinal problems, known as sprue-like enteropathy, can develop months to years after starting on the drug, which is known generically as olmesartan medoxomil.

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Pharmaceutical companies are under increasing pressure to release previously hidden data on how well their drugs work. The primary push for much greater transparency has come from the Cochrane Collaboration, an international network of experts based in Oxford, England; The British Medical Journal; and the European Medicines Agency, which recently proposed that, starting next year, clinical trial data be released once a drug is approved for marketing.

The saga of Tamiflu, an anti-flu drug produced by Roche, a multinational company based in Switzerland, exemplifies the difficulties of extracting information vital to public health. In mid-2009 a Cochrane researcher was hired by the British and Australian governments to update his previous evaluation of Tamiflu, which had concluded that it reduced the risk of complications from the flu. The information was important because the drug was being stockpiled by the United States and other governments in the belief that it would help people survive a potentially severe epidemic of swine flu. 

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Hundreds of people who say they’ve been harmed by a Medtronic spinal device are pursuing a new legal pathway around rulings that have kept them from getting a day in court.

They argue that the Food and Drug Administration, which approved limited use of the Infuse bone growth product in 2002, offered a 2008 warning to doctors about “life-threatening complications” from unapproved applications. Then, the Spine Journal in 2011 and the U.S. Senate Finance Committee in 2012 each harshly criticized Medtronic for allegedly paying physicians hundreds of millions of dollars to write scholarly articles about Infuse while editing those articles to downplay Infuse’s dangers.

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Fifty-five hospitals in 21 states agreed Tuesday to pay the U.S. government more than $34 million to settle charges that they submitted false claims to Medicare for kyphoplasty procedures, the Justice Department said.

Kyphoplasty is a minimally invasive procedure used to treat certain spinal fractures that often are caused by osteoporosis.

“The Department of Justice is committed to ensuring that Medicare funds are expended appropriately, based on the medical needs of patients rather than the desire of medical providers to maximize profits,” said acting Assistant Attorney General Stuart F. Delery, who heads the department’s Civil Division.

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The National Highway Traffic Safety Administration is intensifying its investigation into whether General Motors should have recalled about 551,000 vehicles instead of 8,000 for a brake light problem, according to a report posted on the agency’s Web site. It is the third time this year N.H.T.S.A. has challenged the adequacy of G.M. recalls.

In February, N.H.T.S.A. began what is called a recall query, which was basically a challenge to the adequacy of a recall. The agency said it was prompted by receiving 212 complaints about brake light problems from owners of 2005-8 Pontiac G6s. The recall in 2009 covered only 2005-6 models.

The safety agency now says it has received 314 complaints and G.M. has admitted that it has received 1,104 complaints, in addition to about 14,400 “potentially related warranty claims.” There was also one complaint of a crash, although it did not result in an injury. Accordingly, the agency is upgrading the investigation to an engineering analysis. That will more than likely – albeit not certainly – result in a recall.

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Hyundai is recalling 5,200 model-year 2012-13 Azera sedans due to a problem with the airbag system that could prevent it from recognizing whether a passenger is an adult or a child, according to the National Highway Traffic Safety Administration.

Affected vehicles were manufactured between May 22 and Nov. 23, 2012. The occupant detection system may fail to properly differentiate whether the front passenger-seat occupant is an adult, a child or a child-safety seat; if this happens during a crash in which airbags deploy, the affected airbag may respond with greater or lesser force than appropriate, increasing the risk of an injury. Jim Trainor, Hyundai spokesman, said the automaker believes the actual number of vehicles with the problem will be "less than 1 percent" of the 5,200 included in the recall.

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The National Highway Traffic Safety Administration is investigating owner complaints of unexpected braking and whether there should be a recall of almost 344,000 Honda Odyssey minivans from the 2007-8 model years. The complaints are similar to those that resulted in the recall of about 183,000 different Honda and Acura models in March.

The safety agency says it decided to investigate after receiving 22 complaints from Odyssey owners saying “that the vehicle suddenly applies the brakes by itself,” according to a report posted Saturday on the N.H.T.S.A. Web site.

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The Food and Drug Administration said on Friday that it had identified another product contaminated with Hepatitis A, which was the cause of a recall of frozen organic berries earlier this month.

As a result, the Scenic Fruit Company of Gresham, Ore., has recalled three different lots of its Woodstock Frozen Organic Pomegranate Kernels, which were shipped from February through May to United Natural Foods Inc. distribution centers in 12 states – California, Colorado, Connecticut, Florida, Georgia, Indiana, Iowa, New Hampshire, Pennsylvania, Rhode Island, Texas and Washington.

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PETER DOSHI walked across the campus of Johns Hopkins University in a rumpled polo shirt and stonewashed jeans, a backpack slung over one shoulder. An unremarkable presence on a campus filled with backpack-toters, he is 32, and not sure where he’ll be working come August, when his postdoctoral fellowship ends. And yet, even without a medical degree, he is one of the most influential voices in medical research today.

Dr. Doshi’s renown comes not from solving the puzzles of cancer or discovering the next blockbuster drug, but from pushing the world’s biggest pharmaceutical companies to open their records to outsiders in an effort to better understand the benefits and potential harms of the drugs that billions of people take every day. Together with a band of far-flung researchers and activists, he is trying to unearth data from clinical trials — complex studies that last for years and often involve thousands of patients across many countries — and make it public. 

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