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Posts Tagged ‘Food and Drug Administration’

The announcement by the U.S.Food and Drug Administration (FDA) that propoxyphene-containing products are finally going to be taken off the market – because of dangers previously known and acted upon, with bans announced in the UK almost six years ago, and in Europe, almost 1½ years ago – is a serious indictment of the FDA’s long-lasting unwillingness to protect people in this country from a deadly but barely effective painkiller. In announcing the ban in 2005, the UK stated that the efficacy of propoxyphene (sold generically and under the brand name Darvon) “is poorly established and the risk of toxicity in overdose, both accidental and deliberate, is unacceptable” and that “[I]n relation to safety, there is evidence that fatal toxicity may occur with a small multiple of the normal therapeutic dose and a proportion of fatalities are caused by inadvertent overdose.” The FDA’s claim that this is the first evidence that the drug is dangerous at the “standard therapeutic dose” thus rings dangerously hollow.

The FDA’s deadly delay in this case starkly illustrates how one of the most important public health concepts, the precautionary principle, was embraced by the UK and Europe, but was for too long recklessly rejected by the FDA.  (more…)

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The FDA has announced that it will revoke approval of a medical device for injured knees because, as Public Citizen testified in 2008, the Menaflex device made by New Jersey-based ReGen Biologics should never have been approved in the first place.

Public Citizen researchers told the FDA there was no scientific evidence to support the device’s approval. Subsequent events revealed how political pressure from some New Jersey members of Congress forced the device  through the FDA approval process. Dr. Jonas Hines, the Public Citizen researcher who appeared before the FDA, said that political shenanigans “cast a shadow on the ostensibly objective approval process.” The FDA’s decision to revoke the ReGen approval should be the agency’s first step in overhauling the medical device approval process.

“Although we are pleased that the FDA acknowledges its mistake in clearing the ReGen Menaflex, this decision is long overdue,” Jonas said. “We hope this represents the beginning of a new era in medical device approval, one in which the health of Americans supersedes any industry threat of the stifling effect on innovation of improvements in regulation.”

Gardiner Harris in the NYT writes that the FDA “had never before admitted that it approved a drug or device mistakenly, never rescinded such an approval without citing new information about the product, never admitted that a regulatory decision was influenced by politics, and never accused a former commissioner of questionable conduct.”

So is it a “new day” at the FDA? It might be a little premature to bust out the champagne, but following the decision earlier this month to pull the dangerous diet pill Meridia from the shelves, we will go so far to say that October has been a good month for patients.

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Last week, the Food and Drug Administration took the inadequate measure of restricting the sale of the dangerous diabetes drug Avandia. Public Citizen has long been pushing the FDA to ban Avandia, much like its European counterparts recently did.

Now comes this troubling look at the extent to which GlaxoSmithKline, the maker of Avandia, covered up the life-threatening side effects of its diabetes medication. Paul Thacker, who was the leading investigator for Sen. Chuck Grassley’s Finance Committee,  writes in Mother Jones what he learned during his three-year investigation:

During that time, my colleagues and I combed through over 250,000 pages of internal GSK documents and interviewed dozens of witnesses and whistleblowers. What emerged was a troubling picture of a company that had placed corporate profits over patient safety. While suppressing inconvenient evidence about the risks of its top-selling drug, the company even began to develop another drug to treat the very side effect Avandia has been linked to.

Yes, you read that right — Instead of recalling Avandia, which was linked to causing heart attacks in patients, GlaxoSmithKline decided the better thing to do was to develop another drug that could treat the condition caused by Avandia.

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Dr. Sidney Wolfe, director of Public Citizen's Health Research Group

Wolfe

By failing to ban the dangerous diabetes drug, Avandia, generic name rosiglitazone, the Food and Drug Administration (FDA) again caved to industry pressure. Although the FDA has made progress highlighting the risks of using Avandia by severely restricting the drug, it did not go far enough. Too many people could still be exposed to this dangerous product. Rather, the FDA should have acted with its European counterpart and outright banned Avandia from the market.

Why did it take the FDA so long to decide that a drug with no evidence of any advantage in health benefits, but abundant evidence of a variety of risks compared to other diabetes drugs, should be severely restricted? Why did it not ban this unsafe product?

More than three years ago at an FDA advisory committee meeting, Public Citizen urged the FDA to ban Avandia. Since then, 9 million prescriptions for the drug have been filled in the United States. This means that, just in the past three years alone, tens of thousands more patients have needlessly suffered hospitalizations for heart failure or deaths than would have had they taken Actos, a comparable, but safer drug.

There is not a single study finding that Avandia is safer than Actos, but there are numerous studies finding that Avandia is more dangerous than Actos. The FDA and GlaxoSmithKline have acted recklessly in allowing Avandia to stay on the market for so long after its unique dangers have been known.

The FDA should reconsider its decision to merely restrict such a hazardous product and directly remove it from the market.

Public Citizen petitioned the FDA in 2008 to ban Avandia.

Click here to learn more about Public Citizen’s work on Avandia.

Dr. Sidney Wolfe is the director of Public Citizen’s Health Research Group.

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Tomorrow, our own Sid Wolfe will be testifying before an FDA advisory committee about the much talked about diabetes drug Avandia, manufactured by drug maker GlaxoSmithKline.  The New York Times reported today that GlaxoSmithKline hid data indicating Avandia’s adverse effects for 11 years. The New York Times also explained the history of this dangerous drug.

In the fall of 1999, the drug giant SmithKline Beecham secretly began a study to find out if its diabetes medicine, Avandia, was safer for the heart than a competing pill, Actos, made by Takeda.

Avandia’s success was crucial to SmithKline, whose labs were otherwise all but barren of new products. But the study’s results, completed that same year, were disastrous. Not only was Avandia no better than Actos, but the study also provided clear signs that it was riskier to the heart.

But instead of publishing the results, the company spent the next 11 years trying to cover them up, according to documents recently obtained by The New York Times. The company did not post the results on its Web site or submit them to federal drug regulators, as is required in most cases by law.

Excuse our impatience, but we’ve been warning about Avandia for a decade. We petitioned the Food and Drug Administration to ban Avandia (also known as Rosiglitazone) back in 2000. Sid Wolfe has been saying all the things “recently uncovered” for years. It finally looks like something might happen though; the FDA is meeting to discuss Avandia today.

Check out Public Citizen’s history advocating for the removal of Avandia from store shelves.

You should also look at worstpills.org, our comprehensive fact-check website for all sorts of medications.

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