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Archive for the ‘Pharmaceuticals’ Category

Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, joined Democracy Now!’s Amy Goodman and Juan Gonzalez this morning to talk about our new report that shows the pharmaceutical industry has overtaken the defense industry in the amount of fines paid for violating the Fair Claims Act.

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Defense contractors,who may never live down their reputation of overcharging the government (remember the $640 toilet seats?), can now offer up that there is a worse industry when it comes to cheating the government. A Public Citizen report released today found that the pharmaceutical industry has now become the biggest defrauder of the federal government.

The study found that pharmaceutical cases accounted for at least 25 percent of all federal Federal Claims Act violation payouts over the past decade, compared with 11 percent by the defense industry.

The fraud results were a key finding from a Public Citizen analysis of all major pharmaceutical company civil and criminal settlements on the state and federal levels since 1991 and found that the frequency with which the pharmaceutical industry has allegedly violated federal and state laws has increased at an alarming rate. Of the 165 pharmaceutical industry settlements comprising $19.8 billion in penalties during the past 20 years, 73 percent of the settlements (121) and 75 percent of the dollar amount ($14.8 billion) have occurred during the past five years.

Many of the infractions, and the single largest category of financial penalties, stemmed from the practice of off-label promotion of pharmaceuticals – the illegal promotion of a drug for uses not approved by the Food and Drug Administration (FDA). Off-label promotion can be prosecuted as a criminal offense because of the potential for serious adverse health consequences to patients from such promotional activities. Another major category of federal financial penalties was purposely overcharging for drugs under various federal programs, which constitutes a violation of the FCA.

Here’s the report: (more…)

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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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Today’s Flickr Photo

The U.S. Supreme Court for Sale. Flickr photo by takomabibelot.

 

If you read one thing today . . .

We already knew that pharma giant GlaxoSmithKline wasn’t above putting profits before patient health. There’s the case of its diabetes drug Avandia, the sale of which the FDA recently restricted. And now comes the disturbing news that the British drug maker knowingly sold contaminated baby ointment and an antidepressant that didn’t work. Glaxo will pay $750 million to settle criminal and civil complaints in this latest round of court cases, write Gardiner Harris and Duff Wilson in the New York Times. The case was sparked by complaints from Glaxo’s former quality manager, Cheryl D. Eckard, who told the FDA about serious problems at Glaxo’s premier manufacturing facility in Puerto Rico:

But Ms. Eckard soon discovered that quality control was a mess: the water system was contaminated; the air system allowed for cross-contamination between products; the warehouse was so overcrowded that rented vans were used for storage; the plant could not ensure the sterility of intravenous drugs for cancer; and pills of differing strengths were sometimes mixed in the same bottles.

Although F.D.A. inspectors had spotted some problems, most were missed. And the company abandoned even the limited fixes it promised to conduct, the unsealed lawsuit says. Ms. Eckard complained repeatedly to senior managers; little was done. She recommended recalls of defective products; recalls were not authorized. In May 2003, she was terminated as a “redundancy.”

Overheard:

By now you’ve probably seen the video from the Rand Paul for U.S. Senate campaign rally in Lexington, Ky. where Paul supporters wrestled a female MoveOn.org protestor to the ground and one man stepped on her head.  The guy who appears on video to be stomping 23-year-old Lauren Valle has told reporters that he wasn’t trying to hurt her. Rather, he was trying to hold her down for police and had to use his foot because a bad back prevents him from bending over. Valle told police she was assaulted while trying to take a photo with Paul while holding a fake “employee of the month” award:

“I think that this is an extreme example of the kinds of sentiments that people are feeling in many races across the country,” Valle said. “I think that tension is incredibly high.”

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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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Dr. Wolfe

 

The Food and Drug Administration (FDA) approved Meridia in 1997 despite pre-approval randomized trial evidence of significantly increased blood pressure and heart rate (both risk factors for heart attacks) and despite the opposition of the FDA medical officer who reviewed the drug and the FDA’s advisory committee. Our 2002 petition to the FDA to ban the drug was based on this information and a growing number of post-marketing cases of heart attacks with no other explanation in relatively young patients.

Since then, more than 3 million prescriptions have been filled for Meridia, with many patients inevitably having had heart attacks or strokes because of its known toxicity. Even since January of this year (after our December 2009 re-petition to ban the drug), when the European Medicines Agency decided to withdraw the drug from Europe, there have been more than 160,000 prescriptions filled for Meridia in the U.S.

The FDA’s decision today to ask pharmaceutical maker Abbott to withdraw the drug is commendable, but dangerously too late for all of the victims of its unacceptable risks. It appears that it was banned only because of the rare concordance about banning a drug between FDA’s Office of New Drugs (OND) and FDA’s Office of Surveillance and Epidemiology (OSE), as documented in last week’s Oct. 4 memo from those two divisions to Center for Drug Evaluation and Research Director Dr. Janet Woodcock.

In both of the other cases in which drugs have recently been taken off the market in Europe – Darvon (propoxyphene) and Avandia (rosiglitazone) – OSE also urged a ban in this country but was “overruled” because of the reckless unwillingness of OND or Dr. Woodcock to ban the drugs. Thus, both of these unacceptably dangerous drugs remain on the market in this country, predictably injuring or killing many people, who, unlike their European counterparts, do not have the government protecting them from drugs with no unique benefits, but significant, unique risks.

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

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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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