Protect Consumer Justice » pharmaceuticals

Conflicts of interest reported for FDA panel that signed off on Yaz birth control drug

jg — Wed, 11 Jan 2012 18:32:48 +0000

Washington Monthly blog: Jeanne Lenzer and Keith Epstein report some members of a U.S. Food and Drug Administration committee of medical experts that looked into the potential dangers of the Bayer birth control pills Yaz and Yasmin had potential conflicts of interest. “[A]n investigation by the Washington Monthly and the British medical journal BMJ has found that at least four members of the committee have either done work for the drugs’ manufacturers or licensees or received research funding from them,” they wrote. “The FDA made none of those financial ties public.”

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FDA advisers recommend stronger warnings for Yaz, Yasmin birth control pills

jg — Fri, 09 Dec 2011 23:28:33 +0000

Washington Post: “A popular new generation of birth control pills should carry stronger warnings about the risks they pose of potentially life-threatening blood clots, federal advisers recommended,” according to Rob Stein. Members of two U.S. Food and Drug Administration committees voted that the current labels on Yaz and Yasmin, both products of Bayer, fail to provide adequate warning about the potential of blood clots. But the committees also voted that “the benefits of the pills in preventing unwanted pregnancies outweighed the risks,” Stein reports.

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Former FDA head says Bayer withheld data about Yasmin

jg — Mon, 05 Dec 2011 22:17:58 +0000

Bloomberg: Former U.S. Food and Drug Administration commissioner David Kessler says in court documents that pharmaceutical giant Bayer withheld information from the FDA that users of the company’s Yasmin birth control pills had increased reports of blood clots. Margaret Cronin Fisk and Jef Feeley report Kessler’s comments about Yasmin were part of expert testimony in a federal lawsuit against Bayer in Illinois. More than 10,000 lawsuits have been filed against Bayer stemming from injuries allegedly suffered by users of Yasmin and its sister product Yaz.

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Yaz contraceptive continues to generate lawsuits

jg — Tue, 12 Jul 2011 00:05:07 +0000

Newark (N.J.) Star-Ledger: The mother of an 18-year-girl who died while taking the birth control pill Yaz, sold by Bayer Healthcare, is among thousands who are “alleging Bayer did not provide adequate warnings about the health risks associated with Yaz, and they are blaming the drug for causing blood clots, heart attacks, strokes and, in some cases, sudden deaths,” according to Susan Todd. A Bayer spokeswoman told Todd, “The lawsuits filed by plaintiffs focus on side effects that are warned about in the labeling for Yaz and Yasmin.”

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Drugmaker agrees to pay more than $1 billion in Paxil settlements

jg — Wed, 28 Jul 2010 20:06:59 +0000

Bloomberg BusinessWeek: “GlaxoSmithKline Plc has agreed to pay more than $1 billion to resolve more than 800 cases alleging its Paxil antidepressant caused birth defects in some users’ children,” according to a Bloomberg report. That brings the total Glaxo has agreed to pay to settle Paxil-related suits to more than $2 billion.

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Jury awards $8 million in Fosamax case

jg — Mon, 28 Jun 2010 22:35:43 +0000

Associated Press: A 72-year-old woman has been awarded $8 million in compensatory damages, Linda A. Johnson reports, from pharmaceutical giant Merck. A New York federal court jury ruled the osteoporosis drug Fosamax is “unreasonably dangerous due to defective design,” leading to Shirley Boles suffering serious pain and disability when her jawbone was destroyed near her ears.

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A (small) victory for medical patients, and ethics

scott — Thu, 24 Jun 2010 17:20:01 +0000

The University of Michigan Medical School has decided that it will no longer accept cash from drug companies to underwrite courses designed to keep doctors’ medical licenses current — a small but welcome step in trying to reduce the influence of Big Pharma over how doctors treat patients.

It would seem to be a no-brainer to keep some distance between the folks who profit from selling drugs and training the doctors in a position to prescribe those drugs, but that’s the way the post-doctoral education system works, the New York Times reports today.

Millions of dollars are involved, which naturally has led to some heated gnashing of teeth over whether doctors sitting through pharmaceutical-financed courses would tend to look kindly on the drug companies’ wares when it comes time to writing prescriptions. From the article:

But Dr. Michael Steinman, an associate professor of medicine at the San Francisco V.A. Medical Center who has studied the use of medical education as a marketing strategy, said that companies face an inherent conflict of interest. “The course providers have a subtle and probably unconscious incentive to put on courses that are favorable to industry because they know where their bread is buttered,” he said.

[...]

Proponents of industry support for such courses point to a few studies in which the majority of doctors who attended the programs reported that they perceived the events to be free of commercial bias.

But Dr. Steinman, who conducted one of the studies, said that related research in social science demonstrates that people who receive gifts often feel obliged to return the favor. “Industry wouldn’t be paying billions of dollars to do this stuff if it didn’t benefit them,” he said.

No kidding. Maybe the medical school leaders need a remedial course in ethics, and the corrupting influence of money.

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