Could Avandia be the drug industry’s ReGen?
The New York Times reported Tuesday that for over a decade, GlaxoSmithKline hid the results of its own study that showed its diabetes drug Avandia “provided clear signs that it was riskier to the heart.”
The Food and Drug Administration ultimately approved Avandia. But in 2007, a doctor at the Cleveland Clinic published a study questioning the drug’s safety after reviewing information the company was forced to disclose in a lawsuit.
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And in February, a pair of FDA reports concluded that type 2 diabetes patients taking Avandia needlessly suffer heart attacks and heart failures every month because of the drug. One FDA report recommended the agency withdraw the drug from the market immediately.
GlaxoSmithKline’s behavior is bad enough; but the FDA (once again) looks even worse.
From the NYT story:
According to the documents, Dr. John Jenkins, director of the agency’s office of new drugs, who has argued internally that Avandia should remain on the market, briefed the company extensively on the agency’s internal debate.
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In the deposition, Dr. Rosemary Johann-Liang, a former supervisor in the drug safety office who left the FDA after she was disciplined for recommending that Avandia’s heart warnings be strengthened, said of Dr. Jenkins’ conversations with GlaxoSmithKline: “This should not happen, and the fact that these kind of things happen, I mean, I think people have to make a determination about the leadership at the FDA.”
Ouch.
If all this sounds vaguely familiar, it should. In March, the FDA said ReGen Biologics Inc. failed to produce adequate evidence that its Menaflex knee implant was safe before it was cleared to hit the market in late 2008.
Alerted to the ReGen case by whistle-blowers, Congress harshly criticized the FDA, which eventually concluded that political figures pressured the agency into approving Menaflex over the objections of its staff scientists. The FDA is weighing whether to revoke its approval of Menaflex.
The ReGen episode arguably led to the resignation of Dr. Dan Schultz, the agency’s medical device chief whom critics accused of being too pro-industry. The medical device community, especially in Minnesota, suspect the ReGen case has made the FDA too risk averse and fear the agency might alter or even scrap the popular 510(k) approval process.
Let’s see. With both ReGen and Avandia, companies withheld information from the FDA. The agency approved the products despite serious objections from its own staff. Whistle-blowers emerged. And a top FDA official was seen as too chummy with the companies.
And now we have two high-profile cases this year in which the FDA must decide whether to pull a product after it approved it. An FDA review panel is meeting today and Wednesday to determine Avandia’s future.
Drugs and medical devices, of course, are two separate industries. But at this point, I don’t think you can overestimate the collective mood circulating in Washington these days. Thanks to ReGen, the FDA is understandably sensitive about the perception, rightly or wrongly, that the agency is not doing enough to protect safety.
Avandia certainly does nothing to refute that perception.
