Articles Posted in Avandia

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Lots going on in GlaxoSmithKline’s Avandia world. They’ve been wounded but avoided summary execution yesterday when twelve of 33 members voted to allow it to stay on the market, albeit with significant restrictions and black box warnings. See CNN’s article.

One expert cited in the article noted that:

“I don’t have any patients currently taking Avandia,” said Nathan. He stopped prescribing the drug because “it just didn’t make sense,” considering there are alternatives that didn’t carry the potential risk, he said.

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May 6, 2001.

We’ve reported a lot on Avandia this year. It is a drug, manufactured by GlaxoSmithKline (GSK), used to treat type 2 diabetes mellitus. It is being associated with heart attacks and liver failure. There are 13,000 filed lawsuits over the drug, and GSK just settled about half of them, including the case first up for trial this month in Philadelphia.

In May, GSK settled 700 lawsuits to the tune of $60 million. We don’t know how it was divided, but if it were divided equally (no reason to think it was), each plaintiff would have received $85,714.00 in the Avandia settlement. Now, GSK settled approximately 5,000 more Avandia claims. We don’t know the amount, but this represents about 44% of the Avandia cases. Assuming that the amount was consistent with the first settlement, GSK has now paid about $488,569,800, nearly half a billion. As all the analysts say, this puts their expected total exposure at much less than the predicted $6 billion (just as we predicted way back when).

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The medical journal The Lancet is chiming in on the Avandia debacle. Back in 2009, The Lancet published a paper about the RECORD study (funded by Avandia manufacturer GlaxoSmithKline) which was widely criticized. The major complaint is that the article did not include the drop-out rate—without knowing which patients went off the drug, it is impossible to calculate the risk of Avandia-caused heart attacks. Now, The Lancet issued an editorial titled “Strengthening the credibility of clinical research.” It describes briefly the Avandia situation, likening the recent Senate Committee on Finance report to a John Grisham novel: “GlaxoSmithKline (GSK), intimidated researchers and manipulated the scientific process for commercial advantage.”

Here are some “talking points” from the editorial:

  • At a time when some pharmaceutical firms have received record fines for misconduct, the saga of rosiglitazone [Avandia] tests the limits of tolerance
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The Avandia debacle heats up, this time in the medical journal community. The editor of the premier medical journal, The Journal of the American Medical Association (JAMA) has taken other journals to task for their methods of publishing articles. Using the Avandia RECORD study as the example of the conflicts of interest rampant in the medical publishing community, the editor explains “concerns about preserving market share apparently trumped concerns about the potential for causing patient harm.” For the past ten years, JAMA has required:

…at least 1 author must show that she or he “had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Additionally, that author cannot be funded by any commercial funding source. The source for this criterion is the age-old Hippocratic Oath—that physicians, above all else, must do no harm. The JAMA editor understands that when industry pressures are brought to bear, physicians may be (and have been) influenced to in a manner inconsistent with good science. And the result is that people rely on bad studies, and patients take bad drugs with incomplete and faulty information. The editor further recommends that drug study data be freely available to academic researchers.

Not only will the editor’s suggestions (if enacted by other journals) provide a means to double-check data to ensure its quality, but it will provide an extra reason for scientists and researchers to do the right thing from the beginning, and to stay true to the scientific method.

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Copy%20of%20Avandia%20Much%20Ado%20about%20nothing%20Sequel-03-05-10%29.JPGYesterday I clicked a link from @pharmaguy: End-of-Life Warning at $618,616 Makes Me Wonder Was It Worth It, an article in Bloomberg by Amanda Bennett. Don’t read it unless you have 5-10 minutes of quiet time—this is a powerful story.

This story, the story of Amanda Bennett, Terrence Bennett, and their children and doctors and the U.S. healthcare system and drugs and drug companies and life and death raises several issues. It questions whether medical cost spending, much of which occurs in the finals days and weeks of life, is worth it. Ms. Bennett calculates that his seven-year medical bill was $618,616, discounted to $254,176. She notes that:

Would I do it all again? Absolutely. I couldn’t not do it again. But I think had he known the costs, Terence would have fought the insurers spending enough, at roughly $200,000, to vaccinate almost a quarter-million children in developing countries. That’s how he would have thought about it.

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Avandia%20Much%20Ado%20about%20nothing-03-04-10%29.JPGToday’s Washington Times featured commentary by Dr. Gilbert Ross. “When Senators Play Doctor: Risk-mongering can stifle innovation, cost lives.”

Dr. Ross essentially argues that the senators have completely misinterpreted the Avandia data, whether intentionally or not, in order to fulfill their objective of creating an independent drug safety division within, but separate from, the FDA. Perhaps Dr. Ross thinks that’s a bad thing—it’s not clear from his commentary. It seems to me that erecting another level of safety in regulating drugs can only be a good thing. But that’s another blog post.

The criticism boils down to the fact that these are senators—mere politicians—who are sticking their noses where they don’t belong—in areas of science of medicine. Unfortunately, we don’t have a separate job for “scientist politicians” who can this job, so our political system is left having to deal with it as it is. Also, the senators criticizing the FDA’s handling of Avandia are undoubtedly relying on the opinions and conclusions of doctors and scientists, mainly because Dr. David Graham, employed by the FDA (the commentary paints him to be an anti-Pharma crusader—perhaps this is true, but perhaps he just puts patient safety a little higher on his list than others do).

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Avandia-logo-02-24-10.jpgIf my Google Reader subscriptions are any indication, about 50% of the new blog posts across the web in the past couple of days have been about Avandia. This post is intended as a hub for basic information on Avandia and the status of the proposed Avandia recall.

Avandia is used to treat type 2 diabetes mellitus. That type of diabetes, commonly called adult-onset diabetes or non-insulin-dependent diabetes mellitus, is reflected by high blood glucose and insulin deficiency/resistance. Avandia (rosiglitazone), as well as Avandamet and Avandaryl (two drugs combining rosiglitazone with either metformin or glimepiride), is intended to help the body use its natural insulin for better glucose control.

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