Wednesday, July 21, 2010

Docs for Sale: The FDA Advisory Panel on Avandia

Thanks in part to Postscript, I was guided to two articles by Alicia Mundy in the on-line Wall Street Journal:

It appears this story has kept investigative reporter Mundy quite busy in the wake of last week's FDA advisory committee hearings on Avandia. Most of you know from the popular press that the committee voted 20-12 to keep Avandia on the market, though 17 of the 20 favored stronger warning labels or other measures to restrict use of the drug.

First Mundy found out that Philadelphia endocrinologist David Capuzzi, who was one of the three lonely members of the committee to give Avandia a free ride (keep it on the market without any extra warnings), had received $14,750 as a paid speaker from Avandia's manufacturer, GlaxoSmithKline. He argued that he had no conflicts of interest because he never gave any talks specifically about Avandia; instead he spoke about a different GSK drug.

Hardly was the ink dry (metaphorically; I know nobody writes with ink anymore) on that report than Mundy was out there again telling us about Abraham Thomas, head of endocrinology and diabetes at Henry Ford Hospital, Detroit. Thomas had been one of the 12 votes for taking Avandia off the market. He'd given two talks for Takeda, the manufacturer of the diabetes drug Actos, on behalf of that drug and made $2000-3000, between 2007 and 2008. Actos is the rival to Avandia that is the drug most patients are likely to be switched to if their physicians take them off Avandia and look for a similar drug to replace it. Dr. Thomas said he told the FDA all about his Takeda money and noted that the conflict-of-interest screening he'd been put through before this committee met was "extensive."

By way of exploring the dynamics of drug company funding of medical KOLs ("key opinion leaders"), consider what Dr. Capuzzi had to say to Mundy in his own defense. First, he said that even though he had voted in the most pro-Avandia way possible on the panel, he really did not think very much of that drug. He told Mundy "he isn't a fan of Avandia and uses metformin, an older diabetes drug, in his practice." [Hooray! An endocrino9logist, finally, who actually believes that you should treat diabetes patients with a drug that has been well-documented, in controlled studies, to reduce the risks of the serious complications of diabetes; and that's available generically to boot.] So why then did he vote to be so careful not to upset Avandia's role in the marketplace? Well, he said he was worried about Actos. He's worried that the rival drug may also have safety problems, and that switching patients from one to the other would do them no good.

Now, we can note two things about this line of reasoning. First, his opinion about Actos-related dangers is definitely a minority opinion; the panel overwhelmingly voted that Actos was safer than Avandia. Second, a standard industry ploy, when your drug is accused of causing bad side effects and your previous efforts to ward off attention to those effects have all failed, is that as a last-ditch effort you try to claim that so what, all the rival drugs cause the same risks. (That's why we now have a totally ridiculous warning label on Naprosyn claiming that it increases the risks of heart disease, because that was supposed to divert attention from whether Celebrex caused almost as much heart risk as Vioxx.)

Bottom line: Can we prove that Dr. Capuzzi voted the way he did because he was paid by GSK? Of course not. Can we claim a certain association between a doctor taking money from a drug company speaker's bureau, and the doc demonstrating patterns of thought that happen to resemble how industry marketers think about drugs? You be the judge.

Bottom bottom line: What is it going to take to get my fellow physicians, when a drug company waves dollar bills at them and invites them to join the speakers' bureau, to say, "No thanks, who needs that grief"? So that when Alicia Mundy goes to write her next story about unseemly behavior among highly-regarded professionals, she has to go write about lawyers, or politicians, or somebody other than doctors?

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