Sunday, June 03, 2007

Russian roulette is probably safer

Drug companies, the FDA, and some doctors, don't appear to have your health as one of their top priorities. Newsflash.

First up, clinical trials in general:
After Sanctions, Doctors Get Drug Company Pay
Published: June 3, 2007

[NYT article, may require registration to view]
A decade ago the Minnesota Board of Medical Practice accused Dr. Faruk Abuzzahab of a “reckless, if not willful, disregard” for the welfare of 46 patients, 5 of whom died in his care or shortly afterward. The board suspended his license for seven months and restricted it for two years after that.

But Dr. Abuzzahab, a Minneapolis psychiatrist, is still overseeing the testing of drugs on patients and is being paid by pharmaceutical companies for the work. At least a dozen have paid him for research or marketing since he was disciplined.

Medical ethicists have long argued that doctors who give experimental medicines should be chosen with care. Indeed, the drug industry’s own guidelines for clinical trials state, “Investigators are selected based on qualifications, training, research or clinical expertise in relevant fields.” Yet Dr. Abuzzahab is far from the only doctor to have been disciplined or criticized by a medical board but later paid by drug makers.

An analysis of state records by The New York Times found more than 100 such doctors in Minnesota, at least two with criminal fraud convictions. While Minnesota is the only state to make its records publicly available, the problem, experts say, is national.

But we have the FDA looking out for us, keeping up with this, keeping us safe, because that's why the agency was created in the first place, right? Wrong.
Drug makers are not required to inform the agency when they discover that investigators are falsifying data, and indeed some have failed to do so in the past. The F.D.A. plans to require such disclosures, Dr. Woodcock [deputy commissioner and chief medical officer of the Food and Drug Administration] said. The agency inspects at most 1 percent of all clinical trials, she said.

Just a side note, but it looks like Minnesota is a good state to practice in if you're not a very good doctor:
The records most likely understate the extent of the problem because they are incomplete. And the Minnesota Board of Medical Practice disciplines a smaller share of the state’s doctors than almost any other medical board in the country, according to rankings by Public Citizen, an advocacy group based in Washington.

And here, one drug in particular:
Doctor Says Drug Maker Tried to Quash His Criticism of Avandia
Published: June 2, 2007

[NYT article, may require registration to view]

I don't think I'll pick out any quotes from this one, it's difficult to tell from this article whether the drug company suppressed data, or the doctor has an axe to grind because he has some kind of interest in a competing drug. Looks like it could be either or both or some of each, but none of it gives me a warm fuzzy feeling about clinical trials.

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