Sunday, March 22, 2009

The Seroquel Story--There They Go Again

Veteran reporter Shankar Vedantam gave us the main scoop earlier in the week in the Washington Post:

Bottom line--lawsuits over Seroquel causing diabetes and weight gain have revealed internal company documents from AstraZeneca discussing Study 15, released to the FDA in 1997 but never published or publicized. Study 15 showed that Seroquel, a "second generation" antipsychotic, performed no better than its older counterpart, Haldol, but caused considerable weight gain. Study 15 found much the same thing as a larger, publicly funded comparison of the two generations of drugs that was not published till a decade later.

The internal documents show very clearly that it was the opinion of company medical experts that the data from Study 15 were reliable and that, if released, would cause physicians to lose confidence in Seroquel's safety and efficacy. Perhaps the most damning single passage:

Within the company, meanwhile, officials explicitly discussed misleading physicians. The chief of a team charged with getting articles published, John Tumas, defended "cherry-picking" data.
"That does not mean we should continue to advocate" selective use of data, he wrote on Dec. 6, 1999, referring to a trial, called COSTAR, that also produced unfavorable results. But he added, "Thus far, we have buried Trials 15, 31, 56 and are now considering COSTAR."

What I found most intriguing about Vedantam's article was his frank acceptance as a reporter that this story is really pretty ho-hum--that the suppression of unfavorable results is hardly a newsworthy scandal but is rather the normal operating procedure for a major drug firm.

Vedantam mentions in passing that AstraZeneca, at the same time as they were suppressing Study 15, were publicizing aggressively the findings from a study that showed favorable comparisons between Seroquel and Haldol, despite internal documents showing that they thought little of the scientific merit of the latter study. The author of the flawed study was Dr. S. Charles Schulz, now head of psychiatry at the University of Minnesota--a school already rocked with notoriety due to its dean's apparent blase attitude toward industry conflicts of interest. The Minneapolis papers took off after Dr. Schulz:

You have to feel a little bit for Dr. Schulz (who says he has learned his lesson and will no longer take industry funding). AstraZeneca bigwigs were writing memos to each other disparaging his study and its methods--memos that are now released for the world to see. But apparently believing that Schulz was a "KOL" (key opinion leader) on whose good side they wished to stay, the company never shared any of their internal concerns with him--leaving him now holding the bag to defend the integrity of his work against the word of his former corporate sponsors. This in a very small way illustrates the ultimate corruption of science at the hands of commercial forces.

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