Monday, January 17, 2005

Curiouser and Curiouser - the Case of the Allegedly Missing Prozac Documents

The case of the BMJ news article about missing Prozac documents, which we have discussed before, just gets curiouser and curiouser.
Today, the NY Times published a news article that seems to suggest something big went wrong at the BMJ. "Dispute Puts a Medical Journal Under Fire," by Barry Meier, asserted "the staid, usually methodical world of medical journals could suffer its own black eye," and that "the incident may prove to be a messy one for the BMJ."
But Meier produced little evidence to support these apparently quasi-editorial conclusions.
Let's go back to the original BMJ article. Its key assertions were that
"confidential drug company documents ... went missing during a controversial product liability suit more than 10 years ago;" "the documents appear to suggest a link between the drug fluoxetine (Prozac), made by Eli Lilly, and suicide attempts and violence;" and "Eli Lilly officials were aware in the 1980's that fluoxetine had troubling side effects and sought to minimise their likely negative effects on prescribing."
Meier's NY Times news article reported that Eli Lilly vigorously contested the content of the BMJ article. Specifically, its lawyers "notified the publication that the company considers the article to be 'inaccurate and defamatory,' asserting that the records were not missing and that all their relevant data had been previously submitted to the FDA. Also, Lilly issued an analysis last week of the 52 pages of records that the BMJ had received, which the company said supported its claims." Yet Meier's article does not give any specifics of how Lilly disputed the main points of the BMJ article. So apparently Meier concluded that the BMJ deserved a "black eye" just because Lilly did not agree with it. Why he seemed to think that Lilly was right and the BMJ was wrong, especially without seeing the documents in question, is not clear.
Furthermore, other statements by Lilly, available on its web site, muddy things further.
Lilly's press release of January 4, 2005, asserted that the "documents reveal no new clinical or scientific information," and that "the information in the documents has already been shared with the U.S. Food and Drug Administration (FDA) and other regulatory bodies, published in medical journals, or produced through legal discovery and available for use at various legal trials for more than a decade." Of course, this did really address the BMJ's assertion that specific documents went missing. Furthermore, information produced through legal discovery may not be sufficiently available to physicians to affect their prescribing decisions.
The second Lilly press release of January 13, 2005, contains an assertion by Lilly CEO Sidney Taurel that "it is simply wrong to suggest that information on Prozac was ever missing or that important research data on the benefits and possible side effects of the drug were not available to doctors and regulators." Lilly complained about "the media reports stating that Prozac is 12 times more likely to cause suicide than other, older antidepressants" as "patently false." The BMJ news article, however, contained no such claim. Taurel's statement seems to be an attempt to declare guilt by association. (Perhaps Taurel was referring to a document posted by CNN that purports to show a suicide attempt rate of 3.7% for fluoxetine vs. 0.8% for amitryptiline, and 0.2% for trazadone.)
More curiously, the press release stated "Lilly is calling on the BMJ to make the full documents available to the media and other interested parties." However, in its accompanying "analysis", Lilly itself declined to make the actual documents public, stating "due to court orders requiring confidentiality of some of the documents contained within the 52 pages, Lilly is unable to relsease the 52 pages of documents." But then did Lilly mean to call on the BMJ to violate a court order? This statement, of course, also contradicts Sidney Taurel's assertion that all relevant information in the documents was freely available to doctors and regulators. How were doctors supposed to access information that was rendered "confidential" by court order?
Thus, there is nothing I can find so far in Lilly's media barrage that refuted the claim made by the BMJ news article that Lilly had tried to prevent data on adverse effects of fluoxetine from affecting doctors' prescribing decisions. And I cannot figure out why a NY Times reporter decided that it was the BMJ, not Lilly, who figuratively earned a "black eye."
Finally, let me state again, we should not let smoke and mirrors distract us from the fundamental issue that suppressing and/or obfuscating information about adverse effects of drugs is bad for patients, bad for doctors, bad for science, and bad for society.

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