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    Friday, December 31, 2004

    And Now, Prozac: The latest drug to come under fire isProzac:

    Eli Lilly & Co. documents linking the antidepressant Prozac to violence have been turned over to the U.S. Food and Drug Administration by the British Medical Journal, the publication says in its Jan. 1 issue.

    The documents ``appear to suggest a link'' between Lilly's Prozac and suicide attempts and violence, the journal said. The papers ``went missing'' during a product liability lawsuit 10 years ago and were recently sent to the medical journal by an anonymous source, according to the journal's account.

    A jury in 1994 found in favor of Lilly in the lawsuit, brought on behalf of victims of a 1989 workplace shooting. Joseph Wesbecker, who had a long history of depression, killed eight people and himself at a Louisville printing plant in 1989, a month after being put on Prozac.

    The BMJ article describes the missing study:

    One of the internal company documents, a report of 8 November 1988, entitled "Activation and Sedation in Fluoxetine Clinical Trials," found that in clinical trials "38% of fluoxetine-treated patients reported new activation but 19% of placebo-treated patients also reported new activation yielding a difference of 19% attributable to fluoxetine."

    "Activation" refers to increased incidences of anxiety, agitation, and agressiveness. People experience depression in different ways - some mostly as anger, some as anxiety, some as suicidal despondency. It's difficult to sort out whether or not the increase in motivation to act on those feelings is due to the anti-depressant working - just improving things enough to improve motivation to but not wiping out the anger, anxiety, or suicidal thoughts - or how much of it is due to the chemistry of the drug:

    Dr Joseph Glenmullen, a Harvard psychiatrist and author of The Antidepressant Solution, published by Free Press, said it should come as little surprise that fluoxetine might cause serious behavioural disturbances, as it is similar to cocaine in its effects on serotonin.

    The SSRI's like Prozac still remain much safer than than the older anti-depressants, and it would be a terrible shame to lose them. But Eli-Lilly's behavior, as described in the BMJ seems reprehensible:

    The plaintiffs in the Wesbecker product liability sought to show that Eli Lilly withheld negative study data from the FDA and that fluoxetine tipped Wesbecker over into a homicidal rage. Lilly won a 9 to 3 jury verdict in late 1994 and subsequently claimed that it was "proven in a court of law... that Prozac is safe and effective."

    The trial judge, Justice John Potter, suspecting that a secret deal had been struck, pursued Lilly and the plaintiffs, eventually forcing Lilly in 1997 to admit that it had made a secret settlement with the plaintiffs during the trial. Infuriated by Lilly's actions, Judge Potter ordered the finding changed from a verdict in Lilly's favour to one of "dismissed as settled with prejudice," saying, "Lilly sought to buy not just the verdict but the court's judgment as well."

    David Graham, currently associate director in the FDA's Office of Drug Safety, criticised the analysis of post-marketing surveillance data submitted by Lilly to the FDA. After discovering that Lilly failed to obtain systematic assessments of violence and had excluded 76 of 97 cases of reported suicidality, Dr Graham concluded in a memo dated 11 September 1990 that "because of apparent large-scale underreporting, [Lilly's] analysis cannot be considered as proving that fluoxetine and violent behavior are unrelated."

    An FDA advisory panel was convened in 1991 to review the fluoxetine data. It concluded that fluoxetine was safe despite the concerns raised by Dr Graham and others, leading critics to point out that several of the panellists had financial ties to Eli Lilly.

    ...Dr Kapit, the original reviewer for fluoxetine, told the BMJ, "If we have good evidence that we were misled and data were withheld then I would change my mind [about the safety of fluoxetine]. I do agree now that these stimulatory side effects, especially in regards to suicidal ideation and homicidal ideation, are worse than I thought at the time that I reviewed the drug."

    A lot of this current mess could have been avoided if the companies making these drugs had been more upfront with their findings a decade and more ago. The drugs probably would have been approved, but with warnings about the potential side effects. It's the lack of transparency that chafes so.


    posted by Sydney on 12/31/2004 10:13:00 AM 0 comments


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