Missing Eli Lilly and Co Documents Suppressed Prozac’s Violent and Suicidal Side Effects

[GFirmer]

When did the event happen?
1990

Describe what happened.
In 1990 Lilly was accused that Prozac caused suicidal or homicidal tendencies, but the company said there were no clinical evidence to support the charges. British Medical Journal obtained and sent to the FDA internal Lilly documents that the company suppressed the troubling side effects of Prozac back in the 1980s involving suicide and violence

After the US food and drug administration reviewed eli lilly documents handed over by the BMJ(who received it from an unknown source). The memos appeared to suggest that the officials were aware of the side effects back in 1980 and sought to minimise their likely adverse effect on prescribing.

The documents received by the BMJ reportedly went missing during the 1994 Wesbecker case that grew out of a lawsuit filed on behalf of victims of a work-place shooting in 1989. In 1989 Joseph Wesbecker, who shot eight colleagues dead, wounded 12 more and then killed himself. Mr Wesbecker had a history of depression and was prescribed Prozac a month before the shootings.

Criminal lawyers, used what became known as the Prozac Defense—the argument that individuals accused of committing murder while they were using the drug should not be held legally responsible for their actions.
Dr Richard Kapit, the FDA clinical reviewer who approved fluoxetine, said he was not given the Lilly data. “These data are very important. If this report was done by Lilly or for Lilly, it was their responsibility to report it to us and to publish it.”
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.”
Justice John Potter(the trial judge) 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.”
Lilly was hit with a series of multimillion-dollar lawsuits.

David Graham, (associate director in the FDA's Office of Drug Safety) criticised the analysis of post-marketing surveillance data submitted by Lilly to the FDA. Turns out Lilly failed to obtain systematic assessments of violence and had excluded 76 of 97 cases of reported suicidality, In 11 September 1990 he noted “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 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.
Lilly declined to be interviewed but issued a written statement saying, “Prozac has helped to significantly improve millions of lives. It is one of the most studied drugs in the history of medicine, and has been prescribed for more than 50 million people worldwide. The safety and efficacy of Prozac is well studied, well documented, and well established.”

How did this affect the accessibility of the medicine?
Since Eli Lilly and co are the largest producers of Fluoxetine and it’s products are sold in 125 countries with 60 million prescribed, there are clearly a lot of customers. After the company suppressed their side effects, including violence and suicidal thoughts there were a downfall to their sales. This decreased the accessibility as many customers questioned the brand’s reliability and safety to purchase and consume the product. Despite the controversy, FDA’s advisory panel in 1991 reviewed the fluoxetine data and concluded that fluoxetine was safe, so Eli Lilly’s Prozac is still in use and as effective.

Reference.
none