Internal Eli Lilly documents link fluoxetine and suicide

Indianapolis drug manufacturer Eli Lilly is on the defensive after the British Medical Journal claimed last week it had been sent documents proving the company has known for more than 15 years of an alarming link between fluoxetine (Prozac) and akathisa, a drug-induced insanity that manifests in suicide, aggression, hostility, hatred and rage. Eli Lilly is under fire after allegations of its unethical handling of Prozac.

According to the BMJ, the documents they received from an anonymous source include internal company memos indicating Lilly officials sought to minimize troubling clinical trial results. One document reportedly states the risk of akathisa was 19 percent greater in patients taking fluoxetine compared to those taking a placebo.

The BMJ claims the documents originally disappeared during a 1994 lawsuit brought on behalf of victims of Louisville resident Joseph Wesbecker who shot and killed eight co-workers and injured 12 others before turning the gun on himself in 1989. Wesbecker had been prescribed Prozac one month before the shootings occurred.

Lawyers have long searched for evidence that would prove Lilly knew Prozac increased the risk of suicide. Without it, they have never won a case against the pharmaceutical company - though at least 50 cases have been settled between plaintiffs and the drug manufacturer.

The Wesbecker case also included a cash settlement.

During the trial, Lilly negotiated a deal reportedly worth $25 million in return for the plaintiff's attorneys to withhold evidence of Lilly's 1985 guilty plea to 25 criminal counts for failing to tell the FDA about instances of death and violence that occurred in patients taking the arthritis drug Oraflex. The deal also required the plaintiffs not to seek punitive damages or appeal the case if Lilly won.

After the jury acquitted Lilly, trial Judge John Potter became suspicious. When he learned of the $25 million payment, the judge pushed all the way to the Kentucky Supreme Court in order to have the ruling in the case changed from an acquittal to a settlement. The change in the ruling prevented Lilly from using a court victory to bolster its claims of Prozac's safety.

In response to the allegations published in the BMJ, Eli Lilly officials released this statement on Dec. 31: "There has never been any allegation of missing documents from the Wesbecker trial."

That, however, is not entirely true.

In 1995, 28 boxes of Prozac documents from the Wesbecker trial were ordered to be put in a Chicago federal repository so attorneys in a consolidated federal lawsuit could share them. For 18 months the whereabouts of the documents were supposedly unknown until Lilly reluctantly provided them in November of 1996, claiming they were doing it as a cautionary measure rather than at the request of the judge.

Last week's press release also states, "It has always been Lilly's objective to publicly disclose data about both the safety and efficacy of fluoxetine."

This, too, is not entirely accurate.

In September of 1990, FDA Chief of Epidemiology Dr. David Graham, who garnered national headlines in late 2004 as an FDA whistleblower, wrote that Lilly's research trial information was unreliable and encouraged an FDA hearing on Prozac's safety.

In an internal FDA memo, Graham wrote, "Because of apparent large-scale underreporting, [Lilly's] analysis cannot be considered as proving that fluoxetine and violent behavior are unrelated."

Graham's memo was in response to a study citing no significant difference in suicidal behavior in patients treated with fluoxetine compared to those receiving other antidepressants.

An FDA panel conducted an investigation into the link between violent behavior and fluoxetine in 1991. But as Graham pointed out in congressional testimony last fall, the relationship between the FDA and drug manufacturers quite often creates a conflict of interest.

Before the hearing began, the FDA disclosed that a number of members had financial conflicts of interest. One member had grants pending from Eli Lilly, and had received nearly $4 million in research grants from drug manufacturers in the five years prior to the Prozac hearings. Another panel member had been paid by Eli Lilly to make speeches about the drug's benefits and safety.

At the end of the hearings, the FDA panel voted 10-0 that there was no evidence linking fluoxetine to violent or suicidal behaviors.

Their position has since changed.

In September of last year, the FDA began requiring makers of antidepressants to put a "black box" warning about suicide on the label.

The label comes after several studies concluded that antidepressants increase the risk of suicidal thinking and behavior in children and adolescents.

Eli Lilly fought against a warning label for Prozac for well over a decade, all the way back to the tenure of then senior vice president of corporate strategy and policy, Mitch Daniels, who told The Indianapolis Star in April 2000 there was "no way Lilly would put an explicit warning about suicide and violence on Prozac labeling because it'd be inaccurate and it'd be misunderstood."

Daniels also boasted "mountains of medical studies that testify to Prozac's safety have become Himalayas." Those Himalayas might prove to be molehills if the BMJ report is accurate. FDA officials and members of Congress are already calling for a full-scale investigation.

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