Boston Globe
June 6, 2000
By Mitchell Zuckoff

Opening a new front in the battle over Prozac and suicide, the children of a man who killed his wife then himself while taking the drug are accusing Eli Lilly and Co. of fraud for allegedly concealing damaging details about its blockbuster antidepressant.

In a federal lawsuit filed yesterday in Hawaii, the family of William Forsyth says that Lilly "committed a fraud on the court" by failing to tell the family's lawyers about a patent that claims a new version of the drug eliminates side effects of the existing Prozac, including violent and suicidal thoughts among a small percentage of users.

Despite consistently denying any link between Prozac and suicide, Lilly has purchased an exclusive license to market the new drug from a Massachusetts company that owns the patent.

The suit says Lilly actively concealed the potentially explosive patent language during a trial last year over Prozac's alleged role in the couple's deaths. The trial ended with a verdict in Lilly's favor; the family has appealed.

"Lilly wanted a verdict that it could herald in the marketplace as being the definitive vindication of their claims, and they were willing to get it by withholding important information from the judge and jury," said Houston lawyer Andy Vickery, who represents the dead couple's adult children.

Vickery said he decided to file the lawsuit after reading a May 7 report in the Globe in which the patent language for the new drug was publicly disclosed for the first time.

A spokesman for Lilly declined comment on the suit yesterday, saying the company had not seen it.

Whatever the outcome, the lawsuit seems certain to fuel the longstanding dispute over the Indianapolis drug company's efforts to blunt criticism of the popular antidepressant, a green-and-white capsule that has earned the company billions of dollars and become a totem of modern life.

"To me the new patent can be compared to the tobacco papers. It's a pharmaceutical company document that acknowledges this dangerous side effect which has been downplayed by Eli Lilly and other pharmaceutical companies for a decade," said Dr. Joseph Glenmullen, a Cambridge psychiatrist whose new book, "Prozac Backlash," has helped to trigger the renewed controversy.

Lilly has built its defense of Prozac on a 1991 finding by the federal Food and Drug Administration that there is no credible evidence linking Prozac to suicide. Glenmullen and others have challenged that finding, alleging it was based on flawed clinical testing and marred by alleged conflicts of interest held by several members of the FDA's panel of outside experts.

Though sales have slipped somewhat in recent years as other antidepressants entered the market, more than 35 million people worldwide have taken Prozac, and Lilly derived more than 25 percent of its $10 billion in revenues last year from the drug.

The lawsuit also focuses attention on the new drug, which Lilly hopes will extend its antidepressant franchise after the last Prozac patents expire in 2004.

The key patent for the new drug was obtained in 1998 by two officials at Sepracor Inc., a Marlborough-based drug company, along with Dr. Martin H. Teicher, an associate professor of psychiatry at Harvard who works at McLean Hospital in Belmont.

The patent brought Teicher full circle in the Prozac debate: He had ignited the decade-long controversy with a 1990 paper about sudden, self-destructive tendencies among patients who had recently begun taking Prozac.

The patent describes an antidepressant derived from Prozac that, the inventors assert, is formulated in such a way as to decrease the current drug's adverse effects, ranging from headaches and nervousness to "intense violent suicidal thoughts and self- mutiliation." That assertion is based on Teicher's paper.

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