Prozac Data Kept From Trial

The Boston Globe

Prozac data was kept from trial, suit says

By Mitchell Zuckoff, Globe Staff, 6/8/2000

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.

Although that patent language directly contradicts Lilly's longtime position on Prozac, the Indianapolis-based drug company clearly saw great value in the drug described in the patent.

In December 1998, Lilly paid Sepracor $20 million for exclusive rights to the patent, a portion of which went to Teicher and McLean. Lilly also promised the inventors $70 million in milestone payments depending on the new drug's progress through ongoing clinical trials, and a percentage of sales if the drug is approved and sold.

Three months after that deal was struck, in March 1999, a federal jury in Honolulu began hearing a civil lawsuit Vickery filed on behalf of the two adult children of William and June Forsyth.\

A wealthy couple, married for 37 years, the Forsyths had been going through a rough patch in their marriage in late 1992 and early 1993. William Forsyth, 63, began suffering panic attacks, and in February 1993 his doctor prescribed Prozac. After feeling wonderful the first day, Forsyth underwent a change for the worse and admitted himself to a psychiatric hospital. After a week, while continuing to take Prozac, he checked himself out.

On March 3, 1993, 11 days after he began taking Prozac, Forsyth fatally stabbed his wife multiple times with a serrated kitchen knife then impaled himself on the blade.Their children blamed the drug for what they said were their father's completely uncharacteristic acts.

Of some 200 lawsuits filed against Lilly asserting that the use of Prozac led to suicide or violence, the Forsyth case was only the second to yield a verdict. Lilly settled many of the others, and the only other one to reach a jury, in 1994, was widely reported to have been a victory for the company. In fact, it was settled in a secret agreement between Lilly and the plaintiffs.\

Lilly obtained its long-sought courtroom victory in the Forsyth case when the jury said the drug could not be held responsible for the murder-suicide. In the suit filed yesterday, however, the Forsyths'children say the victory for Lilly was tainted by the failure to disclose its link to the new Prozac patent and should be set aside for a new trial.

A key element of Lilly's defense was its assertion that if Forsyth suffered from the severe form of agitation his children said led to the deaths, he would have experienced inner and outer restlessness. No one at the psychiatric hospital noticed restlessness in Forsyth before his release, and Lilly's lawyers and expert witnesses used that to rebut his children's case.

In the patent, however, the side effect is described purely as inner restlessness, a condition known as akathisia. Vickery said that difference is crucial because, if the patent had been disclosed at the trial, it would have been a powerful answer to Lilly's argument that outer restlessness characterized by relentless fidgeting was required as evidence of the side effect. It also might have challenged Lilly's overall assertions about suicide, he said.\

For instance, a top Lilly scientist, Dr. Gary Tollefson, testified during the trial that it was his opinion ''that there is absolutely no medically sound evidence of an association between any antidepressant medicine, including Prozac, and the induction of suicidal ideation or violence.''

The new patent's language, and Lilly's purchase of exclusive rights to it, might have convinced the jury otherwise, Vickery said.\

Vickery is basing the suit partly on a 1995 ruling by the US Court of Appeals for the 9th Circuit, which includes Hawaii. That case, Pumphrey v. K.W. Thompson Tool Co. of New Hampshire, involved the death of a man who dropped a handgun manufactured by Thompson. The gun fired, sending a bullet through his heart.

The court found that Thompson committed a fraud upon the court by failing to disclose that it had produced a video that showed the same type of gun fired accidentally when dropped. The court said the existence of the video should have been revealed by a Thompson lawyer who knew about it and attended the trial.

Vickery contends that Lilly acted similarly to Thompson because a patent lawyer for the drugmaker attended the Forsyth trial but never disclosed the language on suicide in the patent that Lilly licensed from Sepracor.

This story ran on page A01 of the Boston Globe on 6/8/2000. © Copyright 2000 Globe Newspaper Company.