6/10/2000 – Boston Globe carries story on Forsyth suit

http://199.97.97.16/contWriter/yhd7/2000/06/08/medic/8169-0102-pat_nytimes.h
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Eli Lilly Sued By Family Of Prozac User Who Killed Wife, Self

Mitchell Zuckoff
c.2000 The Boston Globe

Opening a new front in the battle over Prozac and suicide, the family 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 in Hawaii, the family of William Forsyth
claims 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 Boston 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 Wednesday, saying
the company had not seen it.

Whatever the outcome, the lawsuit seems certain to fuel a revival of
a 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, Mass. 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 U.S.
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 conflicts of
interest among 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. Lilly derived more than 25 percent of its $10 billion in
revenues last year from the drug.

The lawsuit, filed Wednesday in U.S. District Court in Honolulu,
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, Mass. drug company, along with Dr.
Martin H. Teicher, an associate professor of psychiatry at Harvard University
who works at McLean Hospital in Belmont, Mass.

The patent brought Teicher full circle in the Prozac debate: He had
ignited the decade-long controversy over suicidality 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 claim, 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 claim 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 ultimately 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 the late 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 claiming 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 Wednesday, however, the Forsyths’ children
claim 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 claim that if Forsyth
suffered from the severe form of agitation his children claim 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 refute his children’s case.

In the patent, however, the side-effect is described purely as inner
restlessless, 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 claims 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
(thoughts) or violence.”

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

—-
(The Boston Globe Web site is at http://www.boston.com/globe/

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