PFPC Daily - January 14, 2005

Prozac: A class action lawsuit is filed in Montreal

MONTREAL, Jan. 14 /CNW Telbec/ - A class action lawsuit was filed
before the Superior Court in Montreal this morning. Giant drug maker
Eli Lilly is alleged to have withheld vital information on the safety
of Prozac, its flagship drug for years. Yesterday, the Indianapolis
based drug maker completely vindicated the British Medical Journal,
which it had charged earlier this week with misleading its readers,
when it posted a document on its website called Annotations. Eli
Lilly had been invited on numerous occasions to answer whether a
document called Summary of a preliminary analysis of clusters of
adverse events based on pooling data from multiple studies was
authentic and whether it had been released to health authorities
around the world.

Eli Lilly confirmed the authenticity of the document and implicitly
admitted that it had never been released to health authorities,
including the FDA, or anyone else. The document consisted of data
stemming from numerous studies conducted by Eli Lilly and that showed
that Prozac caused activation in 38% of its users compared with 19%
with placebo and 4% for Tricyclic, a then well known drug in the
treatment of depression.

When Eli Lilly representatives attended the FDA hearings on the
safety of Prozac in 1991, they had known the existence of the study
for years but failed to disclose it to the FDA, in the word of the
lead plaintiff's attorney, "lest it should warrant a much stringent
warning on the label of the drug with regard to its safety, thereby
seriously hampering Eli Lilly's efforts to market its new drug as
effective and safe." In the words of Serge Petit of the law firm
Petit Desjardins based in Montreal, Canada, that represents the lead
plaintiff "such a likelihood was looming large since Eli Lilly knew
that if doctors had been made aware that Prozac, back then being
introduced as the new kid on the block, caused activation in 38% of
its users compared with 19% of patients taking a placebo and 4% of
those taking a drug then well known to doctors, Tricyclic, they would
certainly have hesitated before prescribing Prozac. It was nearly a
ten folds increase in activation compared with the other drug they
could prescribe."

The lead plaintiff contends that the reason why Eli Lilly failed to
disclose the document to Health authorities was that it would have
placed another study, that consisted of a pooling of what is called
spontaneous reports and showed alarming increases in suicide attempts
and other violent acts in patient using Prozac as compared with four
other drugs, in a totally new perspective and prevent it from being
dismissed by FDA and Eli Lilly as inconclusive. To Serge Petit "had
the study on activation and the one on spontaneous reports been put
side by side before the FDA, Eli Lilly would have faced an uphill
battle as to the safety of its drug".

The class action contends that Eli Lilly misled health authorities
around the world and therefore the millions of users of its drug
Prozac around the world as to the safety of its drug by failing to
disclose the said document. To Serge Petit, "the passage of time
cannot condone Eli Lilly's behavior and it must be held accountable
for circumventing the safeguards that have been put in place to
protect the public health." The lead plaintiff is seeking $10,000 in
punitive damages and $5 000 for herself and each member of the
group from Eli Lilly for misrepresenting the safety of its drug.

SOURCE:
http://www.newswire.ca/en/releases/archive/January2005/14/c3130.html