December 19

Documents Show Eli Lilly Lied about Zyprexa

Noting the documented evidence spelled out in Alex Berenson's report about
the revelations contained in Eli Lilly's secret documents about the hazards
of Zyprexa and the company's gloss over them, the The New York Times is
calling for congressional hearings.

The fact is, this drug causes far greater health hazards than drugs that
have been pulled from the market–yet Zyprexa is still being marketed.

It is marketed not only for schizophrenia and bi-polar disorder–for which
it was approved– but this drug is being widely prescribed for children and
the elderly. The drug poses life-threatening risks that neither prescribing
physicians nor patients are informed about.

The documented debilitating adverse effects of this drug:
>From its date of approval to July 1999, there were 7,193 spontaneous Adverse
Event Reports involving impaired metabolic function, abnormal blood / sugar,
and hyperglycemia and diabetes melitus;

Following an aggressive marketing campaign (2000) to primary care
physicians, by 2002, there were 31,024 spontaneous reports involving 16,113
cases of such serious adverse events. Those voluntarily submitted reports
comprise but a small fraction of actual events.

As the government funded CATIE study demonstrated that none of the new
neuroleptics–of which Zyprexa is the biggest seller–have any demonstrable
benefits greater than the old, cheap neuroleptics.

The science and the moral medical principle leave no doubt that this harm
producing drug should be removed from the market.

Below see letter to The Times

Contact: Vera Hassner Sharav


December 19, 2006

Playing Down the Risks of a Drug

It was bad enough when studies showed that the newest and most heavily
promoted drugs for treating schizophrenia weren't worth their high cost. Now
the disturbing tale of their excessive use has taken a tawdry turn with
revelations that Eli Lilly, a pharmaceutical giant, has consistently played
down the risks of its best-selling antipsychotic drug, Zyprexa, and has
promoted it for unapproved uses.

The details were spelled out in The Times this week by Alex Berenson, who
drew on hundreds of internal Lilly documents that have surfaced in legal
proceedings. Although Lilly says the documents present an inaccurate
picture, they offer persuasive evidence that the company engaged in
questionable behavior to prop up its best-selling drug, which creates almost
30 percent of Lilly's revenue.

Zyprexa belongs to a class of drugs that were billed as a significant
advance over the first generation of antipsychotic drugs but turned out to
have serious flaws. Zyprexa, for example, has a tendency to raise blood
sugar and to promote obesity, both of which are risk factors for diabetes.
Some 30 percent of the patients taking Zyprexa gain 22 pounds or more after
a year on the drug, with some gaining 100 pounds or more. Yet the documents
show that Lilly encouraged its sales representatives to play down these
adverse effects when talking to doctors.

The documents also show that Lilly encouraged primary care physicians – far
less sophisticated than psychiatrists in treating mental illness – to
prescribe the drug for older patients with symptoms of dementia even though
it was approved only for schizophrenia and bipolar disorder. It is illegal
for companies to promote drugs for unapproved uses, but nearly every major
drug company is under civil or criminal investigation for alleged efforts to
do so.

Lilly contends that it has never promoted Zyprexa for unapproved uses and
has always shown its marketing materials to the Food and Drug
Administration, as required by law. Both claims ought to be tested in
Congressional hearings that should focus on how well the industry complies
with existing laws and how effectively the F.D.A. regulates the industry's
marketing materials.

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