Lilly Shares Fall After BMJ Report About Prozac Documents_NYT

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ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness and Full Disclosure

www.ahrp.org

FYI

The New York Times reports that Jeanne Lenzer's investigative report in the

current (Jan 1) British Medical Journal, citing Eli Lilly secret documents

showing that company officials knew since 1988 that Prozac increased violent

and suicidal behavior in patients who tested the drug in clinical trials,

has resulted in Lilly stock losses.

Congressman Maurice Hinchey, a member of the Appropriations Committee, which

oversees federal agencies including the F.D.A., said the documents date back

to the 1980's and include memos between Eli Lilly employees: " clearly show

a link between Prozac and actions of violence perpetrated by people taking

the drug against themselves and against others. The documents we have show

that the company was instructing its employees to hide this information.

We're seeing evidence here that it was a conscious act on the part of the

company. "

The FDA has demonstrated an incapacity to bring drug giants into compliance

with safety requirements.

The immoral and illegal conduct by corporate management who concealed

Prozac's hazardous effects resulted in tragic loss of lives. Additionally,

Lilly shareholders will incur substantial losses, as the company will likely

have to pay huge settlement fees to injured patients (and family survivors)

who now have smoking gun evidence of company concealment.

Lilly shareholders-like all corporate shareholders--have significant

leverage they can exercise to bring the company management into compliance

with regulatory and ethical standards. Management's immoral and illegal

conduct may also invite shareholder litigation under the 2002 Sarbanes Oxley

law which reinforces the requirement that companies must provide full and

fair disclosure to shareholders--including disclosure of contingent

liabilities.

Contact: Vera Hassner Sharav

212-595-8974

veracare@...

http://www.nytimes.com/2005/01/01/business/01prozac.html?pagewanted=print

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THE NEW YORK TIMES

January 1, 2005

Lilly Shares Fall on Report About Prozac Documents

By KEN BELSON

SShares in Eli Lilly & Company fell yesterday after an article in a medical

journal suggested that the drug company had long concealed evidence that its

well-known antidepressant, Prozac, could cause violent and suicidal

behavior.

The accusations were made in the Jan. 1 issue of The British Medical

Journal, which said it had turned over documents related to the allegations

to the United States Food and Drug Administration. The F.D.A. was reviewing

the papers, which had been missing for more than 10 years, according to the

Journal article, which said they were originally gathered during a lawsuit

against Lilly on behalf of victims of a gunman in Kentucky who had

reportedly been taking Prozac for a month before going on a rampage.

An F.D.A. spokeswoman, Kathleen Quinn, could not confirm yesterday whether

or not the agency had received the documents mentioned in the medical

journal. But at least one member of Congress said he had obtained copies of

the documents reportedly given to the F.D.A.

In a written response, Eli Lilly said: " To our knowledge, there has never

been any allegation of missing documents " from lawsuits involving Lilly. The

company also said it tried unsuccessfully to obtain copies of the documents

from The Journal.

" Lilly has consistently provided regulatory agencies worldwide with results

from both clinical trials and postmarketing surveillance, " including data

related to Prozac, the company's statement said.

Eli Lilly's stock fell 75 cents, or 1.3 percent, to $56.75.

It is unclear what, if any, action might result from the matter. In October,

the F.D.A. ordered pharmaceutical companies to include " black box " warnings

on the labels of their antidepressants, including Prozac.

The warnings are the strongest restriction the government can impose on

pharmaceutical companies, short of banning a drug.

The warnings state that antidepressants increase the risk of " suicidal

thinking and behavior in children and adolescents. "

British medical regulators have recommended that many antidepressants not be

prescribed for children and teenagers, but had not included Prozac in those

advisories.

Even if the documents do not prompt legal or regulatory action, they could

sully Eli Lilly's image. The company's fortunes have been closely tied to

Prozac.

The company has long defended the drug in the face of legal and medical

challenges and insisted that it has not suppressed relevant information

about the drug.

The report comes at a time of renewed scrutiny of the pharmaceutical

industry and the government's process for approving drugs.

Representative Maurice Hinchey, a Democrat from Kingston, N.Y., and a vocal

opponent of the government's drug approval process, said yesterday that he

had some of the documents cited by the journal article. The congressman, who

is a member of the Appropriations Committee, which oversees federal agencies

including the F.D.A., said the documents date back to the 1980's and include

memos between Eli Lilly employees.

They " clearly show a link between Prozac and actions of violence perpetrated

by people taking the drug against themselves and against others, " Mr.

Hinchey said. " The documents we have show that the company was instructing

its employees to hide this information. We're seeing evidence here that it

was a conscious act on the part of the company. "

Copyright 2005 The New York Times Company

http://www.nytimes.com/2005/01/01/business/01pfizer.html?oref=login & pagewant

ed=print & position=

January 1, 2005

F.D.A. Approves Pfizer Remedy for Nerve Pain From Diabetes

BBloomberg News

Pfizer

<http://www.nytimes.com/redirect/marketwatch/redirect.ctx?MW=http://custom.m

arketwatch.com/custom/nyt-com/html-companyprofile.asp & symb=PFE> Inc. said

yesterday that it had won United States approval to sell its Lyrica pill to

treat nerve pain associated with diabetes and shingles.

The Food and Drug Administration is still reviewing Lyrica as a potential

treatment for seizures in adults, Pfizer said in a statement.

In September, the F.D.A. delayed action on Lyrica until Pfizer provided more

data.

Henry A. McKinnell Jr., the chief executive of Pfizer, which is battling a

sliding stock price and fallout from a study linking the company's Celebrex

painkiller to heart attacks, is counting on new drugs like Lyrica to

increase sales as some of the company's biggest products face competition.

Lyrica is the successor to a Pfizer epilepsy drug, Neurontin, which had $2.2

billion in United States sales in 2003 before generic competitors entered

the market this year.

" Having the product available for most of 2005 is a big positive for the

company, " said Trevor Polischuk, a pharmaceuticals analyst at Orbimed

Advisors in New York, which manages investments, including Pfizer shares.

Pain is the most important indication for Lyrica, with epilepsy being " a

very small opportunity, " Mr. Polischuk said.

Shares of Pfizer slipped 12 cents, to $26.89, in New York Stock Exchange

composite trading.

Diabetes can damage nerves over time, leading to numbness or pain in hands,

arms, feet and legs, according to the National Institutes of Health. Almost

half of the 18 million Americans with diabetes will develop some form of

nerve pain, Pfizer said in a statement.

Worldwide sales of Lyrica as a treatment for pain and seizures may reach

$2.9 billion by 2008, said Sena Lund, an analyst with Cathay Financial in

New York, who has a neutral rating on Pfizer and owns the stock. He did not

have a sales estimate for Lyrica as a pain treatment only, although he said

more than 70 percent of Neurontin's sales come from uses other than

epilepsy.

" The important thing is they got approval, " Mr. Lund said.

Pfizer has not set a date for Lyrica's introduction in the United States or

a price for the drug, a spokeswoman, nn Caprino, said in an e-mail

message. The company won European approval in July to sell Lyrica for

epilepsy and nerve pain.

Lyrica will compete with Eli Lilly & Company's Cymbalta antidepressant,

which the F.D.A. cleared in September as a treatment for peripheral

neuropathic pain. Cymbalta was the first drug in the United States

specifically approved for that use.

Copyright 2005 The New York Times Company

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