| Dr. Jai Maharaj 2005-01-06, 11:09 am |
| NYT - Lilly Shares Fall After BMJ Report About Prozac Documents
Forwarded message from "veracare" <veracare@ahrp.org>
[ Subject: Lilly Shares Fall After BMJ Report About Prozac Documents_NYT
[ From: "veracare" <veracare@ahrp.org>
[ Date: 1 Jan 2005 11:55:52 -0600
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@ahrp.org
http://www.nytimes.com/2005/01/01/b...agewanted=print
http://www.nytimes.com/2005/01/01/b...=print&position
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."
The New York Times
http://www.nytimes.com/2005/01/01/b...print&position=
January 1, 2005
F.D.A. Approves Pfizer Remedy for Nerve Pain From Diabetes
BBloomberg News
Pfizer
http://www.nytimes.com/redirect/mar...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, Mariann 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.
The New York Times
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