Belson, Ken. "Lilly Shares Fall on Report About Prozac Documents," New York Times, 1

 

Belson, Ken. "Lilly Shares Fall on Report About Prozac Documents," New York Times, 1
January 4005, p. C2.

Shares of Eli Lilly and 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 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 as 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 said.

Ely 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
antidepresssants, including Prozac.

The warnings are the strongest restriction the government can impose on pharmaceutical
companies, short of banning a drug.

The warnings state the antidepressants increase the risk of "suicidal thinking and behavior in
children and adolescents."

British medical regulators have recommended that many antidepresssants not be prescribed for
children and teenagers, but had not included Prozac in those advisories.

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 hid this information. We're seeing
evidence here that it was a conscious act on the part of the company."