posted January 02, 2005 05:48 PM         

Lilly Shares Fall on Report About Prozac Documents
By KEN BELSON
New York Times
Published: January 1, 2005

Shares 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."

AND

Prozac Documents Add To Patients Lack Of Trust In Industry
January 01, 2005

An article published today in the British Medical Journal alleges officials at the Eli Lilly company suppressed drug safety data on Prozac, one of the most popular antidepressant medications prescribed by physicians.

The documents indicate Lilly knew that Prozac could cause suicidal behavior as far back as the 1980's, but never disclosed the safety data to the US Food and Drug Administration.

This latest episode of an alleged pharmaceutical cover-up is adding to the increasing mistrust consumers have for drug companies.

Because the allegations are being made by one of the world's most respected medical journals, this only adds to the speculation that drug companies are putting profits ahead of patient safety.

Eli Lilly denies the allegations, however, the damage to their reputation may never be reversed. Share prices in Lilly fell Friday on the news.

In recent months the pharmaceutical industry has been forced to defend itself as supposedly "safe" drugs have been shown to cause a variety of problems, including Merck's Vioxx, and Pfizer's Celebrex and Bextra.

The BMJ said it turned over the Lilly documents on Prozac to the US FDA.

Although it's too soon to predict the legal ramifications of the documents, most experts at this time don't believe Lilly will face a barrage of lawsuits over the allegations.

Late last year the FDA warned that antidepressants may cause suicidal behavior, agitation, panic attacks, insomnia, and aggressiveness. One expert said the documents obtained by the BMJ provide the "missing link," between the recent FDA warning and what Lilly scientists knew 16 years ago.
http://www.healthtalk.ca/prozac_trust_01012005_2201.php

posted January 03, 2005 04:12 PM         

I agree. I think antidepressants have done alot of good for some people. I know people who wouldnt be here w/o out them. I also think that there is a better way to go, but it can be complicated and take alot of inner work - not an easy road. And definitely not for everyone. So for some people the best thing to do is go on the meds. I think you are on the right track by choosing to take them but also looking at other ways to be able to live w/o them at some point.

I was at one point on Prozac. When I was 17, my mom made me go on them. I've never been a pill person and I stopped taking them one day, which I later found out is very dangerous to do - to just stop. Your supposed to slowly come off of them. I agree that they made me happier but in a weird way. I felt like I was living in a dream world of fake happiness. It made me uncomfortable. I felt drugged and spacey. My opinion is the happiness people seek can only be found within. By getting to the root of the unhappiness - which is a looooong, hard road. I'm not totally against anti-depressants, I think they are a must for some people. I'm glad your experiences have been good on them. You amaze me, Phil. You arent a "poor me" kind of person. Youre out there trying, learning and growing.

A "vortex therapist"?? Wow! Sounds cool. I've never heard of that. Does that have anything to do with balancing chakras? That's what it sounds like. Let me know how it goes.