January 5, 2005 - "Lilly today confirmed, after reviewing a collection of Prozac documents that had been alleged 'missing' in the January 1 issue of the British Medical Journal (BMJ), that the documents reveal no new clinical or scientific information. The information in the documents has already been shared with the U.S. Food and Drug Administration (FDA) and other regulatory bodies, published in medical journals or produced through legal discovery and available for use at various legal trials for more than a decade. Lilly received these documents yesterday evening, not from the BMJ, but from the office of Congressman Maurice Hinchey (D-NY), who had been provided the documents by the BMJ."

Once you tread the first 4 pages of the document in question, a few things come to mind. Let's say Eli Lilly did disclose all of the data in this document over the years.

It means Prozac is not safe and never has been safe to use. In Eli Lilly's own words, they documents are real. Eli Lilly just claims they were never hidden or removed. Even if this is true, now we have all of the data in one place and it is very clear to see Prozac is not safe.

Click here to read the clinical trial information that has been missing for 15 years. Requires PDF on your computer to open. (Also opens new browser window)

Jan. 13, 2005. Eli Lilly now comes out and states what was released regarding Prozac is not true! Can the truth please stand up?

I do have a feeling a press release is forthcoming from U.S. Rep. Maurice Hinchey, D-N.Y.

What will this mean for Eli Lilly?

Their public relations executive that gave their statement will be fired. This statements admits Prozac is not safe and the data in the document is true.

Eli Lilly will lose billions of dollars in their company value with their stock plummeting.

Eli Lilly will eventually try and put the blame on some rogue executive or person within their company for the misplacement of these documents.

The FDA is under too much internal and external pressure to bail Eli Lilly out again.

Lawsuits will number in the millions regarding Prozac.

Other people working for the pharmaceutical firms will want to come clean and also free their heart and soul of the guilt they have lived with for many years knowing of other yet to be disclosed data and come fourth.

Scientist within the FDA will start coming clean.

An amnesty will be offered to pharmaceutical firms and employee's to disclose what they know or face criminal prosecution.

Does the above seem far fetched? Print this page and cross each item as it comes to pass.

Jim Harper
 

Eli Lilly and Co. offered proof Tuesday that a batch of Prozac documents given recently to a British medical journal have not been kept secret from government regulators, doctors and trial attorneys.

The 60 pages of documents, which date to the early 1990s, discuss rates of suicide and agitation among users of Prozac, Lilly's once best-selling antidepressant that went on the U.S. market in 1988.

"The information in the documents has already been shared with the U.S. Food and Drug Administration and other regulatory bodies, published in medical journals or produced through legal discovery and (made) available for use at various legal trials for more than a decade," the Indianapolis drugmaker said in a statement.

The BMJ, formerly called the British Medical Journal, reported last week that it had been given the documents by an unnamed source. The journal quoted an FDA official saying that he didn't think that one of the documents, an early 1990s review of suicide rates among Prozac users, had been submitted to the FDA.

Lilly noted that the documents bore a stamp indicating they were used in a 1994 trial. Lilly also said the suicide rate study was widely available because it was published in the Journal of Clinical Psychopharmacology in 1992.

The study, by an unnamed Lilly author, tracked 14,198 Prozac users from 1982 to 1991 and found that 3.7 percent of them, or 519 patients, attempted suicide. That was a far higher rate of suicide attempts than among patients tracked who were using older antidepressants, called tricyclics.

Lilly's policy "is to make available to regulatory bodies, healthcare professionals and patients important safety and efficacy information related to Prozac as well as other Lilly medicines," the company's chief medical officer, Dr. Alan Breier, said in a statement.

"Lilly is greatly concerned that a reputable medical journal has relied on an anonymous source and published data without validating the information at hand or conducting standard peer review," he said.

The free-lancer who wrote last week's BMJ story, Jeanne Lenzer, said "there is a question what the FDA saw" of the documents the BMJ was given. "That's why we handed it over to the FDA," she said of the cache of documents.

Lenzer said Lilly "may have presented in piecemeal fashion bits and pieces" of the documents that portrayed the higher suicide rate among Prozac users. But "at some point it appears they effectively disappeared" from public view, she said.

The journal also gave copies of the documents to U.S. Rep. Maurice Hinchey, D-N.Y., a frequent critic of the FDA, who in turn made the documents available this week to the media and Lilly.

The suicide rate study that the BMJ article cited was handed over to plaintiffs' attorneys in a 1994 trial in which Lilly faced allegations that Prozac drove a Louisville, Ky., pressman to open fire on co-workers and shoot himself.

"That (document) obviously wasn't missing because it was used in the trial," said one of the plaintiffs' attorneys, Nancy Zettler, a Chicago area lawyer.

But Zettler said she concluded, after studying numerous Lilly documents as part of the 1994 trial, that Lilly "absolutely" wasn't forthcoming to the FDA about issues involving Prozac and suicide.

The 1994 trial ended with a jury absolving Lilly of guilt in the deaths.

Zettler inherited several hundred boxes of Lilly documents from the trial and additional Prozac cases and still oversees their storage in a Chicago area warehouse, where they are available to attorneys suing Lilly over Prozac.

Hinchey plans to ask the FDA to review the documents he got from the BMJ to see if Lilly properly submitted them for agency review, said Jeff Lieberson, a spokesman for the congressman.

"We're trying to figure out exactly what was made public," said Lieberson.

FDA spokeswoman Cindy Fitzpatrick said Wednesday the agency had received the documents from BMJ but had not yet completed a review of them.

Lilly recently set up the first publicly accessible Web site by a major drugmaker that contains all clinical trial study results for its marketed drugs.

Lilly's move came after other drugmakers were faulted for withholding publication of studies that showed their drugs weren't as safe or effective as hoped.

Prozac has become a minor drug for Lilly in the past two years after losing its U.S. patent protection, which allowed cheaper generic products to take over the market.

The Associated Press contributed to this story.

Call Star reporter Jeff Swiatek at (317) 444-6483.

FAIR USE NOTICE: This may contain copyrighted (C ) material the use of which has not always been specifically authorized by the copyright owner. Such material is made available for educational purposes, to advance understanding of human rights, democracy, scientific, moral, ethical, and
social justice issues, etc. It is believed that this constitutes a 'fair use' of any such copyrighted material as provided for in Title 17 U.S.C. section 107 of the US Copyright Law. This material is distributed without profit.