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Untitled Document

Hinchey Calls On FDA To Immediately Investigate Prozac Documents

Washington, D.C.  - Deeply concerned over documents he was given by the British Medical Journal (BMJ) indicating that Eli Lilly & Company has long known of a potential link between its anti-depressant medication, Prozac, and increased rates of suicide and violence, Congressman Maurice Hinchey (NY-22) yesterday called on the FDA to launch an immediate investigation.  Hinchey said that the recent revelations raise serious concerns as to when Eli Lilly and the FDA knew of these increased risks and why no action has been taken to alert the public.

Following, is the text of Hinchey's letter to FDA Acting Commissioner Lester Crawford:

January 5, 2005

Dr. Lester Crawford
Acting Commissioner
Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857

Dear Commissioner Crawford:

During the past week, there have been several news reports about Eli Lilly and Co. documents, dating back to the mid-1980s, that discuss a possible link between Prozac and increased suicidality. The British Medical Journal sent me copies of these documents and it is my understanding that BMJ sent copies to FDA as well. There are conflicting reports as to whether all of these documents, and the information they contained, were previously available to FDA.

Before going further, it is important to note that the documents in question were uncovered during the discovery process of product liability lawsuits like those your former Chief Counsel, Daniel Troy, had sought to shut down. Your agency has been criticized lately for being too close to the drug industry and I have shared in that criticism. There is no better example of these allegations than the actions of Mr. Troy, who filed unsolicited court briefs on behalf of pharmaceutical companies being sued by injured patients. This would eviscerate the public's, as well as FDA's, ability to access previously undisclosed information that may be vital to the public interest. We are fortunate that this was not FDA's policy at the time of the Fentress trial and others.

In September, FDA "directed manufacturers of all antidepressant drugs to revise the labeling for their products to include a boxed warning and expanded warning statements that alert health care providers to an increased risk of suicidality (suicidal thinking and behavior) in children and adolescents being treated with these agents, and to include additional information about the results of pediatric studies. " This decision, while welcomed by many, was long delayed.

The documents I have received raise several critical questions about what FDA and Eli Lilly may have known about a potential relationship between Prozac and increased suicidality thirteen or more years ago. They include adverse event reports that indicate Prozac may have had a far higher rate of suicide and violent acts than those for four other commonly used antidepressants in the 1980s and early 1990s. For example, according to one adverse event report chart, 3.7 percent of fluoxetine (Prozac) reports, which totaled 14,198, were suicide attempts.  This rate is nearly five times higher than that of Amtriptuline, which had the next highest suicide rate, as well as more than 12 and 18 times the rates of Desipramine and Trazodone respectively.  One Eli Lilly document, entitled "Activation and Sedation in Fluoxetine Clinical Trials" describes how fluoxetine (Prozac) had an activation rate (38 percent) twice that of a placebo (19 percent).

Given this information and the fact that increased activation has recently been considered as a cause for increased suicidality, I call on you to initiate immediately an investigation into this matter to determine the following:

1. Did FDA have every single one of the Eli Lilly documents regarding Prozac that BMJ provided recently to your agency and was it aware of all the issues raised in those documents?

2. If yes, what was FDA's response to the information contained in these Eli Lilly documents, in particular the 38 percent activation rate I referred to earlier?

3. If no, why do you believe that Mr. Troy's attempts to shut down product liability cases, which may bring to light undisclosed, yet critically important health information, to be in the best interests of FDA and the public health?

4. Was FDA aware of the adverse event reports denoting significantly higher suicide and violent act rates for Prozac than those of other commonly used antidepressants in the mid 1980s and early1990s?

5. If yes, what was FDA's response to this information?

6. Do these documents reveal any new information that requires a response from FDA or Eli Lilly?

Thank you for your attention to these concerns. I look forward to receiving your prompt response.

Maurice D. Hinchey

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