PROZAC: Patients 12 times more likely to commit suicide: CNN

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Wed, 5 Jan 2005 21:13:39 -0500

 

[sSRI-Research] PROZAC: Patients 12 times more likely to

commit suicide: CNN

 

 

 

http://money.cnn.com/2005/01/04/news/fortune500/prozac/

 

Document may reveal Prozac risk

Company apparently knew in 1988 that patients were more than 12 times

as likely to commit suicide.

 

January 4, 2005: 9:26 AM EST

By CNN Newsdesk Editor Tom Watkins

 

ATLANTA (CNN) - An internal document purportedly from Eli Lilly and

Co. appears to show that the drug manufacturer had data more than 15

years ago showing that patients on its antidepressant Prozac were far

more likely to attempt suicide and show hostility than patients on

other antidepressants.

 

The document also suggests that the company attempted to minimize

public awareness of the side effects.

 

The document, made public Monday, was provided to CNN by the office of

Rep. Maurice Hinchey, D-N.Y., who has called for tightening FDA

regulations on drug safety.

 

" The case demonstrates the need for Congress to mandate the complete

disclosure of all clinical studies for FDA-approved drugs so that

patients and their doctors, not the drug companies, decide whether the

benefits of taking a certain medicine outweigh the risks, " he said.

 

The 1988 document indicated that 3.7 percent of patients attempted

suicide while on the blockbuster drug, a rate more than 12 times that

cited for any of four other commonly used antidepressants.

 

The document, which cited clinical trials of 14,198 patients on

fluoxetine -- the generic name for Prozac -- also stated that 2.3

percent of users suffered psychotic depression while on the drug, more

than double the next-highest rate of patients using another

antidepressant.

 

In addition, the paper said that 1.6 percent of patients reported

incidents of hostility -- more than double the rate reported by

patients on any of four other commonly used antidepressants.

 

The trials reviewed in the document said that 0.8 percent of users of

Prozac reported causing an intentional injury -- eight times the rate

associated with any of the other antidepressants.

 

In the paper, titled " Activation and sedation in fluoxetine clinical

trials, " the authors said that the drug may produce nervousness,

anxiety, agitation or insomnia in 19 percent of patients, and sedation

in 13 percent of patients.

 

The paper, apparently produced by the drug company's marketing

department, said " several suggestions may be helpful in presenting

this information to physicians, " including emphasizing that more

patients on another class of antidepressants stopped taking their

drugs than did those on Prozac.

 

Murder, theft and deals

 

 

The existence of the document obtained by CNN and other documents was

reported last week by the British Medical Journal. Its editors said

the documents had been reported missing from a 10-year-old murder

case, and that they had sent them to the Food and Drug Administration

for review.

 

 

A spokesman for Lilly (Research) said his company was expecting the

release of the purported internal documents, but that he could not

comment until he had seen them.

 

The journal said the documents disappeared in 1994 during the case of

Joseph Wesbecker, a printing press operator who had killed eight

people at his Louisville, Ky., workplace five years before while

taking fluoxetine. He then shot and killed himself.

 

Each of the four pages of the paper obtained by CNN is stamped

" Confidential " and " Fentress, " the name of one of Wesbecker's victims.

 

In a civil suit against Eli Lilly, victims' relatives contended the

company had long known about the side effects of fluoxetine, including

its alleged role in increasing a user's propensity to violence.

 

Lilly initially won the case, but it was later forced to admit that it

had made a secret settlement with the plaintiffs during the trial,

which meant that the verdict was invalid, the journal said.

 

The FDA has recently warned that antidepressants can cause side

effects such as agitation, panic attacks, insomnia and aggressiveness.

 

FDA spokeswoman Susan Cruzan said last week that the agency had no

comment on the documents.

 

In a statement posted on Lilly's Web site, the company said, " To our

knowledge, there has never been any allegation of missing documents

from the Wesbecker trial or any other trial involving Lilly. Further,

it has always been Lilly's objective to publicly disclose data about

both the safety and efficacy of fluoxetine.

 

" Lilly has made several requests to the BMJ to obtain copies of the

supposed 'missing' documents; we still await these documents. We are

surprised and concerned that a leading medical journal would not find

it important to share these documents with us so that we could respond

to the public in a meaningful way. "

 

Based on its history of having provided regulatory authorities with

study results, the statement said, " Lilly believes that there is no

new scientific information to review on this topic. "