Prozac

Psychiatrist: Company hid Prozac, suicide link

By Marilyn Elias, USA TODAY (1/5/05)

Lives were threatened and Americans treated like "guinea pigs" because Eli Lilly & Co. officials lied 15 years ago in denying there was any evidence the anti-depressant Prozac could cause suicidal behavior, a Harvard psychiatrist has charged. 

The comments by Martin Teicher come as concern mounts over Lilly documents on Prozac described in the British medical journal BMJ last Friday. USA TODAY has obtained a copy of the documents, which were part of a 1994 lawsuit filed against Lilly for victims of a Louisville workplace shooting. The gunman, who killed himself and eight others, had been treated with Prozac. 

Teicher, a prominent researcher and clinician, was the first to publish case reports showing an apparent link between Prozac and suicidal behavior in adults. But a few months before his March 1990 report, Teicher said he asked Lilly officials if studies showed such a link. 

" 'Oh no, no, we never heard of such a thing,' they told me," Teicher said. But studies from the 1980s showed such dangers, he said, and German drug regulators wouldn't license the drug when Lilly first applied in 1985, citing "suicidal risk." The Food and Drug Administration (FDA) approved Prozac in 1987. But when problems started surfacing, the agency held a scientific advisory panel hearing in 1991 and found no evidence of a link to suicide. 

The documents summarized in the BMJ article suggest that twice as many patients on Prozac as on a placebo may experience such symptoms as anxiety, agitation and nervousness — 38% versus 19%. These symptoms are important because therapists say they can precede suicide or violent acts. 

Another document appears to show an FDA official questioning Lilly's actions in deciding apparent suicide attempts in studies weren't real attempts or were not due to the antidepressant. Scientists have some discretion in identifying the causes of bad reactions in a study. 

David Graham, associate director in the FDA's Office of Drug Safety, reviewed Prozac's safety record in 1990. "Lilly excluded so many cases of suicidal behavior that I felt a problem couldn't be ruled out," he said.