FDA Rejects Scientology Warnings About Prozac, But Public Isn’t
INDIANAPOLIS (AP) _ The Church of Scientology’s campaign against the antidepressant Prozac was rejected by the Food and Drug Administration, but flat sales for the drug show the public is heeding the warnings.
The drug’s manufacturer, Eli Lilly and Co., as well as mental health groups and drug industry analysts say there’s no question sales have suffered from warnings that Prozac causes violent behavior and suicidal thoughts among its users.
″Some people have indeed quit taking it. Other people have pressured their relatives to stop taking it,″ said Edward West, spokesman for Indianapolis- based Lilly.
The FDA said Thursday it had found no evidence that Prozac is addictive and causes movement disorders, thereby rejecting a request to pull marketing approval for the drug. The request came last October from the Los Angeles- based Citizens Commission on Human Rights, an affiliate of the Church of Scientology, which opposes the practice of psychiatry in general.
Prozac enjoyed phenomenal sales growth from the time it was approved by the FDA in December 1987 until mid-1990, when its share of new prescriptions topped out at 26 percent worldwide, analysts say. After a wave of negative publicity generated by the Scientologists and more than 50 lawsuits against its manufactuer over the drug, that share has fallen to about 20 percent.
″There’s been virtually no growth in domestic sales in the last four quarters,″ said analyst Craig P. Baskin of the Chicago investment firm of Duff and Phelps. ″My guess is that it would be (because of) the adverse publicity.″
The lawsuits followed publication of a study by a Harvard Medical School researcher that described six patients who developed violently suicidal thoughts while being treated with Prozac.
The FDA said clinical trials did not show any more suicide attempts among depressed patients on Prozac than among those being given placebos or other anti-depressants.
″Depression itself is highly associated with suicide,″ the agency said.
Initial Wall Street estimates were that worldwide sales of Prozac would approach $1.2 billion in 1991. In recent months, that has been scaled back to $950 million to $1 billion. Sales in 1990 were $760 million.
Neil B. Sweig of Brenner Securities of New York said he was surprised with the effectiveness of the Scientology campaign, which included full-page advertisements in USA Today and other publications.
″All that surprises me is how far it has gone. Does this put it to rest? Hopefully,″ Sweig said.
Sanford Block, executive director of the Citizens Commission on Human Rights, said the group will lobby against Prozac at a meeting later this year of an FDA advisory committee. The committee will consider whether Prozac and other antidepressants cause suicidal thoughts.
Peter Docks, a spokesman for the group, said: ″Obviously we are greatly disappointed in the FDA’s decision. ... Time will tell, from the various victims around the country, that this drug is a killer drug.″
The American Psychiatric Association, reacting to the FDA’s ruling, condemned the effect the campaign had on Prozac use.
The FDA said Prozac labels already note that violent behaviors have been reported among a small number of patients and that, in clinical trials, hostile behavior was observed at rates ranging from one in 100 to one in 1,000.