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FDA Rejects Scientology Claims, But Public Isn’t

August 2, 1991

INDIANAPOLIS (AP) _ The Food and Drug Administration rejected the Church of Scientology’s campaign against the antidepressant Prozac, but flat sales growth for the drug show the public is listening to the claims.

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 claims 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 on Thursday refused to pull marketing approval for Prozac. The request came 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.

The agency released a letter to the commission saying it had found no evidence for the claims against Prozac. Aside from the violent behavior claims, the group also said Prozac is addictive and causes movement disorders.

Prozac, approved by the FDA in December 1987, enjoyed phenomenal sales growth until mid-1990, when its share of new prescriptions for treatment of depression topped out at 26 percent, analysts say. That was before a wave of negative publicity generated by the Scientologists and more than 50 lawsuits filed against Lilly over the drug.

The lawsuits followed publication of a study by Harvard Medical School researcher Dr. Martin Teicher describing case studies of six patients who developed violently suicidal thoughts while treated with Prozac.

Today, Prozac’s share of new prescriptions and prescription refills for treatment of depression is about 20 percent. Initial Wall Street estimates that worldwide sales of Prozac would approach $1.2 billion in 1991 have been scaled back in recent months to a range of $950 million to $1 billion. Sales in 1990 were $760 million.

″There’s been virtually no growth in domestic sales in the last four quarters,″ said industry analyst Craig P. Baskin of Chicago-based Duff and Phelps. ″My guess is that it would be (because of) the adverse publicity.″

Neil B. Sweig of New York-based Brenner Securities said the FDA rejection of the withdrawal request was expected, since the agency has repeatedly stated its confidence in the safety and efficacy of Prozac.

The effectiveness of the Scientology campaign was not expected, he said.

″All that surprises me is how far it has gone. Does this put it to rest? Hopefully,″ Sweig said.

The Scientology campaign has included full-page ads in USA Today and a magazine printed in response to a negative cover story on the church in Time magazine.

The FDA reiterated that its Psychopharmacological Drugs Advisory Committee will hold a meeting later this year to consider whether Prozac and other antidepressants cause suicidal thoughts.

Sanford Block, executive director of the Citizens Commission on Human Rights, said that meeting will give the group its opportunity to prove its claims of a ″direct link between violence and psychiatric drugs.″

In that sense, the FDA rejection of its petition in not a defeat, he said. ″We actually see it as a step forward,″ Block said.

The American Psychiatric Association also welcomed the meeting. It condemned the chilling effect the Scientology campaign has had on Prozac use.

Lilly has pending before the FDA a new drug application for Lovan, a treatment for obesity that uses the same actitive ingredient in Prozac - fluoxetine.

Sweig and Ron Nordmann of PaineWebber predict FDA approval for the new drug, Lovan, will come before the end of the year, and when it does, it will provide a rich new sales opportunity for Lilly.

Even better for Lilly, ″the use of the product for the treatment of obesity has not been associated with violent behavior,″ Nordmann said.