ANTI-PROZAC CAMPAIGN BY SCIENTOLOGISTS MAY BROADEN

Executive Summary

ANTI-PROZAC CAMPAIGN BY SCIENTOLOGISTS MAY BROADEN to include attacks against individual FDA officials, said a spokesperson for the church-backed Citizens Commission on Human Rights at an Aug. 7 press conference in Washington, D.C. Spokesperson Dennis Clarke announced that within "a couple of weeks" CCHR is "going to name names" of FDAers who are conspiring with Prozac-manufacturer Lilly to protect the product (fluoxetine) from charges that the antidepressant causes some patients to become suicidal and violent. CCHR held the press conference in reaction to FDA's Aug. 2 denial of the group's petition to have the serotonin re-uptake inhibitor withdrawn from the market. The group alleges Prozac has induced suicidal tendencies, suicides, and violent acts, including murder, in patients receiving the drug. In response to the petition, FDA stated that while "suicidal ideation" is included in Prozac labeling as a potential adverse effect of the product, CCHR's submitted material and data from FDA's post-marketing surveillance system "do not indicate that Prozac causes suicidality or violent behavior" ("The Pink Sheet" Aug. 5, T&G-7). The agency noted that there has been extensive publicity in the last year over the possibility that Prozac is linked to suicidal feelings and that the diagnosed depressive patient population is at an increased risk for suicide compared to the general population. A combination of the two factors may have contributed to a high rate of reporting of possible Prozac-linked suicide attempts, the agency explained. The Scientology group also released a letter to HHS Secretary Sullivan calling for an investigation into FDA's refusal to withdraw Prozac from the market. "The fact that this deadly drug could have received approval raises further concerns similar to those uncovered by Congress regarding FDA officials accepting bribes from drug companies to give quick approval to drugs," CCHR's letter states. CCHR's Clarke said repeatedly at the press conference that "two or three people" at FDA were responsible for the group's failure to win Prozac's withdrawal. "I think what we're dealing with here is a very small handful of people [at FDA]. The structure [of FDA] is such that two or three people literally are able to block any actions by the FDA to remove this drug from the market," Clarke maintained. He also described FDA as "a political entity controlled by the drug companies." The group also presented testimony from witnesses who said they had been harmed by the antidepressant. They included a woman who has filed suit against Lilly, claiming that Prozac caused her to attempt suicide; a parent who asserted that Prozac had caused her mentally ill child to become self-destructive; and the husband of a woman who murdered her children and attempted suicide while on Prozac. The Church of Scientology, which opposes conventional psychiatry and the use of drugs to treat mental illness, has been conducting an extensive and expensive campaign against the Lilly antidepressant. The campaign has included advertisements warning against the product and comparing it to heroin and LSD. Past targets of Scientology's vitriol against psychotherapeutics include Ciba-Geigy's Ritalin and Upjohn's Halcion. The CCHR is not the only group to have raised concerns about Prozac and suicides. Public Citizen's Health Research Group filed a petition May 23 urging that a stronger warning against the possibility of suicidal ideation be included in Prozac labeling. HRG did not suggest any limits on the drug's distribution, but asked for additional warnings because the drug is being widely prescribed by non-psychiatrists without close monitoring of patients. The drug is being prescribed for such unlabeled indications as smoking cessation and weight loss, HRG contended. Since its 1988 introduction, Prozac has been prescribed for 3.5 million patients worldwide. Lilly has predicted that its 1991 sales of the drug will top $ 1 bil. FDA has announced that it is planning a meeting of its Psychopharmacologic Drugs Advisory Committee for early fall to address the suicidal ideation potential of antidepressants as a class ("The Pink Sheet" July 22, T&G-9). In a letter sent to manufacturers of antidepressants, the agency invited submissions of data on the problem and said that the upcoming discussion could have "implications for the labeling of all antidepressant drug products."