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CITIZENS COMMISSION ON HUMAN RIGHTS (CCHR) SAYS NEW FDA DOCUMENTS REVEAL DOCTORING OF PROZAC TEST DATA BY FDA, ELI LILLY

Documents Also Show Prozac Adverse Reactions Climb to 28,623, CCHR Says
 WASHINGTON, Oct. 7 /PRNewswire/ -- The Citizens Commission on Human Rights, established by the Church of Scientology, issued the following:
 New documents obtained under the Freedom of Information Act (FOIA) from the U.S. Food and Drug Administration (FDA) revealed that the FDA condoned the tampering of scientific data in pre-market trials of the controversial drug Prozac. The documents also show that Eli Lilly, the drug's manufacturer, told Prozac researchers not to report some of the drug's adverse side effects during the pre-market safety testing period which is required before a drug can be sold on the market.
 The new documents reveal that an FDA safety reviewer uncovered evidence of psychotic episodes connected to Prozac not revealed by Lilly and that reported adverse reactions have now soared to 28,623, more than any drug in history.
 Among the adverse reactions to Prozac were over 1,349 reported deaths. According to FDA Commissioner David Kessler, the percentage of adverse reactions reported is only from 1 to 10 percent of the actual adverse reactions, making the death count since Prozac came onto the market six years ago possibly over 100,000.
 One document shows that the FDA told Eli Lilly to tamper with their studies after the FDA reviewed the testing results on Prozac, which they found to be no more effective than placebo. An FDA statistician told Eli Lilly to re-tally their own studies against a lesser criteria. Once this was done, Eli Lilly and the FDA had a drug which now appeared to be "more effective than placebo."
 This same document also discloses that Eli Lilly told the doctors testing Prozac not to record many of Prozac's side effects as adverse reactions to the drug, but instead to classify these as symptoms of the individual's own "depression." According to the FDA efficacy reviewer, this act would have led to a gross under-representation of Prozac's adverse reactions while it was being tested.
 Another document states that in 1986 an FDA safety reviewer discovered Eli Lilly had withheld information about the onset of psychotic episodes on at least 52 patients during Prozac's testing. Although the FDA made this discovery, no action was taken against the manufacturer.
 According to Peter Dockx, director of the Citizens Commission on Human Rights in Washington, "This Thursday, the National Institute of Mental Health and Eli Lilly are selling 'depression' to America through the `National Depression Screening Day.' Eli Lilly has continued to defend Prozac, a drug that was proven to be a killer drug, and now are trying to boost its sales. Lilly boasts that the drug was approved by the FDA, the very agency which ordered tests to be altered and condoned irregular and possibly even illegal procedures by the manufacturer."
 Prozac is now the subject of 170 lawsuits and is linked to many mass murderers and suicides. In 1989 Joseph Wesbecker, while on Prozac, shot 20 people, killing eight, then himself, in Louisville, Ky. National headlines covered the tragic death of Del Shannon, who shot himself in his California home after being on Prozac. Tucker Moneymaker of Virginia came home and found his children had been killed by their own mother, who was on Prozac.
 "The reason there are more than 170 lawsuits filed against Eli Lilly is because of the non-stop destruction linked to Prozac these past six years. With this new information from the FDA, people may finally demand that this drug be pulled from the market" Dockx concluded.
 The Citizens Commission on Human Rights was established in 1969 by the Church of Scientology to investigate and expose psychiatric violations of human rights.
 -0- 10/7/93
 /CONTACT: Rick Duarte of the Citizens Commission on Human Rights, 213-467-4242/


CO: Citizens Commission on Human Rights ST: District of Columbia IN: SU:

KD-DC -- DC030 -- 9974 10/07/93 19:47 EDT
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Publication:PR Newswire
Date:Oct 7, 1993
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