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FDA, ELI LILLY CHARGED BY CCHR WITH VIOLATING FEDERAL REGULATIONS IN TESTING PROZAC; COMPLAINT FILED WITH DEPT. OF HEALTH & HUMAN SERVICES

 WASHINGTON, Dec. 13 /PRNewswire/ -- The Citizens Commission on Human Rights (CCHR) issued the following:
 The Citizens Commission on Human Rights today filed a complaint with the Inspector General, Department of Health and Human Services, charging grievous violations in the clinical testing of the controversial drug Prozac which resulted in needless deaths of 27 persons.
 The commission, a watchdog group which monitors psychiatric abuses and violations of human rights, stated the Food and Drug Administration (FDA) and Prozac manufacturer Eli Lilly violated federal regulations which direct the procedures by which a drug is approved for the market.
 The complaint charges that during the clinical testing of Prozac, 27 people died with 15 of those being suicides. Both Eli Lilly and the FDA had the power, authority and the responsibility to act during all phases of the clinical testing of Prozac and to stop the drug from ever getting to the market if there was evidence that the drug was unsafe or could pose a risk to the public.
 The complaint by the commission also charges that Eli Lilly instructed its clinical trials investigators not to include symptoms of depression when reporting adverse reactions to the drug, citing that this is what the drug is prescribed for.
 The complaint further charges that Eli Lilly sought to suppress any adverse reaction reports about its drug that might reveal the very aspect of it that one of the FDA's safety reviewers, Richard Kapit, M.D., found to be of greatest concern -- that its most common side effects were the "signs and symptoms" of depression -- the very "illness" the drug purported to treat and the very "illness" that both Eli Lilly and the FDA associate with suicidality.
 "The suicides alone during the clinical trials were all that either Eli Lilly or the FDA needed to stop the testing and withdraw the drug from the approval process," said Bruce Wiseman, president for the commission. "But neither acted. And now over 1,800 people have attempted suicide after being prescribed Prozac. Over 1,700 people are dead. It's an obscenity."
 Wiseman stated that the FDA had every opportunity to get the facts and act, but they failed.
 "The FDA and Eli Lilly failed in their responsibility to protect the American public. The Department of Health and Human Services needs to act and investigate this complaint. We are giving them the information they need, with clear evidence of federal violations by both the FDA and Eli Lilly."
 The Citizens Commission on Human Rights was established in 1969 by the Church of Scientology to investigate and expose psychiatric violations of human rights. It provides a toll-free hotline for anyone who wishes to report their own experience with Prozac, or who would like more information. Call 800-869-2247.
 -0- 12/13/93
 /CONTACT: Rick Duarte of the Citizens Commission on Human Rights, 213-467-4242/ CO: Citizens Commission on Human Rights; U.S. Food and Drug
 Administration; Eli Lilly; U.S. Department of Health and Human
 Services ST: District of Columbia IN: MTC SU: EXE


DC-KW -- DC015 -- 3156 12/13/93 12:15 EST
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Publication:PR Newswire
Date:Dec 13, 1993
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