Congressional Intervention Needed on FDA Failings

Click the link below to see the 1991 testimony of victims and surviving family telling the FDA advisory committee about how Prozac caused suicides. Then see the conflicts of interest these psychs had before they got to vote on warning the public about this dangerous drug.

Dr. Karl Hoffower

Congressional Intervention Needed on FDA Failings

15 Year Lapse Before Warning of Antidepressant Suicide Risks is Negligent Says Human Rights Group — Warnings Don’t Go Far Enough

Washington DC: December 14—Members of the Citizens Commission on Human Rights (CCHR), the group that orchestrated an FDA Hearing into the antidepressant Prozac in 1991—today met with Members of Congress to demand an overhaul of the FDA’s reporting system and accountability to the American public. The demand is in response to the FDA’s Psychopharmacological Committee yesterday recommending an extension of the 2004 “black box” warning of suicide risk to under 18 year olds to include those 25 years of age and under. However, the Committee stopped short of applying the warning to all age groups.

Spokesperson and General Counsel for CCHR, Mr. Rick Moxon, who testified at yesterday’s hearing into antidepressants and suicide, presented footage of the 1991 FDA hearing where adults, with no history of violence or suicide, testified that they were driven to murderous acts of self-harm, influenced by the antidepressant. Moxon had filed a Freedom of Information request to the FDA in 1990, obtaining copies of the 17,000 adverse reactions reports (ADRs) against Prozac—at the time more ADRs than any other drug in the FDA’s history. Yesterday, he accused the FDA of “acting in the interest of the pharmaceutical companies instead of the public that you serve” when it ignored the earlier and yesterday’s testimony of adult suicide risk from antidepressants.

“The stories from the victims have not changed – but more importantly – neither has the FDA,” Moxon said. The 1991 panel included psychiatrists with financial interests in pharmaceutical companies and this incestuous relationship, Moxon said, has placed consumers at risk because of the FDA’s failure to warn them of antidepressant dangers. Yesterday it was given the opportunity to correct this and failed, according to Moxon.

“The FDA has not changed in the past 15 years,” Moxon added. “It is still dismissing adults who experience suicidal and violent side effects as anecdotal and still relying upon the pharmaceutical companies and psychiatrists for its information.” With deeply imbedded financial ties to the antidepressant industry, whose sales topped $15.5 billion in 2005, FDA panel members routinely ignore testimony that threatens profits.

Mrs. Suzanne Gonzales admonished the panel for not acting in time to save her 40-year-old husband, who shot himself in the head shortly after he started taking Paxil. “I hold you all responsible for his death, and I always will,” she said.

In July, Senator Charles Grassley, who has conducted oversight of the FDA, responded to a Union of Concerned Scientists survey about the FDA, in which 81% of the 998 FDA scientists surveyed, agreed that the “public would be better served if the independence and authority of the FDA post market safety systems were strengthened.” Since then, he coauthored bipartisan legislation to improve post market surveillance of drugs by the FDA (S. 930) and to require information about clinical trials be publicly available (S. 470). Senator Grassley said that the FDA needed to “re-establish its relationship with its own scientists and distance itself from the drug industry.”

Moxon said this should also extend to the psychiatric industry that profits from pharmaceutical company funding. Congressional investigation and intervention is needed to ensure the FDA acts in the interest of consumers it was established to protect.

CCHR is an international psychiatric watchdog that has been in the vanguard of patients' rights since it was co-founded in 1969 by the Church of Scientology and Dr. Thomas Szasz, Professor of Psychiatry Emeritus at the State University of New York Upstate Medical University in Syracuse, to investigate and expose psychiatric violations of human rights.