GROUP PROPOSES REFORMS OF FDA'S DRUG APPROVAL PROCESS
TO PROTECT PUBLIC FROM DANGEROUS DRUGS
WASHINGTON, Jan. 27 /PRNewswire/ -- The Citizens Commission on Human Rights issued the following:
The Citizens Commission on Human Rights (CCHR) will release its proposed reforms for the Food and Drug Administration's (FDA) drug approval process today to Congress, FDA, HHS, the President's Council on Competitiveness and other Washington-based consumer groups.
Citing the existence of conflicts of interest in the FDA's advisory committee system, CCHR is calling for broad, sweeping reforms in order to protect the American public from dangerous drugs.
CCHR's Legislative Affairs Director Peter Dockx, stated: "The FDA is, by law, charged with the responsibility of protecting the public by independently reviewing drugs and medical devices before they are allowed on the market, and then approving them only after they are found to be safe and effective. However, the FDA is placing the health and safety of Americans in jeopardy with the current system of approval and monitoring of drugs."
Dockx cited FDA's history of approving dangerous drugs and medical devices such as Halcion, Prozac, and silicone breast implants as well as past corruption within the agency which has resulted in injury or even death.
For example, in 1986, after more than 300 deaths were linked to a faulty heart valve, the manufacturer withdrew the device from the market. However, the FDA did not take action to protect the public against the faulty device until 1990, when it ordered the manufacturer to notify recipients about the high failure risk in a certain number of the devices.
In 1989, U.S. Rep. John Dingell (D-Mich.) uncovered favors, gifts and bribes given to FDA officials by generic drug company executives in return for fast approval of their drugs. As a result, the U.S. attorney in Baltimore convened a grand jury which indicted at least seven generic drug company executives and four FDA officials for giving and taking bribes.
In October 1991, the Ministry of Health in the United Kingdom banned the psychiatric drug Halcion, commonly used as a sleeping pill, because of reports that the drug had caused paranoid delusions and violent outbursts. The British government became concerned when it learned that the drug's manufacturer withheld information about these drug reactions from the FDA. Yet, despite a frightening number of similar reports in the United States, the FDA has not acted against this drug.
The FDA moved against silicone breast implants only after an enormous amount of adverse publicity followed damaging revelations about the implants. Interestingly, the FDA's advisory committee had recently ruled in favor of these implants. Yet FDA Commissioner David Kessler only asked for a moratorium on the sale of these implants.
On Sept. 20, 1991, the FDA's Psychopharmacologic Drug Advisory Committee held a hearing to look into complaints that antidepressant drugs, especially Prozac, can cause suicide and violence. Despite significant damaging evidence in the FDA's own files, as well as four and one half hours of public testimony from nearly three dozen people from around the country whose own lives or lives of family members had been destroyed by Prozac, the advisory committee voted against even a warning label for Prozac or antidepressants as a class. An ethics complaint has subsequently been filed with the Office of Government Ethics by CCHR against the panel, alleging that half of its members had active financial conflicts of interest with pharmaceutical manufacturers.
Recently received documents from the FDA by CCHR concerning adverse drug reaction reports on Prozac through Jan. 9, 1992, shows that Prozac now has 18,087 total reports. Of that, there were 1,187 "suicide attempts" listed, or over 6-1/2 percent. The total number of patients that have died while taking Prozac, with our without other drugs, is now 1,102. In the last year, the FDA received an additional 3,322 adverse reaction reports, with over 33 percent of them involving suicide attempts.
Dockx noted: "If anyone has been wondering why the FDA doesn't act effectively against dangerous drugs or medical devices, yet stages raids on orange juice manufacturers, peanut butter factories and vitamin companies, the answers lie in the conflicts of interest present at the FDA. Our recommendations will help eliminate these conflicts."
The Citizens Commission on Human Rights was established by the Church of Scientology in 1969 to investigate and expose psychiatric violations of human rights. The commission maintains a toll-free hotline number, 800-869-2247, for information on patients' rights.
/CONTACT: Leslie McCaffrey for the Citizens Commission on Human Rights, 800-869-2247, or Lisa-Marie Cashman for Bain & Lichtenstein, 703-838-8085/ CO: Citizens Commission on Human Rights ST: District of Columbia IN: HEA SU:
SB -- DC018 -- 3831 01/27/92 14:18 EST