The Declaration of Helsinki defines ethical research:
“In any medical study, every patient – including those of a control group, if any – should be assured of the best proven diagnostic and therapeutic method.” (1964; 1996)
That standard for ethical research was reaffirmed by the World Medical Association in 2000:
“The benefits, risks, burdens and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic, and therapeutic methods. This does not exclude the use of inert placebo in studies in which no proven diagnostic or therapeutic method exists.”
1997. U.S. government sponsored placebo-controlled HIV experiments conducted in Africa
The researchers failed to provide available treatment to HIV infected, pregnant African women—an experimental design that admittedly could not have been done in the U.S. “Only when there is no known effective treatment is it ethical to compare a potential new treatment with a placebo.” Drs. Marcia Angell, Peter Lurie, and Sydney Wolfe. The Ethics of Clinical Research in the Third World, the NEJM, 1997; NY Times, Sept. 18, 1997.
- President Clinton issues a formal apology to the subjects of the Tuskegee syphilis experiments. The National Bioethics Advisory Committee (NBAC) continues investigation into genetics, consent, privacy, and research involving persons with mental disorders.
FDAMA – FDA Modernization Act FDA Modernization Act gives pharmaceutical companies a huge financial incentive – a 6 month patent exclusivity extension—if they conduct drug tests on children. The incentive can yield $900 million.
In 1997, Stanford University tested varying doses of the psychiatric drug Depakote on 61 teenage inmates at a California Youth Authority correctional center at Stockton.
“Researchers and sponsors covet prison populations for reasons of opportunism and convenience. Access to a large pool of captive human beings facilitates rapid enrollment in clinical trials. As captives they can’t drop out – thereby eliminating a major problem for clinical trialists. Prisoners don’t move without leaving an address – their whereabouts are monitored 24 hours a day, and their diet and waking regimens are controlled. Beyond convenience, prisoners are devalued, disenfranchised human beings for whom society has no sympathy. Their deprivations and status as an underclass are particularly valued by academic and industry researchers who use the opportunity to dispense with whatever formal procedures are followed at civilian research centers. Prisons, which are a world onto itself, are an easy place to bury the bodies with impunity.” Testimony by Vera Sharav, Cheaper than Chimpanzees
In weeks of testimony, medical experts described “horrifying” and “barbaric medical conditions in California prisons… resulting in as many as 64 preventable deaths of inmates a year and injury to countless others. California also has the dubious distinction of locking up the largest number of juveniles in the nation. Between 4,000 and 10,000 youthful offenders (called wards) are incarcerated in at California Youth Authority facilities where they are subjected to inhumane, institutionalized brutality beyond belief.
Many were locked in cells for 23 hours per day, sprayed with mace, heavily drugged with psychotropic chemical restraints, and during their one hour of classroom “instruction” they were locked into steel mesh cages like pit bull dogs.
The drug is approved for the control of epilepsy, but was tested to determine if it would make the teens less aggressive. The experimental use of the drug violated state law banning medical research on prisoners. The Stanford Institutional Review Board approved the tests which were conducted over a period of eight weeks at Stockton on youths aged 14 to 18.
1998: National Bioethics Advisory Committee issues Report Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity.