August 1

2005: IOM Committee Considers Return to Prison Research

Today’s New York Times Magazine cover story, Planet of the Retired Chimpanzees By Charles Siebert, reports that chimpanzees who have served as subjects in biomedical research can look forward to being set free in one of 12 specially built chimp sanctuaries the prettiest places in all of Florida. This is the result of a recognition that we have an ethical / humanitarian responsibility toward research chimps.

Chimps that are used in research are protected by two federal laws: The Animal Welfare Act of 1966 and the 1997 Chimpanzee Research Retirement Act. There is a surplus of chimps due to the aggressive breeding initiated by the National Institutes of Health initiated in 1986, in response to the AIDS epidemic. Chimps can contract the virus, but are virtually immune to its effects.

Without depriving chimps of their perks, one cannot but notice the sharp contrast between the treatment of animal research subjects and human subjects. Human research subjects have no federal law to protect them–and certainly humans are given no perks for their research “contribution” – even if they¹ve been injured permanently during the course of research.

Prior to the 1978 federal regulations, the most preferred of all medical research animals were prisoners. Jessica Mitford  quoted a doctor who expressed the sentiment of the medical community:

“Criminals in our penitentiaries are fine experimental material – and much cheaper than chimpanzees.” (Experiments Behind Bars: Doctors, Drug Companies, and Prisoners in the Atlantic Monthly, 1973)

Indeed, in 1976, the president of PhRMA confirmed that 85% of all Phase I and II drug trials were then conducted on prisoners. PhRMA and its biomedical research partners have once again set their eyes on prisoners as “fine experimental material.”

Current federal regulations restrict the use of prisoners in medical experiments that: “have the intent and reasonable probability of improving the health or well-being of the subject.” See: 46 CFR 46.302 Stakeholders in the academic-pharmaceutical industrial complex are intent on overturning the foremost principle of the Nuremberg Code in order to gain access to a cheap, captive population : “The voluntary, informed consent of the human subject is absolutely essential.” The US military tribunal at Nuremberg recognized that voluntary, informed consent is, by definition, impossible to obtain in a prison setting. Therefore, research on prisoners is not permissible under the Nuremberg Code–nor under any other code of medical ethics.

Prisons are a world onto themselves. A captive prisoner in a US prison lives under threat, intimidation and fear for his / her personal safety. The reason prisons are shrouded in a veil of secrecy is they hide a world of institutionalized brutality and abuse – both physical and psychological. No one outside of prison walls knows what happens in a prison. Visiting outsiders – such as public officials, Congressional subcommittees, or advisory committees – have no inkling about the level of fear, intimidation that prisoners are subjected to.

A Committee of the Institute of Medicine has been convened to examine the “Ethical Considerations for Revisions to DHHS Regulations for the Protection of Prisoners Involved in Research.” The IOM Committee held a very low-profile public meeting in San Francisco (July 18) at which 14 invited presenters –12 of who favor rolling back federal restrictions on the use of prisoners in research – offered their perspective.

In my presentation, “Cheaper than Chimpanzees,” I laid out the background that prompted the adoption of federal regulations in 1978: ³American doctors regularly injected and infected inmates with malaria, typhoid fever, herpes, cancer cells, tuberculosis, ringworm, hepatitis, syphilis and cholera.²

Except for the representatives from the Center for Disease Control, the presenters on July 18 are employed at medical centers that have a vested financial interest in conducting clinical drug trials. These stakeholders are stymied by a shortage of volunteers – not even thousands of dollars spent on ³finder¹s fees² has resulted in sufficient numbers of patients needed.

Pharmaceutical companies and their partners in academia are seeking to circumvent voluntary, informed consent requirements in the free world by outsourcing clinical trials. The most sought after populations to serve as human guinea pigs are in underdeveloped nations and prisons. In passing, some of the academics who made presentations acknowledged: “it is so much easier to enroll prisoners than those in the community!!”

Among the specious arguments made by the academics who addressed the IOM committee: “prisoners are eager to give back to society”; “prisoners are altruistic”; “research offers prisoners, such as those infected with HIV, the benefit of better health care and life-saving drugs.”

The Alliance for Human Research Protection submitted a compilation of documents–from California and Texas –providing the IOM committee with evidence of current prison health care conditions; evidence of ³inhumane² “barbaric” treatments – as revealed by the Office of the Inspector General, expert witnesses who examined the medical records of prisoners, and investigative reporters.

The revelations of institutionalized abuse, brutality and inhumane conditions in California’s penal system, led a federal judge to remove California’s entire $1.1 billion prison health care system from the state’s jurisdiction (July 1, 2005), declaring the system “an outright depravity.”

Letters of determination by the Office of Human Research Protections show the utter inadequacy of the oversight system. In 2000, OHRP shut down 95 clinical trials at the University of Texas Medical Center, Galveston, but clinical trials on prisoners continue to be conducted at Galveston. The University of Texas is among those seeking to expand its experiments utilizing prisoners, and is one of the most aggressive lobbyists for the removal of federal restrictions. Read Mike Ward and Bill Bishop Whiff of Oversight: Healing or Harming, Medical Tests Rarely Held up to Scrutiny, American-Statesman, Monday, December 17, 2001. But Texas is not alone. Under the Freedom of Information Act, the AHRP has obtained an extensive current list of academic research centers and contract freestanding IRBs that have approved experiments on prisoners.

Read more AHRP presentation, “Cheaper than Chimpanzees


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