October 26

IOM Committee Considers Prison Research

IOM Committee Considers Prison Research

Sun, 24 Jul 2005

Today¹s 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 ³the prettiest places in all of Florida.² 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. Go to Article at: http://www.nytimes.com/2005/07/24/magazine/24CHIMPS.html?

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 ³contribution² – 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’s galvanizing essay in the Atlantic Monthly (1973) quoted a doctor who expressed the sentiment of the medical community: “Criminals in our penitentiaries are fine experimental material – and much cheaper than chimpanzees.”

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 ³fine experimental material.² A Committee of the Institute of Medicine has been convened to examine the ³Ethical Considerations for Revisions to DHHS Regulations for the Protection of Prisoners Involved in Research.²

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.

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. 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.

Excerpt from the AHRP presentation, “Cheaper than Chimpanzees”:

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), have been incarcerated at any given time in camps and institutions operated by the California Youth Authority (CYA) – at an annual cost of $80,000 per ward.16, About 50% have a mental or emotional problem–44% of males and 61% of females – and 38% of males and 50% of females have both mental and substance problems. The juvenile justice system was not intended to be punitive, and CYA¹s stated mission16 is exemplary: ³We treat all people with dignity, respect and consideration.² Also, ³We demonstrate behavior which is fair, honest, and ethical.² State law requires CYA to provide youthful offenders an ³education, training, and treatment services.² But the reality bears no resemblance to any of its written commitment. Wards housed at CYA facilities 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 ³instruction² they were locked into steel mesh cages like pit bull dogs. The cages are euphemistically called, SPAS (acronym for Special Program Areas). One juvenile admitted: ³I was living in fear 22 hours a day in that place.² Another stated: ³It was too dangerous to sleep at night.² Fifteen youths have committed suicide since 1996.16

Juveniles who are detained in deplorable conditions are certain to fill the adult prisons. Nationally, the recidivist rate for juveniles is between 56%–91%. Inmates released from CYA return or ³graduate² to adult prisons within 3 years. Recently, a publicly aired video tape provided a glimpse into institutionalized depravity. A guard was taped setting his German Shepard to attack a juvenile at Stockton. At this same facility, in 1997, a Stanford psychiatrist conducted an experiment on 61 inmates aged 14-18, to test the effectiveness of the anti-epileptic drug, Depakote, for use as a chemical intervention to reduce aggression. [Attached] Federal regulations restrict the use for minors who are wards of the state to research ³conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as subjects are not wards.² Wards at CYA facilities are captive prisoners. As such, they are entitled to state and federal restrictions. California law explicitly states: ³no medical research shall be conducted on any prisoner in this state.² The Stanford IRB approved it, and its lawyers defended it. Beyond the legitimacy of its approval, there are many questions about informed consent, disclosure of risks associated with Depakote.

It is inconceivable that an Institutional Animal Care and Use Committee (IACUC) would ever approve research to be done on animals housed under prison conditions. IACUC panels who inspect animal facilities can better appreciate that inhumane living conditions are not suitable for research. A prison doctor told the Chronicle Prisons ³were not designed to be the Mayo Clinic. They are essentially dungeons.” ŠŠ.xxxxxx

Š..A four part investigative series in the American Statesman, ³Sick in Secret: The Hidden World of Prison Health Care,² by Mike Ward and Bill Bishop (December 2001-2003) uncovered a covert, interlocking system of abuse in the Texas prison health care system operated by the University of Texas Medical Branch (UTMB) since 1993.  The Texas Statesman series provided documented evidence of how UTMB operated a twotrack health care system of vastly unequal quality. UTMB¹s two track system of care ensure that prisoners will seek better care at the University¹s Galveston branch to avoid being maltreated in sub-standard prison clinics, where their lives are put at risk. But to gain access to UT hospital care there was a hitch: prisoners had to become human subjects in experimental drug trials. Advertisements at UTMB’s public hospital in Galveston promised free treatment to those who enroll in research trials. UTMB has run thousands of clinical research trials and its Office of Clinical Trials boasts that one of the “special features” available at UTMB is the prison hospital, and the tens of thousands of Texas inmates who look to that hospital for medical care.

See: Mike Ward and Bill Bishop Whiff of Oversight: Healing or harming, medical tests rarely held up to scrutiny, American-Statesman, Monday, December 17, 2001 http://www.statesman.com/specialreports/content/specialreports/prisons/17prisonoversight.html

Complete presentation is posted on the AHRP website.

Contact: Vera Hassner Sharav

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