An article in In These Times provides an overview of recent ethical violations in US medical experiments on prison inmates.
The medical research community stakeholders in pharmaceutical bio-tech industry are collaborating on removing the regulatory barriers under the Federal Code of Regulations, 45 CFR 46.
The Prison as Laboratory
By Silja J.A. Talvi, In These Times.
January 10, 2002.
As a trade-off for adequate medical care and higher hopes for early release, increasing numbers of prisoners are subjecting themselves to experimental — and potentially harmful — medical research.
"The voluntary consent of the human subject is absolutely essential," reads the Nuremberg Code of 1947, which was drafted in direct response to the sheer barbarity of Nazi-era medical experiments on Jews and other captive groups. "[The] person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching or other ulterior form of constraint or coercion."
Yet in a convenient disassociation from the ethical implications of the Nuremberg Code, the United States became the only nation in the world to officially sanction the use of prisoners in experimental clinical trials. From the ’40s through the early ’70s, American doctors regularly injected and infected inmates with malaria, typhoid fever, herpes, cancer cells, tuberculosis, ringworm, hepatitis, syphilis and cholera in repeatedly failed attempts to "cure" such diseases. Doctors in prisons pulled out prisoners’ fingernails and inflicted flash burns to approximate the results of atomic bomb attacks and even conducted various "mind-control" experiments using isolation techniques and high doses of LSD, courtesy of the CIA.
By 1972, the pharmaceutical industry was doing more than 90 percent of its experimental testing on prisoners. The appeal and the advantages of an always accessible, highly controlled study group were obvious to researchers and trial sponsors alike; and, as researchers liked to point out, inmates themselves were eager to do something good for society, make money, or win favorable treatment or early release. But failures of these research studies often had devastating results on their captive subjects.
In October 2000, nearly 300 former inmates filed suit against the University of Pennsylvania, dermatologist Albert M. Kligman and corporate giants Dow Chemical and Johnson & Johnson for injuries, lingering physical illnesses and psychological trauma suffered as a result of experimental research conducted at Holmesburg Prison in Philadelphia between 1951 and 1974. The lawsuit, now pending in federal district court, alleges that University of Pennsylvania researchers deliberately exposed prisoners to dangerous and toxic substances without informing them of the attendant risks. The experiments—which formed the focal point of Allen M. Hornblum’s 1998 book Acres of Skin—included the application of powerful skin creams, new cosmetics, dioxin and high doses of LSD.
The majority of the plaintiffs are low-income African-American men who were paid $2 to $3 per day for lending their bodies to "science" while incarcerated. The majority of these former prisoners have died, according to Thomas M. Nocella, the attorney representing the plaintiffs; of those still alive, all are in poor health. Now in their fifties and sixties, the men and women suffer from breathing problems, gynecological complications, and all manner of skin rashes and infections. The Holmesburg suit comes on the heels of a $2.4 million settlement awarded in March 2000 to a group of former Washington State prisoners whose testicles had been sliced up and radiated in experiments from 1963 to 1973.
This grossly perverted "era of experimentation" in prisons should be an unpleasant and distant memory. From the late ’70s through the early ’90s, a variety of state and federal laws, as well as carefully worded university regulations regarding the protection of human subjects, brought rampant prison experimentation to a screeching halt. American Correctional Association policy generally prohibits the use of inmates for medical, pharmaceutical or cosmetic experiments.
But evidence has emerged that prison-based research studies are again being conducted in numerous states—including Arkansas, Connecticut, Florida, Maryland, Rhode Island, South Carolina and Texas—and that hundreds of clinical trials and experimental therapies may have subjected prisoners to unjustifiable medical risks, in clear violation of existing federal regulations.
Research involving human subjects has become big business.
Currently, more than 10,000 programs and an estimated 45,000 researchers conduct medical research on humans in the United States. With some 2 million Americans now behind bars, prisoners are increasingly being viewed in utilitarian terms by researchers eager to test experimental procedures on an array of chronic medical problems, ranging from asthma to cancer. Prisoners represent a particularly compelling and convenient test group for anti-viral medicines and vaccines: At least 17 percent of people living with HIV/AIDS in the United States have spent time in correctional facilities, and the HIV rate in prisons is believed to be six times greater than in the outside population. In addition, prison populations have the highest concentrations of Hepatitis C in the country; from state to state, between 20 to 60 percent of inmates are believed to harbor the virus.
Revelations about medical research on prisoners began to come to light when the federal Office of Human Research Protections (OHRP), a division of the Department of Health and Human Services, suspended federally funded research projects at the University of Texas Medical Branch (UTMB) in Galveston because the university had not followed federal regulations aimed at protecting research-study volunteers. Of some 300 studies suspended in July 2000, 195 involved Texas prisoners; another 25 studies were brought to a halt in September 2000.
The OHRP would not provide any details about the studies and clinical trials, most of which involved treatments for HIV and AIDS, according to reports in the Austin American-Statesman. Dr. David Paar, director of the AIDS Care and Clinical Research Program at UTMB, also declined to comment on the state of clinical research at the facility, pending the results of an "ongoing inquiry." But documents obtained through a Freedom of Information Act request offer insight into the types of studies conducted on prisoners at UTMB. A September 14, 2000 letter from the OHRP to UTMB listed numerous research projects that did not fall into any of the categories of permissible research on prisoners, finding "scant evidence" that the university’s institutional review board followed federal regulations when it reviewed and approved the studies.
According to federal regulations, research in prisons must fit into one of four permissible categories: studies of the possible causes and effects of incarceration and criminal behavior; studies of prisons as institutional structures or of prisoners as incarcerated persons; research on conditions affecting prisoners as a group; and research involving a therapy likely to benefit the inmate involved. In all cases, studies are required to present no more than a "minimal" risk to the prisoner. Yet in many of the clinical trials reported to the OHRP, those regulations were clearly violated. "Those sorts of things put us on guard," says Jackie Walker of the National Prison Project of the American Civil Liberties Union. "Boundaries were clearly overstepped."
The listed studies included those on induction of labor among pregnant inmates; a study of different methods of obtaining biopsies from inmates; a Phase I clinical trial (used to test a new drug or treatment for the first time in a small group) involving an experimental HIV vaccine; and another using a new experimental therapy of the intrahepatic (directly into the liver) delivery of a powerful chemotherapy drug.
Perhaps most shocking was a Phase I study, ongoing since 1997, that used prisoners to test a radically experimental approach to treating lung cancer. In that study, the prisoner was anesthetized and then connected to a machine called the BioLogic-HT System. According to the consent form, the test subject would agree to be heavily sedated and then to have tubes inserted into veins in the leg and neck to obtain blood. The blood removed from the volunteer would then be heated by the machine and returned to the body, inducing a dangerously high body temperature of 108.5 degrees and resulting in a sustained "hyperthermia" for two hours. (Dr. Joseph Zwischenberger did not respond to a list of questions about the study he directed.)
The consent form for the study cites a long list of serious potential side effects, including brain and spinal cord damage, loss of limbs, heart attack, hallucination, memory loss, burns at body pressure points, congestive heart failure, internal bleeding, seizures and death. While consent forms for experimental studies typically do list a wide array of possible complications, this form carried the additionally disturbing warning that the university would not compensate a research subject in case of injury. Participants in the study signed a form that read: " I understand that I cannot … receive financial remuneration for any injuries resulting from my participation in this project."
Federal regulations specifically prohibit any language in informed consent documents whereby a subject is made to release, or appear to release, the investigator or the institution from liability for negligence. "The protection of all human research subjects, including prisoners who volunteer for research, is paramount," explains Dr. Michael A. Carome, director of the OHRP’s Division of Compliance Oversight.
Yet while UTMB was given specific guidance on how to improve its reporting, reviewing and informed consent procedures, at no point, confirms the OHRP, were any of the prisoners in these studies interviewed about their experiences as test subjects. Paperwork was submitted by the university in response to concerns raised by the OHRP. On the basis of that paperwork—although no further site visits were made—the researchers were given the go-ahead by the OHRP in mid-January 2001 to resume their work, although it is unclear which of the objectionable studies were allowed to continue.
No information was furnished in response to a detailed FOIA request, and UTMB officials declined to answer questions about the trials by phone or e-mail.
Texas isn’t the only university to come under scrutiny for its experiments on prisoners.
In 2000, the OHRP also directed the University of Miami to suspend enrollment of volunteers in a medical study of juvenile inmates, noting the existence of three other university studies involving prisoners that had not been reported to the appropriate federal office. In addition, the OHRP instructed the University of Florida, Yale University and Brown University to drastically improve their reporting and oversight procedures for several studies involving prisoners. Researchers and administrators at the three institutions did not respond to requests for information about ongoing studies involving prisoners, although Brown noted that a study in the Philippines examining STDs and the high-risk behaviors of female prisoners had ended.
Recent examples of invasive and potentially dangerous experiments have not only raised concerns about the diligence of universities in protecting the well-being of prisoners. They’ve also thrown into question the OHRP’s ability to keep tabs on federally funded studies involving human subjects. Carome confirms that his office still has not collected data on the number of prisoners participating in medical research studies. "This type of data has not been previously collected," he explains, "nor am I aware of any plan to collect such data in the future."
As such, no national estimates exist for how many prisoners are enrolled in federally funded clinical trials or research studies. Furthermore, the OHRP does not keep tabs on failed research studies or prisoner deaths. Independent of federal oversight, privately funded clinical trials have even less of a chance of meeting with public scrutiny. "Most drug trials fail," notes Dr. David Egilman, a professor at Brown and critic of medical research on prisoners. "Drug companies don’t publish those failures so that their competitors will repeat the same mistakes."
Last year, the National Bioethics Advisory Committee called for regulations requiring doctors to reveal their financial interests to patients and for drastic changes in the existing federal oversight of research involving humans. A Senate hearing in May addressed the concerns of family members who had lost relatives to questionable medical research. And some critics want to see the OHRP separated from the Department of Health and Human Services because of the inherent conflicts of promoting and regulating studies conducted on humans. But change is likely to be slow in coming, since medical research enjoys heavy pharmaceutical funding and federal government support.
At a medical research summit held in Washington, D.C. in March, more than 200 researchers, medical ethicists and administrators gathered to discuss, among other issues, the disclosure of financial ties between clinical-trial researchers and pharmaceutical companies. When questions about federal oversight of studies involving human subjects were raised, Dr. Thomas Puglisi, the former director of compliance for the Office of Protection from Research Risks (now the OHRP) said: "What we’ve got from the regulatory standpoint is a mess. I couldn’t say that when I worked for the federal government, but I can say that now."
The resurgence of medical research on prisoners has sparked renewed debate about its ethical implications. AIDS researchers, medical and legal experts, ethicists, and prisoner advocates convened a meeting in October 1999 at Brown University to develop detailed guidelines for medical research that would do more to protect prisoners. Those guidelines have since "languished," says Dr. Anne De Groot, one of the conference organizers and director of the TB/HIV lab at the Brown University School of Medicine. But Eligman says researchers were asking the wrong question. "Instead of asking how prison research should be done," he says, "they should be asking if it should be done at all."
The National Commission for the Protection of Human Subjects, which provides ethical guidance to the OHRP, has found that prisoners often volunteer for medical research as a means of accessing competent medical care. The OHRP’s own guidebook states that "prisoners and patients in mental institutions are confined under the strict control of people whom they must please and to whom they must appear cooperative and rational if they are to earn their release. These potential subjects may believe … that agreeing to participate in research will be viewed positively by their wardens, psychiatrists, or social workers."
Last year, the St. Petersburg Times reported that some HIV-positive prisoners in the clinical trials may have been pressured to enroll in those studies. Several inmates specifically told the newspaper they had agreed to participate in the studies "to escape poor medical care, abusive conditions or lack of access to up-to-date HIV drugs at other Florida prisons."
Jeffrey Kahn, director of the Center for Bioethics at the University of Minnesota, believes that prison represents such a captive environment that researchers should use inmates for research only when the research could benefit prisoners as individuals or as a group. He adds, "Research policy must balance preventing the exploitation of subjects against overprotecting groups [so] that they lose out on the research benefits offered to others."
In this way, researchers overseeing clinical trials in prisons have stressed the potential benefits of such studies to seriously ill prisoners themselves. "Incarcerated populations may not have access to cutting-edge therapies except through clinical investigation," says Dr. David Thomas, director of health services at the Florida Department of Corrections.
Indeed, numerous prisoner-advocacy groups, as well as groups such as the National Minority AIDS Council, are quick to point out that not all prisoners involved in research studies have been unwitting or unwilling participants. Increased access to clinical trials, they note, serves an important purpose for prisoners with chronic illnesses, given that medical care in prison is generally substandard. "Our position is that prisoners should not be excluded from trials that are efficacious, that are going to improve their health, and that they would normally have access to if they were in the community," notes Walker of the ACLU. "But we also don’t want prisoners to be used as guinea pigs for trials that companies wouldn’t complete in the community."
Silja J.A. Talvi is a Seattle-based journalist and an editor of LiP Magazine (www.lipmagazine.org).
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