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January 23, 2002
The Prison As Laboratory
Experimental medical research on inmates is on the rise.
he 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 experimentswhich formed the focal point of Allen
M. Hornblums 1998 book Acres of Skinincluded 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
But evidence has emerged that prison-based research studies are again being
conducted in numerous statesincluding Arkansas, Connecticut, Florida,
Maryland, Rhode Island, South Carolina and Texasand that hundreds of clinical
trials and experimental therapies may have subjected prisoners to unjustifiable
medical risks, in clear violation of existing federal regulations.
esearch 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 universitys 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.
he 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
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 OHRPs
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 paperworkalthough no further
site visits were madethe 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.
exas isnt 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. Theyve also thrown into question the OHRPs 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 dont 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 weve got from the regulatory standpoint is a mess. I
couldnt say that when I worked for the federal government, but I can say
he 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
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 OHRPs 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 dont want prisoners to be used as guinea pigs
for trials that companies wouldnt complete in the community.
Silja J.A. Talvi is a Seattle-based journalist and an editor of LiP