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Texas and Florida Prisoners Used in Medical Experiments
When the AIDS epidemic struck in the mid eighties and pharmaceutical companies wished to test new and promising drugs, what better place than in the nation's prison systems? AIDS has no known cure and test subjects in the prison population are far more available and expendable than test subjects in the general population. The rate of HIV infection is higher there than in the general population and drug companies could and would supply complete expensive medical care for HIV and AIDS infected prisoners.
There is an inherent contradiction, however, in the use of prisoners as human guinea pigs. Mandatory Standard 34373 of the American Correctional Association (ACA) specifies that "Written policy and practice prohibit the use of [prisoners] for medical, pharmaceutical or cosmetic experiments" Among the few states that allow the testing of prisoners are Texas and Florida. The ACA has not explained how any of the experimental drug programs being carried out on prisoners in those states can pass muster under the standard. Nor has either the Texas or the Florida DOC attempted to justify its programs.
The use of prisoners in medical testing is banned in many states because testing conducted over the years since the 1930s subjected prisoners to the exploitation of drug companies rushing to test new products for the commercial market. "Prison reformers likened some of the studies, which included cancer and hepatitis drugs, to inhumane experiments conducted by [Nazi] doctors during World War Il. Some ethicists contended that even though the research might hold great promise for society, [prisoners] could never give truly informed consent because they live in a closed environment that can never be free of coercion." [St. Petersburg Times]
Three provisions protect participants in medical tests when the U.S. Office for Human Resource Protections (OHRP), of the Department of Health and Human Services, grants funds for such tests. The tests may not be impermissibly risky; they must provide a "reasonable probability" of improving the health of the participants; and said participants must have given their informed consent for the testing. In the case of prisoners, precisely because they are prisoners, the decision to take part in a test must be "truly voluntary and uncoerced." Testing sponsored and funded by the National Institute of Health and pharmaceutical companies is supervised by the NIH office known as the Office for Protection from Research Risks. Together with funding provided by the pharmaceutical companies whose drugs are being tested, these agencies spend billions to develop drugs and get them onto the shelves of pharmacies.
The University of Texas (UT) Medical Branch at Galveston, chief medical provider for the Texas prison system, was receiving OHRP funds in the summer of 2000 for trials of drugs to treat HIV and AIDS, hepatitis C and cancer. In July, OHRP expressed concern that the university was not following requirements for the protection of prisoners and ordered it to stop enrolling them in the programs. UT Medical Branch was not alone; in August the University of Florida stopped enrolling prisoners, also at the request of federal investigators. In September, UT Medical Branch was ordered to suspend some 300 of its medical research projects, among them 26 tests involving 99 prisoners.
According to the AustinAmerican Statesman, the letter which ordered the halt, written in mid September 2000, two weeks after federal officials had visited the UT Medical Branch facilities, made it clear that "OHRP is particularly concerned that some of the (tests) ... involved greater than minimal risk and did not involve research on practices which had the intent and reasonable probability of improving the health or wellbeing of the subjects" The agency also indicated that UT Medical Branch had failed to ensure that the review process included prisoner advocates. The medical projects in which prisoners were involved, however, had not been suspended at all; it seems UT Medical Branch doctors "determined it was in the best medical interest of the [prisoners] to continue programs uninterrupted," according to the Austin paper. Contradictory as it may appear, federal officials concurred.
UT Medical Branch insisted the problem was one of "changing and evolving" rules, misunderstandings with respect to documentation but not about the quality of care given participants in the medical tests. A week later, on 27 September, the problem was evidently resolved: UT Medical Branch was allowed to resume all of its research testing, albeit under increased federal oversight. Some of the changes implemented included the creation of two review boards to replace the existing single panel. Prisoner advocates were to be named to both boards. UT Medical Branch public affairs director, Chris Comer, concluded, "it was not that we were not doing good work, it was that we just weren't documenting properly how we were doing that good work... We think we have successfully addressed the concerns of the federal officials."
"...[A] spokesman for the [federal) agency said the lifting of the suspension was `standard procedure:' ` it seemed that the "prisoner advocate" required on the review board had not been a prisoner at all but rather a university doctor who worked at a prison hospital. Though university representatives maintained this did not constitute a conflict of interest, the federal investigators disagreed.
University officials who took part in the investigation could not or would not provide further details on the research or on the amount of money involved in its funding.
In December of 1997, under the supervision of the University of Miami, 64 HIV positive and AIDS infected Florida state prisoners began a course of experimental treatment in a series of nine studies conducted at the South Unit of the Central Florida Reception Center near Orlando. Four of the trials were funded by the NIH; three by Glaxo Wellcome PLC, the producer of AZT; one by Merck & Co.; and one by Pharmacia & Upjohn Inc. Of these, six were still in progress as of August, 2000. A dozen drugs and drug cocktails produced by nine pharmaceutical firms have been and are being employed in the tests. All of the trials are under the supervision of Dr. Margaret Fischl, who had previously worked on the development of AZT. She says she "remains proud of that work," in spite of the fact that AZT never measured up to its promise and AIDS activists have charged that she manipulated the results obtained at Glaxo Wellcome to cast the company in a good light.
When it was originally suggested to use prisoners for the trials, the Department of Corrections agreed only after it had established an oversight group. Federal rules require the presence of a prisoner or prisoner advocate in such groups. In the role of prisoner advocate and theoretically head of the group was David L. Thomas, MD, director of DOC health services. He is an enthusiastic proponent of the research project. When the University of Miami selected him, however, critics charged conflict of interest since he is both a University of Miami graduate and an employee of the prison system. "Even in the most humane and enlightened prison, it's utterly preposterous to claim that any individual who is either from a correctional facility or the state is an advocate. They are adversaries," according to Ruth Macklin, a bioethicist at New York City's Albert Einstein College of Medicine. To which Thomas responded, "I thought I was an appropriate person. I've got a background in ethics." He denies financial impropriety, and the Department of Corrections defends his stand, yet Brown University listed him as a consultant and speaker for Agouron Pharmaceuticals and BristolMyers Squibb, both of which gave him honoraria as a result. These two companies made anti AIDS drugs used in the South Unit testing.
When, because of requirements of the oversight meetings, it became difficult to recruit members for the monitoring group, Thomas, a lawyer and a former Republican whip in the Florida House of Representatives, called upon his wife, who duly became a member. To no avail, however, as the Department of Corrections disbanded the group in the fall of 2000, because its members lacked the scientific knowledge to complete the necessary oversight. They were unable to determine how prisoners were selected or whether staff numbers and training were sufficient to handle potential problems. Since then there has been no monitoring of the testing. The DOC is presently considering a new oversight panel but seven of the ten members chosen so far are employees of the prison system. It must, as previously stated, appoint a prisoner or a prisoner advocate and ideally it should contain no state employees at all.
HIV positive prisoners are lured into volunteering for the trials by niceties such as air conditioning and new sneakers in addition to the quality medical care they cannot receive in prisons that do not have the experimental programs. Some prisoners receive as many as 53 pills a day divided fairly evenly into morning, afternoon and evening doses. Yet these same prisoners seem woefully uninformed about the possible dangers of the drug cocktails they are receiving. Dave Whiters, a convicted cocaine dealer now at the South Unit, whose medication sheet showed one of the drugs he was receiving to be a placebo, admitted he did not know what that was when he was asked.
Abacavir (Ziagen), by Glaxo Wellcome, which can cause a "potentially life threatening" hypersensitivity reaction according to prisoners' consent forms, is one of the drugs being tested but prisoners are not given explanations of its potential side effects. When the drug became available in late 1998, the FDA ordered that all patients receiving it be given detailed written explanations. Prisoner patients often do not ask nor are they told about this provision in the consent forms they sign. The forms themselves are written in what some forms writing experts have deemed at a "15" grade level, that is, at a reading level expected of third year college students. Most daily newspapers, by comparison, are written at about a fifth grade level.
Prisoners tend frequently to downplay the side effects caused by drugs because of the otherwise excellent medical care and living conditions they receive in return for lending their bodies and lives to the pharmaceuticals' quest for profit. In the words of prisoner Dave Whiters, "If you want yourself taken care of, go to South Unit." True, but there one must take what is proffered; second opinions on treatment options are not available. The side effects prisoners hesitate to report, and most likely would prefer to forget, include muscle pain, nausea and vomiting, fatigue and sleep disorders and tingling legs, numb feet and ingrown toenails (hence the new sneakers, supra).
The University of Miami itself declines to release information about the reports it prepares when prisoners suffer adverse reactions to the prescribed drug regimen; it cites federal regulations forbidding such disclosure. According to Associated Press and reported by Sydney P. Freedburg in the St. Petersburg Times, eight deaths have associated with abacavir have occurred nationwide; there was no way, of course, to prove abacavir responsible. [For a complete history of American prisoners as subjects of medical experimentation see Acres of Skin: Human Experiments at Holmesburg Prison," 1998, by Allen Homblum, distributed by PLN.)
Sources: Austin American Statesman, Austin, Texas; web site for The Chronicle of Higher Education: www.chronicle.comldaily; St Petersburg Times, St. Petersburg, Florida, ACA Standards for Adult Correctional Institutions, Third edition.
There is an inherent contradiction, however, in the use of prisoners as human guinea pigs. Mandatory Standard 34373 of the American Correctional Association (ACA) specifies that "Written policy and practice prohibit the use of [prisoners] for medical, pharmaceutical or cosmetic experiments" Among the few states that allow the testing of prisoners are Texas and Florida. The ACA has not explained how any of the experimental drug programs being carried out on prisoners in those states can pass muster under the standard. Nor has either the Texas or the Florida DOC attempted to justify its programs.
The use of prisoners in medical testing is banned in many states because testing conducted over the years since the 1930s subjected prisoners to the exploitation of drug companies rushing to test new products for the commercial market. "Prison reformers likened some of the studies, which included cancer and hepatitis drugs, to inhumane experiments conducted by [Nazi] doctors during World War Il. Some ethicists contended that even though the research might hold great promise for society, [prisoners] could never give truly informed consent because they live in a closed environment that can never be free of coercion." [St. Petersburg Times]
Three provisions protect participants in medical tests when the U.S. Office for Human Resource Protections (OHRP), of the Department of Health and Human Services, grants funds for such tests. The tests may not be impermissibly risky; they must provide a "reasonable probability" of improving the health of the participants; and said participants must have given their informed consent for the testing. In the case of prisoners, precisely because they are prisoners, the decision to take part in a test must be "truly voluntary and uncoerced." Testing sponsored and funded by the National Institute of Health and pharmaceutical companies is supervised by the NIH office known as the Office for Protection from Research Risks. Together with funding provided by the pharmaceutical companies whose drugs are being tested, these agencies spend billions to develop drugs and get them onto the shelves of pharmacies.
The University of Texas (UT) Medical Branch at Galveston, chief medical provider for the Texas prison system, was receiving OHRP funds in the summer of 2000 for trials of drugs to treat HIV and AIDS, hepatitis C and cancer. In July, OHRP expressed concern that the university was not following requirements for the protection of prisoners and ordered it to stop enrolling them in the programs. UT Medical Branch was not alone; in August the University of Florida stopped enrolling prisoners, also at the request of federal investigators. In September, UT Medical Branch was ordered to suspend some 300 of its medical research projects, among them 26 tests involving 99 prisoners.
According to the AustinAmerican Statesman, the letter which ordered the halt, written in mid September 2000, two weeks after federal officials had visited the UT Medical Branch facilities, made it clear that "OHRP is particularly concerned that some of the (tests) ... involved greater than minimal risk and did not involve research on practices which had the intent and reasonable probability of improving the health or wellbeing of the subjects" The agency also indicated that UT Medical Branch had failed to ensure that the review process included prisoner advocates. The medical projects in which prisoners were involved, however, had not been suspended at all; it seems UT Medical Branch doctors "determined it was in the best medical interest of the [prisoners] to continue programs uninterrupted," according to the Austin paper. Contradictory as it may appear, federal officials concurred.
UT Medical Branch insisted the problem was one of "changing and evolving" rules, misunderstandings with respect to documentation but not about the quality of care given participants in the medical tests. A week later, on 27 September, the problem was evidently resolved: UT Medical Branch was allowed to resume all of its research testing, albeit under increased federal oversight. Some of the changes implemented included the creation of two review boards to replace the existing single panel. Prisoner advocates were to be named to both boards. UT Medical Branch public affairs director, Chris Comer, concluded, "it was not that we were not doing good work, it was that we just weren't documenting properly how we were doing that good work... We think we have successfully addressed the concerns of the federal officials."
"...[A] spokesman for the [federal) agency said the lifting of the suspension was `standard procedure:' ` it seemed that the "prisoner advocate" required on the review board had not been a prisoner at all but rather a university doctor who worked at a prison hospital. Though university representatives maintained this did not constitute a conflict of interest, the federal investigators disagreed.
University officials who took part in the investigation could not or would not provide further details on the research or on the amount of money involved in its funding.
In December of 1997, under the supervision of the University of Miami, 64 HIV positive and AIDS infected Florida state prisoners began a course of experimental treatment in a series of nine studies conducted at the South Unit of the Central Florida Reception Center near Orlando. Four of the trials were funded by the NIH; three by Glaxo Wellcome PLC, the producer of AZT; one by Merck & Co.; and one by Pharmacia & Upjohn Inc. Of these, six were still in progress as of August, 2000. A dozen drugs and drug cocktails produced by nine pharmaceutical firms have been and are being employed in the tests. All of the trials are under the supervision of Dr. Margaret Fischl, who had previously worked on the development of AZT. She says she "remains proud of that work," in spite of the fact that AZT never measured up to its promise and AIDS activists have charged that she manipulated the results obtained at Glaxo Wellcome to cast the company in a good light.
When it was originally suggested to use prisoners for the trials, the Department of Corrections agreed only after it had established an oversight group. Federal rules require the presence of a prisoner or prisoner advocate in such groups. In the role of prisoner advocate and theoretically head of the group was David L. Thomas, MD, director of DOC health services. He is an enthusiastic proponent of the research project. When the University of Miami selected him, however, critics charged conflict of interest since he is both a University of Miami graduate and an employee of the prison system. "Even in the most humane and enlightened prison, it's utterly preposterous to claim that any individual who is either from a correctional facility or the state is an advocate. They are adversaries," according to Ruth Macklin, a bioethicist at New York City's Albert Einstein College of Medicine. To which Thomas responded, "I thought I was an appropriate person. I've got a background in ethics." He denies financial impropriety, and the Department of Corrections defends his stand, yet Brown University listed him as a consultant and speaker for Agouron Pharmaceuticals and BristolMyers Squibb, both of which gave him honoraria as a result. These two companies made anti AIDS drugs used in the South Unit testing.
When, because of requirements of the oversight meetings, it became difficult to recruit members for the monitoring group, Thomas, a lawyer and a former Republican whip in the Florida House of Representatives, called upon his wife, who duly became a member. To no avail, however, as the Department of Corrections disbanded the group in the fall of 2000, because its members lacked the scientific knowledge to complete the necessary oversight. They were unable to determine how prisoners were selected or whether staff numbers and training were sufficient to handle potential problems. Since then there has been no monitoring of the testing. The DOC is presently considering a new oversight panel but seven of the ten members chosen so far are employees of the prison system. It must, as previously stated, appoint a prisoner or a prisoner advocate and ideally it should contain no state employees at all.
HIV positive prisoners are lured into volunteering for the trials by niceties such as air conditioning and new sneakers in addition to the quality medical care they cannot receive in prisons that do not have the experimental programs. Some prisoners receive as many as 53 pills a day divided fairly evenly into morning, afternoon and evening doses. Yet these same prisoners seem woefully uninformed about the possible dangers of the drug cocktails they are receiving. Dave Whiters, a convicted cocaine dealer now at the South Unit, whose medication sheet showed one of the drugs he was receiving to be a placebo, admitted he did not know what that was when he was asked.
Abacavir (Ziagen), by Glaxo Wellcome, which can cause a "potentially life threatening" hypersensitivity reaction according to prisoners' consent forms, is one of the drugs being tested but prisoners are not given explanations of its potential side effects. When the drug became available in late 1998, the FDA ordered that all patients receiving it be given detailed written explanations. Prisoner patients often do not ask nor are they told about this provision in the consent forms they sign. The forms themselves are written in what some forms writing experts have deemed at a "15" grade level, that is, at a reading level expected of third year college students. Most daily newspapers, by comparison, are written at about a fifth grade level.
Prisoners tend frequently to downplay the side effects caused by drugs because of the otherwise excellent medical care and living conditions they receive in return for lending their bodies and lives to the pharmaceuticals' quest for profit. In the words of prisoner Dave Whiters, "If you want yourself taken care of, go to South Unit." True, but there one must take what is proffered; second opinions on treatment options are not available. The side effects prisoners hesitate to report, and most likely would prefer to forget, include muscle pain, nausea and vomiting, fatigue and sleep disorders and tingling legs, numb feet and ingrown toenails (hence the new sneakers, supra).
The University of Miami itself declines to release information about the reports it prepares when prisoners suffer adverse reactions to the prescribed drug regimen; it cites federal regulations forbidding such disclosure. According to Associated Press and reported by Sydney P. Freedburg in the St. Petersburg Times, eight deaths have associated with abacavir have occurred nationwide; there was no way, of course, to prove abacavir responsible. [For a complete history of American prisoners as subjects of medical experimentation see Acres of Skin: Human Experiments at Holmesburg Prison," 1998, by Allen Homblum, distributed by PLN.)
Sources: Austin American Statesman, Austin, Texas; web site for The Chronicle of Higher Education: www.chronicle.comldaily; St Petersburg Times, St. Petersburg, Florida, ACA Standards for Adult Correctional Institutions, Third edition.
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