PHILADELPHIA, Aug. 7 — An influential federal panel of medical advisers has recommended that the government loosen regulations that severely limit the testing of pharmaceuticals on prison inmates, a practice that was all but stopped three decades ago after revelations of abuse.
- Chemical Warfare Study by the U.S. Army (March 1969)
- Dioxin Experiments for Dow Chemical (Dec. 1964)
- Radioactive Isotope Experiments (March 1966)
- Project MKULTRA, The CIA's Program of Research in Behavioral Modification (Aug. 1977)
- Human Drug Testing by the CIA (Aug. 1977)
Reports on Experiments Conducted on Prisoners at Holmesburg and Elsewhere
The proposed change includes provisions intended to prevent problems that plagued earlier programs. Nevertheless, it has dredged up a painful history of medical mistreatment and incited debate among prison rights advocates and researchers about whether prisoners can truly make uncoerced decisions, given the environment they live in.
Supporters of such programs cite the possibility of benefit to prison populations, and the potential for contributing to the greater good.
Until the early 1970’s, about 90 percent of all pharmaceutical products were tested on prison inmates, federal officials say. But such research diminished sharply in 1974 after revelations of abuse at prisons like Holmesburg here, where inmates were paid hundreds of dollars a month to test items as varied as dandruff treatments and dioxin, and where they were exposed to radioactive, hallucinogenic and carcinogenic chemicals.
In addition to addressing the abuses at Holmesburg, the regulations were a reaction to revelations in 1972 surrounding what the government called the Tuskegee Study of Untreated Syphilis in the Negro Male, which was begun in the 1930’s and lasted 40 years. In it, several hundred mostly illiterate men with syphilis in rural Alabama were left untreated, even after a cure was discovered, so that researchers could study the disease.
“What happened at Holmesburg was just as gruesome as Tuskegee, but at Holmesburg it happened smack dab in the middle of a major city, not in some backwoods in Alabama,” said Allen M. Hornblum, an urban studies professor at Temple University and the author of “Acres of Skin,” a 1998 book about the Holmesburg research. “It just goes to show how prisons are truly distinct institutions where the walls don’t just serve to keep inmates in, they also serve to keep public eyes out.”
Critics also doubt the merits of pharmaceutical testing on prisoners who often lack basic health care.
Alvin Bronstein, a Washington lawyer who helped found the National Prison Project, an American Civil Liberties Union program, said he did not believe that altering the regulations risked a return to the days of Holmesburg.
“With the help of external review boards that would include a prisoner advocate,” Mr. Bronstein said, “I do believe that the potential benefits of biomedical research outweigh the potential risks.”
Holmesburg closed in 1995 but was partly reopened in July to help ease overcrowding at other prisons.
Under current regulations, passed in 1978, prisoners can participate in federally financed biomedical research if the experiment poses no more than “minimal” risks to the subjects. But a report formally presented to federal officials on Aug. 1 by the Institute of Medicine of the National Academy of Sciences advised that experiments with greater risks be permitted if they had the potential to benefit prisoners. As an added precaution, the report suggested that all studies be subject to an independent review.
“The current regulations are entirely outdated and restrictive, and prisoners are being arbitrarily excluded from research that can help them,” said Ernest D. Prentice, a University of Nebraska genetics professor and the chairman of a Health and Human Services Department committee that requested the study. Mr. Prentice said the regulation revision process would begin at the committee’s next meeting, on Nov. 2.
The discussion comes as the biomedical industry is facing a shortage of testing subjects. In the last two years, several pain medications, including Vioxx and Bextra, have been pulled off the market because early testing did not include large enough numbers of patients to catch dangerous problems.
And the committee’s report comes against the backdrop of a prison population that has more than quadrupled, to about 2.3 million, over the last 30 years and that disproportionately suffers from H.I.V. and hepatitis C, diseases that some researchers say could be better controlled if new research were permitted in prisons.
For Leodus Jones, a former prisoner, the report has opened old wounds. “This moves us back in a very bad direction,” said Mr. Jones, who participated in the experiments at Holmesburg in 1966 and after his release played a pivotal role in lobbying to get the regulations passed.
In one experiment, Mr. Jones’s skin changed color, and he developed rashes on his back and legs where he said lotions had been tested.
“The doctors told me at the time that something was seriously wrong,” said Mr. Jones, who added that he had never signed a consent form. He reached a $40,000 settlement in 1986 with the City of Philadelphia after he sued.
“I never had these rashes before,” he said, “but I’ve had them ever since.”
The Institute of Medicine report was initiated in 2004 when the Health and Human Services Department asked the institute to look into the issue. The report said prisoners should be allowed to take part in federally financed clinical trials so long as the trials were in the later and less dangerous phase of Food and Drug Administration approval. It also recommended that at least half the subjects in such trials be nonprisoners, making it more difficult to test products that might scare off volunteers.
Dr. A. Bernard Ackerman, a New York dermatologist who worked at Holmesburg during the 1960’s trials as a second-year resident from the University of Pennsylvania, said he remained skeptical. “I saw it firsthand,” Dr. Ackerman said. “What started as scientific research became pure business, and no amount of regulations can prevent that from happening again.”
Others cite similar concerns over the financial stake in such research.
“It strikes me as pretty ridiculous to start talking about prisoners getting access to cutting-edge research and medications when they can’t even get penicillin and high-blood-pressure pills,” said Paul Wright, editor of Prison Legal News, an independent monthly review. “I have to imagine there are larger financial motivations here.”
The demand for human test subjects has grown so much that the so-called contract research industry has emerged in the past decade to recruit volunteers for pharmaceutical trials. The Tufts Center for the Study of Drug Development, a Boston policy and economic research group at Tufts University, estimated that contract research revenue grew to $7 billion in 2005, up from $1 billion in 1995.
But researchers at the Institute of Medicine said their sole focus was to see if prisoners could benefit by changing the regulations.