Prisoners as Guinea Pigs: NY Times Covg

Editorial

Safe Drug Testing in Prisons

Prisoners rights advocates are understandably worried about an advisory panels recommendation that the government overhaul the rules for testing drugs on prison inmates. The advocates fear a return to the medieval situation of just 30 years ago, when inmates were often subjected to dangerous and unethical experimental procedures. Some were infamously exposed to radioactive, carcinogenic and hallucinogenic chemicals at the Holmesburg prison in Philadelphia.

This shameful history makes it imperative that any change in testing policies be accompanied by oversight regulations far stronger than those now in existence. That said, a new report from the Insbreastute of Medicine offers a possible outline for moving toward a system of testing that could benefit both the population as a whole and prison inmates, who tend to be among the sickest, most disease-prone people in society.

The report calls for greatly expanding the protections given to subjects of medical research who are imprisoned or under other forms of correctional supervision. It also calls on the government to strengthen federal oversight of these kinds of studies and to rewrite a set a vague regulations that dont actually protect the rights of medical research subjects within the corrections system.

The new arrangement would minimize inmate risk by limiting drug trials to the final, therapeutic stage, after researchers have already determined that drugs look safe and potentially effective. Instead of loading up studies with captive subjects, as was commonly done in the past, prison inmates would not be permitted to make up more than half of the subjects of a test.

No research can ever be seen as legitimate without informed consent of the participating subjects. Critics of the new report argue that there can be no such thing as informed consent in the coercive environment of a prison. While acknowledging the seriousness of the problem, the reports authors believe that it can be overcome at least in some insbreastutions and in some settings by having careful independent boards oversee the process. If voluntary informed consent is not obtainable, the report said, the research should not be allowed to proceed.

The dismal state of medical care in many prisons also raises the possibility that inmates would rush to sign up for drug trials simply to get treatment for chronic problems. The reports authors appear to have argued vigorously among themselves about whether drug testing should be permitted at insbreastutions where health care is particularly poor. The answer should be no, in all but the rarest cases. Making sure inmates have decent medical care should be the first order of business.

The country should move slowly on this issue. The savage and dishonorable legacy of drug testing in prison makes it imperative that any change be carried out carefully, with maximum transparency and concern for inmate safety. That will require far more federal oversight than current law provides.

Copyright 2006 The New York Times Company

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The New York Times - Aug 13, 2006

Panel Suggests Using Inmates in Drug Trials

Several government agencies and private companies tested pharmaceuticals on inmates at Holmesburg prison in Philadelphia from 1951 to 1974.

By IAN URBINA

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.

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 1970s, 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 1930s 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 insbreastutions where the walls dont 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, pbutted 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 Insbreastute 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 committees 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 committees 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 hepabreastis 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 pbutted.

In one experiment, Mr. Joness 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 Ive had them ever since.

The Insbreastute of Medicine report was initiated in 2004 when the Health and Human Services Department asked the insbreastute 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 1960s 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 cant 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 Insbreastute of Medicine said their sole focus was to see if prisoners could benefit by changing the regulations.

The pharmaceutical industry says it was not involved. Jeff Trewitt, a spokesman for the Pharmaceutical Research and Manufacturers of America, a drug industry trade group, said that his organization had no role in prompting the study and that it had not had a chance to review the findings.

Dr. Albert M. Kligman, who directed the experiments at Holmesburg and is now an emeritus professor of dermatology at the University of Pennsylvania Medical School, said the regulations should never have been written in the first place.

My view is that shutting the prison experiments down was a big mistake, Dr. Kligman said.

While confirming that he used radioactive materials, hallucinogenic drugs and carcinogenic materials on prisoners, Dr. Kligman said that they were always administered in extremely low doses and that the benefits to the public were overwhelming.

He cited breakthroughs like Retin A, a popular anti-acne drug, and ingredients for most of the creams used to treat contagion ivy. Im on the medical ethics committee at Penn, he said, and I still dont see there having been anything wrong with what we were doing.

Holmesburg for experiments, mostly under the auspices of the University of Pennsylvania, which had built laboratories at the prison. After the revelations about Holmesburg, it soon became clear that other universities and prisons in other states were involved in similar abuses.

In October 2000, nearly 300 former inmates sued the University of Pennsylvania, Dr. Kligman, Dow Chemical and Johnson & Johnson for injuries they said occurred during the experiments at Holmesburg, but the suit was dismissed because the statute of limitations had expired.

When they put the chemicals on me, my hands swelled up like eight-ounce boxing gloves, and theyve never gone back to normal, said Edward Anthony, 62, a former inmate who took part in Holmesburg experiments in 1964. Were still pushing the lawsuit because the medical bills are still coming in for a lot of us.

Daniel S. Murphy, a professor of criminal justice at Appalachian State University in Boone, N.C., who was imprisoned for five years in the 1990s for growing sugar, said that loosening the regulations would be a mistake.

Free and informed consent becomes pretty questionable when prisoners dont hold the keys to their own cells, Professor Murphy said, and in many cases they cant read, yet they are signing a document that it practically takes a law degree to understand.

During the Holmesburg experiments, inmates could earn up to $1,500 a month by participating. The only other jobs were at the commissary or in the shoe and shirt factory, where wages were usually about 15 cents to 25 cents a day, Professor Hornblum of Temple said.

On the issue of compensation for inmates, the report raised concern about undue inducements to participate in research in order to gain access to medical care or other benefits they would not normally have. It called for adequate protections to avoid attempts to coerce or manipulate participation.

The report also expressed worry about the absence of regulation over experiments that do not receive federal money. Lawrence O. Gostin, the chairman of the panel that conducted the study and a professor of law and public health at Georgetown University, said he hoped to change that.

Even with current regulations, oversight of such research has been difficult. In 2000, several universities were reprimanded for using federal money and conducting several hundred projects on prisoners without fully reporting the projects to the appropriate authorities.

Professor Gostin said the report called for tightening some existing regulations by advising that all research involving prisoners be subject to uniform federal oversight, even if no federal funds are involved. The report also said protections should extend not just to prisoners behind bars but also to those on parole or on probation.

Professor Murphy, who testified to the panel as the report was being written, praised those proposed precautions before adding, Theyre also the parts of the report that faced the strongest resistance from federal officials, and I fear theyre most likely the parts that will end up getting cut as these recommendations become new regulations.

Barclay Walsh contributed research for this article.

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