Panel Suggests Using Inmates in Drug Trials

From the NY Times, part of a much longer article

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 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.

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.”

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.”

From 1951 to 1974, several federal agencies and more than 30 companies used 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. (Holmesburg closed in 1995 but was partly reopened in July to help ease overcrowding at other prisons.)

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 they’ve never gone back to normal,” said Edward Anthony, 62, a former inmate who took part in Holmesburg experiments in 1964. “We’re 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 1990’s for growing marijuana, said that loosening the regulations would be a mistake.

“Free and informed consent becomes pretty questionable when prisoners don’t hold the keys to their own cells,” Professor Murphy said, “and in many cases they can’t read, yet they are signing a document that it practically takes a law degree to understand.”

Of course, psychiatric abuse was all just a part of this.