More than half of prisoners have mental health problems. Roughly 70% didn’t graduate high school. Still, the Institute of Medicine (IOM), the government’s adviser on improving the nation’s health, recommends that federal and state prison inmates be allowed to participate in “risky” pharmaceutical clinical trials: studies designed to test the safety and effectiveness of experimental medicines. Today, some states permit prisoner testing that poses no more than a “minimal” risk. The IOM now recommends that all experiments “whose risk of physical or psychological harm is no greater in probability and severity than that ordinarily encountered in their daily lives” be allowed if the drugs might benefit inmates.
But will the disproportionately African-American detainees really gain? Or is the IOM looking out for the pharmaceutical industry, which, according to marketing research firm Cutting Edge Information, loses between $600,000 and $8 million daily when it can’t recruit enough participants? Do they need a literally captive audience?
“The idea that there are physicians and medical ethicists who want to get back into this gives me a chill,” says Temple University professor Allen Hornblum, author of Acres of Skin: Human Experiments at Holmesburg Prison. In the 1970s, inmates at that Philadelphia facility were paid to test products that they later learned contained harmful chemicals. Hornblum says the new recommendations may green-light further mistreatment. The financial incentive to participate and prisoners’ mental health problems and low literacy levels could lessen their ability to provide informed consent, as required by law. “They may feel coerced to participate to get better medical care or accommodations,” says Nancy Neveloff Dubler, former editor and founder of the Journal of Prison and Jail Health: Medicine, Law, Corrections and Ethics.
Clinical trials are essential to finding lifesaving drug treatments, and medications are tested on lab animals before humans. But a history of mistreating inmates makes reinstituting risky trials, well, risky. The Department of Health and Human Services is inviting public comment. To send your opinion, write to Michael O. Leavitt, the secretary of the U.S. Department of Health and Human Services, at 200 Indepen-dence Ave. SW, Washington, DC 20201. If someone you know is incarcerated, have them inform you or a prison advocate before participating in a clinical trial.
Health writer Glenn Ellis serves as a patient advocate on two Philadelphia clinical trial review boards.
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