HIV/AIDS: Florida Inmate Study Sparks Ethical Concerns
Dozens of inmates at the Orlando, Fla.-based South Unit of the Central Florida Reception Center are being treated with powerful HIV therapies in studies to determine "which drugs work best in which doses for which kinds of patients," the St. Petersburg Times reports. However, some inmate advocates, citing Nazi experimentation at Nuremberg, worry that prisoners may be coerced into taking part in the research without fully understanding the potential risks of the drug regimens. Led by world-renowned AIDS researcher Dr. Margaret Fischl, the central Florida prison study is one of only a handful of studies nationwide that uses inmates as study participants. Inmates are viewed by many researchers as "ideal test subjects," as they have a constant daily routine, eat the same meals, always take their medications and in most cases are treatment naive -- meaning they have never taken HIV drugs. Citing the potential for exploitation, many states do not allow experiments on prisoners and many prison advocates argue that prisoners can "never give truly informed consent." However, the AIDS epidemic has changed the stakes of medical research, and many HIV-positive inmates themselves want access to experimental AIDS treatments. Two years ago, Florida prison officials "quietly lifted" the ban on research involving HIV-positive inmates and Fischl, a University of Miami researcher who helped develop the world's first AIDS treatment, AZT, was tapped to run the studies. However, the Florida Department of Corrections agreed to the testing only after a system of oversight and a watchdog group were established.
Despite the preliminary precautions, the prison research has drawn fire from many sides. Inmate advocates are concerned with Fischl's financial ties to pharmaceutical companies that manufacture the drugs being tested. But Fischl and University of Miami officials contend that objectivity is not compromised since the funds enter a restricted university account. Further, critics argue that the Department of Corrections has failed to carefully monitor the studies, pointing out that the watchdog group has been disbanded. And the University of Miami will not release adverse event reports, citing federal confidentiality guidelines. But the university's Vice Provost for Research Dr. Norman Altman said that the university is cooperating with the Office of Protection from Research Risks, an arm of the NIH that oversees human subject trials. "It's our intention to do this right. And if things aren't being done right, it's our intention to correct them," Altman said. Fischl maintains that she is "careful and plays it straight with inmates."
The Inmate Perspective
Fischl, who sat with many inmates to explain the consent forms "line by line," is viewed by many prisoners as a "goddess." In interviews, many inmates downplayed the drug regimens' side effects and focused on their restored health. One inmate said, "I'm a living, breathing, walking miracle. I thank God for the study." Many of the prisoners said that they were participating in the study because they had improved access to quality health care and treatments. "Compared to other prisons, the way they take care of you at the South Unit is like a newborn child," another inmate said. Still, inmate advocates are concerned that many prisoners remain unclear about the details of the studies. One inmate said that he was unsure exactly what researchers hoped to uncover. However, Fischl said she thinks that some of the drug combinations have reduced the viral levels in some inmates without negative side effects. And Fischl and prison officials say that prisoners are under no pressure to participate. Dr. David Thomas, the prison system's director of health services, said, "There is no coercion. There are no promises of better treatment or easier life" at the South Unit (Freedberg, 3/19).