The March 7 Lab Seminar was led by Edmond J. Safra Lab Fellow Carl Elliott. Elliott is a Professor in the Center for Bioethics, the Department of Pediatrics, and the Department of Philosophy at the University of Minnesota. His current research deals with the exploitation of the homeless in clinical trials--specifically Phase 1 trials, which are done to determine the safety of a drug (not its efficacy).
Elliott opened the seminar by providing some background on Phase 1 trials and the people who serve as subjects in them. He explained that as the drug industry has expanded, so has their need for healthy subjects to participate in Phase 1 trials. Historically, drug companies typically turned to universities to run trials and recruit subjects. However, as the need for subjects has grown, more and more companies have turned to the private sector, and the people who serve as subjects in these trials increasingly come from the homeless population (often the only people who are willing to participate in Phase 1 trials for such a comparatively small amount of money). Since these are private trials, they are not regulated by the FDA, but rather by IRBs--which have also become commercial, for-profit entities that provide little, if any, oversight of the conditions that participants are subjected to during the trials. They might see the trial on paper, but there is little or no oversight of the trial site itself.
Elliott pointed out that because these trials are not regulated, trial subjects receive almost none of the protections of the ordinary worker. There are no regular safety inspections, and if they are injured in the trial, subjects almost always have to pay for their own medical care. Essentially, as the clinical trials have moved into the private sector, the regulatory framework has yet to keep pace. As a result, an already vulnerable population--the homeless--are being exploited. This is particularly apparent in psychiatric trials, which have difficulty recruiting healthy volunteers. In these trials, many of the participants are homeless, and actively recruited by the drug companies.
Several seminar participants pointed out that in addition to exploiting the homeless, such trials are unlikely to be of any scientific value because they test on subjects who are often already suffering from mental illness, as well as other possible physical ailments. In thinking about solutions to the problem, other participants suggested drawing attention to the risk that these people take with their health when they enroll in Phase 1 trials, and a recognition of the fact that in putting themselves at risk, they are providing a public good for all of us. Other participants suggested reforming the IRB oversight of the trials, possibly by including a community member who has been a subject themselves, and incorporating more surveillance of the actual trial sites.