Tuesday, June 03, 2008

Exploitation in drug safety trials

The New England Journal of Medicine, amazingly, has published a piece on research ethics that you can access online for free. And it is a worthwhile article too: in Exploiting a Research Underclass in Phase 1 Clinical Trials, Carl Elliot and Roberto Abadie describe the basic conditions of those who sign up for safety trials on new drugs, and the analogies with sweatshop labor is never far away. Elliot and Abadie argue that participants in such trials are exploited for three reasons: they are unlikely to gain access to the drugs that are being tested on them, there is little effective regulatory oversight of the clinical drug trial industry, and there is little to no compensation for research-related injuries. In short, it is a bad job, disproportionately done by the poor. Yes, like the positions on offer at the meat-packing plant, you do get money for it. Yes, it is a step up from unemployment and/or living in cardboard box. Yes, you could always argue that this is not exploitation, but merely a fair exchange: the research participant offers his or her body to test drug effects, and gets cash in return. There is no shortage of complex arguments in bioethics that end up defending the status quo in this area. But Elliot and Abadie will have none of it: if participants in phase 1 clinical trials are 'drug tasters' for the more affluent, exposed to the prospect of uncompensated injury and buried far beneath the radar of regulators, that is not a 'negotiating position' for a fair trade of services -- it is a rotten place to be.

The article is a reminder that there are populations in affluent industrial nations analogous to those in the developing world, and equally vulnerable to the corporate model of clinical trial research. It is not that we can do without drug safety trials involving human beings: we can't. But as long as phase 1 clinical trials round up the usual suspects as participants -- low income, without health insurance, immigrants (documented or not) -- the accusations of exploitation will not, and should not, go away.

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