In the wake of the Guatemala syphilis study scandal, in which US-funded researchers committed atrocities against vulnerable Guatemalans, President Obama directed his bioethics commission to conduct an investigation “to assure that current rules for research participants protect people from harm or unethical treatment, domestically as well as internationally.” Yesterday the Commission released its report, entitled “Moral Science – Protecting Participants in Human Subjects Research.” It concludes that “the rules governing federal research today adequately guard against abuses analogous to those perpetrated in Guatemala in the 1940s and that current regulations generally appear to protect people from avoidable harm or unethical treatment, insofar as is feasible given limited resources, no matter where U.S.-supported research occurs.”
The report acknowledges that it is the latest in a long line of similar examinations, and for the most part its recommendations mirror those of previous inquiries. It frankly notes that the federal government has largely ignored key recommendations from those previous reports, and urges federal agencies responsible for the conduct of research to implement them. The report also expresses the Commission’s judgment that subjects harmed in the course of research should be compensated for their injuries, but declines to “specify what an optimal system to carry out this ethical mandate would look like.”
Although the report’s recommendations are reasonable, it’s hard not to view this exercise as a missed opportunity to address the most troubling aspects of contemporary human subjects research. The problem is not that the Commission failed to carry out its mandate, but that its mandate was circumscribed in a way that all but precluded the Commission from addressing the most egregious abuses currently being inflicted on many human research subjects. Specifically, in limiting the Commission to examining whether federal regulations offer adequate protections to participants in studies “supported by the Federal Government,” President Obama exempted privately-funded research from the Commission’s inquiry.
This is no small shortcoming. The NIH’s clinical trials database shows nearly 11,000 industry-funded clinical trials that are currently recruiting human participants. (Since this figure does not include active trials that have stopped recruiting, and because researchers are not required to report Phase I clinical trials to the NIH, the number of currently active human trials is surely much higher.) Pharmaceutical companies – and the “clinical research organizations” to whom they outsource many trials – are responsible for a series of outrageous abuses, and yet continue to operate with relative impunity. Just a few notable examples include:
- Eli Lilly testing the safety of new drugs on homeless alcoholics recruited from a nearby shelter;
- America’s largest clinical testing center “recruiting undocumented Latino immigrants desperate for money, housing them in a converted Holiday Inn, and paying them to take untested drugs in studies overseen by an unlicensed medical director whose degree comes from an offshore medical school in the Caribbean;”
- Industry studies performed on victims of a gas explosion in India, without adequate consent (and often without the patients’ knowledge), without investigations into the causes of several deaths of trial subjects and without compensation for subjects’ “participation.”
In light of the fact that private companies are conducting research on hundreds of thousands of people worldwide, and given the clear inadequacy of existing regulations to protect against these kind of abuses, the Commission’s conclusion that “current regulations generally appear to protect people from avoidable harm or unethical treatment” in federally-funded research rings hollow.
Although examining industry-funded research may have been beyond the scope of its charge, the Commission certainly wasn’t obligated to treat the pharmaceutical industry as a paragon of medical ethics, or to credulously accept the testimony of industry representatives about their ethical practices. Nor did the President’s charge preclude the Commission from recommending additional studies into protections for human participants in industry-funded research. Having failed to do so, the Commission’s conclusion that the “U.S. system provides substantial protections for the health, rights, and welfare of research subjects” provides misleading assurances that all is basically well in the clinical trials industry.
Rather than congratulating ourselves for guarding against the kinds of abuses that were being committed 70 years ago, we should be asking what contemporary practices will shock the conscience of future generations. In expressly limiting the Commission’s mandate to protections for participants in federally-funded studies, the Obama administration appears to have deliberately averted the Commission’s gaze from the most egregious abuses of the day.
Why do you suppose it would want to do that?