President’s Bioethics Commission Continues Review of Guatemalan Syphilis Experiments

The President’s Commission for the Study of Bioethical Issues convened last week to conduct a “thorough review of human subjects protection to determine if Federal regulations and international standards adequately guard the health and well-being of participants in scientific studies supported by the Federal Government.” The bioethics commission was specifically charged to

• review contemporary ethical standards in clinical trials
• assure the President that the current rules protect people from harm both domestically and internationally, and
• if they cannot assure the President, then they will make recommendations (webcast).

Their mandate was prompted by last year’s shocking revelations that the U.S. conducted secret medical experiments that involved intentionally infecting Guatemalan mental patients with syphilis. That scandal has now led to a class action suit [1,2] against the U.S. Department of Health and Human Services filed by seven Guatemalan citizens who were either victims, or the legal heirs to victims, of the Guatemalan syphilis tests. The plaintiffs – whose number is expected to continue to increase as word spreads – allege that the U.S. Public Health Service, eight months after the Nuremberg Trials, deliberately moved a continuation of Dr. Cutler’s Terre Haute prison study to Guatemala since offshore testing was not subject to the same level of scrutiny of oversight as in the U.S.

The documents discovered by Susan Reverby are rich in detail. One remark in Cutler’s 1947 correspondence with his supervisor Dr. R.C. Arnold provides a chilling indication of his mindset and motivations:

“Well, all I can say is, it’s against the law to do many things, but the law winks when a reputable man wants to do a scientific experiment... Unless the law winks occasionally, you have no progress in medicine."

Cutler’s seemingly altruistic rationale is a clear example of the continuing need for oversight, transparency, and accountability in human subjects research. This is especially critical now, with the dramatic increase of conducting clinical trials overseas compared to the “tiny” number of these research sites that are inspected by the FDA, as documented in the Reuters Special Report: Big Pharma's Global Guinea Pigs.  

Today’s researchers unfortunately face the same temptations to conduct their work outside the scrutiny of American law as Cutler did when he moved his VD trials from Indiana to Guatemala. It’s all too likely that many of these outsourced trials do not satisfy the standards of medical research ethics as set forth in the Belmont Report. And these theoretical bioethical principles may not adequately capture the challenges involved with carrying out tests involving vulnerable populations and obtaining meaningful informed consent in poor countries.  

The President’s bioethics commission is on track to deliver its report this summer. Let’s hope their recommendations lead to adjustments that end any ongoing human rights violations in research involving human subjects - and that prevent them in the future.

Previously on Biopolitical Times:

• No More Guatemalas
• Time to Nationalize IRBs?
• Clinical Trials on Trial