The Presidential Commission for the Study of Bioethical Issues recently released the results of its investigation into syphilis studies conducted in Guatemala in the 1940s by a doctor working for the US Public Health Service, John C. Cutler. The report, “Ethically Impossible”, described his work as a dark chapter in medical history. John D. Arras, Porterfield Professor of Biomedical Ethics at the University of Virginia, is a member of the Commission. BioEdge interviewed him about the report.

BioEdge: Were you surprised to hear that these experiments had taken place? Do you think that there are other projects which are still unknown? 

John D. Arras: Yes, I was quite surprised. I had always thought that the infamous Tuskegee experiment was about as low as we could sink in this area. There researchers “merely” refrained from treating poor black sharecroppers for 40 years to see what the effects might look like. In Guatemala, US researchers actually exposed hundreds of people to syphilis, gonorrhea and chancroid, and only treated roughly half of those exposed.

The Nuremberg doctors’ trials had just finished and the need for informed consent was well-known. Why did Cutler and his colleagues ignore it? Were they ignorant, arrogant…?

The Nuremberg Code had indeed just been published, but most US researchers believed at that time that such a code wasn’t necessary here, where doctors could be trusted to take good care of their patients. They viewed the Nuremberg code as a standard for Nazis, not for civilized docs. So they weren’t entirely ignorant. Indeed, they knew quite well that the public would react negatively to their studies, which is why they went out of their way to keep their activities a secret from the wider public. Ignorant no, arrogant definitely.

Was the research high quality? Why was it never published? 

I’m not a medical researcher, but my physician-researcher colleagues on the Presidential Commission have concluded that the quality of the research and record keeping in Guatemala was very poor. The research was conducted haphazardly, in no logical order. Phases of the research that were supposed to be based on prior epidemiological / serologial studies were done without the benefit of such background studies.

By the standards of the day were the experiments unethical?

Yes, the Commission concluded that the research was clearly unethical, as judged by the standards of the day. The same researchers did similar work in the US at a federal prison in Terre Haute, Indiana, where they insisted on genuine informed consent and a full briefing about risks. Even more damning, they actively exposed hundreds of people with STDs, but only treated roughly half of them.

What lessons can we learn from this disastrous episode?

We have already learned the lessons that Guatemala teaches many times over, but it clearly bears repeating. The Nazi doctors trial, Willowbrook, the Jewish Chronic Disease Hospital case, Tuskegee, and now Guatemala have taught us that patients rights must be protected, that doctors do not deserve unfettered discretion, and that constant vigilance is required to ensure the conduct of ethical research on human subjects. Careful consideration of the ways these actions violated ethical principles both honors the memory of the victims and helps ensure that society learns from these offenses. The Guatemala experiments remind us never to take ethics for granted, let alone confuse ethical principles with burdensome obstacles to be overcome or evaded. We should be ever vigilant to ensure that such reprehensible exploitation of our fellow human beings is never repeated.

Will such an egregious violation of medical ethics ever happen again?

Possibly, but highly unlikely, especially given all the safeguards that have been put in place since the revelations about Tuskegee and other scandals. There’s simply no way that something like the Guatemala syphilis study would survive scrutiny by any contemporary Institutional Review Board.

Michael Cook
clinical trials
Guatemala
informed consent

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Michael Cook

Michael Cook edits BioEdge, a bioethics newsletter, and MercatorNet, an on-line magazine whose focus is human dignity. He writes from Sydney, Australia.

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