Thursday, October 14, 2010

The 'Guatamalan Tuskegee'

When news broke about unethical syphilis studies being conducted by US government agencies in Guatamala back in the 1940's, I was not sure how to take it. My first (well, questionable) reaction was that some research ethics modules and textbooks would need an upgrade, and maybe some lectures on the infamous Tuskegee study might become less tedious, now that the well-worn scandal had both a precursor and an international twist. My second reaction was that I would have no choice but to write something about it, because it got so much press, and because the Guatamalan government received apologies from the US Secretary of State Hilary Clinton and President Barach Obama in a very big hurry. But reading the paper by the historian who broke the story, Susan Reverby, gave rise to deeper reflection on the moral landscape of health research between developed and developing countries, and how in some ways that landscape has not radically changed over the last sixty-some years.

As usual, the ethical problem was not so much with the research question itself. Trying to find a way of preventing men from acquiring syphilis after exposure by using penicillin had some merits. The use of captive and highly vulnerable populations -- prisoners, orphans, soldiers, and mental patients -- without gaining much semblance of informed consent is another story. As were some of the methods. Attempting to infect prisoners by means of deliberately selecting syphilitic prostitutes to visit them in prison, and conducting what sounds like a quite uncomfortable procedure of inoculating the penises of mentally ill patients: this is morally out of bounds. Sweetening the deal by offering the Guatamalan authorities supplies and infrastructure, as well as handing out cigarettes (yes, this was a public health study) to the prisoners, sounds like crossing the line between providing 'research benefits' and greasing the local wheels. There are important ethical differences the Guatamalan studies and Tuskegee: in the former, you had healthy participants being deliberately infected, whereas in the latter, the participants were already infected prior to being recruited. However, in the Guatamala case, those who became infected were all treated with pencillin (albeit without follow up), whereas treatment was infamously withheld from Tuskegee participants for decades.

What is striking in Reverby's paper is how the researchers know what they are doing is -- from a perspective they try to downplay and discredit -- ethically wrong. Reverby quotes a letter written in 1948 by the Public Health Service physician R.C. Arnold to a researcher involved in the Guatamala studies:

I am a bit, in fact more than a bit, leery of the experiment with the insane people. They can not give consent, do not know what is going on, and if some goody organization got wind of the work, they would raise a lot of smoke. I think the soldiers would be best or the prisoners for they can give consent. Maybe I’m too conservative....Also, how many knew what was going on. I realize that a pt [patient] or a dozen could be infected, develop the disease and be cured before anything could be suspected...In the report, I see no reason to say where they work was done and the type of volunteer.

The recipient of the letter, Dr. John C. Cutler, would go on to take a lead role in the Tuskegee syphilis studies and defend them to the end against accusations of wrongdoing.

At the end of her paper, Reverby muses about why this new addition to the history of research scandals matters. She raises two important points. First, US researchers in the Guatamala studies did things that they would not dare to do back home, not even in Tuskegee. In such studies, there is an implicit distinction between (as Reverby puts it) what is morally thinkable in the metropole and what is morally thinkable in the periphery. That distinction between what may be acceptable abroad -- but not at home -- is still very much with us in global health research. Second, we have to be wary about what is done with the case of the Guatamalan syphilis studies. Tuskegee gave rise to the Belmont Report, which strongly informed the Common Rule, arguably the most influential research ethics regulations worldwide. It gave birth to the IRB system. Many take issue with the provisions (and predominance) of US research regulations, and Reverby suggests the scandal in Guatamala -- particularly if it is misrepresented -- could give rise to Frankensteinian effects. But in truth, it is too early to know what this newly revealed scandal will come to mean.

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