Tuesday, October 19, 2010

I am disturbed by an article in Science magazine

Kristen Minogue and Eliot Marshall have written an article in the October 8, 2010 issue of Science titled "BIOMEDICAL ETHICS: Guatemala Study From 1940s Reflects A 'Dark Chapter' in Medicine". The news article focuses on the epidemiological research on syphilis and other sexually transmitted diseases jointly supported by the governments of the United States and Guatemala. I have previously posted on the case, and would make the point that standards for the ethical conduct of medical research have evolved (for the better) since the 1940s when the research in question was conducted.

Some of my problems with the Science article:
  • While the article mentions John Cutler, implying that he was the key official in the program, it does not mention that he went on to have a distinguished career in public health, inventing a key diagnostic test for syphilis, rising to the highest level in the U.S. uniformed Public Health Service, serving as Deputy Director of the Pan American Health Organization and Chair of the Department of Health Administration at the University of Pittsburgh. I knew John Cutler and saw no indication of lack of ethics in his behavior.
  • The lead paragraph of the Science article describes the study in question as "a stunningly unethical U.S. medical study that was conducted in Guatemala 64 years ago." The study seems clearly to have been a collaboration between Guatemalan and U.S. researchers, not a U.S. study conducted in Guatemala.
  • The judgement that the research was "stunningly unethical" would seem to depend in part on the risks to which the subjects of the research were exposed. The article does not provide the reader with information on those risks, and most of the readers of Science probably do not know much about the diseases involved. The article quotes a CDC report that there were high levels of infection, but it occurs to me that the prevalence of those diseases might have been high in prisoners and military personnel in Guatemala in the 1940s. The diseases in their early phases are quite responsive to antibiotics, and the protocol was for infected subjects to be treated. 
  • The article states that "as far as is known, most were treated, but records suggest that only 76% of those directly inoculated and infected with syphilis received "adequate" amounts of penicillin." Was the problem a failure of the record keeping, an rejection of treatment by the subjects, departure from the experiment of subjects (such as by completion of jail sentences or military duties), cure with less than the optimal dose of penicillin, or some other cause? Is there any reason to infer that people were in fact infected and not cured?
  • The article states that "the doctors who ran it (the research project) for the U.S. Public Health Service (PHS) never published results. It does not mention that the Guatemalan principal investigator did publish the results in the Bulletin of the Pan American Sanitary Bureau. This omission implies a failing on the part of Dr. Cutler, which may not have been merited. Moreover, it would usually be the principal investigator who would publish the results of an experiment. Dr. Juan Funes, the author of the report on the research was at the time Chief of the venereal disease control division of the Guatemalan Ministry of Public Health, a physician who had received post doctoral training in the United States. Was he in fact the principal investigator in the research? The article does not even raise the possibility that Cutler, at the time a very junior officer recently out of medical schools, was the junior partner in the project.
I agree that the syphilis study would not pass modern ethical standards and that it should stand as a warning against the inappropriate conduct of research funded even in part by the United States in other countries. On the other hand, Science should give a more balanced and complete account of such controversial events, and should be very careful to refrain from inappropriately blackening the reputation of scientists (especially those who have died and are thus unable to defend themselves).

Officials of the Government of the United States have hastened to apologize publicly that the United States funded and participated in the research. I recall that the Government of the United States was very much involved in the overthrow of the Guzman government of Guatemala in 1954, even though that government was democratically elected. The Dulles brothers, who headed the Department of State and the CIA at the time, were shareholders in United Fruit and that company's lands were threatened by expropriation by the Guatemalan land reform program at the time. If the Obama administration wishes to apologize to the world for unethical behavior in the past, perhaps the overthrow of the elected government of Guatemala would be a more important event than the syphilis study.

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