Sunday, October 3, 2010

Guatlemalan Syphilis Trials and the Nuremburg Code

The New York Times has a piece this week revealing that “from 1946 to 1948, American public health doctors deliberately infected nearly 700 Gautemalans – prison inmates, mental patients and soldiers – with venereal diseases in what was meant as an effort to test the effectiveness of penicillin.”

Susan M. Reverby is a professor at Wellesley College and a medical historian who has previously written two books on the Tuskegee syphilis trial, discovered records of these experiments in the archives of the University of Pittsburgh as she was preparing a research paper. The archives also revealed that NIH funds were used to pay syphilis-infected prostitutes to sleep with prisoners in order to infect them. If that method didn’t work, patients were infected by experimenters pouring live bacteria over abrasions on their scraped up body parts or injected directly into the spine.

The connection to Tuskegee is not accidental. The Guatemalan experiments were led by one John C. Cutler,  a public health service doctor who was to become instrumental in the Tuskegee experiments later on, and it was his unpublished Guatemala work that Reverby discovered at Pitt. Reverby told the Times that she had previously presented her findings at a conference last January but received no reaction. In June she submitted a manuscript for a future issue of the Journal of Policy History to Dr David J. Sencer , former director of the CDC (a body that has its own not completely benign role in the Tuskegee affair), and he requested a government investigation.

All of this was going on at the same time military and civilian lawyers at Nuremburg were mounting a vigorous prosecution of Nazi physicians in the Doctors’ Trial following WWII. From this prosecution came the Nuremburg Code from whose appearance many ethicists date the modern era of human subjects protection, a code which included such protections as voluntary consent, a favorable risk/benefit analysis, avoidance of needless suffering, appropriate prior animal data, the right to withdraw, and so on. US public health doctors were conducting VD trials on presumably unconsented (or at least not fully informed) subjects at the same time physicians were being hanged in Germany for doing the same things. The theme connecting these events is this: lack of respect for person, the unwillingness of the experimenters to see research subjects as full human beings deserving of protection and respect.

In the wake of these revelations, Secretary of State Clinton and HHS Secretary Sebelius have issued an apology to Guatemalans, the subjects and their descendents, and of course it is not their fault. We do not need to waste time looking for conspiracies in the US government. FDA regulations, the Common Rule, the Declaration of Helsinki and ICH and WHO-CIOMS guidelines for GCP are all designed to protect future human subjects. Our job is to make sure that we educate our successors so that things like this never happen again.