President Obama calls for a review of human subjects’ protection following the unraveling of the Guatemala STD study.

On October 5, 2010, I reported on this same blog on the recently discovered Tuskegee-like scandal, which took place in Guatemala in the ’40s and saw the purposeful infection of prisoners and other vulnerable populations with the syphilis bacterium (https://humanitiesandhealth.wordpress.com/2010/10/05/clinton-delivers-formal-apology-for-a-newly-discovered-tuskegee-like-study/). The study was only recently brought to light thanks to the studies of Wellesley College history professor Susan Reverby, which resulted in a formal apology delibered by Secretary of State Hillary Clinton on October 1, 2010, much on the footsteps of the apology given by former President Bill Clinton in 1997 to the Tuskegee victims.

More than two months have passed since Hillary Clinton’s public apology, and now President Obama has officially asked the Presidential Commission for the Study of Bioethical Issues to undertake an exhaustive review of human subjects’ protection guidelines. As we can read in the Presidential Memorandum, says Obama:

In light of this revelation [The Guatemalan study], I want to be assured that current rules for research participants protect people from harm or unethical treatment, domestically as well as internationally. I ask you, as the Chair of the Presidential Commission for the Study of Bioethical Issues, to convene a panel to conduct, beginning in January 2011, 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. I also request that the Commission oversee a thorough fact-finding investigation into the specifics of the U.S. Public Health Service Sexually Transmitted Diseases Inoculation Study”.

The Presidential Commission for the Study of Bioethical Issues was appointed by Barack Obama one year ago to substitute the dismantled “President’s Council of Bioethics” and is chaired by political theorist Amy Gutmann, who symbolizes the greater emphasis put by the President on the policy implications of ethical positions taken by the Commission.

The past few years have witnessed an increasing number of clinical trials being moved offshore, i.e. to low and middle income countries, and as reported by Nellie Briston on the Lancet this week: “A thorough review of the safeguards in place to protect modern human trial participants is appropriate and timely” .

Also on a related topic, the Commission will need to explore the relationship between the FDA and Helsinki Declaration regulating internationally clinical research on human subjects. The Helsinki Declaration was controversially shelved by the FDA in October 2008, which favoured instead the adoption of Good Clinical Practice (GPC) Guidelines, which represent a weaker ethical standard as, for example, they are silent on the use of placebos in clinical trials when there exists an active treatment as an alternative.

The Presidential Commission will start its work on the issue in January and has 9 months to deliver the reports.

Further readings

Bristol, N. US reviews human trial participant protection, The Lancet 2010; 376(9757):1975-6, doi:10.1016/S0140-6736(10)62247-7; http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2810%2962247-7/fulltext?rss=yes

Camporesi, S. The FDA decision to shelve the Helsinki Declaration: Ethical considerations, ecancermedicalscience, June 10, 2008; doi=10.3332/eCMS.2008.LTR76, http://www.ecancermedicalscience.com/comment-letters-to-the-editor.asp?doi=10.3332/eCMS.2008.LTR76#letter

McNeil, D. U.S. Apologizes for Syphilis Tests in Guatemala, The NewYorkTimes, October 1, 2010, http://www.nytimes.com/2010/10/02/health/research/02infect.html

Presidential Memorandum-Review of Human Subject Protection, November 24, 2010, http://www.whitehouse.gov/the-press-office/2010/11/24/presidential-memorandum-review-human-subjects-protection

US Secretary of State Hillary Rodham Clinton delivers formal apology for a newly discovered Tuskegee-like study

Back in 1997 Bill Clinton delivered a public apology to the victims of the infamous Tuskegee study, where about 400 people infected with syphilis among the black sharecroppers in Alabama had been left deliberately without the existing cure, penicillin, so that doctors could follow the “natural course” of the disease. Together with the public apology delivered by former US president, a large financial aid (about $200,000) was offered to the people of Tuskegee and Macon Countee to set up the Tuskegee Bioethics Center, which was inaugurated in 1999.

Almost 15 years later, it is now the turn of another Clinton, namely Bill’s wife and current US secretary of State, Hillary Rodham Clinton, to give another formal apology for a study which shares many striking and scary similarities with the Tuskegee study.

Between 1946 and 1948, almost 700 Guatemalan prison inmates, mental patients and soldiers – categories which in medical ethics we would surely refer to as “vulnerable”- were deliberately infected by US doctors with the Treponema pallidum (the bacterium responsible for syphilis), with the aim of studying the effectiveness of penicillin as a treatment.

Infection modalities were to be chosen among the following three: a) infected prostitutes paid to infect their clients; b) Treponema pallidum bacteria poured directly onto the genital organs, face or arms of other individuals (for which apparently option a) was not available; or c) bacteria were injected directly by spinal puncture.
Apart from scenario a) then,  it is quite difficult to imagine that individuals were not realizing that something odd was going on!

The Guatemalan experiment was brought up by Susan M. Reverby, professor at Wellesley College, who had initially presented her research on the trial at a conference last January, though without eliciting any out-of-the ordinary attention. The deserved attention arrived a few months later, when in June 2010 Reverby sent a draft of the manuscript she was working on for the Journal of Policy History to Dr David J. Sencer, former Director of the US Center for Disease Control. It was then up to Dr Spencer – apparently a person of stronger political power than Dr Reverby – to push the US government to commence a deeper investigation on the case.

Susan Reverby had already found some documents about the Guatemalan case back in 1985, when she was working at the University of Pittsburgh. The documents were signed by Dr Cutler, “principal investigator” of the trial, and also later involved in – guess what?- the Tuskegee study (to note, esteemed professor Cutler kept defending the soundness of the Tuskegee trial in terms of science and ethics until his death-bed).

Among public reactions to Clinton’s (Hillary) apology, it seems to me interesting to report here the one by professor Mark Siegler, Director of the Maclean Center for Medical Ethics at the University of Chicago. According to Siegler, the Guatemalan study is much worse from an ethical point of view than the Tuskegee study. His rationale is the following: in the Tuskegee study, the black sharecroppers in Alabama were already infected with the venereal disease, and not given the existing treatment, whereas in the Guatemalan study men were being deliberately infected with the disease (the full comment by Professor Siegler can be read on the New York Times)

Which do you think is better (or less ethically blamable, I should maybe say): to deliberately infect individuals with various -more or less pleasurable- ways, and then cure them and try to save their lives; or deliberately not curing already infected and socially disadvantaged people?