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.
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