The use of the word Tuskegee evokes images of the terrible Nuremburg medical experiments that precipitated the development of worldwide ethical guidelines for human research including those developed by the World Medical Association ( Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects)
The Tuskegee experiments did not occur in Nazi Germany or in a country dominated by nefarious dictators. It occurred in Tuskegee, Alabama between the years of 1932 and 1972 ( “I don’t know what they used us for“ – from a survivor.) Following the revelation of the Tuskegee experiments, The Belmont Report (1979) was formulated, the Office for Human Research Protection established and federal laws enacted requiring Institutional Review Boards (IRBs) for the protection of human research subjects.
In 2005, Dr. Susan Reverby of Wellesley College, while researching documents on the Tuskegee experiments uncovered 1940 experiments performed in Guatemala which outdid the Tuskegee experiments in violations of human rights. Once again the experiments were conducted by the United States Public Health Service under the direction of the very same physician, John Charles Cutler, who later participated in the Tuskegee syphilis experiments.
The revelation of yet another US government-sponsored unethical clinical research study resulted in a directive from President Obama in October, 2010 to the Presidential Commission for the Study of Bioethical Issues to review the Tuskegee and Guatemala experiments and determine whether unethical practices exist in the current conduct of national and international clinical research in studies sponsored by the US government.
The current Director of National Institutes of Health, Francis Collins referred to the Guatemala experiments as,”… a dark chapter in history of medicine…” and then published an article in the Journal of the American Medical Association implying that violations of ethical guidelines for human research supported by the US government could not occur with current safeguards that oversee the conduct of clinical research (Frieden and Collins, 2010.) We do not share that assurance and believe that there are current clinical research studies on vulnerable women and children that violate some of the same ethical standards that were violated in the Tuskegee and Guatemala studies. One such study is the National Institutes of Health sponsored study called HPTN 052. Another is HPTN 046.
In an admittedly scientifically sound research study, HPTN 052 was conducted in resource poor countries using vulnerable research subjects who were not informed that they had enrolled in a research study that would place them at risk for HIV infection and disease progression. http://www.hptn.org/research_studies/hptn052.asp They were not informed of international standards of care recommendations for the treatment and prevention of HIV. Nor were they informed that some of their governmenst provided free drugs to treat HIV at higher CD4 counts. At least 27 individuals became HIV infected because the researchers ignored the results of previous research studies performed as early 2005 that showed that their study was unnecessary and would place HIV infected and uninfected individuals at risk.
It is our opinion that the continuation of the HPTN 052 study after the recommendation of international health organizations to initiate treatment at early stages of HIV infection and prior studies which showed the benefits of early treatment of HIV at higher CD4 counts violated ethical principles that govern research studies in humans. The circumstances were uncomfortably similar to the Guatemala and Tuskegee experiments which were designed to either deliberately infect individuals or withhold treatment that was known to be effective while failing to inform research participants of these facts and other risks of participation in research.
The questionable ethics demonstrated in HTPN 052 may not be unique among current NIH funded research. In the NIH sponsored study HPTN 046, a study of prevention of mother to child HIV transmission in Africa, researchers provided mothers with inferior treatment for HIV prevention placing mothers and their infants at risk for increased HIV infection.
We recently wrote to the Commission to urge it to expeditiously investigate current US Government sponsored studies to determine if the studies are violating the rights of highly vulnerable research subjects, including women and children in resource poor countries (ref: Open letter to Bioethics Committee.) HPTN 052 and 046 might be a good place to start. A good question to ask might be, “Is it ethical to provide substandard treatment to vulnerable research subjects in resource poor countries, place them at risk for acquiring HIV infection and disease progression and not inform them of the risks or the availability of superior treatment?
It is not difficult to imagine that there may be more US government sponsored clinical research studies that violate accepted ethical standards. Today, overview of international research studies is confined to a limited number of groups many of whom are associated with other US government-sponsored studies and who themselves are engaged in international research utilizing vulnerable subjects. Without greater public access to these studies prior to their implementation, outside ethical review, and community participation the ghost of Tuskegee will once more arise.
Arthur J Ammann MD, President/CEO
Kerry Gough JD. Director and Legal Counsel on Gender and Justice
Global Strategies for HIV Prevention