The group charged by President Barack Obama with examining research that intentionally infected unknowing Guatemalans with syphilis in the 1940’s should be ready to report by early summer, its executive director announced at a Washington meeting today – the commission’s first public hearing touching on the controversial experiments, which were funded by the US government.
Valerie Bonham, the executive director of the Presidential Commission for the Study of Bioethical Issues, said that her staff of 12 has in the last eight weeks reviewed 477 boxes of material in archives ranging from Washington, D.C. to the University of Virginia to Morrow, Georgia. Their quest: to answer the questions: “Who knew about Dr. [John] Cutler’s Guatemala studies? What did they know, when did they know it and what did they do about it?” Bonham promised “an independent and comprehensive examination of the facts.”
Obama asked his bioethics commission in this memo last November to conduct a “ thorough fact-finding investigation into the specifics of the U.S. Public Health Service Sexually Transmitted Diseases Inoculation Study.”
That study was revealed last October by historian Susan Reverby of Wellesley College in Massachusetts. (Reverby spoke with Nature last fall; you can read the interview here.)
Conducted between 1946 and 1948 and funded by the National Institutes of Health (NIH) through a grant to the Pan American Sanitary Bureau (now the Pan American Health Organization), the study sought new ways to prevent sexually transmitted diseases. To that end, researchers infected some 1,500 patients with gonorrhea, syphilis or chancroid, a highly contagious genital ulcer. The subjects – prisoners, prostitutes, soldiers and mental hospital patients — were unaware they were being infected. More background on the study, which was uncovered in the archived papers of its principal investigator, John Cutler, is available here and here.
Obama’s November memo also charged the commission with launching a comprehensive review of existing human subjects protections, “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.”
The question is highly relevant at a time when expense and red tape have driven US clinical trials, including many funded by the NIH, increasingly offshore, often to poorer countries.
“We are seeing a massive shift in the conduct of research that used to be dominated by the United States,” Robert Califf, the vice chancellor for clinical research at Duke University in Durham, North Carolina, told the commission. “Many people are even asking if the United states a fit place to do clinical research in the international context…..so the timing of your involvement in this commission couldn’t be better.”
At today’s meeting, the commissioners focused on the second part of their charge – to decide if current US government protections are adequate to safeguard subjects, whether in the United States or abroad. Commission chair Amy Gutmann also announced the 14 members of an International Research Panel, representing ten countries including Guatemala, that will help tackle the question. (The four US members are bioethics commissioners, and include Gutmann.)
The commission heard today from expert witnesses and grappled with thorny problems like where and when a researcher’s obligation to provide treatment to study subjects ends; what standard of care must be delivered by clinical trials, and if it should vary with location; whether international ethics standards for clinical trials can or should be harmonized; and even how to ensure that their own recommendations get implemented.
“There is a policy valley of death out there,” said Eric Meslin, who heads the University of Indiana Center for Bioethics, and who directed the bioethics commission that served President Bill Clinton in the 1990’s. He noted that many commissions’ recommendations fall by the wayside. “We have lots of great reports. And lots of things we’d like to do. And we don’t have a way to translate fantastic ideas into action.”
Another witness, historian Susan Lederer of the University of Wisconsin School of Medicine and Public Health, predicted that “the Guatemala study is unlikely to be the only such study out there lurking in the archives, hidden in the file drawers.” She added: “Faulkner was right to say: `The past isn’t dead, it’s not even past.’”
The Associated Press made that clear yesterday, publishing this article, which reported unearthing more than 40 ethically dubious, decades-old studies culled from the medical literature and press reports, many involving prisoners.