U.S. reviews protection standards for medical study participants in light of ethics violation discoveries
This week the Presidential Commission for the Study of Bioethical Issues is discussing its safety and protection standards for people who participate in federally-funded scientific studies. It’s a sensitive topic for the government, as late last year information surfaced that from 1946 to 1948, the U.S. Public Health Service intentionally infected vulnerable populations in Guatemala with sexually transmitted diseases.
Following today’s discussion on the ethics of neuro-imaging and genetic testing, tomorrow, from 9 a.m.-1:15 p.m. EST at the St. Regis Hotel in Washington, D.C., the commission will review and discuss its human subjects protection with medical experts, researchers and the public — for those who choose to attend and make comments. The conference will also be live-streaming on the Bioethics.gov site.
It was Susan Reverby, a Wellesley College professor, who came across the unpublished papers while doing research on untreated syphilis. She discovered that Dr. John Cutler, a Public Health Service medical officer, had condoned a study that involved injecting soldiers, prisoners and mental hospital patients with gonorrhea and syphilis, which was funded by a grant from the U.S. National Institute of Health to the Pan American Sanitary Bureau.
A summary of initial findings from the U.S. Department of Health and Humans Services:
The first experiments in Guatemala involved infecting female commercial sex workers with gonorrhea or syphilis, and then allowing them to have unprotected sex with soldiers or prison inmates. When few of these men became infected, the research approach changed to direct inoculation of soldiers, prisoners, and mental hospital patients. Gonorrhea was transmitted by inoculations into the urethra; chancroid by skin injection; and syphilis by a variety of means including skin injection and exposing the foreskin of the penis to infectious material. About 1,500 study subjects were involved. Although institutional officials were aware of the study, the study subjects were not informed of the purpose of the study and did not provide consent. The researchers indicated that they treated the vast majority of persons who contracted gonorrhea and chancroid, and most who contracted syphilis. However, the research suggests that some of the persons infected with syphilis were prescribed only partial treatment or not treated at all. At least one patient died during the experiments, although it is not clear whether the death was from the experiments or from an underlying medical problem. There are inadequate records to determine if the commercial sex workers were treated.
After reviewing the U.S. Public Health Service Sexually Transmitted Diseases Inoculation Study, which details how the patients were treated (and that they gave no consent to these studies), President Obama called on the bioethics commission to oversee a fact-finding investigation into the specifics of the study, seeking the insight and perspectives of international experts (including from Guatemala). The president expects findings and recommendations by September.
Obama has also agreed to work with the Guatemalan government and provide them with all the information uncovered in this investigation.
“While I believe the research community has made tremendous progress in the area of human subjects protection, what took place in Guatemala is a sobering reminder of past abuses,” said Obama in a Nov. 24 memo to Dr. Amy Gutmann, chair of the Presidential Commission for the Study of Bioethical Issues. “It is especially important for the Commission to use its vast expertise spanning the fields of science, policy, ethics, and religious values to carry out this mission. We owe it to the people of Guatemala and future generations of volunteers who participate in medical research.”
Doing its own investigation, the Associated Press dug up 40 similar studies, which included giving hepatitis to mental patients in Connecticut, giving the pandemic flu virus to Maryland prisoners and injecting chronically-ill New Yorkers with cancer. The AP notes that in most cases, the studies did not produce useful results.