In a short piece for the American Medical Association Journal of Ethics, Susan E. Lederer discusses what happens when research participants die in the course of medical research.
Lederer opens by noting that in the 1950s, little outrage greeted the reports of deaths among volunteers. For instance:
In March of 1952 James S. Leedom (known as “Stan”) was an 18-year-old freshman honors student at Seattle University, and one of 40 volunteers in a University of Washington study of the safety of blood storage. Leedom received a transfusion of blood that had been preserved for more than three weeks and had become inadvertently contaminated with bacteria. He died three days later. In the newspaper reports about Leedom’s death, two themes were repeated: the safety of the research and the absence of blame.
First, the investigators expressed their confidence in the research project. Although Robert Williams, chair of the department of medicine, and hematologist Clement Finch could not explain how the student had received contaminated blood, each informed reporters that they “would gladly participate in the same experiment tomorrow”. But the response of Leedom’s father was more surprising. When he was interviewed by reporters, Stanley Leedom explained that he held no one at fault in the research. “I don’t blame anyone for this” he said. “I just don’t want this tragedy to deter in any way from the blood donor program or these experiments”
Lederer points out that more recent participant fatalities have tended to draw much stronger reactions. Take, for instance, the 1999 death of Jesse Gelsinger:
In 1999 Jesse Gelsinger, an 18-year-old man with a rare metabolic disorder, died in a clinical trial of gene therapy at the University of Pennsylvania… Gelsinger’s death, the first recognized death from gene therapy trials, prompted suspension of similar trials, numerous public inquiries, and a lawsuit that resulted in fines for the University of Pennsylvania and the Children’s National Medical Center.
A watershed in attitudes towards research deaths came in 1966, Lederer says, with Henry K. Beecher’s paper “Ethics and Clinical Research“. Beecher criticized 22 experiments in which participants had been exposed to risk without informed consent.
Among the worst of these cases was a trial in which 157 patients suffering from typhoid fever were denied an effective antibiotic treatment, chloramphenicol. 23% of them died. In the participants who did get antibiotics, just 8% died. Beecher calculated that 23 people died as a direct result of the experiment.
Lederer notes that in an earlier draft of the paper, Beecher went even further, calling the victims “martyrs to science” – a phrase that had previously been applied to those scientists who had died in the course of their studies.
Lederer SE (2015). Dying for Science: Historical Perspectives on Research Participants’ Deaths. AMA Journal of Ethics, 17 (12), 1166-71 PMID: 26698591