Susan Lederer: The Evolution of 'Beecher’s Bombshell'

Dr. Susan Lederer is the Robert Turell Professor of the History of Medicine and Bioethics and chair of the Department of Medical History and Bioethics at the University of Wisconsin School of Medicine and Public Health. She is also the author of Flesh and Blood:A Cultural History of Transplantation and Transfusion in Twentieth-Century America and Subjected To Science: Human Experimentation in America Before the Second World War. During her keynote address at the 2014 Advancing Ethical Research Conference, Dr. Lederer discusses the significant and compelling role Henry K. Beecher played in the world of clinical research ethics. Play the podcast in the player below or download it to your computer, smart phone, or tablet. Or, subscribe to the podcast on iTunes or Stitcher, listen on Google Play Music, or sign up to be notified when a new podcast is available.

The paper known as "Beecher's Bombshell" was published under the title "Ethical and Clinical Research" in the New England Journal of Medicine in 1966, and exposed the dire ethical state of human subjects research in the US.

Dr. Lederer points out that, by time it was published in the journal, the paper only detailed 22 cases of human rights violations, whereas the original draft included 50 examples. New England Journal of Medicine editor Joseph Garland agreed to publish Beecher’s paper after a series of letters and compromises, but the various drafts and extensive editorial correspondence are readily available in Beecher's papers.

Editors of the journal didn’t find all of the original 50 examples to be equally compelling, which raises the question: In what way were those 28 considered less compelling and how might knowing those change our view of what Beecher was trying to do and could have done? 

Dr. Lederer takes a look at some of the human rights violation examples, as well as the stronger language used by Beecher in his early drafts, to deepen our understanding of human research ethics in the decades following World War II.

Examples of Human Rights Violations

Some examples that did appear in the paper had already been exposed in the popular press. These include a study to determine the period of infectivity of hepatitis performed at institution for "mentally defective" children (the Willowbrook Study), and a study involving the injection of live cancer cells into 22 hospitalized elderly and senile patients to study immunity. 

One example that the editor repeatedly sought to have Beecher remove from the journal, but which stayed in, was a report that studied potential liver damage resulting from the use of an antibiotic to treat acne. The study was performed at a group home for juvenile delinquents and mentally defective children and adolescents. Healthy young men were enrolled in the study and over 50 percent of subjects showed signs of liver poisoning – some even had to have liver biopsies. 

Populations Targeted for Research

Dr. Lederer points out that research subjects often fell into the following categories: very elderly, soldiers, mentally retarded children, alcoholics, children and newborns, charity patients and the terminally ill. She also notes the issue of race: While early drafts of Beecher’s paper did refer to patients of color, the published article removes all mention and makes no acknowledgement of how race and ethnicity made some populations more vulnerable to human rights violations in research. This was likely because the editors were seeking to dampen potentially inflammatory statements.

The Final Draft

To summarize, the published version of Beecher's paper was less evaluative, less emotional, less judgmental and less revealing about subject populations. This isn't surprising: The title was originally "Ethics and the Explosion of Human Experimentation," but was changed to "Ethics and Clinical Research."

Dr. Lederer explains that Beecher had his own compelling reasons to undertake this exposé. As he himself explains, he was at the end of his career and could take personal risk of going public because he was close to retirement. 

Also, he had experience as both a clinician and an investigator and had an established record of research, and considered himself to be a founding father of psychopharmacology. The evolution of Beecher's paper was a complicated journey, to be sure, and Beecher remains a compelling presence in the world of clinical research ethics.