Sunday Read: Rules & Risks of Medical Experimentation

On June 21st, I had the pleasure of attending Dr. Carl Elliott’s luncheon book talk about his latest work, The Occasional Human Sacrifice: Medical Experimentation and the Price of Saying No.

As a Georgetown student majoring in Government and interning at the National Whistleblower Center (NWC) this summer, I’ve had the opportunity to learn how groundbreaking laws like the Dodd-Frank Act and False Claims Act are necessary to combat corruption. While I have limited experience with the medical field, I found that Dr. Elliott’s presentation was especially insightful as he called for increased research regulations and reflected upon his own struggle facing whistleblower retaliation at the University of Minnesota .

In this Sunday Read, we'll discuss the stories of unsung heroes, such as Peter Buxtun, who ended the Tuskegee Syphilis Study, and consider the ethical dilemma that medical professionals must confront before they blow the whistle.

Expectations and Incentives

Each year, pharmaceutical companies spend $14 billion testing experimental substances on human subjects. If you’ve volunteered for one of these trials, you would remember the long list of legal disclaimers typed across mountains of paperwork. Though patients are careful to dot their i’s and cross their t’s, some researchers are reckless.

During the book talk, Dr. Elliott explained how medicine and academia both rely upon a formal power hierarchy that often punishes dissent. When he fought to investigate Dan Markingson’s suicide, a mentally ill man who stabbed himself in 2004 shortly after participating in a drug trial sponsored by AstraZeneca , Dr. Elliott became alienated from his colleagues at the University of Minnesota (UMN). The administration stonewalled him until a state report declared that “the case involves serious ethical issues and numerous conflicts of interest.” Multiple psychiatrists were paid consultants of AstraZeneca, including the head of the UMN Institutional Review Board who approved the study. Dr. Elliott simply wanted to do the right thing, seeking justice for Markingson, but his peers condemned him for stepping out of line.

There was insufficient evidence to prove the trial caused Markingson’s death; however, this case demonstrates the urgent need to strengthen protections for medical patients and whistleblowers.

During the event Q&A, Dr. Adriane Fugh-Berman, a Professor of Pharmacology at the Georgetown University Medical Center , emphasized that clinicians do not take the Hippocratic Oath. All doctors are morally obligated to “first, do no harm,” but there is no equivalent for researchers. While one oath is certainly not enough, it is the cornerstone which supports the foundation of bioethics and all medical care.

Moreover, Dr. Elliott described how Institutional Review Boards (IRBs) exist to protect human subjects yet lack the authority to enforce ethical standards. They are usually for-profit ventures that make subjective decisions under pressure and may receive funding from the same investigators seeking approval. Robert Levine, a Clinical Professor at the Yale School of Medicine , testified before Congress:

“IRBs are not policing bodies, watchdogs, or auditing agents … IRBs were established to work collaboratively with investigators.” So, what happens when the process inevitably breaks down? 

A Question of Life or Death

The notorious U.S. Public Health Service Study of Untreated Syphilis at the Tuskegee Institute began in 1932 before scientists discovered a proven cure for the disease. 600 African American men from rural Alabama were enrolled in the experiment, including 399 syphilis patients and 201 control subjects. The vast majority were poor, illiterate sharecroppers who did not give informed consent.

Researchers told the subjects that they had “bad blood” yet withheld all treatment, choosing to investigate the life-threatening effects of syphilis rather than offer penicillin even after it became widely available in 1947. Though the experiment was initially designed to last for six months, it continued for forty years under the U.S. Public Health Service and then the Centers for Disease Control and Prevention .

The investigation started decades later when Peter Buxtun, a social worker and epidemiologist interviewing patients with sexually transmitted diseases, learned of the cruelty. Buxtun said, “I didn’t want to believe it. This was the Public Health Service. We didn’t do things like that,” but then the Division of Venereal Diseases rejected his first protest in 1966 and the second in 1968, dismissing ethical concerns on the grounds that the study was not yet complete. 

With nowhere left to turn, Buxtun leaked the story to the press in 1972. Jean Heller published an exposé, “PHS Study Denied Patients Treatment,” which shocked the nation. The study immediately became front-page news in the New York Times and was terminated soon after.

Buxtun’s actions saved lives and altered the trajectory of biomedical research. Congress passed the National Research Act, creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in response to the scandalous loss of more than one hundred lives. In 1973, the remaining survivors filed a class-action lawsuit and won a settlement of $9 million.

Stepping Up, Speaking Out

Whistleblowers like Dr. Carl Elliott and Peter Buxtun act as crucial guardrails, defending the most vulnerable when all other safeguards fail. Although the Hippocratic Oath and IRBs are useful preventative measures, researchers on the inside must also be prepared to take corrective actions that mitigate disaster after it has already begun.

The Tuskegee Syphilis Study was unfortunately not an isolated incident. Countless researchers have been caught risking human lives in the name of science, and Dr. Elliott warns that it will happen again unless there is a culture shift that demands bioethics enforcement. His thought-provoking book delves into six case studies, such as Martha Stephens who reported the radiation trials on cancer patients at the University of Cincinnati Medical Center and the Karolinska Institute physicians who blew the whistle on lethal synthetic trachea transplants. It is a must-read, and these whistleblower stories may even save your life someday.

Support NWC

NWC fights to bolster whistleblower programs, inform the public and employees in all sectors about available laws and protections, and help connect them with the right legal representation. As a 501(c)(3) non-profit our awareness building work is made possible with the support of our generous donors. Please consider donating $100 today to help us continue to educate the public on how to find help when it is time for them to blow the whistle, and donors will receive a copy of Rules for Whistleblowers: A Handbook for Doing What’s Right, written by Stephen M. Kohn.

This article was researched and written by Eliana Mlawski , a student of Government and Spanish at Georgetown University.