Experimental Design

Statistics is mainly the study of analyzing data, but where does the data come from? In the introductory part of your class, you will probably learn a little about research design. Most likely you will hear about the desirability of setting up a study with a "control group" (no experimental treatment) and one or more "experimental groups."

Statistical techniques (such as hypothesis tests on the difference of two means or proportions, or of more than two means) are then used to decide whether the differences between the "control" and "experimental" groups are large enough to draw inferences about whether those differences exist in the populations from which the groups were drawn.

These research strategies are valuable, but the discussion in a Statistics text almost always leaves out ethical questions. For example, how should researchers decide what questions to study? If an experimental intervention looks promising, how long should it be withheld from the control group? What does it mean, in practice, to get the "informed consent" of research subjects?

Regrettably, researchers have not always paid attention to these questions, either. One outrageous example was the US Public Health Service study of "Untreated Syphilis in the Negro Male" (1932-1972) at Tuskegee in Macon County, Alabama. Its reverberations through the decades are still causing big problems today.

Not everyone has heard about the "Tuskegee Syphilis Experiment." But many of those who know something about it are suspicious. For example, they worry whether it will be safe for them to get vaccinated for Covid-19, when a vaccine becomes available.

What was the USPHS Syphilis Study?

The stated purpose of this project was to follow the course of untreated syphilis in Black men. Why Black men? Did the researchers think syphilis had a different course in Black men than in white men? Or did they think it was convenient to study poor Black sharecroppers in the South to find out more about syphilis in all men? Either way, was this an appropriate or useful project?

The US Public Health Service recruited 600 Black men, mostly impoverished sharecroppers, in Macon County, Alabama. They were told they would be treated for "bad blood." This was a catch-all term that people used for a range of ailments including fatigue, anemia and syphilis. The "experimental" group consisted of 399 men diagnosed with syphilis and a "control group" of 201 men.

But when the study started in 1932, there was no known effective treatment for syphilis. The men were not "treated." Instead, they were given medical exams, rides and meals on exam days, free treatment for minor problems unrelated to syphilis, and promises of burial stipends for their survivors. They were not even told the actual name of the study.

To make matters much worse, when penicillin became the standard treatment for syphilis in 1947, researchers withheld it from both the experimental group and control group. The men were not told about it or given the option to quit the study and get penicillin elsewhere.

By that time, dozens of the men had died. At least 40 of their wives had been infected, and at least 19 of their children had been congenitally infected.

In 1946-47, the Nuremberg Medical Trials exposed the horrific experiments that Nazi doctors had conducted in concentration camps. [Weindling, Paul et al. “The victims of unethical human experiments and coerced research under National Socialism.” Endeavour vol. 40,1 (2016): 1-6. doi:10.1016/j.endeavour.2015.10.005] The Nuremberg Code of medical research ethics came out of these trials.

Yet many medical researchers in the United States denied that the Nuremberg Code should apply to them. In particular, the USPHS Syphilis Study at Tuskegee continued until 1972!

How and Why the USPHS Syphilis Study Ended

Peter Buxtun, a 27-year-old social worker and epidemiologist from San Francisco, joined the US Public Health Service in late 1965 to interview patients with sexually-transmitted diseases. He was shocked to learn from co-workers about the project at Tuskegee. Amidst an escalating anti-racist struggle nationwide, he filed an official protest on ethical grounds. It was rejected. He filed a second complaint in 1968 and was again rebuffed.

Finally, in 1972, Buxton gave the story to Jean Heller, a reporter who published an account on July 25, 1972 that made national news. Public outcry and Congressional hearings followed, and the USPHS Syphilis Study was finally ended in October -- 40 years after it began.

Fred David Gray, a well-known Black civil rights activist and attorney, filed a class-action lawsuit (Pollard v. U.S. Public Health Service) on behalf of the men and their families. Only 72 of the men were still alive. The case resulted in a $10 million settlement.

A further outcome was federal legislation establishing Institutional Review Boards to protect human research subjects, and setting up what is now the Office for Human Research Protections in the Department of Health and Human Services.

The Continuing Legacy of the USPHS Syphilis Study

The University of Virginia Center for Bioethics and the Historical Collection Section of its library hosted an academic conference in April 1994 entitled "Doing Bad in the Name of Good?: The Tuskegee Syphilis Study and Its Legacy." The Tuskegee Syphilis Study Legacy Committee emerged from this conference, meeting for the first time in January, 1996.

The Legacy Committee was chaired by Dr. Vanessa Northington Gamble, M.D., a Black historian of medicine and medical policy analyst. It aimed to persuade President Clinton to apologize on behalf of the government for the atrocities of the study. And it developed strategies to address the psychological damages of the study to the psyche of African-Americans and others.

The Legacy Committee issued its final report in May, 1996. At a White House ceremony on May 16, 1996, Legacy Committee members, some of the surviving men and relatives, and others received President Clinton's apology from President Clinton.

"Tears streamed down the faces of many black people in the audience," Dr. Gamble remembered. "I heard people sobbing. The pain inflicted by the syphilis study was not limited to the citizens in and around Tuskegee. For many African Americans, the fact that the Tuskegee study occurred at all proves their lives are not valued in America. ...

"The syphilis study has become a powerful metaphor, symbolizing racism in medicine, misconduct in human research, the arrogance of physicians, and government abuse of black people. Efforts to improve the health status of African Americans have frequently come up against the legacy of the Tuskegee Syphilis Study," Dr. Gamble noted. "Many African Americans point to the syphilis study as a reason why they won't participate in clinical trials, donate organs, and ... are wary of being vaccinated.

"We cannot forget the inhumanity of the syphilis study," Dr. Gamble insisted, "but we cannot let it be the only lens through which we examine the history of African Americans and medicine. Even in the face of oppression, African Americans have developed strategies and institutions to provide care, improve health, advance black health care professionals, and to battle racism in medicine."

Dr. Gamble reflected on a conversation she had, the day of President Clinton's apology, with Mr. Herman Shaw, one of the survivors. "My conversation with Mr. Shaw reminded me that the men in the study should not be remembered solely as victims of a federally financed experiment, but as human beings with families, interests and lives."

Source: https://legacy.npr.org/programs/morning/features/2002/jul/tuskegee/commentary.html

Discussion: The Legacy of the US Public Health Service Syphilis Study at Tuskegee

Further Reading:

Gamble, V N. “Under the shadow of Tuskegee: African Americans and health care.” American journal of public health vol. 87,11 (1997): 1773-8. doi:10.2105/ajph.87.11.1773

Reverby, Susan (October 2009). Examining Tuskegee: The Infamous Syphilis Study and Its Legacy. The University of North Carolina Press.