Sociocultural issues in clinical research: Unraveling the Tuskegee syphilis study

Authors


To the Editor:

Brooks and coauthors reported that a recent article I published on the Tuskegee study of untreated syphilis (TSUS), was “plagued with factual errors” in an attempt “to exculpate the medical community from the burden of the Tuskegee study” (1, 2).

My article was not intended to exculpate the medical community. The “Unraveling” article was intended to provide clarity and specificity in understanding the TSUS. Absent from current discussions are the confluence of historic policies, programs, and procedures surrounding syphilis and public health in relation to or concurrent with the TSUS. Some of the material in my article was newly discovered and reanalyzed in the context of the TSUS (e.g., John A. Andrew Clinical Society; the Stanford Study of untreated late latent syphilis in men and women age >50 years; the Blue Star Study; 1943 Alabama mass syphilis survey law; 72 intramuscular injections of penicillin over 9 days as therapy in the mid to late 1940s; Bad Blood's mishandling and/or disregarding information about black professionals). My article challenged issues of contention, provided alternative views, and reduced the racial, ethical, and political overtones associated with the TSUS—a study that existed for 40 years without outrage, until a lay press article exposed it.

Furthermore, I believe the standard interpretations about the TSUS are responsible for alleged negative consequences on the African American community, such as decreased participation in clinical trials. The intent of the “Unraveling” article was to provide alternative information for medical professionals and researchers to discuss with their patients and their patients' families. These medical professional–patient dialogues about some of the issues surrounding the TSUS may prove to be beneficial to patients. For example, perhaps, many African Americans will actively seek to maintain their health, not delay treatment when ill, and participate in clinical research trials. If the article influences research and clinical practice, the future holds promise in narrowing health outcome disparities between blacks and whites. Clearly, patients are the priority, including the information and eventual care they consume. The “Unraveling” article educates, rather than exculpates, the medical community about their responsibility.

Brooks and coauthors did not provide any examples of factual errors in my article. In view of my objectives, constructive criticism would have been helpful for me and the readers of Arthritis Care & Research. However, on careful inspection of their article, they documented several historic accounts of the TSUS that were different from the historic record. I will provide examples that are even referenced in the “Unraveling” article.

The authors' documentation with regard to women differed from the historic record. The authors stated that the Rosenwald demonstrations and the Oslo study were studies of syphilis in men. Both studies included men and women (3–5). The results from the Rosenwald demonstrations in the rural South may have influenced the United States Public Health Service (USPHS), which intentionally selected only men for the TSUS to avoid transmission of congenital syphilis by female participants (6), and because men could give a better history of a primary lesion than women (7).

The authors referred to the African American nurse involved in the study as the “study coordinator.” This was not the term used to refer to her position during that historic period. In the published reports, she was referred to as “a nurse” (8), “public health nurse” (9), “a scientific assistant” (9), “Scientific Assistant” (4), “a Negro nurse” (6), and “Public Health nurse” (10). The use of exact terms, within a historic period, is critical because changing terms could lead to subjective, and therefore differing, interpretations.

Although Miss Eunice Rivers did coauthor 2 of the publications about the TSUS (4, 9), and is usually identified as the major or the only woman involved in the TSUS, 6 other women also coauthored 9 of the TSUS manuscripts in 7 different journals (2). Their names were Geraldine A. Gleeson, Dorothy S. Rambo, Anne Roof Yobs, Martha C. Bruyere, Lida Usilton, and Eleanor V. Price. Dr. Yobs was a physician and chief of medical research, Venereal Disease Research Laboratory. The other 5 women were statisticians who calculated the morbidity and mortality differences between the men with syphilis and the controls. Unlike Miss Rivers, they have not been figured into the equation of responsibility for their involvement in the TSUS. This not only is unfair to Miss Rivers, but it also is unfair to medical professionals, patients, and the general public who consume information about the TSUS. Omitting, obscuring, and minimizing the roles of other women in the study may limit perceptions and distort interpretations of the study.

The authors claimed the permission rate for obtaining autopsies was “close to 100%.” Although the autopsy rate (men with syphilis + controls) was comparable to the rate at many teaching institutions at the time (approximately 60%), it fell short of “close to 100%” (4). The autopsy rates (number of autopsies/number of deaths × 100%) through 1944 (8), 1948 (11), 1952 (10), and 1970 (5) were 72%, 70%, 57%, and 56%, respectively. The data came from rigorous scientific articles, particularly the data from 1952 (an article describing the autopsy results). In a less rigorous article by Rivers et al, reference was made to only 1 autopsy refusal and 145 autopsies obtained (99% autopsy rate) (9). This may be the source of the discrepancy if Rivers and coauthors were referring to “permission” and not actual autopsies.

The authors described the Rosenwald Foundation as the funding source for the pre-TSUS demonstrations in Macon County (and 5 other rural Southern counties) and sponsor of syphilis treatment. This information is incomplete. First, the Rosenwald Foundation ceased to exist in 1948 (12).

Second, some critics of the TSUS, including the authors, credit the Rosenwald demonstrations for the provision of treatment. However, treatment meant 8 or 9 doses of an arsenical—less than adequate treatment (20 doses) and definitely noncurative (70 doses), but sufficient to render patients noninfectious (2). The authors omitted important information about the role played by the Milbank Memorial Fund (which still exists in New York). From 1935 to 1972, the Milbank Memorial Fund provided an annual research grant to Tuskegee Institute to pay for the autopsies performed on the men in the study of untreated syphilis (6). Without this funding, permission for autopsies may not have been achieved. Autopsies were important for correlation with serologic and clinical data.

There were errors in citations in the authors' article. Although a typographical error in numbering citations or dates is one issue, an error in attribution of subject matter in the citation is another. Their reference 14, as part of citation “(14–24)”, was not a TSUS article. This 1999 article was an article about Miss Rivers; however, it did have a list of TSUS articles. Their reference 28 was not a recent article. This 1948 article about the Stanford Study did not mention any of the TSUS articles. The article described how patients—whites and blacks—who were similar to approximately 30% of the men in the TSUS were managed by a major medical institution (2).

Brooks and coauthors seemed to decontexualize the TSUS, by using the word “Tuskegee” to refer to the TSUS in what they called the “Tuskegee effect.” This reduces the TSUS to a single-word sound bite and image. Some other professionals have used “Tuskegee” in a similar manner, suggesting that this is an institutionalized, systemic problem (13–15). The word “Tuskegee” should not be used loosely in scientific discourse. The association of the TSUS as “Tuskegee” dissociates Tuskegee from its major historic context in the African American community. For example, there is a long history of associating the word “Tuskegee” with several entities, such as Tuskegee Institute (now University), Booker T. Washington, George Washington Carver, Tuskegee Veterans Administration Hospital, Tuskegee Civic Association, and the training base for World War II black pilots (now the Tuskegee Airmen). Carmichael and Hamilton (16) applaud “Tuskegee” as having a major positive impact on the African American experience, the community, and the nation during a past period of severe racial segregation and socioeconomic suppression.

Moreover, for health professionals and patients to think of “Tuskegee” in a negative light seems to minimize or distort the historic significance of “Tuskegee,” and perpetuates the myth that there were no positive and substantive events or people in Tuskegee, AL before and concurrent with the TSUS. Negativity associated with the word “Tuskegee” is exemplified by some writers who have suggested revising the name of the TSUS to the USPHS study of untreated syphilis, because of the stigma associated with the study (17, 18). Historic and cultural insensitivity to the true context and significant meaning of “Tuskegee” may have contributed to some of the misrepresentations and factual errors about the TSUS over the years.

In conclusion, patient care and clinical investigations require rigorous standards based on evidence. Although we may disagree about analyses and conclusions, historic reporting requires the same rigor as reporting the results of a clinical trial. It is only through attention to facts and details that we can expect our endeavors in clinical investigation and discourse about the TSUS to contribute toward better patient care. In the scientific and medical communities, dialogues about the TSUS should be with more facts and reason than fiction and confusion.

Robert M. White MD, FACP*, * Silver Spring, Maryland.

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