Historical understanding of the story behind the U.S. Public Health Service (PHS) human experimentation study of syphilis in Tuskegee, Alabama, has shaped policy decisions regarding medical research in this country ever since Jean Heller broke the story to The New York Times in 1972. Public outrage inspired the political push for requirements for informed consent, the protection of vulnerable populations and oversight by institutional review boards as outlined by the 1978 Belmont Report. The Tuskegee story is complex and frightful to those involved in medical care. James Jones, author of Bad Blood, “assumed that the physicians who conducted the study did not see themselves as evil agents who meant to do harm. I believed the study could shed light on how good people could err for what many of them thought were the best of reasons. By pursuing Tuskegee, then, I hoped to learn about moral ambiguity, slippery slopes, and, in the end, moral catastrophe.” To understand these stories, one must first understand the spirochete.
Humans are the only natural reservoir for Treponema Pallidum, the wily spirochete pathogen of syphilis. Pre-Columbian theory suggests that the White man gave syphilis to the Negro. Syphilis is a disease that exists in four different stages. In its primary form, a painless chancre is noted at the point of sexual contact for several weeks post exposure. Secondary syphilis occurs approximately 4-10 weeks after the primary infection and is manifested by skin rash, lesions on mucous membranes and other systemic symptoms. Latent syphilis exists without symptoms but with serologic proof of infection. Tertiary syphilis may occur 3-15 years (or more) post infection and can affect the dermatologic, neurologic or cardiovascular systems and can cause serious morbidity and mortality. Congenital syphilis transmission can also occur during pregnancy or childbirth. Syphilis is diagnosed clinically and confirmed via serologic tests, which exist in nontreponemal and treponemal forms. The Wasserman test is based on complement fixation testing of blood, or CSF, and was developed in 1906.
In 1910, Dr. Paul Ehrlich, a German researcher, developed arsphenamine (also called Salvarsan or 606), the first modern chemotherapeutic agent. Arsphenamine replaced mercury as the treatment of choice for syphilis.
Between 1890 and 1910, Professor C. Boeck, chief of the Oslo Venereal Clinic, withheld treatment from almost 2,000 pre-Wasserman-test White male and female patients infected with primary and secondary syphilis. He was convinced that therapies then available, primarily mercurial ointment, were of no value. Once Dr. Ehrlich discovered arsphenamine, the study ended as new patients were treated with Salvarsan. E. Bruusgaard succeeded Boeck and, between 1925 and 1927, retrospectively reviewed 473 patients from the original 2,000.
In 1933, when discussing the 1929 Oslo Study, Dr. J. E. Moore, one of the nation’s leading venereologists, wrote,
Though it imposes a slight though measurable risk of its own, treatment markedly diminishes the risk from syphilis. In latent syphilis, as I shall show, the probability of progression, relapse or death is reduced from a probable 25-30 percent without treatment to about 5 percent with it; and the gravity of the relapse if it occurs, is markedly diminished.
Moore added, “Another compelling reason for treatment exists in the fact that every patient with latent syphilis may be, and perhaps is, infectious for others.” Some controversy did exist in the field, however. Dr. Blum and the group from Stanford Medical Center VD Clinic followed and intentionally did not treat a mixed race and mixed gender group of 800 patients, 50 years and older, with latent syphilis and normal spinal fluid. Blum was not convinced that the potential disability from latent syphilis justified the risk of pre-penicillin treatment. In 1948, however, he concluded that “the prognosis in later latent syphilis appears to be improved by treatment at anytime, and there seems to be steady improvement with increasing amounts of therapy."
By 1930, the Rosenwald Fund syphilis control demonstration and treatment program noted a 35% Wasserman positivity result in Macon County, Alabama. The high prevalence of syphilis was noted as a significant public health problem for the sharecropper population associated with a significant loss of labor productivity for the landowners in the South.
Taliaferro Clark, Assistant Surgeon General, Division of Venereal Disease, wrote to Dr. Baker, State Health Office, Montgomery, Alabama, on August 29, 1932: “It seems to me that the situation in a very heavily infected population group affords an unparalleled opportunity of studying the effects of untreated syphilis on the human economy.’’ Baker responded on September 23, 1932:
The (Macon County Health) Board was quite enthusiastic about the previous project, and was quite willing for this new understanding to proceed along the suggested lines. According, they passed a motion approving the project, but with the distinct understanding that treatment be provided for those people.
The Tuskegee Study design differed from the Oslo Study in its prospective and controlled design and in its all male, Negro study participants. At the time, some believed that the wily spirochete might behave differently in Black hosts compared with White hosts. Dr. Moore, who also served as an expert consultant to the Tuskegee Study, stated in his letter dated September 28, 1932: “Syphilis in the negro is in many respects almost a different disease from syphilis in the white.”
So in 1932, the PHS convinced 399 Black men with late latent syphilis and 201 Black men free of disease by clinical exam and Wasserman reaction to participate in a nontherapeutic controlled study of untreated syphilis. However, the men were deceived and thought they were patients in a joint federal and local medical and nursing program of the Tuskegee Institute and the Macon County Health Department for the treatment of “bad blood,” a local expression for syphilis and anemias. The men did not consider themselves subjects because they did not know that the study existed. During the course of the study, the PHS physicians prevented the men from receiving syphilis treatment (after allowing some inadequate treatment at study initiation in 1932) and prevented the men from receiving penicillin when available. The men were never given a diagnosis but were provided with the watchful eye of Nurse Eunice Rivers, as well as health examinations, including spinal taps. The PHS distributed to the study participants tonics, aspirins, iron pills, award certificates, free lunches and burial insurance. In exchange, the families of the men agreed to allow for autopsies without the knowledge that these men were part of a study. The researchers sought to document the ravages of syphilis present in the men at the time of necropsy. Thirteen progress reports were published in respectable medical journals over the course of the study.
The ethos of human research in 1932 did not require the preparation of a formal study protocol nor was informed consent of study participants required. Civilian scrutiny did not exist in any form at that time.
The first study design of Dr. Clark in 1932 was for a six-to-eight month investigation of the natural history of untreated, latent syphilis. However, in response to Dr. Baker’s letter noted above, Clark altered the study “to secure the cooperation of the planters … it was necessary to carry on this study under the guise of a demonstration and provide treatment for those cases uncovered … in need of treatment.” So Clark compromised the original study design, and the study at the onset changed from one of observation of syphilis in the untreated Black male to one of observation of syphilis in the partially and inadequately treated Black male. This became a fatal research flaw, and from that point, study information became very difficult to interpret. John Fletcher, former director of the Center for Biomedical Ethics, states “if research was the overriding goal, Clark and Vonderlehr et al deceived themselves as scientists by adding therapy.” Therefore, the Tuskegee Negro Study could never be directly comparable to the Oslo Caucasian Study. “Nonetheless Clark and others lacked the courage to defend a nontherapeutic study to the end.”
In 1951, PHS physician Dr. Heller wrote:
We have an investment of almost twenty years of (VD) Division interest, funds, and personnel as well as a responsibility to the survivors for their care and really to prove (to them) that their willingness to serve, even at the risk of shortening life, as experimental subjects (has not been in vain). And finally a responsibility to add what further we can to the natural history of syphilis.
The White PHS staff clearly strapped their narcissistic self-righteousness on the backs of the Alabama Black men. Even in 1976, after the study was terminated, Heller continued to argue that the study should have continued to “better the ultimate (scientific) information … the men’s status did not warrant ethical debate. They were subjects, not patients; they were clinical material, not sick people.” In the progress reports published by the PHS team, the scientific language encouraged the authors and the readers to disassociate themselves from the Tuskegee men. The reports functioned rhetorically to dehumanize the men and to diminish and obscure the moral issues involved.
The Declaration of Helsinki was released in 1964, and by that time the PHS physicians, according to Fletcher, “had failed to recognize or remedy severe moral violations progressively blameworthy by the moral lights of the period.” In 1993, PHS physician John Cutler spoke about the Tuskegee study: “If I may make an analogy it’s like sending men off to war and knowing some will die. It’s in the interest of the total society … You had to make these value judgments … we had the responsibility, the job to be done and we did it.” By 1993, however, the first and only PHS physician publicly apologized for his Tuskegee involvement. Dr. Sid Olansky’s physician son wrote to the Emory Dermatology Department Chairman that Sid now “admits that he made a mistake in not believing that the patients should have been given penicillin … a feeling based on the belief that the penicillin would not help them physically.“ Sid Olansky continued, “I’m terribly sorry. I wish it had never started. It didn’t accomplish any of the things I wanted it to or thought it might. Sure I’m sorry it cost me a great deal.”
Those who inflict humiliation commonly defend their behavior as being honest or justified by circumstances, and they underestimate the harm they cause. The offended party wants dignity restored and to let go of their hurt, anger and resentment. The restoration of dignity in response to humiliation emerges as one of the most important functions of apology. After the 1999 Institute of Medicine report “To Err is Human,” the profession of medicine now recognizes and recommends that an apology is an appropriate and necessary response following the disclosure of a medical error. Dr. Aaron Lazare, a leader in the apology and patient safety movements, writes:
Apology is a universal healing force for resolving interpersonal or intergroup conflicts in which one party acknowledges responsibility for an offense. The profession of medicine appears to be one of the last to recognize the importance of apologies except for medical errors. At the same time, the tensions, stress and history of medical practice have resulted in a time honored tradition of humiliating behaviors toward patients, colleagues and trainees.
Twenty-four years following the termination of Tuskegee, President William Clinton (but not the PHS doctors) apologized to the participants and their families:
Many Americans would prefer not to remember, but we dare not forgot … our nation broke the trust with our people … It is not only in remembering that shameful past that we can make amends and repair our nation, but it is in remembering that past that we can build a better present and a better future. And without remembering it, we cannot make amends and we cannot go forward.
The socially and economically vulnerable remain an at-risk population as subjects of human research. The present market-place-driven, multicenter research environment, which includes for-profit institutional review boards with the escalating pressure to accommodate research sponsors is an environment that still allows for the generation of unethical human research. As Fletcher comments, “because physicians are not trained to look for conflicts of interest, they often find themselves enmeshed in them without recognizing the problem.”
Herman Shaw, one of the oldest Tuskegee survivors, responded to President Clinton in this way:
The damage done by the Tuskegee Study is much deeper than the wounds any of us may have suffered. It speaks to our faith in government and the ability of medical science to serve us as a force for good. (But) … in my opinion, it is never too late to restore faith and trust.
- Blum, Henrik L., and Charles W. Barnett. "Prognosis in Late Syphilis." Arch Intern Med 42 (1948): 393-409. Print.
- Brandt, A. M. "Racism and Research: The Case of the Tuskegee Syphilis Study." Hastings Center Report (1978). Print.
- Bruusgaard, E. "Über Das Schicksal Der Nicht Spezifisch Behandelten Luetiker." Archiv Für Dermatologie Und Syphilis 157.2 (1929): 309-32. Print.
- "Information on the 1946-1948 United States Public Health Service STD Inoculation Study." United States Department of Health and Human Services. Web. 11 Oct. 2011. http://www.hhs.gov/1946inoculationstudy/.
- "Joint Commission, Healthcare at the Crossroads, Strategies for Improving the Medical Liability System and Preventing Patient Injury." Joint Commission on Accreditation of Healthcare Organization Oakbrook Terrace (IL). Web. 15 Sept. 2011.
- Jones, James H. Bad Blood: The Tuskegee Syphilis Experiment. New York: Free, 1981. Print.
- Kampmeier, R. H. "Final Report on the "Tuskegee Syphilis Study"" South Med J 67 (1974): 1349-354. Print.
- Kent, M. E., and F. Romanelli. "Reexamining Syphilis: An Update on Epidemiology, Clinical Manifestations, and Management." Annals of Pharmacotherapy 42.2 (2008): 226-36. Print.
- Kohn, Linda T., Janet Corrigan, and Molla S. Donaldson. To Err Is Human: Building a Safer Health System. Washington, D.C.: National Academy, 2000. Print.
- Lazare, A., and R. S. Levy. "Apologizing for Humiliations in Medical Practice." Chest 139.4 (2011): 746-51. Print.
- Lazare, A., and R. S. Levy. "Apologizing for Humiliations in Medical Practice." Chest 139.4 (2011): 746-51. Print.
- MacDonald, C. J. "Communications: The Contribution of the Tuskegee Study to Medical Knowledge." J Natl Med Assoc 66 (1974): 1-7. Print.
- Moore, Joseph Earle, Jarold E. Kemp, Harry Eagle, Paul Padget, and Mary Stewart Hooke Goodwin. The Modern Treatment of Syphilis. Springfield, Ill., Baltimore, Md.: C. C. Thomas, 1941. Print.
- "NATIONAL INSTITUTES OF HEALTH." Office of Human Subjects Research. Web. 19 Nov. 2011. http://ohsr.od.nih.gov/guidelines/belmont.html.
- Parran, Thomas. Shadow on the Land: Syphilis. New York: Reynal & Hitchcock, 1937. Print.
- Reverby, Susan. "’Normal Exposure’ and Inoculation Syphilis: A PHS ‘Tuskegee’ Doctor in Guatemala, 1946-48." Journal of Policy History (2011). Print.
- Reverby, Susan. Tuskegee's Truths: Rethinking the Tuskegee Syphilis Study. Chapel Hill, NC: University of North Carolina, 2000. Print.
- Shuster, Evelyne. "Fifty Years Later: The Significance of the Nuremberg Code." New England Journal of Medicine 337.20 (1997): 1436-440. Print.
- Solomon, Martha. "The Rhetoric of Dehumanization: An Analysis of Medical Reports of the Tuskegee Syphilis Project." West J Speech Commun 49 (1985): 233-47. Print.
- Wassermann, A., A. Neisser, and C. Bruck. "Eine Serodiagnostische Reaktion Bei Syphilis." DMW - Deutsche Medizinische Wochenschrift 32.19 (1906): 745-46. Print.
- White, R. M. "Unraveling the Tuskegee Study of Untreated Syphilis." Arch Intern Med 160 (2000): 585-98. Print.