Tuskegee Syphilis Study

A Wake-Up Call for Bioethics

You feel an unsettling nausea wash over you as you wait in line for medication. Your joints start to ache; the disease has already begun to burn through your ligaments. You shudder as you watch the rash on your hand fester with the syphilis bacteria. You are finally called up to the desk. You state your name to the nurse, who shakes her head at you; you’re on the list of people who may not receive penicillin.

The Tuskegee Syphilis Study has been called “the most infamous biomedical research study in U.S. history” (1). From 1932 to 1942, government physicians studied untreated syphilis in 399 black men from Macon County, Alabama (2). By the time the Study was finally terminated in 1972, 128 people had died of syphilis and related complications (3). The participants in the Study were not only denied treatment, but were also actively restrained from obtaining penicillin after the Center for Disease Control deemed it the drug of choice to combat the disease (4). This patent denial of treatment represented the lack of patient empowerment that characterized the medical profession at the time.

The Study
In September 1932, Dr. Taliaferro Clark proposed to Dr. J. N. Baker and Dr. D. C. Gill a study to “learn how untreated syphilis affects Negroes” (4). After an official review, it was decided that Dr. Clark was to give every patient the minimal dosage of medicine to treat the diseases to cut costs. Subjects were to receive eight doses of neoarsphenamine and additional doses of mercury pills (5). The study was approved under these circumstances and testing began.

Once they had recruited enough men with syphilis, providing medication for them became a massive burden. Dr. Clark constantly complained about the treatment, but Dr. Raymond Vonderlehr, the experiment’s on-site director, reassured him that it was necessary to continue the treatment program despite its cost so long as the subjects’ “interest and cooperation could be maintained in doing so” (6). Patients were given different amounts of drugs depending on the patient’s age and severity of illness. Although all of the subjects received doses of the heavy metal therapy, the maximum dosage received by any man in the study was less than half the amount recommended by the Public Health Service to cure syphilis (7). After Dr. Clark resigned his position in the project in June of 1932, Dr. Vonderlehr succeeded him as acting director and ensured the longevity of the experiment for the next four decades.

Throughout the next few months, Dr. Vonderlehr redesigned the research procedure in his vision and visited many local physicians to gather support for his proposal. Treatment was not discussed, since the test subjects were “medically indigent” and had no reason to expect treatment anyway, according to some of the researchers (8). Yet Dr. Vonderlehr sought to examine the course of “untreated syphilis” in men who had already been given medication for the disease. He rationalized that men remained untreated “in the modern sense of therapy” (9).

The addition of nurse Eunice Rivers to the staff provided a connection between the physicians and the subjects. She garnered the trust of the subjects and carried out orders from the doctors. She developed the attitude that the men in the experiment were being given the best of care. Ironically, her presence at the health clinics coupled with her ability to recognize the men on sight ensured that they would not be treated. Not even the advent of penicillin in the mid 1940s could sway Rivers’ opinion that the men were part of a privileged group. They had not been given medication to treat syphilis for over ten years; Rivers had grown accustomed to it. When Dr. John Heller succeeded Dr. Vonderlehr in 1943 as director of the Division of Venereal Diseases, he decided to continue the experiment and withhold penicillin from the subjects, stating: “The longer the study, the better the ultimate information we would derive” (10).

Aftermath
Despite the magnitude of the wrongdoing, there was but a whimper of dissent. Fred Gray, the attorney who later represented the men of the study in Pollard v. United States, wrote that “up [until the mid sixties], there is little in the public record to indicate that anyone, from the PHS, the Milbank Memorial Fund, or Tuskegee Institute raised significant moral or ethical concerns about the Tuskegee Syphilis Study” (11). Finally, in July 1972, Peter Buxtun, an entry-level investigator working for the United States Public Health Service, exposed the study to the Associated Press. The Washington Star and The New York Times ran front-page stories in the subsequent weeks, sending the health department into convulsions (12).

Dr. Merlin K. Duval, the assistant secretary in the Department of Health, created an ad hoc panel to investigate the study. The panel’s initial reports in late April 1973 were highly critical of the study and admitted that the physicians should have given penicillin to the patients. The panel also reported that the existing protection of patients was not effective and recommended immediate reform. However, little was said about the patients themselves.

The panel did not address any legal concerns of the survivors nor did the government apologize to the remaining men for the horror that they endured (13).

Reform
The Tuskegee Syphilis Study was one of the main impetuses for increasing patient empowerment. It was a wake-up call that triggered a wave of new legislation to protect patients. This movement thrust bioethics into the national spotlight. Sen. Ted Kennedy condemned the study as “an outrageous and intolerable situation which this Government never should have been involved in” and worked to completely overhaul the health, education, and welfare regulations by conferring a more important role to institutional review boards (14).

Twenty-five years after the exposure, President Bill Clinton apologized to the remaining victims and pledged to strengthen bioethics programs across the country and encourage more public involvement in the clinical process (15). In 2000, the United States and United Kingdom set up advisories on international research in response to HIV transmission trials. Placebos became prohibited in trails in which the treatment was known. Treatment programs have also been extended to include subjects have already completed their clinical trials. These practices have helped to close the gap between physician and patient to prevent another Tuskegee (16).

The Future
Prior to the Tuskegee Syphilis Study, discussions on informed consent and patient rights had little influence on experimental conduct. After the exposure of this travesty, political outcry forced the discussion into the public forum. The government established a comprehensive set of rules that was strictly enforced, and universities across the country created new programs to address the issue. These programs were expected to take on an active role in clinical testing.

The bioethics debate persists to this day. Bioethicists have also tackled public issues such as global health and human rights in order to expand the field beyond the walls of academia. It is unclear where bioethics will go from here. Scholars continue to debate the financial and administrative securities of these programs while the unpredictable political, racial, and ethnic forces of the American demographic twist and turn the trajectory of bioethics (17).

The Tuskegee Syphilis Study was a sad episode in American history, but out of the ashes emerged a new attitude towards patient safety and informed consent. It encouraged the medical community to take on new responsibilities to protect subjects during clinical trials so that another tragedy of this magnitude could never happen again.

References
1. J. P. Goldsmith, Am. Acad. of Ped. 29, 18 (2008)
2. R. M. White, Arch. of Int. Med. 160, 585-598 (2000).
3. M. Jordan, Hush Hush: The Dark Secrets of Scientific Research (Firefly Books, Buffalo, NY, 2003), p. 172.
4. Centers for Disease Control, Sexually Transmitted Diseases Treatment Guidelines, MMWR Rep. No. 55 (2006).
5. J. H. Jones, Bad Blood: The Tuskegee Syphilis Experiment (The Free Press, New York, 1993), p. 98-99.
6. J. H. Jones, Bad Blood: The Tuskegee Syphilis Experiment (The Free Press, New York, 1993), p. 119.
7. J. H. Jones, Bad Blood: The Tuskegee Syphilis Experiment (The Free Press, New York, 1993), p. 120.
8. J. H. Jones, Bad Blood: The Tuskegee Syphilis Experiment (The Free Press, New York, 1993), p. 145.
9. J. H. Jones, Bad Blood: The Tuskegee Syphilis Experiment (The Free Press, New York, 1993), p. 131.
10. J. H. Jones, Bad Blood: The Tuskegee Syphilis Experiment (The Free Press, New York, 1993), p. 179.
11. J. H. Jones, Bad Blood: The Tuskegee Syphilis Experiment (The Free Press, New York, 1993), p. 61.
12. A. L. Caplan, The Hastings Cent. Rep., 22 (1992).
13. J. H. Jones, Bad Blood: The Tuskegee Syphilis Experiment (The Free Press, New York, 1993), p. 212-217.
14. J. H. Jones, Bad Blood: The Tuskegee Syphilis Experiment (The Free Press, New York, 1993), p. 214.
15. W. J. Clinton, “Remarks by the President in Apology for Study Done in Tuskegee” (The White House, Washington, DC, 1997).
16. S. M. Reverby, Postgrad. Med. Journ., 77, 553-554 (2201).
17. J. P. Kahn. S.M. Wolf, The Hastings Cent. Rep., 35.4, 22-24 (2004).