The Tuskegee Syphilis Experiment, social change, and the future of bioethics.

• Author: Smolin, David M.
• Position: Fred Gray Civil Rights Symposium

1. THE TUSKEGEE SYPHILIS EXPERIMENT AS A CONSEQUENCE OF SOCIAL CHANGE AND ILLUSTRATION OF REPEATED, LONG-TERM ETHICAL FAILURE

   This article presupposes some familiarity with the notorious Tuskegee Syphilis Experiment. In brief, the United States Public Health Service (PHS), from 1932 to 1972, conducted a study of the effects of untreated syphilis on impoverished, rural, African-American males. (1) It is fascinating--and a cautionary tale --to perceive the experiment itself as an unintended consequence of positive social change and of the work of some reputable "change agents." First, the experiment presumably would never have happened, if not for the work of the Julius Rosenwald Fund in regard to "health care for African-Americans in the rural South." (2) Julius Rosenwald was a "Jewish philanthropist" who can be characterized as a positive change agent through his foundation's assistance for both schools and health care. The Rosenwald Fund assisted the Tuskegee Institute, financed construction for schools for African-Americans--the first of which was built in Macon county, Alabama--and helped to construct hospitals and clinics. The Fund sought to improve race relations and promoted the hiring and training of African-American medical professionals and public health workers. The Rosenwald Fund successfully created an alliance with the PHS. (3) It is noteworthy that the federal and state governments, as well as the Rosenwald Fund, were all active in trying to provide treatment for syphilis and sexually-transmitted disease in the period prior to the Tuskegee experiment. The joint work of the PHS and the Fund in 1930-31 demonstrated very high infection rates and very low treatment rates, in six specified locations in the South, with the highest infection rates in Macon County, Alabama. Just as this significant, unmet need for treatment was revealed, however, the Great Depression limited both governmental and private funding for treatment. The Rosenwald Fund, with its funds diminished by lowered stock values, ended its support of syphilis treatment in 1932, and thus was not involved in the notorious Tuskegee experiment itself. (4) However, one can certainly view the experiments as an unintended consequence of the positive work of the Rosenwald Fund, as the Fund's work and partnering with the PHS opened up a pathway of concern and information about syphilis in the local area. The PHS in launching the experiment was able to build upon the good will and local contacts created by the Fund's work in Macon County. (5)

   In its context, the initial decision of the U.S. Federal Health Service to launch the Tuskegee study, while clearly unethical, is more understandable. First, the initial launch was intended as a short study of six to eight months. (6) Second, there was a genuine debate at the time as to whether the forms of treatment than those available, which used heavy metals including arsenic, were more harmful than helpful to patients. Penicillin was not yet available. (7) Third, due to the insistence of Alabama State Health Officer Dr. Baker, treatment was to be provided during the term of the study. While this would provide too short of a course of treatment to be deemed full treatment at the time, it was presumed to be significantly more than the complete lack of treatment that would occur apart from the study. (8) Fourth, initially the study was not designed to examine the ongoing effects of untreated syphilis going forward in time. Instead, the initial intent was to study the effects from untreated syphilis that had already occurred on a population that had suffered high rates of untreated and undiagnosed syphilis prior to the study. (9) Fifth, the study was a result of several intentions: to draw attention to a neglected public health and medical problem in society, by documenting the extent of the harm it produced, and settling issues as to whether there are disparate effects in different racial groups, as prior studies had been done on white Norwegians. In the context of the time, where public health officials believed they were documenting a very significant public health problem, and where funds for treatment were otherwise unavailable, the initial study plan probably seemed like a way to keep their efforts going and hopefully make a case for future attention and prioritization of the problem of untreated syphilis. (10)

   Of course, a fundamental ethical problem at the outset was the decision to mislead the treatment subjects and wider community. (11) However, at the time, such medical paternalism, involving not informing or misleading patients or research subjects, was common in both medicine and research. (12) To note this historical fact is not intended as a support of ethical relativism; such misleading of the research subjects was unethical at the time, despite being a common practice. (13) However, if the Tuskegee study had ended after that first year, it would not have been a historically significant event, but merely one of innumerable examples of a broader trend in which physicians and researchers misinformed patients and research subjects.

   There are at least three more critical moments of decision that made the Tuskegee experiments into such an infamous example of unethical human experimentation. The first occurred in 1933, when PHS officials decided to extend the study as one of untreated syphilis going forward in time. Thus was born the most infamous aspect of the study: the decision to deliberately watch the effects over time of untreated syphilis. At the time, this was conceived as lasting five to ten years, a much shorter time than the eventual term of forty years, but nonetheless a substantial amount of time. Coupled with the continuing decision to mislead the patients and community, this led to the bait-and-switch pattern in which the research subjects were led to believe that they were receiving medical treatment, when in fact the major point of the intervention was to see that they did not receive treatment for their syphilis. Of course their diagnosis was also withheld from them, and a control group of those without syphilis was added to the study. (14) Although the study took on its characteristic form at that time, and was extremely unethical, there were several mitigating factors. Again, the side-effects of the available treatments were thought by some to be worse than the effects of the disease, at least for a significant proportion of patients. (15) Second, the PHS presumably thought that absent their intervention, the patients would not receive any treatment, due to a lack of funding and the general lack of access of the subject population to health care services. Thus, it was possible to envision the study against the backdrop of a baseline or norm of no treatment. From this perspective the only thing the study added was observation, plus some things that were actually of benefit to the research subjects, such as burial insurance and some medical attention. This problem of the baseline (the experience of human research subjects pre-experiment or apart from the experiment) is something that haunts both ethics and bioethics, and has caused severe problems in other settings.

   Of course the study continued far beyond the five to ten years envisioned. Even as many relevant contexts in medicine and society changed, the study continued as though on some kind of ethical autopilot. Shortly after World War II, methods for mass production of penicillin were successfully established, and penicillin became the normative and successful method of treatment for syphilis. One would have thought that these changes would have induced an abandonment of the "no treatment" model at least by 1950, as the creation of a clearly effective treatment modality made the experiment far more unethical and far less medically significant. Indeed, the study took systematic and individualized actions to block the men from being treated with penicillin, thus obliterating the argument that the study itself had no impact on whether the men received treatment. Instead of merely observing what would anyway occur (the men not receiving treatment), deliberate actions were taken to prevent the men from receiving appropriate medical treatment of their conditions. (16) One would have thought that such actions would have been deemed indefensible, even at the time, making it initially difficult to explain the determination to continue the non-treatment model post-penicillin.

   Information that has come to light relatively recently provides some context for the dubious research ethics practiced by the Federal Government during this period immediately after World War II. Between 1946 and 1948, the U.S. Public Health Service and the National Institutes of Health, in collaboration with various Guatemalan governmental agencies, carried out research in which 1308 human subjects were, without consent, deliberately exposed to bacteria causing sexually transmitted diseases (syphilis, gonorrhea, and chancroid). The subjects included female commercial sex workers (CSWs), prisoners, patients in psychiatric facilities, and soldiers. Exposure was accomplished by sexual exposure to CSWs who themselves had been experimentally exposed, as well as direct inoculation. Some of the test subjects were treated with penicillin, but some also apparently received an incomplete course of treatment, and the records indicate that a significant number were never treated. The Guatemala experiments were directed by Dr. John C. Cutler, who in the 1950s and 1960s would help direct the continuing Tuskegee syphilis experiment for the PHS. (17)

   An examination of the career of Dr. Culter illustrates the mainstream nature of those involved in the Tuskegee syphilis experiment, and the tendency of those who viewed themselves as "change agents" to be involved. His 2003 obituary portrays him as a humanitarian and trailblazer in the field of reproductive health...