The American Journal of the Medical Sciences (C) Copyright 1999 Southern Society for Clinical Investigation ---------------------------------------------- Volume 317(1) January 1999 pp 1-4 ---------------------------------------------- Tuskegee: From Science to Conspiracy to Metaphor [Editorial] THOMAS, STEPHEN B. PhD; CURRAN, JAMES W. MD, MPH Dr. Thomas is an Associate Professor of Community Health in the Department of Behavioral Sciences and Health Education, and the Director of the Institute for Minority Health Research, at the Rollins School of Public Health, Emory University, Atlanta, Georgia. Dr. Curran is the Dean and a Professor of Epidemiology of the Rollins School of Public Health, Emory University, Atlanta, Georgia. Correspondence: Stephen B. Thomas, PhD, Department of Behavioral Sciences and Health Education, Institute for Minority Health Research, Rollins School of Public Health, Emory University, 1518 Clifton Road, NE, Atlanta, GA 30322. ---------------------------------------------- Outline Social and Historical Context of the Tuskegee Study Significance of the Tuskegee Study for Contemporary Research in Medicine and Public Health References ---------------------------------------------- On May 16, 1997, in the East Room of the White House, President Bill Clinton issued a formal apology for the Tuskegee Study of Untreated Syphilis in the Negro Male. Directing his words to the survivors, several of whom were over 90 years old, the President said, "...what was done cannot be undone, but we can end the silence. What the United States government did was shameful, and I am sorry." The President placed the burden of responsibility for the abuse on the medical research establishment when he stated, "the people who ran the study at Tuskegee diminished the stature of man by abandoning the most basic ethical precepts. They forgot their pledge to heal and repair."1 Almost 70 years after the study began in 1932, 26 years after it was stopped in 1972, and 1 year after the Presidential apology, there remains a legacy of mistrust among African Americans toward the medical research establishment.2-7 In this issue of The American Journal of the Medical Sciences, Giselle Corbie-Smith's essay argues that this mistrust is legitimate and she illustrates how the long shadow of Tuskegee is a barrier to increasing the participation of African Americans in clinical research. The Presidential apology and the Corbie-Smith essay both demonstrate the danger and the opportunity inherent in any attempt to draw lessons from the Tuskegee Study. In breaking the silence on Tuskegee, Corbie-Smith runs the danger of adding fuel to the fire of outrage and anger that has been smoldering since public disclosure about the study in 1972. The essay also provides an opportunity to illustrate how the Tuskegee Study is just one link in a long chain of "research abuse."8,9 The author describes how the behavior of physicians must be understood within a historical context, how the nature of research risks must be distinguished from clinical practice, how research on racial differences can reinforce prejudice, and finally, how confidence in the process of informed consent can be tenuous. This editorial addresses issues beyond the scope of the essay that are important to clinical investigations in the African-American population. Social and Historical Context of the Tuskegee Study Unfortunately, many details about the Tuskegee study are not well known.10 Therefore, we use the work of historian James Jones 11 to delineate the social and historical context of the study. The Julius Rosenwald Fund, a philanthropic organization in Chicago, was dedicated to the promotion of the health, education, and welfare of black Americans. In 1928, the Fund's director of medical service approached the U.S. Public Health Service (PHS) in an effort to expand activities to improve health status of blacks in the rural South. At that time, the PHS had successfully completed a study on the prevalence of syphilis in over 2,000 blacks employed by the Delta Pine and Land Company in Mississippi. Of the sample, 25% tested positive for syphilis, and the PHS collaborated with the Rosenwald Fund to provide treatment to these employees. The success of this collaboration led the PHS to submit a proposal to the Rosenwald Fund for the expansion of demonstration programs to control syphilis in five counties in the rural South. The proposal was approved with the condition that a black public health nurse be employed on the project. From 1929 to 1931, the Rosenwald Fund sponsored syphilis control demonstration projects in Albermarle County, Virginia, Glynn County, North Carolina, Macon County, Alabama, and Tipton County, Tennessee, to demonstrate that rural blacks could be tested and treated for syphilis. In Macon County, 35% to 40% of the people tested were positive for syphilis. Before the treatment phase of the project could begin, three factors intervened which led to the Tuskegee Study of Untreated Syphilis in the Negro Male. First, there was much speculation in the scientific literature at that time on racial differences in the natural history of syphilis, including theories suggesting that syphilis affected the neurologic functions of whites and that latent syphilis impaired the cardiovascular system of blacks. A retrospective study of white men in Oslo, Norway, published in 1929, found that cardiovascular damage was common and neurologic involvement was rare.11 This finding was contrary to the prevailing scientific view in the United States. Second, in 1932, arsenic and bismuth treatments were quite toxic and of limited efficacy for syphilis, and their efficacy for latent syphilis approached zero. Third, the Depression in 1929 devastated the financial resources needed by the Rosenwald Fund to support the treatment phase of the project. Consequently, the PHS could not develop treatment programs in all five counties. The PHS concluded that the best chance of salvaging anything of value from the project was to conduct a scientific study more rigorous than Oslo, calling it "an unparalleled opportunity for the study of the effect of untreated syphilis"11(p.91) The study would also permit the PHS to maintain the momentum of public health work in Alabama by continuing their close working relationship with state and local health officials and black leaders at the Tuskegee Institute.11 Additionally, Booker T. Washington, the founder of the Tuskegee Institute, had established Negro Health Week in 1915, and by 1932, the Week was well on its way to becoming a national movement. The Negro Health Movement provided a positive context for public health work in black communities across the nation, especially in its Tuskegee birthplace.12 Extensive collaboration among government agencies, along with an unprecedented culturally sensitive community-based approach, contributed to the 40-year continuation of the Tuskegee Study. For example, the PHS was extremely successful in enlisting black church leaders, elders in the community, and owners of local plantations to encourage participation in the study. Additionally, the historical context in which whites ruled blacks in Macon County, coupled with the blacks' extreme poverty and total lack of access to health care, made the men willing "subjects." Researchers presented scientific papers from the study at professional meetings and published in peer-reviewed journals throughout the course of the study.11 However, PHS scientists lost interest in the study during the latter decades and with that came lax administrative oversight. The PHS "experts," without doubt, viewed themselves, and were viewed by residents, as more "progressive" scientifically and socially than the medical providers in Macon County. The physicians who conducted the Tuskegee Study were not monsters; they believed that the study would bring attention and resources to ameliorate the predicament of blacks with untreated syphilis in the rural South. Access to the "benefits" of state-of-the-art medical research and the opportunity to demonstrate their competence as scientists motivated the cooperation of local black physicians, in a time when blacks were believed to be inherently inferior. The men in the study were motivated by the promise of "free" medical care to cure their "bad blood."11 Today, the Tuskegee Study evokes fear of being dehumanized and treated like "guinea pigs."3,5,6,8,13 The men in the study did not receive respect as autonomous human beings; they were treated as a means to an end. By pursing scientific ends at the expense of human rights, even well-meaning investigators may pose a threat to participants in clinical research. Additionally, the scarcity of financial resources is perhaps our greatest barrier. As Curran stated, "competition for health care and research resources will become even greater during the next decade."14(p.5) For example, for the first time in 15 years, the state of North Carolina will be without a comprehensive sickle cell anemia center because the Duke-University of North Carolina research grant was not renewed during a competitive funding cycle. In a story about the situation, the editors stated, "it is by treating patients that the center has conducted its research."15(p.A16) Without money for research, what will happen to the treatment program? Significance of the Tuskegee Study for Contemporary Research in Medicine and Public Health Recruitment and Retention of Participants in Research. It is always inappropriate to overemphasize the "benefits" of state-of-the-art therapies. This can lead to overselling participation in research, and contribute to bias by participants as well as scientists. Because the benefits to the individual may not exceed the risks in a scientifically valid study, the neutrality assumption is one protection against research like Tuskegee. The continuation of the Tuskegee study after penicillin became the standard of care illustrates how longitudinal research can lose ethical scrutiny as well as scientific validity. Finally, we must continue to review the ethics of long-term studies in the context of scientific advancements in new therapies and interventions. Informed Consent. Corbie-Smith's skepticism about informed consent is cause for concern. Legitimate issues about educational differences apply to the elderly, children, and immigrants, as well as to racial and ethnic minorities. We must not allow ourselves to be "resigned" to inadequate consent procedures, particularly if there is danger of overselling the benefits of clinical research. Investigators must recognize that simple compliance with procedures for the protection of human subjects is not sufficient. The researchers who conducted the Tuskegee Study violated trust when they made a conscious decision to withhold information about syphilis from participants. Consequently, blacks today may not believe that they are being told the whole truth about their medical condition. To build community trust, researchers must verify that participants are fully informed about research procedures, costs, risks, and benefits. This is the context in which the process of informed consent becomes a negotiated partnership between the researcher and participant, rather than simple adherence to legal procedures. Biological and Genetic Bases of Disease Variation. Exploring racial differences in disease manifestation, from either a scientific or a "politically correct" perspective, is a double-edged sword. On one edge, it is necessary to provide scientific data on diverse groups in order to explore potential racial differences in drug action and side effects. On the other edge, it is crucial that culturally biased hypotheses do not direct science and society or masquerade as biologic truths. We must acknowledge that race is a social construction with little biologic significance.16 Additional complications arise because politically correct considerations can substitute for sound ethical principles, a danger whether or not political winds change. Tuskegee, from Science to Conspiracy to Metaphor. The Tuskegee Study of Untreated Syphilis in the Negro Male began as an attempt to scientifically study the natural history of the disease in black men. When the PHS stopped the experiment in 1972, newspaper editors compared the study to medical atrocities committed by the Nazis. For many African Americans, the study is evidence of a conspiracy to eliminate black people and justification for the profound lack of trust between African Americans and the health care delivery system.11,17,18 Today, "Tuskegee" is being promulgated as a metaphor to characterize the use of biomedical research in violation of human rights. Metaphors are powerful linguistic devices that can enlighten as well as obscure. Merely to invoke Tuskegee 19 as a weapon of persuasion in an argument over a complex case of clinical research 20 is not the solution. We have a moral obligation to conduct our work with an attitude of respect for the humanity of study participants, regardless of the social, cultural, and economic gulf that may exist between researcher and participant. When Tuskegee is used to obscure, we end up with with competing voices clamoring in confusing and quarrelsome debate. To use Tuskegee to enlighten is to develop and adhere to a set of universal moral and ethical principles, derived from actual practice and refined by reflection and experience. In 1932, the men in the Tuskegee Study trusted their doctors. Almost 70 years later, because the survivors accepted the Presidential apology with forgiveness, we have an opportunity to build a new covenant based upon the three principles outlined in the Belmont Report 21: 1. Respect for persons-the recognition of the right of persons to exercise autonomy; 2. Beneficence-the minimization of risk incurred by research participants and the maximization of benefits to them and to others; and 3. Justice-the principle that therapeutic investigations should not unduly involve persons from groups unlikely to benefit from subsequent application of the research. By generating questions that require the reader to reflect upon the scientific assumptions that drive research, and the social, political, and economic context in which people volunteer as participants, the Corbie-Smith essay makes a meaningful contribution toward a better understanding of the continuing legacy of the Tuskegee Study on medical and public health research. References 1. Thomas S, Quinn S. Presidential apology for the Study at Tuskegee. Encyclopedia Britannica 1998 Medical and Health Annual. Chicago: Encyclopedia Britannica; 1997:280-1. 2. Brandt A. Racism and research: the case of the Tuskegee Syphilis Study. Hastings Cent Rep. 1978;8:21-9. 3. Thomas S, Quinn S. The Tuskegee Syphilis Study 1932-1972: implications for HIV education and AIDS risk reduction programs in the black community. Am J Public Health. 1991;81:1498-1505. 4. Guinan M. Black communities' beliefs in "AIDS as genocide:" a barrier to overcome for HIV prevention. Ann Epidemiol. 1993;3:193-5. Bibliographic Links Library Holdings 5. Stryker J. Tuskegee's long arm still touches a nerve. The New York Times. April 13, 1997. 6. Richardson L. An old experiment's legacy: distrust of AIDS treatment. The New York Times. April 21, 1997. 7. Quinn S. Belief in AIDS as a form of genocide: implications for HIV prevention programs for African Americans. J Health Ed. 1997;28:S6-S11. 8. Gamble V. Under the shadow of Tuskegee: African Americans and health care. Am J Public Health. 1997;87:1773-8. 9. Turner C, Darity W. Fears of genocide among black Americans as related to age, sex, and region. Am J Public Health. 1973;63:1029-34. Bibliographic Links Library Holdings 10. Coughlin S, Etheredge G, Metayer C, Martin S. Remember Tuskegee: public health student knowledge of the ethical significance of the Tuskegee Syphilis Study. Am J Prevent Med. 1996;12:242-6. Bibliographic Links Library Holdings 11. Jones J. Bad Blood: The Tuskegee Syphilis Experiment. 2nd ed. New York: Free Press; 1993. 12. Quinn S, Thomas S. The National Negro Health Week, 1915 to 1951: a descriptive account. Wellness Perspectives. 1996;12:172-9. 13. Thomas S, Quinn S. The burdens of race and history shaping Black American attitudes toward needle exchange policy to prevent HIV infection. J Public Health Policy. 1993;14:320-47. Bibliographic Links Library Holdings 14. Curran J. Our modern plague. J Health Education. 1997;28:S4-S5. 15. Editors. No rest for a disease. The News & Observer (Raleigh, NC). May 20, 1998. 16. Thomas S, Quinn S. The significance of race and ethnicity in public health policy and practice. Curr Issues Public Health. 1996;2:5-8. 17. Allen A. Injection rejection: the dangerous backlash against vaccination. The New Republic. March 23, 1998:20-3. 18. Gamble V. A legacy of distrust: African Americans and medical research. Am J Prevent Med. 1993;9:35-8. Bibliographic Links Library Holdings 19. Angell M. The ethics of clinical research in the Third World. N Engl J Med. 1997;337:847-9. 20. Varmus H, Satcher D. Ethical complexities of conducing research in developing countries. N Engl J Med. 1997;337:847-9. 21. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Belmont Report: ethical principles and guidelines for the protection of human subjects of research. Washington, DC: Government Printing Office, 1988: GPO 887-809. Accession Number: 00000441-199901000-00001 ----------------------------------------------