Human Subjects And The Tuskegee Study example essay topic

The otherwise appropriate and excellent essay "Uses and abuses of Tuskegee" by Amy L. Fairchild and Ronald Bayer (Essays in Science and Society, Science's Compass, 7 May, p. 919) omits important information about the Tuskegee syphilis experiment. This appropriately vilified experiment would not have been possible without the collaboration of African American physicians, nurses, and community workers at Tuskegee Institute. Cartoon from The Atlanta Constitution, 27 July 1997 CREDIT: L. ERICKSON; REPRINTED WITH PERMISSION FROM THE ATLANTA JOURNAL AND THE ATLANTA CONSTITUTION This information is well documented in a book to which the authors refer (1) and in the excellent television documentary "Susceptible to Kindness: Ms. Evers' Boys and the Tuskegee Syphilis Study" by David Feld shush, produced by the American Conservatory Theater, San Francisco. The omission of the collaboration of African Americans in the Tuskegee experiment is common. At a recent conference at Tuskegee (2), the Tuskegee syphilis experiment was repeatedly referred to by the president of Tuskegee University and other speakers. The U.S. Public Health Service and others in the federal government were appropriately castigated, but no one at the conference admitted to the complicity of African Americans.

We African Americans must learn from history, but we will only do so if our abuses to ourselves are not hidden. Too often, we have seen the enemy -- and it is also us. James E. Bowman Department of Pathology, University of Chicago, 5841 South Maryland Avenue, Chicago, IL 60637, USA. E-mail: References J.H. Jones, Bad Blood: The Tuskegee Syphilis Experiment (Free Press, New York, 1981). Plain Talk About the Human Genome Project: A Tuskegee University Conference on Its Promise and Perils and Matters of Race, E. Smith and W. Sapp, Eds. (Tuskegee University, Tuskegee, AL, 1997).

As a physician-researcher working in a public hospital, I have become acutely aware of the strength of the metaphor of the Tuskegee syphilis study in vulnerable populations. A critical point not fully discussed by Fairchild and Bayer is that in both cases of needle exchange, treatment of the underlying medical condition and the social context were not addressed by the intervention, leaving the subjects persistently vulnerable to the possibility of disease. The disconnect between the researchers' agenda and the needs of the community under study parallels the Tuskegee study. In each example cited by the authors, the interventions were focused on the researchers' agenda, not on needs voiced by the community -- effective treatment of substance abuse and early treatment and prevention of HIV. In fact, it is unlikely that the investigators solicited the views of the communities. The absence of community assent subsequently led to questions of how the population under study would benefit from the research (1).

In addition, the authors prescribe very narrow guidelines for invoking the parallels to Tuskegee. As evidenced in their essay, allegations of "another Tuskegee" come just as often from the lay community as from the scientific. The reality is that knowledge of the Tuskegee study in vulnerable populations and their advocates is widespread, but not always bound by historical accuracy (2). Fundamental to each of the examples cited is a population vulnerable because of ethnicity or social class, or both; the perception of withholding therapy; and a controversial disease with the potential to further stigmatize and marginalize that population.

These are the criteria used by the lay public to draw parallels to Tuskegee and a combination that historically has led to exploitation. The suggestion of guidelines based only on historical accuracy further emphasizes how removed we have become from the very populations our investigation is intended to help. Giselle Corbie-Smith Division of General Medicine, Emory University School of Medicine, Grady Memorial Hospital, 69 Butler Street, SE, Atlanta, GA 30303, USA. E-mail: References G. Corbie-Smith, Am. J. Med. Sci. 1,317 (1999). S.B. Thomas and J.W. Curran, ibid., p. 317; G. Corbie-Smith, S.B. Thomas, M.V. Williams, S. Moody-Ayres, J. Gen. Inst.

Med., in press; S.B. Thomas and S.C. Quinn, Am J. Publ. Health 11, 81 (1991); V Gamble, Am. J Prevent. Med.

6 (suppl), 9 (1993). We invoked the Tuskegee study analogy in the perinatal AZT trials because (i) both were prospective studies in which participants were denied known effective treatments; (ii) both were conducted or funded by the U.S. Public Health Service; ( ) both involved people of color; (iv) both included violations of informed consent (1); (v) both were justified by claiming that this was the only appropriate study design; (vi) both were defended by positing differences between previous and present study populations; (vii) both were justified by asserting that study participants would not have been treated anyway; and (v.) both were terminated only after exposure in the lay press. The Alaska needle exchange study meets criteria (i), (ii), (iv), (v), and (vii) (2). Unlike all other needle exchanges, to our knowledge, drug injectors not enrolled in the study cannot use the needle exchange. Drug injectors in the study are provided identification cards and randomized to use the needle exchange or to receive a bus map of Anchorage with pharmacies identified; they are also instructed how to talk and dress in order to convince a pharmacist to sell them a syringe, a violation of local Anchorage law (3). (Fairchild and Bayer note only that pharmacy sales are legal in the state of Alaska.) When a study participant presents himself or herself at the needle exchange, a card reader produces the person's image on a computer screen and instructs the staff person whether to admit the drug user.

If someone randomly assigned to not use the needle exchange attempts to do so, he or she is turned away from the needle exchange and provided the map. Certainly there are differences between these unethical studies and Tuskegee. But the dictionary defines an analogy as "a likeness in one or more ways between things otherwise unlike" (4). Tragically, these studies are similar to Tuskegee in more than enough ways to justify the analogy. Peter Lurie Sidney M. Wolfe Health Research Group, Public Citizen, 1600 20th Street, NW, Washington, DC 20009-1001, USA References H.W. French, New York Times, 9 October 1997, p. A 1. P. Lurie, Am. J. Epidemiol.

149,715 (1998). I.O. Gost in, Z. Lazzarini, T.S. Jones, K. Flaherty, J. Am. Med. Assoc. 277, 53 (1997). Merriam-Webster Dictionary (Merriam-Webster, Springfield, MA, 1997). Fairchild and Bayer are correct to advocate caution in the use of analogies between disputes about contemporary events in research ethics involving human subjects and the Tuskegee study.

Having written extensively about the need for care in drawing analogies, we can only applaud their interest in drawing attention to this issue. However, they are wrong when they take us to task for inappropriately drawing a key ethical lesson from the Tuskegee study in our own critical comments concerning a test of needle exchange in which the subjects were not told the truth about all of their options. The design actively prevented the subjects from obtaining access to interventions that would have put them at less risk and used the incidence of the subject's acquisition of hepatitis B as a marker of efficacy in the trial. The clinical trial at issue was constructed so as to leave subjects open to preventable infection by a serious disease by limiting their knowledge and their options. The ethical argument invoked in defense of this morally repugnant design was that the knowledge to be gained could not be gained by any other methods and was of such value as to justify the design. This, of course, is precisely the justification some defenders of the Tuskegee trial argued at the time the study was being challenged as unethical.

Analogies must be generated with caution. Sloppy analogies to historical events such as Tuskegee abound. Caution and accuracy are crucial so as not to demean or deprecate the horrific moral abuses to which human beings were subjected in the past in the name of medical progress. But the argument we made concerning the Alaska needle exchange study met the criteria for appropriate use of analogy that has appeared both in our own writings and in the essay by Fairchild and Bayer. Our invocation of the argument that Tuskegee provided a crucial ethical lesson -- that the value of research does not permit denying a known, efficacious cure and full disclosure to any human subject -- was and remains valid with respect to the proposed Alaska needle exchange study. It appears that Fairchild and Bayer would restrict the use of analogies only to circumstances that are identical to past abuses.

But analogies and metaphors can appropriately focus our attention on aspects of current problems, even if not entirely identical to what happened in the past. The past deserves respect, but it also must be examined for the lessons it can teach. Tuskegee teaches much richer lessons than Fairchild and Bayer say we can draw. Arthur L. Caplan Center for Bioethics, University of Pennsylvania, 3401 Market Street, Philadelphia, PA 19140, and Health Law Department, Boston University School of Public Health, 715 Albany Street, Boston, MA 02118, USA George J. Annas Health Law Department, Boston University School of Public Health Response The concerns raised by Lurie, Wolfe, Caplan, and Annas center on the question of whether it was ethical to conduct a trial comparing needle exchange to pharmacy access to sterile injection equipment. Clearly, they believe that the available evidence on the efficacy of needle exchange precluded such a study on ethical grounds and that such a trial paralleled the abuses of Tuskegee.

President Clinton and Vice President Gore apologizing to a victim of the Tuskegee syphilis study, 16 May 1997 CREDIT: DOUG MILLS / AP It is instructive to note that on both ethical and empirical grounds, the special National Institutes of Health committee impaneled to review the Anchorage study reached a different conclusion (1). It emphasized that the challenged trial was not a comparison of needle exchange against no intervention -- that would have been unethical. The study, rather, involved an examination of two approaches to the provision of sterile injection equipment [it was such an equivalency trial that Lurie and Wolfe demanded in their critique of the placebo-control trails of the antiviral drug AZT to prevent maternal-fetal human immunodeficiency virus (HIV) transmission in Third World countries]. The committee noted that those in the pharmacy arm would receive a continually updated list of Anchorage pharmacies that would sell needles to people not known to have a medical condition warranting the use of injection equipment.

Reports from project participants about their experience in obtaining injection equipment would aid study staff in updating the list. In addition, those in the pharmacy arm, like those in the needle exchange arm, would receive counseling, educational interventions, and assistance in gaining access to hepatitis B immunization. It was on the basis of these facts that the committee concluded (1), "Given current knowledge that clean needles can reduce the spread of various infections among injecting drug users, it is appropriate to conduct a randomized study to compare the effectiveness of two methods of providing access to clean needles -- a needle exchange program and an enhanced pharmacy sales program. To characterize this research as comparing treatment with no treatment is a serious misrepresentation. Both groups will receive interventions that need to be compared for their relative effectiveness, and the results of this study will inform public policy. This trial meets the ethical justification standard of prior uncertainty about which treatment is superior".

Those who participated in the committee's work were not na " ive about the demands of research ethics or about the complexities of evaluating the relative efficacy of approaches to harm reduction among intravenous drug users. The review panel was headed by Yale physician and expert on research ethics Robert Levine and included James Childress and Ezekiel Emanuel, senior figures in the field of medical ethics, and David Vla hov, an internationally known expert on needle exchange, drug use, and HIV infection. Given both the consideration and conclusions of the review panel, we find it difficult to understand how the allegation that the Anchorage study involved a "morally repugnant design" that bore even the remotest resemblance to Tuskegee can be given credence. One way to avoid the "sloppy analogies to historical events such as Tuskegee" that Caplan and Annas deride is to carefully enumerate the criteria of evaluation characterizing the fundamental nature of abuses that make a study like Tuskegee a critical, enduring point of reference. But enumeration does not preclude sloppy analogy. Thus, of the eight criteria Lurie and Wolfe list, four [numbers (ii), ( ), (v), and (vi) ] might apply to any ethical, well-designed, publicly funded study involving people of color.

Corbie-Smith underscores a point we sought to make in our essay. Tuskegee helps to explain the profound distrust felt by many African Americans for the research establishment. But what she does not acknowledge is the difference between the illuminating role of Tuskegee as a metaphor and the demands imposed by the uses of analogy. Finally, Bowman opens up an issue that, while beyond the scope of our essay, warrants serious discussion -- the way in which those who should be allies of the socially vulnerable may find themselves serving the interests of unethical researchers. It is the prospect of such an unholy alliance that makes the existence of searching external review -- in which the careful uses of historical analogy can serve a critical function -- so imperative. Amy L. Fairchild Ronald Bayer Program in the History of Public Health and Medicine, Division of Socio medical Sciences, Joseph L. Mailman School of Public Health, Columbia University, New York, NY 10032-2625, USA.

E-mail: ;

Bibliography

Report to the Advisory Committee to the Director of the Panel to Review the Aspects of the Study "Interventions to Reduce HBV, HCV, and HIV in IDUs", National Institutes of Health, Bethesda, MD, 12 December 1996, p.
16. Copyright (c) 1999 by the American Association for the Advancement of Science.