"Special treatment": BiDil, Tuskegee, and the logic of race

Journal of Law, Medicine and Ethics

Volumn 36, Issue 3, 2008, Pages 478-484

  Reverby, Susan M ^a  

^a WELLESLEY COLLEGE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

HYDRALAZINE; ISOSORBIDE DINITRATE; ISOSORBIDE HYDRALAZINE COMBINATION; ISOSORBIDE-HYDRALAZINE COMBINATION; VASODILATOR AGENT;

AFRICAN AMERICAN; CLINICAL TRIAL; CONFERENCE PAPER; DRUG APPROVAL; DRUG COMBINATION; ETHICS; ETHNOLOGY; GENETICS; HEART FAILURE; HUMAN; MALE; MEDICAL ETHICS; RACE; SOCIAL PSYCHOLOGY; SYPHILIS; TREATMENT WITHDRAWAL;

AFRICAN AMERICANS; CLINICAL TRIALS AS TOPIC; CONTINENTAL POPULATION GROUPS; DRUG APPROVAL; DRUG COMBINATIONS; ETHICS, MEDICAL; HEART FAILURE; HUMANS; HYDRALAZINE; ISOSORBIDE DINITRATE; MALE; PREJUDICE; SYPHILIS; VASODILATOR AGENTS; WITHHOLDING TREATMENT;

EID: 50249099764     PISSN: 10731105     EISSN: 1748720X     Source Type: Journal    
DOI: 10.1111/j.1748-720X.2008.294.x     Document Type: Conference Paper

References (44)

1. Author interview with Dr. Steven Nissen, Cleveland Clinic, Cleveland, Ohio, February 7, 2006.
2. A. L. Fairchild and R. Bayer Uses and Abuses of Tuskegee in S. M. Reverby, ed., Tuskegee's Truths: Rethinking the Tuskegee Syphilis Study (Chapel Hill: University of North Carolina Press, 2000 589 604 D. T. Brandon, L. A. Isaac, and T. A. LaVeist The Legacy of Tuskegee and Trust in Medical Care: Is Tuskegee Responsible for Race Differences in Mistrust of Medical Care Journal of the National Medical Association 97, no. 7 (2005 951 956.
3. S. Soo-Jin Lee Racializing Drug Design: Implications of Pharmacogenomics for Health Disparities American Journal of Public Health 95, no. 12 (2005 2133 2138.
4. The PHS in Tuskegee used the term "special treatment" in 1933 to encourage participants to come in for the diagnostic lumbar punctures, see Reverby, ed., supra note 2, at 187.
5. I was accused of making the BiDil=Tuskegee claim when I gave this paper at an MIT conference in April 2006. But I never made this simple phrase an equation.
6. For more on the politics of FDA hearings and my own experiences as a consumer representative on the FDA's Obstetrics and Gynecology Devices Advisory Committee, see S. M. Reverby What Does It Mean to Be an Expert? A Health Activist at the FDA Advancing the Consumer Interest 9, no. 1 (1997 34 36.
7. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research Cardiovascular and Renal Drugs Advisory Committee Transcript, vol. II, June 16, 2005, at 207-208 and 214 [hereinafter cited as BiDil Transcript]. Both the Caucus and the Foundation received donations from NitroMed, but only Puckrein acknowledged this. I also attended the committee meeting.
8. See Lee, supra note 3, at 2137.
9. Medication for Blacks Only Redorbit News, July 29, 2005 http://www.redorbit.com/news/display/?id=19l682 (last visited May 21, 2008).
10. T. P. Coates Suspicious Minds Time, July 26, 2005, available at http://www.time.com/time/magazine/arti-cle/0,9171,l077303,00.html (last visited May 21, 2008) S. Rhea Steps Taken To Eliminate Disparities in Health Care CourierPost Online, available at http://www.courierposton-line.com/ coveragedenied/m062005j.htm (last visited September 14, 2006).
11. See Fairchild and Bayer, in Reverby, supra note 2, at 589 S. M. Reverby More Than Fact and Fiction: Cultural Memory and the Tuskegee Syphilis Study Hastings Center Report 31, no. 5 (2001 22 28.
12. S. M. Reverby, The Infamous Study: Tuskegee, Syphilis and American Lore, book manuscript.
13. See Jonathan Kahn Testimony BiDil Transcript, supra note 7, at 226.
14. J. Kahn How a Drug Becomes 'Ethnic': Law, Commerce, and the Production of Racial Categories in Medicine Yale Journal of Health Policy, Law and Ethics 4, no. 4 (2004 1 46 L. Braun Race, Ethnicity and Health: Can Genetics Explain Disparities Perspectives in Biology and Medicine 45, no. 2 (2002 159 175.
15. See Jay Cohn Testimony BiDil Transcript, supra note 7, at 30-31.
16. Joseph Earle Moore to Taliaferro Clark, September 28, 1932, in Reverby, supra note 2, at 79.
17. P. Carley and O. C. Wenger The Prevalence of Syphilis in Apparently Healthy Negroes in Mississippi Journal of the American Medical Association 94, no. 4 (June 1930 1826 1828 C. N. Frazier and L. Hung-Chiung, Racial Variations in Immunity to Syphilis: A Study of the Disease in the Chinese, White and Negro Races (Chicago: University of Chicago Press, 1948).
18. O. C. Wenger to Dr. Reuben Kahn, July 26, 1939, Rosenwald Fund Papers, Box 152, Folder 7, Franklin Library Special Collections-Archives, Fisk University, Nashville, Tennessee.
19. Id.
20. J. L. Herman, The Biology of the Negro (Chicago: University of Chicago Press, 1942).
21. See BiDil Transcript, supra note 7, at 43.
22. See author interview with Steven Nissen, supra note 1. All quotes are from this interview unless otherwise noted.
23. On Nissen's "bad boy" role, see P. Peck Cardiologist Goes Toe to Toe with Drug Companies CNN Worldnews, available at http://www.cnn.com/2005/ HEALTH/ll/0l/profile.cardi-ologist.nissen/index.html (last visited May 28, 2008).
24. See author interview with Steven Nissen, supra note 1.
25. See J. Kaufman No More 'Slavery Hypothesis' Yarns Psychosomatic Medicine 63, no. 2 (2001 324 325 J. Kaufman The Anatomy of a Medical Myth Social Science Research Council Is Race Real?, available at http://raceandgenomics.ssrc.org/ Kaufman/ (last visited May 21, 2008 and Commentary Salt and Hypertension: The Debate That Begs the Bigger Question Archives of Internal Medicine 161, no. 4 (2001 507 510.
26. See J. Kahn, BiDil Transcript, supra note 7, at 226-227 S. Nissen, BiDil Transcript, supra note 7, at 394; and author interview with Steven Nissen, supra note 1.
27. See Herman, supra note 19, at 156-157 T. Parran Syphilis, the White Man's Burden in Reverby, ed., supra note 2, at.
28. On the a priori use of race, see B. Roy The Tuskegee Syphilis Experiment: Biotechnology and the Administrative State in Reverby, ed., supra note 2, at 299-317. 29. See BiDil Transcript, supra note 7, at 396.
29. J. H. Jones, Bad Blood (New York: Free Press, 1992 at 139-140. The criticism of the cardiologists is one of the factors that led to the push for autopsies on the men in the Tuskegee Study. The X-ray diagnosis that Dr. Raymond Vonderlehr (one of the key PHS physicians in the Study) was using was considered "arbitrary," which even he admitted. An analysis of the patient record data of the Tuskegee Study participants makes clear, as well, that the labeling of those with cardiovascular syphilis (as opposed to hypertension) was often arbitrary, and not even decided clearly at autopsy. See Reverby, supra note 12.
30. See BiDil Transcript, supra note 7, at 302.
31. Id. Author telephone interview with Vivian Ota-Wang, February 1, 2006.
32. See BiDil Transcript, supra note 7, at 99.
33. Id., at 187.
34. The Association of Black Cardiologist supported BiDil's approval and received funds from NitroMed even when Dr. Keith Ferdinand argued after it was approved: Self identified African American status, some people think, may be a proxy for some genetic marker. I'm not willing to go that far.... So the physiology may be related to blood pressure, socioeconomic status, stress, socioeconomic disadvantages. We don't know what it is Controversial Heart Drug PBS NewsHour, June 17, 2005, available at http://www.pbs.org/newshour/bb/health/ jan-june05/heart_6-17.html (last visited May 21, 2008).
35. On this difficulty, see L. Braun et al. Racial Categories in Medical Practice: How Useful Are They PLOS Medicine 4, no. 9 (September 2007 1423 1428.
36. See BiDil Transcript, supra note 7, at 355- 365.
37. BiDil Package Insert, 07 January 2005, Final Draft 23 June 2005. However, NitroMed's newest CEO, Dr. Jerry Karabelas, promised investors and bankers on a conference call There is absolutely no question of the value of BiDil in the treatment of congestive heart failure in African Americans NitroMed Conference Call, March 22, 2006, available at http://inves-tors.nitromed.com/phoenix.zhtml? p=irol-eventDetails&c=130535&eventID=1248609 (last visited May 21, 2008).
38. D. Henderson In Sudden Move, 2 Top Executives Quit NitroMed Boston Globe, March 22, 2006, at E5.
39. Redorbit African Americans with Cardiovascular Problems to Get Free, Natural, Low Cost alternative to Controversial Drug in Offer by Thorne Research December 5, 2005, available at http://www.redorbit.com/news/science/321174/ african_americans_with_cardiovascular_problems_to_get_free_natural_low/# (last visited May 28, 2008).
40. Yahoo Financial News, Physicians Believe Drugs Targeted for Ethnic and Racial Groups May Provide Therapeutic Advantages, HCD Research Press Release, June 23, 2005, available at http://biz.yahoo.com/bw/050623/235492.html?.v=l (last visited June 29, 2005).
41. J. W Payne The Race to Market; Heart Supplement Targets Blacks, Echoing Race-Based Drug The Washington Post, December 13, 2005, at F01; Associated Press, "NitroMed Plans Ads for Heart Drug OK'd for Blacks," Boston Globe, September 1, 2006, available at http://www.boston.com/business/globe/ articles/2006/09/0l/nitromed_plans_ads_for_heart_drug_okd_for_blacks (last visited May 28, 2008).
42. Hundreds of New Medicines Now in Development for Diseases that Affect Hispanic Americans September 17, 2006, available at http://www.medicalnewstoday. com/medical-news.php?newsid=52031 (last visited May 22, 2008).
43. Troy Duster argues that sociologists ought not just be decrying the social construction of race, but look specifically at the architecture of this deployment. See T. Duster Comparative Perspectives and Competing Explanations: Taking on the Newly Configured Reductionist Challenge to Sociology American Sociological Review 71, no. 1 (February 2006 1 15.
44. On the problems of "inclusion," see S. Epstein, Inclusion: The Politics of Difference in Medical Research (Chicago: University of Chicago Press, 2007) and. S. M. Reverby Inclusion and Exclusion: The Politics of History, Difference, and Medical Research Journal of the History of Medicine 63, no. 1 (January 2008 103 113.