“Special Treatment”: BiDil,Tuskegee,and the Logic of Race

Author interview with Dr. Steven Nissen, Cleveland Clinic, Cleveland, Ohio, February 7, 2006.

Fairchild A. L. Bayer R. , “Uses and Abuses of Tuskegee,” in Reverby S. M. , ed., Tuskegee's Truths: Rethinking the Tuskegee Syphilis Study (Chapel Hill: University of North Carolina Press, 2000): 589–604; Brandon D. T. Isaac L. A. LaVeist T. A. , “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.

Soo-Jin Lee S. , “Racializing Drug Design: Implications of Pharmacogenomics for Health Disparities,” American Journal of Public Health 95, no. 12 (2005): 2133–2138.

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.

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.

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 Reverby S. M. , “What Does It Mean to Be an Expert? A Health Activist at the FDA,” Advancing the Consumer Interest 9, no. 1 (1997): 34–36.

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.

See Lee , supra note 3, at 2137.

“Medication for Blacks Only,” Redorbit News, July 29, 2005, <http://www.redorbit.com/news/display/?id=191682> (last visited May 21, 2008).

Coates T. P. , “Suspicious Minds,” Time, July 26, 2005, available at <http://www.time.com/time/magazine/article/0,9171,1077303,00.html> (last visited May 21, 2008); Rhea S. , “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).

See Fairchild and Bayer, in Reverby, supra note 2, at 589; Reverby S. M. , “More Than Fact and Fiction: Cultural Memory and the Tuskegee Syphilis Study,” Hastings Center Report 31, no. 5 (2001): 22–28.

Reverby S. M. , The Infamous Study: Tuskegee, Syphilis and American Lore, book manuscript.

See “Jonathan Kahn Testimony,” BiDil Transcript, supra note 7, at 226.

Kahn J. , “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; Braun L. , “Race, Ethnicity and Health: Can Genetics Explain Disparities,” Perspectives in Biology and Medicine 45, no. 2 (2002): 159–175.

See “Jay Cohn Testimony,” BiDil Transcript, supra note 7, at 30–31.

Joseph Earle Moore to Taliaferro Clark, September 28, 1932, in Reverby , supra note 2, at 79.

Carley P. Wenger O. C. , “The Prevalence of Syphilis in Apparently Healthy Negroes in Mississippi,” Journal of the American Medical Association 94, no. 4 (June 1930): 1826–1828; Frazier C. N. Hung-Chiung L. , Racial Variations in Immunity to Syphilis: A Study of the Disease in the Chinese, White and Negro Races (Chicago: University of Chicago Press, 1948).

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.

Herman J. L. , The Biology of the Negro (Chicago: University of Chicago Press, 1942).

See BiDil Transcript, supra note 7, at 43.

See author interview with Nissen Steven , supra note 1. All quotes are from this interview unless otherwise noted.

On Nissen's “bad boy” role, see Peck P. , “Cardiologist Goes Toe to Toe with Drug Companies,” CNN Worldnews, available at <http://www.cnn.com/2005/HEALTH/11/01/profile.cardiologist.nissen/index.html> (last visited May 28, 2008).

See author interview with Steven Nissen, supra note 1.

See Kaufman J. , “No More ‘Slavery Hypothesis’ Yarns,” Psychosomatic Medicine 63, no. 2 (2001): 324–325; Kaufman J. , “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.

See Kahn J. , BiDil Transcript, supra note 7, at 226–227; Nissen S. , BiDil Transcript, supra note 7, at 394; and author interview with Steven Nissen, supra note 1.

See Herman , supra note 19, at 156–157; Parran T. , “Syphilis, the White Man's Burden,” in Reverby , ed., supra note 2, at 63.

On the a priori use of race, see Roy B. , “The Tuskegee Syphilis Experiment: Biotechnology and the Administrative State,” in Reverby , ed., supra note 2, at 299–317.

See BiDil Transcript, supra note 7, at 396.

Jones J. H. , 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.

See BiDil Transcript, supra note 7, at 302.

Id. Author telephone interview with Vivian Ota-Wang, February 1, 2006.

See BiDil Transcript, supra note 7, at 99.

Id., at 187.

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).

On this difficulty, see Braun L. , “Racial Categories in Medical Practice: How Useful Are They?” PLOS Medicine 4, no. 9 (September 2007): 1423–1428.

See BiDil Transcript, supra note 7, at 355–365.

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://investors.nitromed.com/phoenix.zhtml?p=irol-eventDetails&c=130535&eventID=1248609> (last visited May 21, 2008).

Henderson D. , “In Sudden Move, 2 Top Executives Quit NitroMed,” Boston Globe, March 22, 2006, at E5.

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).

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=1> (last visited June 29, 2005).

Payne J. W. , “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/2006/09/01/nitromed_plans_ads_for_heart_drug_okd_for_blacks> (last visited May 28, 2008).

“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).

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 Duster T. , “Comparative Perspectives and Competing Explanations: Taking on the Newly Configured Reductionist Challenge to Sociology,” American Sociological Review 71, no. 1 (February 2006): 1–15.

On the problems of “inclusion,” see Epstein S. , Inclusion: The Politics of Difference in Medical Research (Chicago: University of Chicago Press, 2007) and Reverby S. M. , “Inclusion and Exclusion: The Politics of History, Difference, and Medical Research,” Journal of the History of Medicine 63, no. 1 (January 2008): 103–113.