Hostname: page-component-586b7cd67f-g8jcs Total loading time: 0 Render date: 2024-11-29T11:14:55.008Z Has data issue: false hasContentIssue false

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

Published online by Cambridge University Press:  01 January 2021

Extract

The presence of the Tuskegee Syphilis Study was palpable at the June 16, 2005, Food and Drug Administration’s (FDA) Advisory Committee meeting on BiDil, a heart medication from the pharmaceutical company NitroMed that sought approval as the first race-specific drug. So ubiquitous is the restless and unsettled spirit of Tuskegee that it continues to hover over the African American public and the biomedical research/health care provider communities more than three and a half decades after the actual study “died.” No one invoked the word “Tuskegee” in that dimly lit meeting room as BiDil gained the Advisory Committee’s approval. Yet its power was exerted even when it was not named. The FDA Committee’s chairman, Cleveland Clinic cardiology chief Steven Nissen, acknowledged this after the committee met: “We were putting [Tuskegee]…to rest.”

Type
Symposium
Copyright
Copyright © American Society of Law, Medicine and Ethics 2008

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Author interview with Dr. Steven Nissen, Cleveland Clinic, Cleveland, Ohio, February 7, 2006.Google Scholar
Fairchild, A. L. and 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): 589604; Brandon, D. T., Isaac, L. A., and 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.Google Scholar
Soo-Jin Lee, S., “Racializing Drug Design: Implications of Pharmacogenomics for Health Disparities,” American Journal of Public Health 95, no. 12 (2005): 21332138.Google Scholar
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.Google Scholar
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.Google Scholar
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): 3436.Google Scholar
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.Google Scholar
See Lee, , supra note 3, at 2137.Google Scholar
“Medication for Blacks Only,” Redorbit News, July 29, 2005, <http://www.redorbit.com/news/display/?id=191682> (last visited May 21, 2008).+(last+visited+May+21,+2008).>Google Scholar
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).+(last+visited+May+21,+2008);+Rhea,+S.,+“Steps+Taken+To+Eliminate+Disparities+in+Health+Care,”+CourierPost+Online,+available+at++(last+visited+September+14,+2006).>Google Scholar
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): 2228.CrossRefGoogle Scholar
Reverby, S. M., The Infamous Study: Tuskegee, Syphilis and American Lore, book manuscript.Google Scholar
See “Jonathan Kahn Testimony,” BiDil Transcript, supra note 7, at 226.Google Scholar
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): 146; Braun, L., “Race, Ethnicity and Health: Can Genetics Explain Disparities,” Perspectives in Biology and Medicine 45, no. 2 (2002): 159–175.Google Scholar
See “Jay Cohn Testimony,” BiDil Transcript, supra note 7, at 30–31.Google Scholar
Joseph Earle Moore to Taliaferro Clark, September 28, 1932, in Reverby, , supra note 2, at 79.Google Scholar
Carley, P. and Wenger, O. C., “The Prevalence of Syphilis in Apparently Healthy Negroes in Mississippi,” Journal of the American Medical Association 94, no. 4 (June 1930): 18261828; Frazier, C. N. and 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).CrossRefGoogle Scholar
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.Google Scholar
Herman, J. L., The Biology of the Negro (Chicago: University of Chicago Press, 1942).Google Scholar
See BiDil Transcript, supra note 7, at 43.Google Scholar
See author interview with Nissen, Steven, supra note 1. All quotes are from this interview unless otherwise noted.Google Scholar
See author interview with Steven Nissen, supra note 1.Google Scholar
See Kaufman, J., “No More ‘Slavery Hypothesis’ Yarns,” Psychosomatic Medicine 63, no. 2 (2001): 324325; 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.CrossRefGoogle Scholar
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.Google Scholar
See Herman, , supra note 19, at 156–157; Parran, T., “Syphilis, the White Man's Burden,” in Reverby, , ed., supra note 2, at 63.Google Scholar
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.Google Scholar
See BiDil Transcript, supra note 7, at 396.Google Scholar
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.Google Scholar
See BiDil Transcript, supra note 7, at 302.Google Scholar
Id. Author telephone interview with Vivian Ota-Wang, February 1, 2006.CrossRefGoogle Scholar
See BiDil Transcript, supra note 7, at 99.Google Scholar
Id., at 187.Google Scholar
On this difficulty, see Braun, L. et al., “Racial Categories in Medical Practice: How Useful Are They?” PLOS Medicine 4, no. 9 (September 2007): 14231428.CrossRefGoogle Scholar
See BiDil Transcript, supra note 7, at 355–365.Google Scholar
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). (last visited May 21, 2008).' href=https://scholar.google.com/scholar?q=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++(last+visited+May+21,+2008).>Google Scholar
Henderson, D., “In Sudden Move, 2 Top Executives Quit NitroMed,” Boston Globe, March 22, 2006, at E5.Google Scholar
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).+(last+visited+May+28,+2008).>Google Scholar
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).+(last+visited+June+29,+2005).>Google Scholar
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).+(last+visited+May+28,+2008).>Google Scholar
“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).+(last+visited+May+22,+2008).>Google Scholar
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): 115.CrossRefGoogle Scholar
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.CrossRefGoogle Scholar