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  1. MHRC/UAB Targeting RaceBiomedical Interventions John R. Stone, MD,PhD July 2005 Tuskegee University National Center for Bioethics in Research and Health Care jrstone15366@gmail.com

  2. Acknowledgements • Harold Kincaid • Mona Fouad • Isaac Mwase • Ann Smith

  3. June 2005 FDA approves Bidil for treatment of congestive heart failure in African Americans

  4. Much hype Good idea? Bad idea? FDA Approval of BiDil

  5. Benefit Potential Better CV health for AA-perhaps Better health in general for AA—unknown Particularized care More efficiency Harm Potential Impersonal care More stigma More stereotypes Reify race/biol Reify race/genetics Ignore social Sustain, increase injustices Ethical Issues/BiDil

  6. Talking about race • Uncommon in racially mixed groups • Uncommon in public • Loaded • Scary territory • Opportunity for constructive dialogue

  7. Troy Duster, Buried alive: the concept of race in science. The Chronicle Of Higher Education. 2001;48(3):B11 (emphasis added) • “The major task for Americans is to analyze how and under what circumstances we use the concept of race.” • “It is a mistake to discard race just because racial categories do not map exactly onto biological processes. But it is also a mistake to uncritically accept old racial classifications when we study medical treatments.”

  8. Troy Duster, Buried alive: the concept of race in science. The Chronicle Of Higher Education. 2001;48(3):B11 (emphasis added) • “The task is to determine how the social meaning of race can affect biological outcomes like varying rates of cancer and heart failure. Burying the concept of race can seem very appealing in the short term. But in practical applications, race remains very much alive.”

  9. Jonathan Kahn. How a Drug Becomes “Ethnic”: Law, Commerce, and the Production of Racial Categories in Medicine. Yale Journal Of Health Policy, Law, And Ethics IV:1 (2004), p. 3 (emphasis added) • “At the most basic level, it turns out that BiDil became an ethnic drug through the interventions of law and commerce as much as through medical understanding of biological differences that correlate with racial groups.” (p. 3)

  10. MG Bloche. Race-Based Therapeutics. NEJM 2004;351:2035-2037 (p. 2037) (emphasis added) • “Race is at best a placeholder for other predispositions, and not a biologic verity.”

  11. Possible legitimate reasons to target groups in medical care • Enhance benefit (life, quality) • “Particularize” or “personalize” care (groups ≠ individuals) • Reduce harms (death, suffering) • Enhance efficiency • Facilitate identification of important factors (motive for pharmacogenetics)

  12. Questions • Do investigator economic interests matter in the BiDil case? • Do their conflicts of interest undermine scientific validity?

  13. Questions • Should the FDA approve race-targeted biomedical interventions? • Never/always/sometimes • What guidelines? • What processes? • Safeguards? • Harms? • Benefits? • What after market monitoring and safeguards?

  14. BackgroundCongestive Heart Failure (CHF) • Early death • Sustained, progressive suffering • Huge problem • Causes (Europe/North America) • Hypertension • Coronary artery disease • Valvular heart disease • Cardiomyopathies • Miscellaneous diseases

  15. Background: Earlier CHF Therapy • Pathophysiology: peripheral vascular constriction as CHF progresses • Digoxin • Diuretics • Sodium restriction • Blood pressure control • Weight loss • Cardiac surgery (mainly valvular)

  16. CHF Outcomes • Deaths AA/W reported >2:1 Jonathan Kahn. How a Drug Becomes “Ethnic”: Law, Commerce, and the Production of Racial Categories in Medicine. Yale Journal Of Health Policy, Law, And Ethics IV:1 (2004);1-46.

  17. CHF Clinical Trials • Promote peripheral vasodilation • Arterial • Venous • Hydralazine plus nitrates • ACE Inhibitors • ACE Receptor-blockers (much later)

  18. CHF Trials: Isosorbide Dinitrate + Hydralazine • Limited effectiveness of I + H • ACE inhibitors • More potent (better & longer lives) • Less potent in AA-space for BiDil (Kahn) • Better tolerated • ACE inhibitors standard of care • CHF • Myocardial Infarction • ACE receptor blockers as alternative

  19. BiDil Story: CHF • I/H: Isosorbide dinitrate + hydralazine • 1980-1985: V-HeFT I, VA, , I/H marginally > placebo, not Prazosin (mortality) • 1986-1991V-HeFT II, ACE inhib > I/H, ACE inhibfrontline, I/H backup if intoler (mortality) • 1987 Jay Cohn patent app I/H combo, approv 1989, CHF (no race mention) Jonathan Kahn. How a Drug Becomes “Ethnic”: Law, Commerce, and the Production of Racial Categories in Medicine. Yale Journal Of Health Policy, Law, And Ethics IV:1 (2004);1-46.

  20. BiDil Story • 1992 BiDil Trademark • 1995 Medco intell prop rts f J Cohn • 1996 Medco NDA-FDA-denied • Cohn et al. arg f BiDil and Medco • Advisory committee votes against • Cohn+ arg f I/H’s efficacy (no race focus) • Biostatisticians, FDA Advis Com, argue V-HeFT uncertainties about I/H efficacy • MedCo returns intell prop rts to Cohn Jonathan Kahn. How a Drug Becomes “Ethnic”: Law, Commerce, and the Production of Racial Categories in Medicine. Yale Journal Of Health Policy, Law, And Ethics IV:1 (2004);1-46.

  21. BiDil Story • 1999: Peter Carson, Susan Zeische, Gary Johnson, Jay Cohn., retrospective analysis (J Cardiac Failure, v. 178): • V-HeFT I: AA but not W ↓ mortality w/ I/H (P = .04) • V-HeFT I: Signif AA / W diffs, e.g. CHD • V-HeFT II: only W ↓ mortality (P = .02), • V-I: 180B/450W; V-II:215B/574W Jonathan Kahn. How a Drug Becomes “Ethnic”: Law, Commerce, and the Production of Racial Categories in Medicine. Yale Journal Of Health Policy, Law, And Ethics IV:1 (2004);1-46.

  22. BiDil Story • 1999: NitroMed intell prop rts f J Cohn • 1999: J Cohn, P Carson app patent I/H f AA w/ CHF, transfer rts to NitroMed • 1999 P Carson, colleague publish review, of LV dysf outcomes • reconfirm 2:1 B/W mortality (older studies) • assume underlying hypertension basically biological because supposedly not based on SES. • CHF death rates 35-74, most W > age 74, B < 74 • most B CHF deaths < 74, so ignoring much data; • unsophisticated SES analysis • ignore recent stats sugg B/W mortal rates ~ 1.1:1 Jonathan Kahn. How a Drug Becomes “Ethnic”: Law, Commerce, and the Production of Racial Categories in Medicine. Yale Journal Of Health Policy, Law, And Ethics IV:1 (2004);1-46.

  23. BiDil Story • 2001: Jay Cohn et al., NEJM, ACE inhib less effective in blacks (NitroMed’s V-HeFT underway) • 2001 NitroMed gets support of ABC (Assoc Black Cardiol) and Congressional Black Caucus • 2001 NitroMed raises $31 million vent capital funds for A-HeFT Jonathan Kahn. How a Drug Becomes “Ethnic”: Law, Commerce, and the Production of Racial Categories in Medicine. Yale Journal Of Health Policy, Law, And Ethics IV:1 (2004);1-46.

  24. BiDil Story • 2004 (Nov) NEJM A-HeFT trial • 1050 African Americans (self-identified), randomized • (I/H + best) or bestrandomized • Early termination (deaths) • 43% deathreduct(10.2%6.2%) Anne L. Taylor, et al. Combination of Isosorbide Dinitrate and Hydralazine in blacks with heart failure NEJM 2004;351:2049-2057

  25. June 2005 FDA approves Bidil for treatment of congestive heart failure in African Americans

  26. Questions • Do investigator economic interests matter in the BiDil case? • Do their conflicts of interest undermine scientific validity?

  27. Questions • Should the FDA approve race-targeted biomedical interventions? • Never/always/sometimes • What guidelines? • What processes? • Safeguards? • Harms? • Benefits? • What after market monitoring and safeguards?

  28. Bidil & Race-targeting Burdens/Harms? • ▲ Injustices and Harms? • ▲Stereotypes, bias, prejudice • ▼Focus on health & healthcare ≠ • ▼Treatment for expensive minority conditions? • ▼ Genetics-based research? • Race poor marker • Group diff: only some genetic

  29. Harms/BiDil Example • Reinforces alleged connection of race to biology & genetics, • Pharmacogenetics focus diverts attention from social factors in health inequalities Jonathan Kahn. How a Drug Becomes “Ethnic”: Law, Commerce, and the Production of Racial Categories in Medicine. Yale Journal Of Health Policy, Law, And Ethics IV:1 (2004);1-46.

  30. Bidil & Race-targeting Benefits? • ▲ Greater market motivation? • ▲ Minority niche focus? • ▲ Treatment for minority health conditions? • ▲ Opportunity for increased minority input into treatment development?

  31. Race-targeting: Checks & Balances • Fair involvement of targeted populations in FDA approval processes, including enhanced representation on advisory panels and approval boards. • Fair selection of panel and board members. • Enhanced public input opportunities. • Push after-market monitoring and national registry • Revise our health-care system and relationships with industry (e.g., see Marcia Angell-reference)

  32. Benefit Potential Better CV health for AA-perhaps Better health in general for AA—unknown Particularized care More efficiency Harm Potential Impersonal care More stigma More stereotypes Reify race/biol Reify race/genetics Ignore social Sustain, increase injustices Ethical Issues/BiDil

  33. References Marcia Angell, The Truth about the Drug Companies: How They Deceive Us and What to Do About It. New York: Random House, 2004. MG Bloche. Race-Based Therapeutics. NEJM 2004;351:2035-2037. Troy Duster, Buried alive: the concept of race in science. The Chronicle Of Higher Education. 2001;48(3):B11. Jonathan Kahn. How a Drug Becomes “Ethnic”: Law, Commerce, and the Production of Racial Categories in Medicine. Yale Journal Of Health Policy, Law, And Ethics. 2004;IV:1:1-46