Scientific, Economic, Social and Ethical Implications of Developing Ethnic-Specific Therapeutics, Such As BiDil The National Human Genome Center and Department of Cardiology College of Medicine, Howard University Charles N. Rotimi, PhD Professor and Director Genetic Epidemiology National Human Genome Center College of Medicine, Howard University June 16, 2005

The Genome in Black and White (and Gray) October 10, 2004 (New York Times) By ROBIN MARANTZ HENIG In the not-too-distant future, if you're black and have heart failure, drug- company researchers predict you'll be able to go to the doctor and walk out with a prescription tailor-made for you. Well, not tailor-made, exactly, but something that seems to work in people a lot like you. Well, not a lot like you, exactly, except that they're black, too. In this not-too-distant future, if you're black, your doctor will be able to prescribe BiDil, the first drug in America that's being niche-marketed to people of a particular race -- our first ethnic medicine. African American Heart Failure Trial (A-HeFT)

The question is – “Who is Black?” Australian Aboriginals Masi, Kenya Surma bribe from Ethiopia Confusion: Group identity is confused with group ancestry. For example, the group identity “African Americans” does not reflect a single path of ancestry. Some African Americans may have as much as 40% or 70% Caucasian alleles, while others may have 5% or 10%

All Black Populations Are Equal Problem: leads to group characterization without adequate justification. “The more frequent occurrence of hypertension in black (Afro-Caribbean) subsamples throughout the Caribbean has been traced to ancestral populations in West Africa and is thus at least partially attributable to gene flow from an originally high- prevalence area…” Halberstein RA. Human Biology In the review by Kaufman JS and Hall SA. Epidemiology January 2003 Prevalence of Hypertension by Mean Body Mass Index Among Populations of the African Diaspora North America Caribbean West Africa Cooper RS, Rotimi CN, et al. AJPH. 1997

N=85,000

Study Design Issues and Data Interpretation Blood pressure response to ACE inhibitors 4.6 mm Hg SD=14 mm Hg SD=12 mm Hg African- American European- American Similar drug-associated changes in diastolic BP was 90% (95% CI: 92 to 98) for Calcium blockers. 81% (95% CI: 76 to 86) for ACE (Sehgal, Hypertension 2004) Conclusion: the majority of whites and blacks have similar responses to commonly used antihypertensive drugs. Clinical decisions to use a specific drug should be based on other considerations such as efficacy in individual patients, compelling indications, and cost.

We Advocate For 1. Labeling with language indicating the fact that BiDil does not replace existing drugs for the treatment of heart failure and that although it was tested only among African Americans, it may indeed be an effective treatment for heart failure patients who may not self identify (or be identified) as African Americans. 2.BiDil should not be approved as an African American ONLY drug (and by extension – all “black” people). The history of drug development and approval does not support ethnic labeling. Due to political, social and economic forces, biomedical research was almost exclusively conducted in people, especially men, of European descent. Results of such studies were extrapolated to other groups without such labels as “White Drug”. In the end, the BiDil story will have similar outcome; if the drug continues to be effective in the treatment of heart failure, the global subset of individuals with heart failure who will benefit from the drug will not be accurately described by the label 'African American'.

We Advocate For 3.Strategies that promote overall health not simply the absence of disease (e.g, heart failure). What good is a drug that reduces mortality from heart failure by 43% if: a.Because of patent, an otherwise cheap generically available therapeutics becomes unaffordable; b.It exacerbates racism with resulting increased hypertension and associated complications, including heart failure) due to increased psychosocial stressors; c.It leads biomedical research down a wrong path by suggesting, without proper scientific justification, that the so-called racial categories are biological?