1. BiDil: Patenting “blackness” Critique of the So-Called “Race” – Specific Heart Failure Drug Presentation to the FDA, 16 June 2005 Dedicated to the memory of: Marc Bloch, Jewish French Historian, executed by the Nazis, 16 June 1944 The African Children murdered in the Soweto Uprising, anti-racism struggle, 16 June 1976 The author has no financial interests in any drugs or pharmaceutical companies Shomarka Omar Y. Keita MD, DPhil The author has no financial interests in any drugs or pharmaceutical companies Shomarka Omar Y. Keita MD, DPhil

2. Principles 1.Medications work at the levels of: 1. Pathophysiology 2. Clinical phenotypes 3. Individuals and NOT on sociodemographic categories/groups 2.The “African American” group does not consist of uniform individuals who are biologically the same due to genealogical uniformity, or even environmental insult. 3.The race concept does not apply to modern humans. 4.All aspects of adult biology are not inherited.

3. The Formal (Correct) Race [Subspecies] Concept: 1.Refers to a particular level of infraspecific differentiation and evolutionary divergence 2.Differs from the incorrect colloquial use of “race” in social, sociopolitical, and bureaucratic discourse 3.Does not apply to living humans, no matter how sub- divided 4.The validity of the subspecies category and recognized subspecies (races) of various animals have been criticized: noteworthy since humans are not the subjects 1.Refers to a particular level of infraspecific differentiation and evolutionary divergence 2.Differs from the incorrect colloquial use of “race” in social, sociopolitical, and bureaucratic discourse 3.Does not apply to living humans, no matter how sub- divided 4.The validity of the subspecies category and recognized subspecies (races) of various animals have been criticized: noteworthy since humans are not the subjects

4. POSITIONS: For, with Recommendations For:1. Identifying the specific pathophysiology/clinical phenotype on which the components of BiDil work, and their pathways. 2. Using the components of BiDil to treat the susceptible clinical phenotype in any and all individuals who have it irrespective of “origin” 3. Using the clinical experience of those who have successfully used the components of BiDil 4. Approving BiDil only if the labeling does not state that the drug is a “race”, “black”, or “African American” drug For:1. Identifying the specific pathophysiology/clinical phenotype on which the components of BiDil work, and their pathways. 2. Using the components of BiDil to treat the susceptible clinical phenotype in any and all individuals who have it irrespective of “origin” 3. Using the clinical experience of those who have successfully used the components of BiDil 4. Approving BiDil only if the labeling does not state that the drug is a “race”, “black”, or “African American” drug

5. POSITIONS: Against Against:Labeling of BiDil as a “group” or “race”, specifically “African American” or more generally “black” drug Approving BiDil in this fashion : 1. Is scientifically unjustified in terms of population biology 2. Leads to equating a social designation with a particular medicine as if ontologically connected 3. Ignores the clinical experience of those who have successfully used the components of BiDil 4. Assumes that the developmental and later environmental causes of disease (social inequality) will persist Against:Labeling of BiDil as a “group” or “race”, specifically “African American” or more generally “black” drug Approving BiDil in this fashion : 1. Is scientifically unjustified in terms of population biology 2. Leads to equating a social designation with a particular medicine as if ontologically connected 3. Ignores the clinical experience of those who have successfully used the components of BiDil 4. Assumes that the developmental and later environmental causes of disease (social inequality) will persist

6. Reasons Against Group Labeling of BiDil (Wouldn’t be done to Seventh Day Adventists) 1.It has not been shown that the clinical phenotype that responds to BiDil is exclusive to “African Americans” - ? Presumably Afro-North Americans (? Connotation for ALL “Blacks” – meaning – description of traits ? Designation of ancestry?). 2.All adult biology is not inherited and group genealogically specific, the assumption when the words “race” or “genetic” are invoked to explain group differences. WE MUST NOT IGNORE THE DEVELOPMENTAL ORIGINS OF DISEASE, OR THE LATER ENVIRONMENTAL AND SOCIO- ECONOMIC FACTORS THAT INFLUENCE CLINICAL PHENOTYPE 3There is no evidence for linkage of genes responsible for traits like variations in skin color with those possibly connected to particular causes of heart failure. 1.It has not been shown that the clinical phenotype that responds to BiDil is exclusive to “African Americans” - ? Presumably Afro-North Americans (? Connotation for ALL “Blacks” – meaning – description of traits ? Designation of ancestry?). 2.All adult biology is not inherited and group genealogically specific, the assumption when the words “race” or “genetic” are invoked to explain group differences. WE MUST NOT IGNORE THE DEVELOPMENTAL ORIGINS OF DISEASE, OR THE LATER ENVIRONMENTAL AND SOCIO- ECONOMIC FACTORS THAT INFLUENCE CLINICAL PHENOTYPE 3There is no evidence for linkage of genes responsible for traits like variations in skin color with those possibly connected to particular causes of heart failure.

7. CONCLUSION BiDil should only be approved if the labeling clearly states that it is not a “race”, “Black”, or “African American” drug.