# Presentation: 305047

## 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

## Principles

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

## The Formal (Correct) Race [Subspecies] Concept:

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

## 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

## 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

## Reasons Against Group Labeling of BiDil(Wouldn’t be done to Seventh Day Adventists)

- 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?).
- 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
- There 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.

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