Table 1.

Rationale for approval of BiDil and assessment of rationale

Rationale for BiDil approval	Assessment of rationale
Disparate burden of heart failure among African Americans	A correct health statistic describing a correlation
2:1 Black/white mortality rate due to heart failure at age 35–74	Erroneous calculation. The calculation did not take into account that 71% of Caucasian American mortality due to heart failure occurred after age 74
Lack of effectiveness of ACE inhibitors in African Americans	Disputed. Selective citation of the literature. Other studies showed ACE inhibitors to be equally effective in African Americans
Ethnic difference in pathophysiology of nitric oxide production and utilization between African Americans and Caucasian Americans	Misuse of the word ethnic. Fewer than 40 African-American participants in each of three studies. Umbilical cells studied are of fetal origin, not maternal
35% decrease in mortality rates of blacks	Unexplained