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18 Jul 2007 04:59 pm
The First Ethnic Drug?
Not so fast, says Scientific American:
A close inspection of BiDil’s history, however, shows that the drug is
ethnic in name only. First, BiDil is not a new medicine—it is merely a
combination into a single pill of two generic drugs, hydralazine and
isosorbide dinitrate, both of which have been used for more than a
decade to treat heart failure in people of all races. Second, BiDil is
not a pharmacogenomic drug. Although studies have shown that the
hydralazine/isosorbide dinitrate (H/I) combination can delay
hospitalization and death for patients suffering from heart failure,
the underlying mechanism for the drug’s efficacy is not fully
understood and has not been directly connected to any specific genes.
Third, and most important, no firm evidence exists that BiDil actually
works better or differently in African-Americans than in anyone else.
The FDA’s approval of BiDil was based primarily on a clinical trial
that enrolled only self-identified African-Americans and did not
compare their health outcomes with those of other ethnic or racial
groups.
(Hat tip: 3QD.)
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