Friday, June 17, 2005
FDA admits one size does not fit all
The drug's trial, on just over 1,000 individuals, was launched after the FDA turned away the medication following a study involving all races that showed little improvement - but also gave hints that blacks might have had some benefit.
The maker, NitroMed of Lexington, Mass., then decided on a trial using blacks only, a population that has more than twice the rate of heart failure as whites.
And now, BiDil is approved by a review committee and moves toward full approval. But still with at least two problems. Some question that it can work on one subset of humanity but not others (apparently never heard of sickle-cell anemia or Tay-Sachs) so doubt both original and new tests, others debate whether it should carry a "blacks only" label.
