July 17, 2007
Race in a Bottle
ScientificAmerican.com has a new article about race specific medicine.
The entire article is well worth the read. Here are a few excerpts:
BiDil was also hailed as a means to improve the health of African-Americans, a community woefully underserved by the U.S. medical establishment. Organizations such as the Association of Black Cardiologists and the Congressional Black Caucus strongly supported the drug’s approval.
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.
After the FDA’s rejection of BiDil, Cohn went back to the V-HeFT results from the 1980s and broke down the data by race, examining how well African-Americans had responded to the competing treatments. Such retrospective “data dredging” can yield useful insights for further investigations, but it is also fraught with statistical peril; if the number of research subjects in each category is too small, the results for the subgroups may be meaningless. Cohn argued that H/I worked particularly well in the African-Americans enrolled in the V-HeFT studies. The clearest support for this claim came from V-HeFT I, which placed only 49 African-Americans on H/I—a tiny number considering that new drug trials typically enroll thousands of subjects. In 1999 Cohn published a paper in the Journal of Cardiac Failure on this hypothesized racial difference and filed a new patent application. This second patent was almost identical to the first except for specifying the use of H/I to treat heart failure in black patients. Issued in 2000, the new patent lasts until 2020, 13 years after the original patent was set to expire. Thus was BiDil reinvented as an ethnic drug.
Researchers using race to develop drugs may be motivated by good intentions, but such efforts are also driven by the dictates of an increasingly competitive medical marketplace. The example of BiDil indicates that researchers and regulators alike have not fully appreciated that race is a powerful and volatile category. When used to bolster the commercial value of a drug, it can lead to haphazard regulation, substandard medical treatment and other unfortunate unintended consequences. The FDA should not grant race-specific approvals without clear and convincing evidence of a genetic or biological basis for any observed racial differences in safety or efficacy. Approving more drugs such as BiDil will not alleviate the very serious health disparities between races in the U.S. We need social and political will, not mislabeled medicines, to redress that injustice.
Posted by Staff at 08:42 AM
Category: Health Care