Race, pharmacogenomics, and marketing: putting BiDil in context.
This article endeavors to place into context recent developments surrounding the United States Food and Drug Administration recent approval of BiDil (isosorbide dinitrate/hydralazine hydrochloride) (NitroMed, Inc., Lexington, MA) as the first ever race-specific drug--in this case to treat heart failure in African Americans. It focuses in particular on both commercial incentives and statistical manipulation of medical data as framing the drive to bring BiDil to market as a race-specific drug. In current discourse about pharmacogenomics, targeting a racial audience is perceived as necessary because at this point the technology and resources do not exist to scan efficiently every individual's genetic profile. The article argues that medical researchers may say they are using race as a surrogate to target biology in drug development, but corporations are using biology as a surrogate to target race in drug marketing. Pharmacogenomics may hold great promise, but on our way to that Promised Land, it is imperative to review such short cuts with a critical eye.
Kahn
Jonathan
J
Hamline University School of Law.
D000329:Advertising / Q000941:ethics / Q000639:trends; D001741:Black or African American / Q000235:genetics; D002986:Clinical Trials as Topic; D017277:Drug Approval; D004338:Drug Combinations; D004345:Drug Industry / Q000941:ethics / Q000639:trends; D006333:Heart Failure / Q000188:drug therapy*; D006801:Humans; D006830:Hydralazine / Q000627:therapeutic use*; D007548:Isosorbide Dinitrate / Q000627:therapeutic use*; D010330:Patents as Topic / Q000941:ethics; D010597:Pharmacogenetics / Q000941:ethics / Q000639:trends; D014481:United States; D014486:United States Food and Drug Administration
D004338:Drug Combinations; C431665:isosorbide-hydralazine combination; D006830:Hydralazine; D007548:Isosorbide Dinitrate