700 and Counting

Over the holiday season, in between re-runs of A Charlie Brown Christmas and minute-by-minute updates on where to find a Nintendo Wii, Big Pharma gave the Black community an odd stocking stuffer that received surprisingly little attention: a report by the pharmaceutical industry's lobbying and trade organization (PhRMA) noting that nearly 700 medications are in clinical development to treat diseases that disproportionately affect African-Americans.

It's important to point out that these medicines are not necessarily slated to become the next BiDil, i.e. drugs bearing a race specific label to suggest that they are somehow genetically tailored for only one group. Many of the drugs on PhRMA's list may benefit broader classes of patients beyond those who are Black.

But, given that the story behind BiDil's FDA approval represents how companies can push a failed drug through FDA approval using a questionable clinical trial design and the even more questionable theory that genes are largely responsible for racial disparities, PhRMA's approach should give us some pause. Someone more cynical than I might think that PhRMA is using this report to lay the foundation for race specificity to become the fallback plan whenever a drug's FDA approval for the general population falters.

The economics of this approach might make sense at first as it might help companies recoup the millions of dollars lost when a drug fails to reach market. But FDA approval of race-specific medicines doesn't always mean that communities of color are interested in taking them. Just ask any of the 70 staff members recently laid off from NitroMed after the company decided that BiDil's sales are so slow that it's no longer worth marketing the drug.