IBARW: "Race in a Bottle"
A quick morning link: Scientific American has a story this month entitled "Race in a Bottle." It looks at the history of the approval of the first "ethnic" drug, BiDil, approved to treat congestive heart failure specifically in African-Americans, which is actually a combination of two generic drugs. It concludes that "no firm evidence exists that BiDil actually works better or differently in African-Americans than in anyone else," and that it was presented as an "ethnic" drug for strictly commercial reasons.
It points out that
The patented drug costs about six times as much as the readily available generic equivalents. The high cost has already made many insurers reluctant to cover BiDil and may place it beyond the reach of the millions of Americans without health insurance. Moreover, the unprecedented media attention to the race-specific character of the drug may lead many doctors and patients alike to think that non-African-Americans should not get the drug, when, in fact, it might help prolong their lives.
Perhaps most problematically, the patent award and FDA approval of BiDil have given the imprimatur of the federal government to using race as a genetic category. Since the inception of the Human Genome Project, scientists have worked hard to ensure that the biological knowledge emerging from advances in genetic research is not used inappropriately to make socially constructed racial categories appear biologically given or natural. . . .
The FDA's approval of BiDil was based on accepting NitroMed's argument that the drug should be indicated only for African-Americans because the trial population was African-American. This labeling sends the scientifically unproved message that the subject population's race was somehow a relevant biological variable in assessing the safety and efficacy of BiDil. Most drugs on the market today were tested in overwhelmingly white populations, but we do not call these medicines "white," nor should we. The FDA's unstated assumption is that a drug that proves effective for white people is good enough for everyone; the same assumption should apply when the trial population happens to be black. Otherwise, the FDA is implying that African-Americans are somehow less fully representative of humanity than whites are.
It discusses a paper reviewing 29 drugs claiming to have greater benefits to specific racial or ethnic groups, and point out that the paper was misrepresented in the media, and actually found that less than half those drugs were addressing consequences of genetic or physiological differences.
It concludes by noting to a growing trend toward race-specific drugs, and argues that
When [race is] 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.
Prior post on medical treatment: Implicit Associations Regarding Race and Medical Care.