IBARW: "Race in a Bottle"

[kate_nepveu]

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.

Comments

[fledgist.livejournal.com]

I am particularly curious as to whether such a drug would be prescribed to a person such as myself who is of mixed ancestry (and by mixed I mean mixed) and who does not identify as 'African-American'.

[kate_nepveu]

I can't answer that question with anything but extrapolation, but heck, I'm a lawyer, extrapolating and drawing inferences is what we _do_. So, some random considerations:

I suspect that would be considered off-label use, which may discourage some doctors. (I'm not very familiar with this area and welcome comments.)

A doctor who was aware that there's no evidence that the drug works better for African-Americans, might prescribe the two generic drugs in the same combination if they were indicated for your condition.

And then there's the common human tendency to like easy categories and flow-charts and the like, which I think would be a factor reducing the likelihood that you would be prescribed BiDil.

I'm sure there are more things I'm not thinking of.

[fledgist.livejournal.com]

Hmm. Thanks. That is actually helpful. So my actual genetics wouldn't matter?

[kate_nepveu]

What, for whether BiDil would work for you? There seems to be no evidence that it works better on a genetic basis for anyone.

[fledgist.livejournal.com]

No, for whether I'd get prescribed it. Though the end result's the same.

[dsgood.livejournal.com]

I'd be nervous about taking a whites-only drug, because some of my genetic heritage is Asian. (My mother's cousin looks almost as Oriental as his Korean wife.) And the genes relevant to my medical condition might well not be white-only. The same is true of other people of Eastern European ancestry.

As for African-Americans: Many of them are various mixtures of white, black, and American Indian ancestry. (Note: I don't say "Native American" because I believe very few have Inuit or Aleut ancestors.) "One size fits all" isn't going to work.

[kate_nepveu]

Let me quote the paragraph in full that talks about the 29 drugs, because it was buried in page 4 of the article:

In only four of the 29 medicines identified, Tate and Goldstein found evidence that genetic variations between races could possibly be related to the different responses to the drugs. (All four are beta blockers used for treating high blood pressure and other cardiovascular ills; some research indicates that these drugs work better in individuals carrying a gene variant that is more common in people of European ancestry than in African-Americans.) For nine of the medicines, the authors found “a reasonable underlying physiological basis” to explain why blacks and whites may respond differently to the drugs; for example, some scientists have speculated that ACE inhibitors may be more effective in people of European descent than in African-Americans because of variations in enzyme activity. (Other researchers have contested this hypothesis.) For five of the drugs, Tate and Goldstein found no physiological reasons to explain the varying responses; for the remaining 11 they concluded that the reports of differing responses may not be valid.

And the continuation of the quote about the Human Genome Project:

As a 2001 editorial in the journal Nature Genetics put it, “scientists have long been saying that at the genetic level there is more variation between two individuals in the same population than between populations and that there is no biological basis for ‘race.’” More recently, an editorial in Nature Biotechnology asserted that “race is simply a poor proxy for the environmental and genetic causes of disease or drug response.... Pooling people in race silos is akin to zoologists grouping raccoons, tigers and okapis on the basis that they are all stripey.”

(Personally I like that "stripey" appeared in a scientific editorial. It's a fun word.)

In other words: what you said.

[cyphomandra.livejournal.com]

Thanks for posting this - I'd heard a mention of the drug, and naively assumed it was based on stronger research, possibly tying into the ACE inhibitor data you mention in your above comment, which I'd heard about before (and which now looks like yet another example of subgroup analysis that didn't pan out when specific trials were actually designed to look at differences). Nice - for values of depressingly familiar - to know that it's just another attempt to create and corner a new market.

There are drugs prescribed based on the presence of absence of specific genetic factors (there's an HIV treatment where potentially fatal side effects occur only in patients with a particular genetic marker, so all patients are now screened for that), but using race as a surrogate for these seems like plain bad medicine. Population data is important, but patients are still individuals.

[kate_nepveu]

Thanks. Out of curiosity, do you know if the genetic marker relevant to the HIV treatment you mentioned occurs more in any particular population?