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The FDA's approval of a drug aimed at African-American heart disease is really about increasing prof
It was of course Daryl Gates, unlamented former police chief of this city, who first told us that the veins and arteries of African-Americans "do not open up as fast as they do in normal people."
Now, astonishingly, we're hearing much the same thing from the Food and Drug Administration, which has just approved the commercialization of a new heart disease drug targeted at black patients - the first race-specific medication ever put on the market. BiDil, made by a Massachusetts company called NitroMed, is a combination of two generic drugs, both of which serve to open up the blood vessels in patients with chronic congestive problems.
According to the clinical trials presented by NitroMed, BiDil is not particularly effective in the general population. But when tested exclusively on blacks, it pays handsome dividends: a 43 percent reduction in the death rate, and a 39 percent decrease in first-time hospitalizations for heart failure. Since heart disease is markedly more prevalent in African-Americans than in whites - for years, NitroMed cited a ratio of 2:1, although the evidence for that appears a little shaky - the drug has obvious commercial value.
But it also poses a troubling conundrum. Is it possible, as NitroMed has argued, that "ethnic differences" play a role in the underlying pathophysiology of heart failure? Put another way - and, admittedly, in a rather less incendiary context - has the FDA just suggested that what Daryl Gates said so offensively about black suspects dying in disproportionate numbers from police choke-holds might actually have some medical foundation?
Somehow, the vast majority of the media coverage on BiDil has managed to duck the vexed race-politics implications entirely, heralding the FDA's approval instead as a first step toward an exciting new future of "personalized medicine" - that is, drugs tailored to the individual as much as to the presenting symptoms.
The tenor of the coverage has been guided, perhaps, by the fact that some prominent African-American doctors' groups - including the Association of Black Cardiologists and the National Medical Association - have cheered the commercialization of BiDil more or less uncritically. NitroMed has certainly handled its PR effort admirably: It also approached the NAACP and members of the Congressional Black Caucus to insulate itself against any possible race-related backlash.
The argument in favor is, on the surface, quite alluring. African-Americans are underserved by the health care system. African-Americans suffer a disproportionate number of heart attacks. What's not to like about a pharmaceutical company that pays them and their problems a bit of exclusive attention for a change?
Something, though, is very wrong with this picture. Any time biological differences are ascribed to race it ought to set alarm bells ringing, especially in a country with a tortured history of systemic discrimination and racial violence like this one. Whatever is causing some patients to respond to BiDil more than others, it most certainly is not the color of their skin. Judging patients' cardiac health by their skin pigmentation makes about as much as sense as judging their athletic ability by the size of their nose: It is manifestly absurd.
Now, there may well be some genetic predisposition to respond to BiDil that shows up in a large number of people who happen to be African-Americans. But in that case it is the genetic predisposition which should be identified, and tested in all patients regardless of skin color. Even NitroMed acknowledges that some non-black patients responded well to BiDil. And that should come as no surprise. How, after all, can one realistically define "black" or "African-Americans" as a meaningful scientific, as opposed to social, category? Does it take one black parent, or two? All four grandparents, or fewer? Should one rely on outward physical characteristics alone?
Historically, the only reason to ask such questions has been to try to assert the superiority of one racial grouping over another. Mainstream science, by contrast, has found ever fewer reasons to regard the differences between racial groups as primarily genetic.
So what is really going on here? According to Jonathan Kahn, a medical ethicist who wrote up an exhaustive history of BiDil's development in the Yale Journal of Health Policy, Law and Ethics last year, this ultimately has very little to do with dispassionate inquiry into the medical peculiarities of self-defined African-Americans and everything to do with the tawdry, money-driven world of pharmaceutical research and development.
NitroMed had tried since the late 1970s to bring BiDil to market, but the trials never worked out the way the company hoped. Only in extremis did Jay Cohn of the University of Minnesota, a researcher on the trials, go back over the data and notice the markedly improved response among trial participants who identified themselves as black.
Cohn designed a new test called A-HeFT, the African-Americans Heart Failure Trial, which proved so successful it was actually halted early. One of Cohn's colleagues on the test, Clyde Yancy, became so enthused by what he saw that he went so far as to speculate that heart failure in blacks was a "different disease" than in whites.
To insulate itself against accusations of racism, NitroMed not only wooed influential black groups. It actually paid $200,000 to the Association of Black Cardiologists to help carry out the trials. To protect its discovery, it took out a new patent on BiDil as it relates to African-American patients. The old, universal patent runs out in 2007, while the new, race-specific one continues to give NitroMed exclusive commercial rights until 2020. Handy, given the financial rewards now in the offing.
Did these considerations influence the outcome? How could they not? While the ABC, as an institution, expressed nothing but enthusiasm about the prospects for BiDil, some individual members have acknowledged feeling distinctly uncomfortable that race was being used as a biological determinant. Outside the cozy world of doctors, pharmaceutical companies, and their political contacts, the reaction has been more skeptical still - if not to say downright hostile.
Ever since the notorious Tuskegee experiment, when a group of federal researchers deliberately failed to tell a group of 400 black men from Alabama that they had syphilis and let them go untreated for 40 years as they studied the disease's effects, the knee-jerk reaction of many African-Americans to offers of medical largesse has tended to be deeply suspicious. "How do we know this isn't a conspiracy to get rid of the black race?" was one typical reaction, given by someone who suffers from high blood pressure, to the Charleston Post and Courier newspaper in South Carolina.
Less histrionically, black commentators have questioned just how safe the new drug will prove to be, given the dodgy scientific rationale behind it. The FDA, after all, approved Vioxx and Celebrex for sale before realizing just how dangerous they were.
It's also worth injecting another taboo subject into the debate at this point, and that is class. What if the reason so many black Americans have heart disease is not because of the color of their skin, but because of poverty and the things that go with it: poor diet, poor education, lack of access to health care, and so on? We know that a disproportionate number of African-Americans are poor, and we know a disproportionate number of poor people suffer ill health. If the FDA or any other government agency were serious about extending the length and quality of life of African-Americans, these are the issues they should be addressing. The wonder pill that risks defining them, more or less explicitly, as different from "normal people" can only be an insidious distraction.
Published: 06/30/2005
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