Jewish World Review Nov. 11, 2004 /27 Mar-Cheshvan 5765

Clarence Page

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Consumer Reports

Heart drug for blacks hard to swallow


http://www.NewsAndOpinion.com | At last, a drug of our own.


That was my initial reaction to the big news earlier this week that a new heart drug has been found for African-Americans.


The drug called BiDil, manufactured by NitroMed Inc. of Lexington, Mass., has dramatically reduced deaths and hospitalizations in black test patients, setting the stage for it to become the first drug approved for only one racial group.


As an African-American, I thought this was some of the best news that I have heard since the invention of low-fat soul food.


After all, black Americans are two-and-a-half times more likely than the general population to develop heart failure, which affects 5 million Americans.


But a blacks-only drug? The announcement raised questions in my curious mind: What happens if non-blacks take it? Will their skin turn dark and their hair turn kinky? Will they discover a new appreciation for Bill Clinton?


Ah, just kidding. Talk about race and genetics makes a lot of people nervous — for good reason, since human histories offer ample examples of such talk leading to excuses for inhuman abuses.


News of a blacks-only drug runs up against a persistent reality: Race is more of a psychological, sociological and political construct than a scientific reality. Humans have a lot more genetically in common across racial lines than within each of our own racial groups.


Looking black is not enough. Tiger Woods, for example, looks black by most American standards, but who knows? His African genes probably hold a minority status in his chromosomes by now, thanks to his Asian-American mother and his Euro-Indian-African-American father.


And even your family can fool you. Numerous white Americans have discovered black ancestors in their families and vice-versa. (Had a talk with grandma lately?)

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"Does Race Exist?" asked a headline in Scientific American last November. The author's answer: If races are defined as genetically discrete groups, no. But researchers can use some genetic information to group individuals into clusters with medical relevance.


With that in mind, researchers have noted that the commonly used family of heart drugs called ACE inhibitors works measurably less well in black Americans than it does in other Americans. By comparison, BiDil reduced deaths from advanced heart failure by 43 percent among black patients and reduced hospitalizations by a third in a study reported this week at a New Orleans meeting of the American Heart Association.


The two-year study, co-sponsored by the Association of Black Cardiologists and published in the New England Journal of Medicine, virtually assures Food and Drug Administration approval of the drug for use in black patients.


So far, so good. As my folks used to say, when your life depends on it, you don't argue; you take what the doctor offers.


Even so, you don't have to be a medical ethicist to be troubled to see any drug associated directly with a standard as imprecise as race.


Even though some drugs are known to have different levels of effectiveness on members of different races, we also know that diet and culture and environment have a big effect on disease rates, and recovery rates too.


While black Americans have a higher than average heart disease rate, for example, British blacks have a lower rate than the United Kingdom's national rate, while their countrymen of Asian descent have a higher rate. Maybe British "soul food" has less cholesterol than ours does on this side of the Big Puddle.


Either way, the case of BiDil raises a unique ethical dilemma: If the FDA approves it for use by blacks, physicians could prescribe it to other groups, but insurance companies might not pay for it. Sorry, they could say, "but you're just not black enough."


And it just so happens that patent laws give NitroMed and its competitors a strong financial incentive to avoid doing a larger study on whites. NitroMed's "blacks-only" patent allows it to keep generic versions of BiDil off the market until 2020. An earlier patent for general use of the drug will expire in 2007. That leaves too little time for a drug company to conduct proper trials, win FDA approval and make a decent profit before the patent runs out, making the drug available for generic manufacturers to produce cheaper versions of it.


Such are the strange twists and turns that race can take when it runs up against modern science, government bureaucracies and the health insurance industry. Someday we Americans will be able to get past questions of race, I hope. In the meantime, we have to get through them — and don't forget to lay off the high fat and cholesterol.

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