FDA Panel Weighs Heart Drug for Blacks
ROBERT SIEGEL, host:
From NPR News, this is ALL THINGS CONSIDERED. I'm Robert Siegel.
MELISSA BLOCK, host:
And I'm Melissa Block.
Today, scientists who advise the Food and Drug Administration recommended approval for a drug to treat heart failure. Sounds simple enough, but there was a lot of controversy before the vote. That's because the drug, called BiDil, has only been shown effective in African-Americans. NPR's Joe Palca joins us from Gaithersburg, Maryland, where the panel met this afternoon.
And, Joe, give us a bit of background on BiDil. What led up to this vote?
JOE PALCA reporting:
Well, BiDil is a drug that's actually been around for about 25 years. It was tested in the 1980s and '90s for the treatment of heart failure in basically all comers. If you had a certain degree of heart failure, you could enter these studies. And the studies were disappointing; they didn't show that BiDil was helpful adequately for the FDA, the Food and Drug Administration, to go ahead and approve them.
But when the manufacturer of the drug and the scientists who had developed it looked back at the earlier trials, they noticed something interesting. They found that the population--if they analyzed the data simply based on someone's race, they saw a signal that the drug was working. So they got together with the Food and Drug Administration and said, `Look, if we did a study just in black people, self-identified African-Americans, and showed that the drug worked for them, would you consider approving it?' And the FDA said, `Yeah, go ahead and do that and we'll be happy to hear what you have to say.' So that's what they did, and the results of that study appeared last year in the New England Journal of Medicine and the results seem to be promising.
BLOCK: Well, if the drug was promising then in this population of African-Americans, why so controversial?
PALCA: Well, you know, it's an interesting question, actually, because you'd think, `Oh, well, good, here's a population that is--you know, that's chronically underserved by some accounts and people aren't paying attention to the specific needs of African-Americans and we should be looking at their medical problems.' And so, yes, of course, that seems at first blush to be a reasonable thing to do.
But if you think about it a little further, there's no question--and this is what some of the people who were objecting to this approval were saying--that, look, there's no question that people differ on the question of how they'll respond to a drug; I mean, you know, their height, their age, some biological factor is bound to make a difference. But race isn't a biological factor; at least a lot of biologists say that it's not clearly understood what it means biologically or genetically to be African-American.
So if we use race as the surrogate for that biological data that we're really interested in, we run a big risk. We run the risk of a stigma, of choosing a measure that's not really telling us what we want to do. And so they say, `Look, if BiDil's working, approve it for everybody.' And, you know, by the way, a lot of drugs have been approved that were mostly tested in whites and we don't say, `We'll just use it in white population. Let's--you know, so let's not turn it around here.' So that's what the criticism was all about.
BLOCK: And how did the panel resolve these concerns?
PALCA: Well, I think--you know, again, a lot of these are scientists on the panel, but there's also a lot of doctors. And the doctors say, `Look, the world is the world we have, not the world we'd like to have. And if--race is a relevant issue and, you know, we treat our patients different. We know black patients are going to respond to some drugs better than others, we know that empirically just from what we experience in our clinics.' So they seem persuaded.
And the data--there were criticisms of the data, the one that was published--this study was published last year. But I think in the end, everybody was convinced that there was a strong enough signal that the drug worked that it should be approved.
BLOCK: Joe, this is a recommendation to approve BiDil. What's the next step for the drug?
PALCA: Well, the FDA--you know, they go back and they think it over and discuss it. They can, of course, take the recommendation from one of the panel members which says, `Approve this for everybody, but let people know that it was tested in African-Americans and it might have a better--work better in African-Americans.' But I think they're leaning at this point, if you can read the tea leaves a bit, to approve it for African-Americans and say, `Look, that's the people we studied it in; that's the people we should use it in.'
BLOCK: Joe, thanks.
PALCA You're welcome.
BLOCK: NPR's Joe Palca, talking with us from Gaithersburg, Maryland.
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