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American Morning

FDA Approves Study on Heart Disease in African-Americans

Aired July 29, 2003 - 09:33   ET

THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.

THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.


SOLEDAD O'BRIEN, CNN ANCHOR: The FDA has approved a nationwide study of a drug to treat heart disease, but there is a twist to this trial. The drug is intended specifically for African-Americans. It is the first time that health officials have cleared such a test. Developing drugs for specific racial or ethnic groups is a controversial idea, and in a moment we'll hear a debate on that issue. But first, Dr. Sanjay Gupta joins us with a little background on this. Kind of complicated.
DR. SANJAY GUPTA, CNN MEDICAL CORRESPONDENT: It is complicated, it's a little bit controversial. From a medical standpoint, race has been part of the dialogue of clinical trials for some time. People know very well that certain races have different disease processes that are more likely to affect them and in fact they may respond to medications a little differently as well. And that's part of where this is coming from.

There's obvious challenges here, Soledad. One of the challenges is actually trying to figure who falls into what race. A lot of that's based on self-reporting. A lot of times that doesn't work well. Also, does race serve as racial markers or actually indications of the particular types of diseases of the particular races that are going to be more exposed to. That's also a difficult question as well.

Obviously, you know, you're a good example, Soledad. It's very hard to categorize people into individual races anymore. And as a result, hard to do this as well.

A couple of things, first of all. If you do break down the various categories of race, this is what the FDA has used for clinical trials for some time. You can take a look at list there. American Indian or Alaskan native. And you can read the whole list yourself. But those are the categories of race.

Now take a look at the various categories over time of where the various races fall into the clinical trial process. Eighty-three percent of people involved in clinical trials, of the years, '95 to '99, white. Down to about 1 percent for Asian, 13 percent for black. That somewhat reflects, at least for African-Americans, reflects the nation's population. But not so for some of the other minorities.

At issue now here, Soledad, is a drug called BiDil. The medication is known as BiDil, it is designed to try and target African-Americans with respect to heart disease. To give you some idea, 750,000 African-Americans have heart disease, that's part of 5 million Americans overall that have heart disease. That's a higher proportion than you'd expect based on the population.

2001, they got the green light for the trial. Don't expect to see any results for a couple of years still. But, again, as you mentioned, Soledad, the first time now, the first time the FDA has approved a particular drug to be used only for a particular race.

O'BRIEN: What diseases can be considered race specific?

GUPTA: Well there are some diseases that are considered race specific. A good example, sickle-cell anemia, for example. People believe that sickle-cell anemia sort of evolved on what it is as a protective mechanism against malaria but it's also a disease as well.

Take a look at a list of some -- the way that certain races process medications differently. This is important. Whites, for example, more likely to have lower levels of a particular metabolizing enzyme, that's really important for some drugs. Asians metabolize psychotherapeutic drugs legs quickly. So they stick around longer. African-Americans respond less to some antihypertensive agents and hepatitis C.

Even than, Soledad, though is controversial. Do they really respond less? Is it because they're African-American? Or it because of something else that is associated with being African-American? Less access to health care, things like that overall. And that's something that people are going to have to delve into.

O'BRIEN: Yes, no question about it. Sanjay, thank you very much.

GUPTA: Thank you.

O'BRIEN: We continue the debate. Let's turn now to Chicago where Dr. Richard Cooper, who's a chairman of preventive medicine and epidemiology at Loyola University is for us this morning. And also from Cleveland, Malcolm Taylor, he is the president of the Association for Black Cardiologists.

Thanks for joining us, gentlemen. Certainly appreciate your time. Dr. Cooper, we're going to start with you. You do not support customizing medicines for specific race categories. Why not?

DR. RICHARD COOPER, LOYOLA UNIVERSITY: Well I think I have three concerns with the BiDil study. First, I don't think the evidence really supports the idea that black patients and white patients have a different response to the drugs used to treat heart failure. The studies that have been done either show opposite or conflicting results or don't achieve what we call statistical significance.

The second issue that it's done with a framework of finding a race-specific therapy, but it only enrolls blacks. So, of course it can't tell us any information about the relative value for whites. And if there were a positive result, I think it might, then, be quite confusing. We wouldn't know what other groups might benefit from the drug. And the third concern was the one that was just raised before is how useful is this category of race? We're all amalgam of our complex biological past. And the categories we use, black, white, Asian, are not useful in terms of separating people in terms of the medical response to common drugs or the frequency of common illness.

Race is really an idea that comes from outside of science. And it doesn't really have a strong support population from genetics.

O'BRIEN: Well, Dr. Taylor, let's talk about that because it seems (UNINTELLIGIBLE) most of these studies or many of these studies the patients are asked to self-identify. They say, So, do you consider yourself an African-American? When I think it would be fair to guess that most black people are mixes of some kind way down their genetic link there.

How do people answer that? And doesn't that completely make this study non-scientific?

DR. MALCOLM TAYLOR, PRES., ASSN. OF BLACK CARDIOLOGISTS: No, not necessarily. I think the key is race is a social construct more in this country than a biological construct. But I think the important thing about the BiDil study sponsored by NitroMed is the fact that African-Americans are disproportionately affected by cardiovascular disease, but underrepresented in clinical trials, especially in heart failure.

So many of the drugs used for standard therapy in heart failure have not been adequately tried in African-Americans. The number of African-Americans in those trials have been underrepresented. So this is a study to make sure we have enough data, enough African-Americans in the study to draw conclusions. And I think this is an effort toward making sure we can improve the longevity of African-American who have heart failure by using a new drug on top of standard therapy.

O'BRIEN: Dr. Cooper, there's no question that heart disease is a major killer of all Americans and some studies show, as we just heard from Mr. Taylor, that blacks are twice as likely to suffer heart failure, twice as likely to die.

So then what would be the big deal? I mean why not test the drug? And as you say, you won't be able to tell anything about the results because you can't compare it back to a white control, but if it works really well, isn't that good news for the black population that's suffering very heavily from this problem?

COOPER: Sure. I mean, I think that the issue is -- it's certainly true that blacks have been unrepresented in trials and that they suffer a higher burden of heart failure.

But I think my concern is that the usual logic of these sort of scientific studies is not to focus on one specific race. I mean, we wouldn't think that would be a particularly appropriate way to do a trial if we had only whites in the study.

And this is driven by a premise that this drug is going to be particularly effective in blacks. That's how the framework was put together and that's how the FDA approved it. And, frankly, I'm just not convinced of that. I mean this is an older drug and there's an attempt to try to find a niche market here and suggest that it would be particularly useful for this group when we have other very effective therapies that we know about that are more widely used.

O'BRIEN: You're going to have the final word, Dr. Richard Cooper. Thank you for joining us, and Malcolm Taylor as well. I appreciate your time. Thank you.

COOPER: Thank you.

TAYLOR: Thank you.

TO ORDER A VIDEO OF THIS TRANSCRIPT, PLEASE CALL 800-CNN-NEWS OR USE OUR SECURE ONLINE ORDER FORM LOCATED AT www.fdch.com







Aired July 29, 2003 - 09:33   ET
THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.
SOLEDAD O'BRIEN, CNN ANCHOR: The FDA has approved a nationwide study of a drug to treat heart disease, but there is a twist to this trial. The drug is intended specifically for African-Americans. It is the first time that health officials have cleared such a test. Developing drugs for specific racial or ethnic groups is a controversial idea, and in a moment we'll hear a debate on that issue. But first, Dr. Sanjay Gupta joins us with a little background on this. Kind of complicated.
DR. SANJAY GUPTA, CNN MEDICAL CORRESPONDENT: It is complicated, it's a little bit controversial. From a medical standpoint, race has been part of the dialogue of clinical trials for some time. People know very well that certain races have different disease processes that are more likely to affect them and in fact they may respond to medications a little differently as well. And that's part of where this is coming from.

There's obvious challenges here, Soledad. One of the challenges is actually trying to figure who falls into what race. A lot of that's based on self-reporting. A lot of times that doesn't work well. Also, does race serve as racial markers or actually indications of the particular types of diseases of the particular races that are going to be more exposed to. That's also a difficult question as well.

Obviously, you know, you're a good example, Soledad. It's very hard to categorize people into individual races anymore. And as a result, hard to do this as well.

A couple of things, first of all. If you do break down the various categories of race, this is what the FDA has used for clinical trials for some time. You can take a look at list there. American Indian or Alaskan native. And you can read the whole list yourself. But those are the categories of race.

Now take a look at the various categories over time of where the various races fall into the clinical trial process. Eighty-three percent of people involved in clinical trials, of the years, '95 to '99, white. Down to about 1 percent for Asian, 13 percent for black. That somewhat reflects, at least for African-Americans, reflects the nation's population. But not so for some of the other minorities.

At issue now here, Soledad, is a drug called BiDil. The medication is known as BiDil, it is designed to try and target African-Americans with respect to heart disease. To give you some idea, 750,000 African-Americans have heart disease, that's part of 5 million Americans overall that have heart disease. That's a higher proportion than you'd expect based on the population.

2001, they got the green light for the trial. Don't expect to see any results for a couple of years still. But, again, as you mentioned, Soledad, the first time now, the first time the FDA has approved a particular drug to be used only for a particular race.

O'BRIEN: What diseases can be considered race specific?

GUPTA: Well there are some diseases that are considered race specific. A good example, sickle-cell anemia, for example. People believe that sickle-cell anemia sort of evolved on what it is as a protective mechanism against malaria but it's also a disease as well.

Take a look at a list of some -- the way that certain races process medications differently. This is important. Whites, for example, more likely to have lower levels of a particular metabolizing enzyme, that's really important for some drugs. Asians metabolize psychotherapeutic drugs legs quickly. So they stick around longer. African-Americans respond less to some antihypertensive agents and hepatitis C.

Even than, Soledad, though is controversial. Do they really respond less? Is it because they're African-American? Or it because of something else that is associated with being African-American? Less access to health care, things like that overall. And that's something that people are going to have to delve into.

O'BRIEN: Yes, no question about it. Sanjay, thank you very much.

GUPTA: Thank you.

O'BRIEN: We continue the debate. Let's turn now to Chicago where Dr. Richard Cooper, who's a chairman of preventive medicine and epidemiology at Loyola University is for us this morning. And also from Cleveland, Malcolm Taylor, he is the president of the Association for Black Cardiologists.

Thanks for joining us, gentlemen. Certainly appreciate your time. Dr. Cooper, we're going to start with you. You do not support customizing medicines for specific race categories. Why not?

DR. RICHARD COOPER, LOYOLA UNIVERSITY: Well I think I have three concerns with the BiDil study. First, I don't think the evidence really supports the idea that black patients and white patients have a different response to the drugs used to treat heart failure. The studies that have been done either show opposite or conflicting results or don't achieve what we call statistical significance.

The second issue that it's done with a framework of finding a race-specific therapy, but it only enrolls blacks. So, of course it can't tell us any information about the relative value for whites. And if there were a positive result, I think it might, then, be quite confusing. We wouldn't know what other groups might benefit from the drug. And the third concern was the one that was just raised before is how useful is this category of race? We're all amalgam of our complex biological past. And the categories we use, black, white, Asian, are not useful in terms of separating people in terms of the medical response to common drugs or the frequency of common illness.

Race is really an idea that comes from outside of science. And it doesn't really have a strong support population from genetics.

O'BRIEN: Well, Dr. Taylor, let's talk about that because it seems (UNINTELLIGIBLE) most of these studies or many of these studies the patients are asked to self-identify. They say, So, do you consider yourself an African-American? When I think it would be fair to guess that most black people are mixes of some kind way down their genetic link there.

How do people answer that? And doesn't that completely make this study non-scientific?

DR. MALCOLM TAYLOR, PRES., ASSN. OF BLACK CARDIOLOGISTS: No, not necessarily. I think the key is race is a social construct more in this country than a biological construct. But I think the important thing about the BiDil study sponsored by NitroMed is the fact that African-Americans are disproportionately affected by cardiovascular disease, but underrepresented in clinical trials, especially in heart failure.

So many of the drugs used for standard therapy in heart failure have not been adequately tried in African-Americans. The number of African-Americans in those trials have been underrepresented. So this is a study to make sure we have enough data, enough African-Americans in the study to draw conclusions. And I think this is an effort toward making sure we can improve the longevity of African-American who have heart failure by using a new drug on top of standard therapy.

O'BRIEN: Dr. Cooper, there's no question that heart disease is a major killer of all Americans and some studies show, as we just heard from Mr. Taylor, that blacks are twice as likely to suffer heart failure, twice as likely to die.

So then what would be the big deal? I mean why not test the drug? And as you say, you won't be able to tell anything about the results because you can't compare it back to a white control, but if it works really well, isn't that good news for the black population that's suffering very heavily from this problem?

COOPER: Sure. I mean, I think that the issue is -- it's certainly true that blacks have been unrepresented in trials and that they suffer a higher burden of heart failure.

But I think my concern is that the usual logic of these sort of scientific studies is not to focus on one specific race. I mean, we wouldn't think that would be a particularly appropriate way to do a trial if we had only whites in the study.

And this is driven by a premise that this drug is going to be particularly effective in blacks. That's how the framework was put together and that's how the FDA approved it. And, frankly, I'm just not convinced of that. I mean this is an older drug and there's an attempt to try to find a niche market here and suggest that it would be particularly useful for this group when we have other very effective therapies that we know about that are more widely used.

O'BRIEN: You're going to have the final word, Dr. Richard Cooper. Thank you for joining us, and Malcolm Taylor as well. I appreciate your time. Thank you.

COOPER: Thank you.

TAYLOR: Thank you.

TO ORDER A VIDEO OF THIS TRANSCRIPT, PLEASE CALL 800-CNN-NEWS OR USE OUR SECURE ONLINE ORDER FORM LOCATED AT www.fdch.com