Jun
17
2005

Yesterday, an advisory panel for the Food and Drug Administration (FDA) recommended approval of a drug, BiDil, for heart failure in African-Americans. (The approval was unanimous, although two panel members voted against the racial indication labeling for the drug.) If the FDA follows the panel's advice, BiDil will become the first drug approved for use by patients of a particular race. The drug is a combination of two generic drugs (isosorbide dinitrate-also known as nitroglycerine-and hyrdralazine) that works by increasing the body's concentration of nitric oxide, which widens the arteries and helps the heart function more efficiently. The drug was tested in 1,050 African-Americans last fall. In that study, patients taking BiDil had much better survival rates and were much less likely to be re-hospitalized for congestive heart failure. Dramatic outcomes like this are a good thing, right? Yes. But the idea that a drug be approved for patients of a specific race makes many doctors uncomfortable, and it may also be bad medicine. Jonathan Kahn, a law professor and medical ethicist at Hamline University, said:

"It sends the message that because [the study] was done only in African-Americans that somehow African-Americans are different genetically than everybody else. And that is a very dangerous message to be sending. It's one that doesn't need to be sent in order to bring this drug to market."

Some cardiologists think the reason the drug works so well for many African-Americans may not be a matter of "race" (for which there is no scientific/genetic basis), but is probably related instead to the root cause of their heart failure: African-Americans are more likely to suffer heart failure due to high blood pressure, while whites are more likely to suffer heart failure due to clots caused by heart attacks or atherosclerosis. But some African-American patients do suffer heart failure caused by clots or hardening of the arteries, and some white patients do have heart failure related to high blood pressure. So critics think that the drug should be labeled for use by patients with heart failure caused by hypertension, instead of use by African-American patients. Dr. Gail Christopher, co-chair of the National commission on Health, Genomics and Human Variation, says:

"It would be 'bad science' to label or market this drug as a 'Black' drug. More importantly, race-based claims are not credible in the face of modern genetic medicine."

The New York Times says:

"The drug's maker, NitroMed Inc., says its decision to test and market BiDil as a drug for African-Americans is based on solid science. But BiDil's application [for FDA approval] has engendered controversy, with many scientists convinced that race is too broad and ill-defined a category to be relevant in determining a drug's approval, especially since geneticists have failed to identify a biological divide separating one race from another. Scientists know that different people have different responses to medications, and in some cases these have been linked to race. The FDA, for example, has said that people of Asian ancestry are more likely than others to get serious side effects from the cholesterol-lowering drug Crestor. But research shows that the underlying genetic variations across races are small. [Studies have shown that genetic variation within any racial group exceeds that between two groups.] Scientists believe that genetic markers will someday be found that explain the different reactions to drugs, but for now, race or ethnicity is an imprecise shortcut. By approving BiDil, the FDA would go well beyond where it has in the past in using race as a category to evaluate which patients respond to drugs."

Other doctors feel that failing to take race into account when treating patients is unacceptable. Dr. Jim Kennedy, a spokesman for the Royal College of GPs, told the Times:

"To close one's eyes to colour is tantamount to a neglect of clinical duties. As a practicing professional, I took an oath not to pay any attention to a patient's race, creed, colour or background, and I take this very seriously. But if there is real evidence that because of your genetic inheritance you should be offered a certain drug, I would be negligent in not offering it to you. There may be people of African descent who will benefit from ACE inhibitors, but trying to guess what genes someone has inherited in impossible. So doctors make a reasonable stab at a first-choice drug and if it doesn't work we'll use our second choice. I think it's far worse if, for reasons of political correctness, we chose to ignore real, hard scientific facts."

What do you think about the prospect of race-based medicine? Should drug companies be marketing to specific ethnic groups? How is this harmful or helpful?

Your rating: None Average: 5 (2 votes)

Your Comments, Thoughts, Questions, Ideas

Liza's picture
Liza says:

Every year, a University of Maryland medical conference reviews the medical records of one historical figure to reexamine the cause of death. This year, they looked at the circumstances surrounding Booker T. Washington's death in 1915, and determined that he died of high blood pressure. (There were no effective treatments for high blood pressure until the 1950s.)

One of Washington's doctors wrote, 90 years ago, that he died of "racial characteristics"--a ridiculous term that included high blood pressure but also syphilis. But Washington's charts show that his blood pressure was 224/145, almost double the normal pressure. And a blood test at the time proved that he was NOT suffering from syphilis.

From the AP article:

"'The cruel irony is that he would be killed by a disease which is a particular threat to African Americans,' said Fitzhugh Brundage, a University of North Carolina-Chapel Hill history professor who spoke at the conference.

While it still is not known what causes high blood pressure or why blacks are more frequently and severely affected, 'what we do know is we can prevent or decrease the likelihood of its development,' said Dr. Jackson Wright, a professor of medicine at Case Western Reserve University who reviewed the records."

posted on Mon, 05/08/2006 - 2:19pm
Anonymous's picture
Anonymous says:

I personally think that racial based medicine could be both a good and a bad thing. Good in the sense that they found a new drug andcan be used by some people in the advancement of medicine and technology. It could help save many lives potentially help us stop heart failure all together. Everything has a starting point and this may be it for the medical world. However, racial based medicine would not be taken well in the society we live in today. Many would regard this as a blow to people of different ethnic backrounds because many would not understand this advancement of medicine. I hope that someday we can help the world with what we have come to discover and that people will take no offense to the growing world of medicine.

posted on Sat, 04/15/2006 - 4:15pm
Liza's picture
Liza says:

This Washington Post article A Cure for Race? Heart Drug Findings Set Off Ethics Debate has a good explanation of how the drug works and why the FDA recommendation is controversial.

The History of Race in Science website has a few interesting articles on the subject of race and medicine, including New Drug Combo Intensifies Race-Based Medicine Debate.

For a discussion of whether or not the FDA should even have the authority to do this, try The Columbia Law School Chapter of the American Constitution Society's blog.

Here's a Spokesman-Recorder article: BiDil controversy raises specter of racial profiling in medicine

posted on Fri, 06/17/2005 - 4:25pm
Liza's picture
Liza says:

Here's a segment from the NewsHour with Jim Lehrer that aired on June 17th.

posted on Mon, 06/20/2005 - 11:50am
Benin Dakar's picture
Benin Dakar says:

BiDil the First Race-Based Medicine
Are Black Americans Encountering Another "Tuskegee" Experiment?

I can understand how some medications can be designed for persons who have a very specific genetic background. However, black Americans are not an isolated racial group. To the contrary, black Americans are probably one of the most genetically diverse groups of people who have ever existed.

Black Americans beyond having an eclectic genetic connection to the multiple peoples who inhabit West Africa, many black Americans have both European and Native American ancestry. And let us not fail to mention about blacks immigrating from Africa and the Caribbean to the United States, who become "black Americans", once they reach these shores. Are medications made for "black Americans" beneficial to the newest arriving black Americans?

My brother, who is a black American, suffers with idiopathic torsion dystonia, a neurological movement disorder that has its highest incidence among the European Jewry. Many of his doctor's are baffled that a black man has this rare disease, until they probe for my brother's known genetic history. Our maternal great grandfather was a German Jew. Many black Americans have similar mixed ethnic identities, although we are socially and self-identified as black Americans.

We must be careful that the development of race based drugs like BiDil is not directed by misguided science. I hope that scientists are not allowing mistaken perceptions of race and pharmaceutical companies their greed to cloud the scientific process, by incorrectly manufacturing and marketing drugs based on race.

Moreover, we must ensure that the black community is not used for 21st Century medical experimentation, like blacks were used in the Tuskeegee experiment.

Benin Dakar
Duluth, GA

posted on Mon, 06/20/2005 - 1:16pm
JNNelson's picture
JNNelson says:

Every time in any biology course someone has brought up the notion of biological race, I've heard that there is more genetic diversity within human "races", than there is between human "races". To have an organization like the FDA to approve a drug on the basis of race is disturbing. It could definitely lend credence to the notion of biological race.

posted on Tue, 07/05/2005 - 8:49pm
Wajones's picture
Wajones says:

I thinks it's a shame that becasue a drug has shown to work better in one race versus another it has to be labled a 'Race-based medicine. It just goes to show America is still struggling with Race and until it overcomes its insecurity about Race, we will continue to have these inane labels that continue to prevent us from regarding all of us as part of the Human Race. I'd be willing to bet there are community activists promoting this as another Tuskeegee experiment thus preventing valuable healthcare in a community that needs it more than today than ever before.

posted on Thu, 08/11/2005 - 3:06pm
Mark's picture
Mark says:

Since I suffer heart disease so I am going to try this new drug after consulting my physician.

posted on Wed, 11/02/2005 - 4:32am
Kisakookoo's picture
Kisakookoo says:

Hi! Why I can't fill my info in profile? Can somebody help me?
My login is Kisakookoo!

posted on Thu, 01/25/2007 - 4:54pm
Anonymous's picture
Anonymous says:

I am a black woman and I have hypertension and I would not take this drug. I believe in science, and race is a sociological concept not a scientific concept. I suppose the counter argument would be that I am endangering myself foolishly, but I would rather die a few years earlier than give credence to the "scientific" concept of race. I know sometimes when I am offended or treated unfairly I can feel the blood whooshing through my veins, maybe that is the cause of hypertension in blacks, our reaction to racism--not our facial features or hair textures or skin color. So the pharmaceutical companies should spend their energy developing a pill to end racism instead of a pill to heal me and "member of my race."

posted on Mon, 06/28/2010 - 2:03pm
Shana's picture
Shana says:

Please don't avoid a drug that could save your life! (Of course, if it is the right one for your illness.)
We need people like you to continue to point out what is offensive, so that panels won't label medications like that in the future. Plus, we just need people who want to see an end to racism.

Personally, I know that I am statistically more likely to develop osteoporosis because I'm white and relatively small--and my ancestors all had it. I know it's not really because of my social identity but because of genetic factors more common in white populations. To ignore that trend could be harmful.

So I agree that the indication should have been for heart failure secondary to hypertension, but please don't throw the baby out with the bath water.

posted on Mon, 06/28/2010 - 3:39pm

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