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January 3, 2011
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Race Drug


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Advisory Committees: Critical to the FDA's Product Review Process



   06.16.05
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Should the U.S. Food and Drug Administration approve a new drug on the basis of race? An FDA review committee is meeting on whether to recommend approval of a heart failure drug for African-Americans. But some experts say race is not a good scientific basis for approving a drug.

A Drug for One Race?

image: NitroMed
The drug, known as Bidil initially failed to show a clear benefit in a broad population of patients with heart failure. But, explained Marc Klapholz, director of cardiology at the University of Medicine and Dentistry of New Jersey (UMDNJ), when it was tested in a sample of African-American patients it significantly improved survival.

Klapholz, an investigator in the clinical trial known as A-HeFT, for "African-American Heart Failure Trial," says this trial was begun after results in the first trial, "Suggested that African-Americans might benefit more than other patients. And so, the FDA agreed for this trial to go forward, and it's likely now that the FDA will approve this treatment for African-American patients who have heart failure," Klapholz says.





Indeed, the A-HeFT trial was halted early so that patients who were getting a placebo could receive the actual drug. "It would have been unethical to continue the trial once one has shown, and it has been proven, that in one arm of the trial patients did statistically significantly better," he explains. "To deny therapy to the other group of patients who were originally randomized to placebo, would be to withhold therapy that we know is beneficial for their survival."

But is targeting a drug by race good science? "That is many times unnecessary and also a dead-end kind of way of approaching the problem," says cardiologist John M. Flack, principal investigator of the Center for Urban and African-American Health at Wayne State University. "There are clear differences between blacks and whites, but what we've also found is that many times the differences that we find within the groups dwarf what we find between the groups," he says.

And Flack points out one-way targeting of race can be misleading — doctors can fail to diagnose cystic fibrosis in blacks because it's most common in whites, and sickle cell anemia in whites because it's most common in blacks.





image: NitroMed
Flack says efforts to make sure and include enough minorities in designing clinical trials are laudable. "Many clinical trials have actually not set themselves up initially to actually recruit enough minorities to be able to make valid conclusions," he says. "And so, what they do at the end of the study, they have a small number of highly select minorities or blacks, and go back and look at the data retrospectively, and draw broad sweeping conclusions and see things that sometimes just don't many any sense."




"So at times it does make sense to consider race and ethnicity," Flack adds. "I think where race and ethnicity becomes dangerous, and becomes bad science, is when people start kidding themselves that they can find something in one racial group that is totally distinct from something they will find in another racial group."

Klapholz says NitroMed, the company behind Bidil, intends to analyze DNA from the A-HeFT patients to search for genes that influence who would benefit from the drug. But meanwhile, he says, until the actual genes that affect responses to the drug are known, race is the easiest indictor of who might benefit.

"We just used the convenience of ethnicity to identify a greater prevalence in a particular patient group," Klapholz says. "In fact, skin color does not define a distinct biological entity, we think that this problem exists in many non-black patients but we are unable to as yet identify that particular group."

If the drug is approved for African-Americans, doctors could prescribe it "off-label" to anyone else they think might benefit.

The FDA review committee's recommendations are not binding but the FDA most often follows the committee's advice.


 
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