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Drug That Responds Better to Blacks Raises Ethics Concerns; Don't Ignore Genetics, Says BiDil's Maker

Posted on: Monday, 18 July 2005, 18:01 CDT

LEXINGTON, Mass. -- When a team of researchers zeroed in on studies that showed blacks responded better than whites to a heart medication, they spent another two years rechecking their work before releasing the findings.

"There was anxiety, I think, that probably made us wait a while until we were absolutely sure from our data that this was a real phenomenon, and not just a play of chance," recalled Dr. Jay Cohn, a University of Minnesota cardiologist involved in the study that was published in 1999.

But the study was clear: Blacks responded better that whites to the drug that Cohn and his colleagues began investigating decades ago. That led to a 2001 clinical trial involving only black patients -- and ultimately to last month's approval to market BiDil to blacks, the first medication approved by the Food and Drug Administration for a specific racial group.

The development has raised ethics concerns about gearing medicines to a certain race, but could help usher in so-called "personalized" medical treatments tailored to an individual's genetics.

The researchers and the company marketing BiDil, Lexington-based NitroMed Inc., caution against assigning too great a role to race and ethnicity in medicine. But they also say doctors shouldn't overlook those factors and they are studying BiDil further, looking to expand its use to other races. That would give NitroMed a much larger slice of the profitable U.S. market for cardiovascular drugs, which the pharmaceutical data firm IMS Health estimates at about $21 billion, including heart failure and blood pressure treatments.

BiDil's approval "has not only vindicated my faith in the drug, but my long-standing belief that we should do trials in targeted populations," said Cohn, a member of NitroMed's scientific advisory board who designed the blacks-only study the FDA required.

According to the U.S. Centers for Disease Control, an estimated 750,000 American blacks suffer from heart failure, which occurs when the heart is too weak to pump effectively. Half the patients die within five years of diagnosis, and middle-aged blacks are more than twice as likely than whites of the same age range to die from the condition.

BiDil is the first commercial product for NitroMed, a 22-year- old biotechnology firm specializing in research on nitric oxide, a substance key to heart health that the company is researching for other uses, including arthritis treatment.

On the Web

Food and Drug Administration: www.fda.gov

NitroMed Inc: www.nitromed.com

Source: Columbian

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