Jun. 25th, 2005

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Okay to sell heart drug to blacks only

A heart failure drug can be marketed to blacks only, the U.S. drug regulator said Thursday.

The approval marks a step toward "the promise of personalized medicine," said the Food and Drug Administration. Critics worried the move smacks of race-based medicine.
BiDil will be marketed to African-Americans.

The drug, known as BiDil, treats heart failure, a condition in which the heart is weakened and does not pump enough blood. BiDil works by elevating levels of nitric oxide, which is important to the health of heart and blood vessels.

Manufacturer NitroMed. Inc. told the FDA it wanted to sell BiDil only to blacks, citing studies that showed blacks fared better on the drug than other races.

Dr. Jay Cohn of the University of Minnesota, who holds a patent on BiDil, theorized the drug helps blacks because evidence suggests they have less nitric oxide in their bodies.

"Today's approval of a drug to treat severe heart failure in the self-identified black population is a striking example of how a treatment can benefit some patients even if it does not help all patients," said Dr. Robert Temple, FDA's associate director of medical policy.

BiDil is the first drug therapy intended for a specific race. It will be sold to people who self-identify as black.

It's hoped that scientists will discover characteristics in people of other races who might be helped by BiDil, Temple added in a release.

Researchers are working on ways to develop genetic tests to target therapies to each patient, an approach that could someday make issues like gender and race irrelevant in medicine, experts said.

Last week, an advisory committee recommended the FDA allow sales of the drug, although two of the nine panelists said the label should not be race-specific.

http://www.cbc.ca/story/science/national/2005/06/23/BiDil-approval050623.html

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