a Heart Failure Drug For Blacks Only

Heart failure is more common among African-Americans than other groups, and they tend not to respond as well to drugs commonly used to treat heart failure.

The U.S. Food and Drug Administration recently approved the drug BiDil to treat heart failure in blacks. BiDil is a combination of two drugs -- isosorbide dinitrate and hydralazine -- each approved separately by the FDA many years ago. Approval of BiDil was based on results of a study of 1,050 black patients with heart failure. Compared to placebo (an inactive substance), BiDil reduced the relative risk of death and the need for hospitalization among these patients by about 40 percent.

BiDil is the first example in the United States of a drug approved for use by a particular racial or ethnic group. Of course, doctors can still prescribe the drug for other people, in what is known as off-label use.

A major problem, in my opinion, is the use of skin color to label a person as black or African-American, because studies have shown an uncertain connection between skin color and genetic makeup. Nonetheless, approval of this drug for use in black patients may foreshadow how the choice of many drugs could be made in the not-too-distant future. Greater understanding of human genetics has opened up the new field of pharmacogenetics, which may one day allow doctors to predict which drugs will be most effective based on an individual patient's unique genetic pattern.

A possible hazard of BiDil is that one of its components, hydralazine, increases the risk of developing lupus. Next week I will discuss the heart risk associated with lupus.