A study showing that a new drug combination dramatically improves outcomes for black patients with heart failure is expected to lead to federal approval of the medication specifically for that group. While some doctors applaud this development, others question its validity and worry about its ethical implications, fearing it will usher in a wave of race-based drug treatments driven more by marketing than by science.
The study, published in the Nov. 11 edition of the New England Journal of Medicine, was halted nine months early when researchers noticed 43 percent fewer deaths among people taking the new drug than among those given a placebo. The test participants were 1,050 people who identified themselves as black, all of whom also took other medications (including diuretics, ACE inhibitors and beta blockers) typically prescribed for heart failure.
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"It's the largest reduction in mortality that's ever been achieved in a heart failure trial," said Jay Cohn, a University of Minnesota cardiologist who co-authored of the study.
The drug, named BiDil, represents a "race-based therapy" approach that many doctors said they expect to see increase, at least partly because such treatments represent a potentially faster route to drug approval. But some doctors say the approach misrepresents race as an easily distinguished biological trait. Studies have shown genetic variation within any racial group exceeds that between two groups.
Race-based therapy is a "bad idea," said Patricia Davidson, a cardiologist at Washington Hospital Center. For a doctor to employ this type of treatment, the practitioner would have to ask a patient, "How much African American blood do you have" in you? she said. "We have to be very careful with that."
Like some other critics, she also expressed worry that approving and marketing a drug to one group only could hurt other patients who might have benefited from the same treatment. A lack of data about a drug's effects on the wider population could leave doctors without sufficient guidance on whether to broaden its use.
NitroMed, the Massachusetts-based company that made BiDil and funded the trial, plans to apply for Food and Drug Administration (FDA) approval by the end of the year, said Manuel Worcel, the company's chief medical officer. It hopes for approval sometime in 2005.
Heart failure, a condition in which the heart loses the ability to pump enough blood through the body, is often associated with coronary artery disease, high blood pressure and diabetes, according to the National Heart, Lung, and Blood Institute. Of the roughly 5 million people nationwide who had heart failure in 2001 -- the most recent year for which data is available, said Cohn, some 1 million were black. In 2001, about 9 percent of the 52,828 people for whom heart failure was listed as the primary cause of death were black, according to the American Heart Association.
BiDil is a combination of two drugs -- hydralazine and isosorbide dinitrate (also known as nitroglycerin) -- that have been available for decades in generic forms.
Hydralazine, often used to treat hypertension in the 1960s, went out of favor with the development of newer, more profitable drugs, such as ACE inhibitors and beta blockers.