BiDil for heart failure in black patients: The U.S. Food and Drug Administration perspective.
نویسندگان
چکیده
Critics of the U.S. Food and Drug Administration (FDA) approval of the fixed combination of hydralazine hydrochloride, 37.5 mg, and isosorbide dinitrate, 20 mg, for treating heart failure in black patients have suggested that data were insufficient to distinguish treatment effects in black and white people; that distinctions based on race, rather than pathophysiology, were scientifically unreasonable; and that a "race-based" approval could be a commercial ploy to avoid a more expensive and prolonged full evaluation of a drug. The criticisms acknowledge that data supporting the approval came from a well-designed clinical trial in which self-identified black patients with heart failure who took hydralazine hydrochloride-isosorbide dinitrate with standard therapy experienced a statistically significant 43% (95% CI, 11% to 63%) reduction in mortality compared with those who took only the standard therapy. The criticisms do not always recognize that the decision to conduct the trial in only black patients reflected careful analyses of 2 previous trials in racially mixed patient populations that compared hydralazine hydrochloride-isosorbide dinitrate with placebo or with enalapril. Both trials showed little or no overall effect of hydralazine hydrochloride-isosorbide dinitrate in the mostly white patient population but hinted at a substantial effect in subsets of black patients. Perhaps most critically, the criticisms do not appreciate the urgency of strong scientific evidence of a substantial survival benefit in black patients. A serious attempt to avoid race-based approval by mandating study of a mixed population to identify a possible white patient-responder subset, particularly without a plausible hypothesis as to what that subset might be, would have required years of work, many thousands of patients, and wholly unreasonable delay in approval of a treatment whose effectiveness had been well-documented in the group for which it was intended.
منابع مشابه
From disparity to difference: how race-specific medicines may undermine policies to address inequalities in health care.
On June 23, 2005, the U.S. Food and Drug Administration (“FDA”) formally approved the heart failure drug BiDil to treat heart failure in “selfidentified black patients.” The drug itself is not actually new; it is merely a combination of two generic drugs that have been used to treat heart failure for over a decade. BiDil's newness derives primarily from its public presentation as the world's fi...
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In 2005, the combination of hydralazine hydrochloride and isosorbide dinitrate was approved by the U.S. Food and Drug Administration (FDA) for treating heart failure in black patients. In departing from its long history of approving drugs for general clinical indications without regard to demographic classification, the FDA cited the need to address racial disparities in health as an important ...
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In June 2005, the Food and Drug Administration (FDA) announced a historic decision: it approved the first pharmaceutical indicated for a specific race.1 BiDil, a combination drug that relaxes the blood vessels, was authorized to treat heart failure in self-identified black patients. BiDil had been tested in the African-American Heart Failure Trial (A-HeFT) launched in 2001.2 A-HeFT enrolled 1,0...
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Two years ago, on June 23, 2005, the U.S. Food and Drug Administration approved the first “ethnic” drug. Called BiDil (pronounced “bye-dill”), it was intended to treat congestive heart failure—the progressive weakening of the heart muscle to the point where it can no longer pump blood efficiently—in African-Americans only. The approval was widely declared to be a significant step toward a new e...
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A drug called BiDil is poised to become the first pharmaceutical ever approved by the U.S. Food and Drug Administration (FDA) to treat heart failure specifically in African Americans—and only African Americans. On March 8, 2001, NitroMed, then a privately held biotech firm in Massachusetts, issued a press release triumphantly announcing the receipt of a letter from the FDA “describing the regul...
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ورودعنوان ژورنال:
- Annals of internal medicine
دوره 146 1 شماره
صفحات -
تاریخ انتشار 2007