Landmark Ruling by the FDA Provides Hope for African-Americans Diagnosed with Heart Failure
- Created on December 12th, 2005
BiDil is the first race–specific drug ever to be approved by the FDA.
The FDA’s approval of BiDil for treatment of heart failure in Blacks marked the first time the agency has accepted a drug for use in people of a specific race. The approval represents a major step in the direction of medicines targeted at particular ethnic groups.
There are an estimated 750,000 Blacks living with end stage cardiovascular disease. Studies have shown that African–Americans between the ages of 45 and 64 are 2.5 times more likely to die prematurely from heart failure than their non–black counterparts. In addition, Blacks diagnosed with heart failure tend to die at an earlier age, 50% of which die within five years of their diagnosis.
The reasons why African–Americans are prone to heart failure is still being debated on the grounds of environmental and socio–economical effects such as poverty and racism, which lead to hypertension – a major contributor to heart failure. From a biological standpoint, research studies point to a compound in the body known as nitric oxide that causes veins and arteries to dilate properly and promotes a smooth blood flow throughout the body. Science has also proven that African–Americans tend to be nitric oxide deficient. BiDil, a combination of hydralizine and isosorbide dinitrate, alleviates the effects of that deficiency in Blacks.
The incidental discovery that BiDil is more effective in African–Americans than in whites raises questions about the inclusion of African–Americans in clinical trials. In the 1980’s two clinical trials were conducted in the general population of heart failure patients using a combination of the drugs hydralizine and isosorbide dinitrate. The results of the trial showed no statistical evidence that the compound was of benefit and was disapproved by the FDA. However, only 1% of the test populations were Black. Several years ago, the findings within the Black populations were reviewed and led to the creation of the African–American Heart Failure Trial (A–HeFT).
A–HeFT was the first major clinical trial to test the effectiveness of a heart failure medication in a targeted population. The trial consisted of 1,050 Black patients at 170 locations around the country, including Meharry Medical College in Nashville, the nation’s largest private, independent historically Black medical school. The results of the study showed a staggering 43% reduction in the death rate of patients taking BiDil. This reduction can be attributed in part to the fact that BiDil is a nitric oxide donor which raises the level of the compound in the body. Since Black people tend to be nitric oxide deficient, BiDil has a more profound impact on their body’s chemistry.
The subsequent FDA approval of BiDil validates the idea that certain medicines can prove more effective in one specific race based on biological differences. The significance of this ruling will impact the way clinical trials are conducted, but more importantly will allow grandparents diagnose with heart failure the opportunity to enjoy their grandchildren.