WASHINGTON — Now that the FDA has for the first time approved a drug specifically for blacks, medical experts are sure to debate the implications, with some questioning the validity of medical research that focuses on race.
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“There are many, many who claim these use of (racial) categories may not have any biological meaning, only social meaning, and basing medical decisions on them may be problematic,” said David Magnus, director of the Stanford Medical Center for Biomedical Ethics.
For example, Magnus said, researchers could also look at whether a particular drug worked more effectively on Catholics than Protestants. The more categories explored, the more likely one can find data showing that one category of people is helped more than the others when it comes to a particular medicine, he said.
“But the more we know genetically, the more we know these social categories don’t correspond to genetic groups,” Magnus said.
The Food and Drug Administration approved the drug BiDil on Thursday for the treatment of heart failure in black Americans, calling it a step toward “the promise of personalized medicine.”
While that approval may prompt debate, a rejection of BiDil likely would have also raised serious questions.
Data clearly showed that BiDil had a positive effect on a population disproportionately burdened by cardiovascular disease, said Dr. Anne Taylor of the University of Minnesota Medical School and a lead investigator in the research of BiDil.
“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,” she said. “FDA approval of BiDil represents an important leap forward in addressing this health disparity.”
43 percent reduction in deaths
FDA officials say that in the case of BiDil researchers did not start out looking for a drug that worked better for a particular racial group. Two earlier trials of the drug on the general population of heart failure patients found no benefit, the FDA said, but they did suggest that BiDil helped the few blacks participating.
Based on those results, NitroMed Inc. of Lexington, Mass., launched a study of 1,050 blacks with severe heart failure. Half of them got standard heart failure drugs and a placebo; the other half got standard drugs plus BiDil. The study showed a 43 percent reduction in deaths and a 39 percent decrease in hospitalizations compared with a placebo, and the study was stopped ahead of schedule last year when doctors saw BiDil clearly was better.
“The information presented to the FDA clearly showed that blacks suffering from heart failure will now have an additional safe and effective option for treating their condition,” said Dr. Robert Temple, the agency’s associate director of medical policy. “In the future, we hope to discover characteristics that identify people of any race who might be helped by BiDil.”
Heart failure occurs when the heart is too weak to pump effectively, causing fluid to back up in the lungs and leaving people weak and short of breath. Half die within five years of diagnosis. Heart failure, or end-stage cardiovascular disease, affects about 5 million Americans, including an estimated 750,000 blacks.
The National Medical Association, which promotes the interests of black physicians and patients in eliminating health disparities, applauded the FDA’s decision. The organization also encouraged the scientist involved in testing BiDil to conduct larger clinical trials to see whether it would be helpful to other populations.
“It is our hope that BiDil will be brought to market as quickly as possible to enhance its life saving impact,” said Dr. Winston Price, president of the National Medical Association. “Any day of delay represents an unacceptable missed opportunity to save lives.”
BiDil is a combination of two older drugs, hydralazine and isosorbide dinitrate, neither of which is approved for heart failure. Some common side effects of the drug are headache and dizziness. The company has yet to announce the price it will charge for the medicine.
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