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.
"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...
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."
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.
My published articles are archived at iSteve.com -- Steve Sailer
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