The US Food and Drug Administration is expected to approve a drug specifically designed for African-Americans, after a study showed that it mainly helps them
Stephanie Saul New York Times, Haaretz, Walla News
At the end of a discussion that dealt with the relationship between race, genetics and medicine, an advisory team of the US Food and Drug Administration (FDA) recommended that a drug for heart failure be approved specifically for African Americans.
The Food and Drug Administration usually acts according to the recommendations of the advisory teams. This means that the drug, BiDil, is likely to be the first treatment to be marketed exclusively to one racial group. The final approval of the drug by the FDA should be received this week.
The recommendation of the advisory team, which was accepted unanimously, was given despite the doubts of two members of the team, who said that they were concerned about the transition to the production of drugs intended for a certain breed without a solid scientific basis.
Dr. Vivian Ota Wang, a geneticist from the National Institutes of Health who was a member of the advisory team, said that race is a "social and political construct." "The implication of the decision is that we are using race as a surrogate for the biological process," said Dr. Wang. "I think this gives us a false sense that race has a biological basis, when in fact there is no proof of this."
Wang supported the approval of the drug, but stressed that she believes it should be accessible to people of all races. On the other hand, Dr. Steven Nissen, a cardiologist at the "Cleveland Clinic" who served as the chairman of the panel, said that in his opinion the decision is in line with the desire to help patients.
In 1997, the Food and Drug Administration did not approve the use of the drug for all patients, after two clinical trials did not show a significant statistical advantage between the subjects who received the drug and the control group. In an experiment done last year, funded by the manufacturer, the NitroMed company, 1,050 patients of African-American origin who suffer from heart failure participated. The results of the experiment were unequivocal: the mortality rate among the subjects who received the drug was 43% lower compared to a control group that received a placebo drug.
The advisory team's vote (eight in favor, not even one against) was a victory for NitroMed, a new pharmaceutical company from Lexington, Massachusetts, and for the drug's developer, Dr. Jay Kuhn, a cardiologist from the University of Minnesota.
Advertisement The vote was held after a public debate in which representatives of several African-American organizations claimed that the drug BiDil might contribute to reducing the gap in the quality of medical care provided to blacks and whites in the US.
However, some speakers claimed that the use of the drug should also be approved for members of other races. Dr. Charles Corey, head of the cardiology department at Howard University, where most of the professors and students are African-American, gave as an example a study that tested whether it was possible to lower the cholesterol level in the blood with the help of statin drugs. Only patients of Scandinavian origin participated in the study, but its results were the basis for widespread use of these drugs.
BiDil is a combination of the drugs hydralazine and isosorbide dinitrate; It causes blood vessels to dilate, which helps the heart function.
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