Licensing of 'ethnic' heart drug triggers debate

The US Food and Drug Administration (FDA) has approved the first ever drug targeted specifically at one ethnic group, a heart failure treatment called BiDil. The medicine, actually two existing drugs combined in a single pill, is apparently most effective in African Americans. The FDA approved the drug last week, calling the move a step towards 'the promise of personalised medicine'. However, critics say that there is no biological base for 'race', and basing medical decisions on racial categories is simplistic.

Researchers at the Minnesota-based firm NitroMed halted a clinical trial for BiDil last year, because the evidence for the drug's effectiveness was 'so compelling' that the scientists felt it was unethical to withhold the drug from the participants being given a placebo. All of those taking part in the trial were black, and BiDil - a combination of isosorbide dinitrate and hydralazine - is now the first medicine marketed for a specific ethnic group to be licensed by the FDA. The drug's approval is a 'striking example of how a treatment can benefit some patients even if it does not help all patients', said Robert Temple of the FDA. However, US health policy expert Maxwell Gregg Bloche, of Georgetown University, says that the decision 'invites people to think there are significant biological distinctions between racial groups when in fact the evidence shows nothing of the sort'.

BiDil was originally rejected by the FDA, since it did not help patients in an earlier trial live any longer. But in the trial with solely African American participants, the drug decreased the risk of death by 43 per cent. The FDA's approval of BiDil represents a boost for the science of pharmacogenomics - the development of drugs targeted to different patient groups, based on their genetic make-up. This approach is based on the knowledge that people react to drugs differently, partly because of underlying genetic variation.

Francis Collins, the director of the National Human Genome Research Institute told the journal Nature that BiDil's effectiveness is 'something to celebrate'. However, he also says that 'we should move without delay from blurry and potentially misleading surrogates for drug response, such as race, to the more specific causes'. He is wary of using the 'biologically inaccurate and socially dangerous' concept of race in place of more research into the genetic and environmental factors that influence drug response differences. He points out that even if blacks respond better on average to BiDil than whites, the drug will still be ineffective in some, and there could also be a minority of whites who would benefit from taking it.