NYT. I think this is a stupid editorial. As for the bolded part - why the hell not?
The First Race-Based Medicine
Published: June 19, 2005
With the unanimous endorsement of an expert advisory committee last week, a heart-failure drug aimed specifically at African-Americans moved a big step closer to regulatory approval. If the Food and Drug Administration gives a favorable nod, the drug, known as BiDil, will become the first medicine ever approved for a single racial group. Its arrival could be a boon to black patients, who die at disproportionate rates from congestive heart failure. But the history of this first racial medicine raises troubling questions about the impact of patent considerations on how drugs are tested.
The new treatment, a combination of two generic drugs, was first tested years ago in a broad sampling of patients. The results were deemed inconclusive by the F.D.A., and the drug was rejected for use in the general population. Subsequently, seizing on data indicating that blacks in those early studies had been helped by the treatment, proponents conducted further tests exclusively in self-described African-Americans. The results were so striking - a 43 percent reduction in mortality when the pill was added to standard therapies - that the clinical trial was halted early to allow those on a placebo to benefit.
The drug has been enthusiastically endorsed by black medical groups as a tool to help lessen disparities in health care between blacks and whites. The chief caveat is that race is a very crude category upon which to base medical treatments. Two experts on the panel that recommended approval resisted the notion that the drug should be labeled specifically for African-Americans. The panel's chairman justified race as a rough surrogate for underlying genetic factors that might make some people responsive to the drug and others less so.
What makes the history of this drug troubling is the role played by economic considerations in shaping its conversion to a racial medicine. Some experts believe that even after the first failures in clinical trials, it would have been possible to devise a better study to test the drug in a broad population, not just a single racial group. But the drug's maker, NitroMed, a small Massachusetts company, flinched from that arduous and costly process and opted instead to pursue a narrower market. The patent issue was especially potent. If BiDil were approved for the general public, its patent would expire as scheduled in 2007. Approval as a racially targeted drug would extend patent protection until 2020.
The danger here is that as other drugs emerge with better results in one racial group or another, some manufacturers may be tempted to qualify them as racial medicines rather than broader-based therapies. Once a drug has been approved for marketing, even based on narrow studies, doctors are free to prescribe it as they see fit. But they could be prescribing in the dark if no one has tested safety and effectiveness in the general population. Regulators need to find some way to ensure that drugs of potential value to everyone are tested broadly. |
