[Paleopsych] NYT Editorial: The First Race-Based Medicine
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Wed Jun 22 19:38:20 UTC 2005
The First Race-Based Medicine
http://www.nytimes.com/2005/06/19/opinion/19sun2.html
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.
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