[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

    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

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