NCPA - National Center for Policy Analysis


July 27, 2005

The Food and Drug Administration (FDA) has approved the first medicine that is targeted to a specific racial group. NitroMed's BiDil is a heart medication that has been found to increase nitric oxide levels among black heart-failure patients, says Long Island Newsday.

According to the U.S. Centers for Disease Control:

  • An estimated 750,000 American blacks suffer from hearth failure, which occurs when the heart is too weak to pump effectively.
  • Half the patients die within five years of diagnosis.
  • Middle-aged black men are more than twice as likely as whites of the same age range to die from the condition.

BiDil was developed in the 1970s when it was discovered that when combined with medications that treat heart pain and high blood pressure, nitric oxide levels in patients could be increased. Further trials confirmed that hypothesis and a 1995 study specifically examined BiDil's effects on blacks, since black hearth-failure patients suffer from a greater nitric oxide deficiency.

Recently, an FDA trial was stopped prematurely when it found a 43 percent reduction in deaths among patients taking BiDil. Usage of the drug was promptly approved, but the race-specific clinical trial has generated anxiety among medical professionals.

  • The issue has medical ethicists questioning whether doctors might inappropriately consider race in treating patients.
  • Some worry that prescribing the drug specifically for black patients may ignore the genetic variations among blacks, which can be greater than other groups.
  • Additionally, critics worry about how developers of drugs like BiDil will decide which genetic traits to target.

In response to these concerns, NitroMed is examining genetic commonalities among blacks who benefit from BiDil, and if that review reveals a nonracial characteristic link to effectiveness, further studies could lead to an approval for use in all races, concludes Newsday.

Source: Mark Jewell, "Racially Based Heart Drug Prompts Warning," Long Island Newsday, July 14, 2005.


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