Company seeks to sell heart drug to blacks only
Date: Monday, June 20 @ 00:42:38 MST
Topic: Black Habits Articles
A drug company should be able to market a heart failure drug to blacks only, an advisory panel to the U.S. Food and Drug Administration recommended on Thursday.
The panel weighed the contentious issue of whether to approve what could be the first drug therapy intended for a specific race.
The drug, known as BiDil, treats heart failure by elevating levels of nitric oxide, which is important to the health of heart and blood vessels.
Consultants for manufacturer NitroMed. Inc. told the nine panelists that the company wants to sell BiDil only to blacks, saying a study in the 1980s showed blacks fared better on the drug than other races.
Deaths among those who took the drug were also lower in a follow-up study on 1,050 people with heart failure who identified themselves as black. Participants were given standard drugs and BiDil or a placebo.
Critics charged the approach smacks of race-based medicine.
"I would not use race except perhaps in the most extreme of cir*****stances to dictate the kind of therapy that one would give," said Dr. Jonathan Howlett, a cardiologist in Halifax.
Dr. Jay Cohn, who holds a patent on the drug, has a theory on why BiDil seems to work for one race but not others.
"It is a nitric oxide enhancer," said Cohn, of the University of Minnesota. "The evidence that has grown over this last decade suggests that African-Americans have less nitric oxide in their body."
Others consider Cohn's explanation to be overly simplistic, noting since BiDil was tested only on African-Americans, the company can't say whether it works in other populations.
"There is, as far as I know, no biological rationale why BiDil should have a better effect in African-Americans compared to the other groups," said Dr. Salim Yusuf of the Population Health Research Institute in Hamilton, Ont. "The construct of race is almost certainly spurious and misleading," he added.
Although there are diseases that occur more often among some races, such as sickle cell anemia in blacks or Tay-Sachs in Ashkenazi Jews, these are genetic, not racial disorders. The diseases aren't exclusive to one race.
"If we can find a way to identify a population that will respond to a drug with a favourable effect on survival and quality of life and keep them out of the hospital, I'm all for that," countered Cohn.
Scientists are working on ways to develop genetic tests to target therapies to each patient. Someday, experts said, the tests could make issues like gender and race irrelevant in medicine.
All nine panelists recommended the FDA approve BiDil, but two said the label should not be race-specific.
The FDA, which usually follows the recommendations of its advisory panel, will now decide whether to approve sales of the drug.
Last Updated Thu, 16 Jun 2005 21:47:07 EDT