Posted on June 16, 2005

Heart Pill For Blacks Nears FDA Approval

Glenn Howatt, Minneapolis Star Tribune, June 16

A heart drug developed by Minnesota researchers appears headed for approval by federal regulators as the country’s first race-based medicine.

Food and Drug Administration staff members Wednesday recommended that BiDil be approved as a heart medicine for black patients.

Critics say the race designation is a marketing ploy because there’s scant scientific evidence that the drug is a better treatment for blacks compared to whites.

The drug was originally developed by Dr. Jay Cohn, a cardiologist at the University of Minnesota. Recent research showing promising results in blacks was led by a colleague, Dr. Anne Taylor, a heart specialist and associate dean of the university medical school.

In that study, BiDil increased survival rates and improved quality of life for 1,050 black patients with heart failure, which is a slow deterioration of the heart. The drug cut the rate of hospitalization by about one-third, according to results released last November.


Critics contend that FDA approval would reinforce disproved beliefs of significant genetic differences between the races.

If the medicine is approved, doctors would be free to prescribe it regardless of a patient’s race. Indeed, drug founder Cohn has used the drug for patients of all races.

An FDA advisory panel will meet today to review the drug and is expected to issue a final recommendation by week.