Glenn Howatt, Star Tribune
June 16, 2005
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.
NitroMed Inc. of Lexington, Mass., is the drug's manufacturer. Its publicly traded stock price has soared on news of the drug's effectiveness. Stock analysts have predicted that if approved, the drug would be successful for the company because blacks have a higher rate of heart failure than whites.
BiDil is a combination of two generic drugs that have been used for decades to treat chest pain and high blood pressure. The drug combo is easier to administer than separate generic pills.
Developed by Cohn 30 years ago, the drug was turned down by the FDA. NitroMed took up the drug after Cohn discovered that it tended to work better in blacks in the studies he had conducted.
But still, no research study has proved that the racial differences affect the drug's performance.
Jonathan Kahn, a law professor at Hamline University in St. Paul, has criticized the effort to repackage BiDil along racial lines.
"BiDil did not begin as an ethnic drug," he wrote in a critique in the Yale Journal of Health Policy, Law and Ethics last year. It only became one because it failed to win wider approval, he said.
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.
Glenn Howatt is at howatt@startribune.com.
Posted by gruwell at June 16, 2005 4:26 AM | TrackBack