A new heart drug that has significant positive effects for only African Americans has been put on the fast track for Federal Drug Administration (FDA) approval, after test results were released Monday, Nov. 8, at a meeting of the American Heart Association in New Orleans.

The drug, called BiDil, is manufactured by Mass. based NitroMed inc. and will be the first ever drug labeled and marketed for a specific racial group, according to the FDA.
After receiving a patent for the drug in late August, NitroMed submitted drug trial data to the FDA that will set launch time for the new drug in early 2005.

The original study in the 1980s did not focus on one specific race, but after analyzing the data, principal researcher Dr. Jay Cohn of the University of Minnesota discovered that the drug reduced heart failure significantly in African Americans.

A second test trial confirmed the benefits of the new drug in African Americans. Over two years, BiDil reduced the death rate in African American patients from 10.2 percent to 6.2 percent and reduced hospitalizations from 24.4 percent to 16.4 percent.

With the drug, African Americans had a 43 percent better survival rate. The second trial of the drug was halted before it could be completed so test subjects receiving a placebo could be given the medication.

“If its effective and I believe it should be released,” said De'George Griffin, 20, an African American student at SF State. Griffin said that if BiDil worked mostly for whites, there would probably be no controversy.

BiDil is a combination of the generic drug isosorbide dinitrate, which stimulates production of nitric oxide in the body and is beneficial to the heart, along with Hydralazine, which is used in the treatment of high blood pressure. Combined, the two drugs work better than traditional heart treatment medications in African Americans.

Recent controversy surrounding the drug, centers on the racial aspects of treatment and marketing.

Because the drug has real benefits, it is likely to be approved by the FDA, Dr. M. Gregg Bloche of Johns Hopkins University wrote in an editorial in the New England Journal of Medicine.

But because the drug is beneficial only to African Americans and will be labeled as an African American only drug marketed strictly to that race, it is a potential problem in colorblind medical treatment, Bloche also wrote.

Not releasing the drug because of its racial selectivity would have drawbacks as well. In 2003, a potential AIDS vaccine called AIDSVAX failed in drug trials in all groups except African Americans. When the report was released, there was outcry from the black community to continue the trials for Blacks, who have been hit hard by the AIDS epidemic all over the world.

“Our country has this kind of favoritism,” said Griffin. “They market fashion to African Americans, why not drugs as well?”