Nitromed heart drug designed for blacks wins U.S. approval

Jun 26 2005

A new heart drug designed specifically for blacks has been approved by U.S. officials.

The heart-failure treatment is expected to sharply reduce deaths among the black population.

In a study run by the drug company Nitromed Inc. it was found that their drug BiDil cut deaths by 43 percent.

Controversy erupted earlier over the company's marketing strategy with critics complaining it was race generated.

Dr. Robert Temple, the Food and Drug Administration's associate director of medical policy, says that the trial of 1,050 people clearly demonstrated that blacks suffering from heart failure now have an additional safe and effective option for treating their condition.

Temple adds that in the future, they hope to discover characteristics that identify people of other races who might be helped by BiDil.

The FDA's approval for the drug specifically for blacks benefits Nitromed because the company holds patent rights for that use until 2020.

The patent for BiDil for general use expires in 2007, a fact that has prompted criticism.

Jonathan Kahn, a law professor and ethicist at Hamline University in Minnesota who has studied BiDil's development, says the approval of BiDil is not about personalizing medicine but more about exploiting race to make money by extending patent protection.

While Kahn and other critics argue that BiDil should be approved for all patients, regardless of race, because there is no biological reason blacks should react differently than others, Nitromed officials are insisting their efforts are based on solid science and will address a major public health problem.

Studies have found that African-Americans are more likely than others to develop heart failure and to die early from the disease.

Dr. Anne Taylor, a NitroMed consultant and lead researcher on the BiDil study, says that FDA approval of BiDil represents an important leap forward in addressing that health disparity.

Company officials have said that future research may yet identify a genetic variation in people of different races that indicates a good outcome from BiDil.

The drug which is a combination of two generic medicines, isosorbide dinitrate and hydralazine, which dilate blood vessels and was designed to treat congestive heart failure, a progressive weakening that impairs the heart's ability to pump.

According to NitroMed, 750,000 African-Americans have been diagnosed with heart failure, and half die within five years of diagnosis.

In tests of BiDil in the 1980s a benefit for patients overall was not shown but the researchers said blacks had better results than others.

Following that, Nitromed and the Association of Black Cardiologists then studied 1,050 advanced heart failure patients who identified themselves as black, and gave them standard drug therapy plus either BiDil or a placebo.

Deaths appeared so much lower in the BiDil group that researchers ended the study early so all patients could take BiDil.

Fifty-four patients, or 10.2 percent, died in the placebo group, compared with 32 deaths, or 6.2 percent, in the BiDil group.

Hospitalizations from heart failure also were reduced.

Even with an approval for blacks only, doctors could prescribe BiDil for anyone they thought it might help.

BiDil is the first drug to reach the market for Lexington, Massachusetts-based Nitromed.