Drug Trial to Study Blacks Only

If you're black and suffer from heart failure, you've probably heard the bad news. Blacks are twice as likely as whites to suffer from the disease and twice as likely to die from it.

Particularly confounding for doctors, blacks don't respond as well to popular heart drugs that are more effective in white patients.

Soon, though, that could all change. The Food and Drug Administration has given the go-ahead for Massachusetts-based NitroMed to begin final testing of a drug designed to treat black patients with heart failure, a disorder in which the organ loses its ability to pump blood efficiently.

The drug, BiDil, is believed to be the first government-approved medication that will be developed and marketed specifically for a racial group.

In a field generally characterized by a one-drug-fits-all approach, BiDil marks the beginning of what scientists say is a new era: tailoring medications to individuals. (see sidebar)

The upcoming clinical trial to test BiDil, which will include only African-Americans, is a milestone. Historically, prescription drugs have been developed based on research on white males. Doctors have only started including women in clinical research in the last decade.

The Nitric Oxide Connection

"This whole area of medicine has blossomed with the understanding that not everyone benefits the same way — either to the same degree, or benefits at all — to the drugs we give," says Dr. James Young, medical director of the Kaufman Center for Heart Failure at the Cleveland Clinic Foundation.

Researchers don't completely understand why blacks don't respond as well to widely successful heart failure drugs, such as beta-blockers or ACE inhibitors.

One popular theory is that blacks may produce less nitric oxide in their bodies than Caucasians, explains cardiologist Dr. Jay Cohn of the University of Minnesota. Since the effectiveness of ACE inhibitors hinges on the production of nitric oxide, this could explain why blacks aren't responding as well to the drugs, Cohn said.

BiDil, a pill combining two long-established heart drugs, works by restoring depleted nitric oxide levels and protecting nitric oxide formed naturally in the body, according to NitroMed.

Someday, tests may exist allowing doctors to test patients for reduced nitric oxide. Until then, however, researchers say they are targeting African-Americans for BiDil because preliminary data suggests they respond to the drug combination.

Misleading Marketing?

Despite its groundbreaking significance, BiDil has some experts worried. If NitroMed starts bombarding blacks with ads, those patients and their doctors could ignore other potentially effective treatments, said Dr. Charles Curry, a cardiologist at Howard University Hospital in Washington, D.C.

Patients don't respond to medications in the same way, so marketing drugs by race can be misleading, Curry says. "Skin color is not necessarily a reflection of someone's blood vessels," he said.

For Paul Doering, a pharmacy professor at the University of Florida, the company's marketing strategy is disturbing.

BiDil is really no more than a combination of hydralazine and isosorbide, long used in patients who are allergic or non-responsive to other heart failure treatments, he said.

"To me, the only thing newsworthy about this is the company's apparent efforts to deceive," said Doering, co-director of the Drug Information and Pharmacy Resource Center.

An Addition, Not a Substitution

But Dr. Anne Taylor, the Bidil study's principal investigator, says the trial is necessary because earlier data on blacks and heart failure drugs were weak.

Further, she said, although the medications are already on the market, combining them into one pill could have benefits. "The fewer medications a patient needs to take, the more likely they are to take all of them," she said.

The trial, starting next month and lasting about a year, was developed in partnership with the Association of Black Cardiologists and will include 600 patients. All will continue using their existing medications.

Half will add BiDil to their regimen, and the other half will take a placebo.

For doctors, the BiDil research is a positive step toward treating patients according to their individual needs, Young said. "It will be very nice and very important in the end to figure out who responds to which drug and prescribe the drug they'll respond to," he said.