A Bitter Pill for Black Hearts

By Margaret Kimberly, The Black Commentator. Posted June 28, 2005.

It is hard to oppose an effort that purports to improve health care for African Americans. Black people suffer more from everything bad, including ill health. When a drug company announced that it would market a heart failure treatment specifically for use by blacks, the silence from otherwise thoughtful persons and organizations was noticeable but not very surprising.

In 1997 the federal Food and Drug Administration declined to approve BiDil, a treatment for heart failure. BiDil is actually a combination of two generic drugs used to treat chest pain and hypertension. The FDA concluded that there was no proof of BiDil's effectiveness. That should have been the end of BiDil, until good old-fashioned capitalism and marketing turned its fortunes around.

BiDil has now been approved for use in black heart failure patients. It is the first drug in America that has been approved specifically for the use of one racial or ethnic group. NitroMed, the pharmaceutical company that will produce BiDil, acted very shrewdly. The drug maker achieved this success by giving the heads up to black leadership, lest it be accused of recreating the infamous Tuskegee experiment.

NitroMed first went to the Congressional Black Caucus, the National Medical Association and the NAACP. The drug company was "aware of the political fallout if they did not have African American participation," said B. Waine Kong, executive director of the Association of Black Cardiologists. Too bad the participants didn't ask a question or two in the process.

We are told that BiDil showed great success in black patients. That doesn't mean very much because it was only tested on black patients. There is literally no evidence that the drug works better on one racial group than on another.

NitroMed did what other pharmaceutical companies have always done. It gave money to people who later gave its medication the thumbs up. The Association of Black Cardiologists co-sponsored the clinical trials for BiDil, received $200,000 from NitroMed, and enthusiastically supported the drug's approval.

That arrangement wasn't unusual. In July 2004 the National Institutes of Health published a study urging millions of Americans to take statin drugs in order to lower their risk of heart disease. It was later revealed that eight of nine authors of the study had financial ties to makers of statin drugs. The ties were not made public when the dubious findings were first announced.

No one knows if BiDil is very effective or safe. If it isn't it will not be different from other drugs given FDA approval that were later discovered to be dangerous. Fenfluramine was marketed as Redux, a drug used to treat obesity. It was taken off the market after causing cases of heart valve damage and pulmonary hypertension. How many commercials exhorted consumes to ask their doctors about Vioxx and Celebrex? We now see commercials from law firms exhorting us to pursue malpractice suits against the makers of those drugs.

Margaret Kimberley is a freelance writer living in New York City. She also maintains the Freedom Rider blog.

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