A Bitter Pill for Black Hearts

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.

Past experience indicates that BiDil shouldn't be greeted as a health care panacea for anyone. It should be treated like all newly approved pharmaceuticals, with great caution if not suspicion. As Raymond Woosley, vice president for Health Sciences at the University of Arizona, advised Public Television, "Americans need to recognize that every time they put a pill in their mouth, especially a new pill that they've never taken before, it's an experiment. How big an experiment depends on the pill and how well it's been studied."

NitroMed is using black people to get a drug approved that it couldn't get approved otherwise and in the process maintaining a patent that keeps cheaper generics off the market until the year 2020. "[I]f BiDil is approved for African Americans only, the drug will have patent protection to 2020," wrote Motley Fool biotechnology industry analyst Karl Thiel. "That's because patents based on this demographic were filed after studies showed the drug was ineffective in a broader population. If the drug is approved for a general heart failure audience, older use patents will apply and the drug would appear to have exclusivity only to 2007."