The Billiken's Bluff

NitroMed Inc. is seeking FDA approval for their drug BiDil which helps fight heart disease by increasing levels of nitric oxide, which widens blood vessels. I just ate a Wendy's Bacon Cheeseburger so this BiDil sounds like a good solution to some potential clogged arteries I might be facing down the road. Too bad I'm white...

NitroMed studied the effects of BiDil on 1,050 African-American heart failure patients. The study showed that the drug significantly reduced death and hospitalization.

So far, so good. Researchers know that different people have different responses to medications, and in some cases these have been linked to race. The F.D.A., for example, has said that people of Asian ancestry are more likely than others to get serious side effects from the cholesterol-lowering drug Crestor.

However, NitroMed did not test BiDil on even a SINGLE non-black individual. Dr. Joshua Hare, a cardiologist at the Johns Hopkins University Medical Center realizes that this is troublesome.

"My criticism of the African-American Heart Failure Study is that they only studied African-Americans. To really test the hypothesis is to study both populations and then show, aha, the African-Americans did respond better. They didn't do that."

I'm not very knowledgeable about the challenges, both financial and logistical, that pharmaceutical companies face during the clinical trial stage of drug development, however, it seems to this blogger that if you are going to make a claim that a new drug that helps fight heart disease works only on ONE race of individuals (in this case African Americans), then you should probably have included some test subjects who WERE NOT African American in the clinical trial!!!

Isn't that the most basic element of a scientific experiment, having a TEST GROUP to TEST your results against?

In NitroMed's defense, Dr. Loberg said it would have been daunting and prohibitively expensive for a small company to conduct such broad trials. "It doesn't mean that others won't benefit as well," he said. "We just haven't identified who those others might be."

So rather than perform the exhaustive research that I assumed went into clinical drug research, NitroMed instead comes to a dubious conclusion that Dr. Hare thinks may very well prove to be incorrect:

"I don't believe for a second that this drug combination is only going to prove to be beneficial in African-Americans; it's just not conceivable," said Dr. Hare.

NitroMed didn't have enough finances to perform a thorough experiment; however they did scrounge up $200,000 to pay Dr. B. Waine Kong the director of the Association of Black Cardiologists to work with them on the clinical testing. Dr. Kong elaborates:

"By the time they got to us, they had made presentations to the Congressional Black Caucus and the N.A.A.C.P.," said B. Waine Kong, the cardiologist group's executive director. "I'm sure they were aware of the political fallout if they did not have African-American participation. And that was a wise decision."

It looks like NitroMed should not only reconsider their BiDil Pill, they should reconsider the business they are in entirely. Rather than developing medicine, maybe they should open a consulting group that lobbies on Capitol Hill.