Playing the Race Card

This is a complicated story, which is difficult to summarize, especially for those who aren't already pharmaceutical policy wonks, but I'll do my best. Pamela Sankar and Jonathan Kahn at Health Affairs tell it in all its horrifying glory.

As readers know, I am very concerned about health disparities, and I believe that health equity is a positive message that progressive activists and political candidates can get behind successfully. But it is the opposite of progress for people to start to claim that disparities are based on biological differences among the "races." Unfortunately, there is a vested interest in the race concept, and it's not just among white supremacists -- it's among people who use race (rather than ethnicity, discrimination, labeling, culture, poverty, and most to the point, racism)as their personal meal ticket. And you know who you are.

Okay. In June the FDA granted approval to a formulation called BiDil, specifically as a treatment for heart failure in African Americans. Note that African Americans are people who belong to an ethnic group -- they are not a "race." Some African Americans have more European than African ancestry. Some people in the U.S. who have predominantly African ancestry are not African American. How could this happen?

It turns out that many years ago, two generic drugs called hydralazine and isosorbide dinitrate, hereafter H/I, when used in combination, were found to be very beneficial to patients with heart failure. So they were combined into a single pill called BiDil. Then, drugs called ACE inhibitors turned out to be even more effective. BiDil is still patented, but the patent runs out in 2007. Meanwhile, there's nothing to stop generic manufacturers from marketing the two components separately. Also, the FDA had not approved BiDil (a separate step from a patent), so the patent wasn't worth anything. That's basically because the original trials weren't intended to win new drug approval, and didn't have good enough design for that purpose. (The generics didn't need approval, and there was no sense getting approval for the combined pill.)

Then, the original developer analyzed the old data by race and noticed that the 49 Black subjects on H/I seemed to do better than white subjects. Given such a small number, this could easily have been a coincidence, but it gave the developer an opening to get a new patent to use H/I specifically to treat heart failure in African American patients, and then get funding for a clinical trial for BiDil (the two drugs in a single pill), as an adjunct to the standard ACE inhibitor therapy in African American patients. Mirabile dictu, it worked. The combination of BiDil and ACE inhibitors was better than ACE inhibitors alone. So now the company, NitroMed, has applied for new drug approval, which will be good till 2020, to market BiDil specifically for African American patients.

Got all that? Sorry, go back and read it again if you have to. The point is, it probably works just as well for everybody. There is absolutely no reason to believe that it is especially efficacious for black patients, or that it won't work just fine for everybody else. But the manufacturers couldn't have gotten a monopoly on that basis. And it will cost almost $11/day, compared with a little over a buck for the two generics. Since doctors know that it really works for everybody, NitroMed hopes they'll prescribe it off label for non-Black patients (wink wink), and they'll make a fortune, but they can only market it to Black people.

As your mind boggles, consider this:

The financial incentives for drug research and development are completely dysfunctional. What companies are compelled to do to make money has little to do with rational inquiry that will benefit our health.

This sordid story means that the bogus, pseudo-scientific concept of "race" will be reified, not only in FDA policy, in a mass marketing campaign to sell pills.

Meanwhile, the research to prove that H/I is beneficial to everyone, when added to ACE inhibitors, could have been done -- but it wasn't because nobody would make a fortune off of that information. All it would have done is save lives.