Dr. Yancy's and NitroMed's responses makes several unexceptionable observations about the nature of heart failure and the value of providing BiDil as an adjunctive therapy to help reduce mortality from this debilitating and ultimately fatal disease. In this we find ourselves in agreement. Our primary area of disagreement is my conclusion that doctors should consider prescribing BiDil (or its generic equivalents) to everybody, regardless of their race. I fail to see how it is a "misguided passion" or "negative rhetoric" to argue that more, not fewer, patients should have this therapy be made available to them.
Yancy argues that this issue is not black and white but has many shades of gray. Certainly, I agree. But he then characterizes my argument as challenging BiDil "more as a commercial advantage for a pharmaceutical company rather than as a breakthrough in medical science." This either/or approach to the relation between commerce and science wholly misses the point. Of course BiDil is a breakthrough in medical science. Of course it saves lives. These are good things. Moreover, there is nothing inherently wrong in designing a trial to develop a drug that makes money. That is how most drug development works. The problem comes when you skew your interpretation of the results to fit your commercial interests. Arguing that BiDil should be approved for African-Americans simply because the trial included only African-Americans is one such skewed interpretation.
Despite all the discussion of the importance of treating heart failure or the early results of post hoc genetic analyses, Yancy and NitroMed never really address the basic question of why the A-HeFT trial was designed to include only African Americans and why they sought race-specific FDA approval for BiDil. They point to the trials V-HeFT I & II, but the FDA found that only V-HeFT I showed any racial difference in response to the generics that make up BiDil. Following this "signal" from 15-year-old data on the 49 African-Americans who were on the BiDil combination in V-HeFT I is a slender reed indeed upon which to balance the design and implementation of a multimillion dollar clinical trial. Far stouter support, it seems to me, was provided by NitroMed's race-specific patent without which NitroMed's effective monopoly over BiDil would expire this year..
Yancy asserts that "none of us are comfortable with race as a descriptor of drug efficacy." This is passing strange. If Yancy and NitroMed are not comfortable with using race in this way, then why did the company apply for the race-specific patent prior to designing the race-specific clinical trial that led to their petition for race-specific drug approval? If the cardiologist Jay Cohn, the original holder of the BiDil patents, says that BiDil should work for people regardless of race, why can't Dr. Yancy and NitroMed say the same thing?
