BiDil Falters, Casting Doubts on Race-Based Medicine

About 2 years ago, NitroMed garnered a lot of publicity and a lot of debate when it won approval for BiDil, a heart failure drug for black people. On one side of the debate were people who thought that medicines that were closely targeted at specific populations could provide advances in healthcare. On the other side were those who argued that race is a poorly defined biological characteristic and that most race-based differences in population health are due to the environment.

Nitromed just reported its 1Q earnings and … they suck, to put it bluntly. The drug has had just $3.2 million in sales, according to analysts Friedman Billings Ramsey.

FBR’s analysis:

"The company continues to gain formulary acceptance for BiDil, but prescriptions, which peaked in October last year, have not demonstrated any meaningful improvement …"

"Management intends to add an additional 30 personnel to support its marketing effort during the next two quarters."

"At the end of 1Q07, the company had $32.5 million of cash, representing a decline of $9.5 million, compared with the end of 2006. At the current burn rate, NTMD has a little more than three quarters of cash remaining."

My opinion: Whether the science is there or not, without funding or demand it's not going forward. One possible factor is that the FDA approval was for "self-identified black patients." The problem with that is that  a lot of people turn out to be not as black -- or white, or whatever -- as they think they are when their DNA is examined. Nicholas Kristoff examined the issue in this NYT column, in which he revealed that despite thinking he was white, genetic testing reveals he has Ethiopian genes.

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IMO, the key BiDil problem is not self-identification of being black, as reported here, nor is it ineffective marketing, as reported by John Mack (although this is an important factor in all disappointing launches). The key problem is one of strategy. NitroMed conducted a great trial that proved 2 generic drugs, in combination, worked very effectively in black HF patients. They assumed insurers/patients would pay a premium for a re-formulated version of these 2 drugs that was much more

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