From an article in today's New York Times ("U.S. to Review Heart Drug Intended for One Race"):
"Scientists believe that genetic markers will someday be found that explain the different reactions to drugs, but for now, race or ethnicity is an imprecise shortcut. By approving BiDil, the F.D.A. would go well beyond where it has in the past in using race as a category to evaluate which patients respond to drugs."The drug in question is BiDil (developed by NitroMed, Inc.), a heart failure treatment that was rejected by the FDA eight years ago based on studies in the general population. The company now is seeking approval of the drug for use only in blacks based upon a clinical trial involving self-identified African-Americans only (the African-American Heart Failure Study).
For more on this topic, see "'Ethnic Drugs' and 'Genetic Marketing'"
More Than Science at Work Here
A controlled, scientific study is the gold standard. More than science, however, is at play here, which is always the case with pharmaceuticals. Ethics and politics are involved as well as economic factors and marketing savvy. You can read the story yourself.
Redesigning the clinical study to be able to win approval to market to a specific segment of the population is a novel approach. It may set a precedent. Note that once a drug is approved -- even if just for a segment of the population -- it can be prescribed for anyone. "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. Joshua Hare.
The controversy is likely to generate -- and is already generating -- a lot of press and support from black politicians and cardiologists. So there will be a lot of buzz and viral marketing available to bolster the sales of BiDil if it is approved. Thus the marketing savvy angle.
Please take the Pharma Marketing News Survey to give your opinion on the following questions:
- Is race -- at least for now -- a legitimate category to determine which patients respond to drugs?
- How should pharma companies design clinical trials to support use of a drug in a specific ethnic or racial category?
You'll be able to see a de-identified summary of the results after taking the survey. I will report the overall results here (with comments) at a later date.