BiDil, a combination drug that has shown in clinical trials to drastically improve the survival rate among African-Americans with heart failure, should receive FDA approval later this year. NitroMed, Lexington, Mass., makes the drug and awarded the creative duties for the account to Publicis Groupe's Vigilante Advertising, New York.
But despite its apparent accomplishments during the study of 1,050 African-Americans-which resulted in an overwhelming 43% reduction in deaths in patients with advanced heart failure-BiDil had already generated debate in both medical and marketing circles.
Critics have said it is the dawn of pharmacogenetics, or medicines tailored to people's genetic make-up, and have dubbed the advertising as "race-based marketing."
"My initial response to that is that every drug, by nature, is sort of specific," said Larry Woodard, president of Vigilante. "It appears to be, on the surface, ethnic. But there are plenty of drugs out there, like Estrogen, or children's medications, that target specifics, be it race or gender."
Vigilante, which handles urban and youth marketing for General Motors Corp., Heineken and Western Union, and also created the Pontiac G6 car giveaway on the "Oprah Winfrey" show last year, will begin advertising 90 days after BiDil's approval. Initial marketing to medical professionals will come from Publicis Groupe's Saatchi Klempner.
Mr. Woodard did not provide any details of Vigilante's marketing plans, but said he will eschew what some might think of as obvious places to advertise for the African-American community, such as TV networks UPN, The WB and BET. "A group that needs BiDil is going to be older," he said. "It's quite likely this group is going to be reached with [National Public Radio], for instance."
Still, no matter where Mr. Woodard and Vigilante advertise BiDil, it is likely to continue the controversy. The biggest concern of critics is whether NitroMed's intentions are driven by altruism or cash.
BiDil was originally owned by Medco Research, now King Pharmaceuticals. But after studies in a multiracial population showed little benefit, the FDA rejected the brand.
That was 1997.
NitroMed then acquired the rights and paid for the most recent test, conducted only on African-Americans.
The company has been criticized for not paying for clinical studies of BiDil with other segments of the population. But it has no motivation to do so: If, as expected, the FDA approves BiDil for use in African-Americans, the patent will not expire until 2020 and nearly a generation will pass before generic versions can come into the market.
Jonathan Kahn, a research scholar at the University of Minnesota's Center for Bioethics, wrote in the Yale Journal of Health, Policy and Law that "BiDil became an ethnic drug through the interventions of law and commerce as much as through medical understanding of biological differences that correlate with racial groups."
NitroMed declined to be interviewed.
In preparation for what it believes will be a product launch that happens no later than the second quarter, NitroMed last month held a public stock offering of 3.25 million shares at $24.46 apiece. The offering brought in $79.6 million. Analysts have said BiDil could bring in sales of more than $120 million in 2005, and in the range of $350 million in 2008.