MINEAPOLIS (NNPA) – A new heart medication may help African Americans with heart failure live longer, a new study finds. If the FDA approves the drug, called BiDil, only African Americans will be going to their pharmacies to get it.
NitroMed, Inc, the maker of the drug, is waiting for FDA approval to market the drug to African Americans only, making it the first ”ethnic” drug.
The investigators, drug maker, financial analysts, and media have already started to call BiDil the latest breakthrough and blockbuster drug.
“It works,” said Anne Taylor, the African-American heart doctor, and assistant dean of the Medical School at the University of Minnesota, who led the study team.
“It saves lives. It makes quality of life better.”
The findings, published in November 11 issue of The New England Journal of Medicine, are based on a study of 1,050 African-Americans with heart failure.
To determine which treatment works best in Black heart failure patients, participants were randomly assigned to receive either BiDil and the standard heart failure therapy, or just the standard therapy.
Patients who took BiDil, in addition to standard therapy, lived longer, visited the hospital less, and had an improved quality of life compared to those taking just the standard therapy, the study showed.
BiDil is made up of two generic drugs, which alone are used to treat high blood pressure and chest pain. The standard therapy includes drugs such as ACE inhibitors and beta-blockers.
Because the results of a preliminary analysis were overwhelmingly positive, Taylor said, the study’s data and safety monitoring board decided to end the trial early so all patients can be put on BiDil. Soon after, NitroMed received a second patent for the drug, and the company’s stock soared.
This study is significant because it may lead to more treatment options for Blacks with heart failure, Taylor says, and may help eliminate racial disparities in death from the disease.
But some think the drug is controversial. At the heart of the debate is whether doctors and drug companies are “racial tailoring” or “racial profiling” in medicine.
“We can say it is racial tailoring, not racial profiling,” said Waine Kong, CEO of the Association of Black Cardiologists, the organization that recruited participants for the study. ”It’s a good thing, not a bad thing,” he said.
However, critics like Jonathan Kahn, a law professor at Hamline University, call it racial profiling.
“The question for me is not whether it works,” Kahn said. “Does the end justify the means?”
“People look to this, and it’s already happened throughout the media coverage of BiDil, and say, ‘Look, there really are differences between the races,’ ” he said.
“And in our country, historically, when you say races are different biologically, bad things happen.”
While social factors also play a role, Kong says, we cannot dismiss the idea that race has a biological basis.
Kahn argues there no clear line between society and biology. ”Race changes biology because discrimination changes biology,” he said.
Jonathan Kahn argues both doctors and drug marketers play a role creating “ethnic” drugs.
“Doctors use race as a surrogate to get at biology,” Kahn says, “And marketers use biology as a surrogate to get at race. The pharmaceutical industry is trying to create new ethnic markets to sell drugs and generate profit from two generic drugs,” he says.
Instead of prescribing and marketing BiDil to patients who are non-responsive to standard therapy and who have a certain type of hypertension, doctors and corporate marketers use race as a short cut.
It’s difficult to market to people with a certain set of clinical factors, said Kahn. “But I can market to Blacks,” he said. “It’s a well-established ethnic marketing profile. There are all sorts of strategies already out there in the ad world for what they call ethnic marketing.”
“And I am not sure what types of bad things are going to come out of it,” said Kahn.
“It’s not going to lead to slavery, but I am worried because of discrimination. We’re not past racism in the country, and discrimination is very tricky.”