Federal regulators will begin consideration of a new medicine for patients with congenital heart disease this week, and it could break new ground in the United States as the first to target a specific racial group.
The drug is called BiDil and its makers, NitroMed, intend marketing it exclusively to
African Americans.
They say clinical trials have shown that it promises greater benefits to black people.
But the claim has stirred opposition, in part because it challenges the notion of biological parity between the races.
"There has been a lot of controversy but we know we have to take ethnic origin into account," said Manuel Worcel, NitroMed's chief medical officer. "Heart failure is a catastrophe. This is huge progress."
In one trial, the drug decreased mortality in 47 per cent of black patients compared with 15 per cent of white patients. Critics say that NitroMed has pushed the "black-only" character of the drug to build political support for it and extend lucrative patent protection.
They also question the legitimacy of the trials, arguing not enough was done to determine the effect of the drug on whites.
After data collected in the early 1980s seemed to show a convincing bias of benefit among African Americans, NitroMed followed up with its own trials involving 1050 African American heart failure patients.
"We just basically followed the data," said Michael Loberg, head of NitroMed. "We took a drug that was not seen to be particularly effective in the general population and defined a sub-population.
"We think it's a great day, but in no sense do we want to imply that this works in every African American."
Food and Drug Administration experts will begin considering approval of BiDil this week.
- INDEPENDENT
