First 'black' drug nears approval

Nature ^ | 7/23/04 | Helen Pearson

[LibWhacker]

Controversial study suggests treatment should factor in the patient's ethnic group.

A heart drug being tested in black patients is on course to become the first medicine approved for use in a specific ethnic group, challenging those scientists who believe that race is a bad basis for prescriptions.

The drug, made by Massachusetts-based pharmaceutical company NitroMed, was abandoned after a trial in the 1980s produced unimpressive results. But, because the data hinted at differences between white and black patients' responses, in 2001 NitroMed decided to carry out a further clinical trial using only African Americans.

This week NitroMed announced that the trial, in over 1,000 black heart-failure patients, has been stopped early because it appears so effective when used on top of normal therapy. "I'm so thrilled about it," says study leader Anne Taylor of the University of Minnesota, Minneapolis. If the drug, called BiDil, receives regulatory approval, the company says it will aim to launch it in early 2005.

But BiDil revives controversy about whether, and how, race should be used to prescribe medicines. In the clinic, for example, doctors will have to work out who is classed as African American in a racially mixed population. "It really becomes problematic," says Sandra Soo-Jin Lee, an anthropologist who studies race in science at Stanford University, California.

Skin deep

Doctors have long known that different ethnic populations can have different susceptibility to diseases or react differently to drugs. Drug labels for the common heart drugs called ACE inhibitors note that they may be less effective in black people.

BiDil contains two generic medicines that together boost production of nitric oxide, a molecule that relaxes blood vessels and eases strain on the pumping heart. Taylor believes that African Americans, who have a higher rate of heart disease, react better because they tend to have lower levels of nitric oxide than other ethnic groups.

"I still think skin pigment is a lousy predictor of heart function" -- Howard McLeod Fritz Haber Institute of the Max Planck Society, Berlin

Some scientists argue that race is a poor way of guessing a person's response to a drug. "I still think skin pigment is a lousy predictor of heart function," says Howard McLeod of Washington University in St Louis, Missouri.

McLeod argues that it is better to identify the one or more genetic variations that control whether the body reacts well to a drug and prescribe it to those people, regardless of race. In the case of BiDil, for example, the genetic difference responsible probably occurs more commonly in the African American population. But the same genetic difference could exist, at a lower frequency, in Caucasian, Asian or other ethnic groups.

Surrogate markers

The genetic argument was backed up by a study in 2001, in which British researchers divided a population into four different groups based on 40 genetic markers. They found that these groups were a better predictor of drug response than ethnic ones.

"We hold the trump card: it works" -- Karsten Horn Anne Taylor, University of Minnesota, Minneapolis

Taylor acknowledges these points and says that she plans to scan the genes of those patients who responded to BiDil to find those that will foretell a patient's response. Until these results are in, Taylor argues that race may serve as a reasonable surrogate for making prescriptions, when used alongside a patient's medical history. "We hold the trump card: it works," she says.

Future tests could show that other ethnic groups respond to the drug when it is given, as in the current trial, alongside conventional treatment. But Taylor is urging the traditionally white-dominated clinical trials to incorporate patients from all ethnicities now, so that differences in their responses can be picked up from the start.

[steplock]

I knew if I looked I could find it - another REAL Doctor that recognizes that - YES! - races are different!

I Am a Racially Profiling Doctor Published Nov 29, 2002 - 03:30 PM I Am a Racially Profiling Doctor May 5, 2002 SALLY SATEL In practicing medicine, I am not colorblind. I always take note of my patient's race. So do many of my colleagues. We do it because certain diseases and treatment responses cluster by ethnicity. Recognizing these patterns can help us diagnose disease more efficiently and prescribe medications more effectively. Note: Sally Satel, a fellow at the American Enterprise Institute, is the author of "PC, M.D.: How Political Correctness Is Corrupting Medicine." Read more...

[Rokurota]

Oh, first approved drug...

because we all know that crack was made by the CIA specifically to affect blacks.

[LibWhacker]

Good article. It's going to be a big step backward for all races -- especially for minorities -- if this kind of research is blocked.

[Tall_Texan]

I didn't know black was a disease.

[ICX]

Not only made, but distributed and contained in the ghetto.

[gathersnomoss]

I wonder if they can come up with a drug that can help me to jump higher.

[Tall_Texan]

we all know that crack was made by the CIA specifically to affect blacks.

"I did yo drug"

"Da bitch set me up!"

[uglybiker]

I wonder if they can come up with a drug that can help me to jump higher.

I'm wondering if it's true about all those drugs that claim to add inches to my manhood.