Often when a monumental advance in medical science is made, the
discovery is celebrated throughout the health care community. But
the arrival of a nationwide study pioneering a racially targeted
drug used to treat heart failure in blacks is stirring up
controversy among many experts in the legal and medical fields.
BiDil, the drug tested in the study, is not actually a new
development. Recent findings ““ in which UCLA was involved
““ have simply confirmed its potential to treat heart failure
in individuals with low nitric oxide levels, a characteristic
sometimes overlooked in past studies but is known to be lower in
blacks.
Dr. Jay Cohn, a cardiologist at the University of Minnesota and
the author of several studies involving BiDil, has spent nearly 30
years researching the drug, prescribing its two components to heart
failure patients.
BiDil is a combination medicine comprised of two generic drugs
and works by enhancing levels of nitric oxides in the blood stream,
reducing risks associated with heart failure.
Since nitric oxide levels are known to be lower in blacks than
in whites, a study jointly sponsored by the pharmaceutical company
Nitromed and the Association of Black Cardiologists, was
implemented to test the effects of BiDil on blacks with heart
failure. Known as the African American Heart Failure Trial, the
study is the largest of its kind.
In the trial, over 1,000 black heart failure patients nationwide
were given either BiDil or a placebo pill.
Patients receiving BiDil showed a 43 percent reduction in
mortality, as well as a great reduction in hospitalization compared
to the control group.
According to Dr. Karol Watson, who did not participate in the
study but is a member of the Association of Black Cardiologists and
an assistant professor at UCLA’s medical school, it is rare
to see results such as these in clinical trials.
She added that because the results of the trial were so
compelling, it was stopped early in July to give BiDil to all the
patients.
In the wake of the promising results, Nitromed has submitted
BiDil for approval by the Food and Drug Administration and would be
the first drug to be marketed to a specific racial group. The
company expects approval by the year’s end.
Though the benefits of the drug suggested by this recent study
seem clear, many experts have spoken in opposition to the idea of
racially directed research and marketing.
“Trying to distinguish health care on the basis of race is
a very slippery slope,” Watson said.
She additionally noted that when biological differences in races
are brought up, it raises issues about withholding treatment from
certain groups.
Those opposed to the study raise the question of why the drug
was not tested on all racial groups. Because the drug was tested
solely on blacks, its effects on other races are not known. Many
doctors, including Watson, believe that other groups may benefit
from using BiDil as well.
Supporters of the trial point out that minorities are often
neglected in clinical studies, which often focus on white
males.
“99.999 percent of clinical trials done in the world have
an incredibly small number of African Americans. But when something
like this happens, everybody is up in arms,” Watson said.
Other doctors are concerned that Nitromed will simply be
profiting by being able to market effectively to a single
demographic. Since BiDil is a combination of two previously
existing generic drugs (drugs that doctors such as Cohn have
already used for years to treat heart failure), wary opponents
question whether the company is just combining the two medications
into a single pill to generate profits characteristic of such
patented drugs in the pharmaceutical industry.
After repeated attempts, Nitromed could not be reached for
comment.