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SCIENCE-FOR-THE-PEOPLE  June 2005

SCIENCE-FOR-THE-PEOPLE June 2005

Subject:

U.S. to Review Heart Drug Intended for One Race

From:

"S. E. Anderson" <[log in to unmask]>

Reply-To:

Science for the People Discussion List <[log in to unmask]>

Date:

Mon, 13 Jun 2005 05:25:49 -0700

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text/plain

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NOTE: In this White Supremacist-dominated world of monopoly capital
imperialism, this kind of "race-based" "science" will be used
to the detriment of People of African Descent. We must fight
this at every level we can. We must have a grassroots educational
campaign in our communities thruout the US and Diaspora to NOT
support this pseudoscience "medical advance." As long as this
"scientific" work is being conducted within a the normalcy of
white supremacist notions and policies, we will see nothing but
further oppressive and genocidal uses for these "breakthrus."

Remember: race is a construction made by racists to justify their
"superior" position over others... primarily Africans, Asians,
Pacific Islanders and indigenous Americans... and then later
Jews, Southern and Eastern Europeans. So how can a drug "work"
on POLITICALLY defined groups of people?

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The New York Times
June 13, 2005

U.S. to Review Heart Drug Intended for One Race
By STEPHANIE SAUL

In 1997, a new heart failure treatment called BiDil appeared
dead on arrival. The Food and Drug Administration rejected the
drug, saying that studies supporting it were inconclusive.

Then, proponents of BiDil refocused their strategy. This Thursday,
eight years after the drug was rejected for use in the general
public, an F.D.A. panel will consider whether BiDil should become
the first drug intended for one racial group, in this case, African-Americans.

A study of 1,050 African-American heart failure patients showed
that BiDil significantly reduced death and hospitalization, prompting
the American Heart Association to call BiDil one of the top developments
of 2004. BiDil increases levels of nitric oxide, which widens
blood vessels.

The drug's maker, NitroMed Inc., says its decision to test and
market BiDil as a drug for African-Americans is based on solid
science. But BiDil's application has engendered controversy,
with many scientists convinced that race is too broad and ill-defined
a category to be relevant in determining a drug's approval, especially
since geneticists have failed to identify a biological divide
separating one race from another.

The drug has also raised questions about how marketing, regulatory
and political considerations play a role in new drug development,
with critics of NitroMed saying the company has artfully managed
the regulatory system and patent law, as well as historical inequities
in medical treatment for African-Americans, to drive its product
to market.

The idea of seeking approval of BiDil for African-Americans grew
out of a study at veterans hospitals in the 1980's. The research
indicated that the drug, a combination of two generic drugs,
worked better in African-Americans than in whites.

"Basically, all we did was follow the data," said Dr. Michael
D. Loberg, NitroMed's chief executive. But the strategy of focusing
on African-Americans carries extra benefits for NitroMed, which
used the drug's racially specific indication to extend BiDil's
patent protection by 13 years, to 2020. And to prove the drug
works in African-Americans, NitroMed conducted narrowly focused
clinical trials, which cost less than the trials required in
the broader population.

The Friedman, Billings, Ramsey Group, an investment bank, expects
"robust" pricing for the drug and potential annual sales of $825
million based solely on the 750,000 African-American heart failure
patients in the United States.

Many physicians contend that BiDil will work in other races,
too. Indeed, Wall Street's enthusiasm is partly due to BiDil's
expected "off label" use in other patients. Once a drug is approved,
doctors can use it any way they see fit.

"I don't believe for a second that this drug combination is only
going to prove to be beneficial in African-Americans; it's just
not conceivable," said Dr. Joshua Hare, a cardiologist at the
Johns Hopkins University Medical Center.

Dr. Hare, who supports approval of BiDil, says that any contention
that the drug works better in blacks than others remains an untested
hypothesis, because NitroMed did not do the broader studies.

"My criticism of the African-American Heart Failure Study is
that they only studied African-Americans," he said. "To really
test the hypothesis is to study both populations and then show,
aha, the African-Americans did respond better. They didn't do
that."

Dr. Loberg said it would have been daunting and prohibitively
expensive for a small company to conduct such broad trials. "It
doesn't mean that others won't benefit as well," he said. "We
just haven't identified who those others might be."

Recognizing racial controversy as a potential deterrent to BiDil's
approval, NitroMed reached out to African-American politicians
and physicians, including the Association of Black Cardiologists.

After considerable debate, the heart doctors agreed to be co-sponsors
of BiDil's clinical trial, embracing the drug as a way to redress
years of inequality in medical care, starkly symbolized by the
Tuskegee syphilis study that began in the 1930's, in which black
men were denied lifesaving treatment.

"By the time they got to us, they had made presentations to the
Congressional Black Caucus and the N.A.A.C.P.," said B. Waine
Kong, the cardiologist group's executive director. "I'm sure
they were aware of the political fallout if they did not have
African-American participation. And that was a wise decision."
NitroMed paid Dr. Kong's group $200,000 for its assistance with
the BiDil trial, Dr. Kong said.

The idea of a drug for one race has drawn the concern of several
medical ethicists and scientists.

Jonathan Kahn, a medical ethicist at Hamline University law school
in St. Paul, said BiDil's approval as a black-only drug would
give an official ring to the discredited idea that race is a
biological category.

"It gives me great concern and pause to be going down this road,
because we can't foresee all the bad consequences," said Dr.
Kahn, who wrote an analysis of BiDil last year in The Yale Journal
of Health Policy, Law and Ethics.

Scientists know that different people have different responses
to medications, and in some cases these have been linked to race.
The F.D.A., for example, has said that people of Asian ancestry
are more likely than others to get serious side effects from
the cholesterol-lowering drug Crestor. But research shows that
the underlying genetic variations across races are small.

Scientists believe that genetic markers will someday be found
that explain the different reactions to drugs, but for now, race
or ethnicity is an imprecise shortcut. By approving BiDil, the
F.D.A. would go well beyond where it has in the past in using
race as a category to evaluate which patients respond to drugs.

The question before the F.D.A. panel is even more complex because
people who "self-identify" as African-American could have just
one or a few black ancestors, rendering them poorly connected
to the group's underlying genetics, according to Dr. Gregg Bloche,
a medical ethicist at Georgetown University Law Center who raised
that issue last fall in The New England Journal of Medicine.

The panel review is a crucial hurdle for BiDil, because the F.D.A.
usually follows the recommendations of its advisory panels when
considering whether to approve a drug. The F.D.A. does not discuss
drugs when their approval is pending.

The heart specialist who has worked on BiDil for the last 25
years, Dr. Jay N. Cohn, said the controversy "reflects the discomfort
that has grown up in this country regarding the racial issue."

"Unfortunately, that's taken a lot of attention away from the
science," he said.

The science began in the early 1980's, when Dr. Cohn, then working
at a Veterans Administration hospital in Washington, organized
trials to test a combination of two drugs already available:
isosorbide dinitrate and hydralazine. The trials were called
V-HeFT (pronounced vee-heft) for vasodilator - heart failure
trial.

"I think from a scientific level all of us who worked on V-HeFT
were convinced that this drug was effective and the mortality
benefit was real," Dr. Cohn said of the V-HeFT studies, which
included both white and black V.A. heart-failure patients.

But Dr. Cohn, now a professor of medicine at the University of
Minnesota, said he had trouble finding financial support for
research, even though the combined drug, which he called BiDil,
would be more convenient than taking the two generics.

"We had a drug that was not attractive to makers because these
pills were generic," Dr. Cohn said in a recent interview. Drug
companies generally prefer to develop new molecules with long
patent protection.

With Dr. Cohn's help, the biotechnology company Medco Research
filed an application with the F.D.A. for the drug's use in all
patients, relying on the earlier V.A. trials to prove its benefit.

During 1997 hearings, Dr. Cohn urged an F.D.A. panel to keep
an open mind, because the V-HeFT trials lacked the sophistication
of more modern trials. Several panel members agreed that BiDil
seemed to extend the lives of patients, but the trials fell statistically
short, and the panel voted down the drug.

In going over the data from the first trial, which involved 630
people, 180 of them African-American, Dr. Cohn noticed that the
African-Americans showed a statistically significant benefit.
The reason, Dr. Cohn suspects, involves nitric oxide.

Several studies have suggested that African-Americans have deficiencies
of nitric oxide, a compound that occurs naturally in the human
body.

Based on Dr. Cohn's findings in the V.A. studies, the F.D.A.
gave NitroMed, which specializes in nitric oxide therapy, an
"approvable" letter in 2001, saying that a positive study in
African-American heart failure patients could be a basis for
the drug's approval.

Dr. Cohn said that despite any flaws in the first studies, the
similar findings in the new trial suggest the original data was
accurate. "The replication gives me confidence that this combination
is more likely to be effective in people who call themselves
black than in people who call themselves white," he said. "Do
I believe this drug should work in whites? Biology would tell
me it should."

Copyright 2005 The New York Times Company

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