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SCIENCE-FOR-THE-PEOPLE  June 2005

SCIENCE-FOR-THE-PEOPLE June 2005

Subject:

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

From:

Mitchel Cohen <[log in to unmask]>

Reply-To:

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

Date:

Mon, 13 Jun 2005 10:24:26 -0400

Content-Type:

text/plain

Parts/Attachments:

Parts/Attachments

text/plain (256 lines)

According to the article below, the drug works by increasing Nitric Oxide.
A certain amount of Nitrogen is needed for flexibility in blood vessels.
Which is why holistic cardiologists increase flexibility and regulate
nitrogen levels by recommending L-Arginine, an important amino acid, which
I take regularly along with other amino acids: Acetyl L-Carnitine,
L-Taurine, and L-Lysine. (The latter is to suppress the expression of
viruses that may affect you with the increase in arginine.) I also take
Co-Enzyme Q10, 300 mg/day to increase the utilization of oxygen by the
body, and organic Lecithin (made from non-GMO soy). All should be taken
withVitamins B-6, B-12, C, and folic acid.

The above regimen is a much more effective means for addressing blood
vessel flexibility.

There are a number of other nutrients I take since my heart attack 4-1/2
years ago, from 30 years of a pizza and Coke diet, and 12 years of sitting
at the computer with little exercise (me, who grew up playing baseball and
basketball throughout my earlier life!). I don't take any pharmaceuticals,
and haven't since I got out of the hospital, and do not recommend any
except in an emergency. I do however recommend sleep, healthy diet and
exercise. (Big revelation, I know.)

If anyone wants further information on healthy "alternatives" to the
beta-blockers, ACE inhibitors, blood thinners, and the pharmaceutical
model, drop me a line.

I also recommend the books: "Prescription for Nutritional Healing," by
Phyllis and James Balch, available in most health food stores; and "Heart
Disease, Stroke & Hight Blood Pressure: Heart Problems Can Be Prevented and
Reversed Using Clinically Proven Alternative Therapies," by Burton
Goldberg. The latter will scare the shit out of you and the former will
give you healthy ways to improve your condition.

The "race based" drug, below, is just a scam, a way of spinning to provide
a rationale so that the manufacturer could extend its patent and niche
market the drug.

- Mitchel Cohen

At 08:25 AM 6/13/2005, Sam Anderson wrote:
>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?
>
>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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