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SCIENCE-FOR-THE-PEOPLE  June 2005

SCIENCE-FOR-THE-PEOPLE June 2005

Subject:

F.D.A. Approves a Heart Drug for African-Americans

From:

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

Reply-To:

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

Date:

Fri, 24 Jun 2005 08:09:10 -0400

Content-Type:

text/plain

Parts/Attachments:

Parts/Attachments

text/plain (51 lines)

NOTE: Would Adam Clayton Powell, Mariah Carey, WEB DuBois, Lena Horne, Huey Newton, or even Farrakhan (i.e. light-skinned Blackfolk obviously of mixed heritage) benefit from this "BiDil"? That is to say, what distinguishees "African American" from nonAfrican American? The answer: Choice & US socially acceptable body features as denoting who is "African American" and who is not. Does BiDil work on Ugandans, Moraccans or Ethipians? Does it work on East Timorese or Aleuts?

Lastly, what would stop a fundamentally racist science-governmental-corporate institutional structucre and white supremacist individuals from pursuing the negative/genocidal aspect of this research? Don't be suprised if it hasn't started already.... Pandora's Box is now wide open....
==========================

June 24, 2005
F.D.A. Approves a Heart Drug for African-Americans
By STEPHANIE SAUL

The Food and Drug Administration took a controversial step toward a new frontier of personalized medicine yesterday, approving the first drug ever intended for one racial group, African-Americans.

The drug, a heart failure therapy called BiDil, makes it easier for the heart to pump by relaxing blood vessels. A study of 1,050 African-American heart failure patients showed that BiDil reduced deaths by 43 percent.

No one is sure why BiDil works better in blacks than in other races, but scientists theorize that it is because BiDil increases the body's levels of nitric oxide, a naturally occurring compound. Many heart failure patients suffer from a deficiency of nitric oxide, but the deficiency is more common in African-Americans.

Although the BiDil label will say the drug is for self-identified black patients, many cardiologists believe BiDil will work for many people of other races as well. Wall Street is factoring use of the drug by people of other races into its forecasts for BiDil. Analysts' sales predictions range from $500 million to $1 billion by 2010.

An estimated five million Americans, 750,000 of them black, suffer from heart failure, a debilitating and frequently fatal condition in which the heart is weakened and does not pump enough blood.

"In the future, we hope to discover characteristics that identify people of any race who might be helped by BiDil," said Dr. Robert Temple, the F.D.A.'s associate director, in a statement yesterday announcing the drug's approval.

The drug's maker, NitroMed, of Lexington, Mass., has said that a sales force of 195 people and a batch of BiDil tablets are ready and that it will begin marketing the product almost immediately. The sales force will focus on doctors who are known to treat African-American heart failure patients.

The tablets are being manufactured for NitroMed by Schwarz Pharma Manufacturing, of Seymour, Ind.

BiDil is a combination of two generic drugs that are already available - hydralazine and isosorbide dinitrate. Because taking the combination would be convenient, the company does not expect its franchise to be undermined by the generic competition. NitroMed has not yet disclosed the price of the drug.

BiDil was endorsed last week by an F.D.A. advisory panel of outside experts. But controversy surrounded the discussions. Geneticists worried that, by approving a drug for one group, the F.D.A. was using race as a crude shortcut for genetic typing.

On another, more philosophical level, critics said that endorsing a drug for one race gave official government imprimatur to the discredited notion of race as a biological category.

Several influential black political and scientific groups embraced BiDil, however, as a way to redress years of inequality in medical treatment and outcomes. NitroMed reached out to several of those organizations, recruiting the Association of Black Cardiologists to help organize its clinical research. The company paid the association $200,000.

BiDil was the discovery of Dr. Jay N. Cohn, a University of Minnesota cardiologist, who in the 1970's began experimenting with vasodilators, or vessel-widening treatments, for desperately ill heart failure patients.

Dr. Cohn organized studies of the drug in veterans hospital patients in the 1980's and found that it reduced mortality. But the F.D.A. denied BiDil's approval in 1997 after determining that Dr. Cohn's results were not statistically significant.

In 2001, the F.D.A. said that BiDil could be approvable as a treatment for African-Americans, but only if a study confined to African-Americans clearly showed a reduction in mortality.

BiDil is meant to be taken three times a day, in addition to the heart failure medications patients already take.

Artificial Heart Is Not Endorsed

WASHINGTON, June 23 - (AP) Government scientists on Thursday narrowly rejected the first fully implantable artificial heart, saying they were unsure if a few extra months of life outweighed the serious side effects.

The AbioCor artificial heart, made by Abiomed of Danvers, Mass., has been tested in only 14 patients. Two died immediately. The rest survived about five months. Many patients had severe strokes that compromised their final days.

One patient lived 17 months. His family and one other family told advisers to the Food and Drug Administration that the heart provided priceless extra time. But the advisers wanted more testing to determine just which dying patients should be offered a chance to try the heart.

The F.D.A. is not bound by its advisers' recommendations, but usually follows them.

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