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U.S. to Review Heart Drug Intended for One Race
NY Times ^ | June 13, 2005 | STEPHANIE SAUL

Posted on 06/12/2005 10:31:44 PM PDT by neverdem

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.

(Excerpt) Read more at nytimes.com ...


TOPICS: Business/Economy; Culture/Society; Front Page News; Government; News/Current Events; Politics/Elections; US: District of Columbia; US: Maryland
KEYWORDS: blacks; health; healthcare; heartfailure; medicine
Political correctness runs amuk. Blacks respond to two major classes of meds for high blood pressure, beta blockers and ACE inhibitors, as well as they respond to placebos.
1 posted on 06/12/2005 10:31:44 PM PDT by neverdem
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To: neverdem
Political correctness runs amuk.

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

I can't believe that's a real headline! LOL! "One Race"... sounds like Adolf language to me! Gotta love the Old Gray B*tch.
2 posted on 06/12/2005 10:37:57 PM PDT by USAfearsnobody
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To: USAfearsnobody

LOL!


3 posted on 06/12/2005 10:38:43 PM PDT by cyborg (I am ageless through the power of the Lord God.)
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To: cyborg; El Gato; JudyB1938; Ernest_at_the_Beach; Robert A. Cook, PE; lepton; LadyDoc; jb6; ...
FReepmail me if you want on or off my health and science ping list.

Systematic review: antihypertensive drug therapy in black patients.

DATA SYNTHESIS: The efficacy of beta-blockers in reducing systolic blood pressure and the efficacy of angiotensin-converting enzyme inhibitors in achieving diastolic blood pressure goals did not significantly differ from that of placebo (weighted mean difference for beta-blockers, -3.53 mm Hg [95% CI, -7.51 to 0.45 mm Hg]; relative risk for angiotensin-converting enzyme inhibitors, 1.35 [CI, 0.81 to 2.26])

4 posted on 06/12/2005 10:58:24 PM PDT by neverdem (May you be in heaven a half hour before the devil knows that you're dead.)
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To: USAfearsnobody

Better get ready for more in this vein, as it seems race biology is the hot new trend (well, in the Times at least...) ;)

http://www.nytimes.com/2005/06/03/science/03gene.html

http://www.economist.com/science/displaystory.cfm?story_id=4032638


5 posted on 06/12/2005 11:18:33 PM PDT by dob
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To: neverdem
This chart was generated by computer program designed to cluster groups based on genetics. No assumptions were made about the existance of races among humans, yet, remarkably, the clustering seems to match many humans notions of the major races.

More here.

6 posted on 06/12/2005 11:19:36 PM PDT by mc6809e
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To: mc6809e

Thanks for the link, but not the kink in my neck.


7 posted on 06/12/2005 11:33:26 PM PDT by neverdem (May you be in heaven a half hour before the devil knows that you're dead.)
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To: neverdem
No problem for me here.

Look, we already know there's some component at work even if we might be ignorant of the cause we can see statistical evidence that it exists. When I do my physical the forms specifically ask about race in order to determine if tests might be called for that are more likely to effect one group over others. Tay Sachs and Sickle Cell Anemia are two diseases more likely to be found in Jews and blacks (in the order). Still other groups might be at risk for other problems. Why must we knee-jerk mischaracterize this as eugenics and racism?

If this drug works best for one group than others with similar health concerns then it is what it is, approve the drug for that group's use. As it is already, not every drug is suitable for every patient regardless of ethnic makeup.

This should be about HEALTH CARE and not politically correct notions about race.

8 posted on 06/13/2005 12:18:07 AM PDT by newzjunkey (Remind Liberal Cowards Why America Freed Iraq: http://massgraves.info/)
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To: newzjunkey
This should be about HEALTH CARE and not politically correct notions about race.

Exactly right. If it helps one group, let it help.

However, I can see Jesse Jackson type people saying the drug companies are "exploiting" blacks with this new drug. Still, it would be worth having this distraction if the drug actually helps people.

9 posted on 06/13/2005 4:13:45 AM PDT by libertylover (Liberal: A blatant liar who likes to spend other people's money.)
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To: neverdem
It's a stupid headline but I don't see a problem with making or the marketing a product for "one (specific) race". After all is/was anyone here offended by Afro Sheen? And as to political correctness running amok, the pc running amok nonsense is saying 'we' are all alike. We're not - white men can't jump.

Another case in point: last week there was a CSI rerun in which they got the bad guy because he was Norwegian and as such, was subsepticle to getting a foot allergy from algae mold. A German or Pole stepping in the same stuff wouldn't be affected.

10 posted on 06/13/2005 5:31:19 AM PDT by Condor51 (Leftists are moral and intellectual parasites - Standing Wolf)
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To: neverdem
Welcome to bio-technology... when you're using the human genome to develop drugs, it should come as no surprise that some of those drugs will be more effective for those with certain genetic characteristics, race being just one of possibilities.
11 posted on 06/13/2005 5:36:36 AM PDT by kevkrom (Jack Bauer / Chloe O'Brien '08)
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To: neverdem
I have been suggesting (unsuccessfully) some type of genetic testing to see if there is a correlation between genotype and drug efficacy. "Race" along seems a bit too coarse a division.
12 posted on 06/13/2005 6:21:04 AM PDT by Doctor Stochastic (Vegetabilisch = chaotisch is der Charakter der Modernen. - Friedrich Schlegel)
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To: neverdem
The efficacy of beta-blockers in reducing systolic blood pressure

These drugs could possibly cause more problems than the high blood pressure if the patient is experiencing high blood pressure due to syndrome X. They can worsen insulin resistance.

13 posted on 06/13/2005 7:49:47 AM PDT by Nov3 ("This is the best election night in history." --DNC chair Terry McAuliffe Nov. 2,2004 8p.m.)
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To: Nov3
These drugs(beta blockers) could possibly cause more problems than the high blood pressure if the patient is experiencing high blood pressure due to syndrome X. They can worsen insulin resistance.

Enter (diuretics OR beta blockers) AND mortality into PubMed. It might take a month of Sundays just to read the abstracts. Diuretics can have similar adverse metabolic effects, yet these older drugs are still advocated as first line therapies. It's too bad, but medicine is not simple.

Mechanism of differential effects of antihypertensive agents on serum lipids.

" beta-Blockers and diuretics tend to negatively affect both glucose tolerance and plasma lipids."

14 posted on 06/13/2005 10:35:40 AM PDT by neverdem (May you be in heaven a half hour before the devil knows that you're dead.)
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To: neverdem
I believe Dr. Atkins was right. The most important indice you can treat in older patients is their insulin sensitivity. As he said in one of his posts on his BBS if you get the insulin and sugar levels in the low normal range all the other problems including blood pressure, lipids etc will almost always go away.

He advocated diet(of course), minerals (vanadyl and chromium) and I believe metformin. He strongly opposed any drug that would either destroy insulin sensitivity (beta blockers) or any drug that would up your body's ability to produce insulin (some of the oral anti-diabetics). He said that if you treat the symptoms incorrectly you will end up treating them forever.

I wish it was all that simple. Maybe to a degree it is. I do know this nothing good can come from a destroyed sensitivity to insulin and the resultant sky high insulin levels that are necessary to live with it.

15 posted on 06/13/2005 4:02:37 PM PDT by Nov3 ("This is the best election night in history." --DNC chair Terry McAuliffe Nov. 2,2004 8p.m.)
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To: neverdem
Effects of beta2-adrenergic receptor gene variants on adiposity: the HERITAGE Family Study.
16 posted on 10/12/2005 5:30:09 AM PDT by neverdem (May you be in heaven a half hour before the devil knows that you're dead.)
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To: neverdem

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12740450&query_hl=46


17 posted on 10/12/2005 5:35:40 AM PDT by neverdem (May you be in heaven a half hour before the devil knows that you're dead.)
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