Skip to comments.U.S. to Review Heart Drug Intended for One Race
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 ...
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])
Better get ready for more in this vein, as it seems race biology is the hot new trend (well, in the Times at least...) ;)
Thanks for the link, but not the kink in my neck.
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.
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.
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.
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.
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.
" beta-Blockers and diuretics tend to negatively affect both glucose tolerance and plasma lipids."
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.