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FDA... Racist?
Sunday, June 19, 2005 4:31 PM on j-body.org
http://www.cbc.ca/story/science/national/2005/06/16/race-medicine050616.html

Quote:

Company seeks to sell heart drug to blacks only
Last Updated Thu, 16 Jun 2005 21:47:07 EDT
CBC News

A drug company should be able to market a heart failure drug to blacks only, an advisory panel to the U.S. Food and Drug Administration recommended on Thursday.

The panel weighed the contentious issue of whether to approve what could be the first drug therapy intended for a specific race.

The drug, known as BiDil, treats heart failure by elevating levels of nitric oxide, which is important to the health of heart and blood vessels.

Consultants for manufacturer NitroMed. Inc. told the nine panelists that the company wants to sell BiDil only to blacks, saying a study in the 1980s showed blacks fared better on the drug than other races.

Deaths among those who took the drug were also lower in a follow-up study on 1,050 people with heart failure who identified themselves as black. Participants were given standard drugs and BiDil or a placebo.

Critics charged the approach smacks of race-based medicine.

"I would not use race except perhaps in the most extreme of circumstances to dictate the kind of therapy that one would give," said Dr. Jonathan Howlett, a cardiologist in Halifax.

Dr. Jay Cohn, who holds a patent on the drug, has a theory on why BiDil seems to work for one race but not others.

"It is a nitric oxide enhancer," said Cohn, of the University of Minnesota. "The evidence that has grown over this last decade suggests that African-Americans have less nitric oxide in their body."

Controversial approach
Others consider Cohn's explanation to be overly simplistic, noting since BiDil was tested only on African-Americans, the company can't say whether it works in other populations.

"There is, as far as I know, no biological rationale why BiDil should have a better effect in African-Americans compared to the other groups," said Dr. Salim Yusuf of the Population Health Research Institute in Hamilton, Ont. "The construct of race is almost certainly spurious and misleading," he added.
Dr. Jay Cohn

Although there are diseases that occur more often among some races, such as sickle cell anemia in blacks or Tay-Sachs in Ashkenazi Jews, these are genetic, not racial disorders. The diseases aren't exclusive to one race.

"If we can find a way to identify a population that will respond to a drug with a favourable effect on survival and quality of life and keep them out of the hospital, I'm all for that," countered Cohn.

Scientists are working on ways to develop genetic tests to target therapies to each patient. Someday, experts said, the tests could make issues like gender and race irrelevant in medicine.

All nine panelists recommended the FDA approve BiDil, but two said the label should not be race-specific.

The FDA, which usually follows the recommendations of its advisory panel, will now decide whether to approve sales of the drug.


So whaddaya think? Bad Science or focused therapy?



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Re: FDA... Racist?
Sunday, June 19, 2005 9:15 PM on j-body.org
As far as I know, Nitric Oxide helps anyone with a cardiovascular disease.

If the drug was only tested on African-Americans, then of couse it's bad science to make a decision based on that.

That article provides too little information to tell, though.




Re: FDA... Racist?
Monday, June 20, 2005 8:59 AM on j-body.org
The source article has some supplimentary links that I didn't copy over...

My bad.



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Re: FDA... Racist?
Monday, June 20, 2005 6:40 PM on j-body.org
Wait so the "lab rats" that fared better identified themselves as black, so all of the other races can get by just fine by stating to the medication that they are indeed black.

Sounds like some white people in the area of Providence are all set there.

All joking aside, I find it interesting that they want to release this, I mean obviously it would be prescription only, but to me it is a lawsuit against a doctor just waiting to happen. Whether it be racism or malpractice done to avoid being called a racist (i.e. giving anyone the medication)


Do I really need a signature?
Re: FDA... Racist?
Tuesday, June 21, 2005 11:24 AM on j-body.org
Well, as the article said, it was focused on blacks, but I didn't get too far into the supplimental stuff...

If there were an edit button, I'd add in the extra links.



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Re: FDA... Racist?
Thursday, June 23, 2005 12:31 PM on j-body.org
is this considering or concerning sickle cell anemia? last i remember blacks were 99% more likely to develop sickle cell than any other race.





Re: FDA... Racist?
Saturday, June 25, 2005 8:29 AM on j-body.org
Quote:


Although there are diseases that occur more often among some races, such as sickle cell anemia in blacks or Tay-Sachs in Ashkenazi Jews, these are genetic, not racial disorders. The diseases aren't exclusive to one race.


It happens, but the study of eugenics (the actual SCIENCE that maps out the racial makeup of a person) has shown that most people actually have genetic markers from other races lying dormant in their genes. its why 2 white parents can come together and have a child that looks mulatto...

Basing treatment on skin colour alone is foolish. Ideally, when a child is born, along with most of the cord blood, the child's DNA will be analysed and potential diseases and disorders can be comensated for or halted immediately. Of course, keeping ALL the records confidential, a person can get a regimen of pills, shots, patches or whatnot that will combat the progression of the disease or disorder. Again, it's geared for patient to patient, not on the supposition of race but the individual.

Of course, before that happens, you'll probably want to get universal health care first.




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Re: FDA... Racist?
Saturday, June 25, 2005 9:24 AM on j-body.org
I think that it's ridiculous that somethign which can help all people would be limited to just race preference. I think if this is allowed there should be a MAJOR lawsuit on the grounds of discrimination! We the people allow the government too much oversight on how we live without much contest.


"Speak the truth, and leave immediately after"
"The urge to save Humanity is almost ALWAYS a false front for the urge to rule"
"He who knoweth things as they are and not as they are said or seem to be, he truly is wise, and is taught of God more than of men."
Re: FDA... Racist?
Saturday, June 25, 2005 12:47 PM on j-body.org
I screwed up the Tags.. should have been quotes.

Chamillionaire: I think most people are either too lazy to fix it, or too opiated or stressed to care.


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Re: FDA... Racist?
Saturday, June 25, 2005 12:50 PM on j-body.org
You people need to check the facts before you comment. The FDA didn't approve this drug earlier because they couldn't provide evidence that it worked. When the drug company further analized the data, they found that it had shown to be beneficial to black people. Now the drug company has reapplied for the drug to be approved for black people.

Once a drug is approved, it's up to doctors to prescribe them to whoever they want and for whatever reasons they want. Doctors could prescribe it for white people or mexicans, asians or whomever.
Re: FDA... Racist?
Saturday, June 25, 2005 1:12 PM on j-body.org
Quote:


Controversial approach
Others consider Cohn's explanation to be overly simplistic, noting since BiDil was tested only on African-Americans, the company can't say whether it works in other populations.

"There is, as far as I know, no biological rationale why BiDil should have a better effect in African-Americans compared to the other groups," said Dr. Salim Yusuf of the Population Health Research Institute in Hamilton, Ont. "The construct of race is almost certainly spurious and misleading," he added.


Dr. Yusuf needs to tell that to a Tay-Sachs suffering child's parent.

Anyhow... The testing regimen was focused on Blacks, but the issue was whether or not the doctors should prescribe to anyone... the FDA is considering adding a warning sheet saying that it should be prescribed mainly to negroid people.

That was the issue.

At present the FDA is still considering approving sales of the drug... Once it goes on sale, you'll see entries of it in the Pharmacologists Reference Quarterly, instead of just journals of medicine. You're right in that as soon as it is approved for sale, it won't matter if there is a caucazoid, negroid or mongoloid taking it, it's up to the doctor. The question is whether or not the race-specific text should be added.




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