I don't understand why but I'm starting to feel like I'm writing in
Portuguese or something because some key points keep getting
missed. Let me refer interested readers to the pro-business
"Business Insider" which has a short article on this case and
praises the decision to let Big Pharma market a drug for the
treatment of any condition whatsoever regardless of whether
it has been shown to be an effective treatment for it; see:
http://www.businessinsider.com/alfred-caronia-legal-victory-2012-12
Here is a critical bit:
|It's always been perfectly legal for doctors to prescribe drugs
|for uses that the FDA hasn't approved. However, federal law
|has barred drug companies from promoting medicine for anything
|other than its officially approved use.
So, even if the decision is reversed on appeal, this does not mean
that the "black helicopters" of FDA will swoop down in the dead of
night to people's homes to take their off-labeled used drugs. Even
if reversed, a doctor will still be able to prescribe drugs for off-label
use even though (a) there may be no scientific evidence that such
usage produces a benefit outside of a placebo effect and (b) Big
Pharma may promote such practice because it may keep a drug
profitable.
So, the failure of critical thinking is manifested in the lack of
realization
that using a drug off-label has no real empirical basis outside of a
possible
placebo effect. Is it possible that some off-label use will lead to
research
that actually shows the drug to be effective? Yes. Is it also possible that
research will show the off-label drug is no more effective than placebo?
Yes. Which case is true in reality? No one knows until the proper
research is done. Nonetheless, some people might think that they need
expensive placebos effects.
Finally, a legal point that I want to make perfectly clear:
THE FDA PROSECUTES THE ***MARKETING OF DRUGS***
AS TREATMENTS FOR ILLNESSES THAT THEY HAVE NOT BEEN
SHOWN TO BE EFFECTIVE FOR.
That is what Caronia and his colleagues were charged with and most found
guilty for except until the court made its weird first amendment
interpretation.
So, if one is using generic or brand name drugs off-label, they can continue
to do so JUST REMEMBER THAT BEING OFF-LABEL MEANS THAT
THERE IS NO EVIDENCE THAT THEY ARE EFFECTIVE FOR WHATEVER
IS BEING TREATED.
Remember: think.
And now we've gotten Walmart and cannoli into the mix! Either stop the
insanity or pass me a cannoli.
-Mike Palij
New York University
[email protected]
P.S. The singular form of cannoli is cannolo but Americans treat cannoli
as singular and wind up using cannolis for the plural. Since I'm not one
of those anal-retentive APA style perfectionists, it don't make no never
mind to me. For more on Cannoli, see:
http://en.wikipedia.org/wiki/Cannoli
Mmmm, cannoli! ;-)
------------- Original Message ---------------
On Tue, 08 Jan 2013 14:53:16 -0800, Ken Steele wrote:
Hi Joe:
One difficulty I have with evaluating your argument is that I
don't know the specific details of your case. This is not a
call to reveal private details but it is difficult for me to plumb
your benefit/danger ratios without details.
I think Mike P's point is that dealing with Big Pharma is like
dealing with Walmart, an aggressive and well-financed
organization with a clear goal. Your point is that the entire
world is not all like Walmart, or that there are good deals
to be had at Walmart if you are a smart shopper.
Both seem plausible positions, but are we talking about canoes
or cannolis?
Ken
PS - Sorry to all who must live with a Walmart analogy; it is
my world and there is not a fresh cannoli to be purchased in Boone.
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