First of all -- in the words of Obiwan Cannoli: NO ONE has just one cannola. And more seriously.... First, is this legal thinking or medical reasoning? Second, is this a weakness on the part of "Business Insider", or on the part of their readers and consumers in general? And third, this is assuming that the main motivation of the BioMed industry is curing disease.
On Jan 8, 2013, at 5:54 PM, Mike Palij wrote: > 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. > > > --- > You are currently subscribed to tips as: [email protected]. > To unsubscribe click here: > http://fsulist.frostburg.edu/u?id=13438.3b5166ef147b143fedd04b1c4a64900b&n=T&l=tips&o=22779 > or send a blank email to > leave-22779-13438.3b5166ef147b143fedd04b1c4a649...@fsulist.frostburg.edu Paul Brandon Emeritus Professor of Psychology Minnesota State University, Mankato [email protected] --- You are currently subscribed to tips as: [email protected]. To unsubscribe click here: http://fsulist.frostburg.edu/u?id=13090.68da6e6e5325aa33287ff385b70df5d5&n=T&l=tips&o=22782 or send a blank email to leave-22782-13090.68da6e6e5325aa33287ff385b70df...@fsulist.frostburg.edu
