How Many is Too Many? Off-Label Uses and RX Drugs

J0321092 There was a lot of coverage as well as sturm and drang about a study published by the Archives of Internal Medicine regarding the off-label use by prescribers of medications.  According to the report, there should be further study to see if off-label use of drugs doesn’t present a safety issue.  That seems logical and straight forward.

But the media coverage of this study tended to be a little more sensational.  One article stated "that 1 in 7 prescriptions were written without good medical evidence that they would work."  That seems very much like a conclusion reached prior to any further study to see if off-label use doesn’t present a safety issue. 

I contest that.  In my experience, physicians don’t write off-label prescriptions for the hell of it, they write them because they have, through their own study and experience, determined that there is a good, sound reason for doing so.   It is that e3xperience which would seem to be "good medical evidence" in my mind. 

I have sat through more advisory committee meetings than I care to count.  I have watched advisory committees allow drugs to the market, only to judge later that they should be taken off, only to judge later that they should be placed back on the market (Lotronex, e.g.).

I have seen advisory committees refuse an OTC switch for Zovirax because they believed that physicians examined patients with herpes to determine the infection before prescribing (they don’t). 

I have seen advisory committees have hours of discussion based on the belief that physicians follow treatment guidelines to the letter (they don’t). 

I have seen the FDA put a Black Box Warning on a label because of a demonstration of cancer in rats, only to remove it later when it appeared to be species specific and when the drug became the world’s most prescribed drug (omeprazole).

So frankly, I don’t see why I should judge the decision of my physician any less.  Actually, the "1 in 7 " was a figure I thought low, but the media attention seemed to think was terribly high, glom onto it and make some conclusions with their reporting I don’t think were justified by the nature of the study

After all, look how many uses aspirin has.  I can imagine that there are many other drugs that have multiple benefits.  In fact, there are many drugs out there that are found to be good for another ailment, even though they were originally investigated for another condition (Rogaine). 

My bottom line is this:  I’m not alarmed by the statistic that 1 in 7 drugs prescribed are for off-label use.  In fact, I think it is good.  It shows that there is innovation out there that is beyond the single-minded system of the FDA – one based on real, rather than theoretical experience.  Many of the articles stated that "good science" is lacking in these off-label uses.  I would say it differently – I would say that "different science" applies to off-label use.  It is the science of the physician’s experience and practice.  I’m not sure I trust it less or more than the FDA’s method.  I think we need them both. 

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