Tuesday, December 3, 2013

Off Label Use of Medical Products Increasing: Is Using a Prostate Product on Your Brain a Good Idea?

English: Logo of the .
English: Logo of the . (Photo credit: Wikipedia)
As reported by the StarTribune, the use of off label medical products is increasing rapidly.  While the FDA regulates the approved use of medical devices, physicians have complete discretion to use medical devices in any way they think it will help their patients. This discretion comes with risks.  Just ask the women who got surgical mesh for incontinence.  The FDAs oversight only applies to device makers, not physicians.  The FDA repeatedly says its not our place to say how patients should be treated.

So, what gives.  First, progress in technology requires risk.  That's a fact.  However, the rub comes when the risk is not relayed to the to patients, damage occurs, and everyone points their finger at someone else.  In theory, all too often it plays out as follows.  A new use for a product is developed.  Medical device manufacturers improperly market for off label uses--- it just happens---because there is too much money at stake. Physicians are told by the cute sales reps who bring lunch literally every day how great this new off label use is of the product.  The physician, who enjoys those great, all expenses paid educational trips to exotic locations and the nice sales reps, start using the product in a manner not approved.

You know how the story ends.

If you are going to use me a Guinea pig, then tell me that you are going to use me as a test case and let me decide if my condition, my pain, etc is such that I am willing to take the risk.  Is that really too much to ask?

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