Saturday, October 2, 2010

FDA says NO to Colchicine and Tanezumab


The implications of the FDA's two far reaching actions last week can impact every doctor and patient in the world.

First, clinical trials of a drug were halted because it was "too good".  A potential drug for Osteoarthritis - Tanezumab, was stopped from development because patients were doing better than expected and as a result hurting their joints with increased activity. I can tell from my own patient's experiences that it worked well. And it is not even a narcotic.


http://www.bloomberg.com/news/2010-09-29/pfizer-arthritis-drug-cut-pain-too-well-leading-to-joint-damage-in-study.html

Second, in truly spinning the wheel backwards, FDA is removing generic colchicine from the shelves to make room for branded colchicine (Colcrys). The difference in price is 10 cents per pill vs $5 per pill. Colchicine has been around for more than a few decades, in fact more than a century in some form or another. Now a drug company decides to manufacture it as a branded drug and go through FDA's approval process. How does that make the old generic drug any more dangerous? I am asking my patients to stock up on the generic while it is still around...and I am determined not prescribe Colcrys ever.



I am baffled by these two announcements. What are they trying to do? Will the FDA now remove ALL pain killers - such as Morphine for being too good , and ALL unapproved old drugs - such as Aspirin for being dangerous?  
Perhaps they could have approved Tanezumab with the same warning as they have on cigarettes - "Taking Tanezumab can be injurious to your health"....


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