Home › Blog › We Need Another Nasty High Dose/Long Acting Narcotic Like a Hole in the Head

The FDA just approved the latest ultra-high dose narcotic. The pill will pack huge amounts of the painkiller hydrocodone in a single pill. We need this drug like we need gaping holes in our collective heads. Let me explain.

This weekend I kept seeing the same commercial. A dour looking elderly woman can’t play with her grand kids because of back pain. She then pops a pill and her back pain is better, gets a big smile, and plays with those darn grand kids! As someone who knows something about how to find the cause of back pain and treat those root causes, I was appalled. Not that she got to play with those little ones, but because pain is a signal telling us there’s something wrong that needs to be fixed and anything that promotes the concept that you can just pop a pill and mask it while you injure this area further is bad medicine.

One of my favorite authors, Issac Asimov, used to say that “Violence is the last resort of the incompetent”. My application of his quote to pain management is that “Pain Pills are the last resort of the incompetent physician”. What I mean by that, is like violence (i.e. war), there are times when you have to protect yourself, but recognizing that it’s because you screwed up somewhere else is part of the process of preventing future violence. The same holds true for pain medications given to somebody with chronic pain. While a physician may have to prescribe these drugs sometimes, he or she also needs to see it as abject failure so that the physician can learn enough to avoid the medications in the future.

FDA Zohydro Approval

This morning I was greeted with the news that the FDA has just approved yet another ultra-high dose long acting narcotic pill. As if the tragedy of Oxycontin wasn’t enough? This one of course again has no technology to keep addicts from crushing it up and abusing it. As a result, the FDA approval panel, an institution known to be stocked with industry insiders, voted 12-2 to not approve it! Somehow the drug got approved anyway. Why and how?

The why of the approval decision makes no sense. The company that will now make billions said that it was good for doctors to have a long acting version of the popular short acting pain killer Vicodin. As a physician, this is stupid. We already have long acting morphine, oxycodone, hydromorphone, and fentanyl. Did the FDA want to complete the set like some kind of deadly trading cards by adding hydrocodone? We need a fifth choice like we need another call from the coroner’s office that yet another patient was found dead in their sleep because they happened to add a few social drinks on top of their pill that packs the equivalent of 20 Vicodin tablets. As a result, MedPage Today wrote a poignant op-ed on the decision this morning. 

The “how” is even more interesting. The approval panel voted 12-2 to kill the drug, but somehow it was approved anyway. When you add the “why” to this calculus, you can be left with only on inescapable conclusion-it was an influence game. Also note the red arrow above from a company advertisement. It points to the statement, “PDUFA Date March 1, 2013”. This is the date that the company paid large sums of money to the FDA under the Prescription Drug Users fee Act (PDUFA). The concept behind PDUFA was supposed to be that by Pharma funding FDA’s drug approval process this would shorten approval times, instead it has turned the agency into a commercial interest.

The upshot? This is a dangerous move by FDA to approve another Oxycontin like drug that isn’t needed. It’s even nuttier that the drug doesn’t have any technology to prevent abuse and that the approval panel voted overwhelmingly to kill the drug.

Chris Centeno, MD is a specialist in regenerative medicine and the new field of Interventional Orthopedics. Centeno pioneered orthopedic stem cell procedures in 2005 and is responsible for a large amount of the published research on stem cell use for orthopedic applications. View Profile