Everyone knows the dangers and no one is doing anything about it.
Given that Colorado has the second highest pain pill abuse rate in the country, it’s shocking that Colorado’s much beloved Attorney General John Suthers was not on the list of 28 attorneys general who in December 2013 signed a very short-and-to-the-point letter addressed to Commissioner Margaret Hamburg with the U.S. Food and Drug Administration strongly urging her and the FDA to reconsider their recent approval of Zohydro.
According to a December 2013 Journal Sentinel article, Zohydro, an opioid painkiller and an Alkermes product, contains 10 times more opioids than traditional hydrocodone products. It’s also crush-able which means people will be able to snort it, or worse, shoot it.
According to Dr. Andrew Kolodny, M.D., Chief Medical Officer of Phoenix House and President of Physicians For Responsible Opioid Prescribing, one capsule of Zohydro will pack enough hydrocodone to kill a child. An adult lacking a tolerance to opioids could overdose from taking just two capsules.
In their letter, the 28 attorneys general said that they did not want a repeat of the recent past when potent prescription painkilling drugs entered the market without abuse-deterrent formulas and without clear guidance on how they were to be prescribed. (One form of abuse deterrence, for instance, is cutting hydrocodone with acetaminophen.)
They went on further to say that the unchecked release of these painkillers “created an environment whereby our nation witnessed a vicious cycle of overzealous pharmaceutical sales, doctors overprescribing the narcotics and patients tampering with these drugs, ultimately resulting in a nationwide prescription drug epidemic claiming thousands of lives.”
Acutely aware of of these dangers, the FDA’s own advisory committee voted 11-2 against approving Zohydro for public release. Nevertheless, the FDA and Alkermes are plunging forward – public health be damned.
It will be interesting how the rollout of Zohydro proceeds over the next coming months. I would bet that the actuaries for Alkermes have already calculated that the risk-reward balance weighs in their favor, notwithstanding the inevitable high number of wrongful death suits that will surely coincide with Zohydro’s rollout.
We’ll see if Alkermes goes down the same road as Purdue Pharma did with oxycontin in 2007, but it seems to me that the simpler thing to do would be for the federal government to step in and do the right thing: stop this dangerous, killer drug.
September 2014 Update:
Governors from Massachusetts, Vermont, New Hampshire, Rhode Island and Connecticut are urging the FDA to rescind its approval of Zohydro, arguing that the prescription painkiller should be yanked because of an “epidemic” of opioid addiction that is spreading through their states.