Wednesday, October 8, 2014

Zohydro Update, A Year Later


Zohydro has been the subject of this blog before, Zohydro in the News Again (12.12.13), More Powerful Opiods Approved (11.13.13) and Zohydro and Closed Formularies (12.09.13). What has been referred to a "heroin in a pill" has generated much discussion, some litigation, and the story continues. You can read about it on CNN ("genuinely frightening"), Forbes ("just too dangerous?"), the Wall Street Journal and even High Times ("Heroin Pill"). 

The short story is that the Food and Drug Administration approved Zohydro about a year ago. The FDA approval process involves review of medication by panels of experts. The panel in this instance recommended against approval, 11 to 2. The FDA disregarded their expert's recommendation and approved the drug.

Late last year, the Attorneys General of 29 jurisdictions (including Florida) wrote a letter to the FDA and asked them to reconsider its approval. They expressed their concern and belief that the "approval of Zohydro ER has the potential to exacerbate our nation's prescription drug abuse epidemic." They noted that Zohydro is five to ten times more potent than other opiods, and that it lacks "abuse deterrent properties."

More recently, it is now reported that the FDA approval "has been nothing but 11 months of aggravation for the agency and its leader." Fiercepharma reported last month that anti-addiction groups are now calling on FDA Commissioner Margaret Hamburg to resign. They express their frustration with "the FDA's continued approval of new, dangerous, high-dose opiod analgesics that are fueling high rates of addiction and overdose deaths."

These advocacy groups are addressing their concerns and the call for Hamburg's resignation to her boss, the Secretary of Health and Human Services. According to Fiercepharma, the FDA acknowledges that opiod abuse is "a serious issue," and committed that Secretary Burwell would provide a response to their letter. 

According to Workcompcentral (WCC), the coalition calling for resignation is comprised of "70 advocacy groups." They marched on Washington September 28, 2014 to express their views. Medical Daily reports the call is from "the National Coalition Against Prescription Drug Abuse and 15 other anti-addiction groups." That number is echoed by American Health Line, while other sources like The Fix, and In Pharma, reference more generally "over a dozen groups." According to the "Fedup" website, the Workcompcentral number would appear to be more accurate. 


According to Workcompcentral (WCC), the FDA response to the criticism of the agency and leadership appears to be "an article in a prominent medical journal defending its (FDA) approval of" Zohydro. This article purportedly states that Zohydro is a minimal portion of the market. According to WCC, the journal article says that "in July 2014 . . . there were 3,588 outpatient retail prescriptions dispensed." This "represents .23% of the 1.6 million ER/LA opiod analgesic prescriptions and 0.02% of the nearly 18 million prescriptions dispensed for all opiod analgesics during the month."

Pause a moment and let that sink in. If you are inclined to skip over these statistics because they support Zohydro is such a small percentage (.23% or .02%), fine. But note that in one month there were "nearly 18 million prescriptions dispensed" for opiod analgesics. According to the census bureau, there are 316,128,839 Americans. of those, 74,181,467 are under 18 years old. So there are 241,947,372 adults. That 18 million prescriptions means that about 7.5% of American adults had an opiod script dispensed in July 2014.

The comments to the Fiercepharma story are on both sides of the issue. Some advocate that the decision of taking opiods should be strictly up to the patient. Some argue that opiods are the only alternative for those with unrelenting pain. Others argue that there are better alternatives to treat pain. 

Recently, a group of neurologists joined the debate expressing their conclusion that opiods are a bad choice for most chronic pain. 

The American Academy of Orthopedic Surgeons published a September 2012 story, Can I have a Refill on My Percocet, which describes the dilemma some physicians perceive in the opiod debate. 

With the volume of people concerned ("70 advocacy groups"), it seems unlikely that either the Zohydro debate or the national opiod discussion will disappear anytime soon. Some estimate that "2.1 million Americans suffer from substance abuse disorders related to prescription opiod pain relievers." The U.S. is not alone. Canadians are hearing about the supply of opiods also. 

What are the alternatives for the treatment of pain? What are the costs, monetary and human, of the current pain situation and those alternatives? What role will the FDA play in the debate and the ultimate decisions? The Zohydro story does not seem to be going away and watching it, and the larger opiod debate, play out will be interesting. The effects on injured workers, regardless of the outcome of the debate, may be profound. 

Update 10.11.14: On October 10, 2014 Workcompcentral reported that Arizona will start its efforts toward comprehensive treatment guidelines with adoption of the "chronic pain and opiod sections of the WLDI Official Disability Guidelines." Another story Friday reported that Tennessee's Medical Advisory Committee is drafting protocols "with an emphasis on tapering of opiods and other pain drugs."

Could there be a trend developing towards uniformity in dealing with opiods?

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