I almost drove my car into a ditch yesterday as even my beloved National Public Radio (NPR) can’t seem to get the Zohydro story right. The recently approved long acting hydrocodone product has not even hit the streets yet but the misinformation, conspiracy theories and media warnings (“be afraid, be very afraid”) abound. NPR’s panel continued to give a voice to the anti-opioid fringe; the ones that never seem to let facts confuse them. Intellectual dishonesty rules the day. If you ever happen to be listening to someone from the far anti-opioid right bemoaning the overuse of opioids and they happen to spout out that the US uses 99% of the world’s hydrocodone without qualifying that we are one of the only countries that has it, then that should be your warning to take everything else they say with a grain of salt; that is the MALEATE version of prochlorperazine. You know they are trying to scare and overstate and mislead.
But in the end, the reasonable pain doc ended up providing a bit of disappointment when rushing toward the close of the show. While throughout the show he was on message, opioids have risks and benefits; we prescribe them trying to balance these based on risk stratification; we try to use tools and safeguards that are now available to us to monitor adherence and detect problems early like urine drug testing and prescription monitoring programs; we try to use a multi-pronged approach of which opioids are only one piece. All of his points were well-taken, perfectly reasonable and on point. All this while the anti-opioid fringe speaker continued over-stating risks, generalizing about how opioids are highly addictive to everyone and don’t work for anyone.
Whether or not anyone agrees that Zohydro should have been approved at all, or should have been approved as is (without abuse deterrent features) it was approved based on clinical trials data and a perceived need for an extended release hydrocodone product for people with pain. Conspiracy theories were plentiful intimating that the approval came in a smoke filled room between company executives and FDA personnel with questionable motives. PLEASE. The drug has been in development for years, the requisite trials were carried out and the company agreed to unprecedented post marketing surveillance and efforts to ensure safe use. In fact, the absence of acetaminophen alone is a beneficial step in the right direction for certain patients with hepatic issues or those receiving hepatotoxic drugs.
And then the clincher – a man calls in and states that we don’t need such highly addictive drugs when we have safe, proven efficacy in the form of medical marijuana. And the host asks the pain doctor if he agrees and he says somewhat tentatively that it does indeed have proven efficacy. Now, no one disputes that there is anecdotal and small “n” trial support for some medical uses of cannabis and some analogue cannabinoid drugs have shown promise in some neuropathic pain states in better trials. But to even remotely intimate that marijuana has been the subject of any trials with the size, scope and sophistication of even one of the pivotal trials conducted leading to the approval of Zohydro or any other FDA approved drug in the last decade, is to suggest that someone is smoking cannabis and not necessarily for medical purposes.
Disappointing to be sure; the medical marijuana lobby is making the same mistake that the opioid movement made, which is to argue for legalization or broader use by trivializing risk. Claiming the drug is safe across the board(er). No drug is. Every drug has risks and benefits. Vulnerable people encountering any drug at a vulnerable time, can have a bad outcome, and if we legalize cannabis, it should be because the majority in our democracy wants it to be legal, not because it is completely safe or effective for everyone. Just like people with pain sometimes have problems with loss of control of opioids because they have an exposure to a drug with abuse potential at a vulnerable time (stressed, hurting, isolated) which if combined with personal vulnerabilities (genetic, psychiatric, spiritual) can lead to problems, the same might be expected for a cannabis exposure for pain, especially when combined with other sedative-hypnotic drugs. The likelihood of this occurring to an individual should be calculated thus leading the prescriber to a weighing out of risks and benefits before cannabis would be used in that person, at that time, for their pain. A professional would need to be ready to intervene if disaster strikes, with addiction medicine expertise, time and tools to help. Oh and some reimbursement for their time doing so.
Alas all this talk about whether a given drug or group of drugs is safe or not and distracting everyone from fixing the problems of our healthcare system in the management of pain and addiction. And while we have been busy fiddling while Rome burns, CMS has been in the process of enacting a new local coverage determination (LCD) on drugs of abuse testing that threatens to castrate one of the most effective tools we have in the fight against drug abuse in and outside of the pain management setting. They are threatening to put all of their stock in a 35 cent outdated cup technology while employing it in a fashion that harkens back to the early days of urine drug testing as a forensic and vocational, not clinical, tool. Rather than fighting about whether the drugs are the problem, all of us should be expressing our outrage toward CMS and protesting their taking away of our discretion to use a tool that we value in ways that help our patients.
THIS IS THE FIRST OF TWO ZOHYDRO POSTS.
Another blog slamming a recent CNN Zohydro report is on the way. Whether or not extended release hydrocodone provides a useful therapeutic option is a very different question than whether or not is should be in an abuse deterrent formulation. While the media has successfully intertwined these issues, I will help to clarify in the next post.
And, as always, your comments are encouraged and welcome!