(Editor’s note: John Burke is president of National Association of Drug Diversion Investigators and Pharmaceutical Diversion Education Inc., which provide educational and consulting services on prescription drug abuse issues to law enforcement, health professionals, and the pharmaceutical industry.
Mr. Burke also serves on the Safe Use External Advisory Board for Zogenix, the maker of Zohydro, for which he receives compensation.)
Recently, the state of Massachusetts governor declared through an emergency order that single entity hydrocodone products could not be sold in his state. This eliminated Zohydro and any specialty compounding of the drug for patients. This of course is long after the FDA approved the extended release analgesic as a Schedule II controlled substance.
A few days before, an Ohio legislator introduced a statute to change the drug to a Schedule I in my home state, a category that means “no medical use”. All of this was done without a single dose of Zohydro being sold or diverted!
This is an incredibly slippery slope when government decides that they will ignore the FDA, a body that has been appointed to decide what medications are safe, effective, and have value to an identified group of patients.
With the abuse of opioid medications in the 15%-20% range, 80-85% of legitimate patients are denied this choice in these states. Why not eliminate hydrocodone sales altogether, and while they are at it, remove oxycodone 30mg tablets that are being abused nationwide in part as a fallout from the reformulation of OxyContin?
Of course all of this is absurd in my opinion, and you have to wonder who, if any, healthcare professionals were consulted before moving forward with these actions. Scare tactics and the “sky is falling” type rhetoric helped to drive these decisions. In addition, news reports of the endless junkies this new drug will cause are simply unfounded.
More likely, from my experience, those that will end up abusing Zohydro are those that are already addicted to an opiate or abusing it. Other hydrocodone, oxycodone, oxymorphone, hydromorphone, morphine or heroin addicts would be the most likely abusers of an extended release hydrocodone single entity drug.
However, if you listen to some critics, this drug will bring addicts out of the woodwork!
Apparently we have a whole host of “would be” opiate addicts that have been waiting for the day an extended release, single entity hydrocodone hits the market so that they can start their life of misery and ultimate death. If you believe that, I have a very long bridge in Brooklyn to sell you!
I don’t believe anyone thinks the FDA is perfect. However, they are the federal body that determines the safety and efficacy of drugs in our country, and by and large does a good job. I don’t want politicians deciding that a drug the FDA approved for pain patients (or any patients) is too dangerous to distribute to the public, especially when it was launched less than a month ago and no diversion has yet been reported.
The FDA continues to stand strong that marijuana is not for legal consumption (with the exception of prescription Marinol, aka dronabinol), regardless of the actions by several states to either make it a legitimate medicine or allow recreational use. Although I certainly don’t oppose the FDA approved use of THC products that are deemed effective for medicinal use, I would like to see the current U.S. Attorney enforce the laws on the sale and possession of marijuana.
If the FDA would decide to approve marijuana in any of its abuseable forms and declare it a legitimate pharmaceutical, then it should be dispensed only out of legitimate pharmacies by a registered pharmacist. Somehow marijuana legalization entities are not excited about that prospect.
The bottom line is that the primary focus of health professionals and law enforcement should be the protection of legitimate patients and their access to bona fide pain medications. Every time a prescriber or dispenser of pharmaceuticals is deceived by a drug-seeker, it can potentially have a negative impact on the legitimate patient.
Therefore, I continue to propose an aggressive pursuit of those involved in pharmaceutical diversion while the prescribers for legitimate pain patients are given all of the legal tools in their toolbox to address the issues of pain. Taking that option away from prescribers will not reduce the number of addicts in this country, but it may negatively impact pain patients.
(Mr. Burke’s column was originally published in paindr.com)