In recent weeks a lot has been said and written about potential pain medication abuse. Lawmakers and policy makers with their own agendas have unfairly painted legitimate patients in need of chronic pain relief as if they are all addicts. This has happened as a result of the one-side public debate around Zohydro ER, an FDA-approved prescription hydrocodone medication developed specifically for the estimated 2.4 million Americans with unrelenting pain who cannot tolerate acetaminophen, an ingredient found in all other hydrocodone products and many other pain relievers and sleep aids. This treatment is no more powerful than others already on the market. Unfortunately, much of what has been written and said is inaccurate and the facts have been lost. As a consequence, the voices of those suffering with pain have not been heard.
Massachusetts’ recent ban on Zohydro® by Governor Deval Patrick (aka Dr. D. Patrick), labeling it as a Schedule I drug in opposition to the FDA’s classification as a Schedule II is particularly hypocritical since this category includes drugs with no medical use. Patrick’s MA Controlled Substance Registrants are prohibited from prescribing, stocking or dispensing Zohydro. [See Prohibition of prescribing and dispensing of any hydrocodone bitartrate product in hydrocodone-only extended-release formulation]. If one is to believe that hydrocodone and morphine are mg for mg equivalent, it begs the question of why “Dr. Patrick” allows morphine extended release products or perhaps even more dangerous, the generic non-abuse deterrent form of oxymorphone ER.
Ironically though , Massachusetts is a state that allows marijuana use which is opposed by the federal government.
Because of this, I approached Commander John Burke to comment on these issues from the perspective of law enforcement. Aside from his many accolades and current positions (detailed below), he is Commander, Greater Warren County, Ohio, Drug Task Force and President, Pharmaceutical Diversion Education, Inc.
Commander John Burke writes…
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 as indicated above 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, body that has been appointed to decide what medications are safe, effective, and have value to an identified group 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 IR 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 of course, 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) in this country is deemed 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.
Commander Burke has been a law enforcement officer for over 45 years. He spent 32 years with the Cincinnati Police Department, working in uniform patrol until he was promoted to detective. He then spent several years investigating homicides, rapes, and child sexual assaults and abuses. He was promoted to the rank of sergeant and was ultimately assigned to the Internal Investigations Section. In 1990, he was asked to form and institute the department’s Pharmaceutical Diversion Squad (PDS).
After retiring from the Cincinnati Police Department, Commander Burke accepted a new position late in 1999, and continues as the head of the Greater Warren County Drug Task Force in southwest Ohio. The drug task force investigates the illegal distribution of both licit and illicit drugs. In 2004, he became the commander for the Southern Ohio High Intensity Drug Traffic Area (HIDTA) for major drug case initiatives and interdiction.
Commander Burke has provided education and lectured across the United States to law enforcement and health professionals on the topic of prescription drug abuse. He has published numerous articles on the topic, and has written a monthly column for the past 10 years in Pharmacy Times magazine on pharmaceutical diversion.
He is the president of the National Association of Drug Diversion Investigators a non-profit organization, and is the owner and president of Pharmaceutical Diversion Education Inc., a company which provides education and consulting work on a wide variety of prescription drug abuse issues to law enforcement, health professionals, and the pharmaceutical industry.
DISCLOSURES: Commander John Burke serves on the Safe Use External Advisory Board for Zogenix, the maker of Zohydro®. He was put on the board to assist in providing Zogenix with a third party law enforcement liaison to help postulate risks in an attempt to mitigate diversion of Zohydro®.