A Government In Disarray Over Opioid Therapeutic Use vs. Addiction

As a reader of this blog, you are probably already aware of the many shouting voices of government Agencies trying to get in on the action concerning the so-called “opioid crisis” in the US. As pharmacist Steve Ariens pointed out to me recently, it seems like everybody wants to pursue their own agendas. And none of the agendas match up.

The recently fired and replaced Surgeon General Vivek H. Murthy has stated that addiction is a mental health disease rather than a moral failing. That didn’t keep him from writing every General Practitioner in America to advocate for restriction of opioid prescribing to pain patients, in favor of non-opioid medications or behavioral therapies. The unfortunate reality of such “alternatives” is that for the great majority of people in severe pain, they simply don’t work and should never be regarded as a replacement for opioid analgesics. When NSAIDs are part of the mix, they also increase risk of death by sudden cardiac arrest or liver toxicity. More people die from Tylenol and Ibuprofen every year than from opioid prescriptions under active management by a physician.

The CDC issued prescription guidelines in March 2016 which advocated for a threshold of risk at 90 Morphine Milligram Equivalent Daily Dose (MMEDD). When prescribing above that level, doctors were advised to evaluate risks and benefits before continuing opioid therapy. Unmentioned in the Guidelines are serious problems of consistency in computing MMED for some medications. Likewise, because of natural genetic variability, there are tens of thousands of pain patients in the US who need dose levels above 200-400 MMED in order to get any pain relief at all. And although the Guideline was phrased as voluntary, Congress made compliance mandatory for the Department of Veterans Affairs a full four months before CDC published. Multiple US States have legislated limits on prescribing. Tens of thousands of patients are being plunged into agony, unsupervised opioid withdrawal and disability as their doctors are driven out of practice or choose to deny them the medications they need.

The FDA in its turn held a Workshop in May 2017 to plot a way forward on educating physicians in pain management and safe prescription of opioids. Unfortunately for their good intentions and unknown to most of the bureaucrats who attended, there is effectively no accepted standard of practice in which doctors can be educated. The CDC guidelines are widely understood by medical professionals to be unscientifically biased against opioids, grounded upon very weak science or personal opinions, egregiously incomplete and actively dangerous to patient health and welfare. Hundreds of published papers and articles reveal the guidelines to be, in the words of one title, “simple, plausible, and generally wrong”.

Insurance companies have also gotten in on the act. In a transparent effort to reduce their costs, companies lobbied the US Centers for Medicare and Medicaid to impose payment restrictions on pharmacies which dispense opioid analgesics, using what are called “soft” and “hard’ audits. Pharmacists will be forced to contact the prescribing doctor to confirm any prescription above 90 MMED as medically necessary, before dispensing. A lengthy and contentious process of back and forth argument will be imposed for doses over 200 MMED. At the very least, this will result in many patients facing days of delay after they have run out of their prescriptions. Predictably, it will drive even more pharmacies to stop carrying these drugs than have already.

Now comes the most recent insult to intelligence and common sense. Attorney General Sessions is lobbying Congress not to renew the Rohrabacher-Farr Amendment which restricts DEA from spending money to prosecute marijuana cases in States where medical marijuana is legal. Sessions wants to prosecute marijuana dispensaries and harass them out of business.

Contrast this initiative against recent published findings of the US National Institute on Drug Abuse in “Is Marijuana Safe and Effective as Medicine?” (April 2017). As NIDA reports, an analysis by the RAND Corporation, has shown that:

“…legally protected access to medical marijuana dispensaries is associated with lower levels of opioid prescribing, lower self-report of nonmedical prescription opioid use, lower treatment admissions for prescription opioid use disorders, and reduction in prescription opioid overdose deaths. Notably, the reduction in deaths was present only in states with dispensaries (not just medical marijuana laws) and was greater in states with active dispensaries.”

A Presidential Commission on “Combating Drug Addiction and the Opioid Crisis” was scheduled to meet on Friday June 16th, to add its voice to the general clamor. Led by Governor Christie, and lacking any sitting members with medical background as practitioners, the Commission has already published its intended schedule for generating a report to President Trump. The draft report is to be reviewed on June 26th, 2017 — ten days after the first working meeting!

On such a schedule, I’d give 100 to 1 odds that the fix is already in. We should anticipate more of the “war on drugs” mentality from politicians who don’t have a clue! Despite having been allowed to comment by email to the National Office of Drug Control Policy, pain patients will have no effective voice in the outcomes, whatever they turn out to be and however many people are carelessly harmed.