After an eventful summer, and my short hiatus from blog writing, Dr. Lawhern agreed to kick off the academic year with our first post of the year. I’m sure you will all enjoy this hot topic. Please welcome guest blogger Richard A. Lawhern, Ph.D.
As a subject matter expert on public policy for opioid analgesic therapy, I have been deeply frustrated over the purported opioid crisis during the past three years. I have seen the grievous harms being worked by government bureaucrats who refuse to correct their own errors and biases. The 2016 CDC guidelines on opioid prescription in chronic pain — and misdirected doctor persecutions carried out by the Drug Enforcement Agency — are responsible for driving significant numbers of doctors out of pain management practice and denying pain relief to people in agony as memorialized at these three links.
Although CDC does not appear to be collecting suicide data specific to the denial of pain treatment, I read patient and family reports in multiple chronic pain community groups every month that seem to support this. Although we do not have definitive National statistics, several case reports show trends that deserted patients have committed suicide because of provider abandonment, unrelenting pain, rapid opioid tapers, or a combination of all three.
Government bureaucrats have been informed repeatedly of their errors in public media. But they are passively refusing to do anything to correct course.
I’ve corresponded with senior officials at the US FDA, the Department of Health and Human Services, the National Institutes on Drug Abuse, and the Centers for Disease Control and Prevention. I’ve spoken in public hearings of the FDA Opioid Policy Steering Committee and the HHS Inter Agency Task Force on Best Practices in Pain Management. Some agencies have acknowledged my e-mails or sent me politely dismissive responses. At least one official at CDC has outright lied to me in writing. None have engaged with the issues on merit.
Perhaps as Samuel Johnson informs us, “when a man knows he is to be hanged in a fortnight, it concentrates his mind wonderfully.” Though it is considered bad form to call governmental officials liars to their face, I don’t believe it is slander toward a public figure when it’s true.
My argument with the CDC, FDA and HHS revolves around three basic assumptions that shaped the work of the consultants group that wrote the CDC opioid guidelines. All three of these assumptions are fundamentally in error, but our government is stone walling to avoid admitting their errors. See Are Prescription Opioids Driving the Opioid Crisis? Assumptions vs Facts.
1. It is claimed by multiple State Attorneys General and in much of popular media, that America has a “prescription opioid crisis” caused by doctors who naively over-prescribed opioids to their patients, who then became drug dependent and later addicted. Neither the CDC data nor the National Institutes of Drug Abuse support this.
2. It was also claimed in the CDC Guideline, that opioid pain relievers don’t work for long term management of severe pain. Multiple published studies and over 1.6 million patients maintained on doses over 200 MMED, reported by the Department of Health and Human Services in their 2017 Drug Outcomes Surveillance Report disprove this claim.1-3
3. Finally, it was claimed in the CDC Guideline that safe and effective non-pharmaceutical alternatives for pain management exist and are preferable to opioids. Details of a major outcomes study of the US Agency for Healthcare Research and Quality conclusively disprove this claim, even while asserting that unproven non-opioid therapies should be tried as substitutes for proven opioid analgesics.4
Let’s examine these assumptions:
Was the Opioid Crisis Created by Over Prescription?
Published data of the CDC itself disprove this assertion. When State by State rates of doctor prescriptions for opioid pain relievers are compared to rates of opioid overdose related mortality, we find no relationship at all. Any contribution by medically managed opioids is so small that it gets lost in the noise of illegal street drugs that include opioids from licit and illicit sources, with or without other sedative hypnotics including alcohol.
If prescription opioids were substantially contributing to opioid-related deaths, then we should see higher mortality rates in groups which use more prescriptions. But this doesn’t happen, as seen in Analysis of US Opoid Mortality and ER Visit Data [CDC Wonder and AHRQ HCUP-US Databases. Opioid-related deaths among youth and young adults have skyrocketed since 2001, largely because of illicit fentanyl. But opioid deaths from all sources among people over 50 have been stable. Seniors are prescribed opioids about 250% more often than teens. Thus, the group that benefitted most from liberalized prescribing policies of the early 2000’s has shown no increased mortality due to opioid drugs from all sources as seen in the link immediately above.
Also compelling is a direct quote from Dr Nora Volkow, Director of the National Institutes on Drug Abuse:
“Unlike tolerance and physical dependence, addiction is not a predictable result of opioid prescribing. Addiction occurs in only a small percentage of persons who are exposed to opioids — even among those with pre-existing vulnerabilities… Older medical texts and several versions of the Diagnostic and Statistical Manual of Mental Disorders (DSM) either overemphasized the role of tolerance and physical dependence in the definition of addiction or equated these processes (DSM-III and DSM-IV). However, more recent studies have shown that the molecular mechanisms underlying addiction are distinct from those responsible for tolerance and physical dependence, in that they evolve much more slowly, last much longer, and disrupt multiple brain processes.”
Do Opioids Work Long Term for Chronic Pain?
Writers of the 2016 CDC guidelines “stacked the deck” against opioid therapy by unfairly rejecting any opioid trials conducted for less than a year, but including much shorter trials for non-opioid medications and behavioral therapy. They got caught at this fraud by their medical peers.
Are Safe and Reliable Substitutes for Opioids Available?
While it is appropriate for doctors to try non-opioid medications first before proceeding to opioid therapy, anti-inflammatory drugs have their own problems and side effects mostly related to gastrointestinal bleed, kidney dysfunction, and cardiac risk. Additionally, there are inherent toxicities and contraindication to all medications, including but not limited to various anticonvulsants, noradrenergic reuptake inhibitors such as certain antidepressants, anticonvulsants, skeletal muscle relaxants, and others.
In June 2018, the US Agency for Healthcare Research and Quality published a systematic outcomes review for non-invasive, non-pharmacological therapies in chronic pain. Among 4996 published trial reports for six categories of chronic pain, only 218 survived rigorous quality review. Quality of medical evidence was “weak” in more than 150. . However, AHRQ flinched from admitting the basic problem of the “alternatives” literature: none of the alternatives has undergone large scale Phase II or Phase III trials. Though most appear safe, we don’t know yet if they work any better than placebo.
The Bottom Line for the CDC
By resisting the imperative to perform an outcomes assessment for their 2016 opioid guidelines, the CDC is resisting a recommendation made by their own Board of Scientific Advisors, weeks before publication. If done fairly, such an assessment will likely establish that the Guidelines are destroying thousands of lives while protecting nobody. It is time to admit to their errors in a major rewrite and policy redirection.
As always, comments are encouraged and welcome!
Richard A Lawhern, Ph.D. is a technically trained patient advocate. His work has been published or featured in National Pain Report, Pain News Network, PainWeek, The Journal of Medicine of the US National College of Physicians, Practical Pain Management, and other online media.
1. Ballantyne JC, Shin NS. Efficacy of opioids for chronic pain. Clinical Journal of Pain. 2008;24:469-78.
- Rauck RL, Nalamachu S, Wild JE, Walker GW, Robinson CY, Davis CS, et al. Single-entity hydrocodone extended-release capsules in opioid-tolerant subjects with moderate-to-severe chronic low back pain: a randomized double-blind, placebo-controlled study. Pain Medicine. 2014;15:975-85.
- Milligan K, Lanteri-Minet M, Borchert K, Helmers H, Donald R, Kress H-G, et al. Evaluation of long-term efficacy and safety of transdermal fentanyl in the treatment of chronic noncancer pain. Journal of Pain. 2001;2:197-204.
- Lawhern RA, Nadeau SE. Behind the AHRQ Report – Understanding the Limitations of ‘Non-Pharmacological, Non-invasive’ Therapies for Chronic Pain”, Practical Pain Management, October 2018