I would like to take a moment to thank Mr. Richard Lawhern for a very well written article on the subject of chronic pain, pain control, pain medication, how they all work into the 2016 CDC Guidelines and most importantly how those guideline affect us the “non-addicted part of the population who use these medications for pure pain control and to help us live our lives. Thank you sir.
November 9, 2019 • 5 Likes • 0 Comments
Richard Lawhern Subject Matter Expert in Chronic Pain Support Groups and Public Policy
In October 2019, the US Agency for Healthcare Research and Quality released a draft report for 30-day public comment, via their own website, with a deadline of Tuesday November 12th. I have commented twice at length. My initial comments are summarized in an article by Pat Anson on Pain News Network, titled “Feds Using ‘Cone of Silence’ Again for Rx Opioid Review November 06, 2019″ at,
The following is my second paper (~2200 words). I believe those who follow my work in patient advocacy on Linked In and in social media may find this of interest.
Abstract:
As issued by the Agency for Healthcare Research and Quality, the draft 2019 comparative outcomes study for “opioid treatments for chronic pain” suffers from the same unsupported assumptions, deliberate omissions, errors of interpretation and cherry picking of research that characterized the original 2013 review that it is intended to replace. The report is fatally flawed and must be immediately withdrawn without replacement. AHRQ owes the public and millions of people in pain a public apology for its malfeasance and misdirection.
A vernacular observation sums up the substance of this report rather well, if pointedly: you can dress up a pig in silks and put a golden crown on his head… but beneath the ornaments, he remains a pig.
About the Author
I have previously entered general comments to this draft report by email to the public comment address identified by the Agency for Healthcare Research and Quality. The present entry continues and expands upon those remarks.
I speak and write as a subject matter expert on public policy for regulation of prescription opioid medications, with 23 years’ experience moderating chronic pain forums in social media and tens of thousands of contacts with pain patients, caregivers, and medical professionals. I have over 75 published articles and papers in this field, some co-authored with medical professionals (two of whom are on CC as references) . I have addressed FDA public meetings on the training of pain management physicians, the FDA Opioid Policy Steering Committee, and three public sessions of the HHS Task Force for Pain Management.
Some elements of the discussion below are edited from published work co-authored with Andrea Trescot, MD, and/or Stephen E Nadeau, MD. However contents of the discussion below are solely the responsibility of the author.
Discussion
Beginning immediately in the Evidence Summary, this draft report shows clear evidence of being written to a political agenda.
Extract from the report: “Opioids are often prescribed for chronic pain. In the United States, prescription of opioid medications for chronic pain more than tripled from 1999 to 2015. [5] This increase was accompanied by marked increases in rates of opioid use disorder and drug overdose mortality [5-7] involving prescription opioids.”
My Response: This is a classic example of the post hoc ergo propter hoc fallacy. While both assertions are generally true, neither is related to the other. It should also be noted that prescription rates have been dropping since 2010 and are now at levels not seen since 2006. From 2010 to 2018, overdose related mortality from all sources (legal or diverted prescriptions, illegal street drugs) more than doubled despite major reductions in prescribing.
It is now known beyond any reasonable contradiction that opioid mortality is not driven by doctors over-prescribing and never was. This is true despite the relatively poor training of many doctors in pain management, and the misrepresentation of medical opioids’ addictive potential for a few people, by pharmaceutical companies.
Reference: Jeffrey A Singer MD, Jacob Z Sullum, Michael E Schatman, Ph.D. “Today’s nonmedical opioid users are not yesterday’s patients; implications of data indicating stable rates of nonmedical use and pain reliever use disorder”, J Pain Res. 2019; 12: 617–620. Published online 2019 Feb 7. doi: 10.2147/JPR.S199750 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6369835/
Reference: Richard A Lawhern, Ph.D., “Over-Prescribing Did Not Cause America’s Opioid Crisis”, Lynn Webster, MD BLOG March 30, 2019, http://www.lynnwebstermd.com/over-prescribing/
In 2017, according to published data of the CDC, medical opioids were prescribed six times more often to seniors over age 62 than for youth under age 19. But overdose related mortality in youth is six times higher than in seniors. Overdose mortality in seniors has been largely stable for 20 years while skyrocketing in youth. This outcome cannot be attributed with any credibility to prescribing.
Report Extract: “In 2013, the Agency for Healthcare Research and Quality (AHRQ) commissioned a comparative effectiveness review on the effectiveness and risks of opioid therapy for chronic pain, focusing on studies with long-term (≥12 months) followup. [1] The review addressed the risks and benefits of opioids for chronic pain, dosing strategies, and risk assessment and risk mitigation strategies. The AHRQ report found insufficient evidence to show benefits of long-term opioid therapy for chronic pain, due to the absence of trials with followup of at least 1 year.’
My Response: This finding was prominent in the 2016 CDC Guidelines, and is equally misdirected. The absence of long term trials is an artifact of medical ethics: it is unethical to subject patients to abject pain by giving them placebos. Many will drop out of any long term trial due to breakthrough pain. There are alternatives to double-blind studies, notably enriched-enrollment trials, but little attention is given to these alternatives in the draft report.
Likewise unmentioned in this phrasing is the reality that long-term trials of non-opioid medications and behavioral therapies are equally as scarce as those for opioids. In layman terms, AHRQ and CDC have been caught with their fingers on the balance scales, in a deliberate and unconscionable effort to bias public policy against the use of opioid therapies regardless of the medical evidence. CDC violated its own research standards by failing to explicitly acknowledge that the medical evidence for alternatives to opioids is no stronger than for opioids. Now AHRQ proposes to compound that lack of public transparency.
Reference: Baraa O. Tayeb, Ana E. Barreiro, Ylsabyth S Bradshaw, Kenneth K H Chui, Daniel B Carr, “Durations of Opioid, Nonopioid Drug, and Behavioral Clinical Trials for Chronic Pain: Adequate or Inadequate?” Pain Medicine, Volume 17, Issue 11, 1 November 2016, Pages 2036–2046 https://academic.oup.com/painmedicine/article/17/11/2036/2447887
Every major conclusion of the 2016 CDC Guidelines has been challenged in public narratives on grounds of anti-opioid bias, lack of substantive science support, drawing of strong conclusions from weak or non-existent evidence and ignorance or omission of genetic factors which produce a very wide range of minimum effective dose levels in individuals. The draft AHRQ report ignores the many published contradictions to both process and content of the Guidelines.
Reference: Mark Edmund Rose, BS, MA “Are Prescription Opioids Driving the Opioid Crisis? Assumptions vs Facts“ December 17, 2017, Pain Medicine, Volume 19, Issue 4, April 2018, Pages 793–807, https://doi.org/10.1093/pm/pnx048
Reference: Stephen A. Martin, MD, EdM; Ruth A. Potee, MD, DABAM; and Andrew Lazris, MD, “Neat, Plausible, and Generally Wrong: A Response to the CDC Recommendations for Chronic Opioid Use” https://medium.com/@stmartin/neat-plausible-and-generally-wrong-a-response-to-the-cdc-recommendations-for-chronic-opioid-use-5c9d9d319f71
As noted by the American Medical Association (AMA) House of Delegates meeting of November 2018, MMED is not useful for anything more than the most general discussion and guidance on prescribing practice. This understanding prompted AMA to issue Resolution 235, quoted in full here:
“RESOLVED, that our AMA affirms that some patients with acute or chronic pain can benefit from taking opioid pain medications at doses greater than generally recommended in the CDC Guideline for Prescribing Opioids for Chronic Pain and that such care may be medically necessary and appropriate, and be it further
RESOLVED, that our AMA advocate against misapplication of the CDC Guideline for Prescribing Opioids by pharmacists, health insurers, pharmacy benefit managers, legislatures, and governmental and private regulatory bodies in ways that prevent or limit patients’ medical access to opioid analgesia, and be it further
RESOLVED, that our AMA advocate that no entity should use MME (morphine milligram equivalents) thresholds as anything more than guidance, and physicians should not be subject to professional discipline, loss of board certification, loss of clinical privileges, criminal prosecution, civil liability, or other penalties or practice limitations solely for prescribing opioids at a quantitative level above the MME thresholds found in the CDC Guideline for Prescribing Opioids.”
Reference: AMA House of Delegates, November 2018, quoted from Richard A. Lawhern, PhD, Stephen E. Nadeau, MD, and Andrea Trescot, MD, “Recommendations of the HHS Pain Management Task Force — A Response by Medical Professionals and Patient Advocates” June 2016, Practical Pain Management
Specifically, the AHRQ conclusion that non-opioid alternatives to opioid therapy are available and preferred is deeply contradicted by your own June 2018 AHRQ systematic outcomes review of non-invasive, non-pharmacological therapies. The state of medical evidence for effectiveness of such “alternatives” to pharmacological treatment is simply abysmal. No Phase II or Phase III multi-center trials have been conducted and no available trial now provides a scientifically sound evaluation of such alternatives as replacements for opioids.
If a quality assessment of individual studies and trials was in fact conducted for this report, then inclusion of the SPACE trial by Krebs et al suggests that the assessment was either deliberately biased or naive. The Krebs study was fatally flawed by inadequate titration of opioid doses, inclusion of trial subjects with medical conditions that are rarely treated with opioids, and incorrect definition of Tramadol as a “non-opioid” treatment. Co-prescription of anti-depressant medications with NSAIDS also likely introduced confounds; it is known that Tricyclic anti-depressants in themselves reduce neuropathic pain in some patients.
Ref: Krebs EE, Gravely A, Nugent S, et al. Effect of opioid vs nonopioid medications on pain-related function in patients with chronic back pain or hip or knee osteoarthritis pain: the SPACE randomized clinical trial. JAMA. 2018 03 06;319(9):872-82. doi: 10.1001/jama.2018.0899. PMID: 29509867.
Ref: Lawhern RA and Nadeau SE, “Behind the AHRQ Report — Understanding the limitations of “non-pharmacological, non-invasive” therapies for chronic pain.”. Practical Pain Management, V18 Issue 7, October 2018 https://www.practicalpainmanagement.com/resources/practice-management/behind-ahrq-report
It is truly alarming that the AHRQ review team has chosen to ignore the implications of major findings of the largest epidemiological study ever conducted on overdose-related deaths — despite having referenced the work.
In an analysis of a year of medical records for the entire population of North Carolina, Dasgupta, et al, identified opioid overdose mortality rates associated with both the population as a whole and with the two-million plus patients who were prescribed opioids by healthcare providers. Overdose mortality was estimated at 0.022% per year among those prescribed opioids — a rate significantly lower than commonly associated with preventative treatment of atrial fibrillation in post-stroke patients treated with modern blood thinners.
The same report indicates that nearly 2 million people got both a Benzodiazepine drug and an opioid, but only 386 died of an overdose where both were implicated in the span of 1 year. Every overdose death is a heartbreak; but the numbers clearly speak to a general safe use of the meds together, in direct contradiction to the conclusions of the AHRQ team.
Reference from the draft study:
Dasgupta N, Funk MJ, Proescholdbell S, et al. Cohort study of the impact of high-dose opioid analgesics on overdose mortality.[Erratum appears in Pain Med. 2016 Apr;17(4):797-8; PMID: 27025778]. Pain Med. 2016 Jan;17(1):85-98. PMID: 26333030.
The Commonwealth of Massachusetts also analyzed overdose mortality for two years in that State and found that mortality was dominated by self-administered poly-pharmacy employing multiple street drugs and alcohol. In only 1.3% of overdose-related deaths was the decedent found to have a current prescription for an opioid identified in postmortem tox screens.
Reference: Massachusetts Department of Public Health, “An Assessment of Opioid-Related Deaths in Massachusetts [2013-2014], Boston MA 2016.
Reference: Pat Anson, editor, Pain News Network, “Study Finds Only 1.3% of Overdose Victims Had Opioid Prescription October 18, 2019, https://www.painnewsnetwork.org/stories/2019/10/18/study-finds-only-13-of-overdose-victims-have-active-prescription-for-opioids
The AHRQ draft report is remarkable not only for the errors and biases which it uncritically includes, but also for its exclusion of discussions of genetic polymorphism in six key liver enzymes which govern opioid metabolism in the human liver. A well-known literature establishes that there is a very wide range in minimum effective dose levels from individual to individual, with millions of people being either poor metabolizers of opioid analgesics, or “hyper” metabolizers. AHRQ has had six years to correct this omission in its 2013 report, but has chosen not to address the subject. This choice further suggests that the Agency is operating under a political agenda that has little to do with medical evidence or truth.
These patients can and often do benefit from very high doses of opioid pain relievers — but not from doses in the 50 to 90 MMED range proposed by the 2016 CDC Guidelines as a threshold of risk. There are case reports of patients who are awake, intellectually cogent and experiencing significantly improved quality of life and pain management at doses exceeding 2,000 MMEDD. Indeed, as pointed out in the final report of the 2019 DHHS Task Force on Pain Management, there is no “one size fits all” pain patient or therapy plan.
The implications of variable opioid metabolism for the medical literature and for medical practice standards cannot be under-estimated. Unmeasured and unremarked metabolic effects may account for many of the apparent “failures” of opioid therapy for some patients reported in the trials literature. It is entirely plausible within this range of highly idiosyncratic opioid effects, that the mildly elevated mortality rates associated with higher dose levels may be a measurement artifact rather than a cause-and-effect outcome of opioid exposure per se.
Some patients on elevated doses are opioid-resistant. Others are among the sickest patients treated by physicians, with multiple and interacting underlying medical disorders that may contribute to high blood pressure, stress, tension, social isolation, depression and vulnerability to cardiac arrest. We should thus expect elevated mortality from underlying disease entities and complications, in the population treated with higher doses of opioids.
Mandated tapering of patients off opioid therapy has been widespread since publication of the CDC guidelines. Despite FDA warnings in April 2019 concerning too-rapid tapers as a safety risk, patients continue to be discharged without withdrawal support or told they will not be treated with opioids because of the Guidelines or public laws that refer to the Guidelines.
Tapering is addressed tangentially in the AHRQ report, but without explicit reference to the fact that there are no published trials which identify any positive outcomes from involuntary taper. Dr Sean Mackey and four other past Presidents of the American Academy of Pain Medicine have written the Governor of Oregon setting forth major objections to proposals to mandate tapering of all Oregon Medicaid patients who are presently maintained on opioid analgesics to zero dose. Thus far the Oregon Chronic Pain Task Force has ignored all external input, regardless of professional source.
Reference: Lynn Webster, MD, “Oregon Chronic Pain Task Force Revised Proposal Regarding Opioids December 8, 2018, http://www.lynnwebstermd.com/letter-to-governor-kate-brown/
Social media are replete with patient reports of worsened pain, loss of employment due to disability, medical collapse and some patient suicides when pain becomes too horrid to bear. In multiple STAT News commentary threads for articles describing the crackdown on opioid prescribing, we see the reports of hundreds of patients unilaterally tapered over their own objections, discharged and deserted by their doctors, and unable to get referral for treatment by any other practitioner. Responsibility for this atrocity must be laid squarely at the door of the CDC and the AHRQ report of 2013. In the opinion of the author, mandated tapering of patients who are otherwise stable and benefiting from opioid therapy is never medically justified, and may reasonably be considered patient abuse and desertion.
This unscientific and insupportable bureaucratic madness must STOP!
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As a footnote to AHRQ senior management: be aware that the comments of this paper will be shared with an open collaborative network of over 400 medical professionals, healthcare editors and authors, knowledgeable patients and caregivers. It will also be published to social media platforms that generate over 200,000 impressions per day, and distributed to healthcare legislative assistants and policy analysts throughout the US Congress.
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