2019 STUDY SHOWS CDC OPIOID GUIDELINES ARE WRONG: FURTHER UNDERMINING NEARLY ALL UNITED STATES DEPARTMENT OF JUSTICE AND DEA’S “OPIOID” PROSECUTIONS OF PHARMACISTS AND PHYSICIANS

Point Paper for National Centers for Accident Prevention and Control, Board of Scientific Counselors – December 2019 Meeting

Bishop Lester Love, New Orleans _____

“THE UNINFORMED WILL ALWAYS BE ON THE WRONG SIDE”

Richard A Lawhern*, Ph.D., Andrea Trescot, M.D., Stephen E Nadeau, M.D.

The following paper was sent to the administrators of the December 2019 meeting of the Board of Scientific Advisors to the US CDC National Center for Injury Prevention and control, by its authors.  Contrary to the published protocols of the meeting, the paper was made to disappear.  We presently do not know whether anyone on the Board of Scientific Advisors even read it.  How typical of the CDC! 

Point papers are a long-standing tradition in military and government policy-making circles.  Unlike most medical journal papers, they are formatted with a minimum of verbiage to summarize an issue for decision-making.   The authors write in that tradition, adding references for key points.  We speak on behalf of millions of people in pain and their healthcare providers, who have been predictably and unnecessarily harmed by the 2016 CDC Guidelines on prescription of opioids to adults with chronic non-cancer pain.  

“I’VE NEVER SEEN ANYTHING LIKE IT”
  • Guidelines were not only “misapplied” but factually in error on multiple issues [1] 


o Sweeping conclusions were drawn from very weak data or unsupported opinion. [2].

 o Paucity of long-term trials was incorrectly interpreted as evidence that opioids are ineffective in the long term. [3]

o Well known genetic factors in opioid metabolism were ignored; these factors invalidate generalization of dose thresholds for effectiveness and risk. [4] [5]

o Real risk of addiction or mortality from prescription opioids was grossly over-magnified and hyped.

o Patient addiction from medical exposure is in fact rare. [6]

  • Over prescribing of opioid pain relievers by physicians to their patients did not create America’s public health crisis — and data published by CDC prove it beyond contradiction [7]

   o Seniors over age 62 are prescribed opioids for pain six times more often than youth under age 19.

   o Youth have overdose mortality six times higher than seniors.

DEA’S THE WAR OF PAIN SUFFERERS

   o Overdose mortality among seniors has been relatively stable for 20 years while skyrocketing in youth.

   o Prescribing cannot possibly account for this demographic inversion.

  • The true cause of the opioid crisis continues to be the illicit use of opioids, particularly heroin admixed with illicit fentanyl. The U.S. Department of Health and Human Services recently provided further validation of this statement with 2019 data: 47,600 opioid deaths, 14,944 from prescription opioids (scarcely changed from 2012) and 32,656 (68.6%) from illicit opioids.
  • Morphine Milligram Equivalent Daily Dose (MMEDD) is not a useful measure in defining limits on opioid dosage and as such, it has been repudiated by the AMA [8]. Its major utility is as a rough guide to the clinician in making a safe transition from one opioid to another.

   o Many patients benefit from opioid therapy at dose levels exceeding thresholds proposed in 2016 guidelines — often for years.


   o Individual genetic variations in opioid metabolism render generalizations on dose levels meaningless [op cit, Ref 4, 5]


   o AMA House of Delegates Resolution 235 [November 2018] and AMA Board of Governors Study 22 [June 2019] apply directly.

   o American Academy of Family Physicians and five other medical associations declared on behalf of front-line physicians [April 2019]:  that law enforcement must be removed from doctors’ offices. [9]

• Proven-reliable and safe alternatives to opioid therapy for moderate to severe pain do not yet exist.

   o Medical evidence for effectiveness of non-pharmacological therapies is very weak; there is no direct comparisons with opioids (a critical absence), and there are no Phase III trials. [10]

   o Some published studies comparing NSAIDs to Opioid therapy are fatally flawed by errors of methodology; [11]. Tylenol and Ibuprofen are likewise associated with thousands of hospital admissions for liver toxicity and gastrointestinal bleeds.

   o Opioid analgesics must remain an indispensable therapy in pain management for the foreseeable future and this must be acknowledged.


   o Incidence of protracted prescribing in opioid-naive post-surgical patients is less than 1%. [12]

   o Incidence of diagnoses of post-surgical substance abuse is less than 0.6% — influenced by hostile regulatory environment as much as by any actual patient drug seeking. [13]

   o Mortality risk from managed exposure to medical opioids is on the order of 0.02% per year — too small to reliably measure or control. [14]. Even for daily dosage greater than 100 MMED, it is only 0.25%/year — comparable to the risk associated with use of anticoagulants to prevent stroke.

  • No published trials demonstrate benefit from involuntary tapering of legacy patients. Coerced tapering instead risks patient medical collapse. [15] 

   o There are no proven profiling instruments with predictive accuracy to assess risks of opioid prescribing in individual patients.  [16]

   o “Tapering” as now practiced often amounts to unilateral patient discharge and desertion without support.

   o There is no medical, ethical, or moral justification for coerced tapering of chronic pain patients who are otherwise stable. 

o Denial of effective pain relief to new patients when it is available and managed by medical professionals may be a fundamental violation of human rights.

  • If CDC is to rewrite the 2016 CDC guidelines, then AMA House of Delegates Resolution 235 must become an explicit and central guiding principle in recommended practice.

   o Guidelines writers’ group must include multiple patient advocates and comprehensive pain management experts as voting members. 

o Explicit attention must be given to removing 2016 and newer Guidelines from drug enforcement legislation.

o Draft treatment guidelines must be publicly circulated with a 90-day comment period, a commitment to full public transparency and incorporation of the comments received.

RICHARD A LAWHERN PHD.

FOR NOW, YOU’RE WITHIN

YOUWITHINTHENORMS.COM , (WYNTON MARSALIS CONCERTO FOR TRUMPET AND 2 OBOES, 1984)

THE NORMS

References

[1] 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

[2] Mark Edmund Rose, BS, MA “Are Prescription Opioids Driving the Opioid Crisis? Assumptions vs FactsDecember 17, 2017,Pain Medicine, Volume 19, Issue 4, April 2018, Pages 793–807, https://doi.org/10.1093/pm/pnx048

[3] 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

[4] Howard S Smith, MD, “Opiod Metabolism” Mayo Clinic Proceedings, 2009 Jul; 84(7): 613–624. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2704133/ 

[5] Michael E. Schatman, PhD; Jeffrey Fudin, PharmD, “The Myth of Morphine

Milligram Equivalent Daily Dose”, Medscape, March 18,2018

[6] Nora D Volkow, MD, and Thomas A McLellan, Ph.D., “Opioid Abuse in Chronic Pain — Misconceptions and Mitigation Strategies” . NEMJ 2016; 374:1253-1263 March 31, 2016]. http://www.nejm.org/doi/full/10.1056/NEJMra1507771

[7] Richard A Lawhern, PhD “Stop Persecuting Doctors for Legitimately Prescribing Opioids for Chronic Pain”,  STAT News, June 28, 2019,  https://www.statnews.com/2019/06/28/stop-persecuting-doctors-legitimately-prescribing-opioids-chronic-pain/

[8] AMA House of Delegates, November 2018, quoted in  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

[9]  American Academy of Family Physicians, American Academy of Pediatrics, et al, “Frontline Physicians Call on Politicians to End Political Interference in the Delivery of Evidence Based Medicine”  May 15, 2019. https://www.aafp.org/media-center/releases-statements/all/2019/physicians-call-on-politicians-to-end-political-interference-in-the-delivery-of-evidence-based-medicine.html

[10] Richard A Lawhern PhD and Steven E Nadeau M.D., “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

Original of the AHRQ Report: “Non-Invasive Nonpharmacological Treatment for Chronic Pain”, June 11, 2018, https://effectivehealthcare.ahrq.gov/products/nonpharma-treatment-pain/research-2018

[11] Richard A Lawhern, PhD and Stephen E Nadeau  M.D., “Recommendations of the HHS Pain Management Task Force — A response by medical professionals and patient advocates “  June 2019 Issue, Practical Pain Management Online Exclusive. https://www.practicalpainmanagement.com/resources/practice-management/recommendations-hhs-pain-management-task-force

[12] Gabriel A Brat, Denis Agniel, Andrew Beam, Brian Yorkgitis, Mark Bicket,  Mark Homer, Kathe P Fox,  Daniel B Knecht,  Cheryl N McMahill-Walraven, Nathan Palmer, Isaac Kohane, “Postsurgical prescriptions for opioid naive patients and association with overdose and misuse: retrospective cohort study”, BMJ 2018;360:j5790 
http://www.bmj.com/content/360/bmj.j5790.long

[13]  Eric C. Sun,  Beth D. Darnall, Laurence C. Baker, Sean Mackey, “Incidence of and Risk Factors for Chronic Opioid Use Among Opioid-Naive Patients in the Postoperative Period”, JAMA Internal Medicine 2016;176(9):1286-1293.  
https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2532789

[14] 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

[15]  Mackey, Sean, MD, et al, “Call for Action on Forced Opioid Tapering Proposal in Oregon]  https://drseanmackey.com/blog/2018/12/5/pain-leaders-call-for-action-on-forced-opioid-tapering-proposal-in-oregon

[16] US Agency for Healthcare Research and Quality, “Opioid Treatments for Chronic Pain” – Draft Comparative Effectiveness Review, circulated October 2019 for public comment, pp 202-204.

Key Messages:  “No instrument has been shown to be associated with high accuracy for predicting opioid overdose, addiction, abuse, or misuse “

  • From: Richard A Lawhern PhD.

Those who have followed my work for a while are aware that I publish a lot of papers and articles. I offer the following paper from December 2019, co-authored with Stephen E Nadeau MD, and Andrea Trescot MD,  as a compendium of “talking points”. These may be useful in dealing with governmental and professional authorities concerned with regulatory policy on prescription opioids. Dr Nadeau has 45 years’ experience in treating pain, with over 150 papers published in medical literature. Dr Trescot is a former President of the US Association for Interventional Pain Physicians and was a sitting member of the 2018-2019 HHS Inter Agency Task Force on best practices in pain management. She is author of numerous papers in medical literature and of four books widely used as texts in training pain doctors. 

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