National Institute on Drug Abuse
“THE UNINFORMED WILL ALWAYS BE ON THE WRONG SIDE”
Bishop Lester Love, New Orleans _____
NORMAN J CLEMENT RPH., DDS, NORMAN L. CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, BELINDA BROWN-PARKER, IN THE SPIRIT OF JOSEPH SOLVO ESQ., INC.T. SPIRIT OF REV. IN THE SPIRIT OF WALTER R. CLEMENT BS., MS, MBA. HARVEY JENKINS MD, PH.D., IN THE SPIRIT OF C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., MBA., IN THE SPIRIT OF THE HON. PATRICE LUMUMBA, IN THE SPIRIT OF ERLIN CLEMENT SR., EVELYN J. CLEMENT, WALTER F. WRENN III., MD., JULIE KILLINGSWORTH, RENEE BLARE, RPH, DR. TERENCE SASAKI, MD LESLY POMPY MD., CHRISTOPHER RUSSO, MD., NANCY SEEFELDT, WILLIE GUINYARD BS., JOSEPH WEBSTER MD., MBA, BEVERLY C. PRINCE MD., FACS., NEIL ARNAND, MD., RICHARD KAUL, MD., IN THE SPIRIT OF LEROY BAYLOR, JAY K. JOSHI MD., MBA, AISHA GARDNER, ADRIENNE EDMUNDSON, ESTER HYATT PH.D., WALTER L. SMITH BS., IN THE SPIRIT OF BRAHM FISHER ESQ., MICHELE ALEXANDER MD., CUDJOE WILDING BS, MARTIN NJOKU, BS., RPH., IN THE SPIRIT OF DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS
From:
“Point Paper for National Centers for Accident Prevention and Control, Board of Scientific Counselors – December 2019 Meeting“
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.
Guidelines were not only “misapplied” but factually in error on multiple issues [1]
a) Sweeping conclusions were drawn from very weak data or unsupported opinion. [2].
b) Paucity of long-term trials was incorrectly interpreted as evidence that opioids are ineffective in the long term. [3]
c) Well known genetic factors in opioid metabolism were ignored; these factors invalidate generalization of dose thresholds for effectiveness and risk. [4] [5]
d) Real risk of addiction or mortality from prescription opioids was grossly over-magnified and hyped. 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]
e) Seniors over age 62 are prescribed opioids for pain six times more often than youth under age 19.
f) Youth have overdose mortality six times higher than seniors.
g) Overdose mortality among seniors has been relatively stable for 20 years while skyrocketing in youth.
h) Prescribing cannot possibly account for this demographic inversion.
THE TREE OF KNOWLEDGE WILL NEVER BE SUPPRESS
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.
i) Many patients benefit from opioid therapy at dose levels exceeding thresholds proposed in 2016 guidelines — often for years.
j) Individual genetic variations in opioid metabolism render generalizations on dose levels meaningless [op cit, Ref 4, 5]
UPDATED REPORT FROM 2018 NOT APART OF ORGINAL ARTICLE
4 alternate Resolution 235, “Inappropriate Use of CDC Guidelines for Prescribing Opioids.” The
5 second resolve in the alternate resolution asked:Download
On June 10, the AMA issued Board of Trustees Report 22 which, among other things, condemns the use of “high prescriber” lists by national pharmacy chains to blacklist high-prescribing physicians and prevent their patients from having pain prescriptions filled.
k) AMA House of Delegates Resolution 235 [November 2018] and AMA Board of Governors Study 22 [June 2019] apply directly.
l) 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.
m) 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]
n) 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.
p) Incidence of protracted prescribing in opioid-naive post-surgical patients is less than 1%. [12]
q) 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]
r) 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]
s) There are no proven profiling instruments with predictive accuracy to assess risks of opioid prescribing in individual patients. [16]
t) “Tapering” as now practiced often amounts to unilateral patient discharge and desertion without support.
u) There is no medical, ethical, or moral justification for coerced tapering of chronic pain patients who are otherwise stable.
v) 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.
w) Guidelines writers’ group must include multiple patient advocates and comprehensive pain management experts as voting members.
x) Explicit attention must be given to removing 2016 and newer Guidelines from drug enforcement legislation.
y) 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.
CONCLUSION UPDATE 2024
“Substance abuse” is a very different beast: it is characterized by continuing cravings and use of opioids even when the user knows that such use is harmful to their relationships and quality of life.
The DSM-5 identifies a spectrum of symptoms to characterize the severity of substance abuse.
However, nowhere in that deeply flawed document is a clinical framework offered within which clinicians may choose a therapeutic course of action that is appropriate to the patient’s needs if they suffer from both chronic pain and substance abuse.
Likewise, the consequence of patient exposure to prescription opioids is almost always an improvement in quality of life.
We now know definitively that — despite repeated misdirection from the US CDC and DEA — there is no relationship between physician prescribing and either opioid addiction or overdose-related mortality.
Many so-called “diagnoses” of opioid use disorder by clinicians actually reflect a disorder called “pseudo-addiction,” suffered not by patients but by clinicians intimidated by the risk of possible criminal sanctions.”
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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 Facts“ December 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.
“…holding all sides together…”
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.
Doctors are still cutting off legacy chronic pain patients and rare disease patients (hEDS) with no other options for care EXCEPT opiates for their pain and doing it for no other reason except for the fact that they ARE RARE DISEASE AND CHRONIC PAIN PATIENTS. This is is CIVIL RIGHTS ISSUE OF OUR TIME and THE LAW is TURNING AWAY.
No attorney will DEFEND THE PATIENT and WE ARE DYING.
I will personally DIE before visiting my local hospital or MEDICAL CLINICS due to the DISCRIMINATION and LACK OF MEDICAL CARE GIVEN to me (cut off care) and my husband (terminated care) even if I’m having a heart attack or bleeding out. Why? I do not trust any nurse, provider, or person to provide trustworthy care to me in a time of crisis because I am a chronic pain and rare disease patients on opiates. They’ve denied me pain meds after major surgery when I’ve been in excruciating pain. They’ve shown they have no ability to understand or care for me and they discriminate against me. They’ve recently done the same intentionally against my husband to the point of lying about him.
This issue is the genocide of a group of people— those who need, take, or abuse opiates of any type.