Bishop Lester Love, New Orleans _____

“THE UNINFORMED WILL ALWAYS BE ON THE WRONG SIDE”

From:

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

This online article critiques the CDC’s opioid guidelines and the role of the National Institute on Drug Abuse (NIDA). It presents a point paper arguing that the guidelines are factually incorrect and have harmed chronic pain patients. 

The authors contend that the over-prescription of opioids is not the primary driver of the opioid crisis. Instead, they attribute the crisis to illicit opioid use, particularly heroin laced with fentanyl. 

The article references studies and statements from medical organizations questioning the validity of Morphine Milligram Equivalent Daily Dose (MMEDD) limits and advocating for patient access to opioid therapy when medically necessary. 

It criticizes the practice of involuntary tapering and the denial of effective pain relief. It suggests alternative treatments are unproven.

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.  

The main criticisms are that the guidelines were based on weak data or unsupported opinion, incorrectly interpreted the lack of long-term trials as evidence that opioids are ineffective long-term, ignored genetic factors in opioid metabolism, over-magnified the risk of addiction and mortality from prescription opioids, and ultimately led to patient harm due to misapplication and factual errors.

The document also criticizes the guidelines for not including patient advocates and pain management experts in the guideline writing process.

Guidelines were not only “misapplied” but factually in error on multiple issues [1] 

Critique of the 2016 CDC Guidelines: Understand the central argument that the 2016 CDC guidelines on opioid prescriptions for chronic non-cancer pain have caused unnecessary harm to patients. Identify the specific flaws the authors attribute to these guidelines.

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]

Morphine Milligram Equivalent Daily Dose (MMEDD): Understand the article’s critique of MMEDD as a measure for defining opioid dosage limits, focusing on its utility and limitations.

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

REPORT OF THE American Medical Association BOARD OF TRUSTEES 2018:

PAIN MANAGEMENT IS A HUMAN RIGHT

The document addresses the inappropriate application of the CDC’s opioid prescribing guidelines by pharmacies, insurance companies, and pharmacy benefit managers. It highlights concerns that blanket restrictions based on numerical thresholds are interfering with the patient-physician relationship and patient care. 

The AMA has been actively engaging with stakeholders to advocate against these policies, emphasizing the guidelines were intended for acute pain management, not as rigid limits for all patients. While supporting judicious prescribing and pharmacist collaboration, the AMA opposes policies that create barriers to necessary pain medication.

 The report specifically calls out Walmart for its “blacklist” letters to physicians and advocates for policies that prioritize individualized patient care over hard thresholds. It recommends the AMA support balanced opioid-sparing policies and oppose the use of “high prescriber” lists that lack due process. 

The document further reinforces AMA’s existing policies supporting optimal pain care and opposing arbitrary restrictions on patient access to effective treatment.

ANALYSIS AND FINDINGS OF FACTS

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

REFERENCES:

CDC Opioid Guidelines Review

I. Key Concepts and Arguments

• Critique of the 2016 CDC Guidelines: Understand the central argument that the 2016 CDC guidelines on opioid prescriptions for chronic non-cancer pain have caused unnecessary harm to patients. Identify the specific flaws the authors attribute to these guidelines.
• Data Misinterpretation: Focus on how the article claims the CDC misinterpreted data regarding opioid prescriptions and overdose mortality, particularly the relationship between prescription opioids and the rise in opioid-related deaths.
• Role of Illicit Opioids: Understand the argument that the primary driver of the opioid crisis is the use of illicit opioids, especially heroin mixed with fentanyl, rather than prescription opioids.
• Genetic Factors: Be familiar with the role of genetics in opioid metabolism and how the authors argue this invalidates blanket dosage recommendations.
• Morphine Milligram Equivalent Daily Dose (MMEDD): Understand the article’s critique of MMEDD as a measure for defining opioid dosage limits, focusing on its utility and limitations.
• Tapering Concerns: Study the arguments against forced or coerced tapering of opioid prescriptions for stable chronic pain patients, focusing on the potential risks.
• Alternatives to Opioids: Understand the article’s perspective on the current state of alternative pain management therapies and their effectiveness compared to opioids.
• AMA and Other Medical Associations’ Stance: Be familiar with the AMA’s resolutions and statements, as well as those of other medical associations, regarding the CDC guidelines, high-prescriber lists, and law enforcement interference in medical practice.
• Pseudo-Addiction vs. Opioid Use Disorder: Differentiate between genuine opioid use disorder and the concept of “pseudo-addiction” in the context of clinician fear of legal repercussions.
• Human Rights: Study the argument that denial of effective pain relief constitutes a potential violation of human rights.

II. Key Figures

• Wilson M. Compton, M.D., M.P.E.: Identify his role as Deputy Director of the National Institute on Drug Abuse (NIDA) and the article’s critique of his leadership.
• Richard A. Lawhern, Ph.D.: Recognize him as one of the authors of the point paper and his expertise on the subject.
• Andrea Trescot, M.D.: Recognize her as one of the authors of the point paper and a former president of the US Association for Interventional Pain Physicians.
• Stephen E. Nadeau, M.D.: Recognize him as one of the authors of the point paper.
• Jesse M. Ehrenfeld, MD, MPH: Former President of The American Medical Association.

III. Timeline of Events

• 2016 CDC Guidelines: Understand the initial publication of the CDC guidelines and the subsequent criticisms.
• 2018 AMA House of Delegates Resolution 235: Be aware of the AMA’s resolution expressing concerns about the CDC guidelines.
• 2019 AMA Board of Governors Study 22: Be aware of the AMA’s Board of Governors Study expressing concerns about the CDC guidelines.
• December 2019 Point Paper: Focus on the significance of the point paper presented to the CDC’s Board of Scientific Advisors and its (alleged) disappearance.

IV. Study Questions: Short Answer

1. What is the central argument of the 2019 point paper regarding the 2016 CDC opioid prescribing guidelines?
2. According to the article, what is the primary driver of the opioid crisis, and how does this differ from the CDC’s perceived focus?
3. Explain the article’s criticism of using Morphine Milligram Equivalent Daily Dose (MMEDD) as a strict guideline for opioid prescriptions.
4. What are the potential risks associated with forced opioid tapering, according to the authors?
5. How do genetic variations in opioid metabolism impact the effectiveness and risks of opioid therapy?
6. What is “pseudo-addiction,” as defined in the article, and why is it relevant to the discussion on opioid use?
7. What was the AMA’s stance on “high-prescriber” lists and pharmacy policies that restrict access to opioid prescriptions?
8. Briefly describe the point paper’s argument regarding the effectiveness of non-pharmacological alternatives to opioids for chronic pain.
9. What does the article suggest regarding the inclusion of patient advocates and pain management experts in future guideline revisions?
10. What are the authors’ views on the role of illicit fentanyl in the opioid crisis?

V. Study Questions: Essay Format

1. Evaluate the arguments presented in the article against the 2016 CDC opioid prescribing guidelines. To what extent do you find these arguments persuasive, and what additional information would strengthen or weaken their case?
2. Discuss the ethical implications of forced opioid tapering for chronic pain patients. Consider the principles of patient autonomy, beneficence, and non-maleficence in your analysis.
3. Compare and contrast the perspectives presented in the article regarding the role of prescription opioids versus illicit opioids in driving the opioid crisis. Analyze the data and evidence cited to support each viewpoint.
4. Analyze the potential conflicts of interest and biases that may influence the development and implementation of opioid prescribing guidelines. Consider the roles of government agencies, pharmaceutical companies, medical associations, and patient advocacy groups.
5. Propose a revised set of guidelines for opioid prescribing that addresses the concerns raised in the article while still promoting patient safety and responsible pain management. Justify your recommendations with evidence-based practices and ethical considerations.

VI. Glossary of Key Terms

• CDC Guidelines (2016): The Centers for Disease Control and Prevention’s guidelines for prescribing opioids for chronic pain, released in 2016. The article argues these are flawed.
• NIDA: National Institute on Drug Abuse.
• Opioid Crisis: The ongoing public health crisis in the United States related to the misuse and abuse of opioids, both prescription and illicit.
• Illicit Opioids: Opioids that are not legally manufactured or prescribed, such as heroin and illegally produced fentanyl.
• Fentanyl: A potent synthetic opioid, often implicated in overdose deaths due to its high potency and presence in the illicit drug supply.
• Morphine Milligram Equivalent Daily Dose (MMEDD): A standardized measure used to calculate the total daily opioid dose, converted to the equivalent amount of morphine.
• Opioid Metabolism: The process by which the body breaks down opioids, influenced by genetic factors and individual variations.
• Tapering: The gradual reduction of opioid dosage, often implemented to mitigate risks or discontinue opioid therapy.
• Pseudo-Addiction: A condition where patients exhibit drug-seeking behaviors due to undertreated pain, often mistaken for true addiction.
• High-Prescriber Lists: Lists created by pharmacies or regulatory agencies that identify physicians who prescribe a high volume of opioids, often used to restrict prescribing practices.
• Legacy Patients: Patients who have been on long-term opioid therapy for chronic pain prior to the implementation of stricter prescribing guidelines.
• Opioid Use Disorder (OUD): A problematic pattern of opioid use leading to clinically significant impairment or distress.
• DSM-5: Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, used to diagnose mental health disorders, including OUD.

VII. Answer Key for Short Answer

1. The central argument is that the 2016 CDC guidelines have caused unnecessary harm to chronic pain patients by misinterpreting data, exaggerating risks, and promoting restrictive prescribing practices. They argue the guidelines are based on weak data and flawed assumptions.
2. The article asserts the primary driver of the opioid crisis is the use of illicit opioids, particularly heroin mixed with illicit fentanyl. This contrasts with the CDC’s perceived focus on prescription opioids as the main culprit.
3. The article criticizes MMEDD as a rigid guideline because it fails to account for individual genetic variations in opioid metabolism and the fact that many patients benefit from doses exceeding suggested thresholds. Its utility is limited to a rough guide for transitioning between opioids, not as a hard limit.
4. Forced opioid tapering can lead to patient medical collapse, withdrawal symptoms, increased pain, psychological distress, and, in some cases, suicidal ideation, according to the authors. They emphasize the lack of evidence supporting involuntary tapering.
5. Genetic variations in opioid metabolism influence how individuals respond to opioids, affecting both the effectiveness of the medication and the risk of side effects. The article argues these variations invalidate generalizations on dose levels for the population.
6. “Pseudo-addiction” refers to drug-seeking behaviors displayed by patients whose pain is undertreated, often due to clinicians’ fear of legal repercussions. It is distinct from true opioid use disorder and highlights the impact of the regulatory environment on patient care.
7. The AMA condemned the use of “high-prescriber” lists by pharmacy chains to blacklist physicians, as this restricts access to necessary pain medication for patients. They argued such policies interfere with the doctor-patient relationship.
8. The point paper asserts that medical evidence for the effectiveness of non-pharmacological therapies is weak, lacks direct comparisons with opioids, and lacks Phase III trials. They are not reliable and safe alternatives to opioid therapy.
9. The article suggests that guidelines writers’ groups must include multiple patient advocates and comprehensive pain management experts as voting members to ensure a more balanced and patient-centered approach. This would contribute to public transparency and incorporate comments received.
10. The authors emphasize that illicit fentanyl is the true cause of the opioid crisis. The illicit use of opioids, particularly heroin

Briefing Document: Analysis of “HOW 2019 STUDY REFUTES CDC OPIOID GUIDELINES”

Date: October 26, 2024 Source: youarewithinthenorms.com (September 26, 2024) Subject: Critique of CDC Opioid Guidelines and NIDA’s Deputy Director, Dr. Wilson Compton

Executive Summary:

This document analyzes a post from “youarewithinthenorms.com” which presents a critical perspective on the CDC’s 2016 opioid prescribing guidelines and the role of the National Institute on Drug Abuse (NIDA), particularly its Deputy Director, Dr. Wilson Compton. The post centers around a “Point Paper” from December 2019 intended for the CDC’s Board of Scientific Counselors, authored by Richard A. Lawhern, Ph.D., Andrea Trescot, M.D., and Stephen E. Nadeau, M.D. The central argument is that the CDC guidelines are based on flawed data and have led to negative consequences for chronic pain patients, including misapplication, dose limitations, and forced tapering. The article challenges the prevailing narrative of physician over-prescribing as the primary driver of the opioid crisis and emphasizes the role of illicit opioids. It also calls for a more balanced and patient-centered approach to pain management.

Main Themes and Key Arguments:

1. Flawed CDC Guidelines: The post argues that the 2016 CDC guidelines on opioid prescribing are fundamentally flawed and have caused significant harm to chronic pain patients.

• “Guidelines were not only “misapplied” but factually in error on multiple issues [1]”
• “Sweeping conclusions were drawn from very weak data or unsupported opinion. [2]”
• “Paucity of long-term trials was incorrectly interpreted as evidence that opioids are ineffective in the long term. [3]”

1. Misrepresentation of Addiction and Mortality Risks: The authors contend that the CDC has exaggerated the risks of addiction and mortality associated with prescription opioids.

• “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]”

1. Illicit Opioids as the Primary Driver of the Crisis: The post emphasizes that the opioid crisis is primarily driven by the use of illicit opioids, particularly heroin and fentanyl, rather than prescription painkillers.

• “The true cause of the opioid crisis continues to be the illicit use of opioids, particularly heroin admixed with illicit fentanyl.”
• “47,600 opioid deaths, 14,944 from prescription opioids (scarcely changed from 2012) and 32,656 (68.6%) from illicit opioids.”

1. Opposition to Arbitrary Dose Limits and Forced Tapering: The authors criticize the use of Morphine Milligram Equivalent Daily Dose (MMEDD) as a rigid metric and oppose forced tapering of opioid medications.

• “Morphine Milligram Equivalent Daily Dose (MMEDD) is not a useful measure in defining limits on opioid dosage”
• “No published trials demonstrate benefit from involuntary tapering of legacy patients. Coerced tapering instead risks patient medical collapse. [15]”
• “There is no medical, ethical, or moral justification for coerced tapering of chronic pain patients who are otherwise stable.”

1. Importance of Individualized Treatment: The post stresses the importance of considering individual genetic variations and patient needs when prescribing opioids.

• “Well known genetic factors in opioid metabolism were ignored; these factors invalidate generalization of dose thresholds for effectiveness and risk. [4] [5]”
• “Many patients benefit from opioid therapy at dose levels exceeding thresholds proposed in 2016 guidelines — often for years.”
• “Individual genetic variations in opioid metabolism render generalizations on dose levels meaningless [op cit, Ref 4, 5]”

1. Lack of Effective Alternatives: The authors assert that there are currently no proven-reliable and safe alternatives to opioid therapy for moderate to severe pain.

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

1. Call for Reform and Transparency: The post calls for revisions to the CDC guidelines, increased transparency in the guideline development process, and the inclusion of patient advocates and pain management experts in the process.

Supporting Quotes:

• “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]”
• “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.”
• “Likewise, the consequence of patient exposure to prescription opioids is almost always an improvement in quality of life.”

Additional Points:

• The post includes personal anecdotes, such as the comment from Renee Blare, highlighting the discrimination and lack of care faced by chronic pain patients.
• It contains a list of individuals “in the spirit of” whom the authors dedicate their work, suggesting a broader movement and historical context to their advocacy.
• The author requests donations for legal defense, indicating a legal component to the issues raised.
• The piece cites various studies and articles to support its claims, providing a foundation of evidence for its arguments.

Potential Implications:

The content suggests a need for critical re-evaluation of opioid prescribing guidelines, emphasizing individualized treatment approaches, and addressing the underlying causes of the opioid crisis, such as the illicit drug supply.

If taken seriously, the arguments presented could influence policy changes, medical practice, and public perception of pain management and opioid use.

The post is clearly advocating for a major shift in how chronic pain is treated and how the opioid crisis is understood.