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BMJ 2021; 372 doi: https://doi.org/10.1136/bmj.m4901 (Published 05 January 2021) Cite this as: BMJ 2021;372:m4901

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Letter from Physicians for Responsible Opioid Prescribing (PROP) to the American Medical Association (AMA) -- RE: AMA’s Opposition to Dose & Duration Guidance for Opioid Prescribing

February 16, 2021

Susan R. Bailey, MD
President, American Medical Association
330 N. Wabash Ave., Suite 39300
Chicago, IL 60611-5885

RE: AMA’s Opposition to Dose & Duration Guidance for Opioid Prescribing

Dear Dr. Bailey:

On behalf of Physicians for Responsible Opioid Prescribing (PROP), we are writing to share our concern about the AMA’s recent public statements on opioid prescribing. It is disappointing that the AMA chose to fight key elements of the CDC’s effort to address the scourge of overprescribing of opioids in its letter to Dr. Deborah Dowell.[1] While appropriately advocating for measures to help individuals struggling with opioid use disorder (OUD), the AMA concurrently repudiates the CDC’s pain treatment recommendations on opioid dose and duration, guidance that is needed to reduce the incidence of OUD and opioid-related overdoses. In December, in both an issue brief specifically related to the opioid crisis during the COVID pandemic, and in a policy roadmap addressing opioid use disorder more broadly, industry friendly messaging on opioid use for pain can be found buried amid the effort to repair the problems created in the first place, and in no insignificant part, by erroneous messaging. [2]

Particularly concerning are erroneous statements such as “the nation no longer has a prescription opioid-driven epidemic” and regressive policy recommendations including “the AMA urges governors and state legislators to take action [to] remove …. arbitrary dose, quantity and refill restrictions on controlled substances.” Together, these statements send a strong message that opioid prescribing for pain is no longer problematic, and that the CDC’s recommended guardrails are no longer needed. Nothing could be further from the truth. There is compelling evidence that many of those currently struggling with opioid dependence and addiction were introduced to opioids through use of medically prescribed opioids used to treat chronic pain. Medically prescribed opioids remain a common gateway to illicit opioid use and are themselves frequent causes of opioid addiction and overdose, even if illicit opioids currently cause the greater number of deaths. We also now know that the population of people most likely to progress to prolonged high dose prescription opioid usage, or turn to illicit opioids, are the most distressed amongst us. This is a population that has grown with the COVID-19 pandemic and is likely to continue to grow during pandemic recovery.

While it has been reported that some of the CDC’s recommendations were misapplied as strict limits, this does not lessen the need for evidence-based opioid prescribing guidance on dose and duration. Revisions to the CDC guideline, developed in response to an urgent public health problem, are of course helpful when based on accumulating evidence and experiences. But that does not mean that sound principles contained in the guideline should be abandoned. Rather, misapplications of the guideline should be addressed specifically, while continuing to recognize that harmful past messages that promoted opioid use as safe and effective for an indefinite duration and dose contributed to rising rates of opioid use disorder and overdose deaths. Suggested dose and duration restrictions are not “arbitrary”, they are based on considerable evidence of when harm far exceeds benefit. They only become “arbitrary” when applied too rigidly, or if they are used as license to abruptly cut prescribing to individuals that have become dependent on opioids for stability.

The evidence shows that opioids are helpful when prescribed appropriately for short-term pain (including end-of-life), and less helpful, and markedly more harmful, when prescribed for a long duration. This contention is supported by abundant clinical, epidemiological and biological data. All moral, ethical, regulatory, legal and political arguments that opioids are needed so that people do not suffer needlessly should apply specifically to short-term pain management where there is proven benefit, and not to long-term pain management where evidence of benefit is largely anecdotal, and there is compelling evidence of harm. It does not make sense to apply the moral argument to a treatment known to result in harm for the majority of those treated. Being unclear about this important distinction led to a soaring increase in opioid prescribing along with parallel increases in OUD and overdose deaths. Why then is the AMA applying the moral argument to the false premise that people will suffer needlessly if they do not have unrestricted access to opioids? By all means apply moral arguments and principles to make sure opioids are available for the right indications, but it makes no sense at all to suggest that removing guidance on opioid dose and duration is needed so that people with chronic pain do not suffer. This is simply a repeat of the pharmaceutical industry’s playbook that led to an epidemic of opioid use disorder. Why is the AMA echoing messages from that playbook now that prescribing of opioids for chronic pain is trending in a more cautious direction? Why impede this trend when prescription opioid use remains far higher in the U.S. than in any other country on earth? Physicians were relieved to have the standards provided by the CDC guidelines. Removing these evidence-based norms for opioid prescribing will not help either physicians or patients.

Sincerely,

Jane C. Ballantyne, MD, FRCA
President, PROP
Professor, Anesthesiology and Pain Medicine
University of Washington

Judy Butler, MS
Research Fellow, PROP

Paul Coelho, MD
Medical Director
Salem Health Pain Clinic
Salem, Oregon

Gary M. Franklin, MD, MPH
Vice President, State Affairs, PROP;
Research Professor, Dept of Environmental Health, Neurology, & Health Services, University of WA; Medical Director, WA State Dept. Labor and Industries

Adriane Fugh-Berman, MD
Professor, Department of Pharmacology & Physiology
Georgetown University Medical Center

Stephen G. Gelfand, MD, FACP
Rheumatology consultant

Chris Johnson, MD
Diplomate, American Board of Emergency Medicine
Member & Former Chair, Minn. Dept. of Human Services Opioid Prescribing Work Group

David Juurlink, MD, PhD, FACMT, FAACT
Professor and Head,
Division of Clinical Pharmacology and Toxicology,
University of Toronto

Andrew Kolodny, MD
Vice President, Federal Affairs, PROP;
Medical Director, Opioid Policy Research Collaborative,
Heller School for Social Policy & Management
Brandeis University

Anna Lembke, MD
Associate Professor &Medical Director
Addiction Medicine, Department of Psychiatry,
Stanford University School of Medicine

Danesh Mazloomdoost, MD
Medical Director
Wellward Regenerative Medicine
Lexington, KY

Rosemary Orr, MD
Professor Emeritus,
Department of Anesthesiology and Pain Medicine,
University of Washington

Jon Streltzer, MD
Professor Emeritus, Department of Psychiatry, Associate Director, Addiction Psychiatry Residency
John A. Burns School of Medicine, University of Hawaii

Mark D. Sullivan, MD, PhD
Professor, Psychiatry and Behavioral Sciences
Adjunct Professor, Anesthesiology and Pain Medicine, Bioethics and Humanities
University of Washington

David J. Tauben, MD, FACP
Clinical Professor Emeritus
Depts of Medicine and Anesthesia & Pain Medicine
University of Washington

Betts Tully
Patient advocate

Michael Von Korff, ScD
Vice President, Scientific Affairs, PROP; Investigator Emeritus, Kaiser Permanente Washington Health Research Institute

1 Letter from James Madara, M.D., CEO of the American Medical Association, to Deborah Dowell, M.D. Chief Medical Officer, National Center for Injury Prevention and Control, U.S. Centers for Disease Control and Prevention. Accessed on February 4, 2020. https://searchlf.ama-assn.org/undefined/documentDownload?uri=%2Funstruct...

2 National Roadmap on State-Level Efforts to End the Nation’s Drug Overdose Epidemic. December 2020. https://end-overdose-epidemic.org/wp-content/uploads/2020/12/AMA-Manatt-... ; AMA Issue brief: Reports of increases in opioid- and other drug-related overdose and other concerns during COVID pandemic. Updated December 9, 2020. https://www.ama-assn.org/system/files/2020-12/issue-brief-increases-in-o...

Competing interests: [Competing interest statement updated on 15 March 2021 by BMJ Editorial] All authors are on the Board of Physicians for Responsible Opioid Prescribing, an organization that advocates for more cautious opioid prescribing and improved regulation of opioid manufacturers. The following authors have nothing else to disclose: Judy Butler, Paul Coelho, Stephan Gelfand, Chris Johnson, Rosemary Orr, Jon Streltzer, David Tauben, Betts Tully, Michael Von Korff. Jane Ballantyne, Andrew Kolodny, Anna Lembke and Danesh Mazloomdoost receive fees for serving as expert witnesses on behalf of government plaintiffs in litigation against the opioid industry; Adriane Fugh-Berman is a paid expert witness at the request of plaintiffs in litigation regarding pharmaceutical and medical device marketing practices, including in cases regarding opioids and she directs PharmedOut, a research and education project that fosters rational prescribing at Georgetown University Medical Center; Gary Franklin receives federal funding for opioid related research and serves as an unpaid witness for the State of Washington against the opioid industry; David Juurlink has received payment for expert testimony for medicolegal actions related to opioids. In the past 36 months, Mark Sullivan has provided expert testimony for the States of Maryland and Missouri. He has received a research grant from Purdue Pharma not related to the current work. He has no ongoing conflicts and plans none in the next 12 months.

16 February 2021
Jane C Ballantyne
President
Judy Butler, Paul Coelho, Gary M. Franklin, Adriane Fugh-Berman, Stephen G. Gelfand, Chris Johnson, David Juurlink, Andrew Kolodny, Anna Lembke, Danesh Mazloomdoost, Rosemary Orr, Jon Streltzer, Mark D. Sullivan, David J. Tauben, Betts Tully, Michael Von Korff
Physicians for Responsible Opioid Prescribing (PROP), 2233 University Ave. W, Suite 325, St. Paul, MN 55114