Undisclosed Conflicts of Interest by Physicians Creating the CDC Opioid Prescribing Guidelines: An Epilogue

The landscape of opioid prescribing guidelines and their implementation has seen significant shifts since the initial publication of concerns regarding conflicts of interest among their creators. A pivotal development is the release of the 2022 CDC Clinical Practice Guideline for Prescribing Opioids for Pain, which supersedes the influential 2016 guidance. This epilogue revisits the critical issues raised, examines the ensuing developments, and analyzes the potential implications of the newly revised guideline on pain management and national opioid policy.

Disclosure of Conflicts of Interest Amidst Scrutiny

Following the September 12, 2022, publication of an article in Pallimed detailing alleged undisclosed conflicts of interest (COIs) by physicians involved in crafting the 2016 CDC Opioid Prescribing Guidelines, notable actions have transpired. The article specifically highlighted concerns surrounding Dr. Mark Sullivan, a member of the advocacy group Physicians for Responsible Opioid Prescribing (PROP), and his expert witness work in opioid litigation, as well as the medical journal PAIN’s role in its publication. Just two days after the Pallimed piece, on September 14, 2022, PAIN electronically published statements disclosing Dr. Sullivan’s previously omitted COIs. While PAIN had initially acknowledged these COIs in May 2022, the timing of their public disclosure, directly following the critical article, raises questions about the promptness of their action and suggests a potential correlation rather than mere coincidence. This development underscores the importance of transparency in academic publishing and the scrutiny applied to potential conflicts that could influence clinical guidance.

FOIA Requests Uncover Further Disclosure Issues

The initial Pallimed article also raised concerns about other PROP members and allies who participated in the creation of the 2016 Guideline, alleging a pattern of failure to disclose relevant COIs that could have potentially disqualified them under CDC policies. In response to these concerns, a Freedom of Information Act (FOIA) request was submitted to the Centers for Disease Control and Prevention (CDC) seeking materials related to disclosures or waivers for these individuals.

On October 18, 2022, the CDC provided disclosure agreements for Dr. Jane Ballantyne and Dr. Lewis Nelson. However, these documents reportedly did not fully disclose their roles in developing and publishing opioid policy statements on behalf of PROP. Dr. Ballantyne disclosed her work in "legal consulting," but failed to clarify that this involved receiving payments from law firms engaged in multidistrict litigation against opioid manufacturers and distributors, a fact she had previously disclosed in several published works. The extent to which the CDC investigated this specific disclosure remains unclear.

Further scrutiny was directed towards Dr. Roger Chou, a co-author of both the 2016 and 2022 CDC Opioid Guidelines. A FOIA request sought clarification on his COIs related to his authorship roles. The CDC’s response was unusual, providing no responsive documents but instead citing Dr. Chou’s public disclosure of his conflict of interest and recusal from proceedings during a July 2021 meeting of the CDC’s Board of Scientific Counselors (BSC)-NCIPC. Subsequent investigation revealed that Dr. Chou received funding in September 2014 from the Agency for Healthcare Research and Quality (AHRQ) through his position as Director for the Pacific Northwest Evidence-based Practice Center and his employment at Oregon Health and Science University. According to CDC’s rules for clinical guideline development, this funding should have been disclosed using the "Declaration of Interests for CDC Experts" form.

A subsequent FOIA request for Dr. Chou’s "Declaration of Interests for CDC Experts" document related to his 2014 AHRQ funding was forwarded by the CDC to AHRQ on October 26, 2022. A representative from the U.S. Department of Health and Human Services (HHS), responding on behalf of AHRQ, closed the file stating, "Your letter discusses issues outside of the scope of the FOIA, and does not appear to include a request for records, which is required in order to be treated as a FOIA request." In the absence of further clarification, this response implies that the CDC considers Dr. Chou’s July 2021 COI disclosure to encompass any authorship role in either iteration of the CDC Opioid Guideline.

The Federation of State Medical Boards Workshop and the 2022 Guideline

A significant event contributing to the evolving discourse on opioid prescribing was the Federation of State Medical Boards (FSMB) workshop on opioids and addiction treatment, held in Washington, D.C., on September 27-28, 2022. One of the authors, Dr. Chad D. Kollas, provided testimony as an invited guest. This workshop included a representative from the CDC’s National Center for Injury Prevention and Control (NCIPC), which facilitated a series of meetings and communications with CDC leadership. These interactions proved instrumental in gaining a deeper understanding of the then-forthcoming 2022 CDC Clinical Practice Guideline for Prescribing Opioids for Pain. The guideline was publicly released on November 3, 2022, accompanied by an editorial letter in the New England Journal of Medicine that provided a concise overview of its objectives, scope, and intended effects.

Understanding the Nuances of the 2022 CDC Guideline

The 2022 CDC Clinical Practice Guideline for Prescribing Opioids for Pain, hereafter referred to as the new Guideline, represents a notable shift in approach. According to Dr. Christopher Jones, Acting Director of the CDC NCIPC, the guideline is "not meant to be implemented as absolute limits of policy or practice by clinicians, health systems, insurance companies, [or] governmental entities." Crucially, it does not establish rigid dosing thresholds for opioid prescriptions. Instead, its core aim is to "promote equitable access to effective, informed, individualized, and safe pain management that improves patients’ function and quality of life, while clarifying and reducing the risks associated with opioid use."

A critical distinction of the new Guideline is its exclusion of patients experiencing pain from sickle cell disease, cancer, or those receiving palliative care and end-of-life care. For these patient populations, the Guideline explicitly directs clinicians to other established clinical guidelines. This selective application acknowledges the distinct therapeutic needs and management strategies required for these complex conditions, aiming to prevent the misapplication of general pain management recommendations.

Addressing the Risk of Misapplication and Charting a Path Forward

The CDC has publicly committed to monitoring the implementation of the 2022 Guideline to prevent the recurrence of misapplication, a concern stemming from the unintended consequences of the 2016 Guideline. However, the CDC has also emphasized the need for support from a broad coalition of stakeholders to assist in this monitoring process and to advocate against any misinterpretations or misapplications.

Drawing upon the lessons learned from previous analyses of the opioid crisis and guideline development, a call is being issued to responsible advocates for evidence-based pain care. The objective is to foster a collaborative effort to restore balance to national opioid policy and, most importantly, to preserve and improve the quality of life for individuals living with pain. This initiative seeks to move beyond overly restrictive policies that may have inadvertently harmed patients and to embrace a more nuanced, patient-centered approach to pain management.

Supporting Data and Background Context

The opioid crisis in the United States has been a protracted and devastating public health emergency. Overdoses, primarily involving opioids, have claimed hundreds of thousands of lives since the late 1990s. Initial efforts to curb opioid prescribing, while well-intentioned, are now understood to have had significant negative consequences for patients with legitimate pain conditions who were denied necessary treatment, leading to increased suffering and, in some cases, a turn to illicit substances.

The 2016 CDC Guideline, while aiming to reduce opioid-related harms, has been criticized for its rigid language and the broad interpretation by various entities, including state legislatures, insurers, and healthcare systems. This led to widespread adoption of policies that often imposed arbitrary limits on opioid dosages and durations, irrespective of individual patient needs or clinical judgment. For instance, early interpretations often focused on the 90-milligram morphine milligram equivalent (MME) per day threshold, despite the guideline stating this was for chronic pain and that higher dosages may be appropriate for some patients. This misapplication contributed to increased patient distress and a sense of being abandoned by the medical community.

The new 2022 Guideline aims to rectify these issues by emphasizing patient-centered care, shared decision-making, and the importance of individualized treatment plans. It seeks to empower clinicians to make informed decisions based on the specific needs of their patients, rather than adhering to inflexible mandates. The shift in language from "recommendations" to "clinical practice guideline" further signals a move towards more flexible and adaptable guidance.

Chronology of Key Developments

• 2016: CDC releases the Guideline for Prescribing Opioids for Chronic Pain.
• Post-2016: Widespread adoption and often rigid implementation of the 2016 Guideline by various stakeholders, leading to concerns about patient access to care.
• September 12, 2022: Pallimed publishes an article raising concerns about undisclosed conflicts of interest among physicians involved in creating the 2016 Guideline.
• September 14, 2022: Journal PAIN publishes statements disclosing previously omitted conflicts of interest for Dr. Mark Sullivan.
• October 18, 2022: CDC provides FOIA responses regarding disclosures for Dr. Jane Ballantyne and Dr. Lewis Nelson, with ongoing questions about completeness.
• October 26, 2022: CDC forwards a FOIA request regarding Dr. Roger Chou’s disclosures to AHRQ.
• October 28, 2022: HHS, on behalf of AHRQ, closes the FOIA file regarding Dr. Chou’s disclosures, citing issues outside FOIA scope.
• November 3, 2022: CDC releases the 2022 CDC Clinical Practice Guideline for Prescribing Opioids for Pain.

Broader Impact and Implications

The evolution of the CDC’s opioid prescribing guidance reflects a broader societal reckoning with the complexities of pain management and addiction. The misapplication of the 2016 Guideline served as a stark reminder that well-intentioned policies, when implemented rigidly and without adequate consideration for individual patient needs, can lead to unintended negative consequences.

The 2022 Guideline’s emphasis on patient function, quality of life, and individualized care represents a potential paradigm shift. If implemented thoughtfully and with appropriate oversight, it could lead to improved pain management outcomes for millions of Americans. However, vigilance will be required to ensure that this new guidance is not subjected to the same restrictive interpretations that plagued its predecessor. Collaboration between clinicians, patients, policymakers, and advocacy groups will be essential to foster a more balanced and effective approach to pain care, prioritizing patient well-being while mitigating the risks associated with opioid therapy. The ongoing scrutiny of conflicts of interest within guideline development processes remains a critical component of ensuring public trust and the integrity of clinical recommendations.

About the Authors:

• Chad D. Kollas, MD: Medical Director for Palliative and Supportive Care at the Orlando Health Cancer Institute in Orlando, FL. Dr. Kollas serves as the American Academy of Hospice and Palliative Medicine (AAHPM) Delegate to the American Medical Association (AMA) House of Delegates, where he chairs the AMA Pain and Palliative Medicine Specialty Section Council and is a member of the AMA Substance Use and Pain Care Task Force. He has extensive experience as a medical expert witness and has received educational research grants. He is also an editor for the Advocacy section of AAHPM Quarterly and serves on editorial advisory boards for several prominent medical journals.
• Beverly Schechtman: A patient with chronic illness and pain, Ms. Schechtman has dedicated the past five years to patient advocacy. She holds the position of Vice-president of The Doctor Patient Forum and has been a volunteer with Don’t Punish Pain since its inception in 2017. She is a passionate researcher and advocate committed to giving a voice to those experiencing pain. The Doctor Patient Forum is a registered 501(c)(3) non-profit organization that accepts donations.
• Carrie Judy: An unpaid contributor and researcher at The Doctor Patient Forum, Ms. Judy contributes her research expertise to support patient advocacy efforts.

Competing Interests:

Dr. Kollas has disclosed numerous professional roles and affiliations related to pain management, palliative care, and medical ethics, including his positions within the AMA, expert witness work, and editorial roles. Ms. Schechtman’s competing interests are outlined through her leadership role at The Doctor Patient Forum, a non-profit organization. Ms. Judy’s role as a volunteer researcher for The Doctor Patient Forum is also noted.