Conflicts of Interest and the CDC 2016 Opioid Guidelines Undermine Public Health Policy

A critical examination of the Centers for Disease Control and Prevention’s (CDC) Guideline for Prescribing Opioids for Chronic Pain, United States, 2016, has revealed a complex web of potential conflicts of interest, particularly concerning the involvement of Dr. Roger Chou. A disclosure made by Dr. Chou during a CDC National Center for Injury Prevention and Control (NCIPC) Board of Scientific Counselors (BSC) meeting on July 16, 2021, acknowledging funding for opioid research, has ignited serious questions about the integrity of the 2016 Guideline and casts a shadow over the development of its subsequent iterations. This article delves into the historical context, specific allegations of conflicts, and the broader implications for public health policy surrounding opioid prescribing.

The controversy stems from Dr. Chou’s long-standing association with Physicians for Responsible Opioid Prescribing (PROP), an advocacy group now known as Health Professionals for Responsible Opioid Prescribing. Dr. Chou co-authored an article in 2011 that announced PROP’s formation and was a signatory to their 2012 petition to the Food and Drug Administration (FDA) concerning opioid labeling. Despite these deep ties, Dr. Chou had previously avoided formal disclosure of any conflicts of interest related to his contributions to the 2016 Guideline, a stark contrast to other PROP members who later disclosed their affiliations. The CDC’s own guidelines for the creation of the 2016 Guideline stipulated strict reporting requirements for conflicts of interest, making Dr. Chou’s late disclosure particularly concerning.

The Genesis of Controversy: PROP and the Early Opioid Landscape

The roots of this controversy can be traced back to the early 2000s and the state of Washington’s approach to opioid prescribing within its workers’ compensation system. In 2005, Dr. Gary Franklin, then Director of Washington State’s Labor and Industries Program and later a key figure in PROP, published research suggesting that chronic opioid use might be contributing to abnormal pain sensitivity and preventable opioid-related deaths among injured workers. This led to the development of the "Interagency Guideline on Opioid Dosing for Chronic Non-Cancer Pain" by the Washington State Agency Medical Directors Group (AMDG) in 2007, with subsequent updates in 2010 and 2015.

This AMDG guideline introduced the concept of strict dosing thresholds for opioid analgesics. Despite criticisms from the FDA regarding the lack of scientific support for these thresholds, the guideline was implemented by Washington State to manage prescribing for Medicaid patients, workers’ compensation recipients, and state employees. This policy, in part, promoted the use of methadone, which Dr. Franklin advocated as a cost-saving measure.

The consequences of this policy soon became apparent. By 2009, prominent pain management experts like Dr. Scott Fishman and Dr. Lynn Webster raised concerns about the arbitrary dosing thresholds and the specific risks associated with methadone, noting that even seemingly low doses could be fatal. Professional pain societies, including the American Academy of Pain Medicine, the American Pain Foundation, and the American Pain Society, formally opposed the AMDG Guideline.

Investigative reporting by the Seattle Times uncovered significant harms to Washington’s vulnerable populations, with the promotion of methadone linked to thousands of deaths among Medicaid recipients between 2003 and 2011. This led to a public health advisory in Washington State specifically highlighting the unique risks of methadone. It was in this climate of growing concern over the harms of aggressive opioid restriction policies that PROP was formed, with Dr. Chou’s involvement in co-authoring their foundational article in 2011.

Scrutiny of the 2016 CDC Guideline: Conflicts and Methodologies

The CDC’s stated requirements for participation in the creation of the 2016 Guideline were stringent, emphasizing the disclosure of potential conflicts of interest, including financial relationships, intellectual preconceptions, and previously stated public positions. Experts with conflicts that could have a "direct and predictable effect on the recommendations" were to be excluded. Initially, the CDC reported that no members of the core expert groups had any conflicts of interest that violated these policies.

However, years later, disclosures revealed that several PROP members, including its president, Dr. Jane Ballantyne, and board member Dr. Gary Franklin, had significant conflicts, such as serving as paid consultants and having authorship of the very AMDG guidelines that were later criticized. While members of the Core Expert Group (CEG) and Opioid Guideline Workgroup (OGW), including Dr. Chou, initially disclosed no financial conflicts, a deeper dive into Dr. Chou’s past work reveals potential non-financial conflicts that may have directly influenced the guideline’s recommendations.

In 2008, Dr. Chou authored an article in Pain Medicine on interpreting systematic reviews and clinical practice guidelines. This work was criticized by a group of physicians, including the lead author of several articles in the same issue, for what they termed a misinterpretation of pain guidelines and a focus solely on randomized clinical trials, potentially overlooking other crucial evidence. They argued that developing guidelines without sufficient expertise and relying solely on trials performed by non-specialists could lead to biased outcomes.

Further criticism arose in 2010 when another group challenged Dr. Chou’s interpretation of the American Pain Society’s clinical practice guidelines. They asserted that he had inappropriately utilized and excluded studies, failing to eliminate bias in his evaluations. These critiques suggest that Dr. Chou’s methodological approaches and prior publications on pain guidelines could have directly influenced the evidence synthesis and recommendations of the 2016 CDC Guideline, raising questions about whether these constituted conflicts that should have been disclosed under CDC policy.

Financial Entanglements and a "Self-Funding Loop"

Beyond non-financial conflicts, Dr. Chou’s financial relationships also warrant scrutiny. His involvement with PROP and its funding streams, as well as funding from the Agency for Healthcare Research and Quality (AHRQ) and the CDC Foundation, created a complex network of financial ties.

Dr. Chou’s group received funding from the Group Health Foundation, a key supporter of PROP. This foundation, along with PROP, co-sponsored a National Summit on Opioid Safety in 2012, where Dr. Chou delivered the keynote address. At this summit, he acknowledged funding from AHRQ and a financial relationship with Palladian Health, a company focused on musculoskeletal health where he served on the Clinical Advisory Board.

Crucially, Oregon Health and Science University (OHSU), Dr. Chou’s employer, received a significant contract from AHRQ to serve as an Evidence-Based Practice Center, which funded his work. This marked the beginning of what the authors describe as an "early funding loop" between PROP-affiliated entities and AHRQ, supporting the research that underpinned the 2016 Guideline.

Over time, this network expanded to include the CDC Foundation, an independent non-profit established to support the CDC’s work through philanthropic and private sector resources. Kaiser Permanente, which acquired Group Health Cooperative, became a philanthropic donor to the CDC Foundation. This established a "self-funding loop" involving PROP/Group Health/Kaiser Permanente and AHRQ, providing indirect funding for Dr. Chou’s opioid-related reviews.

In 2018 and 2019, OHSU received substantial funding from AHRQ for the work of the Pacific Northwest Evidence-based Practice Center, directed by Dr. Chou. He publicly acknowledged AHRQ funding for his opioid reviews, even noting it as a relevant financial conflict of interest in a correction to an article published in the Annals of Internal Medicine. However, he characterized this conflict as activity outside the submitted work, a distinction that allowed him to avoid direct identification of a conflict in that specific correction, unlike other PROP members named in the same correction.

The Shadow of the 2022 Guideline and Emerging Harms

The concerns surrounding conflicts of interest extend to the development of the revised and expanded 2022 Guideline. Despite requests under the Freedom of Information Act (FOIA) for documents related to PROP and Dr. Chou’s involvement, the CDC provided heavily redacted materials, raising suspicions about transparency.

Furthermore, the AHRQ’s policy for managing conflicts of interest in its draft reports, which allowed for the retention of individuals with potential conflicts if their expertise was deemed unique and if those conflicts were "balanced, managed, or mitigated," drew criticism from stakeholders. This approach differs from the CDC’s stricter exclusion criteria for the 2016 Guideline.

The implications of the 2016 Guideline have become increasingly apparent, with documented harms emerging from its misapplication. Clinicians reported a rise in patient suicides linked to forced or involuntary opioid tapers. In response, the American Medical Association adopted a policy opposing hard dosing limits and advocating for individualized care. Both the FDA and the CDC issued statements cautioning against the sudden discontinuation of opioid pain medications and the misapplication of the 2016 Guideline.

Research has further substantiated these concerns:

• A 2019 study in Vermont found that Medicaid patients undergoing faster opioid tapering experienced a higher probability of adverse events.
• A 2019 study indicated that opioid tapers were associated with care termination in a significant percentage of cases.
• A 2020 study on veterans found increased risks of overdose or suicide after stopping opioid treatment, with the risk escalating with the duration of prior treatment.
• More recent studies have linked opioid tapering events to an increased risk of overdose and mental health crises among patients on long-term opioid therapy.

Beyond tapering, the 2016 Guideline’s rigid application has also negatively impacted patients with cancer pain and those receiving palliative care, groups for whom the guideline was explicitly not intended due to their unique therapeutic needs. Studies have shown declines in opioid prescribing for patients with bone metastasis from active cancer and an increase in pain-related emergency department visits for cancer patients at the end of life, suggesting worsening pain management. The national opioid epidemic has also contributed to a stigma surrounding opioid use, further undermining pain management for these vulnerable populations.

A Call for Accountability and Policy Reform

The evidence presented suggests that Dr. Roger Chou’s undisclosed conflicts of interest prior to July 16, 2021, likely had a "direct and predictable effect on the recommendations" within the 2016 Guideline. This, coupled with the continuous involvement of PROP and potentially conflicted individuals in the development of subsequent guidelines, has severely compromised the professional integrity and clinical credibility of the CDC’s opioid policy. The authors argue that Dr. Chou was placed in a position of "advocating his own work as national healthcare policy."

In light of these findings, the authors propose several robust recommendations:

1. Rescind Harmful Provisions: The CDC should immediately rescind the most harmful or misapplied portions of the 2016 Guideline, including arbitrary dosing thresholds (MME) and involuntary opioid tapers.
2. Commit to Balanced Policy: The CDC must publicly commit to a balanced opioid policy that emphasizes individualized care for chronic pain patients, acknowledging that some patients, particularly those with serious illnesses, may benefit from judiciously prescribed opioid analgesics.
3. Suspend the 2022 Guideline: The CDC should indefinitely suspend any plans to implement the 2022 Guideline, given its development under similar ethical concerns.

Furthermore, the authors call for investigations by the U.S. Congress or the Department of Justice into Dr. Roger Chou, PROP, and the CDC to determine if any federal laws or policies were violated during the creation of both the 2016 and 2022 Opioid Prescribing Guidelines. They also encourage legal scholars to explore potential avenues for litigation to remedy the harms inflicted upon patients with chronic pain.

The authors conclude that rectifying the ongoing harms caused by the CDC’s opioid prescribing guidelines and preventing further damage from the forthcoming 2022 Guideline is an imperative for public health and pain management. Restoring a balanced approach to pain policy, one that includes access to judiciously prescribed opioid analgesics, is crucial for the millions of Americans living with chronic pain.

This article was written by Chad D. Kollas MD, Terri A. Lewis PhD, Beverly Schechtman, and Carrie Judy. Dr. Kollas serves as the Medical Director for Palliative and Supportive Care at the Orlando Health Cancer Institute. Dr. Lewis is in Rehabilitation and Mental Health Counseling at the National Changhua University of Education. Ms. Schechtman is a chronic pain and illness patient advocate and VP of The Doctor Patient Forum. Ms. Judy is an unpaid contributor and researcher at The Doctor Patient Forum. Dr. Kollas reports competing interests including service on the Board of Directors of the American Academy of Hospice and Palliative Medicine and as a delegate to the American Medical Association.