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by Chad D. Kollas, MD, Beverly Schechtman and Carrie Judy

Several important developments have occurred since the publication of our article, “Undisclosed Conflicts of Interest by Physicians Creating the CDC Opioid Prescribing Guidelines: Bad Faith or Incompetence?” in Pallimed on September 12, 2022 (1). Most notably, this includes the publication of the 2022 CDC Clinical Practice Guideline for Prescribing Opioids for Pain (2), which updated the guidance previously provided by the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain (3). In this epilogue, we will describe those important developments and examine how the 2022 revision of the Opioid Guideline (hereafter the 2022 Guideline) should affect pain care and national opioid policy in the future.

Disclosing Sullivan’s Conflicts of Interest

In our article, we criticized the medical journal, PAIN, and Mark Sullivan, a member of the advocacy group, Physicians for Responsible Opioid Prescribing (PROP), for failing to disclose his conflicts of interest related to his expert witness work in opioid litigation (1). Just two days later, on September 14, 2022, PAIN electronically published statements (4, 5) disclosing Sullivan’s previously omitted COIs. PAIN had initially acknowledged Sullivan’s COIs in May 2022 (6), but it is challenging to believe the timing of its disclosure and the publication of the Pallimed article was entirely coincidental.

CDC’s Response to FOIA Requests

We also noted in the Pallimed article that several other PROP members and allies who participated in the creation process of the 2016 Guideline had apparently failed to disclose other relevant conflicts of interest that may have been disqualifying under CDC rules and policies. We submitted a request to CDC under the Freedom of Information Act (FOIA) to provide materials that included their disclosures or a waiver from CDC from making the disclosure (7). On October 18, 2022, CDC provided disclosure agreements from Jane Ballantyne and Lewis Nelson that did not disclose their roles in developing and publishing opioid policy statements on behalf of PROP (8). Ballantyne disclosed her work in “legal consulting,” but did not clarify that this work involved receiving payments from law firms participating in multidistrict litigation against opioid manufacturers and distributors, which she had disclosed in several articles (1, 8, 9-12). It is unclear whether CDC investigated Ballantyne’s “legal consulting” disclosure more fully.

Additionally, we sought clarification about Roger Chou’s conflicts of interest regarding his role as a co-author of both the 2016 and 2022 Guidelines via our FOIA request. The CDC’s reply was unusual in that it provided no responsive documents, but cited Chou’s public disclosure of his conflict of interest from the July 2021 Meeting of the CDC BSC-NCIPC and recusal from those proceedings (13). While following this response, we confirmed that Chou received funding in September 2014 from the Agency for Healthcare Research and Quality (AHRQ), through his role as the Director for the Pacific Northwest Evidence-based Practice Center and employment by Oregon Health and Science University (14). Based on CDC’s rules and policies for clinical guideline development, Chou should have disclosed that funding to CDC using the “Declaration of Interests for CDC Experts (1, 3).” In light of this, we placed another FOIA request seeking Chou’s “Declaration of Interests for CDC Experts” document for his 2014 AHRQ funding, but CDC forwarded that request to AHRQ on October 26, 2022 (15). On October 28, 2022, on behalf of AHRQ, a representative from Health and Human Services (HHS) responded “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. Therefore, we have closed our file on this matter (16).” In the absence of any statement otherwise, we interpret this all to mean that CDC views Chou’s COI disclosure in July 2021 as applying to any authorship role in either iteration of the CDC Opioid Guideline.

The FSBM Workshop and an Unexpected Opportunity

The Federation of State Medical Boards held a workshop on opioids and addiction treatment on September 27 and 28, 2022, in Washington, DC, and one of us (CDK) provided testimony to that group as an invited guest (17). The workshop group included a representative from the CDC National Center for Injury Prevention and Control (NCIPC), which led to a series of meetings and communications with its leadership (18). These communications were very helpful in better understanding the 2022 CDC Clinical Practice Guideline for Prescribing Opioids for Pain (2), which was released publicly on November 3, 2022, with an accompanying Editorial Letter that provided an excellent summary of the Guideline’s purpose, scope and intended effects (19).

Preventing Recurrent Misapplication of the New 2022 CDC Guideline

According to the Acting Director of the CDC NCIPC, Dr. Christopher Jones, the 2022 CDC Clinical Practice Guideline for Prescribing Opioids for Pain (hereafter the new Guideline) is not “meant to be implemented as absolute limits of policy or practice by clinicians, health systems, insurance companies, governmental entities (20)." It contains no hard dosing thresholds for prescribing opioids and instead “aims 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 (19).” The new Guideline does not apply to patients with pain from sickle cell disease, cancer, or those receiving palliative care and end-of-life care (2, 19), and it cites other clinical guidelines as providing guidance for managing those patients (21-24). Moving forward, the CDC has pledged to monitor the Guideline’s implementation to prevent recurrent misapplication, but seeks support from a wide coalition of stakeholders to assist with monitoring and advocating against its misapplication (18, 19). Based on the lessons we have learned from our trilogy of Pallimed articles (1, 25, 26), we call on responsible advocates for evidenced-based pain care to join in the important endeavor to restore balance to national opioid policy and preserve the quality of life for patients in pain.

About the Authors:

Lead author, Chad Kollas, MD, serves as the Medical Director for Palliative and Supportive Care at the Orlando Health Cancer Institute in Orlando, FL. He can be reached by e-mail at chad.kollas@orlandohealth.com or via Twitter at @ChadKollasMD.

Bev Schechtman is a patient with chronic illness and pain who has spent the last five years volunteering as a patient advocate. She is currently the Vice-president of The Doctor Patient Forum, and she has been with the volunteer organization, Don't Punish Pain, since its inception in 2017. She is a passionate researcher and advocate who hopes to give a voice to those in pain.

Carrie Judy is an unpaid contributor and researcher at The Doctor Patient Forum.

Competing Interests:

Dr. Kollas as the American Academy of Hospice and Palliative Medicine (AAHPM) Delegate to the American Medical Association (AMA) House of Delegates, where he is the Chair of the AMA Pain and Palliative Medicine Specialty Section Council and a member of the AMA Substance Use and Pain Care Task Force. Dr. Kollas provided testimony at a 2004 Congressional Hearing on OxyContin. Dr. Kollas has served as a medical expert witness in cases involving opinions regarding the standard of care in internal medicine and hospice and palliative medicine. He has received educational research grants from the AMA Education and Research Foundation, Geisinger Clinic and M. D. Anderson Cancer Center Orlando. He serves as the editor for the Advocacy section of AAHPM Quarterly and is a member of the Editorial Advisory Board and review for the Journal of Pain and Symptoms Management. He has also served as a reviewer for the Journal of Palliative Medicine, Annals of Internal Medicine, Journal of General Internal Medicine, Journal of Graduate Medical Education, and the Educational Clearinghouse for Internal Medicine.

Ms. Schechtman serves as the Vice-president of The Patient Doctor Forum, which accepts donations as a registered 501(c)(3) non-profit organization.

Ms. Judy serves as a volunteer researchist for The Doctor Patient Forum.

For more Pallimed posts about opioids.
For more Pallimed posts by Dr. Kollas click here.

References

1. Kollas CD, Schechtman B, Judy C. Undisclosed Conflicts of Interest by Physicians Creating the CDC Opioid Prescribing Guidelines: Bad Faith or Incompetence? Pallimed. September 12, 2022. Available at: https://www.pallimed.org/2022/09/undisclosed-conflicts-of-interest-by.html. (Last accessed on October 25, 2022).

2. Dowell D, Ragan KR, Jones CM, Baldwin GT, Chou R. CDC Clinical Practice Guideline for Prescribing Opioids for Pain — United States, 2022. MMWR Recomm Rep 2022;71(No. RR-3):1–95. DOI: http://dx.doi.org/10.15585/mmwr.rr7103a1.

3. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016. MMWR Recomm Rep 2016;65(No. RR-1):1–49. DOI: http://dx.doi.org/10.15585/mmwr.rr6501e1.

4. Sullivan MD. Long-term opioid therapy unsettles us both coming and going. Pain. 2022 May 1;163(5):807-808. doi: 10.1097/j.pain.0000000000002453. PMID: 34407030. Erratum. PAIN: September 2022 - Volume 163 - Issue 9 - p e1040 doi: 10.1097/j.pain.0000000000002722.

5. Sullivan MD. Reply to Fields and Darnall. Pain. 2022 May 1;163(5):e690-e691. doi: 10.1097/j.pain.0000000000002519. PMID: 35426891. Erratum. PAIN: September 2022 - Volume 163 - Issue 9 - p e1040 doi: 10.1097/j.pain.0000000000002722.

6. Personal communication: Francis J. Keefe, Editor-in-Chief, PAIN, e-mail to Chad Kollas, dated May 31, 2022. (Subject: Decision onyour Submission: PAIN-D-22-00416).

7. The Freedom of Information Act, 5 U.S.C. § 552. Available at: https://www.justice.gov/oip/freedom-information-act-5-usc-552 (Last accessed on November 8, 2022).

8. Personal communication: Roger Andoh, CDC/ATSDR FOIA Officer, Office of the Chief Operating Officer, Centers for Disease Control and Prevention and Agency for Toxic Substances and Disease Registry (CDC/ATSDR) Freedom of Information Act (FOIA). E-mail to Bev Schechtman, dated October 18, 2022, at 12:20:18 PM EDT (RE: Final Response With Redactions - 22-01939-FOIA).

9. Sullivan MD, Ballantyne JC. When Physical and Social Pain Coexist: Insights Into Opioid Therapy. Ann Fam Med. 2021 Jan-Feb;19(1):79-82. doi: 10.1370/afm.2591. Epub 2020 Dec 21. PMID: 33355099; PMCID: PMC7800754.

10. Ballantyne JC, Sullivan MD, Koob GF. Refractory dependence on opioid analgesics. Pain. 2019 Dec;160(12):2655-2660. doi:10.1097/j.pain.0000000000001680. PMID: 31408053.

11. Manhapra A, Sullivan MD, Ballantyne JC, MacLean RR, Becker WC. Complex Persistent Opioid Dependence with Long-term Opioids: aGray Area That Needs Definition, Better Understanding, Treatment Guidance, and Policy Changes. J Gen Intern Med. 2020 Dec;35(Suppl3):964-971. doi: 10.1007/s11606-020-06251-w. Epub 2020 Nov 6. PMID: 33159241; PMCID: PMC7728942.

12. Ballantyne JC, Sullivan MD. Intensity of Chronic Pain--The Wrong Metric? N Engl J Med. 2015 Nov 26;373(22):2098-9. doi:10.1056/NEJMp1507136. PMID: 26605926.

13. National Center for Injury Prevention and Control, Centers for Disease Control and Prevention. NCIPC Board of Scientific Counselors Meeting, Friday, July 21, 2021; Atlanta, GA. Available at: https://www.cdc.gov/injury/pdfs/bsc/BSC_NCIPC_Meeting_Minutes_7_16_2021_Final. pdf; see also https://www.youtube.com/watch?v=wb4ysxY0sUo at 0:46 mark. (Last accessed on October 25, 2022).

14. Chou R, Deyo R, Devine B, Hansen R, Sullivan S, Jarvik JG, Blazina I, Dana T, Bougatsos C, Turner J. The Effectiveness and Risks of Long-Term Opioid Treatment of Chronic Pain. Evid Rep Technol Assess (Full Rep). 2014 Sep;(218):1-219. doi: 10.23970/AHRQEPCERTA218. PMID: 30313000.

15. Personal communication: Laura Spencer, CDC/ATSDR FOIA Office, Office of the Chief Operating Officer, Centers for Disease Control and Prevention and Agency for Toxic Substances and Disease Registry (CDC/ATSDR) Freedom of Information Act (FOIA). E-mail to Bev Schechtman, dated October 26, 2022, at 4:29 PM EDT.

16. Personal communication: Ms. Carol Maloney (via Ruhma Sufian), Deputy Agency Chief FOIA Officer U.S. Department of Health and Human Services, Office of the Assistant Secretary for Public Affairs. E-mail to Bev Schechtman, RE: HHS Case No: 2023-00091-FOIA-PHS, dated October 28, 2022, at 1:26:16 PM EDT.

17. Personal communication: Lisa Robin, Chief Advocacy Officer, Federation of State Medical Boards (FSMB). E-mail to Chad D. Kollas MD, dated September 17, 2022, at 2:11 PM. RE: Speaker Invitation (Workgroup on Opioids and Addiction Treatment, September 27 and 28, 2022, at the Omni Shoreham Hotel in Washington, DC).

18. Personal Communication: Christopher M. Jones, PharmD, DrPH, MPH, Acting Director, CDC National Center for Injury Prevention and Control (NCIPC). E-mail to Chad D. Kollas MD, dated October 17, 2022, at 1:38 PM. RE: Follow-up from last week’s FSMB Workshop.

19. Dowell D, Ragan KR, Jones CM, Baldwin GT, Chou R. Prescribing Opioids for Pain - The New CDC Clinical Practice Guideline. N Engl J Med. 2022 Nov 3. doi: 10.1056/NEJMp2211040. Epub ahead of print. PMID: 36326116.

20. Stone W, Huang P. CDC issues new opioid prescribing guidance, giving doctors more leeway to treat pain. NPR, November 2, 2022. Available at: https://www.npr.org/sections/health-shots/2022/11/03/1133908157/new-opioid-prescribing-guidelines-give-doctors-more-leeway-to-treat-pain (Last accessed on November 7, 2022).

21. Brandow AM, Carroll CP, Creary S, et al. American Society of Hematology 2020 guidelines for sickle cell disease: management of acute and chronic pain. Blood Adv 2020;4:2656–701. PMID:32559294 https://doi.org/10.1182/bloodadvances.2020001851. 22. Swarm RA, Paice JA, Anghelescu DL, et al.; BCPS. Adult cancer pain, version 3.2019, NCCN clinical practice guidelines in oncology. J Natl Compr Canc Netw 2019;17:977–1007. PMID:31390582 https://doi. org/10.6004/jnccn.2019.0038.

23. Tevaarwerk A, Denlinger CS, Sanft T, et al. Survivorship, version 1.2021. J Natl Compr Canc Netw 2021;19:676–85. PMID:34214969 https:// doi.org/10.6004/jnccn.2021.0028.

24. Paice JA, Portenoy R, Lacchetti C, et al. Management of chronic pain in survivors of adult cancers: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol 2016;34:3325–45. PMID:27458286 https://doi.org/10.1200/JCO.2016.68.5206.

25. Kollas C. Mandated PROP’s Disproportionate Influence on U.S. Opioid Policy: The Harms of Intended Consequences. Pallimed. May2021. Available at: https://www.pallimed.org/2021/05/props-disproportionate-influence-on-us.html. (Last accessed on November 8, 2022).

26. Kollas CD, Lewis TA, Schechtman B, Judy C. Roger Chou’s Undisclosed Conflicts of Interest: How the CDC’s 2016 Guideline forPrescribing Opioids for Chronic Pain Lost Its Clinical and Professional Integrity. Pallimed. September 2021. Available at: https://www.pallimed.org/2021/09/roger-chous-undisclosed-conflicts-of.html. (Last accessed on November 8, 2022).

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by Chad D. Kollas, MD, Beverly Schechtman and Carrie Judy

Introduction

In May 2021, Pallimed published our commentary that described the inappropriate and disproportionate influence given to the advocacy group, Physicians for Responsible Opioid Prescribing (PROP, also known as Health Professionals for Responsible Opioid Prescribing) during the creation process of the Centers for Disease Control and Prevention (CDC) 2016 Guideline for Prescribing Opioids for Chronic Pain, hereafter the 2016 Guideline (1-3). In September 2021, Pallimed published our second commentary, which focused on the astonishing disclosure of an important conflict-of-interest (COI) by Dr. Roger Chou (5), who co-authored the 2016 Guideline, calling its integrity into question (4, 5).

This commentary, the final in our trilogy, expands on these articles to quantify and clarify the extent of Chou’s COI. We also explore additional COIs from the 2016 Guideline’s creation group before the final release of the updated CDC 2022 Clinical Practice Guideline on Prescribing Opioids for pain, hereafter the 2022 Draft Guideline (6,7). Our results suggest that advocates for unfocused reductions in opioid prescribing propagated a false narrative that physician overprescribing drove increases in overdose deaths over the last two decades. Using this false narrative, these advocates facilitated a corresponding moral panic that produced flawed national opioid policy that has increased drug overdose deaths and harmed patients in pain but has also served the competing financial and intellectual interests of the CDC, health insurers, mass tort litigation attorneys, state attorneys general and anti-opioid stakeholders.

Background/Chronology

“Just because you're paranoid doesn't mean they aren't after you (8).”

In a moral panic, a group of people are portrayed as posing a threat to themselves or society, thereby “justify[ing] intolerance and unfair treatment” of that group, while the “evidentiary standard” for treating them that way is lowered (9, 10). A moral panic can effectively sway public opinion to force a shift in public policy (9-11). “Moral entrepreneurs… crusade for making and enforcing rules that benefit their own interests by bringing them to the attention of the public and those in positions of power and authority under the guise of righting a society [sic] evil ” created by those causing the threat (9, 11). Medicine is not immune to such moral panics, and in the case of opioid policy, patients using opioid analgesics - whether to treat pain or opioid use disorder - became the group posing a “threat to society (9),” while physician advocates for unfocused reductions in opioid prescribing became moral entrepreneurs (9, 10).

How Did the Media Contribute to this Moral Panic?

In November 2003, the Orlando Sentinel published a series of articles on OxyContin, exemplifying the media’s moral panic about opioids (12). The series garnered national attention and culminated in the scheduling of a Congressional hearing on the dangers of OxyContin, popularizing the concept of “The Opioid Crisis (13, 14).” Suspicions about the veracity of the articles’ sources triggered an internal investigation, which led to the author’s resignation (15-17), but the series had created a foundation for a false narrative: duped by pharmaceutical companies’ deceptive marketing, physicians allegedly overprescribed opioids to patients with mild pain inappropriately, who eventually died from overdoses after becoming addicted to prescription medications.

Moral Entrepreneurs Seize the Opportunity

Opioid prescribing increased during the mid-1990s after widespread calls to improve pain management, particularly at the end of life (18-21). This unexpectedly and undesirably increased health insurers’ medication costs, including Medicare and Medicaid (22). Responding to an underfunded Medicaid program in 2003, Washington State’s Prescription Drug Preferred Drug List “steered people with state-subsidized health care — Medicaid patients, injured workers and state employees — to methadone” as a money-saving choice versus other opioid analgesics (23-25). By 2007, the Washington State Agency Medical Directors Group (AMDG), which included several eventual PROP members (23), published an “Interagency Guideline on Opioid Dosing for Chronic Non-Cancer Pain (26) that introduced the concept of hard dosing thresholds for opioid analgesics, which was later incorporated into the 2016 Guideline (2, 3). Although this reduced Washington state’s Medicaid costs, it contributed “to the deaths of at least 2,173 people between 2003 and late 2011 (23, 25).”

Despite these deaths, the false narrative gained traction and clarity when it was advanced by Andrew Kolodny, who co-authored a 2011 article with Roger Chou which announced the formation of the physician advocacy group, Physicians for Responsible Opioid Prescribing or PROP (26). Kolodny further asserted that physicians “contributed to an epidemic of overdose deaths and addiction by overprescribing opioids (27, 28).” PROP and Chou petitioned the Food and Drug Administration (FDA) to change opioid labeling in July 2012 (29, 30), but FDA rejected PROP’s call for a maximum daily dose of opioid analgesia of 100 morphine milligram equivalents (MME) based on a lack of supporting data (31).

The 2016 Guideline, Its Misapplication and Patient Harms

In the CDC, PROP found a more willing collaborator than FDA during the formation of the 2016 Guideline, prompting numerous concerns about the transparency and flawed integrity of its creation process (1, 4, 32-34). For example, in late 2015, Washington Legal Foundation alleged that one of the members of CDC’s Core Expert Group (later identified as PROP member, Jane Ballantyne) had “served as a paid consultant to a law firm planning multi-district litigation against opioid manufacturers (4, 33, 34).” WLF’s complaint compelled the CDC to re-open a second open comment period for the public, lasting 30 days in duration, rather than the two-day period for comment which CDC had originally presented via a September 2015 webinar (4, 35).

Despite transparency concerns and worries about conflicted interests on the part of the Guideline’s creators by key stakeholders (36-39), CDC published its 2016 Guideline on March 18, 2016 (2-4). That same month, Kolodny – who had served as a Stakeholder Reviewer for the 2016 Guideline - deflected concerns about PROP members’ relationships with law firms suing opioid manufacturers (34) and instead characterized key stakeholders’ open comments to CDC as driven by “financial relationships with opioid manufacturers (40).”

By November 2018, misapplication of the 2016 Guideline had begun to cause serious patient harms, including diminished access to medically appropriate opioid analgesia (41). Moreover, a group of CDC scientists publicly questioned the accuracy of CDC data on drug overdose deaths, which had not accounted for deaths involving illicit fentanyl (42). In response, the American Medical Association (AMA) called against widespread misapplication of the 2016 Guideline, including its embrace of hard dosing thresholds (1, 43). Other stakeholders quickly joined AMA’s call against misapplying the 2016 Guideline (44-47), and in April 2019, the Guideline’s co-authors acknowledged its widespread, including “inflexible application of recommended dosage and duration thresholds and policies that encourage[d] hard limits and abrupt tapering of drug dosages, resulting in sudden opioid discontinuation or dismissal of patients from a physician’s practice (48, 49).” That same month, FDA posted a public safety announcement warning against sudden discontinuation of opioid medications (1, 50), supplemented by a podcast warning against rapid opioid tapers (51). CDC issued another public warning against misapplication of the 2016 Guideline on April 24, 2019 (52).

Moral Entrepreneurs Undermine a Call for Balanced Opioid Policy

Just a few months earlier, a new hope for balanced opioid policy had emerged via the U.S. Department of Health and Human Services (HHS) Inter-Agency Task Force Draft Report on Pain Management Best Practices (53, 54). Pain management experts felt that the HHS Draft Report would “improve the access to pain care and remove the stigma, providing patients and providers with appropriate education, training, risk assessment, and evaluation (55).”

Opposing that view, however, the National Association of Attorneys General (NAAG) sent comments to HHS Assistant Secretary for Health, Dr. Vanila Singh, encouraging HHS not to move away “from key components of the CDC Guideline for Prescribing Opioids for Chronic Pain,” citing concerns that doing so “would undermine ongoing legislative initiatives [and] refinements to standards of medical care (56).” PROP hypocritically criticized the HHS Draft Report, noting that “HHS should have excluded individuals and organizations with financial ties to opioid manufacturers from serving on the HHS Pain Management Task Force (57).” The HHS Draft Report on Pain Management Best Practices quietly faded into obscurity.

Reassessing the 2016 Guideline; Creating the 2022 Opioid Guideline

As part of a planned assessment process, CDC opened a docket for public comments on its 2016 Guideline in April 2020 (58). Key stakeholders again expressed concerns about growing patient harms arising from the Guideline’s misapplication, especially from nonconsensual opioid tapers and denials for pain care, which amplified calls to rescind hard dosing thresholds (59, 60). In contrast, PROP predicted “the downward trends in new starts of chronic opioid treatment achieved by the 2016 guideline should be seen as a positive development that will encourage people to find alternative means of controlling chronic pain, which… will ultimately result in better outcomes and less distress (61).” Despite PROP’s optimism, CDC observed that “age-adjusted overdose death rates involving synthetic opioids, psychostimulants, cocaine, heroin, and prescription opioids during 2013–2019” increased 1,040%, largely as the result of illicit fentalogues (62-64). PROP deflected this news by criticizing AMA’s opioid policy as tainted by contributions from the pharmaceutical industry (65, 66).

When Roger Chou unexpectedly disclosed his conflict of interest (COI) from receiving “funding to conduct reviews on opioids (4, 5),” evidence of harms from misapplications of 2016 Guideline had become more apparent (67-73). In the wake of Chou’s admission, the CDC 2022 Opioid Work Group (OWG) expressed additional concerns about the 2022 Draft Guideline, including that it was “not balanced and missing key studies” about potential opioid benefits and contained a constant tension between “public health benefits [versus] patient benefits (74).” The OWG also cited concerns about “including specific opioid dose thresholds in the recommendations” in the 2022 Draft Guideline (74). In light of the OWG’s concerns, we explored the depth of Chou’s COI disclosure (4, 5) and sought to uncover any other relevant, unreported COIs by those who created the 2016 Guideline and shaped current U.S. opioid policy.

Methodology

We qualitatively explored undisclosed or omitted conflicts of interests (COIs) from journal articles authored by the group of physicians who had advocated publicly, mainly through their PROP-related activities, for reduced opioid prescribing before their selection into the creation group of the 2016 Guideline. We examined whether they excluded disclosures of relevant COIs in publications that could influence opioid policy, emphasizing articles that might have prejudiced the creation process for the 2022 Draft Guideline.

We identified relevant publications via a query of PubMed (via the website link, https://pubmed.ncbi.nlm.nih.gov/) using the authors’ names and the search terms “CDC,” “Tapers,” “MME,” “Opioid Treatment,” or “Opioid Epidemic” for the period between September 1, 2015 and June 30, 2022. This start date reflected the timing of CDC’s webinar for its intended release of its 2016 Guideline (2, 3), while the end date preceded a decision by CDC on the final form for its 2022 Revised Opioid Guideline (6, 7). We included articles that articulated policy positions or recommendations relevant to either the 2016 Guideline or 2022 Draft Guideline. These articles contained key themes arising from discourse about the Guidelines, including but not limited to opioid tapering, MME, dosing thresholds and/or opioid prescribing recommendations. We called articles that met these inclusion criteria, “qualifying policy articles (QPAs).” Articles that focused on opioid use disorder or its treatment, acute pain management, or that made no recommendations about opioid treatment or U.S. policy were excluded from the analysis.

We defined “conflict of interest” using the methodology used by CDC itself in its creation of the 2016 Guideline, which “asked potential experts to reveal possible conflicts of interest such as financial relationships with industry, intellectual preconceptions, or previously stated public positions (2).” This included financial and non-financial or intellectual conflicts or competing interests. It also called for the exclusion of any experts that had “conflicts that might have a direct and predictable effect on the recommendations (2, italics ours),” such as taking a public position (such as signing a petition) or making recommendations intended to affect opioid policy. Additionally, we defined the authors’ role within relevant advocacy organizations based on their own statements of membership, or by virtue of their authorship of, or signature on, a supporting a policy document advocating for an opioid policy position.

Results

Table 1 summarizes the undisclosed or omitted conflicts of interest of the study group physicians, who advocated for reduced opioid prescribing prior to their involvement in the creation of the 2016 Guideline (2, 3). In sixty-three of 87 QPAs (72%), these physicians omitted or failed to disclose conflicts of interest (COIs) as defined by the 2016 Guideline (5). Three of these physicians (GF, DT and LN) failed to disclose relevant COIs in all their QPAs, and one physician (JB), failed to disclose COIs in 84% of her QPAs. Only one physician (RC) fully disclosed all COIs in more than half of his QPAs.



Table 2 lists the physicians’ most frequently cited QPAs and relevant conflicts of interest. As a group, four of six physicians (67%) omitted or failed to disclose both financial and intellectual (non-financial) COIs, while two of six physicians had intellectual COIs only. At the time of their selection to the 2016 Guideline creation group, each of the six physicians had an existing intellectual COI (4, 27, 29, 33) and two (RC and JB) had existing financial COIs (3, 4, 33, 34), although these COIs were identified only after they had contributed to the Guideline’s creation process.



Discussion

Conflict Overview, Ethics and CDC’s Guiding Principles

The Institute of Medicine (IOM) has defined a conflict of interest as “a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest (107).” IOM has noted that “expert judgment based on clinical experience remains a significant element in the development of evidence-based practice guidelines,” and recommended that “groups that develop clinical practice guidelines should generally exclude as panel members individuals with conflicts of interest (107).” The American College of Physicians (ACP) recently echoed this sentiment, noting, “One of the hallmarks of a trustworthy clinical guideline or guidance statement is a comprehensive process for disclosure of interests (DOI) and management of conflicts of interest (COIs) (108).” ACP also emphasized that participants creating clinical guidelines should “disclose all active and inactive financial and intellectual interests related to health care,” noting that intellectual COIs “may leave a clinical guideline vulnerable to cognitive biases and may result in indirect financial benefit related to career advancement (108, 109).” Additionally, a Guideline Panel Review working group commissioned by the British Medical Journal (BMJ) identified “red flags” to raise “substantial skepticism” about clinical guidelines’ credibility (110). These “red flags” include any financial conflict by the committee chair, multiple panel members with financial conflicts and “any suggestion of committee stacking that would pre-ordain a recommendation regarding a controversial topic (110).”

Taking these position statements into account, our results suggest that the physicians from this study group have undermined the integrity of both the 2016 Guideline and 2022 Draft Guideline through their PROP- and MDL-related undisclosed or omitted COIs. We have applied CDC’s own ethics and guiding principles to identify these COIs, beginning with its definition of COIs from rules for creating the 2016 Guideline (2, 3). CDC has asserted that “users of guidelines and recommendations need to feel confident that those participating in the development process were not unduly influenced by personal interests. Minimizing competing interests among members of steering committees and technical groups improves guideline acceptability, credibility, and scientific rigor (111).” CDC acknowledged that “a participant with a competing interest might be excluded from participating in the development of the final recommendation statement (111),” and that “guideline developers should make every effort to either eliminate or manage financial, intellectual, or professional interests that compete with the goals of producing an evidence-based guideline (111).” Furthermore, CDC policy states that “reviewers must provide written assurance that their reviews are free of real or perceived conflicts of interest (112)”, and “scientists having real or perceived conflicts of interest with the applications under review may not attend or participate in initial peer review or secondary review meetings (112; italics ours).” Since HHS ethical rules allow obtaining a waiver if an “individual’s services [to an advisory committee] outweigh the potential for a conflict of interest created by the particular financial interest involved (113),” we have submitted a Freedom of Information Act (FOIA) request to CDC to view the waivers of the members of study group (JB, RC, DJ and AK) with financial COIs (see Table 2), the outcome of which is pending at this time (114).

COI Overview and Key Individual Conflicts

All authors should disclose all relevant financial and non-financial or intellectual COIs when creating clinical guidelines intended to influence health policy. In a 2012 study of 114 clinical guidelines created by medical specialty societies (115), COIs were disclosed for 71% of committee chairpersons and 91% of co-chairpersons, which still led to criticism about their trustworthiness for falling short of complete disclosure (116). The physicians in this study group had an overall COI disclosure rate of just 28% in QPAs, which should raise serious concerns about their credibility in matters of health care policy.

While Roger Chou omitted COIs in just 40% of QPAs in this study, he omitted disqualifying financial and intellectual conflicts at the time of his co-authorship of both the 2016 Guideline and the 2022 Draft Guideline (3, 27, 29, 85-91). At the time of his authorship of the 2016 Guideline, Chou did not disclose his pending funding from the Agency for Healthcare Research and Quality (AHRQ) for writing systemic reviews on opioid prescribing, although the grant award was not announced publicly until after its publication (85-91). The National Foundation for the Centers for Disease Control and Prevention, also known as the CDC Foundation, “an independent, private, nonprofit organization chartered by Congress in 1995 and classified as a 501(c)(3) public charity (117),” and AHRQ have both received funding from Group Health that supported Chou’s systemic reviews of opioids (4, 23). Chou’s competing interests should have mandated restriction “from further involvement in development of the clinical guideline… [including] participation in discussions, voting on recommendations, and authorship, or he or she may resign from the committee (108).” Chou did not resign from either the 2016 Guideline or 2022 Draft Guideline creation groups, nor did he step away from authorship, even after disclosing his financial COI publicly (4,5). Several stakeholders commented on these disqualifying COIs during the Open Period for comments on the 2022 Draft Guideline (118-121), but CDC created confusion by redacting Chou’s identity from many of these comments (122) despite public knowledge of his co-authorship of both Guidelines (122).

In addition to Chou’s egregious funding omission, Jane Ballantyne failed to report COIs in 84% of QPAs, while serving as a section editor for a well-known medical journal (123). As an editor, she understood well the ethical principles for reporting competing interests in medical journals (123-125). Furthermore, Ballantyne’s PROP colleague and frequent co-author, Mark Sullivan, recently failed to report his opioid litigation expert witness work as a COI in articles about opioid tapering policies in the journal which she serves as an editor (81, 126), including an article on which she “provided comments on an earlier draft (127).” When notified about the COI in a submitted editorial letter, the journal’s editor-in-chief pledged to publish a correction, but rejected the letter for publication, avoiding publicization of Ballantyne’s ethical violation (128). This correction has not been posted to date (126, 127). Similarly, Sullivan failed to disclose the same conflict in a letter to a medical journal that he co-authored with Ballantyne in March 2021 (129). Rather than publishing an editorial letter identifying the undisclosed COI, however, the article was updated to include the previously unreported competing interest (130). To date, identifying Ballantyne’s failure to disclose these omitted COIs has not affected her status as a section editor for the journal (123).

By contrast, Andrew Kolodny has published three QPAs since September 2019 (131-133), after he corrected his COI disclosures for JAMA articles from 2017 and 2018 (102-105). In more recent QPAs, Kolodny has consistently disclosed COIs arising from his PROP membership and expert witness work for multidistrict litigation (MDL) against opioid manufacturers and distributors (131-133). Unlike Ballantyne’s case, Annals of Internal Medicine posted a comment that revealed that a co-author on one of Kolodny’s QPAs (99) failed to disclose a relevant COI in an opioid policy article (134-136). While Kolodny’s recent reappointment as the president of PROP suggests that disclosing his more recent COIs has not restricted his aggressive advocacy (137), it is unclear whether that has affected the outcome of two recent MDL cases in which he testified for the plaintiffs (138, 139).

Does Disclosing COIs Matter?

The lack of consequences for omitting relevant COIs from QPAs in our study and the failure of many clinical practice guidelines to conform to standards for disclosing COIs (107-117) begs the question of whether disclosing COIs in medical journal articles even matters. Again, the answer comes from the CDC itself: “Guidelines, unlike some types of policies, are not mandatory. In health care and public health, guidelines are not meant to enforce but rather to recommend programs or practices based on the best evidence available. Often, however, CDC and others’ guidelines become ‘the standards of practice,’ unintentionally acquiring the force of policy (111). Users of guidelines and recommendations need to feel confident that those participating in the development process were not unduly influenced by personal interests. Minimizing competing interests among members of steering committees and technical groups improves guideline acceptability, credibility, and scientific rigor (111). Each release of a new CDC guideline might have a lasting impact on clinical and public health practice. Guidelines may be converted to policy, implying widespread implementation by a broad range of groups. Guidelines may be even converted into law, entailing subsequent regulatory enforcement (111; italics ours).”

Ironically, Roger Chou lamented this conversion of the 2016 Guideline into law because of its misapplication in the very same article in which he failed to disclose his funding for writing the systemic reviews upon which he based the both the Guidelines (4, 5, 23, 48, 85, 86). Accurate disclosures of COIs matter because the “public trust in the scientific process and the credibility of published articles depend[s] in part on how transparently an author's relationships and activities, directly or topically related to a work, are handled during the planning, implementation, writing, peer review, editing, and publication of scientific work (125).”

Following the Money

Advocates for reduced opioid prescribing have enjoyed an advantage from the failure of regulatory agencies and medical journals to identify and publicize relevant COIs, thereby propagating moral panic and the false narrative that overprescribing drives the opioid overdose deaths (27, 28). These deaths arose from an epidemic of poisonings from multiple illicit substances, including counterfeit drugs and ethanol, rather than from prescription opioids (42, 140-145). Knowing this, why have federal regulatory agencies and advocates for reduced opioid prescribing cling to a demonstrably false narrative about overprescribing?

As the saying goes, “Follow the money (146).” We described above how changes in opioid policy aimed at reducing Washington State’s Medicaid and Workers Compensation costs contributed to an increase in methadone deaths between 2003 and late 2014 (23-25). Focusing on similar cost reductions, the Centers for Medicare and Medicaid Services (CMS) proposed rules for 2019 including several directives intended to reduce "Opioid Overutilization,” including adoption of the “90 morphine milligram equivalent (MME) threshold cited by the 2016 CDC Opioid Guideline (147, 148). Simply put, reduced prescribing reduces costs for prescribed medications.

Chou received research funding to write systemic reviews of opioid analgesics that shaped both Guidelines, but largely ignored opioids’ potential benefits; he again failed to cite that funding when writing an article bemoaning early harms from the 2016 Guideline’s misapplication (3-5, 48, 74, 85-91). Employing a model created by the tobacco settlements of the 1990s (149), state, federal and local governments have successfully used the 2016 Guideline to justify their legal arguments in settlements of multidistrict litigation (MDL) suits against opioid manufacturers and distributors (150-153). Legal experts’ concerns about Ballantyne’s and Kolodny’s participation in the Guideline’s creation, during which they received financial compensation for MDL-related expert witness work (4, 23, 33, 34, 81-84, 99-105), proved correct when plaintiffs used the 2016 Guideline as a tool to support MDL lawsuits (37, 38, 154).). Andrew Kolodny openly anticipated making $500,000 from his expert witness work on Oklahoma’s lawsuit against opioid manufacturers and distributors (137, 155), while Ballantyne has never disclosed the amount of her personal fees from Motley Rice LLP, “one of the Nation's Largest Plaintiffs' Litigation Firms” and an MDL litigant (156, 157).

As of July 31, 2022, awards from opioid MDL lawsuits settlements had totaled more than $36 billion, with more suits still pending nationwide (158). Many policymakers have called for this settlement money to be spent fortifying public health (159), but tensions have emerged about “what interventions and treatments should be funded (160).” While it remains unclear how much the public will benefit from these settlements, it is very clear that plaintiff expert witnesses from our study group comprise one of the major financial beneficiaries of the MDL lawsuits.

Limitations and Criticisms

When creating our methodology, we purposely borrowed from Kolodny’s methodology (40) to disarm anticipated criticism by PROP and its allies. Similarly, when seeking publication, we received confidential criticism that we self-referenced our prior works in the same way that the study group’s references one another’s work to justify their opioid policy positions. To this we reply, “Turnabout is fair play (161).” Our study examines only physician advocates who served a role in creating the 2016 Guideline. Many more physicians have advocated for open-ended reductions in opioid prescribing and have omitted COIs in journal articles involving opioid policies (126-130, 132, 135), but have not been included in this commentary, because of our intentional limitation on its scope. Finally, we did not identify any participants in the creation process of the 2016 Guideline who possessed “conflicts that might have a direct and predictable effect on the recommendations” related to policy positions supporting medically appropriate opioid prescribing.

Concluding Recommendations

Our results strongly suggest that CDC disregarded or disobeyed its own rules and ethical guidelines (111-113) by allowing PROP members and allies to help create the 2016 Guideline, thereby compromising its ethical integrity (1, 4, 23, 34, 36, 119-123). Those physicians acted entrepreneurially to facilitate a moral panic (9-11) about opioid-involved overdose deaths, using a false narrative about overprescribing that successfully changed opioid policy nationally. These policies have unacceptably increased risks of harm for patients in pain (43-45, 48-52, 67-73). Unfortunately, abolishing or repealing the 2016 Guideline and 2022 Draft Guideline, while ethically justifiable, now seems like an impossible task. The federal government has invested too much time and too many resources into the Guidelines to abandon them, especially while MDL suits against opioid manufacturers and distributers are still pending.

What can be done to undo the harms created by the 2016 Guideline and prevent further harm from the 2022 Draft Guideline? We strongly recommend abolishing hard dosing thresholds from the 2022 Draft Guideline, because their misapplication has emboldened involuntary and/or rapid opioid tapers, contributing to patient harms (43-45, 48-52, 67-73). These hard dosing thresholds have been improperly translated into “mandatory policies and laws throughout the country, becoming, in effect a standard of care used by states, payers, pharmacy benefit plans, health care systems and providers (162).” Next, while the 2022 Draft Guideline offers some improved language toward that goal, CDC must unequivocally denounce the false narrative that overprescribing still drives the opioid crisis, as “the particular focus around reduced opioid prescribing has met with limited success and contributed to subsequent waves of the crisis (163).” CDC’s Opioid Workgroup for the 2022 Draft Guideline cited similar concerns about hard dosing thresholds, but also acknowledged the inherent tension between patient versus public or societal health benefits (74). In addition, we call on policymakers to correct the current policy imbalance between patients’ medical autonomy and society’s benefit, acknowledging that physicians have an individualized, fiduciary duty to act in their patients’ best interests which may sometimes reasonably conflicts with public health goals (164). Patients are not monoliths, and physicians cannot treat them individually using a broad policy brush. Physicians’ primary responsibility is to attend the individualized needs of the patients they are treating. Thus, we envision creating an ethics-based, education-focused informed consent process that allows patients to weigh treatment risks versus potential benefits collaboratively to enhance opioid prescribing safety (165).

Furthermore, we identified a 72% rate of nondisclosure of COIs in our study group, which we find ethically unacceptable, considering the purported importance of transparency when creating clinical guidelines (107-110). CDC itself has acknowledged this moral imperative, but hasn’t adhered to its own ethical rules (111-113). Given the apparent inability of the study group authors and the CDC to transparently self-regulate the conflict disclosure process, we encourage medical journals to become more vigilant about identifying authors’ financial and intellectual COIs in submitted manuscripts about opioid policies. This includes holding editors accountable when they deliberately ignore relevant competing interests (123, 126-128).

Finally, if these recommendations fail to restore balanced U.S. opioid policy, we call upon the U.S. House Committee on Oversight and Government Reform to convene a hearing to scrutinize CDC’s use of a Core Expert Group to write its opioid guidelines instead of complying with the supervisory requirements of Federal Advisory Committee Act (166). Alternatively, we would invite the U.S. Department of Justice to investigate why CDC has repeatedly violated internal rules and ethical policies while creating the 2016 Guideline and 2022 Draft Guideline (111-113). Permitting ongoing patients harms from these Guidelines desecrates the sacred trust between prescribing physicians and patients afflicted by chronic pain.

Dedication:

This commentary is dedicated to the memory of Dr. Terri Lewis, a beloved colleague and tireless advocate for patients with disabilities and chronic pain.

About the Authors:

Lead author, Chad Kollas, serves as the Medical Director for Palliative and Supportive Care at the Orlando Health Cancer Institute in Orlando, FL. He can be reached by e-mail at chad.kollas@orlandohealth.com or via Twitter at @ChadKollasMD.

Bev Schechtman is a patient with chronic illness and pain who has spent the last five years volunteering as a patient advocate. She is currently the Vice-president of The Doctor Patient Forum, and she has been with the volunteer organization, Don't Punish Pain, since its inception in 2017. She is a passionate researcher and advocate who hopes to give a voice to those in pain.

Carrie Judy is an unpaid contributor and researcher at The Doctor Patient Forum.

Competing Interests: Dr. Kollas recently served as Secretary on the Board of Directors of the American Academy of Hospice and Palliative Medicine (AAHPM). He also serves as the AAHPM Delegate to the American Medical Association (AMA) House of Delegates, where he is the Chair of the AMA Pain and Palliative Medicine Specialty Section Council and a member of the AMA Substance Use and Pain Care Task Force. Dr. Kollas provided testimony at a 2004 Congressional Hearing on OxyContin. Dr. Kollas has served as a medical expert witness in cases involving opinions regarding the standard of care in internal medicine and hospice and palliative medicine. He has received educational research grants from the AMA Education and Research Foundation, Geisinger Clinic and M. D. Anderson Cancer Center Orlando. He serves as the editor for the Advocacy section of AAHPM Quarterly and is a member of the Editorial Advisory Board and review for the Journal of Pain and Symptoms Management. He has also served as a reviewer for the Journal of Palliative Medicine, Annals of Internal Medicine, Journal of General Internal Medicine, Journal of Graduate Medical Education, and the Educational Clearinghouse for Internal Medicine.

Ms. Schechtman serves as the Vice-president of The Patient Doctor Forum, which accepts donations as a registered 501(c)(3) non-profit organization.

Ms. Judy serves as a volunteer researchist for The Doctor Patient Forum.

For more Pallimed posts about opioids.
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