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Tuesday, November 29, 2022

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

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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