Friday, September 17, 2021
Roger Chou’s Undisclosed Conflicts of Interest: How the CDC’s 2016 Guideline for Prescribing Opioids for Chronic Pain Lost Its Clinical and Professional Integrity
“I'm present. Uh … I do have a conflict. I receive funding to conduct reviews on opioids, and I'll be recusing myself after the um, director's, uh, um, um, uh… update.”
- Dr. Roger Chou, Center for Disease Control and Prevention (CDC) National Center for Injury Prevention and Control (NCIPC) Board of Scientific Counselors (BSC) Meeting Friday, July 16, 2021.
For those familiar with the controversial relationship between the anti-opioid advocacy group, Physicians for Responsible Opioid Prescribing (PROP, recently renamed, Health Professionals for Responsible Opioid Prescribing), and the Centers for Disease Control’s CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016, (2) (hereafter called “the 2016 Guideline”), Dr. Roger Chou’s disclosure represented a stunning admission (3, 4). Chou had originally announced his intention to help influence opioid policy in a 2011 article that he co-authored with PROP’s founders (5), and he was a bold signatory to PROP’s 2012 Petition to the Food and Drug Administration (FDA) to change opioid labeling (6; See Figures 1a and 1b: First page and signatory page.)
Figure 1a: First Page of PROP Petition to FDA
Figure 1b: Signatory Page of PROP Petition to FDA
Through his participation in these PROP activities, Chou established himself as a significant contributor to PROP efforts. Yet he never formally served as a leader or member of PROP, and until the CDC NCIPC-BSC Meeting on July 16, 2021, Chou avoided all allegations of conflicts of interest (COI) between his opioid research and co-authorship of the 2016 Guideline, unlike several other PROP members (2). Given that the CDC had strict reporting guidelines for COI’s for those involved in the creation of the 2016 Guideline, Chou’s startling disclosure raises many important questions about his involvement in the original publication. It also raises many concerns about his role in the creation of any “draft, updated and/or expanded Guideline (hereafter called the “2022 Guideline”) that might arise from such conflicts (7).
Did Chou fail to disclose a prior conflict of interest (COI) when he drafted the 2016 Guideline? Wouldn’t such a failure to disclose a past COI undermine the integrity of that Guideline? Does Chou’s recent COI disclosure compromise the integrity of the upcoming 2022 Guideline, even before its publication? In making such a mysterious disclosure, was Chou recusing himself from the July 16, 2021, CDC NCIPC/BSC meeting only, or did his statement refer to a recusal from the 2022 Revised and Expanded Guideline entirely? The answers to these questions have profound implications for the CDC’s Opioid Prescribing Guideline’s professional integrity and clinical credibility. This could, in turn, substantially bring into question the CDC’s entire national opioid policy, both in how it was applied in the past, as well as how it might be viewed in the future.
PROP’s Beginnings (2000-2015): Washington State’s War on Opioids in Labor and Industries (the state’s Workman’s Compensation Program)
The AMDG Pain Guidelines
Chou’s entanglement with competing interests began years before the CDC began the process of creating its 2016 Guideline, rooted in the state of Washington’s war on opioids prescribed to Labor and Industry recipients. In 2005, Gary Franklin, MD, MPH, Director of the Labor and Industry Program, who would later become PROP’s Vice President of State Regulatory Affairs, published an article alleging that “that tolerance or opioid-induced abnormal pain sensitivity may be occurring in some workers who use opioids for chronic pain (9).” He concluded that “[o]pioid-related deaths in this population may be preventable through use of prudent guidelines regarding opioid use for chronic pain (7).” Franklin also served on the Washington State Agency Medical Directors Group (AMDG) via the Washington State Department of Labor and Industries (9).
By 2007, the Washington State Agency Medical Directors Group (AMDG) published its “Interagency Guideline on Opioid Dosing for Chronic Non-Cancer Pain (8),” which was updated in 2010 and 2015 (11). This guide introduced the concept of a hard dosing threshold for opioid analgesics, despite an FDA criticism that the concept lacked scientific support and encouraged reduced opioid prescribing or tapering of opioid doses based on these arbitrary thresholds (2, 11). It was also used by the Washington State Department of Labor & Industries to guide prescribing for the state’s “Medicaid patients, Workers’ Compensation recipients, and state employees,” which led to increased use of methadone, which Franklin selected as a less expensive alternative to other opioid analgesics (12).
Harms from the Workmen’s Compensation Program and AMDG Pain Guidelines
The harms from the AMDG Pain Guidelines as applied to Washington’s Workers’ Compensation and Medicaid programs had become evident by 2009. Scott Fishman, MD, and Lynn Webster, MD publicly criticized AMDG’s hard dosing threshold for opioid analgesics, particularly regarding the use of methadone (15) They noted that while a “starting dosing regimen of 10 mg of methadone four times per day, as allowed by most conversion tables, would fall below the 120-mg morphine equivalent level… this amount of methadone [had] been fatal in some instances (15).” They further noted that the AMDG failed to collaborate with pain management experts when creating its guideline and cited formal opposition to the AMDG Guideline by multiple professional pain societies: the American Academy of Pain Medicine (AAPM), the American Pain Foundation (APF) and the American Pain Society (APS) (14).
In a Pulitzer-prize winning series published in the Seattle Times, investigative reporters Michael J. Berens and Ken Armstrong reported that while encouraging prescribers to use methadone may have saved the state of Washington millions of dollars, it also resulted in the deaths of many of the state’s Medicaid recipients (14, 16). The series highlighted the egregious harms suffered by Washington’s “Medicaid patients, Workers’ Compensation recipients and state employees” due to increased use of methadone, encouraged by Franklin via the AMDG Guideline (12). Their reporting prompted the state of Washington to “issue a public health advisory that singles out the unique risks of methadone” as contributing to the deaths of at least 2,173 people between 2003 and late 2011 (14). Despite the identification of these recognized harms, the forces behind the creation of the AMDG Guidelines broadened their efforts to reduce opioid prescribing when they joined forces with PROP, a group whose creation Chou had announced in a co-authored article in 2011 (4).
Exploring Chou’s COIs in co-authoring the Centers for Disease Control’s CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016 (2008-2018)
The Significance of the CDC’s Reporting Requirements for Conflicts of Interest
Prior to participating in the creation of the 2016 Guideline, CDC stated the following with regard to handling potential conflicts of interest (COIs):
• Experts must reveal possible conflicts of interest, such as financial relationships with industry, intellectual preconceptions, or previously stated public positions (18).
• Experts could not serve if they had conflicts that might have a direct and predictable effect on the recommendations (Italics ours, 18).
• They ‘excluded experts who had a financial or promotional relationship with a company that made a product or that might be affected by the guideline.’ (18).
• They had reviewed potential nonfinancial conflicts carefully (e.g., intellectual property, travel, public statements, or positions, such as congressional testimony) to determine if the activities would have a direct and predictable effect on the recommendations (18).
• They determined the risk of these types of activities to be minimal for the identified experts (18).
• All experts completed a statement certifying that there was no potential or actual conflict of interest (18).
• Activities that did not pose a conflict (e.g., participation in Food and Drug Administration [FDA] activities or other Guideline efforts) were disclosed (18).
Based on this, CDC had two main categories of COIs for which it excluded participation in the creation of the 2016 Guideline: 1) financial conflicts and 2) non-financial conflicts, specifically a conflict that “might have a direct and predictable effect on the recommendations (18).” CDC originally published that no members (italics ours) of the 2016 Guideline Core Expert, Peer Reviewer, or Technical Expert groups had any COI’s that were in violation of CDC’s conflicts policies. However, years after the 2016 Guideline was published, members of PROP eventually disclosed multiple serious conflicts of interest. For example, PROP President, Jane Ballantyne, MD, disclosed “that she has served as a paid consultant to Cohen Milstein Sellers and Toll, PLLC, and has special advisory committee responsibilities on the Food and Drug Administration (FDA) Risk Evaluation and Mitigation Strategies Committee (18).” PROP Board Member, Gary Franklin, MD, MPH, disclosed “authorship of the AMDG Interagency Guideline on Prescribing Opioids for Pain (18).” Otherwise, the Core Expert Group (CEG) members and Opioid Guideline Workgroup (OGW), both of which included Chou, a PROP ally, “disclose[d] that they have no financial conflicts of interest (4,18).” Of note, Roger Chou, also disclosed no non-financial COIs related to the professional content of his contributions to the 2016 Guideline (18). Thus, it is now clear that the CDC did not hold the authors and contributors to the 2016 Guideline to its own clearly stated conflicts of interest and ethical policies.
Chou’s Non-Financial COIs in the 2016 Guidelines: Co-Authorship of Opioid Reviews and Professional Criticisms Regarding His Flawed Methodologies
In 2008, Chou authored an article for a special issue of Pain Medicine about interpreting and applying systematic reviews and clinical practice guidelines (19), an activity that one would have reasonably expected to “have a direct and predictable effect on the recommendations (18)” on the 2016 Guideline. A group of physicians, including the lead author of four articles in that same special issue of Pain Medicine (20-23), criticized Chou’s misinterpretation of pain guidelines by the American Society of Interventional Pain Physicians (ASIPP) in the special issue (24):
• They noted that Chou had “focused solely on randomized clinical trials; consequently, [the] evidence may be misinterpreted (24).”
• They further explained that it “is not the stringent standard which shows the evidence, or lack therefore of, but developing guidelines without appropriate expertise on the subject and randomized trials performed by non-specialist academicians (Italics ours, 24).
• They concluded that “[w]ithout any proof that evidence-based medicine is effective and it is based on evidence, it will be best if evidence synthesizers follow the rules appropriately, rather than injecting personal, biased opinions (Italics ours, 24.)”
Similarly, in 2010, a group of authors again took issue with Chou’s interpretation (25) of the American Pain Society (APS) Clinical Practice Guidelines for Interventional Techniques (23):
• Specifically, they wrote that Chou “utilized multiple studies inappropriately and… excluded appropriate studies (26).”
• They also asserted that Chou failed to eliminate bias in his evaluations of the APS Clinical Practice Guidelines for Interventional Techniques (24) …
• Which one would again reasonably expect to “have a direct and predictable effect on the recommendations (21)” on the 2016 Guideline.
Additionally, in 2014, Chou co-authored a systematic review and critical appraisal of guidelines for chronic pain (27). The article concluded, “Despite limited evidence and variable development methods, recent guidelines on chronic pain agree on several opioid risk mitigation strategies, including upper dosing thresholds; cautions with certain medications; attention to drug-drug and drug-disease interactions; and use of risk assessment tools, treatment agreements, and urine drug testing (27).” Ironically, in 2013 Chou had co-authored an AHRQ-sponsored article in which he stated, “Since evidence syntheses depend on the published literature accurately representing what’s known about medical therapies, reporting biases threaten the veracity of what we know (italics ours, 28). This indicates that Chou understood reporting bias, co-authored reviews of guidelines for managing chronic pain, but failed to report what a reasonable individual would correctly interpret as a conflict that “might have a direct and predictable effect on the recommendations,” prior to or during his co-authorship the 2016 Guideline (18). Under the CDC’s rules for inclusion in the creation process of its 2016 Guideline, Chou should have disclosed these conflicts before contributing as a co-author, and these conflicts should have disqualified him from participating in the process of creating the 2016 Guideline (Italics ours.) This is particularly concerning when taken in context with concerns about the strength of evidence upon which the 2016 Guideline were based. As the American Medical Association noted, “It seems incongruous that virtually all of the specific guidelines carry a graded recommendation that CDC believes should ‘apply to all patients with chronic pain and that… most patients should receive the recommended course of action,’ given the limitations of the evidence, especially where CDC experts’ opinions are the essential foundation for the recommendation (Italics ours; 29).”
Chou’s Financial COIs in Both Pain GLs: Funding from PROP/Group Health/Kaiser, AHRQ and the CDC Foundation
Chou also shared financial conflicts through his relationship with PROP and its funding, which “might have a direct and predictable effect on the recommendations” of the 2016 Guideline (18). As mentioned earlier, Chou was a co-author of a 2011 journal article that announced the formation of PROP, and while PROP has resolutely avoided identifying its donors over the last decade, Chou’s group received funding from Group Health Foundation, which lead-author, Michael Von Korff, disclosed as a potential conflict of interest at the time (4). The Group Health Foundation and PROP co-sponsored a National Summit on Opioid Safety on October 16, 2012 (30), during which Chou provided the keynote address, acknowledged funding from the Agency for Healthcare Research and Quality (AHRQ), and disclosed a financial relationship with Palladian Health for implementation of low back pain guidelines (31).
Palladian Health described itself as “comprehensive muscular skeletal health care company that integrates physical therapy, chiropractic, health and fitness with patient care advocacy to improve clinical and economic outcomes,” and listed Chou as a member of its Clinical Advisory Board (32). This represented a conflict with both financial and non-financial implications for his co-authorship of the 2016 Guideline. More importantly, Oregon Health and Science University (OHSU), Chou’s employer, announced on August 31, 2012, that it had received from AHRQ a five-year contract to serve as an Evidence-Based Practice Center, which funded Chou’s work (33). In the 2016 Guideline, Chou acknowledged that he had represented the Oregon Health and Science University with funding from his 2014 systematic review and critical appraisal of guidelines for chronic pain coming from AHRQ Grant HS17954 (18). This marked the beginning of an early funding loop between PROP (through Group Health Foundation, at that time) and AHRQ for work that Chou used to create the 2016 Guideline.
Over the next several years, Chou would expand this tangled web of financial conflicts of interest by adding the CDC Foundation as an indirect funder for his clinical reviews on opioid analgesics. According to its website, “The CDC Foundation is an independent nonprofit and the sole entity created by Congress [in 1992] to mobilize philanthropic and private-sector resources to support the Centers for Disease Control and Prevention’s critical health protection work (34, 35).” Of note, as part of its policy to avoid conflicts of interest, the CDC Foundation is prohibited from “[p]artnership with an organization that represents any product that exacerbates morbidity or mortality when used as directed (36).
Kaiser Permanente acquired Group Health Cooperative in 2017 and formed a new 501(c)(4) foundation from the proceeds from the acquisition, which “was previously part of Group Health Cooperative [but would then] operate collectively as ‘Group Health Foundation’ (37, 38).” The Kaiser Foundation Hospitals Centers for Health Research, which is part of the Kaiser Permanente Center for Health Research (39), is listed as a philanthropic donor to the CDC Foundation (40). In retrospect, Kaiser Permanente attended, as an invited guest, a 2015 online CDC webinar during which the CDC unveiled the 2016 Guideline, which was met with fierce criticism from other medical professional stakeholders (41). By the time the 2016 Guidelines were released, the CDC Foundation was firmly established as part of the Chou self-funding loop already created by PROP/Group Health/Kaiser Permanente and AHRQ.
On November 20, 2018, Chou’s employer, the Oregon Health and Science University, received a delivery order, funded by the AHRQ under Evidence-based Practice Centers, with a potential value of $500,000 (42). The streaming of this funding became clearer in December 2019, when the AHRQ awarded the Pacific Northwest Evidence-based Practice Center (EPC), a program within OHSU directed by Roger Chou, a five-year contract “to develop evidence reviews to inform healthcare decision-making [sic]; promote the uptake of evidence, including health systems; and invest in research methods to improve the quality, usefulness and efficiency of evidence reviews (43).” Chou publicly acknowledged his funding from AHRQ in a presentation at AMDG's "Patient-Centered Approach to Chronic Opioid Management Conference," held on August 9, 2019 (45). Chou, again publicly, albeit in a quiet, subtle way, acknowledged his AHRQ funding as a relevant financial COI in a correction to an article published in Annals of Internal in November 2019 (46, 47). The full extent of Chou’s COI disclosure is only revealed when one follows the link to the article’s complete International Committee of Medical Journal Editors (ICMJE) Disclosure of Interest form (48). Furthermore, while Chou disclosed his financial relationships with AHRQ and CDC related to “funding to conduct reviews on opioids for chronic pain,” he characterized this conflict as relevant activity outside of the submitted work (48). In doing so, he avoided being directly identified as failing to disclose a COI in the Correction published by Annals of Internal Medicine, which explicitly called out PROP members Anna Lembke, MD and Jane Ballantyne, MD, instead (47). More specifically, Ballantyne finally disclosed her involvement with PROP and her consultative fees for consulting in the multibillion-dollar Multi District Opioid Litigation. Lembke also took this belated opportunity to disclose her involvement with PROP (47, 48). They also clarified that the article had misrepresented PROP as “A 501(c)(3) charitable organization (47, 48),” although “PROP is not a registered charity with the Internal Revenue Service (49).”
The Yet-to-be-Released, Revised and Expanded 2022 Guideline (2018-Present)
By the end of 2019, AHRQ had delivered the full amount of its $500,000 award to OHSU for the work done by Chou’s Pacific Northwest EPC (50), and unbeknownst to anyone but the CDC, Chou had moved on to co-authoring the expanded 2022 Guideline. Just a few months later, in April 2020, PROP and Chou were again linked to an AHRQ-funded study examining the “effectiveness of opioids in treating chronic pain (51).” In trying to determine whether PROP and Chou would be involved in writing the 2022 Guideline, Pain News Network filed a request to CDC under the Freedom of Information Act (FOIA). However, PNN received 1,500 pages of documents “so heavily redacted they were completely blank (52, 53; See Figure 2 Below). PNN has filed an appeal for the CDC’s violations of this FOIA request.
Figure 2: CDC’s Redacted Replies to the FOIA Request from PNN
In June 2021, the AHRQ solicited public comments on its Draft Report on Integrated Pain Management Programs, although the draft report is no longer available for review (53, 54). Many stakeholders submitted review comments, including the lead author on this article, who expressed a concern about the AHRQs policy for handling potentials COIs in its report, specifically AHRQ’s statement that “Technical Experts must disclose any financial conflicts of interest greater than $5,000 and any other relevant business or professional conflicts of interest. Because of their unique clinical or content expertise, individuals with potential conflicts may be retained. The TOO and the EPC work to balance, manage, or mitigate any potential conflicts of interest identified (55).”
A month later, during the Roll Call for the Center for Disease Control and Prevention (CDC) National Center for Injury Prevention and Control (NCIPC) Board of Scientific Counselors (BSC) Meeting, Roger Chou disclosed a COI related to receiving “funding to conduct reviews on opioids (1).” In the BSC-NCIPC meeting’s immediate aftermath, participants posted written comments that cited Chou’s COI disclosure as a cause for questioning the legitimacy of his role in co-authoring both sets of Opioid Prescribing Guidelines, especially because of his long-term relationship with PROP (2, 56). Advocate Tamera Lynn Stewart offered live comments during the meeting that bluntly addressed concerns about Chou’s financial COIs (57): “Chou’s been involved in calling for opioid guidelines or restrictions since around 2011. The CDC gets funding for these guidelines, the CDC pays AHRQ to write reviews on which these guidelines are going to be based. AHRQ not only contracts with Dr. Chou to conduct reviews of the opioid studies, but Chou also helped set the AHRQ priorities. Chou is one of the five authors who wrote the draft of the [CDC Opioid Prescribing] Guidelines based on the reviews he was paid to create. Finally, Chou is on the Board of Scientific Counselors, who approves or denies any opposition comments from the (Opioid) Working Group and, being on the BSC, Chou has a say in the final approval of the Guidelines themselves. All of this, and there’s no mention of a conflict of interest until today, July 16th, around 9 AM (57).”
Ultimately, the Opioid Work Group (OWG) of the CDC NCIPC-BSC expressed multiple serious concerns about the 2022 Guideline, “warning the CDC that a draft revision of its 2016 Opioid Prescribing Guideline is focused too heavily on the risks of taking opioid medication, with not enough attention paid to the benefits that opioids have for many pain patients (58).” Chou’s COI disclosure and recusal from the CDC BSC-NPIPC meeting on July 16, 2021, also had many stakeholders wondering whether this signaled an end to his involvement in the further development and roll-out of the 2022 Guideline (1). The answer came at the next scheduled meeting of the CDC BSC-NPIPC, when, on July 29, 2021, during the Roll Call, Chou listed himself as, “Present, no conflicts (59).” This implies that his COI disclosure and self-recusal during the CDC NCIPC-BSC Meeting on July 16, 2021 (1), was meant only for that meeting.
Growing Evidence of Emerging Harms from the CDC Pain Guidelines
Harms from Opioid Tapering
By early 2018, it became increasingly clear to clinicians that misapplication of the Chou co-authored 2016 Guideline had begun to result in serious patient harms (60). This included concerns about a growing number of “suicides within and outside of the Veterans Affairs Healthcare System in the United States” from forced or involuntary tapers off opioid analgesics (60). In response to growing reports of patient harms from misguided opioid policies, in November 2018, the American Medical Association adopted a new policy that opposed hard dosing limits for opioid analgesics, encouraged individualized care when prescribing opioids, and called for the AMA to advocate against ongoing misapplication of the 2016 Guideline (61). By March 2019, an array of medical professional stakeholders had submitted written requests to CDC to speak out against misapplication of its 2016 Guideline, especially regarding their opposition of involuntary opioid tapers due to rising concerns about patient harms (62-64). These efforts prompted both the Food and Drug Administration (FDA) and the CDC to issue public announcements opposing the sudden discontinuation of opioid pain medicines and misapplication of the 2016 Guideline (65-67).
Despite these warnings, researchers have documented growing clinical evidence of patient harms arising from CDC’s opioid policies. In May 2019, Medicaid patients in Vermont who experienced “faster rates of opioid tapering” suffered from “a greater probability of adverse events” than those not tapered or tapered more slowly (8). An August 2019 study noted that opioid tapering was associated with termination of care in 78 of 207 cases (38%), prompting the authors to recommend caution when considering tapers and calling for more research to “fully understand the risks and benefits of opioid tapers (69).” By March 2020, a group researching patients in the Veterans Health Administration observed that “patients were at greater risk of death from overdose or suicide after stopping opioid treatment, with an increase in the risk the longer patients had been treated before stopping (70).” They further noted that “strategies to mitigate the risk in these periods are not currently a focus of guidelines for long term use of opioids (70).” Results such as these prompted a group of clinicians to conclude in June 2020 that policies mandating nonconsensual opioid dose reductions are “not justified clinically or ethically (71).” More recently, a retrospective cohort study of pharmacy claims and enrollment data found that “among patients prescribed stable, long-term, higher-dose opioid therapy, tapering events were significantly associated with increased risk of overdose and mental health crisis (72).
Harms to Patients with Cancer Pain or Receiving Palliative Care
Of greater concern than harms from tapers, several 2021 studies suggest that misapplication of the 2016 Guideline has begun to affect patients who were not intended targets for the 2016 Guidelines: patients with cancer pain or those receiving palliative care. Specifically, “the Guideline [was] not intended for patients undergoing active cancer treatment, palliative care, or end-of-life care because of the unique therapeutic goals, ethical considerations, opportunities for medical supervision, and balance of risks and benefits with opioid therapy in such care (2).” For reasons that were not clarified by its authors, the 2016 Guideline apply to “cancer survivors with chronic pain who have completed cancer treatment, are in clinical remission, and are under cancer surveillance only (2),” without considering legacy status or the frequent presence of well-recognized chronic, cancer-related pain syndromes, which often require multi-modal care for sufficient management, including opioid analgesia, when medically appropriate (73).
In a recent study examining prescriptions dispensed to patients with painful bone metastasis from active cancer using a large commercial claims database, opioid prescribing declined significantly between 2011 and 2017 (74). The authors expressed concerns that claims data did “not provide information regarding clinical indication or appropriateness of opioid prescriptions,” and expressed worry that a decline in opioid prescribing to this group of patients may lead to “a rising rate of undertreated pain (74).” A similar study examined Emergency Department (ED) visits by patients dying from cancer and observed that “opioid use among patients dying of cancer has declined substantially from 2007 to 2017. Rising pain-related ED visits suggests that EOL cancer pain management may be worsening (75).” Furthermore, a recently published study that used structured interviews of patients with advanced cancer found that “the US opioid epidemic has stigmatized opioid use and undermined pain management in individuals with advanced cancer (76).” Despite growing evidence of increasing harms to patients, the CDC has not issued any additional, substantive announcements since April 2019 (67). In fact, despite acknowledging inaccuracies in its own overdose death data, the CDC recently doubled down on rhetoric about prescription opioids: “Regardless of the method used to calculate the total numbers, prescription opioids continue to be involved in a significant proportion of drug overdose deaths (77).”
Where Should We Go from Here?
In this article, we have provided substantial evidence that Roger Chou’s conflicts of interests, undisclosed to the public before the July 16, 2021, had “a direct and predictable effect on the recommendations” contained within the 2016 Guideline, the very language used by the CDC to define a relevant conflict. By virtue of his COI disclosure on July 16, 2021, Chou’s role as a co-author and reviewer of the 2022 Guideline has compromised the professional and clinical integrity of the 2016 Guidelines, and the entire creation process of the Guideline has undermined the credibility of the CDC. Put simply, Roger Chou has been placed in the position of “advocating his own work as national healthcare policy (78).” Despite this, when confronted by stakeholders about harms arising from misapplication of the Pain Guidelines, the CDC response was limited at best (67) or defiant at worst (78).
Given this, we offer the following robust recommendations, several of which enjoy the support of prominent stakeholders seeking balanced opioid policy (79, 80):
1) The CDC should immediately rescind the most harmful or misapplied portions of the 2016 Guideline. This should include renouncing and rescinding arbitrary dosing thresholds, commonly referred to as MME, by health insurers, state and federal governments and pharmacies (81). It should also include a ban against involuntary opioid tapers.
2) The CDC should announce its strong commitment to balanced opioid policy, including individualized care for patients with chronic pain, explicitly acknowledging that some patients with chronic pain – especially those with serious illness – may benefit from treatment of opioid analgesics when medically appropriate.
3) The CDC should suspend indefinitely any plan to implement its 2022 Guideline, which are currently expected to be published in the Federal Register in late 2021. (82).
In addition to these measures, we call on the United States Congress or the U.S. Department of Justice to investigate Roger Chou, PROP and the Centers for Disease Control to determine whether they violated any federal laws or policies when creating either the 2016 or the expanded 2022 Opioid Prescribing Guidelines. We also encourage legal scholars to examine the harms inflicted upon patients with chronic pain as result of the 2016 Guideline, or from their misapplication, to determine whether these harms could be remedied through litigation. Undoing the ongoing harms of the CDC’s Opioid Prescribing Guideline for Chronic Pain and preventing further harms from the expanded 2022 Guideline - which were drafted with all the same ethical conflicts of the 2016 Guideline yet will affect even more patient populations - is an imperative for all invested in public health and the treatment of pain. Undoing the harms of the CDC Pain Guidelines represents a critical step in restoring balanced pain policy, which must include access to judiciously prescribed opioid analgesics, to the millions of Americans living with chronic pain every day of their lives.
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 firstname.lastname@example.org or via Twitter at @ChadDKollas.
Terri A. Lewis serves in Rehabilitation and Mental Health Counseling, National Changhua University of Education (NCUE), in Changhua, Taiwan/Republic of China.
Bev Schechtman is a chronic pain and illness patient who has spent the last four years volunteering as a patient advocate. She is currently the VP of the non-profit, 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 and hopes to give a voice to those in pain.
Carrie Judy is an unpaid contributor and researcher at The Doctor Patient Forum.
Dr. Kollas currently serves as the Secretary of 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, he is the Chair of the AMA Pain and Palliative Medicine Specialty Section Council and is a member of the AMA Opioid Task Force. Dr. Kollas has 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.
Dr. Lewis, Ms. Schechtman and Ms. Judy report no competing interests.
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1. See https://www.youtube.com/watch?v=wb4ysxY0sUo at 0:46.
2. 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
3. Kollas C. Mandated PROP’s Disproportionate Influence on U.S. Opioid Policy: The Harms of Intended Consequences. Pallimed. May 2021. Available at: https://www.pallimed.org/2021/05/props-disproportionate-influence-on-us.html.
4 Anson P. CDC Helped Draft CDC Opioid Guidelines. Pain News Network, September 21, 2015. https://www.painnewsnetwork.org/stories/2015/9/21/prop-helped-draft-cdc-opioid-guidelines.
5. Von Korff M, Kolodny A, Deyo RA, Chou R. Long-Term Opioid Therapy Reconsidered. Ann Intern Med. 2011 September 6; 155(5): 325–328; See: https://www.acpjournals.org/doi/10.7326/0003-4819-155-5-201109060-00011?url_ver=Z39.88-2003&rfr_id=ori%3Arid%3Acrossref.org&rfr_dat=cr_pub++0pubmed&.
6. Ballantyne JC, Belgrade M, Carlisle R, Chou R, et al, PROP Petition to FDA; See: https://www.citizen.org/wp-content/uploads/migration/2048.pdf July 25, 2012
7. See: https://www.cdc.gov/injury/pdfs/bsc/OWG_Terms-of-Ref_FINAL-7-6-2020r.pdf.
8. See: https://www.asahq.org/-/media/sites/asahq/files/public/advocacy/federal-activities/regulatory-activities/pain-medicine/prop-letter-to-fda.pdf?la=en&hash=5427D6B9210FED65861AB50292CD97EB3907827C
9. Franklin GM, Mai J, Wickizer T, Turner JA, Fulton-Kehoe D, Grant L. Opioid dosing trends and mortality in Washington State workers' compensation, 1996-2002. Am J Ind Med. 2005 Aug;48(2):91-9. doi: 10.1002/ajim.20191. PMID: 16032735.
10. See http://www.agencymeddirectors.wa.gov/contact.asp.
11. Interagency Guideline on Opioid Dosing for Chronic Non-Cancer Pain: An Educational Pilot to Improve Care and Safety with Opioid Treatment. Olympia, WA: Washington State Agency Medical Directors’ Group; March 2007. See http://www.agencymeddirectors.wa.gov/Files/Retired%20Opioid%20Guidelines.pdf.
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13. See: https://www.supportprop.org/wp-content/uploads/2014/12/FDA_CDER_Response_to_Physicians_for_Responsible_Opioid_Prescribing_Partial_Petition_Approval_and_Denial.pdf.
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