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

by Chad D. Kollas MD, Terri A. Lewis PhD, Beverly Schechtman and Carrie Judy

“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.

Introduction
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 chad.kollas@orlandohealth.com 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.

Competing Interests

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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Pallimed posts by Dr. Kollas click here. References

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.

12. Mai J, Franklin G, Tauben D. Guideline for Prescribing Opioids to Treat Pain in Injured Workers. Phys Med Rehabil Clin N Am. 2015 Aug;26(3):453-65. See https://pubmed.ncbi.nlm.nih.gov/26231959/.

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.

14. Berens MJ, Armstrong K. State plans emergency warning on risks of methadone. Seattle Times, December 21, 2011. See https://www.seattletimes.com/seattle-news/state-plans-emergency-warning-on-risks-of-methadone/.

15. Fishman SM, Webster LR. Unintended harm from opioid prescribing guidelines. Pain Med. 2009 Mar;10(2):285-6. doi: 10.1111/j.1526-4637.2008.00553.x. Epub 2009 Jan 16. PMID: 19207238.

16. Berens MJ, Armstrong K. State pushes prescription painkiller methadone, saving millions but costing lives. Seattle Times, December 10, 2011.

17. OHSU Partners, Office of Clinical Integration and Evidence-Based Practice. Adult Safe Opioid Prescribing for Chronic, Non-End-of-Life Pain: Evidence Summary. August 9, 2017. See https://www.ohsu.edu/sites/default/files/2018-12/Opioid-Prescribing-Evidence-Summary_8-9-17.pdf. Last accessed 8/5/2021.

18. 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.rr6501e1external icon. See https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm.

19. Chou R. Using evidence in pain practice: Part II: Interpreting and applying systematic reviews and clinical practice guidelines. Pain Med. 2008 Jul-Aug;9(5):531-41. doi: 10.1111/j.1526-4637.2008.00422_2.x. PMID: 18346061.

20. Manchikanti L. Evidence-based medicine, systematic reviews, and guidelines in interventional pain management, part I: introduction and general considerations. Pain Physician. 2008 Mar-Apr;11(2):161-86. PMID: 18354710.

21. Manchikanti L, Boswell MV, Giordano J. Evidence-based interventional pain management: principles, problems, potential and applications. Pain Physician. 2007 Mar;10(2):329-56. PMID: 17387356.

22. Manchikanti L, Datta S, Smith HS, Hirsch JA. Evidence-based medicine, systematic reviews, and guidelines in interventional pain management: part 6. Systematic reviews and meta-analyses of observational studies. Pain Physician. 2009 Sep-Oct;12(5):819-50. PMID: 19787009.

23. Manchikanti L, Singh V, Helm S 2nd, Schultz DM, Datta S, Hirsch JA; American Society of Interventional Pain Physicians. An introduction to an evidence-based approach to interventional techniques in the management of chronic spinal pain. Pain Physician. 2009 Jul-Aug;12(4):E1-33. PMID: 19668280.

24. Boswell M, Abdi S, Manchikanti L. Misinterpretation of evidence synthesis and ASIPP guidelines by Chou. Pain Med. 2009 Mar;10(2):422-4; author reply 425-7. doi: 10.1111/j.1526-4637.2009.00562.x. Epub 2009 Feb 25. PMID: 19254340.

25. Chou R, Huffman L. Guideline for the Evaluation and Management of Low Back Pain: Evidence Review. American Pain Society; Glenview, IL; 2009. (See https://back.cochrane.org/sites/back.cochrane.org/files/public/uploads/2009_evaluation-management-lowback-pain.pdf).

26. Manchikanti L, Datta S, Derby R, Wolfer LR, Benyamin RM and Hirsch JA. A Critical Review of the American Pain Society Clinical Practice Guidelines for Interventional Techniques: Part 1. Diagnostic Interventions. Pain Physician. May/June 2010; 13:E141-174.

27. Nuckols TK, Anderson L, Popescu I, Diamant AL, Doyle B, Di Capua P, Chou R. Opioid prescribing: a systematic review and critical appraisal of guidelines for chronic pain. Ann Intern Med. 2014 Jan 7;160(1):38-47

28. Balshem H, Stevens A, Ansari M, Norris S, Kansagara D, Shamliyan T, Chou R, Chung M, Moher D, Kay Dickersin K. Finding Grey Literature Evidence and Assessing for Outcome and Analysis Reporting Biases When Comparing Medical Interventions: AHRQ and the Effective Health Care Program. In: In: Methods Guide for Effectiveness and Comparative Effectiveness Reviews [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2008–. AHRQ Methods for Effective Health Care. 2013 Nov 18.

20. Madara JL. Letter to Thomas Freiden, Director, Centers for Disease Control and Prevention. Re: Docket No. CDC-2015-0112; Proposed 2016 Guideline for Prescribing Opioids for Chronic Pain. January 12, 2016. See https://searchlf.ama-assn.org/undefined/documentDownload?uri=%2Funstructured%2Fbinary%2Fletter%2FLETTERS%2Fcdc-opioid-guidelines-12jan2016.pdf.

30. See https://www.slideshare.net/grouphealth/national-summit-on-opioid-safety.

31. See https://www.slideshare.net/grouphealth/3-chou-opioid-summit-10-31-12.

32. Palliadian Health, LLC. Palladian's Distinguished Clinicians Present at APTA's National CSM Convention in San Diego on 'Evidenced Informed Management of Chronic Low Back Pain Without Surgery.’ March 16, 2010. See https://www.prnewswire.com/news-releases/palladians-distinguished-clinicians- present-at-aptas-national-csm-convention-in-san-diego-on-evidenced-informed- management-of-chronic-low-back-pain-without-surgery-87763542.html.

33. Chemodanova J. OHSU Awarded New Contract By The Agency For Healthcare Research And Quality. August 31, 2012. See https://stateofreform.com/news/oregon/2012/08/ohsu-awarded-new-contract-by-the-agency-for-healthcare-research-and-quality/.

34. See https://www.cdcfoundation.org/our-story.

35. See https://www.cdcfoundation.org/FAQ.

36. See https://www.cdcfoundation.org/guiding-principles-partner-collaboration.

37. See https://grouphealthfoundation.org/about-ghf/faqs/.

38. See https://www.gih.org/grantmaker-focus/group-health-foundation/.

39. See https://research.kpchr.org/

40. See https://www.cdcfoundation.org/partner-list/foundations

41. Anson P. Special Interest Groups Behind CDC Opioid Guidelines. Pain News Network, September 24. 2015. See http://www.painnewsnetwork.org/stories/2015/9/24/3xz1qq23yuilyeluz63kgwckplwh21.

42. See https://govtribe.com/award/federal-contract-award/delivery-order-hhsa290201500009i-75q80119f32018.

43. See https://effectivehealthcare.ahrq.gov/news/epc-contracts-awarded-december-2019.

44. See https://www.ohsu.edu/evidence-based-practice-center/about.

45. Chou R. Reviewing the Evidence on Outcomes of Opioid Tapers. Patient-Centered Approach to Chronic Opioid Management Conference, August 9, 2019. See http://www.agencymeddirectors.wa.gov/Files/COTS/4_Chou_Tapering%20Bree%20Collaborative%208.19_revised.pdf.

46. Chou R, Ballantyne J, Lembke A. Rethinking Opioid Dose Tapering, Prescription Opioid Dependence, and Indications for Buprenorphine. Ann Intern Med. 2019 Sep 17;171(6):427-429. doi: 10.7326/M19-1488. Epub 2019 Aug 27. Erratum in: Ann Intern Med. 2019 Nov 5;171(9):684. PMID: 31450240.

47. Correction: Rethinking Opioid Dose Tapering, Prescription Opioid Dependence, and Indications for Buprenorphine. Ann Intern Med. 2019 Nov 5;171(9):684. doi: 10.7326/L19-0595. Erratum for: Ann Intern Med. 2019 Aug 27;:null. PMID: 31683287.

48. See https://rmed.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M19-1488&_ga=2.63881967.1144280822.1629813752-857333589.1616690931.

49. Anson P. PROP President Discloses Conflicts of Interest, Pain News Network, November 12, 2019; https://www.painnewsnetwork.org/stories/2019/11/12/prop-president-discloses-conflicts).

50. See https://govtribe.com/award/federal-contract-award/delivery-order-hhsa290201500009i-75q80119f32018.

51. Anson P. PROP Linked to New Federal Opioid Study. Pain News Network, April 20, 2020. See https://www.painnewsnetwork.org/stories/2020/4/20/prop-linked-to-new-federal-opioid-study.

52. Anson P. What is the CDC Trying to Hide? Pain News Network, April 16, 2020. See https://www.painnewsnetwork.org/stories/2020/4/15/what-is-cdc-trying-to-hide.

53. See, for example, https://www.aapmr.org/members-publications/member-news/member-news-details/2021/06/08/ahrq-seeks-comments-regarding-two-pain-management-systematic-reviews.

54. Formerly https://effectivehealthcare.ahrq.gov/products/integrated-pain-management/draft-research. As of August 24, 2021, this link is no longer active; please contact the authors for a PDF copy of this document.

55. Kollas CD. Comments on the AHRQ Draft Report on Integrated Pain Management Programs. Submitted to AHRQ on June 7, 2020. PDF available from authors by request.

56. Lawhern R. Comments to the July 16, 2021 Meeting of The US CDC National Center for Injury Prevention and Control Board of Scientific Counselors. Published on July 18, 2021. See https://www.linkedin.com/pulse/comments-july-16-2021-meeting-us-cdc-national-center-injury-lawhern/?trackingId=UDFjJsc3SYazTQYxt78y3g%3D%3D.

57. Stewart TL. Let me get this straight… P3Alliance speaks on Chou’s COI during Public comment. July 16, 2021. See https://www.youtube.com/watch?v=DndVrnlc0y0.

58. Anson P. CDC Advisory Panel Warns Revised Guideline Ignores Benefits of Opioids. Pain News Network, July 16, 2021. See https://www-painnewsnetwork-org.cdn.ampproject.org/c/s/www.painnewsnetwork.org/stories/2021/7/16/advisory-panel-warns-cdc-revised-opioid-guideline-ignores-risk-of-undertreating-pain.

59. Kollas CD. Personal observation at 10 AM from the Roll Call of the CDC BSC-NPIPC Meeting on July 29, 2021.

60. Darnall BD, et al (including Kollas CD). International Stakeholder Community of Pain Experts and Leaders Call for an Urgent Action on Forced Opioid Tapering. Pain Medicine, 2018; 0:1-4. See https://pubmed.ncbi.nlm.nih.gov/30496540/.

61. See Resolution 235 at https://www.ama-assn.org/system/files/2018-11/i18-refcomm-b-annotated.pdf.

62. Health Professionals for Patients in Pain (HP3), led by Alford DP (and including Kollas CD). Professionals Call on the CDC to Address Misapplication of its Guideline on Opioids for Chronic Pain through Public Clarification and Impact Evaluation. March 6, 2019. See https://healthprofessionalsforpatientsinpain.org/the-letter-1.

63. Carlson RW, et al. Letter to Deborah Dowell, Chief Medical Officer, Opioid Response Coordinating Unit, CDC National Center for Injury Prevention and Control. February 13, 2019. See https://www.asco.org/sites/new-www.asco.org/files/content-files/advocacy-and-policy/documents/2019-NCCN-ASCO-ASH-Letter-CDC.pdf.

64. Nicholson KM, Hoffman DE, Kollas CD. Overzealous use of the CDC’s opioid prescribing guideline is harming pain patients. Stat News, December 6, 2018. See https://www.statnews.com/2018/12/06/overzealous-use-cdc-opioid-prescribing-guideline/.

65. FDA Drug Safety Communications. FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering. April 9, 2019. See https://www.fda.gov/media/122935/download.

66. FDA Drug Safety Podcast. FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering. April 17, 2019. See https://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-identifies-harm-reported-sudden-discontinuation-opioid-pain-medicines-and-requires-label-changes#:~:text=On%20April%209%2C%202019%20FDA,%2C%20psychological%20distress%2C%20and%20suicide.

67. CDC Media Relations. CDC Advises Against Misapplication of the Guideline for Prescribing Opioids for Chronic Pain. Embargoed Until: Wednesday, April 24, 2019, 5 PM, EDT. See https://www.cdc.gov/media/releases/2019/s0424-advises-misapplication-guideline-prescribing-opioids.html.

8. Mark TL, Parish W. Opioid medication discontinuation and risk of adverse opioid-related health care events. J Subst Abuse Treat. 2019 Aug;103:58-63. doi: 10.1016/j.jsat.2019.05.001. Epub 2019 May 5. PMID: 31079950.

69. Perez HR, Buonora M, Cunningham CO, Heo M, Starrels JL. Opioid Taper Is Associated with Subsequent Termination of Care: a Retrospective Cohort Study. J Gen Intern Med. 2020 Jan;35(1):36-42. doi: 10.1007/s11606-019-05227-9. Epub 2019 Aug 19. PMID: 31428983; PMCID: PMC6957663.

70. Oliva EM, Bowe T, Manhapra A, Kertesz S, Hah JM, Henderson P, Robinson A, Paik M, Sandbrink F, Gordon AJ, Trafton JA. Associations between stopping prescriptions for opioids, length of opioid treatment, and overdose or suicide deaths in US veterans: observational evaluation. BMJ. 2020 Mar 4;368:m283. doi: 10.1136/bmj.m283. PMID: 32131996; PMCID: PMC7249243.

71. Kertesz SG, Manhapra A, Gordon AJ. Nonconsensual Dose Reduction Mandates are Not Justified Clinically or Ethically: An Analysis. J Law Med Ethics. 2020 Jun;48(2):259-267. doi: 10.1177/1073110520935337. PMID: 32631183; PMCID: PMC7938366.

72. Agnoli A, Xing G, Tancredi DJ, Magnan E, Jerant A, Fenton JJ. Association of Dose Tapering With Overdose or Mental Health Crisis Among Patients Prescribed Long-term Opioids. JAMA. 2021 Aug 3;326(5):411-419. doi: 10.1001/jama.2021.11013. PMID: 34342618; PMCID: PMC8335575.

73. Levy MH, Chwistek M, Mehta RS. Management of chronic pain in cancer survivors. Cancer J. 2008 Nov-Dec;14(6):401-9. doi: 10.1097/PPO.0b013e31818f5aa7. PMID: 19060605.

74. Zhang H, Paice J, Portenoy R, Bruera E, Reid MC, Bao Y. Prescription Opioids Dispensed to Patients with Cancer with Bone Metastasis: 2011-2017. Oncologist. 2021 Jul 6. doi: 10.1002/onco.13898. Epub ahead of print. PMID: 34227175.

75. Enzinger AC, Ghosh K, Keating NL, Cutler DM, Landrum MB, Wright AA. US Trends in Opioid Access Among Patients With Poor Prognosis Cancer Near the End-of-Life. J Clin Oncol. 2021 Jul 22:JCO2100476. doi: 10.1200/JCO.21.00476. Epub ahead of print. PMID: 34292766.

76. Azizoddin DR, Knoerl R, Adam R, Kessler D, Tulsky JA, Edwards RR, Enzinger AC. Cancer pain self-management in the context of a national opioid epidemic: Experiences of patients with advanced cancer using opioids. Cancer. 2021 Sep 1;127(17):3239-3245. doi: 10.1002/cncr.33532. Epub 2021 Apr 27. PMID: 33905550; PMCID: PMC8355015.

77. Lawhern R. Time for Heads to Roll at the US National Center for Injury Prevention and Control. American Council on Science and Health, August 26, 2021. See https://www.acsh.org/news/2021/08/26/time-heads-roll-us-national-center-injury-prevention-and-control-15759.

78. See https://www.cdc.gov/opioids/data/analysis-resources.html.

79. Mukkamala B. AMA Letter to Gwendolyn H. Cattledge, PhD, MSEH, Deputy Associate Director for Science, National Center for Injury Prevention and Control Centers for Disease Control and Prevention. July 22, 2021. See https://searchlf.ama-assn.org/letter/documentDownload?uri=%2Funstructured%2Fbinary%2Fletter%2FLETTERS%2F2021-7-22-Letter-to-Cattledge-re-CDC-BSC-Comments-final.pdf.

80. Deutsch J. AMA backs update to CDC opioid prescribing guidelines. July 22, 2021. See https://www.ama-assn.org/press-center/press-releases/ama-backs-update-cdc-opioid-prescribing-guidelines?utm_source=twitter&utm_medium=social_ama&utm_term=5205422460&utm_campaign=Advocacy&utm_effort=FBB009.

81. Dasgupta N, Wang Y, Jungjun B, Kinlaw A, Chidgey B, Cooper T, Delcher C. Inches, Centimeters and Yards: Overlooked Definition Choices Inhibit Interpretation of Morphine Equivalence. FDA Workshop, June 7-8, 2021. See https://www.fda.gov/media/150403/download.

82. Anson P. Revised CDC Opioid Guideline Not Expected Until Late 2022. Pain News Network, July 9, 2021. See https://www.painnewsnetwork.org/stories/2021/7/9/revised-cdc-opioid-guideline-not-expected-until-late-2022.



Friday, September 17, 2021 by Pallimed Editor ·

Wednesday, July 14, 2021

How Spiritfarer Helped Me Through the Pandemic

by Matthew Tyler (@PalliDad)

During what can only be described as a challenging year, I found Thunderlotus’s game Spiritfarer just in the nick of time. In this “cozy management game about dying,” you assume the role of a young woman named Stella who is charged with shuttling spirits to the gates of the afterlife. Unexpectedly, Spiritfarer served as both an escape from and means of processing my experience as a healthcare worker during the pandemic.

From top to bottom, Spiritfarer exudes tranquility. The animations are bright and vibrant, and the music is soothing yet melancholy, invoking nostalgia for younger innocent days. With this backdrop, you spend your time in game managing the physical and emotional needs of your passengers. This entails gathering materials to upgrade your boat’s ability to reach more distant islands, constructing customized quarters to accommodate your growing roster of spirits, and cooking meals uniquely suited to each passenger’s preferences. I was especially delighted to learn I could hug passengers to boost their mood, though sometimes they will decline your offer - bonus points to the devs for promoting autonomy! Your efforts are reflected in the mood of each spirit - as it improves they share more about their lives. Ultimately, each story arc culminates in a heartfelt goodbye at the gate to the afterlife. For most of the spirits, at least.


One day, I was passing by the home of one of my favorite companions and saw the outside had been covered with flowers. My stomach lurched. Flowers only appeared after a spirit had passed through the gate, but how could this spirit already be gone? I hadn’t finished their storyline or said goodbye. What kind of closure was that?

At that moment, I was flooded with memories of conversations where I had to tell someone that their loved one was dying from COVID. Since our hospital restricted visitors I never knew the faces of these family members, just their tortured voices as I broke the terrible news by phone. I did this over and over again every day for what felt like an eternity. There were no proper goodbyes for these families. There was no closure, because how could there be? The breakneck pace someone could go from healthy to dying was impossible to wrap their heads around. It was impossible to wrap my head around it too.

In palliative care, we provide the medical knowledge necessary to help patients and families prepare for the future. We don’t talk about how that knowledge helps clinicians cope as well. Understanding how an illness progresses gives us mental schema to process the suffering to which we must bear witness. Yes, it’s awful to tell someone that the last line of cancer treatment didn’t work. But because we know the trajectory of metastatic cancer, it’s a conversation we mentally prepare to have at some point. There was no pre-existing narrative for COVID to emotionally brace ourselves for what was coming. So while I worked hard to navigate the devastation in the most optimal (or least terrible) way, I simultaneously resented the need. None of these people were supposed to be dying in the first place.

Spiritfarer was a gentle nudge to loosen my grip on how I think the future is “supposed to” look. It reminded me that, scale aside, COVID does not hold a monopoly on unanticipated loss in this world. Nor does working adjacent to death afford any control over it. Though the lesson goes deeper than that. Even if we can’t control how or when someone’s story ends, we are still encouraged to play our role in it. We keep working to discover our companion’s favorite dish. We take a moment to embrace them when they are feeling low. We hold space to listen to their stories and what is most important to them. Spiritfarer drives home that the inability to control an outcome does not mean we can’t be active participants in the process. And ultimately, taking care of our community is how we shape our future. So we chart the best course we can, and let the open water take us.

Spiritfarer is available to play on PC (Steam), Xbox, Playstation and Nintendo Switch systems.

This post has a companion piece video narrated by Dr. Matt Tyler and hosted by Digital Doc Games (embedded below). Check out the Digital Doc Games YouTube channel hosted by Dr. Amiad Fredman for videos on how video games have a huge power to have a positive impact on people's lives.





For more Pallimed posts about grief.
For more Pallimed posts about the experience with COVID-19.
For more Pallimed posts by Dr. Tyler click here.
For more Pallimed posts on video games, click here.

Matt Tyler is a palliative care doctor in Chicago. If he's not watching Cocomelon with his daughters, he is probably playing video games or making palliative care skits on TikTok.





Wednesday, July 14, 2021 by Pallimed Editor ·

Monday, June 14, 2021

Two Ways to Share your Palliative Care and Hospice Stories

by Christian Sinclair (@ctsinclair)

This past few days, I came across two great opportunities that I wanted to share with a wider audience of hospice and palliative care clinicians.

First is the podcast and radio show, Radiolab. I've always appreciated the nuance and simplicity the creators can bring to complex issues. They are looking for voice memos from people who work in end-of-life care. They are also looking for patients and families who have been impacted by this work. All you have to do is record a 60-seconds or less voice memo and email it to wnycradiolab@gmail.com. Make sure to include your name, city, and your position or connection to the work. For the official ask see the graphic on this post or this link on Twitter. Share it with your teams!

Second is a project by Dr. Kayla Sheehan, who has written for Pallimed before. She is looking for hospice and palliative care physicians to share their origins stories on how they discovered this work. The answers are intended to be anonymous, so share as much as you feel comfortable. The link is here - https://dk9n3b78ef9.typeform.com/to/yCxDYZzR

For more Pallimed posts about the profession, click here.
For more Pallimed posts by Dr. Sinclair, click here.



Christian Sinclair, MD, FAAHPM (@ctsinclair) is editor of Pallimed, a former hospice medical director and current outpatient palliative care physician at the University of Kansas Cancer Center. He has a experiential degree in Social Media and Health Care Marketing from the school of life.

Monday, June 14, 2021 by Christian Sinclair ·

Monday, May 3, 2021

PROP’s Disproportionate Influence on U.S. Opioid Policy: The Harms of Intended Consequences


by Chad Kollas, MD (@ChadDKollas)

Introduction

A recent study by the Centers for Disease Control (CDC) has captured the attention of the palliative care and chronic pain communities (1). Published on February 12, 2021, in Morbidity and Mortality Weekly Report (MMWR), it observed that the “age-adjusted overdose death rates involving synthetic opioids, psychostimulants, cocaine, heroin, and prescription opioids during 2013–2019” have increased a whopping 1,040% (1). Several critics have attributed this increase in overdose mortality to failed federal opioid policy, particularly the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain and their misapplication (2-4). This criticism has generated recent flurry of activity on social media by the anti-opioid advocacy group (5), Physicians for Responsible Opioid Prescribing (PROP). This commentary will explore how PROP’s flawed policy approach over the last decade has reduced legitimate access to opioid medications and contributed to harms from increases in overdose deaths in the United States (US).

PROP Appears on the Opioid Policy Scene

In 2011, a group of internists, including Michael Van Korff, Andrew Kolodny and Roger Chou, co-authored an article that modern palliative care physicians would recognize as a “warning shot (6)” in the world of opioid policy (7). They announced the creation of Physicians for Responsible Opioid Prescribing (PROP), a “nonprofit organization with no pharmaceutical industry funding or ties,” that would “identify practical approaches to more cautious opioid prescribing in community practice (7).” They declared that “Guidelines for long-term opioid therapy should not be developed by the field of pain medicine alone. Rather, experts from general medicine, addiction medicine, and pain medicine should jointly reconsider how to increase the margin of safety (7).”

PROP Petition to the FDA on Opioid Labeling

The Petition is Filed
In its first effort to influence national opioid policy, in July 2012, PROP submitted a Petition to the Food and Drug Administration (FDA) calling for a change in labeling of opioid analgesics (8). Signatories to the Petition included PROP President, Andrew Kolodny, PROP Vice-president, Michael Van Korff, and PROP Board Members, Jane Ballantyne, Roger Chou, Stephen Gelfand, and Gary Franklin, among other medical specialists, including American Society of Addiction Medicine (ASAM) President, Stu Gitlow (8). In its petition, PROP requested that the FDA to make three main changes to the labeling process for opioid analgesics:

    1) Strike the term “moderate” from the indication for non-cancer pain (the only clinical indication for using an opioid analgesic would be for severe cancer pain).
    2) Add a maximum daily dose of opioid analgesia, equivalent to 100 milligrams of oral morphine, for treatment of all non-cancer pain.
    3) Add a maximum duration of 90-days for continuous (daily) opioid analgesia use for non-cancer pain, after which opioid analgesia would be discontinued (8).

The FDA acknowledged receipt of the PROP Petition on July 26, 2012 (9), and it simultaneously received a letter of support for its petition on the same date, led by Congress member, Representative Mary Bono Mack from California (10).

The Backlash to the PROP Petition Begins
This unity within the supporters of the petitioning group was short-lived. A representative from within the palliative care community alerted PROP FDA Petition signatory and American Society for Addiction Medicine (ASAM) President, Stu Gitlow, about substantial concerns from the pain management and palliative medicine communities about the potential reduced access to opioid therapy for many patients. In response to concerns that the PROP Petition might have a chilling effect on medically-legitimate opioid prescribing, ASAM released a statement by Gitlow clarifying its position that “the relabeling proposals [were] not intended, in any way, to limit a chronic pain patient’s access to clinically appropriate opioid pain therapy or to impinge upon a pain specialist’s ability to make individual decisions regarding the most effective therapy for their legitimate pain patient (11).”

Several prominent pain management experts echoed important concerns about over-restricting patients’ medically legitimate access to opioid analgesics. Bob Twillman, a pain psychologist and Director of Policy and Advocacy for the American Academy of Pain Management (AAPM), pointed out that “the 90-day limit on use of opioid for [non-cancer pain was] arbitrarily chosen (12).” Because PROP’s Petition had criticized the use of long-term opioid therapy by citing a lack of evidence for opioids’ long-term effectiveness, Twillman also pointed out that “when considering opioid analgesics, FDA has used the standard of a 12-week trial of the medication[;] it has not required longer studies (12).” Similarly, co-chair the New York State Palliative Care Education and Training Council and palliative medicine physician, Russell Portenoy, wrote that in light of “the stunning disconnect between the label changes demanded in the petition and the ‘scientific basis’ presented to justify them, I am concerned that all of the signatories possess an incomplete understanding of opioid pharmacology and pain medicine, and as a result, may pursue regulatory changes that are not in the best interest of public health (13).”

Other PROP critics included several medical professional organizations, like the American Society of Anesthesiologists (ASA), who challenged the clarity of a definition of cancer pain, asking rhetorically, “Who will decide whether the persistent pain, for example, of nerve damage incurred during an otherwise curative course of chemo- and radiation therapy is or is not cancer-related? (14).” Likewise, the American Academy of Pain Medicine (AAPM) stated “we have serious concerns about the petition and believe the rationale for the requested changes is seriously flawed, potentially harmful to patients with debilitating pain conditions for whom opioid therapy is indicated, and without substantive scientific foundation (15).”

The American Pain Society (APS) cited similar concerns about the Petition’s “insufficient scientific evidence base to support [its] recommendations. Further, we are concerned that implementation of these labeling changes which would dictate indications, dosing and duration of opioid treatment will not accomplish the intended goals, but instead have unintended negative consequences for patients including but not limited to untreated pain and loss of access to individualized care (16).”

FDA Response to the PROP Petition

On September 10, 2013, the FDA provided its response to the PROP Petition to change opioid labeling, which was granted in part and denied in part (17, 18). The FDA agreed with PROP that “more data are needed about the safety of long-term use of opioids,” and, to this end, they required “all new drug application (NDA) sponsors of ER/LA opioids to conduct postapproval studies and clinical trials… to assess certain known serious risks of ER/LA opioid use: misuse, abuse, hyperalgesia, addiction overdose and death (17).” Additionally, based on stakeholder input, the FDA determined that “safety labeling changes to the labeling of ER/LA opioid analgesics [were] needed to more effectively communicate to prescribers the serious risks associated with [those] drugs, and to more clearly describe the population in whom these drugs should be used be used in light of these serious risks – thus encouraging better prescribing, monitoring and patient counseling practices involving these drugs (17).” This included a new box warning to disclose risks from ER/LA opioid analgesics and the addition of the phrase, “indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time (17).”

Despite calling for these changes, the FDA disagreed with the most important requests from the PROP Petition. It rejected PROP’s separation of non-cancer pain from cancer pain, noting “a patient without cancer, like a patient with cancer, may suffer from chronic pain, and PROP has not provided scientific support for why labeling should recommend different treatment for such patients (17).” The FDA also rejected PROP’s call for a 100 mg/day maximum morphine equivalent (MME) daily dose limitation, noting “the scientific literature does not support establishing a maximum recommended dose of 100 mg MED (17).” Furthermore, the FDA noted that creating a maximum dose of 100 mg MED “could imply a superior opioid safety profile under that set threshold, when there is no data to support that conclusion (17).” Finally, the FDA determined that PROP’s request to limit the maximum duration of treatment with opioid analgesia to 90 days was “not supportable” based on the evidence presented in the Petition (17).

PROP’s Influences the CDC Guidelines

A New Federal Regulatory Target

Although the FDA had rejected the most important changes which PROP had requested, based on a lack of scientific evidence, PROP publicly framed its FDA Opioid Labeling Petition as successful, then repeated its calls for a 100 mg/day MME (19). PROP had also explored other avenues to influence opioid policy and reduce opioid prescribing, reaching out for example to the Federation of State Medical Board (FSMB) to encourage it to make changes in its Revised Model Policy on the Appropriate Use of Opioid Analgesics in the Treatment of Pain (20). Ultimately, PROP identified a more accommodating regulatory agency than the FDA, the Centers for Disease Control and Prevention (CDC), which revealed via engagement webinars on September 16 and 17, 2015, that it had been drafting its own Opioid Prescribing Guidelines (21).

Another PROP Backlash

In the days following these engagement webinars, critics expressed concerns about a lack of transparency in the drafting of the Opioid Prescribing Guidelines, because CDC had failed “to disclose what outside advisors it consulted with during the drafting of its controversial opioid prescribing guidelines for physicians (22).” Additional concerns involved an unusually short, 48-hour period for stakeholders to submit comments about the CDC Pain Guidelines upon their originally planned release in September 2015 (23). Moreover, revelations that at least five PROP Board Members - including PROP President Jane Ballantyne, PROP Vice-President Gary Franklin, PROP Founder Andrew Kolodny, PROP Board Member David Tauben and PROP Board Member David Juurlink – had served on the panels that helped develop the CDC Guidelines, stirred deeper concerns (23, 24). Jane Ballantyne MD, who had succeeded Andrew Kolodny as PROP President, served as the sole clinician from the pain management community to be included in the CDC Core Expert Group (25).

Medical professional organizations joined in criticism of the CDC for a lack of transparency in its policy review process and the scarcity of pain management experts represented in the Core Expert Group (26). The American Medical Association (AMA) wrote that the “review process used to date by CDC, especially the public engagement webinars, [had] generated concern about lack of transparency (26),” and that the “process may have been better served by constructing a more balanced panel that included clinicians from various medical specialty and practice settings (26).” The Patient Quality of Life Coalition (PQLC), an advocacy group that included the American Academy of Hospice and Palliative Medicine (AAHPM), AAPM, the Center to Advance Palliative Care (CAPC), and the Hospice & Palliative Nurses association (HPNA), among others, wrote that “the Guideline in its current form is focused on curbing inappropriate [opioid] use, but seems devoid of empathy for patients who need legally‐prescribed opioid medications for relief from serious and long‐lasting pain that compromises their quality of life and independence (27).”

Following this outcry for transparency and expanded clinical representation regarding content, the CDC announced a second, 30-day open-comment period on its proposed 2016 Pain Guidelines, effective December 14, 2015 (28, 29). This delayed the roll out of the CDC Pain Guidelines past its originally anticipated implementation in January 2016, and prompted PROP founder, Andrew Kolodny to complain, “Opening a docket will tack months on to the process [and also] increases the likelihood that the guideline may never be released. This is an enormous win for the opioid lobby (30)." Interestingly, Kolodny co-authored a subsequent article examining the role of pharma funding and support of the CDC Pain Guidelines, and found that “of the 158 organizations that commented on the CDC’s draft guidelines, approximately 80% supported them either with or without recommendations, including many that received funding from opioid manufacturers (31).”

The CDC Guidelines are Published, Despite Ongoing Concerns

Notwithstanding PROP-founder Kolodny’s fears that the guidelines “may never be released (30),” the CDC Pain Guidelines were published via MMWR on March 18, 2016 (4). While most pain experts generally felt that the Pain Guidelines would be useful for those prescribing opioids in primary care settings, many expressed concerns that the Guidelines could be misapplied and affect a much broader group of patients than intended. For example, AMA board chair-elect, Patrice Harris, said that while the AMA shared the goal of reducing harm from opioid abuse, it remained concerned “about the evidence base informing some of the recommendations, conflicts with existing state laws and product labeling, and possible unintended consequences” including insurance coverage limitations for non-pharmacotherapeutic options for chronic pain (30). Similarly, Bob Twillman, executive director of the AAPM, said the CDC guidance “leaves much to be desired,” particularly regarding the limitations on dose, duration of treatment and arbitrary dosing threshold (32, 32). “Our concern is that, based on experience when states have implemented similar guidelines, some clinicians will interpret these ‘soft limits’ and thresholds as absolute ceiling doses, and that people with pain will suffer needlessly as a result,” Twillman said (32).

On August 29, 2016, a group of scientists from the CDC itself expressed integrity concerns about the agency’s data and its “the current state of ethics,” noting that “[i]t appears that our mission is being influenced and shaped by outside parties and rogue interests (34),” without specifically identifying PROP as one of those forces. Calling themselves the “CDC Spider Group (CDC Scientists Preserving Integrity, Diligence and Ethics in Research),” they reached out to Carmen S. Villar, MSW Chief of Staff, Office of the Director for the CDC, plainly stating that CDC “data were clearly manipulated in irregular ways” for political purposes (34). In October 2016, an article echoed similar concerns regarding CDC’s manipulation of data in a variety of projects, again alleging that the CDC was being influenced by corporate and political interests in a way that compromised its data collection (34). Despite these warnings, the 2016 CDC Opioid Prescribing Guidelines were implemented as planned.

Unintended Harms and the Backlash Against Misapplication of the CDC Guidelines


Just two years later, yet another article authored by CDC scientists was published in April 2018, again calling into question the methodology used by CDC to estimate opioid overdose deaths (35). The authors alleged that the CDC traditional method for calculating opioid overdose deaths overestimated deaths due to prescription opioids because the CDC failed to account for the emergence of illegally-manufactured fentanyl (IMF) as a cause of overdoses in its methodology (35). The authors proposed a method that would exclude IMF-related deaths for a more accurate estimate of total opioid overdose deaths (35). Using its traditional method, the CDC “estimated 32,445 prescription opioid–involved deaths occur[ing] in 2016.” Using these authors’ proposed “more conservative method, 17,087 prescription opioid–involved deaths occurred in 2016.” The concerned scientists concluded that “obtaining an accurate count of the true burden and differentiating between prescription and illicit opioid-involved deaths [was] essential to implement and evaluate public health and public safety efforts (35).”

In addition to concerns about the accuracy of CDC’s overdose data, by 2018 it had become clear that misapplication of its Pain Guidelines had begun to contribute to deaths from “suicides within and outside of the Veterans Affairs Healthcare System in the United States” from forced or involuntary tapers off of opioid analgesics (36). Although the CDC had designed the Guidelines “as non-mandatory guidance for primary care physicians[,] legislators, pharmacy chains, insurers, and others [had] seized on certain parts of its dosage and supply recommendations and translated them into blanket limits in law[s] and mandatory policy (37).” These misapplications and unintended consequences prompted the passage of an AMA Resolution against ongoing, widespread misapplication of the CDC Pain Guidelines in November 2018 (38). Adopted by the AMA House of Delegates at its November 2018 Interim Meeting, the new AMA policy affirmed that:

    1) “Some patients with acute or chronic pain [may] benefit from taking opioid pain medications at doses greater than generally recommended in the CDC Guideline for Prescribing Opioids for Chronic Pain and that such care may be medically necessary and appropriate,”

    2) The “AMA advocate against misapplication of the CDC Guideline for Prescribing Opioids by pharmacists, health insurers, pharmacy benefit managers, legislatures, and governmental and private regulatory bodies in ways that prevent or limit patients’ medical access to opioid analgesia,” and,

    3) “No entity should use MME (morphine milligram equivalents) thresholds as anything more than guidance, and physicians should not be subject to professional discipline, loss of board certification, loss of clinical privileges, criminal prosecution, civil liability, or other penalties or practice limitations solely for prescribing opioids at a quantitative level above the MME thresholds found in the CDC Guideline for Prescribing Opioids (38).”

In the months after adoption of this AMA policy change, more clinical professionals and medical societies would actively seek to reverse the harms of the CDC Pain Guidelines’ misapplication.

In December 2018, a group of clinical leaders and international stakeholders in the pain management community signed an open letter calling for urgent action against forced tapering of opioids (36). On February 13, 2019, the National Comprehensive Cancer Network (NCCN), American Society of Clinical Oncology (ASCO) and the American Society of Hematology (ASH) sent a joint letter to Debra Dowell, Chef Medical Officer of the CDC Opioid Response Coordinating Unit, to follow up on a stakeholder meeting that was held on November 8, 2018, during which those professional organizations called for CDC “to address unintended implementation and reimbursement consequences that have been occurring in practice” because of the misapplication of CDC’s Pain Guidelines (39). On February 19, 2019, Dowell answered back in a letter that stated, “The Guideline is not intended to deny any patients who suffer from chronic pain from opioid therapy as an option for pain management (40).” She also wrote, “CDC encourages physicians to continue to use their clinical judgment and base treatment on what they know about their patients, including the use of opioids if determined to be the best course of treatment (40).” This response letter was embargoed for release until April 9, 2019 (40), to coincide with other anticipated press releases related to federal actions regarding misapplication of the Pain Guidelines (see below).

Similarly, on March 6, 2019, a group identified as Health Professionals for Patients in Pain (HP3) called upon “the CDC to follow through with its commitment to evaluate the impact by consulting directly with a wide range of patients and caregivers, and by engaging epidemiologic experts to investigate reported suicides, increases in illicit opioid use and, to the extent possible, expressions of suicidal ideation following involuntary opioid taper or discontinuation (41).” HP3 also urged “the CDC to issue a bold clarification about the 2016 Guideline – what it says and what it does not say, particularly on the matters of opioid taper and discontinuation (41).” The CDC responded on April 10, 2019, noting that “the Guideline does not endorse mandated or abrupt dose reduction or discontinuation, as these actions can result in patient harm (42).”

FDA Warning and CDC Clarification About the Pain Guidelines

FDA Warning Against Rapid Tapers

One day prior to the CDC response letter to HP3 (42), on April 9, 2019, the FDA posted a safety announcement warning against sudden discontinuation of opioid pain medications (43). In the announcement, the FDA noted that it had “received reports of serious harm in patients who are physically dependent on opioid pain medicines suddenly having these medicines discontinued or the dose rapidly decreased. These include serious withdrawal symptoms, uncontrolled pain, psychological distress, and suicide (43).” This information was also released via a special FDA podcast on 4/17/2019 (44).

CDC Warns Against Misapplication of its Pain Guidelines; PROP Gets Defensive


In view of the embargo for release of the CDC response to the NCCN-ASCO-ASH, which occurred on April 9, 2019 (40), and the CDC response to HP3 (42) on April 10, 2019, it seems likely that the FDA and CDC coordinated their communications to response to the Pain Guideline backlash. CDC then released another embargoed statement on April 24, 2019, in which it advised against the misapplication of its Guideline for Prescribing Opioids for Chronic Pain (45). More explicitly, CDC sought to raise “awareness about the following issues that could put patients at risk:

     - Misapplication of recommendations to populations outside of the Guideline’s scope.
     - Misapplication of the Guideline’s dosage recommendation that results in hard limits or ‘cutting off’ opioids.
     - The Guideline does not support abrupt tapering or sudden discontinuation of opioids.
     - Misapplication of the Guideline’s dosage recommendation to patients receiving or starting medication-assisted treatment for opioid use disorder (45).”

On the heels of this media release, the CDC referenced a companion article published in New England Journal of Medicine (NEJM), co-authored by PROP member and CDC Core Group member, Roger Chou, which was available online on April 24, 2019, and in print on June 13, 2019 (46). Those authors also admitted that “some policies and practices purportedly derived from the guideline have in fact been inconsistent with, and often go beyond, its recommendations (46).” But in contrast to the contrite note struck by the CDC media release, the NEJM article vigorously defended the Pain Guidelines, noting that “the medical and health policy communities [had] largely embraced its recommendations” and that “the guideline was rated as high quality by the ECRI Guidelines Trust Scorecard (46).” The NEJM article also dismissed allegations about the lack of transparency in the Guideline creation, noting that the CDC had “engaged clinicians, health systems leaders, payers, and other decision makers in discussions of the guideline’s intent and provided clinical tools, including a mobile application and training, to facilitate appropriate implementation (46).” Notably, the article ended with this disclaimer: “The views expressed in this article are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention (46).”

Undeclared Conflicts of Interest

Less than a month after the printed publication of the Chou’s NEJM article defending the Pain Guidelines, the US Department of Justice (DOJ) announced obtaining a record-setting $1.4 billion settlement against Reckitt Benckiser, the manufacturer of Suboxone, an opioid addiction treatment drug (47). For years, critics had alleged financial connections between PROP members and Reckitt Benckiser, with suspicions driven by comments by PROP’s Kolodny, who in 2005 - when asked about his financial relationship with the company - replied, “They are not a pharmaceutical company. They make Lysol (48)." In 2015, Reckitt Benckiser had spun off its Suboxone manufacturing to a subsidiary that it named Indivior (49), more commonly identified as its manufacturer currently. Additionally, in recorded testimony during government hearings, Kolodny had encouraged the use of Suboxone as a measure to combat the opioid crisis. In 2011, at a New York State Senate Hearing, then-PROP President Kolodny testified, ““If we want to see a decline in overdose deaths, you have to [sic] provide effective treatment for people who are opioid-addicted. And for this epidemic, that’s probably going to mean buprenorphine (50).” Likewise, during a US Senate Hearing in 2018, Kolodny testified, “The first-line treatment for opioid addiction is buprenorphine, also called ‘’Suboxone.’ Access to this treatment is not sufficient (51).”

Testimony from hearings encouraging the use of Suboxone and deflective comments, like Kolodny’s dismissal about his relationship with Reckitt Benckiser, were less suspicious as betraying conflicting interests before it was revealed that PROP members failed to disclose relevant conflicts of interest when authoring several articles printed in medical journals. Kolodny failed to disclose conflicts of interest pursuant to his executive directorship of PROP and provision of expert witness testimony in malpractice cases involving opioids when he published two articles in the Journal of the American Medical Association (JAMA) in October 2017 and April 2018 (52). Similarly, PROP President, Jane Ballantyne, failed to disclose her affiliation with PROP in an “Ideas and Opinions” article, co-authored with PROP members, Anna Lembke and Roger Chau, in Annals of Internal Medicine in 2019 (53, 54). Moreover, PROP’s Mark Sullivan failed to declare a conflict of interest regarding his work on a opioid tapering device, which occurred during his participation in the drafting of the CDC Pain Guidelines, until he was participating in a CDC-sponsored Clinical Outreach and Community Activity, after the Guidelines’ publication (55). More recently, the British Medical Journal (BMJ) updated a “Rapid Response” that accused the AMA of a pharmaceutical industry bias when creating opioid policy, written by several members of PROP, when it was revealed that one of the co-authors, PROP’s Sullivan, did not disclose his competing interest related to his work as an expert witness in cases in Maryland and Missouri (56).

Despite their collective tendency to under-report relevant conflicts of interest in publications, PROP members continued to place themselves successfully in key positions to enhance their ability to shape opioid policy. In early April 2020, the Agency for Healthcare Research and Quality (AHRQ) disclosed for the first time the identity of the authors of the controversial report, “Opioid Treatment for Chronic Pain,” which had concluded “opioids were no more effective in treating pain than nonopioid medication, and that long-term use of opioids increases the risk of abuse, addiction and overdose, especially at high doses (57).” The lead author of that report was revealed to be Roger Chou, a PROP member who has been described as “a vocal critic of opioid prescribing for years (58).” This revelation was especially concerning at the time, because CDC had announced its plans to review and possibly revise the 2016 CDC Pain Guidelines, which were co-authored by Chou, and because the AHRQ study had reaffirmed many of CDC’s still-disputed conclusions about opioid therapy (58).

CDC Begins a Reassessment of the 2016 CDC Pain Guidelines

Open Docket for Comments

On April 17, 2020, the CDC announced “the opening of a docket to obtain comment concerning perspectives on and experiences with pain and pain management, including but not limited to the benefits and harms of opioid use, from patients with acute or chronic pain, patients' family members and/or caregivers, and health care providers who care for patients with pain or conditions that can complicate pain management (59).” Eventually, it received 5,392 comments from patients, physicians, medical organizations, and other stakeholders with feedback about its 2016 Pain Guidelines (60).

The AAHPM did not mince words when commenting about its concerns of misapplication of the CDC Pain Guidelines: “The 2016 Guideline has been broadly misapplied, with devasting effect on patients and prescribers. Forced tapering of patients’ opioid prescriptions has been incentivized and/or mandated, violating ethical and evidentiary norms of medical practice. This has resulted in many patients’ medical deterioration, loss of care relationships, turning to illicit substances/alcohol, and suicidality. Swapping products and formulations to reduce opioid prescriptions where not medically necessary has also led to medical errors. At the same time, prescribers have faced professional discipline, loss of board certification, loss of clinical privileges, criminal prosecution, civil liability, or other penalties or practice limitations solely for prescribing opioids at a quantitative level above the morphine milligram equivalent (MME) thresholds included in the CDC Guideline (61).”

The AMA echoed these concerns, writing “It is clear that the CDC Guideline has harmed many patients—so much so that in 2019, the CDC authors and HHS issued long-overdue, but greatly appreciated, clarifications that states should not use the CDC Guideline to implement an arbitrary threshold (Italics mine, 62). It also noted that “the CDC Guideline has been misapplied as a hard policy threshold by states, health plans, pharmacy chains, and PBMs,” and that “these policies, moreover, have not withstood any meaningful evaluation or data analysis as to whether they have improved pain care or reduced opioid-related harms (62). There also are no data to suggest that payers have increased access to non-opioid pain care options. If one of the goals of the CDC Guideline was to increase access to non-opioid pain care, that has not been realized (62). Rather, there is evidence that payers continue to erect and support barriers to non-opioid pain care (62).” The AMA urged the CDC to rescind policies employed by “many health insurers, pharmacy chains, and PBMs” based on the concept of a hard MME threshold to avoid “harms done to patients as a result of inappropriate tapering or denials of care (62, 63).

In its comments, PROP conceded that reduced opioid prescribing was associated with downward trends in “prescription opioid related morbidity and mortality (64),” but did not acknowledge a concomitant, upward trend in total opioid-related morbidity and mortality from illicit drug, including illegally manufactured fentanyl. They further argued, “For some patients, continued opioid use is necessary not because it effectively manages the pain that prompted opioid prescribing initially, but because continued use averts the negative effects of opioid discontinuation (64),” a claim advocates for patients with chronic pain have labeled as a gaslighting strategy (65). Furthermore, as discussed later in the article, PROP also incorrectly 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 though harder to employ than the prescription pad, will ultimately result in better outcomes and less distress (65).”

The BSC/NCIPC Workgroup

On July 6, 2020, the CDC announced the formation of a new Opioid Workgroup and the Board of Scientific Counselors, National Center for Injury Prevention and Control Centers for Disease Control and Prevention (The BSC/NCIPC Workgroup), which would “review the Opioid Workgroup’s report, discuss, deliberate, and provide advice and recommendations for CDC to consider as part of the potential update and/or expansion of the Guideline. The updated and/or expanded Guideline is anticipated to be released in 2022 (66).” This announcement was followed by the release of a PowerPoint Presentation entitled, “Update on the BSC/NCIPC Workgroup,” on July 22, 2020, which elaborated on the process of choosing the new Opioid Workgroup (67). An additional update from October 13, 2020, identified the membership of the Opioid Workgroup – NCIPC BSC Committee Members (68). The updated and/or expanded Pain Guideline was anticipated to be released in 2022 (66), but that timeframe was projected before the full impact of the COVID-19 Pandemic.

Increases in Overdose Deaths and CDC Data Flaws

The February 2021 MMWR Report


While the world anxiously awaited word on any new or revised CDC Pain Guidelines, on February 12, 2021, the MMWR Report (1) mentioned at the top of this commentary quickly captured the attention of those already hungry for news from the CDC, including patients with chronic pain and clinicians who manage that pain. In the setting of a 1,040% increase in “age-adjusted overdose death rates involving synthetic opioids, psychostimulants, cocaine, heroin, and prescription opioids during 2013–2019 (1),” it seemed prudent to critically question PROP’s assertion that “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 though harder to employ than the prescription pad, will ultimately result in better outcomes and less distress (64).”

On February 16, 2021, in what felt like an effort to draw attention away from the stark reality of the MMWR Report, PROP wrote a letter to AMA President, Susan R. Bailey, regarding “AMA’s Opposition to Dose & Duration Guidance for Opioid Prescribing (69),” based on AMA’s comments to Dr. Deborah Dowell in the CDC Open Docket (61). PROP concomitantly published this letter to the AMA as a “Rapid Response” to an article entitled, “UK recommendations on opioid stewardship (70, 71).” The letter alleged that AMA Opioid Policy was inappropriately influenced by donations from the pharmaceutical industry (69, 70). AMA President, Susan Bailey, quickly responded back to PROP, in a letter dated February 19, 2021, saying “With respect to the issue you raise in your letter, it might be helpful to point out that the CDC authors of the 2016 CDC Guideline themselves have recognized it has been misapplied (Italics mine; 72, 73).” Additionally, Bailey pointed out, “When policies or organizations focus only on the restriction of a legitimate pharmacologic option to help patients with pain, they miss the chance to address the complexity of policies needed to truly help patients with pain. That misguided focus also has led to harmful stigmatization and other stressors. That is why the AMA provided comprehensive recommendations on the 2016 CDC Guideline and why we continue to advocate for policies that support comprehensive, multidisciplinary, multimodal pain care, including opioid therapy when appropriate. If you choose to cite the AMA’s policies in the future, we encourage you to cite them in their entirety to ensure accurate context (72),” and Bailey provided the link for the AMA’s comments to Deborah Dowell to guide PROP when referencing AMA policy in the future (62).

Inaccurate CDC Data on Opioid Deaths


Just a few weeks later, PROP’s troubles worsened, with the publication of an article by John Peppin and John J. Coleman in Pain Therapy (74) that detailed fundamental methodological shortcomings in CDC’s data on prescription overdose deaths (35). The authors held that “CDC erroneously reported prescription opioid overdose deaths in 2016 and for more than a decade before (74)” in a way that overestimated overdose deaths due to prescribed opioids. They further assert that “the CDC ignored the problem until 2016 data showed serious inconsistencies with other, more reputable, data for prescribing volumes of opioids (74).” Furthermore, in “2018, the U.S. Congress mandated the CDC to ‘’modernize’’ its system for reporting drug overdose deaths but this has not yet occurred (74).” They concluded: “For more than a decade, millions of Americans were misled into believing that—as a White House report once characterized it— ‘opiate overdoses, once almost always due to heroin use, are now increasingly due to abuse of prescription painkillers.’ Little did they know or suspect that the CDC’s coding of prescription painkillers included non-prescribed illicitly manufactured fentanyl and fentanyl analogs and non-prescribed methadone administered or dispensed to patients being treated for opioid use disorder (74).”

This report again exposed PROP’s and CDC’s false narrative that overprescribing of opioid analgesics had driven the US overdose crisis (74). In a predictable response, Andrew Kolodny reacted quickly to soften the crushing blow and establish some semblance of plausible deniability for PROP’s culpability. On March 22, 2021, Kolodny produced a webinar during which he “refuted” several alleged “myths and false narratives” about the opioid crisis (75). This presentation was swiftly characterized as “a rambling dialogue by Kolodny that gaslighted pain sufferers, doctors, patient advocates and anyone else critical of the CDC guideline (76).” For example, in a clear example of a Straw Man Argument (77), Kolodny alleged a myth that the “CDC Guideline forced millions of patients off opioids resulting in an epidemic of suicides (75),” when in fact both the CDC and FDA had publicly acknowledged the potential harms of forced tapers, acknowledging that the extent of the harm was not yet known (Italics mine, 42-45). In response to legitimate concerns about harms from polices influenced by PROP’s advocacy, one of its individual members had responded with gaslighting (75), informal fallacies (77) and deflection, aimed apparently at creating plausible deniability for their contribution to those harms.

Conclusion

Despite being turned back from an effort to bluntly reduce opioid prescribing by the FDA in 2013 based on a lack of scientific evidence for its position (17,18), PROP has had a disproportionate effect on opioid policy in the Untied States for almost a decade. PROP found a willing federal regulatory partner in the CDC, and while PROP may not have “secretly written” the 2016 CDC Pain Guidelines (75), they certainly enjoyed disproportionate representation on CDC’s review panels and Core Expert Group (23-25) in a process that lacked transparency (22, 23, 26, 27). When the CDC admitted that its Pain Guideline had been widely misapplied (40) and joined the FDA in a call against forced opioid tapers (42, 43, 45), PROP doubled down on its rhetoric (46), dismissing legitimate concerns about potential harms in a performative manner (75) that encouraged their ongoing misapplication, while assailing PROP’s critics (76, 77). All of this has occurred as PROP members have repeatedly concealed relevant conflicts of interest, including key conflicts that should have been disclosed during the process of drafting the CDC Pain Guidelines (48-54).

Given this, at a minimum, PROP should no longer enjoy a prominent role in guiding future opioid policy in the United States. This is a particularly urgent concern, as Roger Chou has been linked to authorship of CDC’s New Pain Guidelines, which have not yet been released to the public (78). Chou’s involvement in yet another set of Guidelines and CDC’s recurrent lack of transparency (79) in identifying the new Guidelines’ authors should alarm all advocates who support access to pain medications for all patients with a medically legitimate indication for opioid therapy.

Beyond limiting PROP’s role in developing future, potentially harmful opioid policy, a reasonable individual would be justified in wondering to what extent PROP bears culpability for the harms that arose from misapplications of the 2016 CDC Pain Guidelines. In our country, civil suits – like class action lawsuits, for example – only require a preponderance of the evidence – that is something is “more likely than not” - as the burden of proof for liability. It is more likely than not that PROP’s efforts to affect opioid policy helped shape the CDC Guidelines, which CDC has admitted were misapplied harmfully (40). It is also more likely than not that PROP’s performative advocacy efforts contributed to misapplication of the CDC Guidelines. And it is more likely than not that widespread misapplication of the CDC Guidelines resulted in harms with attendant civil liability. This would expose PROP to civil liability with a potentially enormous settlement if a class action suit were to arise from those harmed by the misapplication of the CDC Guidelines. Perhaps that is why PROP member, Andrew Kolodny, and others have worked so hard recently to create plausibly deniability (75) in the wake of the damaging February 12, 2021, MMWR Report (2).

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Dr. Kollas is board certified in internal medicine and provides pallative and supportive care in Orlando, FL.. He first wrote about his personal experiences with chronic illness and pain in a 1997 article in the “On Being a Patient” series in Annals of Internal Medicine. You can find him on Twitter at @ChadDKollas.

To cite this article: 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

Correction 5/4/2021: A date was incorrectly included in the original article as "April 9, 2021," which was incorrect. It was changed to the correct date of "April 9, 2019."

Addition 5/6/2021: A Twitter user was able to find the PDF link to Reference number 40. The reference was updated with this link.

Conflict of Interest (submitted upon publication, added here 5/4): Dr. Kollas had submitted a Conflict of Interest statement when submitting this article for publication. It was not originally included in error in the original article here due to editor error. You can find the conflict of interest statement here - https://twitter.com/ChadDKollas/status/1389616181762478080. We have a copy of the COI statement, if this link ever is removed or in error.

References

1. Mattson CL, et al. MMWR, February 12, 2021. 70(6):202-7 (or see https://www.cdc.gov/mmwr/volumes/70/wr/pdfs/mm7006-H.pdf).

2. See https://twitter.com/BethDarnall/status/1366901343642742784.

3. See https://twitter.com/ChadDKollas/status/1365661703191560192.

4. See the CDC Pain Guidelines at https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm.

5. See https://twitter.com/supportprop/status/1362043581544947712.

6. Old, JL. Fam Pract Manag. 2011 Nov-Dec;18(6):31-35 (or see https://www.aafp.org/fpm/2011/1100/p31.html.

7. Von Korff M, et al. 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&.

8. PROP Petition to FDA, 2012, See https://www.citizen.org/wp-content/uploads/migration/2048.pdf.

9. See https://www.regulations.gov/document/FDA-2012-P-0818-0002.

10. See https://www.joepaduda.com/2012/08/14/responsible_opi/.

11. See food-and-drug-administration-follow-up-letter-to-relabeling-petition-clarification-of-asam-position-nbsp-september-13-2012.pdf.

12. Originally posted at http://updates.pain-topics.org/2012/08/group-petitions-fda-to-change-opioid.html, but that link is not operational; the article is currently referenced at https://painpolicy.wordpress.com/2012/08/03/why-the-fda-shouldnt-change-the-labeling-of-opioid-analgesics/.

13. Portenoy RK. Letter to Nirav R. Shah, MD, MPH, Commissioner, New York State Department of Health. August 16, 2012. (PDF copy available on request from this article’s author).

14. See https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&ved=2ahUKEwi8i4imqMzvAhU_TDABHQS7Cc4QFjAAegQIBRAD&url=https%3A%2F%2Fwww.asahq.org%2F-%2Fmedia%2Fsites%2Fasahq%2Ffiles%2Fpublic%2Fadvocacy%2Ffederal-activities%2Fregulatory-activities%2Fpain-medicine%2Fasa-letter-fda-prop-8-22-12.pdf%3Fla%3Den%26hash%3D09DC35AB25C0C8F30807578C2038EA0244B7D7C9&usg=AOvVaw1-eZoU2_-k4xbDsC4EYdjT.

15. Grabois M. Letter to Dockets Management Branch, Food and Drug Administration. August 12, 2012. (PDF copy available on request from this article’s author).

16. See https://www.acttion.org/static/docs/aps_letter.pdf; referenced at https://www.acttion.org/news/november-26-2013-american-pain-society-letter-to-fda-commissioner-hamburg-about-immpact-and-acttion).

17. 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.

18. See http://www.fdalawblog.net/2013/09/fda-grants-prop-petition-in-part-proposes-new-labeling-and-requires-post-marketing-studies-for-erla/.

19. See http://www.supportprop.org/wp-content/uploads/2014/01/PROP_OpioidPrescribing.pdf.

20. See http://www.supportprop.org/wp-content/uploads/2014/12/PA_3_29_13_FSMB.pdf.

21. See https://www.cdc.gov/injury/pdfs/fundedprograms/Response_to_Constituent_Comment_CDC_Prescribing_Guideline.pdf.

22. Anson P. CDC Maintains Secrecy Over Opioid Guidelines. Pain News Network, September 18. 2015. See https://www.painnewsnetwork.org/stories/2015/9/18/cdc-maintains-secrecy-over-opioid-guidelines.

23. Anson P. Chronic Pain Groups Blast CDC for Opioid Guidelines. Pain News Network, September 22, 2015. See https://www.painnewsnetwork.org/stories/2015/9/22/chronic-pain-groups-blast-cdc-for-opioid-guidelines.

24. Anson P. Special Interest Groups Behind CDC Opioid Guidelines. Pain News Network, September 24, 2015. See https://www.painnewsnetwork.org/stories/2015/9/24/3xz1qq23yuilyeluz63kgwckplwh21.

25. Anson P. PROP Helped Draft the CDC Guidelines. Pain News Network, September 21, 2015. See https://www.painnewsnetwork.org/stories/2015/9/21/prop-helped-draft-cdc-opioid-guidelines.

26. Madara JL. Letter to Thomas Freiden, Director, Centers for Disease Control and Prevention. October 1, 2015. (PDF copy available on request from article’s author).

27. Patient Quality of Life Coalition. Letter to The Honorable Lamar Alexander, Chairman, Committee of Health, Education, Labor and Pensions, United States Senate. November 13, 2015. (PDF copy available on request from this article’s author).

28. See https://www.federalregister.gov/documents/2015/12/14/2015-31375/proposed-2016-guideline-for-prescribing-opioids-for-chronic-pain.

29. Samp R. CDC Bows To Demands For Transparency And Public Input On Draft Opioid-Prescribing Guidelines. Forbes, December 15, 2015. See http://www.forbes.com/sites/wlf/2015/12/15/cdc-bows-to-demands-for-transparency-and-public-input-on-draft-opioid-prescribing-guidelines/#36c587e1122a.

30. Norman B. POLITICO Pro: CDC opens opioid prescription guidelines to public comment. Politico, December 11, 2015. (PDF copy available on request from this article’s author).

31. Lin DH, et al. Financial Conflicts of Interest and the Centers for Disease Control and Prevention’s 2016 Guideline for Prescribing Opioids for Chronic Pain. JAMA Internal Medicine, March 2017; 177(3):427-8.

32. Fiore K. CDC Comes Down Hard on Opioids for Chronic Pain — Urges physicians not to use opioids first-line for chronic pain. MedPage Today, March 15, 2016. See https://www.medpagetoday.com/publichealthpolicy/publichealth/56745.

32. See http://blog.aapainmanage.org/academys-response-center-disease-controls-guideline-prescribing-opioids-chronic-pain/.

33. See https://usrtk.org/wp-content/uploads/2016/10/CDC_SPIDER_Letter-1.pdf.

34. Gillam C. The CDC is being influenced by corporate and political interests. The Hill, October 17, 2016. See https://thehill.com/blogs/pundits-blog/healthcare/301432-the-cdc-is-being-being-influenced-by-corporate-and-political .

35. Seth P, et al. Quantifying the Epidemic of Prescription Opioid Overdose Deaths. AJPH, April 2018; 108(4):500-2. See https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5844400/pdf/AJPH.2017.304265.pdf.

36. Darnall BD, et al (including Kollas CD). International Stakeholder Community of Pain Experts and Leaders Call for an Urgent Action on Forced Opioid Tapering. Pain Medicine, 2018; 0:1-4. See https://pubmed.ncbi.nlm.nih.gov/30496540/.

37. Nicholson KM, Hoffman DE, Kollas CD. Overzealous use of the CDC’s opioid prescribing guideline is harming pain patients. Stat News, December 6, 2018. See https://www.statnews.com/2018/12/06/overzealous-use-cdc-opioid-prescribing-guideline/.

38. See Resolution 235 at https://www.ama-assn.org/system/files/2018-11/i18-refcomm-b-annotated.pdf.

39. Carlson RW, et al. Letter to Deborah Dowell, Chief Medical Officer, Opioid Response Coordinating Unit, CDC National Center for Injury Prevention and Control. February 13, 2019. See https://www.asco.org/sites/new-www.asco.org/files/content-files/advocacy-and-policy/documents/2019-NCCN-ASCO-ASH-Letter-CDC.pdf.

40. Dowell D. Centers for Disease Control and Prevention. Letter to NCCN, ASCO, ASH, February 28, 2019. https://www.asco.org/sites/new-www.asco.org/files/content-files/advocacy-and-policy/documents/2019-CDC-Opioid-Guideline-Clarification-Letter-to-ASCO-ASH-NCCN.pdf

41. Health Professionals for Patients in Pain (HP3), led by Alford DP (and including Kollas CD). Professionals Call on the CDC to Address Misapplication of its Guideline on Opioids for Chronic Pain through Public Clarification and Impact Evaluation. March 6, 2019. See https://healthprofessionalsforpatientsinpain.org/the-letter-1.

42. Centers for Disease Control and Prevention. Letter to Daniel P. Alford MD MPH, Professor of Medicine, Brown University Medical Campus. April 10, 2019. (PDF copy available on request from this article’s author).

43. FDA Drug Safety Communications. FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering. April 9, 2019. See https://www.fda.gov/media/122935/download.

44. FDA Drug Safety Podcast. FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering. April 17, 2019. See https://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-identifies-harm-reported-sudden-discontinuation-opioid-pain-medicines-and-requires-label-changes#:~:text=On%20April%209%2C%202019%20FDA,%2C%20psychological%20distress%2C%20and%20suicide.

45. CDC Media Relations. CDC Advises Against Misapplication of the Guideline for Prescribing Opioids for Chronic Pain. Embargoed Until: Wednesday, April 24, 2019, 5 PM, EDT. See https://www.cdc.gov/media/releases/2019/s0424-advises-misapplication-guideline-prescribing-opioids.html.

46. Dowell D, Haegerich T, Chou R. No Safecuts to Safer Opioid Prescribing. N Engl J Med 2019; 380:2285-2287. https://www.nejm.org/doi/full/10.1056/NEJMp1904190.

47. Department of Justice, Office of Public Affairs. Justice Department Obtains $1.4 Billion from Reckitt Benckiser Group in Largest Recovery in a Case Concerning an Opioid Drug in United States History. July 11, 2019. See https://www.justice.gov/opa/pr/justice-department-obtains-14-billion-reckitt-benckiser-group-largest-recovery-case.

48. McGray D. The Bitter Pill. Wired, April 1, 2005. See https://www.wired.com/2005/04/bupe/.

49. See https://web.archive.org/web/20150329132943/http://www.rb.com/rb-complete-demerger-of-indivior.

50. See https://medium.com/@jmkillingworth/grandmas-on-smack-and-other-unsavory-tactics-from-prop-benefactor-reckitt-benckiser-group-fb5ee76a3ed5.

51. See https://www.govinfo.gov/content/pkg/CHRG-115shrg31264/pdf/CHRG-115shrg31264.pdf.

52. JAMA. 2019 Sep 4 : e1914523. See https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6727681/?report=printable.

53. Chou R, et al. Rethinking Opioid Dose Tapering, Prescription Opioid Dependence, and Indications for Buprenorphine. Ann Internal Med, Sept 17, 2019;171(6):427-430. See https://www.acpjournals.org/doi/pdf/10.7326/M19-1488.

54. Anson P. PROP President Discloses Conflicts of Interest. Pain News Network, November 19, 2019. See https://www.painnewsnetwork.org/stories/2019/11/12/prop-president-discloses-conflicts.

55 See https://emergency.cdc.gov/coca/transcripts/2016/call-transcript-080316.asp.

56. Personal communication with Sharon Davies, Letter Editor, British Medical Journal. March 15, 2021, at 2:05 PM ET. (Copy of e-mail available on request from this article’s author).

57. Agency for Healthcare Research and Quality, US Department of Health and Human Services. Opioid Treatment for Chronic Pain. AHRQ Publication No. 20-EHC011, April 2020. See https://effectivehealthcare.ahrq.gov/sites/default/files/pdf/opioids-chronic-pain.pdf.

58. Anson P. PROP Linked to New Federal Opioid Study. Pain News Network, April 20, 2020. https://www.painnewsnetwork.org/stories/tag/Roger+Chou

59. See https://www.regulations.gov/document/CDC-2020-0029-0001.

60. See https://www.regulations.gov/docket/CDC-2020-0029.

61. American Academy of Hospice & Palliative Medicine. Letter to Robert R. Redfield, MD, Director, Centers for Disease Control and Prevention. RE: Management of Acute and Chronic Pain: Request for Comment; Docket No. CDC–2020– 0029. June 16, 2020. (PDF copy available on request from this article’s author).

62. Madara JL. Letter to Deborah Dowell, MD, MPH. Chief Medical Officer, National Center for Injury Prevention and Control, U.S. Centers for Disease Control and Prevention. Re: Docket No. CDC-2020-0029. June 16, 2020. See https://searchlf.ama-assn.org/undefined/documentDownload?uri=%2Funstructured%2Fbinary%2Fletter%2FLETTERS%2F2020-6-16-Letter-to-Dowell-re-Opioid-Rx-Guideline.pdf.

63. AMA urges CDC to revise opioid prescribing guideline (Press Release). June 18, 2020. See https://www.ama-assn.org/press-center/press-releases/ama-urges-cdc-revise-opioid-prescribing-guideline.

64. Ballantyne JC et al. Letter to Robert R. Redfield, MD, Director, Centers for Disease Control and Prevention. Re: Docket No. CDC-2020-0029- Management of Acute and Chronic Pain. See http://www.supportprop.org/wp-content/uploads/2020/06/PROP-Comment-CDC-Docket-2020.pdf?fbclid=IwAR2SCNj6MTLhYml9TbthlEm8nfzXQpEQX4tmCGSKFAkptZk42p-OOsKZHZc.

65. Fudin J. Chronic Opioid Patients Speak Out Against PROP. PainDr, August 12, 2012. See https://paindr.com/chronic-opioid-patients-speak-out-against-prop/ in Comments.

66. See https://www.cdc.gov/injury/pdfs/bsc/OWG_Terms-of-Ref_FINAL-7-6-2020-r.pdf.

67. Ross M. Update on the BSC/NCIPC Opioid Workgroup Formation. Board of Scientific Counselors Meeting, July 22, 2020. See https://www.cdc.gov/injury/pdfs/bsc/Ross_OWG-Update-7-7-2020-508.pdf.

68. See https://www.cdc.gov/injury/pdfs/bsc/OWG-Roster-External-10-13-2020-FINAL-a.pdf.

69. Ballantyne JC, et al. Letter to Susan R. Bailey, MD, President, American Medical Association. RE: AMA’s Opposition to Dose & Duration Guidance for Opioid Prescribing. February 16, 2021. (PDF copy available on request from this article’s author).

70. Ballantyne JC, et al. Rapid Response: Letter from Physicians for Responsible Opioid Prescribing (PROP) to the American Medical Association (AMA) -- RE: AMA’s Opposition to Dose & Duration Guidance for Opioid Prescribing. BMJ 2021;372:m4901. See https://www.bmj.com/content/372/bmj.m4901/rr-1.

71. Levy N, et al. UK recommendations on opioid stewardship. BMJ 2021 Jan 5;372:m4901. See also https://pubmed.ncbi.nlm.nih.gov/33402365/.

72. Bailey SR. Letter to Physicians for Responsible Opioid Prescribing (PROP). February 19, 2021. https://static1.squarespace.com/static/54d50ceee4b05797b34869cf/t/6036d35738d4d95a0458ab65/1614205783776/AMA+letter+to+PROP.pdf.

73. Anson P. AMA Scolded for Seeking Changes in CDC Opioid Guideline. Pain Network News, February 17, 2021. See https://www.painnewsnetwork.org/stories/2021/2/17/prop-attacks-ama-for-seeking-changes-in-cdc-opioid-guideline-nbsp.

74. Pepin JF and Coleman JJ. CDC’s Efforts to Quantify Prescription Opioid Overdose Deaths Fall Short. Pain Ther 2021 Mar 24;1-14. Published online ahead of print on March 24, 2021. See https://pubmed.ncbi.nlm.nih.gov/33761120/ or https://link.springer.com/content/pdf/10.1007/s40122-021-00254-z.pdf.

75. See screen capture by Carrie Judy at https://twitter.com/life_is_art___/status/1374453671136616448/photo/1.

76. Anson P. Kolodny: Critics of CDC Opioid Guideline ‘Twisting the Facts’. Pain News Network, March 24, 2021. See https://www.painnewsnetwork.org/stories/2021/3/24/kolodny-critics-of-cdc-opioid-guideline-twisting-the-facts.

77. See, for example https://en.wikipedia.org/wiki/Straw_man.

78. Anson P. PROP Linked to New Federal Opioid Study. Pain News Network, April 20, 2020. See https://www.painnewsnetwork.org/stories/2020/4/20/prop-linked-to-new-federal-opioid-study.

79. Anson P. CDC Won’t Say Who is Writing Update of Opioid Guideline. Pain News Network, April 5, 2021. See https://www.painnewsnetwork.org/stories/2021/4/4/cdc-wont-say-who-is-writing-update-of-opioid-guideline.

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