Monday, September 12, 2022

Undisclosed Conflicts of Interest by Physicians Creating the CDC Opioid Prescribing Guidelines: Bad Faith or Incompetence?

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

Introduction

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

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

Background/Chronology

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

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

How Did the Media Contribute to this Moral Panic?

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

Moral Entrepreneurs Seize the Opportunity

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

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

The 2016 Guideline, Its Misapplication and Patient Harms

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

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

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

Moral Entrepreneurs Undermine a Call for Balanced Opioid Policy

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

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

Reassessing the 2016 Guideline; Creating the 2022 Opioid Guideline

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

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

Methodology

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

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

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

Results

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



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



Discussion

Conflict Overview, Ethics and CDC’s Guiding Principles

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

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

COI Overview and Key Individual Conflicts

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

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

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

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

Does Disclosing COIs Matter?

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

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

Following the Money

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

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

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

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

Limitations and Criticisms

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

Concluding Recommendations

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

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

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

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

Dedication:

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

About the Authors:

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

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

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


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

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

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

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

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Monday, September 12, 2022 by Christian Sinclair ·

Monday, July 11, 2022

Celebrating Hospice and Palliative Medicine as the Fifth Largest Medical Subspecialty

by Christian Sinclair (@ctsinclair)

We have entered a new age! Spread the word! Hospice and palliative medicine (HPM) is the fifth largest medical subspecialty!

You may have sensed we have been climbing the ranks, but I bet you are still surprised. A close look at the fellowship match data from Dec 2021, shows that HPM has the fifth highest number of matched applicants, behind the big 4: Cardiovascular, Pulmonary and Critical Care, Hematology and Oncology, and Gastroenterology.

When I share this good news with HPM colleagues, few put us anywhere near fifth. I did an informal poll on Twitter and less than half of respondents ranked HPM in the top 10. Of those that did rank HPM, the average rank was 7. Clearly, we are not telling our own story very well.

There are many possible reasons to feel skeptical, but yes, HPM is the fifth largest medical subspecialty! Yet, it still may not feel like that...why might that be? In general, I find HPM clinicians to be a humble, cordial bunch. We may be more introverted. We are not ones to generally boast about our accomplishments as a field. Most of that attention is often dedicated to some new technology or medicine anyway.

Also, maybe we percieve oursleves to be a smaller specialty because access to HPM physicians is still highly variable. Centered in metro areas and more likely to be found wandering the halls of academia, there may be local, regional or organizational reasons why HPM has a smaller footprint in one place, while being a driving force in another. A message can be muddled when telling a large audience to access HPM physicians yet there are none in their area.

Additionally, we are still quite a young specialty, with the birth of HPM as an official specialty being announced in 2005, and getting started in 2008. We have just entered our teenage years. Maybe it is OK to think about ourselves for a bit, and test the boundaries of our newfound confidence like any respectable teenager.

Lastly, many are working in health care organizations which still treat palliative medicine and hospice physicians as “nice to have” instead of “essential.” It is hard to feel like you are part of a larger group when there are not many colleagues around you. The teams we work with may still feel empty without all the key disciplines collaborating. A HPM physician is a good start, but when there are no resources, no infrastructure and not enough people to get the work done, HPM may be limited to being little more than a glossy brochure.

So why do we need to talk about this? Because this is a great opportunity to increase visibility which can help in a variety of ways. The message is simple, HPM is the fifth largest medical subspecialty! We are right behind cardiologists, oncologists, critical care and GI and this should be something (when shared) helps to cement our stature. When you are number five, we should not settle for being relegated to choosing ‘other’ on a list of medical subspecialties. If rheumatology is on there, so are we. If geriatrics is on there, so are we. If infectious disease is on there, so are we.

Sharing this message increases our visibility at our own organizations. We should be including this in our presentations on Hospice and Palliative Medicine 101, or frankly anytime we are asked to speak to outside audiences. We need to share this on social media and in conversations with our colleagues, friends and family. People should want to understand what hospice and palliative medicine doctors do, especially when HPM is the fifth largest medical subspecialty.

We are currently in fellowship application season, so this is a message to share when people come to your program. This increased national visibility will also help bring more people to our field with fresh ideas, diverse backgrounds, and new skills. We have important areas to grow with HPM physicians playing an important part including outpatient and community care, hospice care, pediatrics, and research. Right now, we are not filling all of our fellowship slots (85% filled) and we have a looming HPM physician shortage. What a great time to be popular and get the word out to pre-med students, med students and residents of all primary specialties to put HPM onto their short list. It will be hard to act surprised when learners declare an interest in palliative care, because after all, HPM is the fifth largest medical subspecialty.

I am still surprised this Tweet happened as recently as 2018!



I do not expect that to happen in the future. The more we share the growth of our field, that we are here, that we have numbers, that we are strong, and that we will make an impact, then we can reserve OUR seat at the table to make the important decisions shaping the future of health care. I hope you are thinking of the first person you need to tell that HPM is the fifth largest medical subspecialty. Let’s do it!

Original data here from NRMP. Summary of data for this post below.





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Christian Sinclair, MD, FAAHPM is a palliative care physician at the University of Kansas Health System, editor-in-chief of Pallimed, and trying to keep up a resolution to write more about palliative care in 2022.

Monday, July 11, 2022 by Christian Sinclair ·

Friday, May 13, 2022

The Peril and Privilege of Exploration: A Review of Subnautica

by Matt Tyler (@PalliDad)

In the survival game Subnautica, you play the role of a space voyager who has crash landed on an aquatic alien planet. You must find a way to escape while navigating the planet’s beautiful but dangerous flora and fauna. Exploration makes the core of Subnautica, and because I am a palliative care doctor, I couldn’t help but draw a parallel to serious illness conversations. Whether exploring shipwrecks and underwater caverns or the emotions and stories of patients, both require curiosity, methodical skill development, and respect for boundaries.

Any explorer must first and foremost be curious, even in the face of danger. You won’t make progress in Subnautica if you don’t get close to some scary sea monsters. The same is true for serious illness conversations, maintaining curiosity is essential even when encountering a strong emotion like anger. Rather than presuming an angry patient misunderstands the situation, a curious mind wonders about the origins of that anger and the suffering that may be beneath the surface. The empathy that flows from this curiosity can lead to new levels of understanding.

And yet, curiosity alone can only take you so far. At the beginning of Subnautica, your basic equipment will only let you explore a short distance below sea level. To discover the planet’s deepest secrets, you must gradually accumulate the resources necessary to upgrade your diving gear. Likewise, we need more than curiosity to explore the complexities of a patient’s physical, emotional, spiritual, social, and cultural needs in the face of serious illness. It takes time to develop the skillset needed to facilitate these conversations, ideally with observation and feedback from experts.

Even with the most advanced exploration equipment, there are depths in Subnautica that remain out of reach. There are no physical barriers to show that you’ve reached the world’s edge - that understanding only comes with your fully realized abilities. Similarly, seasoned communicators appreciate that although there are parts of a patient’s story that can be explored with advanced skills, there are always boundaries that must be respected. Though it requires a certain level of expertise to see these invisible walls, noticing their presence is vital for creating a patient-centered care plan.

Ultimately, survival in Subnautica depends not on rebuilding the world to suit your specific needs, but on learning how to work with the world on which you’ve crash landed. Building a relationship with our patients requires the same approach. If we are willing to dive into our patient’s world to understand and support what matters most to them, who knows what beauty can be discovered?

Subnautica is available to play on PC (Steam), macOS, PlayStation 5, Xbox and Nintendo Switch systems.

This post has a companion piece video 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.





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

Friday, May 13, 2022 by Pallimed Editor ·

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