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 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 -

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)


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.


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).

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

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:

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 - We have a copy of the COI statement, if this link ever is removed or in error.


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8. PROP Petition to FDA, 2012, See

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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, but that link is not operational; the article is currently referenced at

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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).

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22. Anson P. CDC Maintains Secrecy Over Opioid Guidelines. Pain News Network, September 18. 2015. See

23. Anson P. Chronic Pain Groups Blast CDC for Opioid Guidelines. Pain News Network, September 22, 2015. See

24. Anson P. Special Interest Groups Behind CDC Opioid Guidelines. Pain News Network, September 24, 2015. See

25. Anson P. PROP Helped Draft the CDC Guidelines. Pain News Network, September 21, 2015. See

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

29. Samp R. CDC Bows To Demands For Transparency And Public Input On Draft Opioid-Prescribing Guidelines. Forbes, December 15, 2015. See

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

32. See

33. See

34. Gillam C. The CDC is being influenced by corporate and political interests. The Hill, October 17, 2016. See .

35. Seth P, et al. Quantifying the Epidemic of Prescription Opioid Overdose Deaths. AJPH, April 2018; 108(4):500-2. See

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

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

38. See Resolution 235 at

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

40. Dowell D. Centers for Disease Control and Prevention. Letter to NCCN, ASCO, ASH, February 28, 2019.

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

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

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,%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

46. Dowell D, Haegerich T, Chou R. No Safecuts to Safer Opioid Prescribing. N Engl J Med 2019; 380:2285-2287.

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

48. McGray D. The Bitter Pill. Wired, April 1, 2005. See

49. See

50. See

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52. JAMA. 2019 Sep 4 : e1914523. See

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

54. Anson P. PROP President Discloses Conflicts of Interest. Pain News Network, November 19, 2019. See

55 See

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

58. Anson P. PROP Linked to New Federal Opioid Study. Pain News Network, April 20, 2020.

59. See

60. See

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

63. AMA urges CDC to revise opioid prescribing guideline (Press Release). June 18, 2020. See

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

65. Fudin J. Chronic Opioid Patients Speak Out Against PROP. PainDr, August 12, 2012. See in Comments.

66. See

67. Ross M. Update on the BSC/NCIPC Opioid Workgroup Formation. Board of Scientific Counselors Meeting, July 22, 2020. See

68. See

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

71. Levy N, et al. UK recommendations on opioid stewardship. BMJ 2021 Jan 5;372:m4901. See also

72. Bailey SR. Letter to Physicians for Responsible Opioid Prescribing (PROP). February 19, 2021.

73. Anson P. AMA Scolded for Seeking Changes in CDC Opioid Guideline. Pain Network News, February 17, 2021. See

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 or

75. See screen capture by Carrie Judy at

76. Anson P. Kolodny: Critics of CDC Opioid Guideline ‘Twisting the Facts’. Pain News Network, March 24, 2021. See

77. See, for example

78. Anson P. PROP Linked to New Federal Opioid Study. Pain News Network, April 20, 2020. See

79. Anson P. CDC Won’t Say Who is Writing Update of Opioid Guideline. Pain News Network, April 5, 2021. See

Monday, May 3, 2021 by Pallimed Editor ·

Friday, April 9, 2021

Choosing Palliative Care as a Medical Specialty

by Sylvia Lane (@sylv_lane)

There are few things more introspective than deciding on a specialty in medicine. The decision forces you to analyze what interests and values you hold but also who you are as a person. How do you solve problems? How do you work with others? What brings you joy? As a third-year medical student, I was able to try on many specialties. Rotating through various fields allowed me to soak up knowledge from almost every type of healthcare professional. But this experience comes with a heavy burden of choosing a future career path.

From the beginning, I knew that I was not like most of my fellow medical students. Of course, we all share a special bond dealing with the shared stress of progressing through medical education. But I never felt like my perception of medicine was the same as theirs. I always felt sidelined in discussions, scoffed at as the bleeding-heart empath. As I stepped into my third year of medical school, I was filled with enthusiasm to find people who felt like me. People who view medicine in the way that I do. They must exist, right?

Unfortunately, this was far from my experience. Though each clerkship was a valuable learning opportunity, I continually found something to be missing. Every physician I met was focused on medicine as a cure, while I regularly found myself asking about the impact on the patient’s quality of life and relationships. What will this surgery mean for the patient and their loved ones? How does this treatment impact the patient’s life goals? For me, being a doctor was never about finding a cure. To me, medicine spans not only a patient’s symptoms, diseases, and therapies, but also their family, employment, hobbies, and future. Separating the symptoms from the patient as a human seems impossible to me.

I came to realize that palliative care was the field I had been looking for. I scoured the internet for all the resources I could find. With bright eyes I started to tell everyone: I found my specialty! However, it was not met with the enthusiasm I was expecting. Every time my friends spoke about their specialty of choice, they were received with positivity, warmth, and excitement. But when I started saying, “I want to do palliative care,” I got a different response. Even through their masked faces, I could see shock and discomfort. Most people responded with one word, “oh,” as they completely changed the subject. I was thrilled to find a specialty that seemed exciting to me, but these encounters made me feel like I was somehow wrong.

For weeks, I questioned my choice. Was I missing something? Every person I spoke to seemed to be distressed by my decision. Some teachers I respected told me I was wasting my potential or would ultimately change my mind. Discouraged by the sentiments of those around, I turned to Twitter for support from my medical community near and far. The replies I got were nothing like the responses I had received in person. More than 500 people responded with excitement, positivity, and support. Deciding to pursue a career in palliative care had felt good, but in that exact moment I knew it was right. Finding a community of people like me gave me the courage and strength to stay true to myself. And for that, I will be a better physician.

For more Pallimed posts about (and/or written by) medical students, residents and other learners, click here
For more Pallimed posts by Sylvia Lane, click here. This is her first post, but someday there may be more!
For some ideas on fostering student interest in palliative care see this Pallimed post.

Sylvia Lane is a fourth year medical student at the University of Vermont. Between clinical rotations she spends her time perfecting her baking skills, watching new films, and learning how not to kill all her houseplants.

Friday, April 9, 2021 by Pallimed Editor ·

Tuesday, April 6, 2021

What Is Grief, If Not Love Persevering?: A Palliative Perspective On WandaVision

by SarahScott B. Dietz (@SDietzMD)


In January, WandaVision released on Disney+, promising a weekly serial centered around two romatincally involved and familiar Marvel characters, Wanda Maximoff (aka Scarlet Witch) and Vision. The advertisements showed a black and white, vintage look to the show, and gave few clues as to exactly how it would tie in with the rest of the Marvel Cinematic Universe. Fans were intrigued for many reasons, chief among them being that the last time we saw Vision, he was dead. (CW-Superhero violence/death)

I dove into WandaVision like many fellow geeks: remote in hand, rewinding to scrutinize frames for clues as to what the "Big Story" was, and trying to solve the mystery before they revealed all. My Nick At Nite viewings of My Three Sons and Patty Duke provided ample cultural references for those first few episodes, and my Marvel lore was at least adequate. But where was it all headed?

Somewhere around the third or fourth episode, it hit me like a vibranium baseball bat. WandaVision is a study on grief, loss, and mourning, in layers and layers. I took to Twitter, as one does, noting that colleagues in palliative medicine might want to keep an eye on the show. A friend replied, asking why I would think so.

“It’s Wanda, it’s a giant grief bubble for her. She’s doing this out of grief,” I replied.

"I see it now,” he said, “It’s like superhero complicated grief.”

Complicated grief is what happens when the symptoms of loss and mourning do not begin to subside over time, instead worsening and becoming more intense. People struggling with complicated grief become caught up in their emotional turmoil, and the normal healing process is stalled. They dwell in a world colored by their loss, and may seek out items, locations, or sensations that make them feel proximity to the person they have lost.1

Superhero complicated grief is, in other words, a perfect explanation for trapping an entire town of innocent people in order to build a perfect happy sitcom life with your deceased beloved.

While Wanda is the focus of the story, every character in this series is processing grief stemming from the events in Avengers: Infinity War and Avengers: Endgame, most specifically the “Snap” in which Thanos exterminated half of all life in the universe. Fifty percent of the population disintegrates in place, in front of their helpless loved ones, only to reappear in exactly the same place five years later. In the hospital in Episode 4, we get a window into the chaos, tension, and anxiety in the moments as people return after five years. Is the man shoving his way through the hallway desperate to call his wife because he is just returning, or is he hoping to hear her voice again for the first time in half a decade? A key character, Monica Rambeau is shown reappearing in the same room where she was with her mother 5 years earlier. Only now her mother is not there in the hosptial bed, and Monica finds out that her mother died in the 5 years she had been 'gone.'

In Episode 6, Hayward, a main antagonist, growls at Monica that it was so easy for the ones who vanished, they have no idea how hard it was, how much pain those left behind suffered. Even his pain and, yes, grief, is manifest in that short outburst. (The next bit about Monica not having the stomach to sit with her dying mother, though, that’s just an inexcusable snark.)

Monica’s loss is also heightened by having been disintegrated by the "Snap", and the isolation that she feels as a result. While Monica's mother may have died surrounded by loved ones, Monica was unable to be near her mother, to hold her hand or comfort her in her last moments. Monica has to find her own closure without the benefit of those final good-byes. For too many families, that scenario may hit close to home this year, as COVID-related visitation restrictions have limited our ability to be present with each other, even in times of great need.

In the midst of all the grief processing and mourning on screen, I appreciated the reference to Vision’s advance directives. I found it satisfying that going against his stated wishes not to be re-animated or used as a weapon was presented as proof of serious transgression. It does make me wonder what the contents of an Avenger’s advance directive would look like. Do they have a standard order form? Does it include circumstances in which resurrection would be acceptable?

WandaVision’s executive producer and head writer, Jac Shaeffer, has shared that they set out to build Wanda’s story arc on the stages of grief: denial, anger, bargaining, depression, and finally acceptance. (2) In retrospect, it’s easy to see that progression. Early in the season, Wanda is perky, the problems are light, and she is cheerfully in denial. We see her sink deep into depression, her kids worried about her. Is there anyone who has gone through the grieving process who did not sympathize on some level with the exploding Wanda, energy radiating out away from her in a messy, undirected eruption of frustration and angry sadness?

In the midst of a brutal tour of Wanda’s memories and many losses, it is Vision who crystalizes the essence of our journey: “What is grief, if not love persevering?” To lose someone we have lost does not erase the love we have felt for them, it simply moves the object of our love out of reach. Grief is the space left behind, and it is the work of loving someone who is gone.

One of the most moving moments of the show for me was in the very end, when Wanda and Vision were saying goodbye to their boys, and to each other. There was a genuine sweetness to it, tenderness in a scene that could easily be overwrought. It was the superhero version of a farewell I have seen in my practice, occurring in deeply religious families. It is a mix of emotion found in someone with a deeply held belief that they will surely see their beloved again, someday — certain faith that this will happen, blended with uncertainty of what exactly it might look like, and when. Sadness for the parting, even as they trust it will not be forever.

I am grateful for WandaVision and the conversations it has sparked about grief, loss, and trauma. Marvel being Marvel, we know that even though we have said our farewells this time, we will be able to see these characters again. I can only hope that it will be in a form that is as thought-provoking and enjoyable as WandaVision has been.

For more Pallimed posts about grief.
For more Pallimed posts about culture and media.
For more Pallimed posts by Dr. Dietz click here.

SarahScott B. Dietz, MD practices palliative medicine in western Pennsylvania. She is a life-long geek of many fandoms, and lately has been learning both gardening and how to TikTok.


1 Shear MK. “Grief and mourning gone awry: pathway and course of complicated grief.” Dialogues Clin Neurosci. 2012 Jun;14(2):119-28.

Tuesday, April 6, 2021 by Pallimed Editor ·

Wednesday, March 31, 2021

Advance Care Planning? Meh. - Part 2

by Drew Rosielle (@drosielle)

This is Part 2/2 of a couple posts about advance care planning (ACP). The last post outlined why there are really good reasons to believe that ACP (completion of health care directives and the healthcare conversations that occur around healthcare directive (HCD) completion, implemented on a broad scale) does not lead to any better, patient-centered outcomes, particularly when evaluated as a health intervention to be applied across a population (which is how ACP is typically conceptualized and researched).

In the prior post, I perhaps obnoxiously promised that I thought one of the most important ACP research studies to occur has just been published, although I think it's important for reasons that weren't necessarily intended by its investigators.

The study is in JAMA Internal Medicine and was published a couple months ago.

If you recall from my first post on ACP, one of the challenges with ACP research has been confounding in observational studies. Take an observational study showing that people with HCDs are more likely to have a longer than average hospice length of stay -- that may be true but we don't know why it's true. It could be true because completion of the ACP casually lead to the longer hospice LOS. It could also be true because patients who are inclined towards ACP completion are also inclined towards wanting less 'invasive' EOL care; both of those measurable phenomena stem from underlying personal/social characteristics which presumably emphasize planning, acceptance, surrender, and specific notions of dignity at the EOL which center preferences around being at home (etc) and not being on machines (etc), 'quality over quantity,' what have you.

One of the tricky things about that is that this sort of confounding may even creep its way into ACP randomized trials, because of the possibility that many patients who are skeptical of ACP or otherwise disinclined to engage in ACP-like activities won't even agree to participate in an ACP trial in the first place. Ie, that the current ACP research is enriched with subjects who are already sort of ACP-accepting, because why else would you put yourself into such a study? This seems like a legit problem and one could even wonder if one of the issues with the prior ACP RCT research showing very little in the way of positive patient-centered outcomes is because such research is only investigating pro-ACP patients anyway who are as a group disinclined towards 'invasive' EOL treatments at baseline so it's tough to show any 'benefit' between the group who got an active ACP intervention vs those who didn't.

The JAMA IM study utilized a design to try to mitigate that sort of confounding: they prerandomized subjects before obtaining consent, but still compared the 2 groups on the basis of initial randomization, not whether the patients actually consented and received the intervention (this I learned is called a Zelen design). This is tricky so I'll unpack the Zelen design a bit. The idea is you want to study the effects of a real-world ACP intervention, eg what would be the impact of implementing an ACP program aimed at high-risk patients in a healthcare system, say. If you approach patients about the study to get consent, a whole bunch of patients will decline to participate, for all sorts of reasons, including because some are actively disinclined to do ACP. So those folks never enter the study, and you only study 'pro-ACP' people, and you can't really understand how your intervention would actually affect the entire at risk population. With prerandomization you randomize half the at-risk population to the active group initially, then approach the active group subjects for consent. Within the active treatment group, some will consent to receive the ACP intervention, some won't, but when you analyze the data you compare the entire active treatment group (both those who consented to receive intervention + those who declined it) as a whole vs those randomized to routine care because that mimics the actual effects of your intervention in 'real life.' All this is ethical because all the data essentially comes from administrative health care data and everyone just gets 'routine care' unless they actively agree to the ACP intervention.

The study itself investigated community-dwelling older patients in a 5 county area of North Carolina, and looked at patients only with significant comorbidity/frailty. The ACP intervention was a Respecting Choices ACP program involving a telephone-based nurse-led ACP education visit, followed by the nurse accompanying the patient & a caregiver to a primary care visit where the PCP completed a ACP discussion with prompts to discuss prognosis, disease understanding, unacceptable states at the EOL, and patients' preferred treatment limitations (eg if they wanted a DNR order etc). Providers had an EHR template/platform to document all this. Subjects in the control group received usual care, and their providers had access to the EHR ACP platform but of course no specific actions were taken encouraging/enabling them to use it.

This is a really, really strong study design compared to some ACP trials. I read the methods section and was like 'Damn, they did this one right.' In particular because it used both a nurse-led education intervention plus staged a prognosis/'goals' discussion with a provider.

The primary outcome was new documentation of ACP discussions in the EHR after randomization. They measured a variety of secondary outcomes too including healthcare utilization.

They randomized 765 patients. Of the 379 randomized to the intervention group, about 90 weren't able to be approached for consent to participation (eg they couldn't locate them, etc). Of the 294 approached, 146 consented to the intervention and 139 completed the intervention. Patients had a mean age of 78 years, 60% were women, 17% Black/80% white.

They crushed their primary outcome: 42% of patients randomized to the intervention group had ACP documentation in the chart vs 4% in the usual care group. They collected some data on patient rating about the quality of ACP communication and patients generally rated it very high.

Nothing else though seemed to be different between the groups. About 10% of the entire studied population died in the study (median follow up time of 304 days) and there were no differences in the care they received (as measured in the study: ED visits, hospitalizations, etc).

(In Part 1 post I wondered about studying ACP as a suffering-reducing intervention, and those sorts of outcomes weren't investigated in this study.)

So, top level summary: this was a really well-designed, well-done, RCT of an ACP intervention which showed it did lead to more completion of ACP but did not impact other measured outcomes about the care patients actually received.

The question remains for all of us, though: So what? If you think ACP is intrinsically a patient-good then this is a great outcome. But as I discussed before, there is not any sort of clear evidence from the well-done ACP trials that completing ACP changes things that our patients actually care about: reducing suffering, reducing unwanted/burdensome healthcare interventions at the EOL. This current study is another top-notch, well done, study of a comprehensive ACP intervention which could demonstrate no change in these patients' lives apart from having more ACP documented. Yes, they did not measure every patient-centered outcome they could have, but that is not an argument that we should be treating ACP like some standard of care. Instead, best, it should be an investigational intervention, not ready for widespread implementation. If ACP was some sort of drug or medical device and you did a study aimed at getting more people the medical device, and showed in fact that your well-designed intervention successfully lead to more patients getting the medical device, but nothing else measured about the patient's well-being changed, we'd all be like Ok fine study but why should I do this in the absence of patient benefit? Same with ACP.

So why do I think this study was one of the most important ones in recent memory? Fundamentally, I think it's because this study is the best data yet we have that having done ACP is a good proxy for patients wanting 'less invasive' care at the EOL but doesn't in itself change anything.

This is because of their Zelen design and an incredibly damning (to ACP) exploratory analysis they mention, that compared patients within the randomized-to-being-offered-the-active-intervention group who received the intervention to those who didn't. They found that those patients in the active group who agreed to go through with the ACP interventions had fewer hospitalizations and ED visits than those who declined to. Ie, in the randomized population about half those subjects did not consent to the ACP intervention, and yes those subjects' EOL care looked different from those who consented to receive the ACP intervention. This makes you think maybe the ACP intervention did something. But you need to remember that there was an entire other control group! The people who refused the intervention were not the actual control group! That is, if you compare the entire randomized group to the entire control group (which itself presumably contained an equal measure of ACP-interested and ACP-not interested patients as the randomized group), there were no differences in overall outcomes. Ie, looking at this across the entire population, the ACP intervention made no difference, presumably because the control group itself contained just as many ACP-interested patients as the randomized group. I can't think of any better, available evidence that ACP interventions don't change patient outcomes than this.

All we're doing is capturing a group of patients who weren't going to allow themselves to die in the hospital regardless.

No one is saying that ACP activities don't benefit some patients. I've met some patients myself who have benefitted. But millions of dollars are spent each year getting people to fill out these forms. The opportunity cost of that is gigantic. Imagine, if, 25 years ago, when ACP was really kicking off, people did high quality research which came up short, abandoned ACP, and instead all the resources we've spent on it the last generation were spent on investigating other, better ways to mitigate the suffering of our patients with advanced illness, and provide them with the sort of care they actually want. That's what is at stake here.

For more Pallimed posts about advance care planning.
For more Pallimed posts by Dr. Rosielle click here.

Drew Rosielle, MD is a palliative care physician at the University of Minnesota and M Health Fairview in Minneapolis. He founded Pallimed in 2005. You can occasionally find him on Twitter at @drosielle.

Wednesday, March 31, 2021 by Drew Rosielle MD ·

Monday, March 29, 2021

Advance Care Planning? Meh. - Part 1

by Drew Rosielle (@drosielle)

Several years ago I was giving a talk in front of a mostly palliative care audience and asked, "How often do you find yourself, in the care of your patients, saying to yourself something like 'Thank the stars this patient has a healthcare directive (HCD)'?" The overwhelming answer was a bunch of shrugs and people agreeing occasionally (but not routinely) HCDs are helpful.

For something that seems so central to our work, why is it that so many of my colleagues that day were lukewarm about their utility?

It's fair to say that the last few months have been a controversial one in the hospice and palliative care communities when it comes to ACP, triggered by Dr Sean Morrison's editorial in Journal of Palliative Medicine: Advance Directives/Care Planning: Clear, Simple, and Wrong.

I've been mulling over that editorial for a couple months now and then noticed that, arguably, one of the most important advance care planning (ACP) studies in recent history has just been published, although probably not for the reasons the investigators were hoping for, and I thought I'd write about where we're at a bit for Pallimed.

This post is going to be about my own thoughts as to why I mostly agree with Dr Morrison's editorial. The next post will be about this tantalizingly important paper that was just published.

If you haven't read Dr Morrison's editorial, please read it now--it's not that long and it seems to be open access at the moment. Here's his top-level argument:

As of May 2018, 80 systematic reviews of advance care planning covering >1660 research studies had been published and the National Institutes of Health and the Patient-Centered Outcomes Research Institute had funded >750 research studies at a cost of >$300 million in taxpayer money (an average of $1 million/year). Foundations have spent untold millions. What evidence has all of this research and money wrought? The >1660 studies and 80 systematic reviews on advance directives/care planning have produced only limited and low-quality evidence that advance directives/care planning can actually result in changes in patient, family, clinical, utilization, or financial outcomes. Like the study published in this month's journal, the majority of high-quality research has failed to find a strong link between advance directives/care planning and outcomes of importance. Similarly, despite 30 years of diverse interventions and programs, two-thirds of adults do not have an advance directive (an imperfect yet reasonable surrogate for occurrence of an advance care planning discussion).

I mostly agree with Dr Morrison about this, and will flesh out my thoughts as to why. I need to note that I didn't run any of this by Dr Morrison so any claims I'm making here about what he thinks are my interpretation of his editorial, sort of my own internal conversation with his editorial, and nothing more; I'm not claiming to speak for him. Also--JPM published many letters in response to his editorial, all of which are worth your time reading.

Takes like Dr Morrison's are really controversial (in part) because I think people (clinicians in HAPC), use different definitions of ACP. I sometimes think when people hear stuff like "ACP is not helpful" they think people like Dr Morrison is saying something like "Discussing prognosis and planning for future care with your patients with advanced and serious illnesses is worthless." I.e., this is sort of a 'Big Tent' definition of ACP which includes activities associated with completion of health care directives + really any clinical activity that's in the realm of discussing the future (eg discussions of prognosis, preparing patients for future decisions/what is likely to happen to them in the future, even goals of care discussions). I'm pretty sure though that Dr Morrison and the other detractors of ACP, when they say there's no evidence it actually helps patients, are really talking about the narrow definition of ACP (completion of HCDs and the clinical/healthcare discussions that occur adjacent to HCD patient education and completion), and are not criticizing the idea we should be discussing prognosis / the future with our seriously ill patients.

Also, because I know some of you will be reading this and asking, "But what about Physician Prders for Life-Sustaining Treatments (POLSTs)?"-- for all intents and purposes the following discussion is not really about the POLST movement (which is not to say POLSTs have the sort of evidence behind them we'd like either, but that's another story). All this isn't really about Ariadne's Serious Illness Care project either, and importantly I'll note the Ariadne investigators are doing their best to study their intervention in multiple settings and are not advocating wholesale population wide implementation of their program in the absence of evidence (which is what was done with ACP the last decades).

One could note that there really isn't great evidence for talking with seriously ill patients about prognosis/planning for future care either. That is sort of true, there is some research but not enough and not overwhelmingly convincing (one could look at the recent Ariadne Serious Illness work for some examples of what I mean by sort of true) but honestly I'm less 'worried' about that because as a physician I have a professional obligation to discuss prognosis with my patients. I can't help them make informed care decisions otherwise, and honestly I'm less interested in outcomes research focused on if I should be talking with my patients about the future than how I should be talking with them about the future. I want to learn better/more effective/more compassionate/more accessible/more timely/more culturally- and patient-centered ways of having those conversations, not whether or not I should be having them.

At the same talk I mentioned above, for instance, when people admitted they rarely have found ACPs to be helpful in real clinical practice, I asked people how often are they glad that someone before them had had a realistic discussion with a patient about the future, and everyone indicated that they found this routinely helpful of course.

The same is not true with narrow definition ACP (and from here on out when I say ACP I am only talking about the narrow definition). ACP was adopted as a healthcare innovation really without the sort of scrutiny and demand for proof that it actually helped patients that we'd demand for other innovations like, say, LVADs. The acceptance of ACP as unimpeachably a good, obvious, thing for our patients is so entrenched that people have funded entire careers off of studying how to get people to do ACP, without there being reasonably clear evidence it actually improves patient-centered outcomes.

Much of the ACP research out there is focused on projects/methods to get patients/clinicians to do ACP. I'm not claiming this is bunk research, some of it is really high quality work, however I am claiming that it's high quality work which seems to assume we are benefitting patients by helping them do ACP yet we don't actually yet know that. Importantly here, if you are reading this and thinking to yourself something like I just saw a patient the other day who seemed to benefit in some way from ACP I am not saying you're wrong. I've met that patient too. But, like with anything, acknowledging there are a few patients which benefit from something is very different than concluding something should be a routine, integral part of medicine, implemented widely as a public health intervention, and worth the immense amount of healthcare and research investment of time and dollars spent on it.

I think Dr Morrison's thesis is "ACP is not worth the time/money/effort that has been spent on it as a public health intervention," not "ACP has never helped anyone."

Some ACP research has been about 'congruence,' whether doing ACP activities predicts whether you will later on get the care/treatments you at a prior date said you would want. Especially in the early days of ACP most of the talk was about 'autonomy' and making sure people get what they want, etc. (Indeed, much of the early talk about ACPs was really centered on things like patient rights and autonomy.) There is a moral and philosophical discussion to be had about that topic and whether this is something we should actually be trying to achieve (because patients wishes change over time, and how can patients really make informed decisions about future health states without actually being in such a state, and does it even make sense to ask patients to sort of 'pre-decide' healthcare decisions which on a good day are bleedingly complicated even for cognitively intact and emotionally stable patients). It's an interesting topic, but it doesn't really matter anyway, because there's no high quality research into congruence showing ACP does anything anyway.

To take a couple examples, there is this very well done Australian study from 2010 in the BMJ (the "Melbourne Study") which did a comprehensive ACP intervention in high risk hospitalized older patients. If you read the abstract you'll think that the intervention improved 'congruence' (meaning patients who did the ACP intervention were more likely to get congruent care than those who didn't). If you actually read the study you'll realize that what the intervention group had was better documentation of their wishes so it was easier to 'prove congruence for them (we don't know if the control group had 'congruent' care because their wishes weren't documented) and we don't actually know if the ACP intervention changed any patient care. The 2nd example is the only RCT that I'm aware of the highly revered Respecting Choices ACP model which looks at congruence. This was a RCT of 300 high risk patients (severe heart failure or were on dialysis) who received usual care or the Respecting Choices intervention. This carefully done prospective trial which followed patients long term showed absolutely no improvement in congruence. Think about this one--this wasn't a study of healthy elders, this was a study of people at really high risk of dying (ie the people most likely to benefit from ACP), 300 of them, and yet they couldn't show any difference. It's research like this that Dr Morrison is pointing to I believe when he says ACP has not been shown to benefit patients.

Many of you are probably aware though of all sorts of positive ACP research. People who have HCDs are, compared with those patients who don't have them: more likely to have DNR orders at the end of life, more likely to spend more time enrolled in hospice, less time in ICUs at the end of life, etc. We have a couple decades of research showing this in multiple settings. The problem with this is that nearly all this research which has shown these lovely associations is observational, subject to major confounding. And there is every reason to believe there is huge confounding at play in this sort of research. That is, patients who are open/inclined towards participation in ACP activities are probably more inclined to want 'less intensive' EOL treatments. Think about your own patients, there is a group of them for whom participating in ACP is pretty easy, they want to do it, it's emotional for them but they are committed to it without much encouragement from us, etc. I think there's every reason to believe that the average patient like that is also far more disinclined to want 'invasive' EOL treatments than patients who will not participate in ACP. What this ends up meaning is that having a HCD may just be a proxy for also being disinclined to want 'invasive' EOL treatments, and the actual process of completion of the HCD doesn't impact care one way or the other because these patients already are the folks who are inclined to enroll in hospice earlier, etc. Again, when you do prospective, controlled research, it's much more difficult to show any patient-centered 'benefit' or change in outcomes, apart from the fact that more ACP is documented, even when you are using one of the most highly investigated and validated ACP tools out there, such as in this trial.

I disagree with Dr Morrison on one major point--he seems to be advocating that we wholesale abandon ACP as a clinical and research endeavor. I think there is one domain of patient outcomes which is really under researched, and ACP may really help. This is the possibility that ACP's main benefit to patients/families is essentially a palliative benefit to reduce iatrogenic emotional suffering we in healthcare cause our patients/families due to our decades' long abandonment of our dying patients by forcing them to make decisions they don't want to make. Because we have moved in the last few decades to a situation in which we have decided that desperate, grieving family members are the defacto best people to decide, for instance, if and where tubes should be inserted into their dying family members' bodies, we have caused tremendous suffering, and ACP may be a way of mitigating that suffering. I think this idea has potential and it has increasingly been a subject of investigation in the last decade, which I'm glad to see, although it's still not being investigated routinely. For example the Melbourne Study, while it didn't clearly show any other benefit, did show decreased stress and anxiety symptoms in family members who participated in the ACP process.

This is presumably what Ira Byock meant when he said "I have an advance care directive not because I have a serious illness but because I have a family.” Ira, of course, might be on to something there, and it's been frustrating to me that so few investigators have taken up that outcome as a primary focus of ACP. Admittedly, it's a bit obscene to say it's just iatrogenic suffering here which ACP might mitigate, of course it isn't, and there may be emotional and social benefits outside that--families talking about what's important together, memory and legacy making that can occur adjacent to ACP completion, etc. What I am essentially proposing is that ACP could be studied in a way that's sort of similar to how the Dignity Therapy investigators approach their intervention. ACP is not Dignity Therapy, however I'm arguing it could be investigated as a sort of analogous suffering-reducing, meaning-making intervention.

Importantly, I am not proposing here that we just shift uncritically from saying ACP is good not because it's all about 'honoring'/'respecting' choices (the pre-decisions, autonomy model), or because it reduces unnecessary healthcare costs / keeps people out of ICUs when they are dying, but because it reduces suffering. It's premature to say that. We can't put the cart before the horse. ACP may yet be worthless as a broadly enacted healthcare intervention, and we should continue to consider any benefits hypothetical until proven otherwise

For more Pallimed posts about advance care planning.
For more Pallimed posts by Dr. Rosielle click here.

Drew Rosielle, MD is a palliative care physician at the University of Minnesota & M Health Fairview in Minneapolis. He founded Pallimed in 2005. You can occasionally find him on Twitter at @drosielle.

Monday, March 29, 2021 by Drew Rosielle MD ·

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