<\/span><\/h3>\nThe authors trace the roots of the current opioid policy landscape back to the early 2000s, a period marked by a growing awareness of undertreated pain and subsequent efforts to improve pain management. This era saw an increase in opioid prescribing, which, while intended to alleviate suffering, also led to rising healthcare costs for insurers, including Medicare and Medicaid.<\/p>\n
Early 2000s:<\/strong> In response to budget constraints, states like Washington began implementing policies to manage prescription drug costs. The Washington State Agency Medical Directors Group (AMDG), which included future members of Physicians for Responsible Opioid Prescribing (PROP), published an influential guideline in 2007 that introduced the concept of strict dosing thresholds for opioid analgesics. While this policy reportedly reduced costs, it has been linked to a significant increase in overdose deaths in the state.<\/p>\n2011:<\/strong> Andrew Kolodny, a prominent figure in the anti-opioid movement, co-authored an article with Roger Chou, announcing the formation of PROP. Kolodny became a vocal proponent of the idea that physician overprescribing was the main driver of the overdose epidemic and addiction crisis.<\/p>\n2012:<\/strong> PROP petitioned the Food and Drug Administration (FDA) to impose a maximum daily dose of 100 morphine milligram equivalents (MME) for opioid analgesics. The FDA rejected this proposal due to a lack of supporting data.<\/p>\n2015-2016:<\/strong> During the development of the CDC’s 2016 Guideline, concerns were raised about the undue influence of PROP. The Washington Legal Foundation alleged that a PROP member served as a paid consultant to a law firm involved in multi-district litigation against opioid manufacturers. These concerns led to an extended public comment period for the draft guideline. Despite these transparency issues and conflict of interest allegations, the CDC published its 2016 Guideline.<\/p>\n2016-2019:<\/strong> The misapplication of the 2016 Guideline began to manifest as serious patient harms, including diminished access to pain relief and forced opioid tapers. This prompted criticism from various medical organizations, including the American Medical Association (AMA), and even led to public acknowledgments from the Guideline’s co-authors in 2019 that its "inflexible application" was causing harm. The FDA also issued safety warnings against abrupt opioid discontinuation.<\/p>\n2019-2022:<\/strong> The U.S. Department of Health and Human Services (HHS) initiated efforts to reassess pain management best practices, but these efforts faced resistance from groups like the National Association of Attorneys General (NAAG) and PROP, who advocated for adherence to the principles of the 2016 Guideline. Concurrently, the CDC began the process of updating its guideline, leading to the 2022 Draft Guideline.<\/p>\n<\/span>Unveiling the Undisclosed: A Deep Dive into Conflicts of Interest<\/span><\/h3>\nThe core of the Pallimed article lies in its rigorous examination of undisclosed conflicts of interest among physicians who publicly advocated for reduced opioid prescribing through PROP and related activities before their involvement in the CDC’s guideline development. The study employed a qualitative approach, scrutinizing journal articles authored by these physicians between September 1, 2015, and June 30, 2022, to identify any omitted disclosures of financial or intellectual COIs.<\/p>\n
The researchers defined "conflict of interest" according to the CDC’s own criteria used for the 2016 Guideline, which included financial relationships, intellectual preconceptions, and previously stated public positions that could unduly influence professional judgment. They found a striking 72% rate of non-disclosure or omission of COIs across 87 "qualifying policy articles" (QPAs) authored by the study group physicians.<\/p>\n
Key Findings from the Analysis:<\/strong><\/p>\n\nPervasive Non-Disclosure:<\/strong> Sixty-three out of 87 QPAs (72%) failed to disclose relevant conflicts of interest as defined by the 2016 Guideline’s own standards.<\/li>\nIndividual Patterns of Omission:<\/strong> Three physicians in the study group omitted relevant COIs in all their QPAs, and one physician failed to disclose COIs in 84% of her publications. Only one physician fully disclosed all COIs in more than half of his QPAs.<\/li>\nFinancial and Intellectual Conflicts:<\/strong> The analysis revealed that four out of six physicians (67%) omitted or failed to disclose both financial and intellectual (non-financial) COIs. Two physicians had only intellectual COIs, but these were significant and pre-existing at the time of their selection for the 2016 Guideline creation group.<\/li>\nDr. Roger Chou’s Conflicts:<\/strong> Dr. Roger Chou, a co-author of both the 2016 and 2022 Draft Guidelines, failed to disclose disqualifying financial and intellectual conflicts at the time of their authorship. Specifically, he did not disclose pending funding from the Agency for Healthcare Research and Quality (AHRQ) for writing systemic reviews on opioid prescribing, even though the grant award was announced after the publication of the 2016 Guideline. This funding, along with support from the CDC Foundation, came from Group Health, which had supported Chou’s reviews.<\/li>\nJane Ballantyne’s Undisclosed Work:<\/strong> Jane Ballantyne, a PROP colleague and frequent co-author of Dr. Sullivan, failed to report her opioid litigation expert witness work as a COI in articles about opioid tapering policies published in a medical journal where she serves as an editor. Despite being notified, the journal has not yet published a correction.<\/li>\nAndrew Kolodny’s Advocacy and Disclosures:<\/strong> Andrew Kolodny, while now disclosing COIs from his PROP membership and expert witness work in more recent publications, previously failed to disclose relevant conflicts. His continued aggressive advocacy, despite these disclosures, raises questions about their impact on his influence.<\/li>\n<\/ul>\n<\/span>The Broader Implications: Undermining Trust and Harming Patients<\/span><\/h3>\nThe authors argue that the pervasive non-disclosure of COIs fundamentally undermines the integrity and credibility of both the 2016 Guideline and the subsequent 2022 Draft Guideline. They assert that the CDC itself has violated its own ethical guidelines and principles by allowing PROP members and their allies to significantly influence the creation of these pivotal documents.<\/p>\n
The "false narrative" of physician overprescribing, propagated by these advocates, is presented as a key mechanism that fueled a "moral panic." This panic, characterized by lowered evidentiary standards and intolerance towards certain groups, effectively pressured policymakers to adopt flawed opioid policies. These policies, the authors contend, have not only failed to curb overdose deaths but have actively contributed to them by leading to the harmful, involuntary tapering of opioid medications for patients with chronic pain.<\/p>\nThe financial incentives at play are also highlighted. The article suggests that the push for reduced prescribing directly benefits health insurers by lowering medication costs. Furthermore, the 2016 Guideline has been weaponized in multi-district litigation (MDL) against opioid manufacturers, with plaintiff experts, including some from the study group, potentially earning substantial sums from these lawsuits. Awards from these settlements have already reached over $36 billion, with more litigation pending, indicating a significant financial ecosystem built around the opioid crisis narrative.<\/p>\n
<\/span>A Call for Reform and Accountability<\/span><\/h3>\nThe authors conclude with a series of strong recommendations aimed at rectifying the harms caused by the flawed guidelines and preventing future policy missteps:<\/p>\n
\nAbolish Hard Dosing Thresholds:<\/strong> The 2022 Draft Guideline must eliminate rigid dosing thresholds, which have been misapplied as mandatory policies across the country, leading to involuntary opioid tapers and patient suffering.<\/li>\nDenounce the False Narrative:<\/strong> The CDC must unequivocally reject the notion that physician overprescribing is the primary driver of the current opioid crisis, acknowledging that the epidemic is largely fueled by illicit substances and counterfeit drugs.<\/li>\nRestore Policy Balance:<\/strong> Policymakers need to address the imbalance between public health goals and individual patient autonomy, recognizing physicians’ fiduciary duty to act in their patients’ best interests. An ethics-based, education-focused informed consent process is proposed to empower patients in treatment decisions.<\/li>\nEnhance Journal Vigilance:<\/strong> Medical journals are urged to be more rigorous in identifying and publicizing authors’ financial and intellectual COIs, holding editors accountable for overlooking relevant competing interests.<\/li>\nConvene Congressional Hearings:<\/strong> If these recommendations are not heeded, the authors call for a U.S. House Committee on Oversight and Government Reform hearing to scrutinize the CDC’s adherence to the Federal Advisory Committee Act and its internal ethical rules. Alternatively, they suggest a Department of Justice investigation into potential violations of these rules.<\/li>\n<\/ul>\nThe article is dedicated to the memory of Dr. Terri Lewis, a colleague and advocate for patients with disabilities and chronic pain. The authors, Dr. Kollas (Medical Director for Palliative and Supportive Care at Orlando Health Cancer Institute), Beverly Schechtman (patient advocate and Vice-president of The Doctor Patient Forum), and Carrie Judy (unpaid contributor and researcher at The Doctor Patient Forum), aim to shed light on a complex issue with profound implications for patient care and public health policy. Their work serves as a critical examination of how conflicts of interest and a potentially manipulated narrative can lead to policies that inflict harm rather than alleviate suffering.<\/p>\n","protected":false},"excerpt":{"rendered":"
In a significant development that casts a shadow over the integrity of national opioid policy, a recent analysis by Chad D. Kollas, MD, Beverly Schechtman, and Carrie Judy has uncovered a pervasive pattern of undisclosed conflicts of interest (COIs) among key physicians involved in the creation of the Centers for Disease Control and Prevention (CDC) …<\/p>\n","protected":false},"author":1,"featured_media":5167,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[90],"tags":[94,225,228,93,329,231,92,330,226,229,91,227,230,224],"newstopic":[],"class_list":["post-5168","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-palliative-hospice-care","tag-comfort-care","tag-conflicts","tag-creating","tag-end-of-life","tag-faith","tag-guidelines","tag-hospice-care","tag-incompetence","tag-interest","tag-opioid","tag-palliative-care","tag-physicians","tag-prescribing","tag-undisclosed"],"_links":{"self":[{"href":"https:\/\/homecares.net\/index.php?rest_route=\/wp\/v2\/posts\/5168","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/homecares.net\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/homecares.net\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/homecares.net\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/homecares.net\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=5168"}],"version-history":[{"count":0,"href":"https:\/\/homecares.net\/index.php?rest_route=\/wp\/v2\/posts\/5168\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/homecares.net\/index.php?rest_route=\/wp\/v2\/media\/5167"}],"wp:attachment":[{"href":"https:\/\/homecares.net\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=5168"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/homecares.net\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=5168"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/homecares.net\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=5168"},{"taxonomy":"newstopic","embeddable":true,"href":"https:\/\/homecares.net\/index.php?rest_route=%2Fwp%2Fv2%2Fnewstopic&post=5168"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}