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Comments and Suggestions from Pain Specialists Regarding the CDC's Proposed Opioid Guidelines

Guidelines are important tools inmodernmedicine. They are thought to encapsulate the best available, scientifically sound, evidence-based principles on a specific topic in nonmandatory statements that can help shape clinical practice. The methodology for appropriate guideline development is well established. Recent efforts have intensified to create appropriate methodologies in the quest to achieve more uniform and global standards for health care and to refine guidelines so that they are more readily implemented into real-world clinical practice. Thus, it is quite unusual that an organization such as the Centers for Disease Control and Prevention (CDC), which is not known for expertise in pain management or the complex issue of drug abuse, would issue guidelines that seem to flout these conventions. In particular, the guidelines were not developed transparently and questions and discussions were not permitted. The result is a set of guidelines that are well intentioned but lack sufficient rigor and clinical flexibility, andmight have the unintended consequence of unfairly limiting the medical needs of legitimate pain patients. As true of all complex situations, the devil is in the details. On September 16, 2015, the CDC presented an invitation-only webinar (actually the first of 2 identical webinars, as the first was plagued with technical difficulties that affected some but not all listeners) to present its new proposed guidelines for opioid prescribing. From the outset, the venture was rather unusual. While the CDC does issue guidelines, its focus is primarily on infectious diseases and not pain control. The webinar was invitation-only, and no reports were published nor were audio files or slides made available following the event. During the webinar, the organizers took comments, but did not allow questions or discussion. Questions were subsequently permitted by the CDC Committee with public comment allowed through January 13, 2016. The CDC guideline was published in March 2016. In the CDC webinar, it was stated that “low-quality evidence signals uncertainty, not an absence of evidence,” a statement with which most reasonable people can agree. But the webinar presentation added, “Recommendations can be confidently made, and are frequentlymade, with low-quality evidence” and references the Essential Evidence Plus website. However, that website describes its GRADE rating recommendations with respect to low-quality evidence as established by one or more studies with severe limitations and that “Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.” This statement contradicts the assertion made during the CDC webinar that recommendations can be madewith confidence based on low-quality evidence; indeed, the CDC’s own source says that it is not confident in such evidence as it is likely to change as new findings are reported. It should be added that the final publication removed the statement that recommendations can be confidently made with lowquality evidence and disclosed the methodology for the guidelines. It is only by reviewing the body of literature and then rating the evidence that clear and practical clinical guidelines can be formulated. The Food and Drug Administration (FDA) has been active in the development of Risk Evaluation and Mitigation Strategies (REMS) for long-acting opioids, and it is evident that REMS must be reconciled with these proposed CDC guidelines. While prescription pain reliever abuse increased over recent years, the available evidence suggests that long-term opioid therapy for chronic painful conditions is not a major risk for opioid DOI: 10.1111/papr.12475