Jacob James Rich

In their commentary, “Long-Term Opioid Therapy for Pain What Is Known About Harms—and Still Not Known About Benefits,” Bicket and Bateman bemoan the recent Food and Drug Administration (FDA) decision on opioid labeling (1). While both participated in the meeting upon which FDA made its decision (2), they mischaracterize “the clearest picture to date of long-term risk,” inappropriately using the broadest definition of Opioid Use Disorder (OUD), rather than citing the prevalence of opioid addiction determined by the FDA, which represented the agency’s original task (1, 2). During the hearing, Bicket inquired about measuring “moderate-to-severe OUD and its relationship to abuse,” to which Dr. Jana McAninch of FDA's Office of Surveillance and Epidemiology replied, “The primary definition of moderate-to-severe opioid use disorder was a way to operationalize the outcome of addiction,” which FDA post-marketing report (PMR) 3033-1 estimated to be only about 1.5% when adjusted for the presence of pain (2). Citing the misuse figure seems more disingenuous when realizing that Bicket failed to disclose a conflict of interest for receiving personal fees from a company that provides academic detailing on prescription medications (1, 2, 3). JAMA’s limitations for editorial replies preclude a comprehensive response to other flaws in the commentary, but key points demand rebuttal. Bicket and Bateman repeat the hackneyed call for more “robust” research about the benefits of long-term opioid therapy (LTOT), ignoring many well-designed studies that have offered evidence of LTOT’s effectiveness and safety. Two significant examples employ methodologies that avoid the prohibitive ethical problem of depriving a control group from the benefits of a therapeutic intervention while participating in a long-term, randomized controlled trial (4, 5). In a cohort study of palliative care outpatients receiving LTOT over the course of four years, participants maintained 5-point reductions in pain intensity on a 10-point scale, maintained performance status despite serious illness and experienced reductions in overall overdose risk (4). An examination of a large FDA dataset showed “about one-third of patients successfully titrated on opioids to treat chronic noncancer pain demonstrated continued benefit for up to 12 months (5).” This evidence suggests patients with high-impact chronic pain or severe pain associated serious illness can receive safe and effective pain relief from LTOT and demonstrate clear benefits (4,5). Instead of satisfying Bicket’s and Bateman’s insincere call for more research on opioid benefits, a comprehensive comparison “weighing the harms of continuation of therapy against the harms of discontinuation of therapy when caring for patients on long-term opioid therapy (6)” is long overdue and would offer a better opportunity for achieving balanced opioid policy. “Rather than prioritizing benefit, which is often subjective and more susceptible to discordance between the patient and provider,” opioid policymakers should “evaluate whether the projected harms of continuing opioids outweigh the projected harms of tapering or discontinuing opioids for [a] particular patient (6).” For too long, disingenuous tropes like that offered from Bicket and Bateman have dominated debates about LTOT; our patients deserve a more thoughtful approach to opioid policy. References: 1. Bicket MC, Bateman BT. Long-Term Opioid Therapy for Pain: What Is Known About Harms-and Still Not Known About Benefits. JAMA. 2025 Aug 27. doi: 10.1001/jama.2025.13225. Epub ahead of print. PMID: 40864437. 2. U.S. Food and Drug Administration (FDA). Joint Meeting of the Drug Safety and Risk Management Advisory Committee (DSaRM) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC). May 5, 2025. Available at: youtube.com/watch?v=o3nyj1rD…. Last accessed on September 2, 2025. 3. Agniel D, Brat GA, Marwaha JS, Fox K, Knecht D, Paz HL, Bicket MC, Yorkgitis B, Palmer N, Kohane I. Association of Postsurgical Opioid Refills for Patients With Risk of Opioid Misuse and Chronic Opioid Use Among Family Members. JAMA Netw Open. 2022 Jul 1;5(7):e2221316. doi: 10.1001/jamanetworkopen.2022.21316. PMID: 35838671; PMCID: PMC9287751. 4. Kollas CD, Ruiz K, Laughlin A. Effectiveness of Long-Term Opioid Therapy for Chronic Pain in an Outpatient Palliative Medicine Clinic. J Palliat Med. 2024 Jan;27(1):31-38. doi: 10.1089/jpm.2023.0251. Epub 2023 Aug 8. PMID: 37552851; PMCID: PMC10790545. 5. Farrar JT, Bilker WB, Cochetti PT, Argoff CE, Haythornthwaite J, Katz NP, Gilron I. Evaluating the stability of opioid efficacy over 12 months in patients with chronic noncancer pain who initially demonstrate benefit from extended release oxycodone or hydrocodone: harmonization of Food and Drug Administration patient-level drug safety study data. Pain. 2022 Jan 1;163(1):47-57. doi: 10.1097/j.pain.0000000000002331. PMID: 34261978; PMCID: PMC8675053. 6. Lagisetty P, Kertesz S. Harms Versus Harms: Rethinking Treatment for Patients on Long-Term Opioids. Subst Abus. 2023 Jul;44(3):112-114. doi: 10.1177/08897077231190697. Epub 2023 Sep 22. PMID: 37737138.