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Manufacturer financial conflicts of interest are associated with favourable outcomes in randomised controlled trials of liposomal bupivacaine

2022; Elsevier BV; Volume: 129; Issue: 4 Linguagem: Inglês

10.1016/j.bja.2022.06.032

1471-6771

Kevin J. Finkel, Edmund T. Takata, Carla L. Maffeo-Mitchell, Jonathan Neal, Matthew Nankin, Barbara H. Braffett, Lauren M. Perillo, Samuel Gammerman, William T. Stuart, Aseel Walker,

Health and Medical Research Impacts

Editor—The ongoing opioid epidemic has highlighted a need for opioid-sparing methods of analgesia. Liposomal bupivacaine (EXPAREL®; Pacira, Parsippany-Troy Hills, NJ, USA) is presented as a non-opioid anaesthetic that provides postsurgical analgesia whilst reducing opioid consumption. However, empirical evidence supporting superior efficacy of liposomal bupivacaine compared with standard bupivacaine is contradictory, 1 Dinges H. Wiesmann T. Otremba B. et al. The analgesic efficacy of liposomal bupivacaine compared with bupivacaine hydrochloride for the prevention of postoperative pain: a systematic review and meta-analysis with trial sequential analysis. Reg Anesth Pain Med. 2021; 46: 490-498 Crossref PubMed Scopus (17) Google Scholar , 2 Abdallah F.W. Hussain N. Brull R. Analgesic efficacy of liposomal bupivacaine for surgical site infiltration: a single-outcome meta-analysis (the best we could do). Reg Anesth Pain Med. 2021; 46: 291-292 Crossref PubMed Scopus (3) Google Scholar , 3 Ma T.-T. Wang Y.-H. Jiang Y.-F. et al. Liposomal bupivacaine versus traditional bupivacaine for pain control after total hip arthroplasty: a meta-analysis. Medicine (Baltimore). 2017; 96e7190 Google Scholar and Pacira's recent legal proceedings raise concerns of the company's influence on the relevant research. In 2020, Pacira paid $3.5 million to resolve allegations that it paid physicians in the form of research grants to incentivise them to prescribe liposomal bupivacaine, 4 Pacira Biosciences, Inc. v. American Society of Anesthesiologists, Inc. n.j. 2, 21 (United States District Court District of New Jersey 2021). https://dockets.justia.com/docket/new-jersey/njdce/2:2021cv09264/469581. Accessed date: November 21, 2021 Google Scholar and in 2021, the company sued the ASA, its journal Anesthesiology, and several authors and editors for defamation. 5 United States Department of Justice, U.S. Attorney’s Office, District of New Jersey. Pharmaceutical company agrees to pay $3.5 million to resolve allegations of violating false claims act. Available from: https://www.justice.gov/usao-nj/pr/pharmaceutical-company-agrees-pay-35-million-resolve-allegations-violating-false-claims (accessed 2 February 2022). Google Scholar