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Printable Version
A2044
October 04, 2020
10/4/2020 3:00:00 PM - 10/4/2020 4:00:00 PM
Room Virtual
Systematic Review Of Reported Financial Conflicts Of Interest In Exparel(sacrrifice) Trials
Carla Maffeo-Mitchell, M.D., Jonathan B. Neal, M.D., Matthew Nankin, MS, Lauren Clement, D.O., Samuel Gammerman, M.D., William T. Stuart, M.D., Barbara Braffett, Ph.D., Aseel Walker, M.D., Kevin Finkel, M.D.
Integrated Anesthesia Associates, Glastonbury, Connecticut, United States
Disclosures: C. Maffeo-Mitchell: None. J.B. Neal: None. M. Nankin: None. L. Clement: None. S. Gammerman: None. W.T. Stuart: None. B. Braffett: None. A. Walker: None. K. Finkel: None.
IntroductionSince becoming commercially available in 2012, liposomal bupivacaine (Exparel®), manufactured by Pacira BioSciences, Inc. (previously Pacira Pharmaceuticals, Inc.), has been presented as a non-opioid, long-lasting injectable suspension for postsurgical pain. Based on clinical trial data supporting decreased pain and opioid consumption with various procedures, Exparel® has gained FDA approval for infiltration and interscalene nerve block (1). Although clinical trials of Exparel® have demonstrated potential benefits, the role of industry financial relationships with study investigators remains inadequately described. A report issued by the Institute of Medicine (IOM) describes an association with the publication of industry-favorable research findings (2). In the present study, we conduct a systematic review examining the prevalence and nature of financial conflict of interest (FCOI) disclosures, whether monetary or other royalties, mentioning Pacira BioSciences, Inc. in clinical trials of liposomal bupivacaine. In addition, we evaluate whether there is any association between disclosed FCOIs relating to Pacira BioSciences, Inc and the report of positive outcomes with regard to improved pain control and decreased opioid consumption in those receiving liposomal bupivacaine.

MethodsA PRISMA-guided systematic review was designed to identify randomized controlled clinical trials with a liposomal bupivacaine study arm published prior to January 1, 2020. A search of PubMed, Ovid MEDLINE(R), and Scopus was conducted on April 14, 2020 using the search terms “(liposomal bupivacaine OR Exparel) AND (random* OR placebo OR controlled trial OR controlled clinical trial).” Inclusion criteria were: studies administering liposomal bupivacaine as an intervention, adult participants, and randomized controlled clinical trials. Each article was randomly assigned to two independent study investigators for both screening and data abstraction. Disagreements were resolved by a third reviewer.

ResultsA total of 194 abstracts were screened by study investigators, and of these, 74 met inclusion criteria. A preliminary analysis of reported FCOI forms demonstrated that 30/74 (41%) articles specified financial disclosure relating to Pacira BioSciences, Inc. Author-specific FCOI disclosures were variable, and included being a paid employee or working as a paid consultant for Pacira BioSciences, Inc. In addition, Pacira BioSciences, Inc. provided direct research funding for 22/74 (30%) studies and editorial support for 11/74 (15%) studies. Of the 30 studies reporting any type of FCOI disclosure relating to Pacira BioSciences, Inc. 23/30 (77%) reported at least one positive outcome, as compared to 21/44 (48%) without any pertinent disclosure (p=0.0128). All 11 studies that had editorial support from Pacira demonstrated a superior outcome (vs. 52% with no editorial support, p=0.0030). In addition, 17/22 (77%) of studies that had funding support from Pacira demonstrated a superior outcome (vs. 52% with no funding support, p=0.0423).

ConclusionLiposomal bupivacaine had significantly more favorable outcomes in trials where competing financial interests were declared. When examining peer-reviewed clinical trial results, readers should be aware of these associated FCOI disclosures and the potential implications for published study findings and integrity. The high prevalence of industry conflicts identified in this study highlights the need for accessible, independent research funding to support high-quality clinical trials.

References1.https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022496s9lbl.pdf2. IOM. 2009. Conflict of Interest in Med Research, Education, & Practice. Washington, DC.

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