Drugmaker sues anesthesia journal
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Pacira Biosciences is fighting back against what it's calling “misrepresentation of the clinical effectiveness” of its non-opioid pain reliever Exparel.
Anesthesiology, the official medical journal of the American Society of Anesthesiologists (ASA), published three articles that Pacira claim create the impression Exparel, its post-surgical bupivacaine liposome injectable suspension, is not an effective analgesic. A headline stating “Liposomal Bupivacaine Is Not Superior” to standard local anesthetics was both printed in the journal and published to the website in the February 2021 issue, along with two additional articles that Pacira states “overwhelmingly overlook the positive body of literature that exists for EXPAREL.”
Pacira CEO Dave Stack said in a statement, “We cannot allow this misrepresentation of the clinical effectiveness of EXPAREL to continue to be promoted in the journal and on the website of the American Society of Anesthesiologists, at the risk of confusing stakeholders along the patient care continuum about the value of EXPAREL compared to current treatment modalities. Requests for discussion with the ASA and the editor of Anesthesiology were repeatedly dismissed. This left us with no choice but to take legal action in order to ensure this false and misleading information is not inappropriately cited as an accurate reference in other scientific manuscripts and cannot be used to limit access to patients and providers who require low- and no-opioid care.”
Complaints from Pacira involved the meta-analysis done of the drug, financial and commercial conflicts with journal staff.
According to the lawsuit, “Meta-analyses should only be conducted when the studies included are similar in terms of procedure type, patient population, and outcomes evaluated—this analysis combined a variety of administration techniques which included a variety of off-label uses... for which Pacira does not promote or provide educational support, and employed widely rejected methodologies. When proper methodologies are applied, the results are favorable to EXPAREL.”
In addition to the met-analysis, a paper examining 76 randomized controlled trials determined evidence did not support the use of the drug. There was also an editorial, claiming the drug was not cost effective. Exparel costs about $300 per dose, while the price of generic bupivacaine is around $3 a dose.
This is a drug that was just coming into use when I retired. Obviously, because of the cost, its use was SEVERLY restricted to certain operations (mostly joint replacements). I have zero experience with it.
