The University of Minnesota Medical Center is scaling back its controversial use of a post-surgery painkiller — a drug championed by an anesthesiologist who has received hundreds of thousands of dollars from its manufacturer.
Nurses received a memo this summer that the medical center was restricting its use of Exparel, citing a lack of published research to justify broad use of the injectable anesthetic. The memo stated "there was inadequate literature to support [Exparel's] use in the majority of the surgical population."
The announcement is a departure for the medical center under Dr. Jacob Hutchins, a medical director of the university's acute pain service. He not only encouraged the use of Exparel in "off-label" ways that the U.S. Food and Drug Administration hadn't approved, but at one point in a way the federal agency rejected.
Hutchins has received $800,298 from Exparel's manufacturer, Pacira Pharmaceuticals, since 2013, according to federal records, mostly to travel and speak on the company's behalf at advisory meetings and conferences. He has fully disclosed the relationship to U officials and patients, and defended the arrangement as a way of improving the practice of pain control.
Hutchins' advocacy was based on an enticing premise — that Exparel could reduce reliance on addictive opioid painkillers that have led to a wave of overdose deaths across the nation.
In an e-mail Friday, Hutchins said the change by Fairview Health, which operates the university hospital, doesn't mean that Exparel has failed, just that research hasn't proved its broader uses yet.
"Absence of data does not mean absence of effect," he wrote. "The use of this medication has resulted in a significant decrease in opioid use for our patients in all procedures where it was being used."
The FDA has taken a cautious approach, first approving Exparel in 2011 for direct injection, or infiltration, into surgical sites for post-procedure pain relief. The agency in 2015 rejected Exparel for nerve blocks, injections higher up the nervous system from surgical sites that produce broader and longer pain relief. In 2018, the FDA reversed course and approved nerve blocks, but only for shoulder surgeries.