In April of 2021, as the country continued to suffer over 100,000 drug overdose deaths a year, the Biden administration announced that to increase access to the medication buprenorphine, which treats opioid addiction, they were removing what they believed to be regulatory “barriers” to the medication. Had they read the scientific literature on the topic, they would have seen that the regulations were never identified as significant obstacles to patients getting care.
Nevertheless, they barreled ahead, confident these regulatory changes were needed “in order to expand access to buprenorphine for opioid use disorder treatment” and would “ultimately help more people find recovery.” They thought deregulation would be the answer, and now the results are back: it’s not.
New data reveals that, despite these regulatory changes, the actual prescribing of buprenorphine didn’t budge. Even more concerning, although the medication needs to be taken for a year or two to really establish recovery, the retention in treatment was found to be a dismal 20 percent by just the six-month mark.
As an addiction psychiatrist and chief medical officer of one of the largest opioid treatment programs systems in the U.S., I’ve dedicated my career to helping people get into, and stay in, recovery. I’ve long been a strong proponent for expanding access to FDA-approved medications for Opioid Use Disorder (OUD), but simply loosening regulations and hoping that more patients will receive treatment is insufficient and insincere. Federal deregulation in any sphere, whether banking, airlines, environmental protections, or health care, rarely comes without significant unintended consequences, and can often make things worse. As we continue to face down an opioid crisis caused by lax oversight and even laxer opioid prescribing by largely well-intentioned healthcare providers, Americans deserve better by our policymakers.
Despite the recent data demonstrating no uptake in buprenorphine utilization, Congress has now set its eyes on another FDA-approved OUD drug, methadone. The Modernizing Opioid Treatment Access Act(MOTAA) introduced by Sen. Ed Markey (D-Mass.) and Rep. Donald Norcross (N.J.) would take a dangerous step and deregulate methadone prescribing for OUD by doing away with the proven methadone models and removing oversight to prevent misuse. While methadone is very effective at treating OUD, it’s also a Schedule II narcotic and deadly when misused.
In the early 2000s, multiple government agencies reported that lax methadone prescribing outside of opioid treatment programs led to thousands of excess deaths. Further, our Canadian colleagues have found that compared to when methadone is provided in an opioid treatment program, pharmacy-based dosing of the type advocated in MOTAA is nearly five times worse at retaining patients in care. MOTAA is thus poised to have no meaningful impact on the number of people in care; it will endanger or cost additional lives, and will worsen the fundamental problem, which is retention in care.
Politics is said to be the “art of the possible” and there is no doubt that making regulatory changes is easy compared to the much harder work of addressing the underlying injustices that lead to addiction and deaths of despair. The American people don’t need legislators to pass feel-good laws that make for good campaign ads but do nothing to help us deal with real problems.
As a doctor, I am trained to make clinical decisions based on science and data. To make addiction policy decisions that sound good in theory and then hope for the best may lead to more suffering. In our haste to end the deadly opioid crisis, we cannot overlook the importance of medication-assisted treatment retention, and we must enact policies that are evidence-based.
Benjamin Nordstrom, M.D., Ph.D., is a board-certified addiction psychiatrist and chief medical officer of Behavior Health Group which operates 116 opioid treatment programs and office-based opioid treatment clinics serving 42,000 patients in 23 states.