In April 2021, as the country continued to suffer more than 100,000 drug overdose deaths annually, the Biden administration announced that to increase access to the drug buprenorphine, which treats opioid addiction, they were removing those that they believed to be regulatory “barriers” to the drug. Had they read the scientific literature on the subject, they would have seen that regulations have never been identified as significant barriers to patient care.
However, they moved forward, confident that these regulatory changes were needed “to expand access to buprenorphine for the treatment of opioid use disorder” and that they “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 has not changed. More worryingly, although the drug needs to be taken for a year or two to really establish recovery, treatment retention was found to be a dismal 20 percent after just six months.
As an addiction psychiatrist and medical director of one of the largest opioid treatment program systems in the United States, I have dedicated my career to helping people enter and stay in recovery. I’ve long been a strong advocate of expanding access to FDA-approved drugs for opioid use disorder (OUD), but simply relaxing regulations and hoping more patients get treatment is insufficient and insincere. Federal deregulation in any area, whether it be banking, airlines, environmental protections or healthcare, rarely comes without significant unintended consequences and can often make matters worse. As we continue to grapple with an opioid crisis caused by lax oversight and even more lax opioid prescribing by largely well-meaning health professionals, Americans deserve better from our politicians.
Despite recent data showing no use of buprenorphine, Congress has now set its sights 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 (NJ) would take a dangerous step and deregulate methadone prescribing for OUD by eliminating proven methadone models and removing check to avoid abuse. While methadone is very effective in treating OUD, it is also a Schedule II narcotic and deadly if misused.
In the early 2000s, several government agencies reported that lax methadone prescribing outside opioid treatment programs led to thousands of excess deaths. Additionally, our Canadian colleagues found that compared to when methadone is provided in an opioid treatment program, pharmacy dosing of the type advocated in the MOTAA is nearly five times worse at retaining patients in treatment. MOTAA is therefore poised to have no significant impact on the number of people in care; it will endanger or cost additional lives and exacerbate the fundamental problem, which is maintaining 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 death out of despair. The American people don’t need lawmakers to pass beneficial laws that create good advertisements but do nothing to help us address the real problems.
As a physician, I am trained to make science- and data-based clinical decisions. Making addiction policy decisions that sound good in theory and then hoping for the best can lead to more suffering. In our rush to end the deadly opioid crisis, we cannot overlook the importance of maintaining drug-assisted treatment and must implement evidence-based policies.
Benjamin Nordstrom, MD, Ph.D., is a board-certified addiction psychiatrist and medical director of the Behavior Health Group which manages 116 opioid treatment programs and office opioid treatment clinics serving 42,000 patients in 23 States.
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