Top U.S. addiction researcher calls for broad deregulation of methadone

BOSTON — The U.S. government’s top addiction researcher is calling for broad deregulation of methadone, a key drug used to treat opioid use disorder.

American doctors should “absolutely” be allowed to prescribe methadone directly to patients, Nora Volkow, the director of the National Institute on Drug Abuse, said Wednesday. 

“There’s absolutely no reason why not,” Volkow said. “There are countries where physicians are providing methadone, and the outcomes are actually as good as those they get [at] methadone clinics.” 

Volkow’s comments, which came at the annual STAT Summit, represent perhaps the strongest call yet from a high-profile government official in favor of allowing far broader access to methadone. 

Currently, though, methadone can only be prescribed at specialized methadone clinics known as opioid treatment facilities, or OTPs. Patients are often required to show up at the clinics every morning to receive a single methadone dose and participate in counseling. 

“Methadone is underutilized in part because it requires such stringent conditions in order to be prescribed,” Volkow said. “We have a pretty powerful health structure in the United States, and we should optimize it to maximize access to treatment for people with substance use disorders or other conditions. And that includes methadone.” 

Advocates for expanding methadone access have become more vocal in recent years as the U.S. addiction epidemic has worsened: Currently, 107,000 Americans die of drug overdoses each year. More than 80,000 of those deaths involve opioids. 

Additionally, as the powerful synthetic opioid fentanyl has permeated the U.S. drug supply, physicians have reported challenges using buprenorphine, another medication used to treat opioid addiction, making methadone’s role all the more critical. 

Volkow went further, also advocating for pharmacists to be allowed to dispense methadone to patients in consultation with a physician. 

Despite calls for expanding access, however, the methadone clinic industry has shown strong resistance to making the medication available outside the context of an OTP. Such a move could yield poor treatment outcomes, they’ve warned, and even lead to methadone overdoses — methadone, itself, is an opioid sometimes used to treat pain.  

“There were 5,500 to 6,000 methadone-specific deaths from 1999 to 2015,” Mark Parrino, the CEO of the American Association for the Treatment of Opioid Dependence, the trade group representing methadone clinics, said earlier this month at the group’s annual conference. “We do not want to exacerbate the problem we’ve already got.”   

Roughly 3% of opioid overdoses involve methadone, according to a recent NIDA estimate, though it’s not clear how many of those involved other opioids — and whether, in those cases, methadone was prescribed for pain or addiction, or obtained illegally. 

At the STAT Summit, Volkow also gave her de facto endorsement to the practice of supervised injection — essentially, specialized facilities that allow people who use drugs to do so in the presence of trained health professionals ready to step in and reverse potential overdoses. 

“I am a scientist, and I always deal with data,” Volkow said. But some data is available, she noted, from facilities that have opened in other countries including Canada and Australia. 

“The ones that have done the research have shown that it has saved a significant [percentage of] patients from overdosing,” she said. “Those conditions do document that, in those circumstances, it can save lives.” 

Volkow’s comments come as the Department of Justice, at the direction of President Biden, weighs whether to drop a 2019 lawsuit filed by Trump administration lawyers that would prevent a supervised injection facility in Philadelphia from legally opening.

Some harm-reduction advocates have also called for the federal government to endorse supervised injection sites, but they remain a hot-button political issue — typically among Republicans politicians, but in some progressive strongholds, too. In August, Gov. Gavin Newsom (D) of California vetoed a bill that would have let the state launch a trial network of supervised injection sites, citing potential “unintended consequences.” 

Amid broader calls for rethinking the language Americans use when discussing addiction and drug use, Volkow also re-upped her yearslong push to rename the institute she has run since 2003. “Abuse,” she has said, implies that people with addiction are making active, considered choices each time they use drugs.  

The acronym should remain the same, she argued — but its full title should change to the National Institute of Drugs and Addiction. Upon taking power, the Biden administration also called for the institute’s name to be changed, but such a move requires approval from Congress. 

“I’m very optimistic that they’ll change it,” Volkow said.

STAT’s coverage of chronic health issues is supported by a grant from Bloomberg Philanthropies. Our financial supporters are not involved in any decisions about our journalism.

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