A ‘miracle molecule’ could cut fentanyl deaths in half — or lead more into addiction

America’s sky-high rate of fatal fentanyl overdoses could be halved if users were treated with another opioid, Biden administration officials and a bipartisan group of senators believe.

They and others who support expanded access to methadone argue that allowing addiction specialists to prescribe it outside of the clinics now permitted to dispense it would save tens of thousands of lives.

“We are in a desperate situation right now where the risks of expanding methadone are so outweighed by the benefits of having more people on methadone,” said Noa Krawczyk, a professor at NYU Grossman School of Medicine who studies barriers to drug treatment and supports the administration’s push.

But the proposal faces opposition from the health care providers with the most intimate knowledge of methadone treatment: methadone clinic directors. They tell POLITICO that allowing prescribing outside of clinics is risky without their strict safeguards. Methadone is an addictive opioid that’s deadly if abused.

“The idea that a physician in private practice without support staff … that they're going to be able to treat a complex medical problem like the use of fentanyl, is just not substantiated,” said Mark Parrino, president of the American Association for the Treatment of Opioid Dependence, which represents methadone clinics.

The disagreement over how to proceed comes as fatal overdoses climbed more than 50 percent during the pandemic before declining slightly in the year ending in March to 103,451. And while proponents of making methadone easier to get say that toll is ample reason to rethink treatment rules that are now decades old, the clinics fear it’s a bad idea that could make the overdose problem worse. Thus far, they’re winning the debate in the only forum that matters: Congress.

A bill by an unlikely Senate duo, Ed Markey (D-Mass.) and Rand Paul (R-Ky.), to expand methadone access is languishing despite a bipartisan vote in a key committee and a strong push from National Institute on Drug Abuse Director Nora Volkow. Volkow has said universal access to methadone and similar drugs could bring down fentanyl deaths by 50 percent.

The legislation would reshape not only how methadone is prescribed but also dispensed — patients could pick up their prescription at the pharmacy. Now, most have to go in person every day to a clinic to receive their dose under supervision. That makes it hard to stick to the treatment, patients and bill proponents say, because clinics are often far from where patients live.

But the clinics have succeeded in convincing enough Republicans that expanded access comes with significant risks. Parrino said the proponents of the change are putting too much faith in methadone alone, without considering the support services the clinics provide to help patients.

Lawmakers sensitive to the clinics' arguments, such as Sen. Ted Budd (R-N.C.), also point to the bleak history of the opioid epidemic — fueled as it was by corrupt doctors and pharmacies that handed out OxyContin like candy. Easing access to methadone, they say, risks a repeat.

“Removing diversion-control mechanisms and wrap-around services would cause further abuse and trafficking of methadone, which would perpetuate the opioid crisis instead of solving it,” said Budd.

Advocates of broader prescribing say the clinics are more interested in protecting their turf than in saving lives, and that lawmakers who oppose the change are too risk averse at a time when the current system is not working. They point to studies that say 3 in 4 people who could benefit from methadone, or similar drugs, aren’t getting them.

“If we don't do it, more people are going to die than is necessary,” said Markey.

He said his legislation is also part of a push to change America’s approach to drug use, from criminalizing it to treating it as a health care issue.

“We’re still suffering from the legacy of the Nixon years,” Markey said, referring to the Republican president’s tough approach, which he said stigmatized drug users and created a negative perception of treatment.

The case for methadone

The past year brought a glimmer of hope that fatal overdoses might have finally reached a peak, with provisional data from the Centers for Disease Control and Prevention showing a 7.5 percent decrease in the year ending in March — albeit still well above the 70,000 or so dying when the pandemic began.

The proponents of pharmacy distribution of methadone, which include the American Society of Addiction Medicine, reject the charge that the change would mean abandoning holistic care. They argue expanded access to methadone would help more people stay in treatment, increasing the likelihood of long-term recovery.

“This is why we're still in an overdose crisis: We haven't really built a system to ensure that patients don't drop off of care prematurely,” said Dr. Brian Hurley, an addiction physician in charge of substance abuse prevention and control at the Los Angeles County Department of Public Health and the president of ASAM.

Besides methadone, there are other drugs people can use for opioid use disorder: buprenorphine, often in combination with naloxone and naltrexone. Because their potential for abuse is either low or nonexistent, many doctors can prescribe them, and they can be picked up at a pharmacy.

But they don’t work as well for people addicted to fentanyl, an opioid 50 times stronger than heroin. Methadone’s effectiveness has led some doctors and patients to call it “the miracle molecule.”

But the restrictions governing access to it have prompted another nickname, “liquid handcuffs,” given the need to show up in person to get it.

Some methadone clinic patients see the restrictions as a method of shaming them.

“It’s a culture of cruelty based on a probation model,” said Nick Voyles, who has taken methadone for years and is the executive director of the Indiana Recovery Alliance.

The access debate

There are about 2,100 methadone clinics across the country, treating about 650,000 patients daily.

While it’s unclear how many more people could benefit from expanded access to the drug, a 2023 study estimated that the Senate bill would make methadone available in 63 percent of U.S. census areas compared with 49 percent now.

The study also estimated that some 192,000 overdose deaths occurred in the past decade in counties where a clinic was more than a 30-minute drive and that some 70,000 lives could have been saved if the law expanding prescribing had been in place.

“Our results suggest rural communities stand to benefit the most,” said Dr. Paul Joudrey, one of the researchers and an assistant professor at the University of Pittsburgh School of Medicine.

The Substance Abuse and Mental Health Services Administration changed the rules for methadone prescribing this spring to allow physicians in methadone clinics more flexibility to decide when to give their patients a supply of methadone to take at home. The previous rules required clinicians to consider the amount of time a person had been in treatment and proof that the person was completely abstinent from illicit substances.

The change made permanent eased rules put in place during the pandemic, when people couldn’t come to clinics every day due to lockdowns and social distancing requirements. The relaxed rules weren’t associated with measurable increased harms , according to a study by researchers at Columbia University, NYU Grossman School of Medicine and the New York State Psychiatric Institute.

But it’s up to each state to decide whether to adopt the new rules or maintain stricter controls over who gets methadone doses at home and for how long.

Markey estimates his bill would allow some 7,000 addiction specialists to prescribe methadone outside of clinics.

To prevent diversion to the illicit market, only physicians who are board certified in addiction medicine and registered with the Drug Enforcement Administration, an arm of the Department of Justice that polices access to addictive drugs, would be able to prescribe. Doctors who qualify would have to follow the same SAMHSA rules for take-home doses of methadone as clinics. Finally, states could opt out of registering physicians to prescribe methadone.

But Parrino doesn’t trust the prescribing would be limited to specialized doctors. “Ultimately, the bill is sort of a Trojan horse for doctors prescribing methadone out of their practices,” he said.

A hard sell

Physicians prescribing methadone need to find the right dose for each patient fast so the patient doesn’t experience withdrawal, which often prompts them to drop treatment.

Often, patients using fentanyl need higher doses of methadone than those using other opioids, Parrino said.

It can then take years for people to recover, which SAMHSA defines as being healthier, feeling better, living self-directed lives and striving to reach one’s full potential.

The reality of opioid use disorder is that, for many, there is no cure, experts in the condition say. Rather, it’s a chronic condition needing lifelong medication and management.

Many of those who start methadone treatment drop out within the first year. Only 34 percent of a sample of 39,000 patients at BayMark Health Services, one of the nation’s largest methadone treatment providers, were still in treatment one year after they started, said Jason Kletter, the company’s president.

Ending treatment early increases people’s risk of fatal overdose, researchers and physicians say. Expanding prescribing and dispensing of methadone would give people more options to stay in treatment, said the American Society of Addiction Medicine’s Hurley.

“No one asks: ‘When is my diabetes cured?’ Or: ‘How long will I need to be on this blood pressure medication?’ Hurley said of how long people with opioid use disorder need treatment.

Medication should be the core component of that treatment, he added.

But on Capitol Hill, many in key positions still aren’t convinced.

Kentucky Rep. Brett Guthrie , a Republican who chairs the Energy and Commerce Health Subcommittee through which any House bill would have to go, said he viewed methadone as one option for those fighting opioid addiction, alongside 12-step methods like that of Alcoholics Anonymous, faith-based support and willpower to stop using.

He said he was skeptical of expanding access to methadone in the way proposed by Sens. Markey and Paul. “We have to make sure the right safeguards are in place,” he said.