The U.S. should rethink its entire approach to painkillers and the people addicted to them, panel urges

To reverse a still-spiraling American crisis fueled by prescription narcotic drugs, a panel of experts advising the federal government has recommended sweeping changes in the ways that physicians treat pain, their patients cope with pain, and government and private insurers support the care of people living with chronic pain.

In a comprehensive report on what must be done to staunch the toll of opiates in the United States, a panel of the National Academies of Science, Engineering and Medicine makes clear that steps needed to prevent the creation of future opiate addicts will drive some people who are now dependent on these medications toward street drugs such as fentanyl and heroin.

“It is therefore ethically imperative to couple a strategy for reducing lawful access to opioids with an investment in treatment for the millions of individuals” already hooked on the painkillers, the panel wrote.

Even as lawmakers in Washington debate a healthcare bill expected to reduce access to addiction treatment, the expert panel called on states and the federal government to provide “universal access” to such treatment in hospitals, community-based programs, jails and prisons.

To reduce harms to opioid users who have turned to the streets for their supply, the panel also urged states to buck a current trend of getting tough on illicit drug use. Instead of escalating criminal penalties for drug-related behaviors, the panel said states should adopt practices — including needle exchanges, safe havens for injection-drug users, and broadened access to the opioid-reversal agent naloxone — that reduce overdose deaths and prevent the spread of disease.

A Philadelphia police officer holds a package of the overdose reversal agent naloxone hydrochloride, which is sold under the brand name Narcan. A new report urges "universal access" to addiction treatment. (Dominick Reuter / AFP / Getty Images)

In 2015, some 2 million Americans were thought to be abusing prescription narcotics. Another 600,000 were using heroin, the majority of them onetime prescription opiate users. The report cites research suggesting that, among patients prescribed opioid pain relievers, at least 8% develop “opioid use disorder” and 15% to 26% engage in problematic behaviors that suggest they have become dependent.

“The numbers are extraordinary and unfortunately it’s still getting worse,” said Richard J. Bonnie, chairman of the panel and director of the University of Virginia School of Law’s Institute of Law, Psychiatry and Public Policy.

“We have a habit in our country of noticing certain problems … and then moving on to something else,” Bonnie said. But even with the kind of sustained, “all-hands-on-deck” approach required, the opioid drug epidemic, more than two decades in the making, “will take some significant period of time to unwind,” he added.

Dr. Leana Wen, health commissioner for the city of Baltimore, said the new report’s recommendations are “hard to argue with, because they are comprehensive and evidence-based.” But Wen, who has been an outspoken voice for broader access to addiction treatment, said she had hoped for less fretting over incomplete research findings and more focus on how to expand treatment services.

“We already know what works,” she said. While more could be understood about the biology of addiction, “we do not need more studies” to justify expanded treatment programs. “We do not more rhetoric. We need the resources to get us there.”

The report released Thursday was requested and underwritten by the Food and Drug Administration, an agency whose approach to regulating opioid painkillers would come in for some strong medicine under the panel’s recommendation.

The panel of independent experts proposed that in assessing the safety of prescription opioid drugs for the U.S. market, the FDA consider risks not just to the patients taking them, but also to their families and communities.

New formulations of opioid medications should be subject to that higher standard, the panel said. In addition, manufacturers of those drugs should be required to conduct extensive studies of their products’ use after FDA approval, and the agency should reevaluate their safety one, four, and six years after their entry onto the U.S. market.

Once the FDA has established new standards for evaluating the safety of proposed new opioid products, it should reassess all opiate medications currently on the market according to the same requirements, the committee said.

Panel members said that while imposing that “exceptional” standard on opioid medications represents an expansion of current practice, the FDA already has the power to broaden and expand its regulatory practices for certain risky drugs.

The numbers are extraordinary and unfortunately it’s still getting worse.— Richard J. Bonnie, chairman of the panel that produced the new National Academies report

Many of the panel’s proposals are likely to fly into political headwinds. President Trump has called the crisis of opioid addiction one of his administration’s top priorities, and established a commission, chaired by New Jersey Gov. Chris Christie, to formulate federal responses.

But with that commission’s report incomplete, Trump and his congressional allies are pursuing a wide range of policies that would appear to conflict with those identified by the National Academies panel as needed to stem the epidemic.

In its first months in office, the Trump administration has moved to reduce funding for a wide range of biomedical research and to slash regulations at the FDA. The National Academies report both proposes new layers of FDA regulation for opioid drugs and calls for expanded research on pain processes in humans, on factors that contribute to addiction vulnerability and treatment success, on prescribing practices, and on opiate use patterns and their consequences.

On Capitol Hill on Thursday, Senate Republican leader Mitch McConnell of Kentucky unveiled a healthcare bill that would scale back public funds for addiction treatment. The new bill also would give insurance companies more latitude to offer consumers low-cost policies stripped of services such as treatment for addiction for mental health, or that transfer to customers the cost of services such as non-drug therapies for pain.