Research

To Counter Opioid Crisis, NIH Pushes Researchers to Invent More Drugs

May 31, 2017

At a time when opioid abuse is killing tens of thousands of Americans a year, government-funded university scientists are now being asked to pursue a solution many of them find deeply misguided: Invent even more drugs.

After private consultations with drug-industry leaders, National Institutes of Health directors proposed a strategy on Wednesday that centers on new medications and devices to manage pain and counter addictions.

More than a dozen invited drug companies are eager to help, the NIH’s director, Francis S. Collins, said of his agency’s new opioid strategy. "They have all responded with a great deal of enthusiasm," he said.

But academic experts in opioid abuse are aghast, saying the NIH plan appears to greatly overemphasize the prospect of meaningful help from the drug companies — which the scientists blame for creating the crisis in the first place — to the near exclusion of nonpharmacological treatments, including lifestyle changes and economic development.

"This is a complex bio-psycho-social disease," said one opioid expert, Anna Lembke, an assistant professor of psychiatry and behavioral sciences at Stanford University, "and these interventions really are only looking at the biology piece."

“This is a complex bio-psycho-social disease, and these interventions really are only looking at the biology piece.”
The NIH’s drug-abuse division has already spent too much time and money pursuing new chronic-pain treatments, said Andrew Kolodny, co-director of opioid-policy research at the Heller School for Social Policy and Management at Brandeis University, and "they appear headed toward doing more of this."

For such researchers, the issue reflects a fundamental question about the role of the NIH: Should it direct research dollars mostly toward traditional "bench science" or take a more expansive and interdisciplinary approach to major matters of public health?

To some degree, the NIH accepts that wider definition. The NIH division that produced the new opioid strategy, the National Institute on Drug Abuse, has sponsored research into areas that include improving educational initiatives in schools and assessing programs to monitor prescription drugs.

But the NIH plan, published on Wednesday in The New England Journal of Medicine and written by Dr. Collins and Nora D. Volkow, director of the drug-abuse institute, spoke almost exclusively of ideas for developing new drugs and devices to improve upon and replace opioids, to vaccinate against the effect of opioids, and to improve post-overdose treatment.

‘The Holy Grail’

The strategy is an outgrowth of an annual meeting, held in April, between pharmaceutical-industry leaders and officials at the NIH and other government health agencies. More details of the plan will be developed during three additional meetings over the next six weeks, all closed to the public, between industry scientists and NIH officials, Dr. Collins said.

“The stars are aligning now between the science and the industry, seeing this as a potential market opportunity.”
"The stars are aligning now between the science and the industry, seeing this as a potential market opportunity," he said. A key goal is the development of an opioid medication that offers pain relief without addiction, Dr. Collins said. "That seems like the perfect answer," he said. It’s "the holy grail," Dr. Volkow said.

Dr. Collins and Dr. Volkow, in a briefing with reporters, also said the epidemic of opioid addiction — now affecting at least 2.5 million Americans — grew in large part because the dangers were not understood as recently as 20 years ago.

"The medical profession was very much kind of buying into the idea that this could be a way in which one could manage not just short-term but long-term pain," Dr. Collins said. "The realization of the addictive potential was much more limited then than it is now."

“We've known for millennia that opioids are addictive and that they cause overdose when taken in too high a dose.”
Academic experts disagreed emphatically with the suggestion that opioid risks were previously unknown. "We’ve known for millennia that opioids are addictive and that they cause overdose when taken in too high a dose," Dr. Kolodny said. To the degree that doctors were unaware of that, said Dr. Lembke, the author of a book on the topic, it’s because of the millions of dollars the drug industry spent misleading them about both the risks and the benefits.

New drugs could be useful, said Richard B. Gunderman, a professor of radiology at Indiana University who holds appointments in several other fields, including medical education and philosophy. But rather than pursue new types of opioids as the holy grail, Dr. Gunderman said, scientists should look at psychological, spiritual, and even cultural factors that lead to opioid abuse, especially among people suffering from low incomes and a lack of fulfilling careers.

Such factors are critical, he said, "and we neglect them at our peril."

A Worrisome Plan

Dr. Volkow did mention some nonpharmacological goals, including improving training for emergency-room physicians and doctors in sexual-health clinics who treat opioid-abuse patients.

And the U.S. secretary of health and human services, Thomas E. Price, told a drug-abuse summit in April that improving access to treatment and recovery services was one of his top five priorities in fighting opioid abuse.

At the same time, a House-approved plan for meeting the Trump administration’s request to overhaul federal health-care coverage would reduce patients’ eligibility for Suboxone, the leading long-term treatment for opioid addiction. Losing access to Suboxone "would definitely make the epidemic worse," Dr. Kolodny said.

The NIH plan is so worrisome, Dr. Lembke said, because the drug industry can already provide resources to develop new drugs. Federal money, by contrast, should be directed toward approaches that industry will not cover, such as studying the value of clean-needle-exchange programs, safe-injection facilities, decriminalization policies, and personal behaviors, including exercise, yoga, and tai chi, she said.

"Not a single one of their listed interventions addresses the psychosocial contextual problems that are so central to this" crisis, Dr. Lembke said of the NIH plan.

Paul Basken covers university research and its intersection with government policy. He can be found on Twitter @pbasken, or reached by email at paul.basken@chronicle.com.