The death of Prince—likely the result of prescription opioid abuse—is the latest manifestation of what has been called a national opioid epidemic. Now an advisory panel has unanimously recommended that the FDA make mandatory a currently elective program—Risk Evaluation and Mitigation Strategies, or REMS— designed to educate physicians about the risks of opioid misuse and abuse. The advisory panel’s recommendation is an example of regulatory overreach—based on little or no evidence—that the FDA should reject.

Without question, the United States has an opioid problem. The Centers for Disease Control report that 2 million Americans are currently abusing or dependent on prescription opioids such as Percocet, OxyContin, and Vicodin. Nearly 20,000 Americans die from overdoses of these medicines every year. A recent Health Affairs study found that hospitalizations related to opioid abuse have skyrocketed, along with the associated costs—$15 billion in 2012 for opioid-related inpatient care. The medical research firm Castlight Health reports that workplace disruptions from opioid abuse cost employers $10 billion annually.

The problem has its roots in over 20 years of “expert” claims that physicians under-treat patients’ pain and that opioids pose little addiction or abuse risk. The studies purporting to back up the under-treatment claims were generally small, though, and only documented such under-treatment in cancer or terminally ill patients. Nevertheless, some generalized the results, spreading the notion that all patients—including those with chronic, non-cancer-related pain for which opioid efficacy has not been documented—were being under-treated. In 1995, the American Pain Society published guidelines stating that doctors should routinely assess and record reports of pain along with a patient’s vital signs. In 1999, the Veteran’s Health Administration required physicians to ask patients to assess their pain on a scale of zero to ten during all clinical encounters. Pain was labeled the “fifth vital sign,” along with the traditional indicators of temperature, pulse, blood pressure, and respiratory rate. By 2001, the Joint Commission, an independent nonprofit that accredits 21,000 U.S. health-care programs for Medicare and Medicaid certification, required documentation of pain assessment and treatment at patient visits. States required physicians to take pain-management courses, and providers faced legal liability for undertreating pain. And the Centers for Medicare & Medicaid Services included questions about pain in its patient-satisfaction surveys that determine hospital reimbursement rates.

Not surprisingly, physicians responded to this focus on pain by increasing opioid prescriptions, which jumped from approximately 76 million in 1991 to nearly 207 million in 2013. The new, liberal attitude toward opioid prescribing seemed to disinhibit patients, who increasingly complained of—and demanded treatment for— chronic, non-cancer pain. Thirty-eight million people complain of back pain. Another 17 million have painful osteoarthritis. Fibromyalgia—a painful condition first recognized in 1987—is estimated to afflict 2 percent to 8 percent of the population.

All these factors make the U.S. the world’s biggest consumer of opioids. The American market accounts for almost 100 percent of global consumption of hydrocodone (the ingredient in Vicodin) and 81 percent of oxycodone (the ingredient in Percocet and OxyContin). Overdoses have tripled since 2000.

Will an FDA-mandated physician-training program alleviate this problem? Most of the FDA panelists acknowledged that no evidence exists that REMS training curbs opioid misuse—perhaps because REMS training targets the wrong audience. Physicians don’t live in caves; most now understand the addiction and abuse potential of opioids. The CDC recently issued new guidelines on opioid prescribing and opioid alternatives that physicians and hospitals can implement without hours of mandated education. Some physicians knowingly over-prescribe opioids, but that’s a matter for law enforcement, not education.

Physicians aren’t the problem here. Patients who knowingly or unwittingly divert opioids from legitimate use are responsible for the current epidemic. Most prescription opioid abusers don’t obtain drugs directly from physicians. Castlight Health reports that only 4.5 percent of people receiving an opioid prescription are opioid abusers. Most abusers obtain drugs from friends and relatives, who got them legitimately from physicians. Education and resources should be directed toward patients so they can secure or discard their drugs before they are given to—or stolen by—their drug-abusing friends and family members. Other opioid abusers obtain prescriptions from multiple providers and then either abuse or sell the drugs. States have started to crack down on these schemes, with programs that enable physicians to check if their patient is obtaining opioids elsewhere.

The “pain as the fifth vital sign” movement should come to an end. Unlike traditional vital signs—objective measures assessed by medical personnel—pain is a subjective symptom reported by patients. By equating a subjective indicator with objective information, policymakers created an environment where the people most likely to abuse painkillers were effectively put in control of their access to opioids. Patients and providers alike were misled into believing that any pain, no matter how minimal, tolerable, or transitory, must be eliminated. Some momentum for these changes already exists, as dozens of nonprofit groups and experts have urged the Joint Commission to change its pain-management requirements and asked CMS to remove pain-control questions from patient-satisfaction questionnaires.

Finally, insurance policies and government regulations that limit access to less easily abused pain medicines should be altered. Drug-reimbursement insurance policies must allow for greater coverage of “abuse-deterrent formulation” (ADF) drugs, which have been shown to decrease abuse. “While nearly 60 percent of branded opioids contain ADF properties, only 2 percent of generic products do,” writes former FDA commissioner Peter J. Pitts. “The numbers are staggering— 240,120,330 non-ADF generic opioids were prescribed in 2015 (nearly a quarter of a billion tablets) versus 5,068,398 branded opioids with ADF properties.” The FDA should prioritize approval of generics with ADF properties.

Well-intentioned concern about patients’ pain helped create the opioid abuse problem. Well-intentioned public pressure to do something about it doesn’t justify half-baked education mandates.

Photo by Roel Smart/iStock


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