The FDA has announced new measures designed to combat opioid abuse, promising “an aggressive approach to regulatory action.” Unfortunately, many of the solutions offered by the agency will harm patients while not doing much to reduce overdoses, and might even make the problem worse.
We often hear the problem called an “opioid crisis,” but on closer inspection this moniker appears misleading. Opioids are a potent pain medication that many need and use responsibly. There’s little risk of overdose from the proper medical use of prescription opioids. Most opioid overdoses instead occur from use of powerful synthetics like fentanyl. Even in the roughly 30 percent of fatal overdose cases involving prescription opioids, fentanyl or heroin are also often involved.
Pretty much all of the increase in opioid deaths in recent years are due to the spike in fentanyl related deaths, which is why “opioid-related deaths keep rising as pain pill prescriptions fall.” Our Taxpayers Against Illicit Opioids project exists to further draw attention to this unfortunate misconception.
The FDA at least pays lip services to this reality. Their statement acknowledged “the growing prevalence of illicit fentanyl,” and that “the rate of overdose death continues to increase,” despite declines in prescription opioid use, “due in part to the increasing abuse of potent adulterated or illicitly manufactured fentanyl products purchased through online channels and sold as street drugs.”
And yet, unfortunately, their proposed solutions involve even stronger crackdowns on prescription opioids. They also promise to “strengthen enforcement against illicit opioids,” but they are unlikely to succeed so long as they are creating demand in the illicit market by restricting access to legal drugs.
In a recent study from the Cato Institute, Jeffrey Miron, Greg Sollenberger, and Laura Nicolae compare the standard “more prescription, more deaths” explanation that the FDA seems to accept with a “more restrictions, more deaths” explanation that puts much of the blame on years of restrictive policies like rules that limit prescribing and raids on supposed “pill mills.” What they find is much more evidence for the latter explanation:
The standard view of the opioid epidemic argues that increased prescribing caused the recent increase in opioid overdose deaths. Medical use of opioids, however, is not a major cause of opioid addiction or overdose. Instead, available evidence suggests that the array of recent state and federal restrictions on legal access to opioids likely contributed to increasing overdoses by pushing users to diverted or illicit sources. Over the past few years, the opioid epidemic has accelerated due to overdoses caused by heroin and synthetic drugs such as fentanyl, despite reduced prescribing. Further restrictions on prescribing are unlikely to decrease overdose deaths.
The cost of these restrictive policies can be measured in worse care and lower quality of life for chronic pain sufferers. A recent New York Times op-ed describes the plight of one such patient:
Katie Tulley suffers from an incurable bladder disorder so painful that it feels “like tearing skin off your arm and pouring acid on it, 24/7,” she said. On scans, the organ looks like an open sore.
…Now, because of legal concerns about overdose risk, her doctors have considered stopping her medication, even though she has never misused it. And so, when she recently discovered a suspicious lump in her belly, she found herself hoping it was cancer. “I shouldn’t ‘want’ cancer,” she said. “But at this point it’s the only way to be treated” for her pain.
Pain patients point to a “climate of fear” caused by CDC guidelines on opioid prescribing, which has not only made it harder to get prescribed an effective treatment, but has led some pharmacists fearing government retribution to refuse to fill even those prescriptions that patients do manage to obtain.
The White House tweeted that “reduc[ing] the volume of opioid prescriptions” is a way to “prevent new opioid addiction.” But the best evidence to date suggests otherwise, as does the history of prohibitions more generally. The FDA should revise its approach and stop harming patients.
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Image credit: K-State Research and Extension | CC BY 2.0.
