High Wire is Maia Szalavitz's reported opinion column on drugs and drug policy.
After three years of rising reports of serious harm to chronic pain patients—including dozens of accounts of suicide by people whose medications were cut off and hundreds of stories of increased disability—the Centers for Disease Control and Prevention (CDC) has issued a critical clarification of its 2016 Guideline for Prescribing Opioids for Chronic Pain.
Earlier this month, the Food and Drug Administration (FDA) also released an urgent warning clearly stating that physicians should not abruptly taper patients who are dependent on these medications. The agency also acknowledged the suicide risk associated with rapid tapering and other psychological and physical dangers for patients.
It’s about time that these agencies addressed the widespread suffering caused by the crackdown on medical opioids that resulted from the predictable misapplication of the 2016 guideline.
Advocates are cautiously optimistic that the changes will begin to restore balance to a policy that has ignored the plight of people with chronic pain, while focusing relentlessly on reducing the medical opioid supply.
“I am deeply appreciative that both the FDA and the CDC saw fit to speak now because it sets the table for all of us to have a serious conversation” about both the harms and the benefits of the guideline, says Stefan Kertesz, a professor of preventive medicine at the University of Alabama at Birmingham. Kertesz was one of the key organizers of a letter recently sent to the CDC by the group Health Professionals for People in Pain, which requested just such a clarification.
The guideline urged doctors to be cautious about prescribing opioid doses higher than 90 morphine equivalents (a way to compare opioids of different strengths) and to generally avoid prescribing any opioids for chronic pain, if at all possible. Introduced in a country facing the worst overdose crisis in history, it was not surprising that what was intended as a set of recommendations rapidly hardened into legal and insurance strictures.
Although the CDC says it did not intend to ban high-dose opioid prescribing or force existing patients to quit, such results have been widely reported. Insurers, regulators, pharmacies, and state legislators have made the document—which was supposed to be flexible so that patients with complex needs wouldn’t be harmed—into a set of rigid rules without exceptions. And the guideline was also misapplied by these groups to include patients it was never intended to cover, such as people with cancer, those with post-surgical pain, and those taking medication to treat addiction.
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"I'm glad to see these points laid out so explicitly, although I'm sure there will be those who say ‘too little too late,’” says David Juurlink, head of the division of clinical pharmacology and toxicology at Sunnybrook Health Sciences Centre in Toronto and a board member of one of the key organizations that pushed for the creation of the guideline, Physicians for Responsible Opioid Prescribing.
“To be fair to CDC, these same messages were clear from day one to anyone who actually bothered to read the guideline,” Juurlink adds. “To the extent that the guideline caused problems for patients with chronic pain, it wasn't the recommendations themselves but rather their misapplication.”
One of the many misapplications was legal pressure on doctors from medical boards and criminal prosecutors, who often targeted physicians for deviation from the CDC’s recommendations. Many such doctors reacted by forcing their patients to cut their doses or stop the medications altogether, affecting thousands of Americans. Even now, at least one state is considering requiring all Medicaid patients with certain pain diagnoses to discontinue opioids—regardless of whether they’re benefiting from them.
But as the authors of the clarification (who were also the authors of the 2016 guideline) put it in a perspective piece in the New England Journal of Medicine:
Policies should allow clinicians to account for each patient’s unique circumstances in making clinical decisions…
An unintended consequence of expecting clinicians to mitigate risks of high-dose opioids is that rather than caring for patients receiving high dosages or engaging and supporting patients in efforts to taper their dosage, some clinicians may find it easier to refer or dismiss patients from care.
Clinicians might universally stop prescribing opioids, even in situations in which the benefits might outweigh their risks. Such actions disregard messages emphasized in the guidelines that clinicians should not dismiss patients from care, which can adversely affect patient safety [and] could represent patient abandonment.
Kate Nicholson is a former federal prosecutor and pain patient who has herself required opioids in the past. In March, she and other advocates met with CDC officials to push for change, explaining how patients were being hurt.
“I am delighted that the CDC and the FDA are taking action to protect patients,” she says, “They basically have agreed to do pretty much everything we asked.” She added, however, that “it is only a beginning, given how broadly the guideline has been misapplied at every level of the healthcare system.”
Kertesz agrees. “It is crucial for the institutional actors that have misapplied this guideline to take seriously that both the CDC and the FDA have spoken in crystal-clear fashion,” he says.
He added, “Quality metrics, public and private [insurance companies] that have weaponized the guideline by invoking its authority while disregarding what it said in plain English need to recalibrate. They have to do that urgently.”
As someone who has covered the heartbreaking stories of people who have lost loved ones to suicide in the wake of these policies—and has spoken with dozens of patients who became bedridden or otherwise less functional after previously being able to work and care for families—I am also heartened to see this change.
Taking away needed medication from pain patients does nothing to fight addiction—and pretending that there is no role for opioids in the treatment of chronic pain denies both science and clinical experience. The inexcusable commercial marketing of opioids to doctors has now harmed not only people with addiction, but also two distinct groups of pain patients: those who do benefit from opioids and are now being denied them, and those who don’t benefit but are being tapered without support or alternatives.
Lelena Peacock, a pain patient who has spent much of her time lately trying to help people who’ve become suicidal after losing access to medication, recently experienced an abrupt and involuntary taper herself.
“I was abandoned from medical care like countless other patients on long-term opioids,” she says. “We are now treated as parolees, not patients. We're viewed as unmanageable liabilities that threaten the freedom and livelihoods of healthcare professionals across every point of the continuum of care…. The doctor/patient relationship has been almost completely destroyed. That relationship is now a punitive one. What took the CDC so long?”
We certainly do have a long way to go before we can solve these problems—but at least the relevant agencies have finally recognized that they exist and started to change course.
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Correction 4/25/19: Due to an editing error, the headline of this story said “millions” were affected by the CDC’s rules, when the story itself said thousands of people are affected in the United States. We regret the error.