For millions of Americans with chronic pain, the new draft guidance on opioid prescribing, issued by the Centers for Disease Control and Prevention, could not have come soon enough.
We, too, have a vested interest. One of us, Kate Nicholson, used prescribed opioids so she could continue working as a civil rights attorney at the U.S. Justice Department. (A surgical injury had left her bedridden from the early 1990s through the late 2010s.) The other, Sally Satel, is a psychiatrist who understands the risks of addiction—and how those risks have often been overplayed when it comes to treating patients with long-term pain.
The CDC’s 2016 “Guideline for Prescribing Opioids for Chronic Pain” wrought havoc. Regulators, insurers, pharmacies, clinicians, and law enforcement misinterpreted the document as a government mandate that limited doctors’ use of opioid painkillers for pain or directed them to stop prescribing opioids completely. While the guideline, written amid the opioid crisis, did recommend limits on prescribed painkillers, it was issued only as guidance, and not the near ban many interpreted it as being. Yet the result was (and still is) that tens of thousands of Americans who were in agony because of medical conditions could not get essential pain medication or treatment.
Patients who had functioned well for years became couch bound because they could not get the necessary medication. Others suffered withdrawal from abrupt opioid discontinuation, sometimes turning to street drugs for pain relief. Many “pain refugees,” as the media called them, searched desperately for care when their doctors abandoned them. Some even died by suicide.
We have spent the past few weeks reading every word, table, and citation in the CDC’s draft “Clinical Practice Guideline for Prescribing Opioids,” updated guidance on the treatment of pain. (Full disclosure: Nicholson was a member of the Opioid Workgroup that reviewed an earlier version of the new guideline.)
Fortunately, the CDC’s 211-page update explicitly recognizes the harms that emerged from its previous version and contains significant improvements. Foremost, the new guideline espouses the bedrock philosophy of humane care—strikingly absent from the 2016 guideline—namely, that doctors should rely on their clinical judgment, not on fixed directives. The new document, its drafters firmly state, “should not be used as inflexible standards of care [nor] be implemented as absolute limits of policy or practice.”
Wisely, too, the new recommendations remove the earlier warning against prescribing more than 90 MME—morphine milligram equivalents, a standard dosage measure—per day and omit the prior directive that prescriptions should rarely last more than three to seven days. These are two commonly misapplied provisions from the 2016 guideline.
The value of these changes cannot be overstated, and yet other aspects of the update are troubling and threaten to sabotage them.
For example, the CDC update sends mixed messages. The update’s welcome and overdue emphasis on individualized care is undermined, for example, by a sweeping pronouncement that opioids are “not the preferred treatment” for non-acute pain. Deeming the medication “not preferred” gives insurers a convenient reason to deny opioid coverage for those with severe conditions. For some patients and conditions, opioids are the appropriate choice. A patient might have exhausted other options, experienced bad side effects from them, or derived such great benefit from opioids that the value clearly outweighs the risks.
Another problem with the new draft guideline is that the updated text instructs clinicians to “pause and carefully reassess” (bold in original) if they are raising a dose above 50 MME per day. (A 10 milligram tablet of oxycodone is equivalent to about 15 milligrams of morphine, or 15 MME.) While not bad advice in theory, specifying a dosage threshold is a set-up for clinicians and policy makers to adopt it as a ceiling and not a suggestion.
This is precisely what happened when the 2016 guideline asked clinicians to justify prescribing more than 90 MME a day. Instead of explaining their decisions, nervous clinicians, fearful of law enforcement or lawsuits, seized on the 90 MME dosage as a decree to reduce all amounts below that threshold. A hard limit of 50 MME in the updated guidance threatens to create an even worse outcome.
Finally, in reviewing evidence for opioid treatment of long-term pain, the drafters omitted studies that did not last more than a year, which bizarrely flouts the CDC’s own definition of chronic pain, which is pain lasting three months or longer, not one year or more. Further, discounting those studies removes from the draft the existing evidence that opioids can reduce pain lasting more than three months.
The guidance does suggest alternatives to opioids such as acupuncture, laser therapy, and massage, which may well be beneficial to some patients. But many insurers do not cover these options, making them effectively unavailable for some patients, as the CDC itself acknowledges.
But what concerns us most is that clinicians, health care entities, states, and law enforcement are likely to ignore the guideline’s stern injunctions against patient abandonment, rigid dosage cutoffs, and involuntary tapering.
We have already seen doctors and pharmacies deny opioid medication to patients with cancer and sickle cell disease as well as those receiving palliative care, even though the 2016 guideline explicitly exempted them from its recommended restrictions.
In 2019, we urged the CDC to clarify its guidance—Nicholson in cooperation with Human Rights Watch, and Satel through a widely publicized letter that was signed by more than 300 concerned physicians. To its credit, in April 2019 the CDC published a corrective in The New England Journal of Medicine, cautioning doctors and health care systems against “inflexible application” of the guideline.
We were thrilled—and then nothing happened.
Nicholson, who is the executive director of the National Pain Advocacy Center, an organization that fights for getting available pain treatments to those who need them, continued to receive scores of messages each week from patients who were in unbearable pain from cancer or late-stage multiple sclerosis or amputated limbs. Each story of suffering that lands in her in-box is as heartbreaking as it is needless.
If the CDC’s bold clarification in a leading medical journal had little effect on regulations and practice, will the agency’s new exhortation against patient abandonment be enough?
With the benefit of hindsight, we are skeptical.
Here’s what could really help this time: The CDC needs to draft its final guideline in a way that anticipates and mitigates the potential for policy misapplications. It’s not enough to say that the guidance is voluntary, when we know it will be interpreted as a national prescribing mandate. This is especially important because the new guideline is much broader; it will apply to the treatment of virtually all pain, not just chronic pain. The agency should underscore in unmistakable terms to clinicians, health systems, insurance companies, and government entities that, because pain varies greatly in severity and underlying condition, individualized care is paramount.
The CDC should also be proactive when it comes to the bureaucratic jousting that is likely to ensue. It must pointedly discourage other federal agencies, such as the Centers for Medicare and Medicaid Services and the Drug Enforcement Administration, from imposing blanket prescribing thresholds on doctors. This is a chance for CDC Director Rochelle Walensky to get beyond the various feuds over COVID-19 policy. As a physician on the front lines of the HIV/AIDS epidemic, Walensky has been witness to human suffering and to the stigma that can cause those at the center of public health crises to be denied what they likely need most: appropriate and humane access to care.
With its updated guideline, the CDC has the potential to correct significant, if unintended, harms. But this will only happen if the practical wisdom it now endorses is put into practice.