As I have written here and here, the Centers for Disease Control and Prevention (CDC) plans to “update and expand” its Guideline for Prescribing Opioids For Chronic Pain—United States 2016.

Unfortunately, most states and several pharmacies and third-party payers, including Medicare, have taken the 2016 guideline more seriously than the CDC intended. In fact, 36 states have concretized in statute hard limits on the amount and dosage of opioids premised on those guidelines which—6 years ago—were largely based on “type 3” or “type 4” evidence:

Type 3: “observational studies, or randomized clinical trials with notable limitations.”

Type 4: “clinical experience and observations, observational studies with important limitations, or randomized clinical trials with several major limitations.”

The 2016 guideline was also criticized by many experts in pharmacology and in pain and addiction treatment for lacking any firm basis in the evidence.

That didn’t stop state lawmakers from permanently enshrining these recommendations—meant to provide clinicians a “rule of thumb” for prescribing pain killers—as edicts. Empowered by law enforcement, these edicts caused many health care practitioners to under-prescribe medication for their patients in pain and, in many cases, abruptly taper their patients off opioids that had been providing them long-term relief. Many of these patients became “pain refugees,” seeking relief from other doctors who are afraid to take on new pain patients. Some have desperately turned to the dangerous black market or, worse, to suicide to get relief.

Realizing they had created a monster, the CDC issued an Advisory in 2019, admonishing policymakers and health care practitioners for misinterpreting and misapplying the 2016 guideline.

A day late and a dollar short.

Now the CDC plans to publish a new guideline some time before the end of the year. On February 10, 2022, it published a draft proposal and seeks comments during the next 60 days.

Of course, there is no justification for a government agency, unavoidably subject to special interest pleading and political pressures, to create a guideline for “best practices” and “standard of care” for the treatment of any medical condition—including pain. Professional specialty organizations have existed for decades for just that purpose. These non-profit non-governmental organizations, such as the American College of Physicians, American College of Surgeons, American Academy of Pediatrics, American Academy of Pain Medicine, etc. have committees staffed by clinicians and clinical educators who create “best practices” and “standard of care” guidelines, sensitive to the variabilities and nuances involved in clinical decision-making. When a government agency insinuates itself into the patient-doctor relationship—as the CDC did in 2016—harmful unintended consequences are unavoidable.

Alas, that train has already left the station.

Responding to the CDC’s request for comments, I submitted my comment today. You can read it here.