By Pat Anson, PNN Editor

It was nearly three years ago that the American Medical Association took its first public stand against the CDC’s controversial opioid prescribing guideline.

The AMA’s House of Delegates adopted resolutions calling for an end to the “misapplication” and “inappropriate use” of the guideline by many states, doctors, pharmacists and insurers who imposed hard limits on the amount of opioid medication patients could get, if they could get it at all. Many were left in excruciating pain.

Last year, the AMA went even further, with a 17-page letter to the CDC warning that it was “clear that the CDC Guideline has harmed many patients.”  

Even the CDC acknowledged the 2016 guideline “has been inappropriately cited to justify hard limits or cutting off opioids” and that cancer and surgery patients were suffering as a result.

To date, all of this hand-wringing has changed nothing, as the AMA’s new president recently acknowledged in an exclusive interview with PNN.

“Reports we get from patients and physicians suggest that problems remain. Despite CDC acknowledging that its guidelines should not be used as hard thresholds, there has been almost no effort by state legislatures, health insurance companies, pharmacy chains, or PBMs (pharmacy benefit managers) to evaluate the harmful effects of these one-size-fits-all laws,” said Gerald Harmon, MD, a South Carolina physician who was elected AMA president last month.

“The AMA continues to receive reports that the laws are used to deny, for example, prescriptions for opioid therapy for patients with cancer or in hospice as well as long-time, stable patients with chronic pain.”

Not only has the guideline harmed innocent patients, it failed to achieve its main goal of reducing the risk of opioid addiction and overdose. Opioid prescriptions have been cut to levels not seen in 20 years, while overdoses soared to record highs, fueled largely by illicit fentanyl and other street drugs, not pain medication.

Guideline Meeting

This month we may finally learn what the CDC intends to do after five years of its failed public health experiment, which has been conducted with virtually no effort by the agency to measure its impact on patients. On July 16, the CDC is expected to release a long-awaited draft of a revised guideline during a meeting of its Board of Scientific Counselors (BSC).

(Update: On July 8th, PNN was notified by CDC that the draft guideline would NOT be made public at the July 16th meeting, even though the agenda indicates most of the day will be spent discussing it.

“The draft updated Guideline will not be shared. The BSC Opioid Working Group report is what will be shared and discussed,” CDC spokesperson Courtney Lenard wrote in an email, adding that the public may not get a chance to see the updated guideline until late this year.) 

Although the CDC’s review of the guideline has been underway since 2019, the agency has disclosed no details about its plans, which may include new treatment recommendations for short-term acute pain, migraines and other chronic pain conditions. Even the AMA is in the dark about what the CDC is planning.

“Without seeing a specific proposal, we can’t speculate on what CDC might be considering. We will continue to work with CDC to ensure that any recommendations respect and support care for patients with pain. This includes encouraging CDC to make any drafts open to the public for comment to ensure that any revisions or additions do not make the same mistakes as the 2016 Guideline,” said Harmon.

One of the “mistakes” the CDC made was releasing the guideline during a secretive, ham-handed webinar. The agency also refused to disclose the names of its outside advisors, which included members of the anti-opioid activist group Physicians for Responsible Opioid Prescribing (PROP).  

As recently as last year, the CDC declined to release memos, conflict-of-interest statements and other communications related to the 2016 guideline. Nearly 1,500 pages of documents provided to PNN under a Freedom of Information Act request were heavily redacted or scrubbed of information. Over 1,200 pages were completely blank. 

The CDC is being a bit more transparent this time around. Early in its deliberations, the agency asked for and received nearly 5,400 public comments, most of them from patients who blame the agency for their poorly treated pain. The CDC also made public the identities of a diverse group of physicians, academics and patients appointed to an “Opioid Workgroup” that is advising the agency. Notably, the group includes no members of PROP.

The CDC has not yet disclosed who is writing the guideline revision, although early indications are that at least one of the original three authors is involved again.

“The AMA’s focus will be to continue to advocate that CDC revise its guidelines in an open, transparent manner,” said Harmon. “We continue to urge that CDC specifically remove recommendations tied to hard thresholds and make clear that its recommendations should not be used in state laws or policies implemented by health insurance companies, pharmacy chains, or PBMs.” 

Once a draft of the revised guideline is completed, there will be another public comment period later this year. The CDC may not finalize and release the updated guideline until early next year.

If you’d like to watch the July 16th CDC meeting online, you can register for it here.