After Years of Foot Dragging, CDC Plans Review of Opioid Guideline
/By Pat Anson
Eight years after releasing its controversial 2016 opioid guideline and two years after revising it, the CDC is finally making plans for a review of the guideline’s impact on patients, caregivers, doctors, and the practice of pain management.
In a notice published in the Federal Register on Friday, the CDC said it would open a 30-day public comment period on a “mixed-method quasi-experimental approach” to evaluating the updated 2022 guideline.
In plain English, the CDC plans a web-based survey of about 200 clinicians, and individual interviews with 10 clinicians, 2 dentists, 3 health system leaders, 3 insurers, 3 professional association leaders, and 3 medical board leaders. In addition, CDC will interview up to 15 patients and 15 caregivers in focus groups.
The agency did not indicate how the participants or organizations will be selected, or what questions will be asked.
“CDC is comprehensively evaluating the uptake, implementation, and outcomes of the 2022 CDC Clinical Practice Guideline on evidence-based care for pain management to understand its impact,” the agency said. “The evaluation includes dissemination and impact of the 2022 CDC Clinical Practice Guideline through population-wide changes in prescribing practices for opioids and medications for opioid use disorder.”
This is actually the second time CDC has published a public notice about the guideline review. Only two public comments were received after a similar notice was published in the Federal Register on October 1, which the CDC made no effort to publicize.
‘Timing Is Very Odd’
It’s not clear why a second notice was published during the holiday season and in the final weeks of the Biden administration. CDC did not immediately respond to a request for comment.
“The timing is very odd, and almost everyone missed the opportunity for open comments earlier this year,” said Chad Kollas, MD, a palliative care physician and pain policy expert.
“Few states have backed off from overly restrictive prescribing laws that were created based on the 2016 Guideline. I think that’s the main opportunity here, documenting the failure to implement the revised recommendations in the 2022 guidance. It’s unclear how CDC plans to determine who will get an opportunity to respond in the proposed study, so transparency remains troublesome for them.”
The CDC was slow to acknowledge the harm caused by the 2016 guideline. Although voluntary, the agency’s recommendations were widely implemented as mandatory by states and law enforcement agencies, resulting in patients having their opioid medication reduced or cutoff, and doctors being prosecuted for exceeding the guideline’s dosage recommendations.
To address those issues, CDC issued a revised guideline in 2022. But many of the problems caused by the original guideline linger.
“The 2016 guidelines led to a variety of restrictive policies, including limitations on opioid dosages. These measures created significant barriers for patients trying to access pain care and made it more challenging for physicians to prescribe necessary medications,” Donald Arnold, MD, President of the American Society of Anesthesiologists (ASA) wrote in a letter to the CDC, one of the two public comments made in response to the October 1 public notice.
The ASA surveyed its members on the impact of the 2022 revised guideline. Over half (56%) thought it was “somewhat effective” in reversing the harm caused by the 2016 guideline, while 40% thought it was ineffective.
A PNN survey of over 2,500 patients, providers and caregivers also found mixed reviews of the 2022 guideline. Only 39% of respondents thought it was “improved” or “much improved” over the original guideline. Most respondents said it was about the same or even worse.
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‘Same Problems Still Exist’
The CDC never conducted a comprehensive review on the impact of the 2016 guideline, but it did hire a consulting firm to improve its image after the agency was widely criticized for its secrecy and lack of transparency during the guideline’s development process.
A former CDC epidemiologist was so dismayed by the agency’s lack of accountability that he wrote a book about it, “Greed to Do Good: The Untold Story of CDC’s Disastrous War on Opioids.” Dr. Charles LeBaron says CDC leadership was blinded by its own hubris.
“The problem was not looking at the (guideline) sufficiently quantitatively and then not checking the consequences, or at least responding to the consequences when they're brought to your attention,” LeBaron told PNN. “Many of the same problems continue to exist, even though the personalities are completely different, and there are still significant restrictions on people in chronic pain for no apparent benefit.”
The personalities will change yet again when the Trump administration takes office on January 20. Conservative activists have made clear they want a major restructuring of the CDC, returning the agency to its core mission of collecting and disseminating data on communicable diseases. They want the CDC to stop telling people what to do, and to leave medical guidelines to professional societies and state medical boards.
Unlike other public notices in the Federal Register, the CDC is not making it easy for people to comment online. Comments can be left at a confusing public portal or be sent in written form to this address:
CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503
People can request further information on the guideline review and obtain a copy of the information collection plan by calling (404) 639-7570.
