Although the CDC's pending guidance on opioid prescribing -- expected to be some of the strongest federal advice on opioids to date -- was supposed to drop this month,politics have forced the agency into an additional public comment period.

That has some experts wondering whether strong advice about supply and dosing limits will be preserved.

"I think that having input from as many perspectives as possible will strengthen the applicability and acceptability," Lewis Nelson,MD,of NYU Langone Medical Center,who was an advisor to the draft guidelines,told MedPage Today."However,the focus on benefit versus risk should not be diluted.This has been a shortcoming of some prior opioid guidelines."

Although the guidance won't be legally binding,its impact is predicted to be dramatic -- prompting several groups,some with ties to opioid drugmakers,to work hard against it.Thousands of comments have been submitted to the agency,many of them critical of various elements in the recommendations as well as the process under which they were developed.

One focal point for critics is the draft's recommendations for strict limits on supply and dosing.

For example,in acute pain not related to surgery,it calls for opioid prescriptions to be topped off at 3 days -- and that the lowest effective dose of immediate-acting agents (not extended-release formulations,like OxyContin) should be used.

It also sets a dosing limit,urging clinicians to be careful once doses hit 50 morphine equivalents daily,and not going above 90 morphine equivalents daily.One 80-mg pill of OxyContin is 120 morphine equivalents.

CDC spokesperson Courtney Lenard said the dosing threshold "was determined based on the most recent scientific evidence regarding the association between opioid dosage and overdose risk," which included an Agency for Healthcare Research and Quality (AHRQ) report authored by an outside expert who helped CDC develop the draft guidelines.

"Both this review and CDC's contextual evidence review found that opioid overdose risk increases in a dose-response manner,that dosages of 50 to 99 morphine equivalents per day have been found to increase risks for opioid overdose two-fold to five-fold compared with dosages of 1 to 19 morphine equivalents per day,and that dosages ≥100 increase risks of overdose up to 9 times the risk of 1 to 19 morphine equivalents daily," she said.



Concerns About Transparency
The CDC guidance was written by experts from the agency's division of unintentional injury prevention,along with outside expert Roger Chou,MD,of Oregon Health and Sciences University in Portland,who was the lead author of the 2014 AHRQ report on the risks and benefits of opioids.

The agency also enlisted a core expert group (CEG),which included Nelson and several other experts known for their work on addiction and opioid use,including Jane Ballantyne,MD,and Gary Franklin,MD,both members of Physicians for Responsible Opioid Prescribing (PROP).

Over 2 days last September,CDC gathered another group -- its "stakeholder review group" -- to garner comments on the guidance.A wide range of perspectives were represented,from insurers to patient advocacy groups and medical societies -- including the American Medical Association,the American Chronic Pain Association,the American Pain Society,and the American Cancer Society.

Immediately following those meetings,many of these groups raised concerns about the guideline -- chief among them,that it lacked transparency and that the CEG was biased.

In its letter to CDC director Tom Frieden,MD,the AMA noted that "only a limited number of clinicians who are actively managing chronic pain patients were included."

Similar complaints were listed in a letter from several chronic pain groups,including the U.S.Pain Foundation,the American Cancer Society's Cancer Action Network,and the American Chronic Pain Association.

The agency "failed to disclose the names,affiliations,and conflicts of interest of the individuals who participated in the construction of these guidelines," the groups wrote.

Over the next few months,the fight against the guidelines intensified,first with legal threats from the Washington Legal Foundation,then a letter from the House Oversight Committee.

The Washington Legal Foundation,a libertarian group that advocates for business interests,charged that the CDC had violated the Federal Advisory Committee Act by failing to make the work of its CEG public -- and that it should scrap the current version of the guidelines and start from scratch.

In a Dec.18 letter,the House Oversight Committee asked the agency why it didn't consider its CEG to be an advisory committee under FACA.The letter cites the Washington Legal Foundation comments and requests several lines of documentation regarding the CEG.

The CDC posted its draft guidance on the Federal Register on Dec.14.Commenters have until Jan.13 to respond.As of press time,the document had more than 2,100 comments.

Next Steps
When the comment period is up,CDC will ask its Board of Scientific Counselors (BSC) -- a federal advisory committee -- to do a review.As of Jan.7,the BSC was set to appoint a workgroup that will review the draft guideline and comments and present its observation to the larger group,according to Lenard.

Once the BSC makes its recommendations,the CDC will also review the comments and make final revisions before submitting the new guidance "for CDC scientific clearance," she said.

Lenard noted that CDC received more than 1,500 comments on the guideline even before it appeared in the Federal Register.

"This feedback was from physicians,pharmacists,and other healthcare providers,professional organizations,pain advocacy organizations,state and local health departments,and patients," she told MedPage Today."CDC scientists found this input helpful and made substantial changes to the draft guideline in response to this feedback."

Although the CDC doesn't yet have a final publication date for the guidance,Lenard said it's a priority for the agency: "Given the lives lost and impacted every day,we have an acute sense of urgency to issue guidance quickly."

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