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On Friday, July 16, the National Center for Injury Prevention and Control (NCIPC)’s Board of Scientific Counselors (BSC) met to review a report on the new draft Guideline provided by the Opioid Working Group (OWG), a Centers for Disease Control and Prevention (CDC)- appointed outside group of stakeholders whose job was to review the new Guideline. 

The new Guideline was authored by some of the same individuals involved in the drafting of the 2016 Guideline. Four out of the five authors are employees of the NCIPC who are injury prevention and addiction specialists, not pain management professionals, nor pain advocates, or pain patients. The fifth, a primary care physician, has for years publicly criticized opioid prescribing for pain in op-eds and interviews. Yet, pain patients and pain management providers will be the groups most affected by the new Guideline which describes how and when to prescribe opioid medication for pain.

The new draft Guideline came after the CDC held interviews with 100 stakeholders to get their views of how the 12 recommendations should be updated. It came after public listening sessions in which dozens of pain patients spoke about how they had been harmed by the 2016 Guideline. It came after FDA issued a report on a public meeting with 450 chronic pain patient-participants as well as a public docket that received 2450 comments held in July of 2018 in the aftermath of the release of the Guideline, in which patients uniformly described the burden of trying to access opioid medication that had long helped them detailing reduced dosing, forced tapering, medical abandonment, increased pain, withdrawal, disability, isolation, inability to work, inability to care for self or others, stigma and discrimination, anxiety and depression, self-harm and suicide as a result of loss of or reduced access to opioids.

It came after the Congressionally-mandated Pain Management Best Practices Inter-Agency Task Force (PMTF), of which the CDC was a member, heard public comment, patient testimonials and received over 9,000 e-mails and letters, 87% of which described loss of access to opioid pain medications that had caused all of the same harms described by the FDA report. And finally, it came after a review of the 2016 CDC Guideline conducted by the PMTF at the request of Congress, which pointed out a number of flaws in the Guideline, chief among them the arbitrary nature of the 90 MME/day maximum dose recommendation and the “3-days or less” and “more than 7 days will rarely be needed” duration of therapy limit following an acute, severely painful event. The PMTF review stressed the wide variability in patient, specific drug and disease or injury characteristics that determine the optimal dose for pain relief in each individual patient.

So, it is especially astounding that the Guideline authors made no significant changes in the Updated Guideline. (Click here to see a comparison of the 2016 vs the 2021 Guideline) The problematic and unscientific dose limits and duration of therapy recommendations are exactly the same as in the 2016 Guideline. 

Even more astounding is the focus on reducing and eliminating the legitimate use of opioids for pain management while remaining silent on what patients living in high-impact, relentless severe pain should do for pain management beyond recommending “non-opioid therapies.”

The authors have long said the Guideline is intended for primary care physicians. This is exactly the group who have very little knowledge of current best practices in pain management and are generally not aware of the multitude of therapies including other medications, restorative therapies, interventional procedures, medical devices, behavioral approaches, and complementary therapies that could help patients manage their pain in addition to or in place of opioids. Furthermore, there are many pain patients whose pain is not helped by opioids, or cannot take them for one reason or another, who may be helped by therapies in the categories listed above. 

By not discussing these options in the Guideline, the CDC has missed an important opportunity to educate physicians, patients and other healthcare providers about how best to manage pain. Unfortunately, there are barriers to accessing some of these alternate therapies such as lack of insurer coverage and cost. The CDC’s highlighting of these options could help to remove some of these barriers but not if they are not even discussed in the Guideline.

In addition to public comments during the meeting, the CDC announced that they would accept written comments until July 23 that would be included as part of the meeting minutes. (Click here to see U.S. Pain Foundation’s written comments on the Updated Guideline.) U.S. Pain Foundation sent an alert last week notifying advocates of the opportunity to comment.

The CDC’s process going forward to arrive at a Final Guideline will be for the BSC to consider the OWG’s report and advise the CDC on the update. (Click here to see the OWG Report.) The CDC’s NCIPC authors will revise the Updated Guideline and post a new Draft Guideline for a 60-day public comment by the end of 2021. The CDC will then revise the Draft Guideline and release an official Final Guideline in late 2022.

What you can do

If you and your healthcare have been impacted by the CDC Guideline, then we urge you to write your Congressional Senators and House Representative. 

Tell them your personal story in as concise a manner as possible. Explain how your pain care has been affected by the Guideline. Urge them to tell the CDC to add pain management healthcare providers, pain patients and pain advocates to the group authoring the new Guideline. Request that your representatives tell the CDC not to include daily dose and duration limits on opioid prescriptions for legitimate pain patients who use opioids appropriately to manage their daily chronic pain. 

Dose and duration of treatment is not one size fits all. Many respected medical authorities, including the AMA, the FDA and the HHS Pain Management Best Practices Inter-Agency Task Force, have said there is wide variation in dose and duration of opioid therapy that is optimal for each individual patient.

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