CDC Advisory Panel Warns Revised Guideline Ignores Benefits of Opioids
/By Pat Anson, PNN Editor
An independent advisory panel is warning the CDC that a draft revision of its 2016 opioid guideline is focused too heavily on the risks of taking opioid medication, with not enough attention paid to the benefits that opioids have for many pain patients.
A 12-page report from the CDC’s Opioid Workgroup was discussed Friday during an online meeting of the agency’s Board of Scientific Counselors (BSC). The 23-member workgroup is composed primarily of physicians, academics and researchers involved in pain management, including some who advised the agency during the drafting of the original guideline.
CDC has not made public the revised draft guideline and has no plans to release it for public comment until later this year. The workgroup, however, has seen the draft and many of its members have issues with it.
“Overall, many workgroup members felt that much of the supporting text of the guideline was not balanced and was missing key studies. Many workgroup members felt that the guideline focused heavily on the risks or potential harms of opioids, while less attention was focused on the potential benefits of opioids, or the risk of not taking opioids or undertreating pain,” the workgroup report states.
“Many workgroup members noted how the guideline has a constant tension between public health benefits versus patient benefits. This issue is minimally addressed in the guideline and comes very late. Workgroup members felt it is important to directly address this tension between risks and benefits to public health versus individual patients.”
Although voluntary and only intended for primary care physicians treating chronic pain, the 2016 guideline’s recommended dose limits for opioids were quickly adopted as policy by many states, insurers, law enforcement, pharmacies and doctors of all specialties.
As a result, many pain patients who took opioids safely for years were cutoff or tapered to lower doses. Many new patients who need pain relief can’t even get opioids because their doctors refuse to prescribe them. Opioid prescriptions have fallen to their lowest level in 20 years, but drug deaths continue rising.
Not until 2019 did the CDC publicly acknowledge the “misapplication” of the guideline and promise to make changes – although the process is unfolding slowly. The newly revised guideline is not expected to be released until late 2022.
“We heard the concerning reports about the misapplication of the 2016 guideline and we’ve learned from what happened. We know there is a very real possibility that, even with adjustments, the guideline update could be misused.”
“We heard the concerning reports about the misapplication of the 2016 guideline and we’ve learned from what happened. We know there is a very real possibility that, even with adjustments, the guideline update could be misused,” said Deborah Dowell, MD, Chief Medical Officer of the CDC’s National Center for Injury Prevention and Control (NCIPC), who co-authored the original guideline.
Dowell gave a brief outline of the guideline update to the BSC, noting that it’s recommendations are being expanded beyond chronic pain to include acute pain (pain lasting less than one month) and sub-acute pain (pain lasting 1 to 3 months).
She also disclosed the names of the five co-authors who are writing the update, briefly showing their names on a slide. They include Dowell herself, Kathleen Ragan, a CDC Health Scientist; Christopher Jones, PharmD, Acting Director of NCIPC; Grant Baldwin, PhD, Director of Overdose Prevention at NCIPC; and Roger Chou, MD, Director of the Pacific Northwest Evidence-based Practice Center at Oregon Health & Science University (OHSU), which has received billions of dollars in research funding from the federal government.
The inclusion of Chou as an update co-author is likely to be controversial. As PNN has reported, Chou has been an outspoken critic of opioid prescribing and has numerous ties to Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group. Like Dowell, Chou was a co-author of the 2016 guideline.
“It is wildly inappropriate and unethical that someone with strong ties to the anti-opioid industry and who has significant financial conflicts of interest is leading this process,” Amy Partridge, an intractable pain patient, told the BSC. “The evidence review and guidance are therefore both inherently biased and should be struck in their entirety.”
Chou — who is a member of the BSC — acknowledged he has a conflict of interest at the start of the meeting and recused himself. “I do have a conflict. I receive funding to conduct reviews on opioids, and I'll be recusing myself after the director's update,” said Chou.
Chou’s recusal apparently only applied to his participation in the meeting, not to his continuing involvement in the guideline update or OHSU’s research.
Dose Recommendations Questioned
Some members of the Opioid Workgroup feel the current draft of the update is “not sufficiently patient-centered,” while others believe not enough attention was paid to disparities in pain care and lack of access to effective, non-opioid treatments.
One of the biggest issues for the workgroup is the revised guideline’s recommendation that initial opioid doses be limited to 50 morphine milligram equivalents (MME) per day and not be increased above 90 MME, which is essentially unchanged from the 2016 guideline. The workgroup believes the dose thresholds are arbitrary, based on poor evidence and should be “de-emphasized.”
“Many workgroup members voiced concern about the dose thresholds written into the recommendation. Many were concerned that this recommendation would lead to forced tapers or other potentially harmful consequences. Though workgroup members recognized the need to have thresholds as benchmarks, many felt that including these thresholds in the supporting text could serve to de-emphasize them as absolute thresholds, and thus recommended removing the specific MME range from the recommendation,” the report found.
Dowell said the MME thresholds are only meant to be “a rough guide” and shouldn’t been seen as “absolutes.”
“We certainly are looking at language in the guideline and also looking at feedback about how to better communicate those nuances and their flexibility,” she told the BSC.
Worries About ‘Bad Policy’
Several workgroup members have issues with the recommendation that non-opioid therapies be used for “many common types of acute pain,” because it doesn’t distinguish between post-surgical pain that may require opioids and other types of short-term trauma that could be treated with non-opioid pain relievers. They warned the recommendations for treating acute pain “could be misinterpreted and translated into bad policy.”
The workgroup also took issue with recommended drug testing for anyone prescribed opioids for chronic pain. Their report says false results from urine drugs tests are common and could have “inappropriate negative consequences” for patients, while more accurate and expensive laboratory tests may not be covered by insurance.
Questions were also raised about prescription drug monitoring programs (PDMPs), particularly the use of algorithms and data mining to create risk scores for patients based on their drug history.
It's important to note that the workgroup’s role is strictly advisory. It had no direct role in writing the revised guideline and will not be involved in rewriting it, if changes are even made.
You can watch most of the meeting below (video courtesy of Peter Pischke):
The workgroup’s report drew both criticism and praise during the public comment period. Some speakers believe the guideline can’t be fixed and should be repealed.
“No matter the intent, goal or method that the CDC may desire with these guidelines and their purpose in the American healthcare system, the DEA will still manipulate them to serve their way,” said Margaret Rene Blake, a pharmacist and intractable pain sufferer. “As long as they exist, they can and will be misapplied. The way to stop the harm to patients, providers and the system is to repeal the guideline.”
One critic suggested the workgroup volunteers, who were unpaid, were swayed by the pharmaceutical industry.
“The OWG (Opioid Workgroup) comments perpetuate myths disseminated by opioid manufacturers. Claiming that the guideline focused heavily on the risks or potential harms of opioids, while less attention was focused on the potential benefits is certainly an industry friendly view,” said Adriane Fugh-Berman, MD, Director of PharmedOUT and a PROP board member, who was a paid expert witness in Oklahoma’s lawsuit against opioid manufacturers.
“Several statements in the OWG (report) are just wrong, including the claim that continuing and not tapering opioids avoids risks of poor analgesia, worsening function and suffering.”
Without seeing the revised draft guideline in its entirety, it’s hard to tell if any significant changes have been made to the original guideline. But judging from the workgroup’s report, the changes have been minor so far. The draft guideline continues to maintain that “nonopioid therapies are preferred” for both short and long-term pain, and that doctors should only consider opioids “if expected benefits for pain and function are anticipated to outweigh risks to the patient.”
There is also no indication what the CDC intends to do to persuade states, insurers, pharmacies, doctors and other federal agencies that they should amend opioid policies and laws that are based on the 2016 guideline.
