CDC Won’t Say Who Is Writing Update of Opioid Guideline
/By Pat Anson, PNN Editor
When the Centers for Disease Control and Prevention released the draft version of its opioid prescribing guideline in September 2015, the agency was roundly criticized for its secrecy and lack of transparency.
There were no public hearings. The CDC initially refused to identify who wrote the guideline or who its advisors were. And the public was given just 48 hours to comment on the guideline after a botched online webinar that presented only a summary of the recommendations.
After a congressional investigation and threats of a lawsuit for “blatant violations” of federal laws, the CDC changed course and opened up the guideline to public scrutiny and a 30-day comment period. After a few minor changes, the guideline was released in March 2016.
Five years later, after a tsunami of complaints that the guideline’s recommended dosage limits have been harmful to patients and failed to reduce opioid addiction and overdoses, the CDC is now in the process of rewriting the guideline.
There’s more transparency this time around. The public was given an early invitation to comment and nearly 5,400 people wrote to the CDC about their concerns. The agency also released the names of the “Opioid Workgroup,” a diverse group of physicians, academics and patients that is advising the agency as it updates the guideline.
But one thing hasn’t changed: the CDC won’t identify who is writing the guideline update.
“Primarily CDC scientists are involved in drafting the update,” Courtney Lenard, a CDC spokesperson, explained in an email to PNN. “Many CDC staff are working on the process of updating the 2016 Guideline, including reviewing the scientific evidence; analyzing patient, caregiver, and provider input gathered during the public comment period and conversations held earlier in 2020; and drafting its content.”
The updated guideline will be only reviewed by the Opioid Workgroup, which has been given no direct role in writing it or in making revisions. The workgroup is expected to give its recommendations to the Board of Scientific Counselors at the CDC’s National Center for Injury Prevention and Control sometime this summer.
“At that time the authors of the draft Guideline will also be announced,” said Lenard, adding that the public likely won’t see the draft until late 2021, when it is published in the Federal Register.
Potential Conflicts of Interest
Only after another round of public comments will the revised guideline finally be released in 2022 – a full six years after the initial guideline. Some patient advocates worry about a lack of urgency at CDC and that too much is occurring behind closed doors.
“I remain concerned about an ongoing lack of transparency in the development of an update to the CDC Pain Guidelines,” said Dr. Chad Kollas, a palliative care specialist in Florida. “There will be no disclosure about the authorship of the revised guidelines until their release, which effectively eliminates the opportunity to challenge any of their authors’ potential conflicts of interest proactively.”
“The CDC has put together a writing team without addressing transparency or conflicts of interest to our satisfaction,” says Terri Lewis, PhD, a patient advocate and researcher. “This is unacceptable and nonresponsive to the concerns that have been so clearly expressed by both the patient community and the medical communities since 2016.”
The CDC’s evasive response about who is writing the update raises the possibility that the three authors of the original 2016 guideline are working on the revision: Deborah Dowell, MD; Tamara Haegerich, PhD; and Roger Chou, MD.
In 2019, the trio penned an awkward defense of the guideline in The New England Journal of Medicine, in which they admitted the “misapplication” of guideline was causing harm to patients, but deflected taking any responsibility for it.
Chou’s involvement in the updated guideline would be particularly alarming to critics, because of his advocacy for opioid tapering and collaboration with Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group.
“I'd give long odds that Roger Chou is a member of the current CDC writers group,” says Richard Lawhern, PhD, a prominent advocate in the pain community. “Talk about giving the fox the keys to the hen house!”
In addition to his work on the 2016 guideline, Chou has authored numerous articles on pain management in peer-reviewed medical journals, many of them critical of opioid prescribing.
Chou is listed as an “external reviewer” on a PROP guide promoting “Cautious, Evidence-Based Opioid Prescribing” that at one time was posted — unedited — on the CDC’s website.
In 2019, Chou co-authored an article with PROP President Dr. Jane Ballantyne and PROP board member Dr. Anna Lembke that encourages doctors to consider tapering “every patient receiving long term opioid therapy.”
And in 2011, Chou co-authored another op/ed with PROP founder Dr. Andrew Kolodny and PROP vice-president Dr. Michael Von Korff, calling for a major overhaul of opioid guidelines, which were then primarily written by pain management specialists.
“Guidelines for long-term opioid therapy should not be developed by the field of pain medicine alone. Rather, experts from general medicine, addiction medicine, and pain medicine should jointly reconsider how to increase the margin of safety,” Chou and his co-authors wrote, a call to action that came to pass five years later at CDC with a guideline that he helped write.
“I do not believe the CDC should be writing opioid guidelines,” says Dr. Lynn Webster, a PNN columnist and past president of the American Academy of Pain Medicine.
“The authors of the CDC guideline should not have been tasked with creating the guideline for a few reasons. First, this was outside their areas of expertise. Second, they failed to understand how misguided arbitrary limits of morphine milligram equivalents were in recommending dosing to people in pain. Third, they lacked compassion for people in pain and an understanding that, for some patients, opioids were the only effective, available treatment.”
Should Chou Be Recused?
Chou is a primary care physician who heads research at the Pacific Northwest Evidence-based Practice Center at Oregon Health & Science University. He was the lead investigator for a recent report by the Agency for Healthcare Research and Quality (AHRQ) that found opioids have only “small beneficial effects” when prescribed for chronic pain and “do not appear to be superior to nonopioid therapy.”
Chou’s report, along with four other AHRQ reviews of pain therapies, were commissioned by the CDC. The reports are being used as key resources by the agency as it updates and possibly expands the opioid guideline to include recommendations for opioid tapering, short-term acute pain, migraine and other pain conditions.
Some advocates believe Chou is so biased against opioids he should be recused from any further work on the guideline.
“I agree with that. He’s clearly published things and said things. He is not objective on dealing with people who need high dose opioids. It’s just as simple as that. He’s going to oppose anything that allows people to take opioid drugs,” says Forest Tennant, a PNN columnist and intractable pain expert. “They never put people on there who are for opioids. It’s always against.”
“Absolutely he should (be recused). Dr Chou is in the position of being given an opportunity to defend his earlier misdirected, unscientific, and ethically unsound work by influencing the revised guidelines to confirm his earlier positions. This is a ‘professional’ self-interest at least equally as meaningful of any financial relationship,” said Lawhern.
“The harm the 2016 guideline caused should be sufficient reason to find a new group of individuals to work on the updated recommendations. Having the same authors work on the same guidelines makes it almost inevitable that the same mistakes will be made,” says Webster.
“To paraphrase Albert Einstein, it is insanity to do the same thing again and expect different results. If you want better results, you have to do something differently. I can see that the updated guideline will lack consideration for patients as individuals, just as the 2016 guideline did.”
For much of the past year, the CDC has been preoccupied dealing with fallout from the COVID-19 pandemic. The agency’s once-sterling reputation has been damaged by political interference and shifting recommendations on how to control the virus. The agency’s focus in 2021 is likely to remain on COVID-19.
Pain sufferers and their advocates worry that revising the opioid guideline will not be a top priority at CDC, and that many of the same mistakes made five years ago are being repeated.
“There is no indication that CDC is treating this with the respect it deserves or with the scientific rigor it demands in spite of mounting evidence that the management of prescription opioids in the USA is 'going off the rails' and that very real systemic and structural harms are accruing to patients and the health care delivery system in general,” says Terri Lewis.
“I think it fair to say that we all fear that, based on what we are aware of at the moment, this next round of 'revision' will simply amount to an 'expansion' into territory for which there is almost no verifiable evidence and very weak support in the existing literature.”
