JAMA: Patients on Long-Term Opioids Often ‘Irrational’

By Pat Anson, PNN Editor

Do pain patients on long-term opioid therapy make irrational decisions? Is their mental capacity so diminished by opioids that they shouldn’t be involved in treatment decisions with their doctors?

The answer to both questions is often yes, according to a controversial new op/ed published in JAMA Internal Medicine. At issue is a recent update to the CDC’s opioid prescribing guideline, which calls for shared decision-making (SDM) when a prescriber considers tapering a patient or abruptly discontinuing their opioid treatment. The guideline was revised last year after reports of “serious harm” to patients caused by forced tapering.

“In situations where benefits and risks of continuing opioids are considered to be close, shared decision-making with patients is particularly important,” the 2022 guideline states.

But that advice about consulting with patients goes too far, according to the lead author of the JAMA op/ed, Mark Sullivan, MD, a professor of psychiatry at the University of Washington and a longtime board member of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group.

“The value of SDM has been recognized for many years but also has its limitations, including where patients make irrational or short-sighted decisions,” Sullivan wrote. “Long-term opioid therapy induces a state of opioid dependence that compromises patients’ decisional capacity, specifically altering their perception of the value and necessity of the therapy; and although patients with chronic pain are not usually at imminent risk of death, they often can see no possibility of a satisfying life without a significant and immediate reduction in their pain.”

Sullivan and his two co-authors, Jeffrey Linder, MD, and Jason Doctor, PhD, have long been critical of opioid prescribing practices in the U.S. In their conflict of interest statements, Sullivan and Doctor disclose that they have worked for law firms involved in opioid litigation, a lucrative sideline for several PROP members.

Sullivan, Linder and Doctor call for more “structured” decision-making that includes the patient’s family and friends, “motivational interviewing” of patients about opioid risks and treatment goals, and education about non-drug alternatives such as yoga and meditation.

“We believe that a fully individualized, unstructured decision-making process will not be adequate to protect patients receiving long-term opioid therapy,” they wrote.

“In the case of opioid prescribing, and especially opioid tapering, working to persuade the patient is almost always the best clinical strategy. But there are circumstances where tapering should occur even if the patient objects.”

— Dr. Mark Sullivan

And what happens if a patient refuses to have their dose reduced? The op/ed doesn’t explicitly state it, but in an email to PNN, Sullivan said forced tapering would be acceptable in some situations.

“In the case of opioid prescribing, and especially opioid tapering, working to persuade the patient is almost always the best clinical strategy. But there are circumstances (opioid use disorder, diversion, serious medical risks) where tapering should occur even if the patient objects,” Sullivan wrote.

Opioid diversion by patients is actually rare. The DEA estimates that less than one percent of oxycodone (0.3%) and hydrocodone (0.42%) will be used by someone they were not intended for.

As for patients on opioids behaving “irrational,” Sullivan and his co-authors cite an op/ed published 33 years ago in The New England Journal of Medicine (NEJM). But that article doesn’t even discuss opioids or tapering, it’s about whether patients and doctors should collaborate in making decisions about end-of-life medical care.  It also makes an important disclaimer that “even the irrational choices of a competent patient must be respected if the patient cannot be persuaded to change them."

Sullivan rejects that approach to opioid treatment.

“We cite (the NEJM article) to demonstrate that SDM does not exclude or prevent irrational decisions,” he wrote in his email.  “You are right that we do not endorse the conclusion you cite, that patient’s irrational decisions must be respected.”

In a rebuttal to Sullivan’s op/ed also published in JAMA Internal Medicine, Mitchell Katz, MD, and Deborah Grady, MD, dispute the notion that a patient’s choices shouldn’t be respected.

“Primary care professionals generally highly value the inclusion of the patient’s perspective in decision-making, consistent with the principles of patient autonomy and self-determination, and are loathe to go against a patient’s wishes,” they wrote.

“As primary care professionals, we have found it helpful to tell patients that it is not recommended to take more than a specific threshold of opioids and that we do not want to prescribe something that is not recommended. However, that does not mean sticking to rigid cut points for dose and duration of opioid use, abandoning patients, or having them undergo too rapid a taper.”

Others questioned JAMA’s decision to publish Sullivan’s op/ed.

“While I recognize the editors’ legitimate intellectual interest in providing a forum for open discussion on the opioid policy space, I question their decision to publish an editorial that represents an ongoing call for broad, ill-defined reductions in opioid prescribing,” said Chad Kollas, MD, a palliative care specialist who rejects the idea that patients shouldn’t be involved in their healthcare choices.

“Errantly embracing a lower evidentiary standard for medical decision-making capacity creates an unacceptable risk for harm to patients with pain by violating their rights of medical autonomy and self-determination.”

Opioids were once commonly prescribed in the U.S. for both acute and chronic pain, but those days are long over. Opioid prescribing has been cut in half, to levels not seen since the 1990’s. And many patients today have trouble just getting their prescriptions filled at pharmacies due to opioid shortages.

Despite that, fatal overdoses have climbed to record levels, with illicit fentanyl and other street drugs involved in the vast majority of drug deaths, not prescription opioids.

How Supporters of CDC Opioid Guideline Hijacked Public Hearing

By Pat Anson, PNN Editor

A public hearing on the CDC’s controversial opioid guideline was dominated by anti-opioid activists, who took most of the speaker slots after being tipped off about the hearing by CDC insiders, PNN has learned.   

At issue is a January 28, 2016 public hearing in Atlanta by the CDC’s Board of Scientific Counselors (BSC), an advisory panel that later voted unanimously to recommend the agency’s guideline, which discourages doctors from prescribing opioids for chronic pain. At the time, the CDC was under growing criticism for the secretive process used in drafting the guideline, which allowed for little input from the public, pain specialists and patients.

Faced with a congressional inquiry and accused of “blatant violations” of federal law, CDC postponed release of the guideline, opened a 30-day public comment period, and announced plans for a public hearing. But that hearing was essentially hijacked by anti-opioid activists who were alerted by Dr. Roger Chou, one of the guideline’s co-authors.

PNN has obtained a January 8, 2016 email from Chou to Dr. Andrew Kolodny, Executive Director and founder of PROP (Physicians for Responsible Opioid Prescribing), PROP president Dr. Jane Ballantyne, PROP vice-president Dr. Michael Von Korff, and PROP board member Dr. Gary Franklin. Chou wanted to make sure PROP members and other guideline supporters spoke at the Jan. 28 hearing.

“I was hoping you could help spread the word for folks who are willing and able to help provide some balanced public comments; otherwise much of the public comments are going to be dominated by pharma. The CDC guideline is going to come under a lot of scrutiny by Congress and others so comments coming from credible people would be of great help,” Chou wrote in his email.

“The public comment period at the meeting is 90 minutes long and those who wish to speak must sign up in advance; the slots are first come, first serve, so those who want to do this they will need to sign up quickly as I’ve been told that pharma is already gearing up to take as many slots as they can.”

Kolodny responded quickly to Chou’s email, urging Ballantyne and the other PROP members to sign up as speakers. Although a public notice about the CDC hearing was not officially published in the Federal Register until January 11 -- three days later – the notice was put on “public display” in the Federal Register on Jan. 8, along with a link that allowed speakers to sign up early.

“We need to register ASAP if we hope to get a spot to give oral remarks (which can be done over the phone). I think it’s best for Jane to give remarks for PROP,” Kolodny wrote in an email of his own. “You don’t need to include a full written statement, just mention that you intend to speak in favor of the draft guideline and the need for promoting more cautious opioid use.”

Although the public notice asked that “each organization register one speaker to represent their organization,” PROP wound up having four speakers at the Jan. 28 hearing: Kolodny, Ballantyne, Franklin and Dr. David Juurlink. Franklin registered on Jan. 8, identifying himself as a representative of “Washington State public agencies.” Juurlink signed up as a representative of the “University of Toronto and American College of Medical Toxicology” and Kolodny identified himself as “Chief Medical Officer, Phoenix House Foundation.” Only Ballantyne signed up as representative of PROP.

The four PROP members were joined by over two dozen other guideline supporters, including Gary Mendell, Judy Rummler, Pete Jackson and other anti-opioid activists who have lost children to opioid overdoses. They urged CDC not to change the guideline by “watering it down” or removing dose limits.  

“The CDC guideline is urgently needed. The guideline was very carefully crafted using the best available evidence, expert opinion from a group of individuals with extensive experience of writing practice guidelines, and stakeholder input from a broad and balanced group of stakeholders,” Ballantyne said in her written comments.

“Primary care needs guidance on opioid prescribing that is free of industry bias. The CDC guideline accomplishes this. Evidence shows that the widespread use of opioids for chronic pain is harming more people than it is helping,” said Kolodny, according to minutes of the hearing.

Only four people spoke in opposition to the guideline. One was Howard Techau, a pain patient who pointed out that most overdoses were caused by illicit fentanyl, not pain medication. “Many chronic pain patients are suffering more now due to the (opioid) restrictions that are already in place,” said Techau, according to the hearing minutes.

The hearing ended with BSC chair Dr. Stephen Hargarten thanking the participants for their “extraordinary discussion and input from a variety of perspectives.”

‘Stacking the Deck’

A pain patient who registered for the hearing but was not given a chance to speak was Anne Fuqua. She encouraged dozens of other patients to attend and register as speakers, helping some to fill out their online registration forms. When the hearing ended and none of them were called upon to speak, she remembers feeling the hearing was rigged and stacked against patients

“The whole process felt like such a concerted effort to railroad patients,” Fuqua told PNN. “I remember at the time us saying we felt like it was beyond the realm of chance that they randomly selected the speakers.

“Aside from the 4 PROPers, it just doesn’t seem possible that supporters would have been this successful in flooding the sign-in ahead of everyone else.”

The CDC disputes the notion that anyone at the hearing who was pre-registered was denied an opportunity to speak.

“A total of 37 individuals pre-registered for the meeting and, of those, 30 requested to give oral public comment.  During the 90 minutes allotted for public comment, participants were called on in the order that they registered.  After individuals that had pre-registered were given the opportunity for public comment, public comment was opened to others for the remaining time. One additional person provided public comment at that time,” Courtney Leland, a CDC spokesperson, said in a statement to PNN.

“I don’t understand how they could possibly say only 30 registered to provide public comments. There were so many patients who told me they registered at the time and I registered way more than 30 people myself,” says Fuqua, who provided dozens of donated cell phones to nursing home residents so they could call in.

Others questioned the “first come, first served” process used by CDC to sign-up speakers, which could be easily manipulated by anyone given advance notice.

“The first come-first served method necessarily gives advantages to groups that hire lobbyists to track Federal Register postings, and, apparently, groups that have an inside connection who can alert them to the opportunity,” said Bob Twillman, PhD, former Executive Director of the American Academy of Pain Management. “Individual patients and even patient advocacy organizations are not going to have the resources to find out about these opportunities until the very limited number of slots are filled. CDC needs to seriously re-think this method of filling spots if they do anything like this in the future.”

‘Forward This Announcement to Others’

At least five PROP board members were involved in advising the CDC during the guideline’s development, so it is not clear why they were given yet another chance to express their opinions. Ballantyne and Franklin were members of a key guideline advisory panel known as the Core Expert Group; Dr. David Tauben was on the guideline’s peer review panel; and Kolodny and Juurlink were on a stakeholder review group.

Kolodny has tried to downplay PROP’s role in drafting the opioid guideline, but Chou’s email is direct evidence that there was some degree of collusion.

When asked why he contacted PROP and other organizations to give them an early heads-up about the hearing, Chou said he did so at the request of the CDC. A CDC staffer emailed Chou and other “Partners” involved in the guideline process, urging them to “forward this announcement to others who may be interested in commenting.”

“The information I forwarded to those folks and others was from an email that I received from CDC on January 8 that had been sent out widely to partners/stakeholders. Not sure why there would be any prohibition on sharing that information, which was public,” Chou wrote in an email to PNN.

But the information was not yet public, at least not widely. CDC never sent out a press release about the hearing and the public notice that was in the Federal Register probably wasn’t seen by many people outside of lobbyists.      

“Chou can say all he wants that this justified his efforts to stack the deck, but it also shows CDC was complicit,” says Fuqua.

“The fact that CDC would encourage people to publicize the availability of this speaking opportunity prior to publication in the Federal Register, especially when they were using a first come-first served selection method, is problematic,” said Twillman. 

“It is shameless that Roger Chou gave PROP a head start to prepare. It’s like an author writing their own book reviews,” said Julie Killingworth, a pain patient and independent researcher who helped PNN track the 2016 emails, which were obtained by another journalist through the Freedom of Information Act.  

“PROP members and their cohorts like Chou have proven beyond doubt they will always resort to cheating and lying to promote and profiteer their destructive scientifically faulty agenda. The CDC has unapologetically shacked up with a shadowy lobbying group, endangering the health and well-being of all citizens.”  

As for Chou’s warning that pharma was “gearing up to take as many slots as they can” at the hearing -- not a single representative from the pharmaceutical industry spoke. Pharma did not “dominate” the hearing as Chou predicted, PROP and other guideline supporters did.

Outspoken Critic of Opioids

All of this happened six years ago and may seem like “inside baseball” trivia to people unfamiliar with the CDC and its opioid guideline. But for this reporter and others who have followed the issue for years, it has a familiar ring.

Chou is a prolific researcher who heads the Pacific Northwest Evidence-based Practice Center at Oregon Health & Science University, which over the last five years has received over two billion dollars in research grants from the federal government, much of it spent studying pain management therapies.

Most public health researchers keep a low profile to avoid accusations of bias, but Chou has long been an outspoken critic of opioid prescribing. In a 2019 podcast, for example, Chou said the benefits of opioids were “clinically insignificant” and that the medications are often harmful.

Chou has also collaborated on several prior occasions with PROP. In 2019, he co-authored an op/ed with Ballantyne and PROP board member Dr. Anna Lembke that encourages doctors to consider tapering “every patient receiving long term opioid therapy.”

DR. ROGER CHOU

In 2011, Chou wrote another op/ed with Kolodny and Von Korff, calling for a major overhaul of opioid prescribing guidelines, which were then mostly developed by pain management societies. That major overhaul came in 2016, when the CDC released its own guideline, which was quickly adopted by many states, insurers, physician groups and even law enforcement agencies.

Opioid prescribing fell dramatically as a result, yet drug overdoses rose to record levels, and many pain patients were tapered off opioids or abandoned by doctors who feared prosecution for prescribing the medications. Patients who once led productive lives while on opioids became unable to work, disabled and bedridden. Even the CDC admits the guideline has been harmful to patients and is in need of overhaul.    

Patients may be suffering and overdoses keep rising, yet several members of PROP have done well for themselves. At least six PROP board members have worked for plaintiff law firms involved in opioid litigation, making as much as $850 an hour. Kolodny, by his own admission, was paid up to $500,000 for testifying in one trial.

‘Compromised by Conflicts’

To this day, Chou remains heavily involved with the CDC. He is one of five co-authors drafting a revised and more “flexible” version of the guideline, which is expected for release later this year. He is also now a member of the CDC’s Board of Scientific Counselors. Critics say Chou’s biases and conflicts of interest are excessive and he should be removed from both roles.

“Based on growing evidence from our own research and many credible sources, the CDC inappropriately collaborated with Chou and leaders from the advocacy group PROP, to create and vigorously promote unfocused reductions in opioid prescribing,” says Dr. Chad Kollas, a palliative care physician who co-authored research critical of Chou’s “undisclosed” conflicts and PROP's role in helping to draft the guideline.

“The creation process for the 2016 Guideline lacked transparency and repeatedly violated CDC’s internal rules and policies addressing relevant conflicts of interest, thereby compromising its scientific integrity and its authors’ credibility. While the draft of CDC’s 2022 Clinical Practice Guideline on Prescribing Opioids for Pain seeks to mitigate growing patient harms from the 2016 Guideline, it is difficult to understand why CDC continued to allow Chou, compromised by ongoing conflicts of interest, to lead its effort to improve its failed opioid policy.”

Distrust of the CDC runs deep in the pain community. In a PNN survey of over 2,500 patients, providers and caregivers earlier this year, nearly 96% said they do not trust the agency to handle the revision of the guideline in an unbiased and scientific manner.

This week, an open letter signed by over 35,000 people was delivered by patient advocate Tamera Stewart to the office of Chris Jones, Acting Director of the CDC’s National Center for Injury Prevention and Control. The letter says the 2016 guideline is so deeply flawed and compromised by ethical violations that it should be completely withdrawn and revoked, without any revisions.

Stewart, who is Policy Director for the P3 Alliance, is also asking Congress to investigate the CDC’s alleged violations of federal procedure and scientific methods during the development of the original and revised versions of the guideline.

CDC Director Dr. Rochelle Walensky recently announced plans to reorganize the agency due to mistakes made during its handling of the Covid pandemic, with the goal of improving communication with the public and changing CDC culture. Walensky put three senior CDC officials in charge of a “top-to-bottom review” of the agency.

One of them is Acting Deputy Director Dr. Deb Houry, the former director of the National Center for Injury Prevention and Control, who oversaw the drafting and rollout of the 2016 guideline. Houry will likely be reviewing the work of Dr. Deborah Dowell, who was chief medical officer for the CDC’s Covid Response team. Houry is already very familiar with Dowell, who co-authored both the 2016 guideline and the revised guideline that is awaiting release.  

What Do You Think About Changes to CDC Opioid Guideline?

By Pat Anson, PNN Editor

Do you think the proposed changes to the CDC’s opioid guideline are an improvement over the original 2016 guideline? Will the changes make doctors more or less willing to prescribe opioids? Should the guideline be expanded to include recommendations for treating conditions like migraine and low back pain?

Those are some of the questions we’re asking in a new PNN survey on the long-awaited draft revision of the guideline that was unveiled last month by the CDC.  In addition to giving healthcare providers more flexibility in using opioid medication to manage chronic pain, some experts say the changes effectively transform the guideline into a national “standard of care” for pain management – one that would apply to most doctors and patients, regardless of the severity or duration of their pain.

While the guideline changes have been applauded by professional societies like the American Medical Association for removing “arbitrary doses thresholds” for opioids, some worry that the expansion goes too far and could harm patients -- like the original guideline did -- by depriving them of effective pain treatments.

“The CDC is outside its lane to be recommending how physicians should practice pain medicine. Would they recommend how to treat hypertension or diabetes? If they did, it too would be inappropriate, unless it was in collaboration with one or more of the medical professional societies devoted to those areas,” says Lynn Webster, MD, Senior Fellow at the Center for U.S. Policy and past president of the American Academy of Pain Medicine.

“I have a lot of concerns about the new version. It is better, but still terribly misleading and not grounded in science, which is terrible disappointing.” 

90 MME Threshold Dropped

Perhaps the biggest change to the 2016 guideline is the CDC’s decision to drop a recommendation that opioid doses not exceed 90 morphine milligram equivalents (MME) per day, which quickly became a hard limit for many providers, insurers, states and regulators.

While the CDC still recommends caution about doses exceeding 50 MME, that advice is not enough for Lewis Nelson, MD, a longtime critic of opioid prescribing who advised the agency when the original guideline was created. He thinks the 90 MME limit is based on sound evidence.

“There are good data to support that there is an inflection point at 90 MME. It’s clear that high-dose chronic opioid therapy is associated with a number of adverse consequences -- including addiction, unintentional overdose and potentially death,” says Nelson, the Chair of Emergency Medicine at Rutgers New Jersey Medical School. “In a way, it’s a race to the bottom in pain management, because if you’re not getting better with a reasonable dose of an opioid, there’s nothing to support that additional opioid is going to carry significant benefit and is known to markedly increase the risk.”

Dr. Webster says the use of MME to guide prescribing is misleading because not all opioids are the same or convert well to MME doses. Like others, he worries that 50 MME will become the new hard threshold for opioid doses.

“I think any reference to conversion tables and MME will be interpreted as validation of them. We saw that with the 2016 guideline,” Webster told PNN. “The CDC needs to explicitly state the lack of scientific basis for both and that their use could be dangerous in some cases. They should not cite 50 MME threshold anywhere, as it is meaningless, misleading and will lead to further misapplication of the recommendation. You would think that they would have learned that by the 2016 guideline.” 

Take Our Survey

This is the fifth survey PNN has conducted on the CDC guideline. All of them found that the vast majority of patients and providers believe the guideline was harmful, worsened the quality of pain care, and led some patients to contemplate suicide or turn to street drugs.    

For those who think surveys are a waste of time and the CDC doesn’t pay attention to them -- think again. On Page 53 of its revised opioid guideline, the agency cites PNN’s 2017 survey and has a footnote linking to it:

"An online (non-peer reviewed) survey of over 3000 patients 1 year after the release of the 2016 CDC Guideline found that 84% reported more pain and worse quality of life and 42% said they had considered suicide; however, the survey did not attempt to sample patients with chronic pain using a rigorous methodological approach.”  

It’s true the PNN survey was not peer-reviewed and that patients were not sampled with a “rigorous methodological approach.”  It’s also true that CDC has not conducted a large survey of its own to measure the impact of its guideline on patients. The agency has focused on counting opioid prescriptions — not patient outcomes — as a measure of whether its guideline is working.

To take our new survey, click here.

It should only take a few minutes to complete. We’ll share the results in mid-April.

'This is an opportunity for patients, caregivers, clinicians and others to share their impressions of the 2022 revised and expanded CDC practice guidelines for treatment of acute and chronic pain,” says patient advocate Richard “Red” Lawhern, PhD.

“This guideline will ultimately steer pain care for the foreseeable future, for better or worse. The more involved and informed every part of our community is, the more we can help shape its impact. This survey is one more way to get involved and help guide future efforts,” said Tamera Lynn Stewart, Policy Director for P3 Political Action Alliance.

You can read the revised draft of the CDC guideline and leave an online comment in the Federal Register by clicking here. Comments must be received by April 11.

AMA Says CDC Opioid Guideline Still Harming Pain Patients

By Pat Anson, PNN Editor

It was nearly three years ago that the American Medical Association took its first public stand against the CDC’s controversial opioid prescribing guideline.

The AMA’s House of Delegates adopted resolutions calling for an end to the “misapplication” and “inappropriate use” of the guideline by many states, doctors, pharmacists and insurers who imposed hard limits on the amount of opioid medication patients could get, if they could get it at all. Many were left in excruciating pain.

Last year, the AMA went even further, with a 17-page letter to the CDC warning that it was “clear that the CDC Guideline has harmed many patients.”  

Even the CDC acknowledged the 2016 guideline “has been inappropriately cited to justify hard limits or cutting off opioids” and that cancer and surgery patients were suffering as a result.

To date, all of this hand-wringing has changed nothing, as the AMA’s new president recently acknowledged in an exclusive interview with PNN.

“Reports we get from patients and physicians suggest that problems remain. Despite CDC acknowledging that its guidelines should not be used as hard thresholds, there has been almost no effort by state legislatures, health insurance companies, pharmacy chains, or PBMs (pharmacy benefit managers) to evaluate the harmful effects of these one-size-fits-all laws,” said Gerald Harmon, MD, a South Carolina physician who was elected AMA president last month.

“The AMA continues to receive reports that the laws are used to deny, for example, prescriptions for opioid therapy for patients with cancer or in hospice as well as long-time, stable patients with chronic pain.”

DR. GERALD HARMON

Not only has the guideline harmed innocent patients, it failed to achieve its main goal of reducing the risk of opioid addiction and overdose. Opioid prescriptions have been cut to levels not seen in 20 years, while overdoses soared to record highs, fueled largely by illicit fentanyl and other street drugs, not pain medication.

Guideline Meeting

This month we may finally learn what the CDC intends to do after five years of its failed public health experiment, which has been conducted with virtually no effort by the agency to measure its impact on patients. On July 16, the CDC is expected to release a long-awaited draft of a revised guideline during a meeting of its Board of Scientific Counselors (BSC).

(Update: On July 8th, PNN was notified by CDC that the draft guideline would NOT be made public at the July 16th meeting, even though the agenda indicates most of the day will be spent discussing it.

“The draft updated Guideline will not be shared. The BSC Opioid Working Group report is what will be shared and discussed,” CDC spokesperson Courtney Lenard wrote in an email, adding that the public may not get a chance to see the updated guideline until late this year.) 

Although the CDC’s review of the guideline has been underway since 2019, the agency has disclosed no details about its plans, which may include new treatment recommendations for short-term acute pain, migraines and other chronic pain conditions. Even the AMA is in the dark about what the CDC is planning.

“Without seeing a specific proposal, we can’t speculate on what CDC might be considering. We will continue to work with CDC to ensure that any recommendations respect and support care for patients with pain. This includes encouraging CDC to make any drafts open to the public for comment to ensure that any revisions or additions do not make the same mistakes as the 2016 Guideline,” said Harmon.

One of the “mistakes” the CDC made was releasing the guideline during a secretive, ham-handed webinar. The agency also refused to disclose the names of its outside advisors, which included members of the anti-opioid activist group Physicians for Responsible Opioid Prescribing (PROP).  

As recently as last year, the CDC declined to release memos, conflict-of-interest statements and other communications related to the 2016 guideline. Nearly 1,500 pages of documents provided to PNN under a Freedom of Information Act request were heavily redacted or scrubbed of information. Over 1,200 pages were completely blank. 

The CDC is being a bit more transparent this time around. Early in its deliberations, the agency asked for and received nearly 5,400 public comments, most of them from patients who blame the agency for their poorly treated pain. The CDC also made public the identities of a diverse group of physicians, academics and patients appointed to an “Opioid Workgroup” that is advising the agency. Notably, the group includes no members of PROP.

The CDC has not yet disclosed who is writing the guideline revision, although early indications are that at least one of the original three authors is involved again.

“The AMA’s focus will be to continue to advocate that CDC revise its guidelines in an open, transparent manner,” said Harmon. “We continue to urge that CDC specifically remove recommendations tied to hard thresholds and make clear that its recommendations should not be used in state laws or policies implemented by health insurance companies, pharmacy chains, or PBMs.” 

Once a draft of the revised guideline is completed, there will be another public comment period later this year. The CDC may not finalize and release the updated guideline until early next year.

If you’d like to watch the July 16th CDC meeting online, you can register for it here.