Exclusive: How CDC Will Evaluate the Impact of Its Opioid Guidelines

By Pat Anson

We’ve learned more about a research study the CDC plans to conduct on the impact of its opioid prescribing guideline, which took opioids off the table as a treatment option for millions of Americans suffering from chronic or acute pain. The study was briefly outlined in a public notice published in the Federal Register in October.

It’s been over 8 years since the CDC released its controversial guideline and two years since the agency revised it, after receiving many reports of patient harm, including rapid opioid tapering, withdrawal, poorly treated pain, and suicide.

The agency has released few details on the “mixed-method quasi-experimental design” of the study, the first attempt by the agency to get direct feedback from patients, caregivers and doctors about the guideline’s impact on pain management.

Further details of the study are not coming from the CDC, but from the Office of Management and Budget (OMB), which is evaluating whether the study meets the requirements of the Paperwork Reduction Act, a law that gives OMB broad authority over the collection of data by federal agencies. The CDC’s briefings for the OMB can be found here, here and here.        

“The goal of this research study is to conduct a rigorous, comprehensive evaluation to assess the 2022 CDC Clinical Practice Guideline implementation, uptake, and outcomes. The government will use this information collection to inform CDC efforts and interventions to ensure that Americans have access to safer, effective ways of managing their pain,” the CDC explained.

“We propose conducting an analysis of changes in public and private payers’ policies—e.g., those governing Medicaid, Medicare, private health plans—since late 2022 when the CDC released the Clinical Practice Guideline.”

The study will be conducted over a four-year period and cost nearly $4 million, with much of the work subcontracted to Abt Global, a private research and consulting firm. Abt Global will perform a series of interviews, surveys and focus groups involving patients, caregivers and doctors; as well as dentists, insurers, health system leaders, professional medical associations, and state medical boards.

The DEA and other law enforcement agencies that investigated and prosecuted doctors for “unlawful” opioid prescribing are not included in the study.

The CDC’s previous attempts at evaluating the 2016 and 2022 guidelines relied on data about opioid prescribing rates, not on patient welfare or even whether the guidelines met their primary goal of reducing opioid addiction and overdoses. In that respect, the guidelines have failed. While opioid prescribing has fallen to levels not seen in decades, opioid-related overdoses have nearly doubled since the 2016 guideline’s release.

‘What Has Been Most Effective in Managing Your Pain?’

The CDC is planning an online survey of about 600 doctors (with invitations sent to 3,000) and virtual interviews with 30 of them, asking about their pain management and opioid prescribing practices, as well as any “unintended consequences“ of the agency’s guidelines. Similar questions will be asked of the dentists, insurers, health systems, medical boards, and professional societies.

No interviews or surveys are planned with patients or caregivers. Instead, a series of one-hour focus groups will be conducted involving a total of 135 patients and 90 caregivers, who will receive a $75 gift card as an incentive to participate. The CDC says it will “partner with patient advocacy organizations” to identify participants from their membership lists.

Due to the nature of focus groups, the opinions gathered from patients and caregivers are likely to be viewed as anecdotal or qualitative “perceptions,” not quantitative research.

“We will conduct focus groups with patients to provide an in-depth understanding of a single or small number of cases set in their real-world contexts. Examining the experiences of patients can provide a deeper understanding of real-world behavior within a specific healthcare context to elucidate perceptions of whether and/or how changes occurred in overall treatment and/or pain management, including opioid prescribing,” the CDC said.

The focus groups will be led by Abt Global moderators, who will ask a series of open-ended questions to promote discussion. Notably, there are more questions in the “Patient Focus Group Guide” about non-opioid pain treatments than there are about opioids.

There are also no questions about the CDC’s 2016 guideline. The focus is only on pain management after November 2022, when the revised guideline was released in an attempt to give more flexibility to doctors in using opioids to manage pain.

Focus Group Questions for Patients  

1. What treatments and medications for pain have you tried? What has been most effective in managing your pain?

2. There are a lot of strategies to help with pain. Tell us about your experience with physical therapy or exercise therapy to help with your pain.

3. Counseling or behavioral therapy is often used to help with pain. What has your experience been receiving counseling for pain management?

4. Have you had experience with any other non-medication therapies for pain (e.g., acupuncture)? Can you share your experience with those?

5. Medications other than opioids, such as ibuprofen and acetaminophen, which can be both prescribed or over-the-counter, are also often used for pain management. Tell us your experience with these non-opioid medications to manage your pain.

6. Tell us about your first experience being prescribed opioids for pain. How was your pain after you began taking opioids? What side effects did you experience?

7. When were you initially prescribed opioids for pain? How long were you initially prescribed opioids for? Had you received additional refills for opioids after that first prescription?

8. Have you noticed any changes to how clinicians manage your pain since November 2022? If so, what have you noticed?

9. Give me an example of how the management of your pain has improved since November 2022?

10. Give me an example of how the management of your pain remained the same since November 2022?

11. How has your pain management gotten worse since November 2022?

12. Since November 2022, what other factors may have affected how your pain has been managed, such as a change in primary care clinician or changes in your insurance coverage or changing from a primary care clinician to a pain management specialist?

This kind of detail about the questions, participants and research methods has not been made public before. Only a brief overview of the study was provided in the October 2024 notice in the Federal Register, which the CDC made no effort to publicize to get broad public feedback.

As a result, the notice received only two public comments, one of them a letter from the American Society of Anesthesiologists (ASA). The ASA called the 2022 guideline a “significant improvement” over the 2016 guideline, but added that 40% of its members felt the updated guideline was “ineffective.” There were also criticisms that the guidelines “might lead to reduced access to necessary pain medications.”

The CDC was dismissive of both public comments and said no changes would be made to its study design or methodology.  

“The public comments received did not have specific suggestions that impact any evaluation instruments; therefore, no changes were made to the instruments,” CDC said.      

After Years of Foot Dragging, CDC Plans Review of Opioid Guideline

By Pat Anson

Eight years after releasing its controversial 2016 opioid guideline and two years after revising it, the CDC is finally making plans for a review of the guideline’s impact on patients, caregivers, doctors, and the practice of pain management.

In a notice published in the Federal Register, the CDC said it would open a 30-day public comment period on a “mixed-method quasi-experimental approach” to evaluating the updated 2022 guideline.

In plain English, the CDC plans a web-based survey of about 200 clinicians, and individual interviews with 10 clinicians, 2 dentists, 3 health system leaders, 3 insurers, 3 professional association leaders, and 3 medical board leaders. In addition, CDC will interview up to 15 patients and 15 caregivers in focus groups.

The agency did not indicate how the participants or organizations will be selected, or what questions will be asked.

“CDC is comprehensively evaluating the uptake, implementation, and outcomes of the 2022 CDC Clinical Practice Guideline on evidence-based care for pain management to understand its impact,” the agency said. “The evaluation includes dissemination and impact of the 2022 CDC Clinical Practice Guideline through population-wide changes in prescribing practices for opioids and medications for opioid use disorder.”

This is actually the second time CDC has published a public notice about the guideline review. Only two public comments were received after a similar notice was published in the Federal Register on October 1, which the CDC made no effort to publicize.

‘Timing Is Very Odd’

It’s not clear why a second notice was published during the holiday season and in the final weeks of the Biden administration. CDC did not immediately respond to a request for comment.

“The timing is very odd, and almost everyone missed the opportunity for open comments earlier this year,” said Chad Kollas, MD, a palliative care physician and pain policy expert.

“Few states have backed off from overly restrictive prescribing laws that were created based on the 2016 Guideline. I think that’s the main opportunity here, documenting the failure to implement the revised recommendations in the 2022 guidance. It’s unclear how CDC plans to determine who will get an opportunity to respond in the proposed study, so transparency remains troublesome for them.”

The CDC was slow to acknowledge the harm caused by the 2016 guideline. Although voluntary, the agency’s recommendations were widely implemented as mandatory by states and law enforcement agencies, resulting in patients having their opioid medication reduced or cutoff, and doctors being prosecuted for exceeding the guideline’s dosage recommendations.

To address those issues, CDC issued a revised guideline in 2022. But many of the problems caused by the original guideline linger.

“The 2016 guidelines led to a variety of restrictive policies, including limitations on opioid dosages. These measures created significant barriers for patients trying to access pain care and made it more challenging for physicians to prescribe necessary medications,” Donald Arnold, MD, President of the American Society of Anesthesiologists (ASA) wrote in a letter to the CDC, one of the two public comments made in response to the October 1 public notice.

The ASA surveyed its members on the impact of the 2022 revised guideline. Over half (56%) thought it was “somewhat effective” in reversing the harm caused by the 2016 guideline, while 40% thought it was ineffective.

A PNN survey of over 2,500 patients, providers and caregivers also found mixed reviews of the 2022 guideline. Only 39% of respondents thought it was “improved” or “much improved” over the original guideline.  Most respondents said it was about the same or even worse.

‘Same Problems Still Exist’

The CDC never conducted a comprehensive review on the impact of the 2016 guideline, but it did hire a consulting firm to improve its image after the agency was widely criticized for its secrecy and lack of transparency during the guideline’s development process.

A former CDC epidemiologist was so dismayed by the agency’s lack of accountability that he wrote a book about it, “Greed to Do Good: The Untold Story of CDC’s Disastrous War on Opioids.” Dr. Charles LeBaron says CDC leadership was blinded by its own hubris.

“The problem was not looking at the (guideline) sufficiently quantitatively and then not checking the consequences, or at least responding to the consequences when they're brought to your attention,” LeBaron told PNN. “Many of the same problems continue to exist, even though the personalities are completely different, and there are still significant restrictions on people in chronic pain for no apparent benefit.”

The personalities will change yet again when the Trump administration takes office on January 20. Conservative activists have made clear they want a major restructuring of the CDC, returning the agency to its core mission of collecting and disseminating data on communicable diseases. They want the CDC to stop telling people what to do, and to leave medical guidelines to professional societies and state medical boards.

Women, Elderly and Rural Americans More Likely to Have Chronic Pain

By Crystal Lindell

American women are more likely than men to experience chronic pain and high-impact pain severe enough to disrupt their lives. Americans of both sexes are also more likely to have pain if they live in rural areas, are over age 65, and of American Indian or Alaska Native descent. 

Those are the findings in a new report from the Centers for Disease Control and Prevention, which found that 24.3% of U.S. adults (60 million people) experienced chronic pain in 2023, while 8.5% (21 million) experienced high-impact pain that limited their daily life and work activities. 

What the report doesn’t tell you is that pain rates have risen dramatically since 2016, the year the CDC introduced its controversial opioid prescribing guideline, which drastically reduced patient access to opioids. Not only has the guideline failed to reduce overdoses, it appears to have worsened pain care for millions of Americans.

In 2016, the National Health Interview Survey estimated that 20.4% (50.0 million) of U.S. adults had chronic pain, while 8% (19.6 million) had high-impact chronic pain. What that essentially means is that 10 million more Americans have chronic pain today than in 2016, and 1.4 million more people have debilitating pain.

The CDC report does not speculate about why pain rates have increased, but a recent study that looked at the same survey data offers some insight, suggesting the increase is due to a number of factors, such as long Covid, more sedentary lifestyles, more anxiety and stress, and reduced access to healthcare.

“The widely-cited 20% prevalence of CP (chronic pain) in the adult US population appears obsolete,” wrote co-authors Anna Zajacova, PhD, and Hanna Grol-Prokopczyk, PhD, in medRxiv. “Our findings indicated that chronic pain, already a widespread issue, has reached new heights in the post-pandemic era, necessitating urgent attention and intervention strategies to address and alleviate this growing health crisis.”

While the CDC report neglects to cover the causes of pain, it does provide a detailed look at chronic pain rates by sex, race, age, and location.  For example, researchers found that people aged 65 and older are three times more likely to have chronic pain than young adults, while Whites are more likely to have pain than Blacks, Hispanics and Asians.

Chronic and High-Impact Pain by Sex:

• Women: 25.4% and 9.6%

• Men: 23.2% and 7.3%

Chronic and High-Impact Pain by Age:

• Ages 18–29: 12.3% and 3.0%

• Ages 30–44: 18.3% and 4.9%

• Ages 45–64: 28.7% and 11.3%

• Ages 65 and older: 36% and 13.5%

Chronic and High-Impact Pain by Race: 

• American Indian and Alaska Native: 30.7% and 12.7%

• White: 28% and 9.5%

• Black: 21.7% and 8.7%

• Hispanic: 17.1% and 6.5%

• Asian: 11.8% and 2.6%

Whether you live in a city, suburb or rural area also affects pain rates, with rural Americans significantly more likely to have chronic pain than those who live in cities. In the CDC study, large metropolitan areas of one million or more people are categorized as “central” or “fringe” counties. Medium and small metropolitan areas are counties with 250,000–999,999 people or less than 250,000 people, respectively. Non-metropolitan areas are rural counties with significantly fewer people.

Chronic Pain by Urban Area:

• Large central metropolitan area: 20.5% 

• Large fringe metropolitan area: 22.5%

• Medium and small metropolitan area: 26.4% 

• Non-metropolitan area: 31.4%

The CDC does not address the impact of chronic pain in its bare-bones report. But independent researchers Anna Zajacova and Hanna Grol-Prokopczyk do in their analysis, pointing out that pain “profoundly impacts” physical, mental and cognitive health, as well as employment, relationships, sexual function and sleep. It all adds up to an economic impact of $560-$635 billion annually — more than any other health condition.

“The findings are a call to action for public health professionals, policymakers, and researchers to further investigate the root causes of this increase. Addressing the rise in chronic pain is critical, as pain serves as a sensitive barometer of population health and has profound economic, social, and health consequences,” they wrote.

An Insider’s Perspective on CDC’s ‘Disastrous War on Opioids’

By Pat Anson

Dr. Charles LeBaron is a medical epidemiologist who worked for 28 years at the Centers for Disease Control and Prevention. LeBaron was not directly involved in developing the CDC’s 2016 opioid guideline, but knew colleagues who did and largely supported their efforts to rein in opioid prescribing.

Then LeBaron developed crippling pain from a meningitis infection and learned firsthand how the CDC guideline was harming patients. While hospitalized, he screamed into his pillow at night because a nurse -- following the CDC’s recommendations -- gave him inadequate doses of oxycodone. The pain relief only lasted a couple of hours, and then he had to wait in misery for the next dose.

“I hadn't experienced the pain that so many patients feel, so I hadn't had the level of sensitivity to the issue that would have benefited me. It took full personal experience to straighten me out,” said LeBaron. “You'd rather be dead than in pain. In that bubble of pain, it really is life changing.

“Once you experience that, you tend to view things very differently through a very different lens. At least that was my experience. There was nothing like being in acute pain.”

LeBaron eventually recovered from the infection and no longer needed oxycodone. He also didn’t become addicted. That lived experience made him wonder if the CDC -- his longtime employer – made mistakes in developing the guideline. He came to recognize that the CDC’s push to limit opioid doses was based on weak evidence and the false presumption that many patients quickly become addicted.

Most of all, he was shocked at how quickly the CDC guideline was adopted throughout the healthcare system. He’d never seen anything like it, in all his years at the agency.

“Most of the recommendations we come out with, that people should eat right, exercise or whatever, no one ever bothers doing. We have a tough time getting people to do things. This recommendation? They just had remarkably fast implementation,” LeBaron told PNN.

“I've never seen a recommendation that got implemented that fast and that hard by so many actors. Normally, it’s like herding cats in public health, trying to get everybody involved. And for prescription medications, there are a million cats. There are pharmacies, benefit managers, physicians, insurance and so forth. This thing just took off.”

Now retired, LeBaron decided to write a book about his personal experience with pain, along with a critique of the CDC guideline. “Greed to Do Good: The Untold Story of CDC’s Disastrous War on Opioids” gives a rare insider’s look into how the agency works and thinks.

The word “greed” may suggest there were financial motives behind the CDC guideline, but LeBaron says it’s more a matter of pride and hubris that borders on institutionalized arrogance.

The agency was so caught up in its reputation as the “world’s premier public health agency” -- one that defeated polio, smallpox, HIV and other infectious disease outbreaks -- that it developed an outsized belief that it could do no wrong.

According to LeBaron, that was the mindset that Dr. Tom Frieden had when he was named CDC Director during the Obama administration. While serving as New York City’s health commissioner, Frieden led ambitious campaigns to stamp out tuberculosis, ban smoking in public places, and limit unhealthy trans fats served in the city’s restaurants.  

At CDC, LeBaron says Frieden became “the driving force” behind a campaign to limit opioid prescriptions as a way to reduce rising rates of opioid overdoses.

“I would not attribute vicious and evil impulses to the people who were involved,” says LeBaron. “I think they were gravely mistaken, but not driven by the desire to harm. They conceived of themselves as wanting to do good in a very emphatic fashion.

“The problem here was not the motivation, the notion that if you can kind of reduce prescription opioids, maybe you'll reduce subsequent addiction. The problem was not looking at the thing sufficiently quantitatively and then not checking the consequences, or at least responding to the consequences when they're brought to your attention.”

People working in public health are normally careful about tracking the outcomes of their policies. But before and after the CDC guideline, the agency turned a deaf ear to a chorus of complaints that it was forcing millions of patients on long-term opioids into rapid tapers that resulted in uncontrolled pain, withdrawal and even suicide.    

Worst of all, the number of fatal opioid overdoses doubled to over 80,000 annually after the guideline’s release, an outcome that demonstrated CDC had gone after the wrong target at the wrong time and with the wrong solution.

“The typical person who's having an overdose is a 30-year-old male taking illicit medication. The most typical person who's getting chronic opioids for pain would be a 60-year-old woman with a variety of rheumatological conditions. So you're aiming at a completely off-center target,” LeBaron explained.

“Then subsequently the data started coming in that, in effect, you are worsening the situation. If you take people who really need pain control off their meds, in a sense, it normalizes illegal acquisition.

“If somebody is really in terrible pain, needs opioid medication and can't get it through the legal system, pain is a remarkable motivator. Very few motivators are as strong as pain. And ultimately, somebody will come up to you and say, ‘I know a guy.’ And sure enough, then you end up with completely uncontrolled, unregulated stuff.”

Not until 2022 did the CDC revise its original guideline and give doctors more flexibility in prescribing opioids. By then, its 2016 recommendations were so ingrained in the U.S. healthcare system that the revisions had little, if any, impact.

Frieden left the CDC in 2017. LeBaron says Frieden’s two immediate successors did little to address the overdose crisis and the harms created by the guideline. But he does have hope for the agency’s current director, Dr. Mandy Cohen, because she has experience in public health and a better understanding of the primary role played by illicit fentanyl and other street drugs in the overdose crisis.

Asked if the CDC guideline should be scrapped or withdrawn completely, LeBaron is circumspect. He thinks a review of the guideline is in order, as well as a return to public health policies that are checked and double-checked to make sure they have outcomes that actually work.

“The difficulty here, in my opinion, is many of the same problems continue to exist, even though the personalities are completely different, and there are still significant restrictions on people in chronic pain for no apparent benefit. There continues to be very high rate of overdoses,” LeBaron said.

“I'm kind of a diehard public health guy. I want to see whether anything good happens. Nothing good happened. Time to reconsider.”

What Is CDC Trying to Hide?

By Pat Anson, PNN Editor

The Centers for Disease Control and Prevention made little attempt at openness and transparency when it released a draft version of its controversial opioid guideline in September 2015.

No public hearings were held. Only a select audience was invited to a secretive online webinar in which CDC officials hurriedly outlined the guideline and then refused to answer any questions about it. The guideline wasn’t posted on the CDC website and no copies were made available.

Even more puzzling is that the CDC refused to disclose who wrote the guideline or served on advisory panels such as the so-called “Core Expert Group” that played a key role in drafting the recommendations. Their names leaked out anyway.

What was the agency trying to hide?

Those issues were important five years ago, just as they are today.  While the opioid guideline was only intended as a recommendation for primary care physicians treating chronic pain, it has effectively become the law of the land for all doctors in every specialty – and adopted as policy by states, insurers, pharmacy chains and law enforcement agencies.

As a result, in the name of preventing addiction, millions of pain patients have been cut off from opioids and gone without adequate pain treatment, with an untold number of suffering souls committing suicide.

Only when threatened with a lawsuit and a congressional investigation of the guideline process did the CDC back down, delaying the release of the guideline for a few months. Hearings were held, public comments were accepted, and CDC revealed the names of its experts and outside advisors, including some who had strong biases against opioids.

Five were board members of Physicians for Responsible Opioid Prescribing (PROP), a small but influential advocacy group founded by Dr. Andrew Kolodny, a psychiatrist who was then-medical director of Phoenix House, an addiction treatment chain. PROP President Jane Ballantyne, MD, and Vice-President Gary Franklin, MD, were members of the Core Expert Group, while board member David Tauben, MD, served on the CDC’s peer review panel. PROP member David Juurlink, MD, and Kolodny himself were part of a “Stakeholder Review Group” that provided input to the CDC.

Concerned about the apparent one-sided approach to the guideline, a bipartisan group of congressmen on the House Oversight and Government Reform Committee wrote a letter to then-CDC director Thomas Frieden, a longtime associate of Kolodny.

“We expect CDC’s guidelines drafting process to seek an appropriate balance between the risk of addiction and the need to address chronic pain,” wrote Chairman Jason Chaffetz (R-Utah). “The CDC has utilized a ‘Core Expert Group’ in the drafting and development of opioid prescribing guidelines, raising questions as to whether CDC is complying with FACA (Federal Advisory Committee Act).”

Chaffetz and his colleagues asked Frieden to supply documents and information about the guideline process “as soon as possible.”

‘Some Information Was Withheld’

We were curious about Frieden’s response and filed a Freedom of Information Act (FOIA) request with the CDC last year, asking for “copies of all documents, emails, memos and other communications” that the agency sent in response to Chaffetz’s letter.

The CDC’s reply, received a few weeks ago, is just as puzzling and secretive as the agency’s actions in 2015.  Nearly 1,500 pages of documents provided to PNN were heavily redacted or scrubbed of all information. As a result, over 1,200 pages were completely blank.

“We located 1,449 pages of responsive records and two Excel workbooks (108 pages released in full; 103 pages disclosed in part; 1,238 pages withheld in full). After a careful review of these pages, some information was withheld from release,” Roger Andoh, who heads the CDC’s FOIA Office, wrote in a letter to PNN.

Andoh cited two FOIA exemptions to justify withholding the information. The first exemption protects material under a broad declaration of “deliberative process privilege.” Material that’s in draft form, including a reviewer’s comments and recommendations, can be withheld by the government because they are “predecisional and deliberative.”

The second FOIA exemption cited by Andoh protects information that is private because releasing it would be “a clearly unwarranted invasion of personal privacy.”  

The privacy exemption was applied often to documents from a June 23, 2015 meeting of the Core Expert Group. We can see from the agenda that it was an important meeting, with clinical evidence about opioids reviewed in the morning, followed by a lengthy panel discussion in the afternoon. But we don’t know who said what because the minutes from that meeting have been deleted.

Whenever you see the notations “(b)(5)” or “(b)(6)” appear means that some information was withheld.

SOURCE: cdc foia office

The privacy exemption was also applied to the financial conflict of interest statements filed by all 17 members of the Core Expert Group (CEG). Their names and signatures were redacted, so we have no idea who they were or what conflicts they declared.

One CEG member checked a box indicating they did consulting work for “a commercial entity or other organization with an interest related to controlled substances.” Opioids are a controlled substance and so is Suboxone, an addiction treatment drug. It would be important to know who that person was, but their name was redacted, along with name of the organization they worked for.

The same individual also checked a box indicating they “provided an expert opinion or testimony.” But because the information was redacted, we don’t know if the person was paid for their testimony and, if so, who they were paid by and what the amount was.

Information was also withheld about other CEG members who were given grants, honoraria, and reimbursement for travel and lodging by organizations with an interest in controlled substances. One CEG member was actually employed by such an organization, but we don’t know who that was or who they worked for..

In short, several members of the Core Expert Group had a financial conflict of interest and disclosed it to the CDC, but the agency has decided – five years later -- that information should not be made public.

‘There Was a Cover-Up Here’

We asked three advocates in the pain community to review the documents CDC provided to PNN. All three were puzzled why so much information was withheld.

“I think what they sent is an embarrassment. There is no reasonable or rational explanation to redact any part of a suggested guideline process especially since the CDC admits the guidelines were misapplied and misinterpreted,” said Julie Killingworth, a disabled activist. “I believe the ridiculously heavy number of redactions is a clear admission of guilt. The CDC has committed at least one or multiple federal crimes and the House Oversight Committee needs to closely revisit their December 18, 2015 letter of concern to Dr. Tom Frieden.”

“There was indeed a cover-up here, grounded primarily on the escape clauses in the FOIA enabling legislation which exempts the government from revealing its internal processes or consultations to the public,” said Richard “Red” Lawhern, PhD, who heads the Alliance for the Treatment of Intractable Pain. “Unfortunately, this broad exception to full public disclosure permits agencies to hide their own biases, failures of transparency, or arbitrary decisions.    

“Masking the identities of individuals who contribute to policy can also make it practically impossible to assess bias, conflict of interest, or outright misrepresentation. The extensive redacting of documents raises concern that the reviewing office has engaged in a broad cover-up by masking the identities and professional or personal affiliations of those who contributed to the CDC Guidelines." 

“It could well be that there would be nothing surprising or unseemly in the redacted information. But if you don't want people to think you are trying to hide something nefarious, then the old saying that sunlight is the best disinfectant certainly would seem to apply here,” said Bob Twillman, PhD, a former executive director of the Academy of Integrative Pain Management, who was also a member of the CDC’s Stakeholder Review Group. 

“It's mystifying and sad to me that CDC will not reveal who was involved in the deliberations that led to the issuance of its opioid prescribing guideline, even though they have publicly revealed much of this information elsewhere.” 

Twillman points out that the identities of the Core Expert Group, as well as other advisors and contributors to the guideline, were all published in a JAMA article and by the CDC itself when the final guideline was released in 2016.  

Redacting their names and conflicts of interest, as well as minutes and notes from their deliberations, is likely to fuel long-standing suspicion in the pain community that the guideline process was tainted by bias and that much of the clinical evidence was cherry-picked.

“What's worse for me is the refusal to help people understand the deliberative process that went into drafting the recommendations in the guideline,” says Twillman. “An interesting issue that is probably covered by the redacted material is the decision to reject any evidence except RCTs (randomized controlled trials) when evaluating benefits of opioids, but to accept weaker types of evidence when evaluating harms of opioids. Why did the group decide this was acceptable, and not insist on a level playing field for evidence regarding these two questions?” 

The CDC recently announced plans to update and expand its opioid guideline, most likely to include the treatment of short-term, acute pain. Whether the agency will use more transparency and openness in that process remains to be seen. The updated guideline is expected in 2021.

CDC Considering ‘Update or Expansion’ of Opioid Guideline

By Pat Anson, PNN Editor

When the Centers for Disease Control and Prevention released its controversial opioid prescribing guideline in March 2016, it pledged to study the impact of the guideline on patients, doctors and pain treatment in the United States.

“CDC is committed to evaluating the guideline to identify the impact of the recommendations on clinician and patient outcomes, both intended and unintended, and revising the recommendations in future updates when warranted,” the agency said.

Three and a half years later, after widespread reports of patient suffering, abandonment and suicide, the CDC may finally be getting around to an update. But it may not be what patients and doctors were hoping for.

In a meeting next week of the Board of Scientific Counselors (BSC) for the CDC’s National Center for Injury Prevention and Control (NCIPC), guideline co-author Dr. Deborah Dowell is scheduled to give a 30-minute presentation entitled “Background for Updating the CDC Guideline for Prescribing Opioids.”

According to the agenda for the December 4 meeting in Atlanta, Dowell’s presentation will be preceded by an update from NCIPC Director Dr. Debra Houry, who oversaw development of the opioid guideline. Presentations are also planned on overdose prevention and the formation of an “Opioid Workgroup.”

“CDC is scheduled to give a background presentation for a potential update/expansion of the CDC Guideline,” Courtney Lenard, a CDC spokesperson, said in an email to PNN. “CDC will also request that NCIPC’s BSC establish an Opioid Workgroup to provide expert input and observations on a possible update or expansion of the guideline.”

Public pressure has been building on the CDC to clarify the guideline — but not to expand it. Although voluntary and only intended for primary care physicians treating chronic pain, the guideline’s recommended limits on opioid prescribing have been widely adopted as policy by federal agencies, state governments, insurers, pharmacy chains and many doctors.

The guideline has also been applied to short-term acute pain situations, such as patients being treated for post-surgical pain or emergency room trauma. Last year, CDC Director Dr. Robert Redfield said he wanted the agency to develop opioid prescribing guidelines for acute pain and to use a new enhanced data system to track overdoses in hospital emergency rooms.

“I hope this does not become CDC Prescribing Guideline 2.0. In the original CDC Guideline, the identity of the key expert group was unknown, there were concerns over conflict of interest and secrecy, and legislatures or regulatory agencies eventually adopted the guideline and treated it as gospel despite the limitations stated in the report,” said Stephen Ziegler, PhD, a Professor Emeritus at Purdue University.

Last year the American Medical Association took a stand against the “misapplication” and “inappropriate use” of the guideline -- and adopted a resolution stating that some patients “can benefit from taking opioids at greater dosages than recommended by the CDC.”   

In April, the Food and Drug Administration warned that many patients were being tapered off opioids inappropriately, putting them at risk of withdrawal, uncontrolled pain and suicide. That was followed days later by a pledge from Redfield to re-evaluate the guideline and “clarify its recommendations.”

A clarification is long overdue. In a PNN survey early this year of over 6,000 pain patients and healthcare providers, an overwhelming majority said the guideline was harmful to patients and should be revised.

“Cannot understand or know why the CDC will not speak out on the harm done to undertreated, denied and abandoned patients,” one patient told us.

“The guidelines were written in secret, and the carnage that we predicted has come to pass,” said an emergency medicine physician.

“They should be revoked. People are suffering and committing suicide due to inability to tolerate suffering. This is inhumane,” another provider wrote. “It blemishes CDC’s reputation.”

CDC Funding AHRQ Studies

Instead of getting input from doctors and patients on the impact of the guideline, the CDC appears to be focused on more research to help expand its use. PNN has learned that the CDC is funding three new studies on the effectiveness of opioid and non-opioid therapies — essentially doubling down on previous research that found little evidence that opioids are effective for chronic pain.    

“CDC is funding the Agency for Healthcare Research & Quality (AHRQ) through an interagency agreement to conduct systematic reviews of new scientific evidence that has been published since the Opioid Prescribing Guideline was released,” said CDC’s Lenard. “The reviews will evaluate the effectiveness and comparative effectiveness of opioids, non-opioid pharmacologic therapy, and nonpharmacologic therapy for chronic and acute pain.

“Results of these reviews will help CDC determine whether evidence gaps have been addressed and if the Opioid Prescribing Guideline should be updated or expanded. If a Guideline update or expansion occurs, the development process would include consideration of findings from the systematic reviews and an additional public comment period through the Federal Register once an update or expansion is drafted.”

All three AHRQ studies were awarded on the same day – at an estimated cost of $1.1 million – to the Pacific Northwest Evidence-based Practice Center at Oregon Health & Science University, which is headed by Dr. Roger Chou, one of the co-authors of the CDC guideline.

As PNN has reported, Chou is a primary care physician and longtime researcher who has publicly aligned himself with Physicians for Responsible Opioid Prescribing (PROP), an influential anti-opioid activist group that seeks drastic reductions in the use of opioid medication.  

Chou recently 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.”

Chou also consulted with PROP founder Dr. Andrew Kolodny and other PROP members for Oregon Pain Guidance, an advisory group that claims opioid tapering “will improve the quality of life for the majority of patients.”

DR. ROGER CHOU

It is not clear if PROP members are also involved in the three AHRQ studies, as they were in drafting the CDC guideline. But critics say Chou’s continuing association with PROP raises questions about his impartiality as a researcher.

“For years, we have called out a ‘False Narrative’ that prescription opioids drive the current overdose crisis; current data shows this is demonstrably false,” said Dr. Chad Kollas, a palliative care specialist in Florida. “We have not done as well calling out a “Hidden Narrative,” where PROP-affiliated physicians have wrongly influenced and encouraged the misapplication of federal policy in a way that has systematically harmed vulnerable patients in pain. We must call out their conflicts of interest loudly now.”

As a matter of policy, AHRQ does not release conflict of interest statements or disclose the names of its consultants, investigators and peer reviewers until after its reports are finalized. The AMA is recommending that the agency end that policy.

“We would suggest that AHRQ publish the list of all those involved in any aspect of the report… to help remove any perception of potential conflict,” Dr. James Madara, the AMA’s Executive Director and CEO, wrote in a letter to AHRQ. The letter also urges the agency to clearly state that the opioid epidemic was not fueled by prescription opioids and that its research should not be used to justify tapering.

Draft versions of the three AHRQ studies have been completed and were recently posted for 30 days on the agency’s website. They were removed after a public comment period ended, which is another AHRQ policy. Fortunately, PNN was able to obtain copies before the draft reports were withdrawn from public view.

• Opioid Treatments for Chronic Pain

• Nonopioid Pharmacologic Treatments for Chronic Pain

• Nonpharmacologic Treatment for Chronic Pain

What did Chou and his researchers conclude? The three draft reviews support many of the same conclusions as the CDC guideline — hardly a surprise since Chou helped write the guideline.

“For patients with chronic pain, opioids are associated with small beneficial effects versus placebo but are associated with increased risk of short-term harms and do not appear to be superior to nonopioid therapy. Evidence on intermediate-term and long-term benefits remains very limited and additional evidence confirms an association between opioids and increased risk of serious harms,” one draft says. 

“Findings of this review, with expansion of scope to include short-term trials, support the recommendation in the 2016 CDC guideline that opioids are not first-line therapy for chronic pain and to preferentially use nonopioid alternatives.”    

The AHRQ expects to release final versions of the three pain management reports in early 2020. A list of experts and informants will be released at that time, along with any conflicts of interest. 

Still unclear is what the CDC will do with the reports and what kind of “update or expansion” the agency is considering for its opioid guideline.