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.