CDC Guideline Author Leading New Rx Opioid Study
/By Pat Anson, PNN Editor
One of the co-authors of the CDC’s controversial 2016 opioid guideline is leading a new federal study about the effectiveness of opioid medication in treating chronic pain, Pain News Network has learned.
Dr. Roger Chou is a primary care physician who heads the Pacific Northwest Evidence-based Practice Center at Oregon Health & Science University (OHSU), which was awarded a $500,000 contract to conduct the opioid study by the federal Agency for Healthcare Research and Quality (AHRQ).
A draft version of the AHRQ report echoes many of the conclusions drawn by the CDC – that there is little evidence to support the use of opioids for chronic pain and that nonopioid pain relievers such as Tylenol are just as effective as Vicodin.
Even when used for short-term acute pain, the draft report found “no differences between opioids versus nonopioid medications in improvement in pain function, mental health status, sleep, or depression.”
The AHRQ has not publicly disclosed the authors of the draft report, and only acknowledged in a statement to PNN that “the OHSU team is comprised of several experts who draw upon diverse experience and expertise in pain management.” Their final report is expected in January 2020.
In addition to his work on the CDC guideline, Chou has authored numerous articles on pain management in peer-reviewed medical journals and has led research efforts for the U.S. Preventive Services Task Force, World Health Organization and the American Pain Society. But Chou’s involvement in the AHRQ study has caused some alarm among patient advocates, who believe he and the agency are biased against prescription opioids.
“The agency is operating under a political agenda that has little to do with medical evidence or truth,” said Richard “Red” Lawhern, PhD, a patient advocate with the Alliance for the Treatment of Intractable Pain. “The report is fatally flawed and must be immediately withdrawn without replacement. AHRQ owes the public and millions of people in pain a public apology for its malfeasance and misdirection.”
PROP Collaboration
Most health researchers keep a low profile and try to avoid controversy, but Chou has publicly collaborated 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 and his co-authors thanked PROP Executive Director Dr. Andrew Kolodny and other PROP board members for their help in drafting the article:
“Acknowledgment: The authors thank the Oregon Pain Guidance Working Group (Jane Ballantyne, Roger Chou, Paul Coelho, Ruben Halperin, Andrew Kolodny, Anna Lembke, Jim Shames, Mark Stephens, and David Tauben) for discussions about tapering and for reviewing a draft of this article.”
As PNN has reported, Kolodny, Ballantyne and Lembke have worked as paid consultants to law firms that stand to make billions of dollars from opioid litigation. Their legal work was only recently disclosed in revised conflict of interest statements.
It is not clear if PROP members are involved in the AHRQ study, as they were with the CDC guideline. As a matter of policy, AHRQ does not disclose the names of its consultants and investigators until after reports are completed.
“This policy is aimed at helping the authors maintain their independence by not being subject to lobbying by industry reps or others with conflicts of interest, either financial or intellectual,” AHRQ spokesman Bruce Seeman said in an email.
“AHRQ’s failure to disclose Chou as an author of its draft report is troubling, given his prior work with Ballantyne and Lembke, who have admittedly worked on behalf of PROP in the past.”
“AHRQ’s failure to disclose Chou as an author of its draft report is troubling, given his prior work with Ballantyne and Lembke, who have admittedly worked on behalf of PROP in the past. PROP heavily influenced the creation and implementation of the 2016 CDC Guideline, which was systematically misapplied over the last three years by lawmakers, health insurers and pharmacies in a way that became harmful to many patients with chronic pain,” said Dr. Chad Kollas, a palliative care specialist in Florida.
“Failing to disclose authorship of the AHRQ report reduces the agency’s transparency in a way that raises alarms for those familiar with the misapplication of the CDC Guideline and seek to prevent recurrent harm to patients suffering from chronic pain.”
Chou did not respond to requests for comment for this story. He recently served on a state task force that recommended a rigid tapering policy that would have forced many Oregon Medicaid patients off opioids and into withdrawal. The policy was scaled back after a backlash from patients and pain management experts, who said the recommendations were not supported by evidence or compassionate.
“Compassionate sounds good but it’s a loaded term,” was Chou’s response at the time. “I don’t think there’s anything compassionate about leaving people on drugs that could potentially harm them.”
On a recent podcast, Chou said there was little of evidence to support the use of opioid medication.
DR. ROGER CHOU
“The impact of prescription opioids in terms of mortality and substance use disorder and all the other things that come along with it have really been quite staggering. We have more evidence that the benefits of opioids are really not as large as we’d like them to be. In most studies, they’re actually quite small and often clinically insignificant,” he said.
Chou also claimed in the May 2019 interview that the opioid hydrocodone was “the number one prescribed drug in the United States and has been for many years.” That statement is false. Since 2011, hydrocodone prescriptions have fallen dramatically – as they have for all opioids -- and it is now the fifth most widely prescribed drug in the U.S., ranking behind cholesterol, thyroid and blood pressure medications.
Public Comment Period Ends
On Tuesday, the AHRQ ended a 30-day public comment period on its draft report. Unlike other federal agencies that routinely seek public comments in the Federal Register, the AHRQ only accepted comments on its website. The agency did little to publicize the draft report outside of a mass email to 100,000 subscribers notifying them the report was available for comment.
One critic who had a chance to see the AHRQ’s review of over 150 opioid studies said it was filled with errors, biases and cherrypicked research – much like the CDC guideline that Chou co-authored.
“In laymen’s terms, AHRQ and CDC have been caught with their fingers on the balance scales, in a deliberate and unconscionable effort to bias public policy against the use of opioid therapies regardless of the medical evidence,” Lawhern said in a written public comment. “CDC violated its own research standards by failing to explicitly acknowledge that the medical evidence for alternatives to opioids is no stronger than for opioids. Now AHRQ proposes to compound that lack of public transparency by doubling down on a false narrative.”
Although voluntary, the CDC’s dose recommendations have been widely misapplied by insurers, pharmacies, doctors, and federal and state regulators – who have adopted the guideline as policy or even law — and used it as an excuse to abruptly cutoff or taper patients on opioids.
“We are concerned that the AHRQ review may have similar unintended consequences,” the American Medical Association said in a letter to the agency. The letter points out that most opioid overdose deaths are caused by illicit fentanyl and other street drugs, not prescription opioids.
“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.”
“The AMA urges the AHRQ to clarify that the review does not support a conclusion that the epidemic of opioid-related overdose deaths is due to efforts to treat patients with chronic pain or cancer pain, or to manage pain for patients receiving hospice or palliative care,” said Dr. James Madara, the AMA’s Executive Director and CEO. “The AMA further urges the AHRQ to clarify that this review should not be used to justify or support reductions in opioid therapy for patients with acute, chronic, palliative, cancer-related or other pain when clinically indicated by the patient’s physician.”
The AMA’s letter also urged the AHRQ to publicly identity everyone the agency consulted with before its final report is released.
“We would suggest that AHRQ publish the list of all those involved in any aspect of the report during the comment period to help remove any perception of potential conflict,” Madara wrote.
