PROP Helped Draft CDC Opioid Guidelines
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http://www.painnewsnetwork.org/stories/2015/9/21/prop-helped-draft-cdc-opioid-guidelines
PROP Helped Draft CDC Opioid Guidelines
By Pat Anson, Editor
A lobbying organization that seeks to reduce the prescribing of opioid pain medication appears to be playing a significant role in the drafting and development of opioid prescribing guidelines by the U.S. Centers for Disease Control and Prevention (CDC).
Those controversial guidelines, which were released last week, have frightened and angered many patients in the pain community because they could further restrict access to opioids for the treatment of acute and chronic pain.
Pain News Network has learned that at least five board members of Physicians for Responsible Opioid Prescribing (PROP) are involved in developing the CDC guidelines, including two that helped draft them. The CDC has refused to make public a list of the “Core Expert Group” that drafted the guidelines, claiming their anonymity was important “to provide honest and independent comment and feedback.”
A PROP board member also sits on the CDC peer review panel that will finalize the guidelines, which are intended for primary care providers who treat the majority chronic pain patients.
PROP has been lobbying Congress and federal health officials for years to reduce opioid prescribing and has apparently found a sympathetic ear at the CDC.
PROP President Jane Ballantyne, MD, and Vice-President Gary Franklin, MD, are both members of the CDC’s Core Expert Group, and board member David Tauben, MD, is on the CDC’s peer review panel.
In addition, PROP founder and Executive Director Andrew Kolodny, MD, and PROP board member, David Juurlink, MD, are part of a “Stakeholder Review Group” that will provide input on the CDC guidelines.
A complete list of PROP’s Board of Directors can be found here.
Ballantyne, Franklin and Tauben all have ties to the University of Washington; where Ballantyne is a professor of Anesthesiology and Pain Medicine at the UW School of Medicine, Franklin is a research professor at the UW School of Public Health, and Tauben is the Chief of Pain Medicine at the UW School of Medicine. All three were involved in the development of opioid prescribing regulations in Washington state, which has some of the toughest prescribing laws in the nation.
“As a member of the Core Expert Group, I have been asked not to comment on the (CDC’s final) guideline until it is released,” said Ballantyne in an email to Pain News Network.
Ballantyne was hailed for her “wealth of experience on opioids” by Kolodny when she succeeded him as PROP’s President last year.
“I am delighted to be able to advance the mission of this important organization,” Ballantyne was quoted as saying in a news release. “Opioids are essential medications, especially when used to ease suffering at the end of life and when used short term for severe pain. Unfortunately, their widespread use for common, moderately painful conditions is harming many pain patients and fueling an addiction epidemic.”
Kolodny is chief medical officer for Phoenix House, a non-profit that operates a chain of addiction treatment clinics.
Juurlink is Canadian and a professor at the Sunnybrook Research Institute in Toronto. Juurlink also serves on the Medical Advisory Board of Advocates for the Reform of Prescription Opioids (ARPO), a non-profit based in Canada that seeks to “end the epidemic of death and addiction caused by prescription opioid drugs.” Kolodny also serves on ARPO’s Medical Advisory Board.
“I routinely see patients whose lives have been ruined by opioid painkillers — drugs like morphine, oxycodone and hydromorphone. Most of these patients started with back pain or arthritis; others were given a month’s worth of pills after surgery and simply continued taking them,” Juurlink recently wrote in an Op/Ed piece for the Toronto Star.
Prescribing Guidance for Opioids
The CDC’s draft guidance on opioid prescribing recommends “non-pharmacological therapy” as the “preferred” treatment for chronic non-cancer pain. Other guidelines recommend urine drug testing of all patients who are prescribed opioids, as well as smaller doses and quantities of opioids for patients being treated for acute or chronic pain. A complete list of the guidelines can be found here.
An unusual amount of secrecy has surrounded the development of the CDC's guidelines. The agency refused to provide an advance copy of the guidelines before they were released during an online “webinar” and there was little notice about the webinar itself. Only a summary of the guidelines is available on a CDC website and the agency is no longer accepting public comments on them.
News coverage about the proposed CDC guidelines has also been scant, in large part because the CDC never notified reporters or issued a news release about the webinar.
“Media were not directly included because this public engagement period is part of the guideline development process and was intended to invite feedback specifically from providers, patients, and clinical organizations that would be impacted by these recommendations,” a CDC spokeswoman said.
The CDC says it did notify health insurance providers, professional medical organizations, research entities and some patient advocacy groups about the webinar and gave them 48-hours to submit comments by email. During that period, the agency said 167 emails were received from interested parties.
Still unclear is why the CDC is acting as the lead agency in developing the guidelines, a role traditionally reserved for the Food and Drug Administration. The FDA broke its silence about the CDC’s guidelines with its first public comment today, revealing little about its role – if any – in drafting them.
“The FDA did have an opportunity to comment on the current version of CDC’s Guideline for Prescribing Opioids for Chronic Pain. The guidance has not been finalized yet, so the FDA does not have comments to share at this time,” said Eric Pahon, an FDA spokesman, in an email to Pain News Network.
Prescribing Guidelines Called a 'Travesty'
“I am really concerned about the whole process. First it appears that conflict of interest was not managed well. I can't understand why payer representatives are part of any guideline where their vested interest is to limit access to treatments. They obviously profit from limiting dosing,” said Lynn Webster, MD, past President of the American Academy of Pain Medicine. “The guidelines proposed by the CDC fail to address any of the root causes to either the addiction or pain epidemics in America. This is a travesty.
“We need the CDC to recognize that addiction is a disease that needs access to care not available today. We need to destigmatize the disease so people can get treatment without fearing prosecution and persecution. The CDC could lobby Congress to enact laws to increase access to treatment. We need the CDC to recognize that pain is a disease as well and is associated with an alarming rate of suicides due to lack of effective therapies. Making it harder for many patients to access opioids will increase the suicide rates among people with severe pain.”
Now that the draft guidelines have been released, they’ll be reviewed by the CDC’s Stakeholder Review Group that includes over a dozen professional organizations involved in the field of pain management. Then they’ll be turned over to a three member peer review panel. The CDC hopes to finalize the guidelines for release in January.
PROP is already preparing for backlash from the pain community and some medical organizations when the final guidelines come out. PROP and other affiliated groups are lobbying the U.S. Senate Finance Committee to release details of its investigation into the financial ties that pharmaceutical companies had to certain doctors and non-profit pain organizations.
PROP’s goal, according to the Milwaukee-Wisconsin Journal Sentinel, is to silence critics before the CDC guidelines are released.
"By making the findings of the investigation public and exposing the financial relationships between pain organizations and opioid makers, it will be harder for them to claim that it is the interests of pain patients they are lobbying for," said PROP founder Andrew Kolodny.
The Senate Finance Committee began its investigation over three years ago, but has never released its findings. The investigation targeted Lynn Webster, along with other prominent pain physicians, and professional organizations such as the American Pain Society and the American Academy of Pain Medicine, both of which are part of the CDC’s Stakeholder Review Group.
A spokesman for the Senate committee said it is “unable to release documents or findings until the conclusion of any investigation and the committee's issuance of an official report."
Cindy Steinberg
September 18, 2015
Tom Frieden, M.D., M.P.H.
Director, Centers for Disease Control and Prevention
Debra Houry, M.D., M.P.H.
Director, National Center for Injury Prevention and Control
United States Centers for Disease Control and Prevention
1600 Clifton Road
Atlanta, Georgia 30329-4027
Dear Drs Frieden and Houry:
As members of U.S. chronic pain management professional associations and patient advocacy organizations, we, the undersigned, are profoundly invested in any and all efforts undertaken that could impact either the positive or negative outcomes of pain treatment. We have been anxiously awaiting CDC’s draft opioid prescribing guidelines, now revealed September 16th.
It was our expectation that the prescribing guidelines would have been
-
Developed in a transparent manner, consistent with best-known evidence
-
Where there is no evidence, by incorporating the common elements of long-accepted clinical expert
consensus guidelines developed by a dozen organizations dedicated to the safe and effective treatment of
patients with chronic pain
-
Consistent with those aspects of opioid medication prescribing and risk mitigation efforts that are actually
supported with rigorous clinical trials, i.e. the FDA-approved indications for the full range of opioid formulations and their extraordinary safe use and risk management efforts re: extended release and long- acting opioids.
We were disappointed on all counts and now are deeply concerned that, not only are the CDC draft guidelines inconsistent with established best practices, they will potentially make it difficult for patients who rely on them for pain control to access them from clinicians who are clear on how best to use them.
The CDC slides presented on Wednesday were not transparent relative to process and failed to disclose the names, affiliations, and conflicts of interest of the individuals who participated in the construction of these guidelines. The presenters refused to provide any information other than to read exactly what was written on the slides even when asked directly by audience members to disclose the processes and people who had developed these prescribing guidelines. Since CDC has traditionally not involved itself in developing and disseminating medication prescribing guidelines, and these recommendations are not consistent with current established guides for managing chronic pain with opioids, these process and participant questions are essential to understand.
A statement was made early in the presentation that it is acceptable and common practice to develop clinical recommendations even when there is a limited or non-existent base of evidence for (or against) the recommendation. In those cases, the standard is to convene expert clinicians with vast experiences in the condition and develop consensus around optimal approaches. CDC itself developed and published an analysis of existing guidelines that logically should have been the foundation for these new guidelines.
While there may be slight variances among organizations on specific guideline inclusions or recommendations, there is a broad conformity that extends beyond the focus of the new guidelines. By addressing only how to limit or avoid opioids, the new guidelines will inevitably result in fewer prescriptions overall - including those needed by patients with legitimate medical needs. Chronic pain advocacy organizations hear daily from increasing numbers of constituents who are not being able to access the opioid medications they’ve relied on to live with their chronic painful conditions. That is not an outcome that anyone involved in chronic pain and prescription opioid diversion and abuse wants but this guideline will produce.
In fact, it is CDC’s singular focus on prescription opioid diversion, abuse, addiction, and overdose over any improved understanding of chronic pain incidence, prevalence, trends, and optimal interventions that reveals within CDC an extreme imbalance in its own risk-benefit sensibilities when it comes to this class of medications. In evaluating new medications for approved uses, FDA requires safety and efficacy trials that all approved opioid medications have met. Detailed prescribing instructions are developed based on proven studies. Yet the new guidelines ignore the FDA’s prescribing expertise, recommending different maximum daily doses that appear in no guidelines or package inserts.
We call on CDC to immediately compile, analyze, and report any and all chronic pain data it possesses, managed with or without opioids. Certainly any health condition that impacts one third of our country’s population should, by definition, have a place of priority in CDC’s mission and mandate. CDC has a Center for Chronic Disease Prevention and Health Promotion that reports on arthritis as part of its annual chronic disease monitoring. Diabetes, interstitial cystitis, inflammatory bowel disease are all programs within this center that have, at their core, chronic pain components and may contain useful data. CDC also fields an Annual CDC/NCHS National Health Interview Survey that reports on severe headache or migraine, low back pain, and neck pain among adults. Obviously, a better understanding of how to effectively treat chronic pain should be an essential component to any treatment prescribing guideline. What CDC presented this week is not that.
If the new CDC guidelines reinforced existing recommendations of experts who agree there are tried and true approaches to safely and effectively using opioids to treat chronic pain, it would be a welcomed addition to clinical practices nationwide. Equally important, we need CDC to glean from its prescription opioid addiction and overdose data which cases actually involve chronic pain patients and which involve patients with active substance use disorder so we can help providers better differentiate the two.
The unmet challenge in chronic pain management with opioid treatment is to identify the conditions for which, and patients for whom, opioid use is most appropriate; the regimens that are optimal; the alternatives for those who are unlikely to benefit from opioids; and the best approach to ensuring that every patient’s individual needs are met by a patient-centered health care system. We need CDC to provide some context around the incidence and prevalence of undertreated pain and the related adverse consequences of undertreated chronic pain on all body systems. With these insights it may actually be possible to improve pain care rather than restricting one treatment based on perceived, not quantified, harms to legitimate patients.
We believe the most important outcome of treatment for chronic pain is pain control sufficient to enable people with pain to maintain a high level of patient-determined quality of life and functionality while avoiding or minimizing potential negative outcomes that could outweigh pain control benefits. We believe it is up to the patient, informed by a comprehensive and ongoing discussion with his or her providers, to decide if risks of opioid use apply to them and are acceptable to bear, when compared with the adverse physical, psychological, and quality of life impacts if pain cannot be adequately controlled without opioids. Our concern is ensuring that further stigma and physical harm to patients does not result from policies and guidelines that address only the risk of harm from inappropriately prescribed or used opioids, when what healthcare providers most require are affirmative strategies to help patients manage their pain.
Sincerely,
American Academy of Pain Management
Interstitial Cystitis Association
Pain Connection-Chronic Pain Outreach Center, Inc.
Chronic Pain Research Group - Clinical Pharmacokinetics Laboratory Associates at the School of Pharmacy
and Pharmaceutical Sciences, University at Buffalo
Massachusetts Pain Initiative
National Fibromyalgia & Chronic Pain Association
Oncology Nursing Society
Pain Action Alliance to Implement a National Strategy (PAINS)
Project Lazarus
US Pain Foundation
Virginia Cancer Pain Initiative
Wisconsin Pain Initiative
cc:
Sylvia Burwell, Secretary, US Department of Health and Human Services
Janet Woodcock, Director, CDER
Douglas Throckmorton, Deputy Director for Regulatory Programs, CDER
Sharon Hertz, Division Director of Anesthesia, Analgesia, and Addiction Products, CDER
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