By Pat Anson, Editor
An advocacy group 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 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 belong to a key committee that helped draft them. The CDC has refused to make public a list of members on 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.
"Non-Pharmacological Therapy" for Chronic Pain
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.
A veil 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 public 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 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.
The CDC has rushed to complete the guidelines over the last few months, using "rapid reviews" of clinical evidence on the effectiveness of opioids -- resulting in a limited search of medical databases by years, languages and quality assessment. According to internal agency documents obtained by Pain News Network, the CDC plans a "rapid publication of the guidelines to address an urgent public health need."
Still unclear is why the CDC is acting as the lead agency in developing guidelines for prescribers, 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."