By Pat Anson, Editor
The Centers for Disease Control and Prevention (CDC) will continue to rely on the same panel of experts to advise the agency about its opioid prescribing guidelines – even though some of the experts are allegedly biased and have conflicts of interest.
The CDC announced last week that it would review and delay implementing the controversial guidelines, after they drew widespread criticism from pain patients, advocacy groups, and medical societies. On Monday the agency also began accepting new public comments on the guidelines, which discourage primary care physicians from prescribing opioids for chronic pain.
The review of the guidelines will be conducted by the Board of Scientific Counselors (BSC) for the CDC’s National Center for Injury Prevention and Control. The CDC is developing the guidelines to combat what has been called an "epidemic" of prescription drug abuse, addiction and overdoses. As many as 11 million Americans use opioids for long-term chronic pain.
“We will be asking the BSC, the members of which represent expertise along the spectrum of injury and violence issue areas, to approve formation of a workgroup to review the draft guideline and comments received on the guideline, and present recommendations about the guideline to the BSC,” said Leslie Dorigo, a CDC spokesperson.
“Our intent is for the workgroup to be comprised of members of the original Core Expert Group, members of the BSC, and individuals who represent the perspectives of patients living with chronic pain and who have additional pain medicine expertise.”
The “Core Expert Group” has 17 members and is composed primarily of public health researchers and state regulators. At least two of its members have drawn the ire of critics who say they shouldn’t serve on the panel.
Jane Ballantyne, MD, and Gary Franklin, MD, are the President and Vice-President, respectively, of Physicians for Responsible Opioid Prescribing (PROP), an advocacy group funded by Phoenix House, which runs a chain of addiction treatment centers. Three other board members of PROP will also continue to advise the CDC in their roles as stakeholders and peer reviewers, according to Dorigo.
“For the life of me, I can’t understand why CDC insists on retaining such obvious bias on their panel, as it flies in the face of their scientific integrity,” said Jeffrey Fudin, a pharmacist and founder of Professionals for Rational Opioid Monitoring & Pharmacotherapy (PROMPT).
“I find it hard to believe that CDC can’t find a single qualified physician to speak against opioids that is free from potential conflict. With all that has been drudged up in the professional literature and lay press regarding potential or postulated physician conflicts, CDC’s behavior is nothing less than reverse discrimination.”
Ballantyne and Franklin, who have been vocal critics of opioid prescribing, played key roles in the development of opioid regulations in Washington State, which has some of the toughest prescribing laws in the nation.
Ballantyne recently come under fire for co-authoring an article in the New England Journal of Medicine that said reducing pain intensity should not be the goal of doctors that treat chronic pain. That caused a prominent pain physician to call on Ballantyne to resign or be fired from her academic position at the University of Washington School of Medicine.
“To suggest that physicians should no longer treat pain intensity and let patients suffer goes beyond any sort of decency or concern for humanity,” said Forest Tennant, MD, who has treated pain patients for over 40 years.
Ballantyne’s ties to the pharmaceutical industry have also drawn attention. She has served as a paid consultant to Cohen Milstein Sellers & Toll, a law firm that specializes in antitrust litigation, including lawsuits against pharmaceutical companies over their marketing of opioids.
“I do have difficulty with someone like Ms. Ballantyne in particular because, quite apart from PROP, she appears to have a very strong conflict of interest and is on the payroll of plaintiff’s attorneys who have a lot of money to be made by suing manufacturers,” said Richard Samp, chief counsel for the pro-business Washington Legal Foundation, which has threatened to sue the CDC over its alleged violations of a federal open meetings law while drafting the guidelines.
“They have a strong interest in making sure that the CDC is critical of current prescribing practices, because that would strengthen their current lawsuits. For that reason, I can’t see how somebody who is on the payroll of plaintiff’s law firms is an appropriate person to be on the committee,” Samp told Pain News Network.
Ballanytne could not be reached for comment.
“CDC takes conflict of interest seriously, and worked to eliminate or minimize sources of bias of the experts involved in the guideline development and peer review,” said the CDC’s Dorigo. “Our Core Expert Group was composed of a diverse group of subject matter experts—with substantial knowledge on several aspects of opioid prescribing. The group includes primary care professional society representatives, state agency representatives, an expert in guideline development methodology, and other subject experts.”
Dorigo said the CDC plans to add pain patients and pain management physicians to the new workgroup, but had not determined how many. The agency will hold a public conference call on January 7th to get input from the public on the composition of the panel. The workgroup will present its recommendations to the BSC in a public hearing at an undetermined date.
The Washington Legal Foundation’s chief counsel called that a “step in the right direction,” but emphasized that any deliberations of the workgroup need to be held publicly or it would be a violation of federal law. The Core Expert Group never met publicly.
“The problem was that this group met in secret and the materials submitted to that group were not made publicly available and the deliberations of that group and the materials they produced were never made public,” Samp said.
Fudin believes the CDC needs to start from scratch and appoint a completely new set of experts to advise it.
"In order to regain whatever shred of credibility CDC has left with pain clinicians, a new board should consist of all new members and include board certified pain clinicians that have active current practices with a focus on pain therapeutics in non-cancer pain. In addition, it requires experts in public health, a psychiatrist, psychologist, and legal counsel with expertise in pain, plus matched expertise in addiction medicine,” Fudin said.
“We are happy to see that the CDC has asked its Board of Scientific Counselors to impanel a committee including additional members, which it should have done in the beginning,” said Bob Twillman, Executive Director of the American Academy of Pain Management.
“We hope the new members will be representative of the pain community, including both clinicians and people with pain, and that their contributions to the committee process will be weighed equally with the opinions of the existing group. We’re a little concerned because all of this is taking place in yet another opaque process, but we have little choice but to trust the CDC to get it right this time.”
The CDC’s public comment period on the guidelines continues until January 13th. You can make a comment by clicking here.
The proposed prescribing guidelines and the reasoning behind them can be found in a 56-page report you can see by clicking here.