By Pat Anson, Editor
Friday’s announcement by the Centers for Disease Control and Prevention (CDC) that it will reconsider and delay implementing its controversial draft guidelines for opioid prescribing throws open a process that’s been largely concealed from the public.
But will it lead to changes in the guidelines themselves? And will the agency start listening to pain patients who fear losing access to opioid pain medication?
There are many different opinions from experts and activists who’ve been closely following the debate.
“A delay will not stop the inevitable, nor will a few months serve as a cooling blanket for the medical professionals and patients that are outraged by the approach CDC has taken on these guidelines. CDC’s behavior was so outlandish that is caused an avalanche of pushback,” said Jeffrey Fudin, a pharmacist and founder of Professionals for Rational Opioid Monitoring & Pharmacotherapy (PROMPT).
“It is heartening to see that CDC has decided to do now what it really should have done in the beginning, and I hope the result is a set of recommendations that everyone can support,” said Bob Twillman, PhD, Executive Director of the American Academy of Pain Management.
“Some have said that this delay is a victory for ‘the opioid lobby,’ but I think it’s not really a victory for anyone; it might be a victory for tried-and-true methods of developing practice guidelines, and a victory for transparency, but a delay in producing reasonable, workable guidelines actually does everyone a disservice. That could have been prevented, had CDC used a proper process from the beginning.”
The process that CDC used in developing the guidelines was unusually secretive and one-sided for a public agency. As Pain News Network has reported, the CDC handpicked outside advisers dominated by special interest groups and addiction treatment specialists, most of whom were determined to rein in opioid prescribing. The CDC’s panel of experts and stakeholders included five board members of Physicians for Responsible Opioid Prescribing (PROP), an advocacy group funded by Phoenix House, which operates a chain of addiction treatment centers. Few patient advocates and pain physicians were included in the process.
Not surprisingly, the resulting draft guidelines discourage primary care physicians from prescribing opioids for chronic pain. “Non-pharmacological therapy” such as exercise and cognitive behavioral therapy were recommended instead, along with non-opioid drugs such as over-the-counter pain relievers.
The guidelines were unveiled to a select online audience in September and only a brief 48-hour window was allowed for public comment. That sparked an outcry from the pain community. In a survey of over 2,000 pain patients by Pain News Network and the Power of Pain Foundation, large majorities complained that non-opioid treatments didn’t work for them or were not covered by insurance. Others predicted the guidelines would cause even more addiction and overdoses, not less.
The CDC largely ignored the complaints and said it would continue with plans to implement the guidelines in January, as planned.
Only in recent weeks, when the CDC started getting “feedback” from others did the agency reconsider. It was threatened with a lawsuit by the pro-business Washington Legal Foundation and officials from other federal agencies mocked the guidelines as “ridiculous” and “an embarrassment to the government.”
“CDC appreciates the feedback we have received to date, which has informed and strengthened the document thus far, and we look forward to receiving further input to improve the way opioids are prescribed,” said Debra Houry, MD, the CDC official in charge of developing the guidelines, in an email Friday to stakeholders.
The agency now says it will reopen the public comment period for 30 days, starting on Monday, December 14th. The draft guidelines will also be reviewed by a scientific advisory panel, which will appoint a new work group to consider changes, a process that could take several months or more.
“I think it's a good idea to get broader input. Some have been critical of CDC, but the criticism has swirled primarily around the process itself, particularly the need for more input. More input can't hurt. It's my sense that the draft guidelines themselves have generally been well-received,” said David Juurlink, MD, a PROP board member who served on one of the CDC’s advisory committees.
“Regarding the Washington Legal Foundation, I note that they've lobbied previously on behalf of Exxon Mobil, Philip Morris and Purdue Pharma. People can infer from this what they will.”
Jeff Fudin thinks the review process is yet a smokescreen.
“It seems to me that CDC is forming more committees and more layers to shield liability and hide behind their transgressions. Rather than do this, I’d like to see a committee formed to examine how CDC’s actions around the guidelines happened in the first place, including but not limited to the choice of committee members and all potential conflicts and alliances among participants. Only after we understand how the CDC went awry can a fair scientific board be put in place to avoid a snowball of transgressions,” Fudin said in an email to Pain News Network.
“The CDC realizes that they created a fire storm with their politically driven guidelines,” said Lynn Webster, MD, past president of American Academy of Pain Medicine. “It is good that they have heard the crescendoing opposition to what they have done. We will have to see if it is just a maneuver to appease the concerns or if they are truly interested in working to be more inclusive and scientific in developing the guidelines.
“There are two fundamental concerns with the proposed guidelines. The first is the secretive process and inclusion of advisers who are biased and prejudicial against opioids. The other major concern is that the recommendations do not match the level of evidence. This is what is most bizarre from the CDC, since the CDC is supposed to be a scientific body which uses best evidence in proposing health recommendations for the country. They failed to follow this principle in this case.”
Another bizarre part of the process is that – outside of September’s webinar -- the CDC has never made the guidelines available on its website, in a news release, or in any public forum. That will finally change on Monday when the draft guidelines are published in the federal register.