On behalf of the more than 40,000 members of the California Medical Association (CMA), our association would like to register significant concern about the CDC’s current process to create the Guidelines for Prescribing Opioids for Chronic Pain.
We would like to highlight the following aspects that illustrate a problematic public process:
- The first chance the public had to learn any detail about the recommendations was on a September 16 webinar.
- Limited lines were available to participate in the webinar according the organizers.
- Webinar participants were told they could provide comment within an extremely short timeline while on the webinar or via email by 5 pm the following day.
- There were technological problems on the call, leading CDC to allow for an additional day for comment and schedule a second presentation of the same webinar the following day. It did not appear that there would be any other opportunity for public comment.
- CDC staff would not answer contextual questions about the guidelines on the webinar.
- People who wanted to comment via the phone were provided only a few minutes collectively per recommendation to do so. It appeared that at least once, a person did not get the opportunity to comment on the phone due to time restrictions.
- It was stated that comments would be summarized and presented anonymously in October.
- Detailed background materials were referred to but not made available for review during the comment period. Background materials remain unavailable to the public.
- The 12 recommendations that were posted on the CDC website at the time of the webinar appear to have since been removed.
- The CDC has not publicly revealed who was involved in the creation of the guidelines, including those involved in the Core Expert Group Meeting, the Core Expert Group Review, the Federal Partner Review and the Stakeholder Review Group.
It is deeply concerning that the details behind the 12 recommendations are being made available to some unknown organizations and individuals for review and comment, but not to the general public.
Further, it is inappropriate for a public agency to limit the stakeholders from whom they will accept comments
In addition, an anonymous summary of comment is also not part of a transparent public process, as it allows for potential CDC reinterpretation of the comments.
Specific to California
CMA is particularly concerned about the impact in our state, where the Medical Board of California (MBC) recently conducted a year – long, fully transparent public process that produced well – balanced opioid prescribing guidelines.
The detailed guidelines reflect the realities of patient care and underscore the extraordinary complexity in treating pain.
the MBC guidelines state in the preamble that “Medicine is practiced one patient at a time and each patient has individual needs and vulnerabilities” and the language in the MBC document reflect this statement.
The guidelines also include an extensive discussion about the nature of pain and the treatment of pain that was not reflected in the CDC recommendations.
We are also concerned because the CDC recommendations include a ceiling dose that is in conflict with California’s guidelines, which creates confusion and could have legal repercussions.
CMA requests the following from CDC:
- All materials, including the recommendations and the more detailed supporting materials, need to be made available for public review, with an appropriate public comment period, and allow that public comments made on that document also be available for public review. We recommend at least 90 days for initial comment when the materials are ready for public review.
- We also ask that CDC immediately release to the public complete information about who has served on the Core Expert Group Meeting, the Core Expert Group Review, the Federal Partner Review and the Stake holder Review Group, including conflicts of interest for each participant and their area(s) of expertise with regard to opioid prescribing and treatment of pain.
- Further, we would like CDC to state in writing their interpretation of the legal interaction between CDC guidelines and state guidelines and law