When it comes to the CDC’s new opioid guidelines, attention must be paid -- immediately and publicly. This is the message from a growing constituency of physicians, patients and policy experts concerned and upset about both the CDC’s conflict-ridden, secretive process and, even more importantly, the guidelines themselves.
Regarding the CDC’s lack of transparency, consider first the comments of the California Medical Association:
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. The information available to the public was so limited and the time to comment so brief, that it created the perception that the end result has already been determined. Further, it is inappropriate for a public agency to limit the stakeholders from whom they will accept comments. All entities should have the same opportunity for review and comment. 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. The public must also be able to assess the potential biases and the opioid prescribing expertise for those involved in the creation of the guidelines.
And from the American Cancer Society:
We have concerns that the attempts to solicit public input on the draft guidelines were cursory and did not allow adequate opportunity for thoughtful responses. While a public webinar was held to discuss the recommended guidelines, it was not well advertised and many interested parties were denied access because the webinar lacked sufficient capacity. Further, only a brief summary of each of the recommendations was shared, with no supporting documentation to provide evidence, context, or insight into the process. The public had 48 hours to comment, a rather abbreviated time period when compared to typical 30-90 day comment periods for similarly impactful proposed policies by the administration. By legal definition the guideline is not a proposed regulation subject to the Administrative Procedures Act, but clearly the intent of CDC is that the guideline be distributed to and adopted by state public health entities and certifying organizations as if it had the legal authority of a regulation. Given the potential public impact of the proposed guidelines, CDC should provide more complete information to the public regarding their draft guidelines and provide commensurate opportunity for input.
Of greater importance are the issues with the proposed guidelines themselves.
Per the California Medical Association:
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 (see enclosure). Health care practitioners who treat pain in diverse settings were extensively engaged and given ample opportunity to provide feedback. The detailed guidelines reflect the realities of patient care and underscore the extraordinary complexity in treating pain. For example, to stress the need for flexibility, 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.
And the American Cancer Society points to the fact that the guidelines aren’t based on solid evidence:
CDC purported to follow a widely used framework for producing evidence-based recommendations known as GRADE (Grading of Recommendations, Assessment, Development and Evaluation) to create the proposed guidelines. In reality, however, CDC appears to have deviated significantly from the established methodology, calling into question the integrity and validity of the ensuing recommendations. Seven of the 12 recommendations were based on “very low quality of evidence” and five of the 12 on “low quality of evidence,” yet six of the seven recommendations with evidence rated “very low” and all of the recommendations with “low” evidence ratings were designated as “strong” recommendations. The GRADE process ordinarily permits this discordance only in exceptional circumstances, and this stark departure from GRADE methodology was done without associated justification. The rationale statements appeared to rely heavily on expert opinion, but this was not explicitly acknowledged.
Further, the ACS asks a crucial question, why has the CDC factored in cost in the guidelines development process?
We take strong exception to the use of cost data as an input to the guidelines. The costs highlighted in the document deal with non-medical use, abuse and overdose of opioids, but no mention is made of the costs due to chronic pain. Further, while costs may be a valid consideration in the context of GRADE methodology, it is wholly inappropriate for the government to use cost, rather than efficacy, to suggest restricting access to treatments that patients pay for themselves through copays and insurance premiums.
Bottom line:
CDC’s recent efforts are not appropriate, nor transparent … We strongly urge that CDC provides CMA and others with a reasonable opportunity to provide meaningful comment on such a critical issue.
-- California Medical Association
We share the goal of reducing inappropriate use and adverse events related to opioids, but we also have grave concerns about unduly restricting access to appropriate and effective pain management for individuals with cancer and other chronic conditions. We are concerned that the draft document does not reflect the appropriate weighing of benefits and harms at the individual and population levels, a fundamental element of rigorous guideline development. The process that the CDC followed departed from reliance upon evidence and methodological rigor, as well as accepted standards of transparency. We strongly suggest that CDC withdraw its draft guideline and instead focus on generating additional data to inform future guidelines as well as ongoing educational efforts on harm and abuse prevention.
-- American Cancer Society
The full comments from the California Medical Association and the American Cancer Society are worth a careful read.
An opaque and inappropriate process results in flawed and inappropriate guidelines. Attention must be paid.
