(Note: The endnotes which provide the references for this critique have been collected into the final part of this document.)
The recently released Centers for Disease Control and Prevention (CDC) draft guidelines for the use of opioid analgesics make a mockery of the National Academy’s Institute of Medicine’s (IOM) standards for clinical guidelines. In addition, not only do they violate the standards posted by the CDC, according to which the guidelines these guidelines should be excluded from the National Guidelines Clearinghouse, but they do not even so much as meet the IOM’s definition for “clinical practice guidelines.”
Such strong charges must be backed by arguments from strong evidence, which unfortunately means that these comments will not be brief.
Under a mandate from the Medicare Improvements for Patients and Providers Act of 2008, the IOM, in conjunction with the Agency for Healthcare Research and Quality, developed Standards for Systematic Reviews and Standards for Developing Trustworthy Clinical Practice Guidelines (CPGs).
As defined by the IOM, “Clinical practice guidelines are statements that include recommendations intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options.”[2; emphasis in original]
According to the IOM’s Standard “4.1 CPG [clinical practice guidelines] developers should use systematic reviews that meet standards set by the IOM’s Committee on Standards for Systematic Reviews of Comparative Effectiveness Research.”
The CDC’s own posting says that, “To be trustworthy, guidelines should…Be based on a systematic review of the existing evidence,” and declares that, “Guidelines that have not included a thorough SR [Systemic Review] of the relevant scientific evidence base should be excluded from the NGC [National Guidelines Clearinghouse].” However, the CDC’s description of the review process that it used for its guidelines either fails to document compliance with, or actually documents violation of, most of the IOM’s standards for systematic reviews. For example, “CDC excluded all studies outside the United States.” Why? Even the Food and Drug Administration is legally required to “accept data from clinical investigations conducted outside of the United States.” When data is limited, arbitrarily restricting it further is inexcusable. By its own description, the only portion of CDC’s review that was systematic dealt exclusively with harms, and, astoundingly, its “benefits” analysis focused on “overdose, cardiovascular events, motor vehicle crashes, and fractures.” “Search terms also focused on opioids and chronic pain and their relation to overdose, cardiovascular events, motor vehicle crashes, and fractures (for benefits and harms)….” The CDC justified these separate, nonsystemic, “rapid reviews” of “overdose, cardiovascular events, motor vehicle crashes, and fractures,” for the “Benefits and harms of opioid therapy,” by the need to “streamline” development of prescribing guidelines, but then excluded even them from its strength-of-evidence analysis: “Given the nature of the studies, the purpose that contextual evidence serves, and the short timeline for developing the guidelines, CDC did not conduct rigorous evidence grading of the findings from the rapid reviews” These behaviors, which violate the standard published by the CDC, requiring a “thorough and unbiased review of existing knowledge,” represent a clear pattern, as may be seen from the fact that a study of practice guidelines singled out the CDC “in particular” for compliance that was “substantially worse than that of other organizations” for IOM standards for “Data Collection Method Given” and “Quality of Evidence Rated.”
Although, according to its own posting, standards “Require transparency,” the CDC was secretive[17, 18] about the members responsible for both the review and the guidelines, as well as how they were selected.