Last month, the U.S. Centers for Disease Control and Prevention circulated a revised and greatly expanded draft update to its 2016 guideline on prescribing opioids to adults with chronic non-cancer pain. The new version expands to include short-term acute and “subacute” pain, and it acknowledges some of the harms done by the “misapplication” of its predecessor.
The draft also proclaims that clinicians and their patients should be free to tailor pain therapy to the needs and circumstances of each individual, rather than applying the guidelines as a mandatory or legal standard of care.
Many media commentators have focused on the easing of restrictions on opioid pain therapy. But as often happens, the devil is in the details -- which many commentators have either not read or paid appropriate attention to. In my view, the revised draft is simply version 2.0 of the same “Little Shop of Horrors: published in 2016.
The authors of the revised guideline set out to deceive the public with the appearance of giving doctors more discretion in prescribing opioids. But that new “flexibility” is overwhelmed by wording that subtly informs doctors that they may risk sanctions if they prescribe opioids to anyone, at any level above 50 morphine milligram equivalents (MME) dose per day.
The underlying bias and predetermined agenda of the CDC writers is apparent in the wording of the draft:
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The words “risk” or “risks” appear 512 times, while “benefits” appears 167 times. Clinicians are repeatedly admonished to evaluate “risks versus benefits” of opioid therapy when deciding to prescribe opioids or increase the dose. But the draft acknowledges that “there is no validated, reliable way to predict which patients will suffer serious harm from opioid therapy and no reliable way to predict which patients will benefit from opioid therapy.” In more accurate words, clinicians are on their own when they prescribe these medications.
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“Taper” or “tapering” or “tapers” are mentioned 200 times. Although “abrupt discontinuation” of opioids is discouraged, clinicians are still advised to “appropriately taper and discontinue opioids” for patients on high doses.
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The writers repeat their false claim from 2016, that opioids are not a proven long-term therapy because there are few long-term randomized double-blind trials for opioids versus placebo. They ignore the fact that the rarity of long-term trials reflects high dropout rates among patients who experience breakthrough pain when treated with placebos. This error can be corrected by the use of enriched enrollment trials, which is unmentioned in the draft.
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The writers also assert that “additional dosage increases beyond 50 MME/day are progressively more likely to yield diminishing returns in benefits relative to risks to patients.” However, they offer scant scientific evidence for this assertion. They fail to reference case reports from patients who do well on high doses exceeding 1000 MME.
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Most fundamentally, the entire CDC draft is organized around the concept of “Morphine Milligram Equivalent Dose” – which is now known to be junk science unsupported by any real data.
Errors and distortions of the CDC draft are also apparent in the wording of their 12 recommendations:
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Seven of the recommendations are identified as “Category A recommendations [which] indicate that most patients should receive the recommended course of action.” Any reasonable clinician will recognize these words as a standard of practice that they violate at their own peril.
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The 2nd recommendation is that “nonopioid therapies are preferred for subacute and chronic pain.”
Ignored in this phrasing is the fact that several of the CDC referenced studies on non-steroidal anti-inflammatory drugs (NSAIDs) employed deeply flawed protocols. Likewise, there have been no trials of non-drug therapies as substitutions for opioids in moderate to severe pain. Thus, non-opioid therapies cannot possibly be “preferred.” -
Also glossed over by the draft writers is the strength of evidence supporting seven of the recommendations is rated as “type 4 evidence” (clinical experience and observations, observational studies with important limitations, or randomized clinical trials with several major limitations). Freely translated, this level of evidence simply represents the opinions of the writers, rather than any general consensus among actual practitioners.
The revised guideline is almost as interesting for what it does not discuss as for what it does. Missing from the draft is any mention of the World Health Organization’s “Pain Ladder.” First published in 1986 and oriented to cancer pain, it is now widely used in both doctor training and common practice for all types of pain.
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The first level of the ladder is Tylenol (ibuprofen) and other NSAIDs -- which are used in the short term for mild to moderate pain.
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Second level of the ladder is weak opioids like tramadol, used in longer lasting or more intense moderate to severe pain.
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Third level is strong opioids like hydromorphone or medical fentanyl, used in very severe or treatment-resistant pain.
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Non-drug treatments like acupuncture or massage can be integrated with pain therapy at any level of the ladder, to assist patients in managing pain and increasing function. These are not, however, replacements for drug treatment.
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Interventional treatments like nerve blocks, epidural corticosteroid injections, spinal cord stimulators or fusion surgery may be used when pain is resistant to drug therapy.
The rationale for excluding discussion of this framework from the CDC guideline is nowhere made clear in either the 2016 or 2022 documents. The implied reason for this policy choice seems to be that prescription opioid analgesics were assumed by the writers to carry significant danger of addiction and misuse, even when administered at low doses and for short periods.
It is now clear, however, that such reasoning is seriously wrong on facts. Prescription opioids did not cause and are not sustaining America’s so-called “opioid crisis.” That distinction belongs to illegal street drugs, notably illegal fentanyl.
Given the many failings of the Little Shop of Horrors 2.0, it is reasonable to ask, “What should be next?” In my opinion, it is time to burn this shop to the ground and start all over.
The development of practice standards for pain treatment should be taken entirely out of the CDC and allocated to medical specialty boards and academies whose members are practicing clinicians -- rather than public health bureaucrats who have never treated patients face-to-face.
# Reprinted with permission. The original article can be found on the Pain News Network site.
