CDC Guidelines Refuted with Scientific Evidence

Neat, Plausible, and Generally Wrong: A Response to the CDC Recommendations for Chronic Opioid Use – Medium
Stephen A. Martin, MD, EdM; Ruth A. Potee, MD, DABAM ; and Andrew Lazris, MD

Finally, someone is standing up for the truth about opioids and pain patients. These three courageous M.D.s expose the CDC guidelines for the fraud they are.

They’ve written a well-researched paper that refutes the basis of these unscientific and biased guidelines piece by piece with real evidence from scientific studies to back their claims.

I admire these three authors for having the ethics-based courage not to let this gross misinterpretation of science and be accepted without question.

They show how the CDC cherry-picked data with obvious bias (much as they did people). Repeatedly, the CDC interpreted studies with such a slanted view as to assure the outcome they wanted. 

When interpreting them without bias, the same studies actually refute the CDC’s arguments.

Recommendations from the Centers for Disease Control and Prevention (CDC) for chronic opioid use, move away from evidence, describing widespread hazards that are not supported by current literature.

These recommendations are in conflict with other independent appraisals of the evidence — or lack thereof — and conflate public health goals with individual medical care

The CDC frames the recommendations as being for primary care clinicians and their individual patients. Yet the threat of addiction largely comes from diverted prescription opioids, not from long-term use with a skilled prescriber in a longitudinal clinical relationship  

By not acknowledging the role of diversion — and instead focusing on individuals who report functional and pain benefit for their severe chronic pain — the CDC misses the target.

We provide here a review of the evidence regarding long-term opioid use for chronic pain in order to

a) better point public health efforts, and

b) reduce harm from consequent restriction of these medications for patients who have substantial benefit in their use.

With these new recommendations concerning the use of opioids, the CDC has taken available data and developed a narrative that H.L. Mencken would generally have described as “neat, plausible, and wrong.”

The narrative is as follows:

People in chronic, severe pain are readily provided unproven opioids in ever-increasing doses, get easily addicted and die of overdose either from the opioids prescribed to them or from a switch to lethal heroin.

Neat? Yes. Plausible? Yes. Wrong? Unfortunately, yes.

In addition, the exception “palliative care” is notable.

In defining people to be served by palliative care, the National Consensus Project notes that

“serious or life-threatening illness is assumed to encompass populations of patients at all ages within the broad range of diagnostic categories, living with a persistent or recurring medical condition that adversely affects their daily functioning or will predictably reduce life expectancy.” [7]

Chronic pain, when controlled for sociodemographic factors, has been found to reduce life expectancy by ten years. [8]

It doubles rates of suicidal ideation, attempts, and completion [9]

while quadrupling rates of depression and anxiety. [10]

When people look for some relief of chronic suffering, they are doing so relative to a situation of misery. Given the impact of chronic severe pain, it appears to meet the definition for palliative care itself.

Can people in chronic pain expect meaningful relief from long-term opioid use? Not according to the CDC. The recommendations state there is no evidence for such use and only evidence of harm.

Absence of evidence is not evidence of absence, and the CDC’s claim is also belied by direct reports from patients using long-term opioid treatment who report substantial pain and functional improvements.

The CDC, in telling patients that “the benefits are transient and generally unproven,” [12] is essentially telling patients they are wrong about their pain and function.

When conventional evidence is limited and suffering is high, use of clinical ethics for individual patients has been proposed as a worthwhile decision-making model. [13]

the 2014 National Institutes of Health “Pathways to Prevention Workshop: The Role of Opioids in the Treatment of Chronic Pain” concluded that:

Patients, providers, and advocates all agree that there is a subset of patients for whom opioids are an effective treatment method for their chronic pain, and that limiting or denying access to opioids for these patients can be harmful.

Our consensus was that management of chronic pain should be individualized and should be based on a comprehensive clinical assessment that is conducted with dignity and respect and without value judgments or stigmatization of the patient. [15]

… Biased media reports on opioids also affect patients. Stories that focus on opioid misuse and fatalities related to opioid overdose may increase anxiety and fear among some stable, treated patients that their medications could be tapered or discontinued to “prevent addiction.” [16]

The CDC, in contrast, highlights that prescription opioids are “really dangerous medications which carry the risk of addiction and death.”

Much has been made of opioid-induced hyperalgesia. But even the most recent reviews of this phenomenon are unable to determine its prevalence, and studies have generally been experimental in nature or with unusual administration of opioids (e.g., intrathecal). [22,23]

Whether it is clinically important for patients with chronic pain on standard opioid medication is unclear. [24] As to concern for dose escalation, a recent cohort study found it occurred in fewer than one in ten opioid-naïve patients. [25]

First-line interventions advised by the CDC are limited in their effectiveness

Acetaminophen was recently found to have no impact on osteoarthritis pain. [26]

NSAIDs had their FDA warning strengthened in 2015 regarding heart attacks or strokes [27] and their risks of kidney injury and gastrointestinal bleeding have long been recognized. [28,29]

Anticonvulsants or tricyclic medications for neuropathic pain have a number needed to treat of 5, meaning 4 patients do not have a benefit. [30]

Perhaps “multidisciplinary biopsychosocial care with a prominent component of self-management, generally accepted as the gold standard of care for chronic pain”? According to a pain specialist, its availability has “all but disappeared in the United States.” [31]

the choice to use opioids is not made in a vacuum. The decision is made in comparison with the status quo of chronic, intractable pain despite other medical interventions.

As a comparison, chemotherapy for cancer treatment also has severe side effects, even toxicity. People make the choice to use such treatments because they are choosing against the alternative.

The CDC states that “prescription opioids are just as addictive as heroin.” [32] Others call them “heroin pills.” [33] But a full year after after major surgery, only “0.4% of older opioid-naive patients continued to receive ongoing opioid therapy.”

Unfortunately, recent publications have included “pooled studies with widely differing definitions, outcome variables, and populations,” which detract from their conclusions. [35] Concerns about such misleading data and definitions come from a wide variety of sources. [36–38]

The term “prescription opioids” itself is problematic as the adjective does not distinguish how the drug was actually obtained by the user.

Among those who take opioids long-term for chronic pain, the CDC highlights the potential for overdose (“overdose” is mentioned 144 times in the recommendations) and death

The study cited in the CDC’s own telebriefing [12], however, found “opiate-related” death to occur in 59 of 32,449 (0.2%) patients taking opioids for more than three months. [39] The context of these deaths was unknown

In its review of a Citizen’s Petition to limit doses of chronic opioids, the FDA found that “the scientific literature does not support establishing a maximum recommended daily dose of 100 mg MED [morphine equivalent dose].”[42]

Opioid overdose deaths are generally the result of diverted medications (“diversion” is mentioned 2 times in the recommendations)

heroin, fentanyl, or a combination of these. Diversion is most often from prescriptions for acute, not chronic, pain.[43]

94% of people in treatment for opioid addiction said they chose to use heroin because prescription opioids were “far more expensive and harder to obtain.”

The National Institute on Drug Abuse estimates that fewer than half of young people injecting heroin report abusing prescription opioids beforehand. These crucial details are unacknowledged in the CDC recommendations

Examining this Narrative

Public health interventions are different than clinical interventions.

• The former are scaled, diffuse and unilateral.
• The latter are individualized and shared.

The CDC recommendations are more focused on public health concerns (such as non-medical use of prescribed drugs) rather than the individual risks and benefits of opioids for actual patients.

The CDC recommendations describe a linear relationship between opioid prescribing and nonmedical use. But data on opioid prescribing [55,56] and nonmedical use [57], state by state, tell a more complicated story

A Different Narrative

Our concern for individual patients is that recommendations and regulatory changes [62] concerning prescribed opioids are increasingly being developed not through evidence, but by a flawed narrative of how addiction develops and overdose occurs. [63,64]

The CDC was provided with descriptions of these flaws in the period of public comment, but chose to make only minor revisions

Our concern for public health is that these recommendations do nothing explicitly to address the major source of prescription opioids used in substance use disorders in the United States: diversion.

The continued use of graphs that track kilograms of prescription opioids and overdose deaths, however, misleads when many of those “prescriptions” are taking place outside of a skilled, longitudinal, patient-clinician relationship. [66,67]

The data we provide here describe a more accurate narrative:

Should other treatments not succeed, people suffering from intractable chronic pain may find that carefully monitored long-term opioids, in combination with other modalities, can help reduce their suffering and improve their function.

The evidence indicates they can do so with a low risk of developing opiate use disorder and an exceedingly low risk of overdose death. As with all treatments, the decision to use and continue long-term opioids should be one of ongoing shared decision-making.

Overall, the new recommendations sacrifice accuracy for a fabricated sense of clarity

But this goal is better addressed by recommendations that consider both individual patient choice and the impact of prescribed opioids on public health through diversion, two very distinct issues.

The outcome might be less neat — yet still plausible — and have the added advantage of being beneficial to the many people struggling with chronic pain  

These three individuals are our true heroes.

There are 87 references provided for this article. The authors have done the hard research and now it’s up to us to use this as a tool and spread the message…  as much as we with our lives limited by chronic pain and illness, can.

 

I’ve never asked for anything before, but this is so important I feel justified.

Please help spread this article to all pain patients

by posting it to your other social media accounts or email lists.

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