I am not an attorney, but when someone robs a store and store employee is shot/killed … the person driving the get a way vehicle – gets charged with the same crime – just as if he/she had the gun and pulled the trigger. Should individual professionals, healthcare corporations, insurance/PBM’s that creates edicts, policy and procedures based on some study or such thing like the CDC opiate guidelines that are based on poorly designed studies ? For the harm to pts that happen because those entities who adopted such guidelines without doing their own evaluation of what those guidelines are based on ?
Here is a quote from the 211 pages of the 2022 proposed CDC opiate dosing guidelines
The update process uses multiple key sources of input.
The 2016 Guideline was developed using the best available scientific evidence and followed a rigorous scientific process. The update to the Guideline is following a similar process and includes several opportunities for community and partner engagement. CDC highly values public engagement and has ensured there are multiple opportunities to hear from and incorporate feedback from patients with pain, caregivers, clinicians, and partners.
If the same scientific evidence and similar processes is being used to develop these “new guidelines”… who believes that one could expect the 2022 revised guidelines that was considerably different than the guidelines that were published in 2016?
Does anyone seem that it is strange that both the 2016 & 2022 guidelines only talks about MME’s/day limits, which many consider the conversion ratios being highly inaccurate. There is no mention of the practitioner using CYP-450 opiate metabolism or PGx/Pharmacogenomics to help determine the opiate that the pt’s system utilizes the best, identify a pt that is a fast/ultra fast metabolizer and would need larger or more frequent dosing and/or what intensity of pain should be ideal targeted to help optimize the pt’s QOL.
In reality, when a pt is diagnosed of being a chronic pain pt… the intensity of their pain will ALWAYS be under treated, The probability of pt getting to “zero pain” is pretty much a unrealistic goal. There is a chart on the first page of my blog that lists all the potential complications of pt’s existing comorbidity issues and/or could cause the pt to have developed more health issues.
Then there is the routine suggestions that pts use non-opiate meds ( NSAID’S & Acetaminophen ) which the first can cause kidney damage and the latter can cause liver damage. Focusing pain management/therapy on limiting MME’s/day can often cause a hypertensive crisis ( very high blood pressure), which can cause eye, heart & kidney damage, heart attacks, strokes, not to mention elevated pain intensity levels .. forcing the pts to live/exist in a torturous level of pain, ending in some of these pts to commit suicide to take the final action to stop their unrelenting high intensity of pain.
Could any/all of the people/entities involved in creating/publishing/adopting these guidelines and the studies that the guidelines were based on, be held liable for the adverse health outcomes and/or damages to the pts that are forced to conform to a plan of treatment that was derived from these guidelines?
We’re measuring opioid strength the wrong way
Over the past several years, our government has taken control of doctors’ prescription pads. In an attempt to reduce opioid overdose deaths, lawmakers placed hard quantitative limits on the maximum daily dose of painkilling drugs doctors can prescribe. These dose limits were calculated from a conversion table that was the crux of the Centers for Disease Control. and Prevention (CDC) 2016 opioid prescribing guidelines. But a review of the scientific literature shows that the evidence upon which the table is based is either flimsy or non-existent. Even if the CDC recants its 2016 prescribing guidelines when it updates them later this year, the damage has already been done.
The CDC conversion table was intended to help doctors calculate the appropriate dose of a given opioid by comparing its strength relative to morphine. Supposedly, the use of these “morphine milligram equivalents” (MME) would act as a quick reference for physicians. The CDC recommended 90 MME (90 milligrams of morphine) as the maximum daily dose and that the dose of other drugs be adjusted accordingly. For example, the maximum dose of oxycodone, a drug that is twice the strength of morphine, would be given at half the dose of morphine, or 45 milligrams per day.
Although some scientists voiced skepticism, the recommendations became gospel, and later, law. Indeed, by 2022 38 states enacted laws that restricted the number and dose of opioids doctors may prescribe. Many impose daily limits of 90 MME or less. Medicare requires pharmacists to “confirm the medical need” for patients prescribed doses exceeding 90 MME. Health plans impose restrictions on prescriptions exceeding 90 MME.
Although upon first inspection the conversion table appears authoritative, closer scrutiny reveals otherwise. To support it, the CDC cites only one paper — a 2008 study that is inadequate by any measure. This supposedly pivotal piece of research puts forth a conversion table that is cobbled together from a number of small, clinically insignificant studies dating back over 60 years.
But these studies never even compared the doses of the various opioids that cause respiratory depression and death. The types of trials that went into the table would never be conducted today. We call this junk science.
Never mind; this same deeply flawed science has become policy in many hospitals, health plans and pharmacies.
When junk science is enacted into law, innocent people become “guilty.” In many cases, innocent physicians have ended up in prison for exceeding the 90 MME law, even though this number was never properly determined. And innocent chronic pain patients fared even worse. Many of them who had been on long-term high-dose opioid therapy found themselves in unbearable pain after their pain meds were cut, sometimes sharply, because their doctors were afraid of the consequences of exceeding the 90 MME limit — even when medically appropriate. In desperation, an increasing number have turned to street drugs or worse, to suicide.
Realizing the mess it created, the CDC issued an advisory in 2019 stating their 2016 guidelines were “misapplied,” that it never meant the 90 MME benchmark to be a “hard limit.” The CDC admonished doctors for cutting off or abruptly tapering patients whose pain had been well-controlled with doses exceeding 90 MME, even though this practice continues. That same year the American Medical Association officially stated “no entity should use MME (morphine milligram equivalents) thresholds as anything more than guidance.”
Last June, the Food and Drug Administration requested comments from various experts for a workshop it held to investigate the science and “knowledge gaps” surrounding MME benchmarks. One of us commented, explaining why creating morphine equivalent conversion tables is pharmacological folly.
The last two years of the COVID-19 pandemic should have taught us that medical knowledge is constantly being revised and updated, that it is often based on questionable assumptions rather than evidence, and it is never “one size fits all.”
Writing dubious assumptions into law casts junk science in stone. And the junk science remains embedded in the public mindset long after a law is repealed.
As a result, current pain management policy is a house of cards resting on antiquated and unscientific assumptions with no foundation in evidence, just a collection of incorrect (or unproven) numbers. If the CDC seeks to establish meaningful guidelines, it must focus on modern, scientifically rigorous studies, not a patchwork of unreliable research from the past.
Singer practices general surgery in Phoenix and is a senior fellow at the Cato Institute; Bloom is director of chemical and pharmaceutical science at the American Council on Science and Health
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