Overzealous Use of the CDC's Opioid Prescribing Guideline is Harming Pain Patients Article
Congratulations to Kate Nicholson, Dianne Hoffmann and Dr Chad Kollas on an excellent summary of the many horrid impacts of the 2016 CDC guidelines. As “weaponized” by State and Federal legislators in restrictive regulations and laws, these guidelines are directly responsible for hundreds of deaths due to doctor desertion, patient medical collapse and suicide.
Three key but scientifically unsupported assumptions of the Guidelines writers are now known to be wrong. And the omission of an entire field of medical literature renders moot, the CDC one-size-fits-all dose criterion for safety review. Contrary to the guidelines, we now know:
(1) Managed medical exposure to opioid therapy is rarely associated with substance abuse in pain patients. Published CDC data reveal no cause-and-effect relationship between rates of physician prescriptions of opioids, versus rates of overdose-related mortality. NONE. The idea that over-prescribing caused our US opioid “crisis” is an urban myth invented out of thin air by CDC and DEA policy makers who didn’t do their homework. The published demographics of addiction and chronic pain also contradict this urban myth. Chronic pain patients are almost never abusers, even if they are dependent on opioids for pain management.
(2) Ample data also establish that medically managed opioid therapy is safe and effective for millions of pain patients for long periods. Though there are few long-term double-blind trials due to drop-outs of patients randomized to placebo, the Centers for Medicare and Medicaid Services acknowledge that ~1.6 million patients (plus possibly similar numbers under private insurance) have been maintained on doses exceeding the 90 morphine milligram equivalent daily dose safety threshold of the Guidelines, often for periods of several years. CDC has demonstrated no elevated mortality statistics among these patients.
(3) Publication of a massive systematic outcomes review in June 2018 by the US Agency for Healthcare Research and Quality reveals that there are no proven-safe alternative treatments that may be substituted for analgesic or anti-inflammatory therapy. No trials for non-invasive, non-pharmacological therapies have progressed beyond small scale Phase I trials as additions (adjuncts) to usual therapy. The state of precision in the nearly 5,000 published trials reports is so abysmal that only 218 survived a careful quality review. These therapies may have a role as additions to medical therapy, but not as replacements. And they are most certainly not “preferable.”
(4) The CDC Guideline writers ignored a well-established literature on the metabolism of opioids in the human liver. Due to natural genetic variations in the expression of six liver enzymes, some people are poor metabolizers and others “hyper” metabolizers for up to 90% of all medications. As confirmed by recent AMA resolutions, the high natural variability in minimum therapeutic dose levels between patients makes any effort to standardize dose levels or duration completely inappropriate on the part of legislators or regulators.
The only ethical response to this policy debacle must be immediate withdrawal of the fatally flawed CDC document to correct its many biases, errors, distortions and omissions. State regulations and laws based on the document must also be repealed. The DEA must also be put on notice that in the absence of patient complaints or a pattern of hospital admissions or fatalities, it is grossly inappropriate to investigate individual doctors solely on the basis of the volume of medications that they prescribe. By contrast, it is essential that disproportionate patterns of opioid shipments to rural zip codes by major corporate distributors be investigated to detect the few remaining pill mills.
The public policy environment surrounding pain treatment is about to change in major ways. And it is time for our legislators to participate. Direct the CDC to withdraw the guidelines. And DO IT NOW!
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My thoughts:
This article is so true. Someone like myself who has been on opioids and a combination of other drugs have allowed me to have a life without them I was stuck in my bed with no light or noise. I couldn't get up to go to the bathroom without screaming in pain. Opioids have given me my life back. Every day I have to worry if my pain doctor won't be able to write for my opioids. My family knows if I go back to the pain I was in I will end my life no question. We don't make our animals suffer so why should we do that to humans who aren't going to get better they are only going to get worse. Reflex Sympathetic Dystrophy, Rheumatoid Arthritis, and Chrons don't get better it gets worse as you age so not having a treatment is cruel. It time we fight for chronic pain patients and not make their life any harder.
