Another Day, Another Guideline
As real-world evidence begins to mount showing these practices are causing harm, yet another guideline is issued…
National Public Radio (NPR), among many other outlets, reported in its October 10, 2019 article that the Department of Health and Human Services (HHS) released a new guideline on how to ‘appropriately taper’ a patient off of their long term opioid analgesic medications, and warned that abrupt discontinuation of long term analgesic therapy could actually ‘harm them.’
The article does start off, as many mainstream articles do, with the obligatory and thus far, unfounded claim that analgesics ‘have been massively overprescribed’ in the US, however, what makes this report different are the unreserved admissions contained in the article by one of the architects of the new status quo surrounding analgesics.
Joseph O. Merrill M.D., M.P.H., a University of Washington associate professor of medicine (who is also a certified expert in addiction medicine), made a few stunning admissions to NPR. The article explains that ‘the dangers of paring back opioid prescribing came into sharp focus for Dr. Joseph Merrill when his primary care clinic in Seattle tightened its rules around opioid prescribing nearly a decade ago.’
The clinic began implementing new measures in an attempt to rectify the potential harms of analgesic therapy for long term treatment of pain, ‘measures like urine drug tests, dosing recommendations and guidance to taper patients on higher doses.’
As NPR reported, ‘after the rules took effect, Merrill began to notice certain patients weren’t faring well.’
‘“We had the sense that we were losing some patients,” he says
Merrill says the results were a “wake-up call”
About 20% of the patients died during the study period of all causes. Close to 4% died of a definite or possible overdose and most of those were people whose prescriptions were stopped.
“The most concerning finding was that the group of patients whose opioid prescriptions were discontinued had a higher rate of overdose death than the group who stayed on their opioid medications,” Merrill says.
In a retrospective study published in the Journal of General Internal Medicine, Merrill and his co-authors speculate that those findings “could relate to interruption of other medical care, loss of tolerance, and/or destabilization of an underlying opioid use disorder.”’
For those of you that aren’t aware of this, the idea of a ‘Morphine Milligram Equivalent’ (MME), which was first described in its current iteration by the Centers for Disease Control (CDC) in their Guideline for Prescribing Opioids for Chronic Pain, was essentially borne out of the CONSORT study.
As I mentioned in Unscientific Guidelines Are Being Peddled As ‘Evidence-Based’ Medicine, one of the linchpins of the CDC’s controversial guideline is the MME. This is the arbitrary dosing cap and conversion chart that I was referring to, but before CDC began using the term, it was called ‘Morphine Equivalents’ or MEqs, in fact, it appears that the idea for the MME came directly from the authors involved in a few different organizations in Washington state via CONSORT back in 2008.
CDC provides the source for how they came up with the idea for ‘Calculating Morphine Milligram Equivalent (MME) Doses for Commonly Prescribed Opioids’ right in their guideline overview:
‘SOURCE: Adapted from Von Korff M, Saunders K, Thomas Ray G, et al. De facto long-term opioid therapy for noncancer pain. Clin J Pain. 2008 Jul–Aug; 24(6):521–527 and Washington State interagency guideline on prescribing opioids for pain; 2015.’
They are referencing the paper that describes the CONSORT study from 2008 and the Agency Medical Directors’ Group (AMDG) Washington state prescribing guideline, one of the most radical in the country.
The idea of MEqs came from “De-facto Long-term Opioid Therapy for Chronic Non-Cancer Pain” which was written by Michael Von Korff, who we discussed in my last piece, among others. Another interesting name that was included in that paper was the same man who made the stunning admissions to NPR that his patients weren’t faring well with the new policies that were implemented in his clinic.
Merrill Was a Researcher Involved in the CONSORT Study
Joseph O. Merrill was one of the researchers involved in CONSORT and possibly one of the original researchers that coined the term ‘morphine equivalents’ which was later adapted by CDC and implemented as a linchpin of the CDC guideline as the infamous MME. However, Merrill made one final and alarming statement to NPR in regard to the policies that were implemented by him and others within his clinic, MEqs included: ‘We did not prevent the death rate from going down by our practices,’ in fact, 20% of the 572 patients who were studied died (of all causes). That’s 114 people just in this one small group that were forced to participate in dosage caps or discontinuation, 4% of which ended up being victims of a definite or possible overdose.
However, 20% is significant and only 4% of the 20% died of a possible or definite overdose. How many in that 20% died due to suicide, intractable pain disease (e.g. cardiac arrest), etc.? We don’t know because there are no control systems in place to track that information. I applaud Dr. Merrill for his candid responses to NPR, they’re laudable, but with these kinds of percentages and a lack of appropriate control systems to track other causes of death post-taper, it seems that it’s time we began studying these public health interventions more carefully and apply more caution moving forward in regard to their implementation.
The study that Dr. Merrill was referencing shows that provider-initiated forced-tapers were noted for some interesting reasons. Please see ‘Table 2 Reasons for Discontinuation of COT’. Some reasons for forced-taper are simply absurd. For example, under ‘behavioral issues’, some were tapered because of missed appointments, dosing disagreements, early refill requests, perceived opioid seeking, lost/stolen medications and/or abnormal pill count. Other reasons for initiation were due to a mental health or medical condition.
As it stands, with the small studies that have described harms thus far, it appears to be unwise to continue allowing government and other ‘stakeholders’ who aren’t trained in pain medicine to create ‘guidelines’ and ‘best practices’ that impact individual and population health. Maybe the dosage for patients on long term analgesic therapy should be managed by the physicians who know and treat them and who have years of training and experience under their belt rather than unofficially forcing doctors to remain within arbitrary guidelines that aren’t based on any current scientific understanding, or hauling them off to prison if they don’t remain within the confines of those unscientific ‘guidelines’.
As we discussed in my previous piece, ‘evidence-based medicine’ (EBM) ‘de-emphasizes intuition, unsystematic clinical experience, and pathophysiologic rationale as sufficient grounds for clinical decision making and stresses the examination of evidence from clinical research.’
It appears as if this definition does not see clinical experience as valuable, despite the fact that clinicians are on the front lines and are exposed to patient outcomes daily. Considering that the evidence-base appears to have been corrupted from the start in regard to the CDC guideline and the fact that no control systems were put in place to track outcomes, you would think that something so glaringly unscientific would never make it past the gatekeepers, but it did.
Most of the guidelines that have been offered up, whether via federal or state agencies, have had disastrous results for patients. The fruit of the insistence of bureaucrats to control physicians‘ decisions appears to be rotten and the above isn’t the only case where significant harm has been noted due to these types of policies.
NPR also reported that:
‘There remains “a huge gap” in research about how the policy shift away from opioids is affecting patient outcomes, says Tami Mark who’s senior director of behavioral health financing and quality measurement at RTI International, a research institute based in North Carolina.
Mark coauthored a study published in The Journal of Substance Abuse Treatment earlier this year which examined what happened to patients in Vermont’s Medicaid program when they were tapered off high doses of opioids.
About half of the patients who were discontinued later experienced an opioid-related hospitalization or emergency department visit.
“The typical rate of discontinuation was one day, which essentially means people were not tapered at all — they were just stopped,” Mark says.
She says the University of Washington study is more evidence that doctors don’t feel well-equipped to help patients who are potentially misusing opioids, “other than by having them discontinue opioids which resulted in as high or higher opioid death rates.”’
NPR further reported:
‘At the Seattle clinic, Dr. Merrill says their findings on the risks of discontinuing certain patients did prompt new protocols.
For example, patients who fit the criteria for opioid use disorder can now easily be switched to buprenorphine, an evidence-based form of medication-assisted treatment that suppresses cravings and stabilizes patients.
In fact, the newly released HHS guidelines tell doctors to consider switching patients who are struggling with a taper to buprenorphine, even if they don’t qualify as having a substance use disorder.’
Why are so many patients being force-tapered when in many cases there is no cause for it, and why is HHS now encouraging physicians to place these patients on a Medication Assisted Treatment (MAT) drug that is commonly used for those with a substance use disorder? Where is the evidence that justifies this, especially considering no studies have been done with buprenorphine long-term on the patient demographics they’re now encouraging physicians to place on the drug, many of which have significant health problems?
As Tami Mark pointed out, there remains a ‘huge gap’ in research on patient outcomes despite the many physicians and other professionals, for years, repeatedly warning against these practices, and the small studies that have been completed thus far are showing that patient harm is, in fact, taking place; and likely on a mass scale.
Repeated Warnings Finally Acknowledged by CDC?
‘In March, more than 300 doctors and health professionals, including three former White House Drug Czars, warned the CDC in a letter of the “widespread misapplication” of its 2016 opioid prescribing guidelines for chronic pain.’
More recently, on October 10, 2019, HHS itself released an announcement detailing that they had released their ‘Guide for Appropriate Tapering or Discontinuation of Long-Term Opioid Use.’
The announcement states:
‘Individual patients, as well as the health of the public, benefit when opioids are prescribed only when the benefit of using opioids outweighs the risks. But once a patient is on opioids for a prolonged duration, any abrupt change in the patient’s regimen may put the patient at risk of harm and should include a thorough, deliberative case review and discussion with the patient. The HHS Guide provides advice to clinicians who are contemplating or initiating a change in opioid dosage.’
Unfortunately, despite the CDC, HHS, and FDA all releasing announcements on the harms of rapid forced-tapering or discontinuation of long term analgesic therapy, there has been no real movement for patients or the physicians who treat them toward a more safe and sane environment in regard to prescribing, but why?
The Environment Remains Punitive
Unfortunately, there is another federal agency that has been engaging in overreach, the Drug Enforcement Agency (DEA). The warnings by public health officials and agencies will remain moot as long as the DEA continues this overreach into America’s doctor’s offices, as well as its overreach and interference in the supply chain.
On October 11, 2019, Newsweek released an article stating that:
‘The Drug Enforcement Administration (DEA) has proposed reducing the manufacturing of prescription opioids for the fourth year in a row…The proposal aims to reduce the amount of fentanyl production by 31 percent, hydrocodone by 19 percent, hydromorphone by 25 percent, oxycodone by nine percent and oxymorphone by 55 percent, according to the DEA. Altogether, the cuts would constitute a 53 percent decrease in legal opioid production since 2016.’
This, despite the fact that a recent study relased on October 2, 2019 (9 days earlier), showed that only 1.3% of opioid-related overdose decedents had active legal opioid analgesic prescriptions prior to death at the height of the overdose crisis (2013–2015). This information was confirmed via toxicology reports for these decedents.
Harm reduction advocates like Leo Beletsky, a Professor of Law and Health Sciences who ‘holds a joint appointment with the School of Law and Bouvé College of Health Sciences’, opined on Twitter:
However, instead of acknowledging the emerging science that is beginning to shed light on the harms of rapid forced-tapering, discontinuation of analgesic therapy, supply chain disruptions, etc., DEA doubled down in yet another Newsweek article published on October 14, 2019, stating that the DEA doesn’t ‘regulate practice of medicine.’
They further stated that ‘these cuts should have no bearing on the decisions made by caregivers and their “legitimate pain patients.”’
Yet, the DEA continues to flag prescribers using the Prescription Drug Monitoring Program (PDMP), raiding doctors’ offices with SWAT-style raids, hauling physicians off to prison for ‘overprescribing’, and seizing their assets before a crime has even been proven to have been committed under civil asset forfeiture. These practices have understandably sent a chill through the medical community and many physicians have simply stopped prescribing analgesics altogether, while others have retired, some are sitting in prison, and still many others are awaiting trial for ‘overprescribing’ opioid analgesics.
As we discussed in Unscientific Guidelines Are Being Peddled As ‘Evidence-Based’ Medicine, not only is the MME an unscientific and arbitrary dosing cap that is essentially meaningless, the idea that decreases in the number of pills manufactured or prescribed by physicians is a valid metric that can be used to measure ‘success’ is similarly unscientific, arbitrary, and meaningless and yet; the DEA continues to double down on supply chain disruptions despite admitting that the agency isn’t responsible for regulating the practice of medicine. This is a true statement, it’s actually the FDA that’s responsible for regulating the licit i.e. legal drug market, so why is the DEA interfering in the supply chain at all, raiding clinics and practices, hauling physicians off to prison, and seizing their assets?
With all of this useful data coming out, we still continue to see not so subtle optics like this in nearly every single mainstream media piece covering the overdose crisis, including the NPR and Newsweek pieces:
These practices and policies have failed repeatedly on a smaller scale as these studies are beginning to show, and yet, these same practices and policies are still being forced in the national policy landscape, DEA continues with its rogue overreach, and other federal agencies continue developing guidelines which may impact population/public health in devastating ways.
A full redesign of our healthcare industry is underway and has been for nearly a decade, it’s time we, as a people, began pointing out the harms that American citizens continue to endure with no meaningful remediation and demand that a more cautious and careful approach is employed moving forward.
It‘s time that the American people began demanding to know why these practices continue as they’re not likely to stop at analgesic medications and it’s time the Centers for Disease Control & Prevention, and other federal agencies began trying harder to prevent some of the harms caused by unscientific ‘guidelines’, ‘best practices’, and other forms of clinical decision control.
This should include appropriate tracking and control systems, of which, none have yet been proposed or built. Appropriate tracking systems should have been put in place long before these interventions were forced onto the American people and their physicians whether officially or via de facto policy, but no systems currently exist to rectify these issues that are resulting in harm to the public’s health.
Twenty percent of the patients Dr. Merrill studied died, one of the architects of the MME, and only 4% of those deaths were possible or definite overdose; this is not an insignificant finding. Tami Mark found that the death rate stayed the same or increased when studying those who were forced off of their analgesics and yet, these policies continue to barrel forward and federal agencies continue to claim they are ‘evidence-based’ despite the obvious evidence to the contrary.
Is another ‘guideline’ really what we need, or is it more likely that physicians need to simply get back to managing their own patients rather than the federal government? It appears to me that this new HHS guideline on the ‘Appropriate Tapering or Discontinuation of Long-Term Opioid Use’ is not only not going to make an impact that matters for patients, but it may further entrench justification for force-tapering or changes in medication type when it’s not medically warranted due to fear of prosecution. Instead of leaving patients on the treatments that work for them, physicians have been forced into a model of EBM that isn’t even evidence-based, in fact, the evidence was lacking for the MME to begin with, and thus, anything based on it is scientifically and literally void.
A national discussion on how far federal agencies should go to ‘protect’ human health is long overdue and I encourage those of you who are concerned about these developments to erupt in a cacophony of dissent. Talk to your family, friends, colleagues, and participate in the wider public discourse before it’s too late. These types of policies absolutely will affect you at some point. It only takes one injury, illness, or surgery to turn you into an acute or chronic pain patient. Please heed the warnings, they’re all in plain view.