Non-randomized, uncontrolled study that “should be interpreted cautiously” spun by media as supporting relaxed high-risk opioid dispensing that is established as fueling pandemic ODs

by Clark Miller

Published March 16, 2022

The study, published in JAMA, was a non-randomized, uncontrolled retrospective cohort comparison, the researchers starting with a group  (21,297) of opioid misusers in Ontario, Canada receiving by physician prescription substitute opioids buprenorphine (Suboxone) or methadone in opioid agonist treatment, “OAT” (aka medication assisted treatment, MAT, or opioid substitute treatment, OST) at the time of beginning of COVID pandemic restrictions – late March of 2020.

Under relaxed pandemic safety restrictions for the addictive, commonly diverted and misused opioids, pre-pandemic protocols were relaxed by acceleration of shifts from daily in-clinic dosing, where random urine drug samples would have been collected as part of safety monitoring, to weekly take home supplies or from current weekly-supplied users to dispensing each two weeks.

The basic structure of requirement for daily dosing as seen as clinically necessary by prescribing clinicians for users at high risk was preserved. That is, as a non-randomized study, users with a period of “stability” based on time in program, lack of overdose, negative drug screens, other measures were accelerated in shift to leaving clinics with longer supplies of opioids. Newly enrolled or otherwise less stable and higher risk users were required to visit daily for doses.

It’s important to note that the pandemic recommendations allowing more take-home access did not mean there was no oversight — physicians still used their judgement to identify which patients would benefit and which might be at too much risk.

“There were recommendations around that in terms of making sure that people had safe housing and places to store their medication, that they hadn’t recently had an overdose, that they were fairly stable in their substance use disorder before providing these extended carries,” Gomes said. “So it was not just a carte blanche to kind of provide this to everybody, there’s obviously nuance in there.”

That is, users already established as appearing to be less at risk for high-risk opioid use were selected into the “treatment” groups of increased, less restrictive take-home doses. Less generously and more realistically, we would distinguish between common features in the non-randomized comparison groups: users who had the resources, access to and competence to gain and use the strategies to defeat random urine drug screens (for example by covertly bringing in on their person another person’s urine) in contrast to users cycling through programs while misusing, abusing, and using as currency the no-cost opioids while beating the drug screen odds and for a short “bridging” period between more challenging reliance on illicit (street) opioids. That’s a non-randomized design.

It’s a design that clearly predicts the results without any indication or warranted conclusions about benefit or safety of OAT –  “the findings may be susceptible to residual confounding and should be interpreted cautiously”.

They looked at four groups: those on daily doses of methadone or buprenorphine who started receiving take home doses, and those receiving weekly dispensed methadone or buprenorphine doses who started receiving at least two weeks of doses at a time.

The study found that those receiving daily doses of methadone not only had a lower risk of overdoses if moving to take-home doses compared to those who didn’t receive take-home doses, but they were also 20 per cent less likely to have their treatment interrupted or to discontinue treatment.

Those who received an increase from a one-week supply of methadone to at least a two-week supply had a 28-per-cent reduction in discontinuing treatment and a 31-per-cent reduction in treatment interruption compared to those who didn’t receive any increase. There was also no increased risk of overdose in this group.

There are, of course, important invalidating features of this design

that prevent meaningful or confident conclusions for measured outcomes among groups. 

The likelihood of a non-lethal overdose becoming apparent for patients required to appear and be observed daily  is different than for a group of patients appearing at clinic once each week, and different for a group appearing once each three weeks. 

Similarly, the likelihood of detecting in urine screens additional abused substances (like the commonly added benzodiazepines with Suboxone) that constitute high-risk use and over the long term predict overdose is much greater in the group appearing and observed daily with potential for random urine screens. 

The same, of course for signs of use by injection. 

That is, the longer periods between observations and between random urine screens simply provide greater opportunity to avoid detection of high-risk use and of non-lethal overdose. 

In this context, the statistically significant finding for one subset (daily dosing of methadone versus shift to weekly take-home) is of course meaningless. Patients being seen weekly could have experienced multiple naloxone revivals of overdose outside of ER settings and undetected compared to more likely detection of disruptive incidents for those being seen daily. 

There is nothing surprising or remarkable in those results, or meaningful in evaluation of the already established roles of bupe and methadone in fueling the increasingly lethal iatrogenic opioid crisis. Users who’ve learned to avoid requirements for daily visits and daily risk of drug screens were more successful at continuing access to their supply, and at larger doses.

The meaningful, remarkable and predictable result –

is the lack among groups of a consistent difference in prevalence of overdoses in this study, in any case any differences (including the one statistically significant difference in one subset) unable to be attributed to factors other than, as noted, less frequent clinical contact making detection of non-lethal overdose more avoidable. 

That is, under developed OAT programs – whose rationale and presumed benefit is to reduce opioid overdoses and overdose deaths by reducing high-risk opioid use – in this retrospective cohort comparison there was no such detectible benefit for patients clinically judged by the prescribing OAT physicians and associated treatment teams to be stable and safe on their prescribed OAT opioids, (compared to others judged to be at high enough risk to require daily clinic visits)  those OAT participants having been in OAT “treatment” long enough for such clinical judgments to evolve. 

Remarkable and predictable, particularly in the context of the established role (see here, here, and here) of OAT opioids in fueling increased opioid deaths over the COVID pandemic.

From a recent post – 

A fundamentally relevant and troubling body of evidence –

disallowed for public messaging and discourse – points to what the results reveal about the clinical practices of American Medicine

In a related study, surveyed medical doctors reported they were confident in their ability  to detect misuse of substances, yet 50 percent of samples indicated misuse

Telehealth offered numerous benefits to patients during the COVID-19 pandemic, providing access to care when in-person visits weren’t safe or feasible for many. But a new report shows providers worry that virtual visits allowed signs of drug abuse to slip by unnoticed.

In a report from Quest Diagnostics released Monday, 67% of the over 500 primary care physicians surveyed said they fear they missed signs of drug abuse in their patients during the pandemic.

And nearly all of them were prescribing those often-misused drugs—a whopping 97% reported prescribing opioids within 6 months of taking the survey.

Their concerns extend beyond the pandemic into telemedicine use today. Only 50% of physicians said they were confident they could recognize signs of drug misuse during telehealth visits, a far cry from the 91% that said the same of in-person patient interactions.

. . .

But Quest’s data indicates that just because a physician thinks they can spot patient signs of drug misuse doesn’t always mean they do.

While 88% of the physicians reported feeling confident they could identify patients at risk for drug abuse, nearly half of all patients tested by Quest in 2020 showed signs of drug abuse.

Here’s the report these interpretations were based on, analyzing “nearly 5 million de-identified aggregated Quest Diagnostics test results, including over 475,000 from 2020 alone, with a survey from the Harris Poll of more than 500 primary care physicians”. 

SECAUCUS, N.J., Nov. 15, 2021 /PRNewswire/ — A new Health Trends® report from Quest Diagnostics (NYSE: DGX) finds that almost 70% of physicians fear they missed signs of drug misuse during the pandemic, and, given how the global health crisis disrupted medical care, anticipate rising overdose deaths – especially those involving prescribed and non-prescribed (illicit) fentanyl – even as the pandemic subsides.

By combining an analysis of nearly 5 million de-identified aggregated Quest Diagnostics test results, including over 475,000 from 2020 alone, with a survey from the Harris Poll of more than 500 primary care physicians, “Drug Misuse in America 2021: Physician Perspectives and Diagnostic Insights on the Drug Crisis and COVID-19,” provides a unique snapshot of prescription and illicit drug misuse in the United States during the COVID-19 pandemic. The Partnership to End Addiction was an advisor to the report’s development.*

The new report comes on the heels of the approximately 96,779 drug overdose deaths between March 2020 and March 2021, as reported by the Centers for Disease Control and Prevention (CDC).i It also builds on prior Health Trends research, including a 2019 report that examined physician attitudes on drug misuse and a 2020 report that showed positivity increased by 35% for non-prescribed fentanyl and 44% for heroin among tested individuals during the early months of the pandemic.ii

The degree to which America’s Medical/Media/Institutional expert consensus is off, wrong about MAT and effective responses to substance use epidemics is as tragic, lethal, indicative of diminished capacity, and as criminal as their consensus not so long ago on opioids and chronic pain

You expected them to be right this time? 

Why A Critical Discourse?

Because an uncontrolled epidemic of desperate and deadly use of pain-numbing opioid drugs is just the most visible of America’s lethal crises of drug misuse, suicide, depression, of obesity and sickness, of social illness. Because the matrix of health experts and institutions constructed and identified by mass media as trusted authorities – publicly funded and entrusted to protect public health – instead collude to fabricate false assurances like those that created an opioid crisis, while promising medical cures that never come and can never come, while epidemics worsen. Because the “journalists” responsible for protecting public well-being have failed to fight for truth, traded that duty away for their careers, their abdication and cowardice rewarded daily in corporate news offices, attempts to expose that failure and their fabrications punished.

Open, critical examination, exposure, and deconstruction of their lethal matrix of fabrications is a matter of survival, is cure for mass illness and crisis, demands of us a critical discourse.

Crisis is a necessary condition for a questioning of doxa, but is not in itself a sufficient condition for the production of a critical discourse.

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