UPDATE Opioid Crisis –

U.S. Opioid Substitution Treatment (OST) Failure:

High-Risk Use Measured as Injection-Related Infectious Disease Increasing In Response to OST Provision – Nationally

by Clark Miller

March , 2019

The numbers, as they say, are staggering.

Opioid-related and other drug overdose deaths increasing steadily, now sharply, over decades, 70,000 last year. Seemingly perversely, as population “dose” of the promised, publicly funded U.S. medical industry cure for the medical model “brain disease” of compulsive substance use – dose of substitute opioids that are addictive, diverted and abused – has expanded over the same years.

STAT opioid deaths

As explained in detail in this post and here, evidence for benefit from the medical/pharmaceutical industry medical fix for the medical/pharmaceutical industry-generated lethal opioid crisis requires an explanatory mechanism. Unlike the beneficial lethality-preventing effects of naloxone – observed and counted directly in emergency or medical settings when a user at risk of overdose death is revived by use of naloxone (Narcan), any presumed role of OST in reducing OD deaths or providing other benefit must be achieved, measured, and statistically significant (in credibly designed and interpreted research with durable results and external validity) as reducing high-risk opioid use – that’s how any hypothesized benefit would occur.

NEW EVIDENCE BELOW

In a variety of settings and nationally, high-risk opioid use as measured by non-lethal overdose incidence has worsened with increasing provision of the medical model fix, against prediction if OST provides benefit. Another, independent measure of high-risk use – incidence of opioid- and injection-related infectious diseases including endocarditis – also shows an OST-invalidating pattern of increase in response to large increases over decades of national dose of opioid substitution medicine.

But that evidence has never existed. For a number of invalidating reasons. One primary reason is that use of naloxone has increased concurrently with provision of OST. Studies have not been controlled to allow attribution of any reduced opioid-related mortality to OST versus use of naloxone – the potential exposure to naloxone intervention generally reported to be and predicted to be positively associated (correlated) with patient involvement in OST services and associated medical and psychosocial supports.

Another of multiple invalidating factors is the consistently emerging evidence: national data, data from community programs, associated timelines, and OD death prevention data all point coherently to naloxone acting as the protective factor accounting for any apparent reductions in OD deaths, measured directly, leaving no changes for the hypothesized effects of OST to account for.

There is no body of studies that control for, that is allow differentiation of and assignment of causative effects to, presumed beneficial effects due to OST versus concurrent increases in availability and use of the OD-reversing drug naloxone. That would be almost impossible to control for in any type of study, or in any case be unethical. Community and national programs to increase availability and use of naloxone have developed concurrently with development and/or expansion of OST programs – leaving longitudinal studies confounded by at least two uncontrolled effects. Clearly it would be unethical to block access to the life-saving OD-reversing drug in any type of designed study.

Cincinnati naloxone

In studies that measure mortality, for example, post-prison release, there are uncontrolled confounding factors that preclude attributing benefit – as measured by lower incidence of mortality – to the single factor of use of buprenorphine, or use of methadone:

In studies that are not randomized, subjects volunteering for OST versus those who decline, would be more motivated not only to use the medication, but also to access additional supports and services, some of them evidence-based – psychotherapy; housing support; employment support; social services; other.

Subjects accessing regular medical-setting visits as part of receiving a substitute opioid would necessarily more likely be offered and provided (confounding) protective supports and services especially OD-reversing naloxone kits and instructions on how to use them – for themselves and significant others. Naloxone, from consistent evidence, accounting directly for all apparent reductions in OD deaths in epidemiological trends.

Overdose deaths US trend The Guardian

The more deaths mount,

the more pressure mounts to divert public healthcare resources to the unvalidated medical model provision of addictive, diverted and abused substitute opioids.

False – unsupported by research subjected to competent critical analysis – claims used to rationalize continued diversion of public healthcare funds to the substitution (opioid substitution treatment = OST) of addictive opioids (like buprenorphine and methadone) focus on apparent reductions, over limited time periods, of deaths due to overdose by opioids, not other measures of presumed benefit. There are reasons for that, as we’ll see.

Let’s break it down, take it apart

PREVALENCE OF LETHAL OPIOID-RELATED OVERDOSE DEATHS IS NOT A MEANINGFUL MEASURE OF EFFECTIVENESS OF OST

For reasons outlined above, with links to posts at A Critical Discourse – each post with detailed explanation, linking to primary research and other sources.

That’s why other measures are required, and why popularizers of OST must focus on the overdose death figures. In a vacuum of credible, competent analysis of research, those results can be spun, by research-illiterate researchers, medical authorities, writers and others – to research-illiterate regulators, media, writers, policy makers and the public. That is, studies pointing to reductions in overdose and/or other deaths when OST has been provided can and have served as useful lies – useful especially to producers of the substitute opioids and to a medical industry desperately in need of evidence to distract attention away from its creation of the lethal epidemic – that it has been the provision of OST, rather than other factors in the uncontrolled and in other ways flawed studies, causing the reductions in mortality.

THERE IS NO BODY OF EVIDENCE WITH RESULTS THAT CONTROL FOR THE MOST LIKELY OF CONFOUNDING EXPLANATIONS FOR THE REDUCED DEATHS – CONCURRENT INCREASED AVAILABILITY AND USE OF THE OD DEATH-REVERSING DRUG NALOXONE

Analysis of research that could have provided credible and meaningful interpretation of available evidence and served to protect public health has instead occurred in a vacuum of research literacy and capacities for critical thought, intellectual integrity, and clinical competence in the relevant areas of behavioral health, psychology, and analysis of research design and interpretation. That lethal vacuum, of course, is how we got a worsening opioid crisis and predictable outcomes like this disinformation threatening public health.

On analysis of the evidence, naloxone use – its reduction of deaths acting and measured directly, unlike presumed benefit from OST – directly accounts for all apparent changes (= decreases) in opioid-related overdose deaths. This result holds when results are available on a local level (e.g. here, here, here, and here) and when national data are examined

ATTRIBUTING BENEFIT TO OST REQUIRES EVIDENCE OF REDUCED HIGH-RISK USE OF OPIOIDS –

As described in detail in this, this, and other posts, that is the mechanism by which OST could possibly provide benefit.

When outcomes are critically analyzed, the evidence points consistently to provision of the medical model fix or “treatment” for problem opioid use  worsening, not protective for, high-risk use and associated harms including opioid-related mortality. Because high-risk use, measured as non-lethal overdose incidence (eliminating the confounding, established effects of expanding naloxone use and campaigns) has increased nationally and consistently in multiple locales where date are available as dose of the medical cure increases.

NEW EVIDENCE BELOW

In a variety of settings and nationally, high-risk opioid use as measured by non-lethal overdose incidence has worsened with increasing provision of the medical model fix, against prediction if OST provides benefit. Another, independent measure of high-risk use – incidence of opioid- and injection-related infectious diseases including endocarditis – also shows an OST-invalidating pattern of increase in response to large increases over decades of national dose of opioid substitution medicine.

Another direct measure

of high-risk use of opioids is incidence of opioid injection-related infectious disease, like endocarditis.

Think about it. We are looking at incidence of infectious diseases caused by injection of opioids. That use of opioids is high-risk. If OST provides benefit to at-risk users, the mechanism is by reducing risk and associated problems related to opioid use.

Trends of decreased incidence of an injection-related infectious disease could be attributed to a variety of factors including: changes in public health, prevention, or medical interventions; decrease in high-risk opioid use including use by injection; clean needle exchanges; behavioral health treatments; others. Identifying the factor(s) any decreases could be confidently attributed to would require that multiple congruent, well-designed studies and other lines of evidence point to those factors and not others.

Increases in incidence, like those we’re seeing, are different. If increases of significant magnitude occur over the same time period that an intervention, like the medical OST fix, hypothesized to be a “treatment” or protective factor has also increased, then that constitutes strong evidence against that intervention as beneficial in reducing high-risk use.

As we would predict from everything we know about problem substance use and the failure of medical approaches to provide benefit for that non-medical problem, those diseases are increasing in prevalence.

That’s been true in Ontario, Canada and in Columbus, Ohio.

In Franklin County Ohio –

In Franklin County, Ohio, cases of drug-injection-related infectious endocarditis, a measure of injection drug use, have skyrocketed over the years 2012 – 2017.

Specifically, the increase in incidence of those cases increased 436 percent, most of that increase attributable to use of heroin by injection.

Investigators found that overall admissions for infective endocarditis at Ohio State University Wexner Medical Center increased 101% from 2012 to 2017, with most of the increase coming from the 436% jump in drug-related cases. The research, which was presented at the American College of Cardiology (ACC) 2019 Annual Scientific Sessions in New Orleans, LA, found that most of the cases of endocarditis related to drug use involved heroin.

Significant, extended increases in medical provision of buprenorphine and methadone OST should necessarily have resulted in the opposite outcome – decreases over the same time period of high-risk opioid use . . . unless . . . as is generally and predictably the case, the provision of a medical model “treatment”, unsupported and indicated against by research evidence for an entirely non-medical condition – compulsive problem opioid use – has predictably resulted in a worsening of an iatrogenic lethal opioid crisis rather than providing benefit.

NEW

New reports suggest that the same effect is occurring nationally. In response to large increases in provision of the medical OST fix for high-risk opioid use, over decades –

SAMSHA bupe client trends2

 – nationally incidence of opioid-injection-related diseases have increased as well, the opposite of predicted if OST is providing benefit.

“ . . . growing rates of certain infectious diseases, including HIV/AIDS, hepatitis, heart infections, and skin and soft tissue infections.”

As with increasing rates of another measure of high-risk opioid use – non-lethal overdose – as provision of the medical cure increases, predictable outcomes and patterns are emerging.