UPDATE: Mounting Evidence Increasingly Invalidates French, U.S. Substitute Opioid Medical Fix Campaigns for Lethal Opioid Epidemics

by Clark Miller

December 27, 2018

As outlined and discussed here at A Critical Discourse in a series of posts on the opioid epidemic and its causes, the false promise of medication assisted treatment (MAT) as implemented is increasingly exposed by critical evaluation of diverse lines of evidence and research from U.S. MAT outcomes and from France’s decades-long, least restrictive, most intensive opioid substitute treatment (OST) campaign in the world, held out as the model for a U.S. medical “fix” with substitute opioids.

As established for the lethal iatrogenic opioid crisis the fix is a response to, the research “evidence” was never credibly supportive and predictive of benefit, instead predictive of a mounting body of evidence of failed outcomes and steadily worsening lethal public health epidemics associated with population “dose” of the medical cure increasing substantially and steadily in the U.S. and model country France. That research – vetted by the same expert professional class responsible for ensuring a research evidence base for the medically appropriate, safe, effective use of addictive opioids for the non-medical condition of common chronic pain – was never subjected to competent critical analysis of research design, interpretation and validity, never subjected to a critical discourse, instead successfully endorsed by popularizing writers in mass media.

STAT opioid deaths

That mounting evidence has included –

Retention rates (patients staying in and successfully completing MAT treatment programs) low and trending to zero in natural community treatment settings, with concurrent misuse of other opioids, other drugs – described in this post:

Doxa Deconstructed: Another Medical Fix Not Supported by Evidence – Suboxone for the Opioid Crisis

Evidence in the anomalous case of a Plumas County, California reversing opioid-related OD deaths pointing to Naloxone as the effective protective factor and against OST – described in this post:

In a California county hard-hit by opioid abuse, reduced death rate points to OD reversal drug naloxone, not opioid substitute Suboxone

Consistent evidence – as the national “dose” of substitute opioid medical “fix” and “anti-addiction drug” buprenorphine has steadily and substantially increased – of a concurrently worsening, lethal epidemic – outlined in this post:

More Signs U.S. Medical Industry Magic Pill Approach to Opioid Crisis on Same Track as Decades-Old Failed French Experiment of Unrestricted Buprenorphine Prescriptions in Primary Care

Rampant, runaway diversion and abuse of the prescribed, addictive substitute opioids in France and the U.S., enough in France to fuel buprenorphine abuse epidemics in another country – described in this post:

The French Connection France’s Decades-Long Unrestricted Buprenorphine (Substitute Opioid) Campaign – Promoted as the “Fix” for U.S. Opioid Crisis – is Fueling Widespread Prescribed Opioid Diversion, Trade and Abuse

Lack of evidence to support the claim of efficacy for MAT/OST in reducing OD deaths or for other benefit, instead evidence for diverse harms – described in this post:

The Science: Following French Failure, Americans Get a Substitute Addictive Opioid as “Fix” for the Opioid Crisis, Marketed as Reducing Overdose Deaths Does It?

OST falsely constructed, branded as “treatment” thereby diverting public resources, attention, and policy away from existing evidence-based treatments for problem substance use including opioid use – described in this upcoming post:

Upcoming Post Opioid Epidemic: For Worsening Crisis French and U.S. Medical Systems Dispense Ongoing Addictive, Abused Substitute Opioids With No Evidence-Based Treatments, Predictable Outcomes
and these posts at A Critical Discourse:

Why Addiction Treatment Doesn’t Work

Why There is No Such Thing as “Addiction” – A Fabrication that Diverts Healthcare Resources to the Criminal Treatment Scams Driving Lethal Public Health Epidemics

Effective Substance Use Treatment Requires Ending All Funding and Treatment for “Addiction” – A Fabrication that Diverts Healthcare Resources to the Criminal Treatment Scams Driving Lethal Public Health Epidemics

Evidence falsifying and dismantling claims by the medical/harm-reduction industry that diverted substitute opioids are primarily or largely used in self-treatment by individuals motivated to stop high-risk opioid use, instead affirming misuse and abuse of diverted prescription opioids – described in this upcoming post:

Update, Opioid Crisis – Word from the Street: The Bupe Economy is About Abuse not Self-Treatment

Newly emerging and accumulating evidence outlined below includes

A new, large study of opioid-dependent patients in the UK, followed for 12 months after opioid substitute treatment with buprenorphine and methadone, with no findings of significant benefit in reduction of OD deaths, “drug related poisonings” = DRP.

A new, anomalous case of significantly reduced incidence of OD deaths against the continuously worsening national trend – in Dayton, Ohio – where evidence can directly link the reduction to a naloxone campaign, not to OST/MAT.

Additional outcome measures from France inconsistent with benefit from decades of unrestricted medical provision of substitute opioids as “treatment” – France remaining 5th worst of 20 European nations in “high risk opioid use”.

In the U.S., opioid substitution treatment (OST) primarily with buprenorphine has been successfully branded, marketed and funded with public healthcare resources on claims that research has established effectiveness in reducing opioid-related OD deaths. But that research was never critically analyzed, instead promoted by popularizing writers with interpretations flawed by the most basic of errors: attributing cause-and effect in “before and after” comparisons, when alternative factors were not accounted for and, on examination, have provided the explanation supported by evidence.

Consistently, evidence has supported the OD death-reversing drug naloxone as accounting for any reductions in OD deaths, and not buprenorphine MAT (OST).

One confounding factor common to the inappropriately interpreted studies is that subjects provided OST were typically followed up with for short durations through provision of OST and after the “treatment”. A recent, large UK study is relatively more robust, powerful and externally valid because a large number of opioid-dependent patients (11,033) in natural care settings – not under supervision or criminal justice mandates and controls – were followed up to 12 months after end of treatment, potentially moderating confounding effects due to presumed greater exposure to protective effects of naloxone responders while engaged in community services and recovery-supportive environments.

That study’s conclusions appeared to attribute no significant overall reductions in risk of opioid-related overdose deaths (“drug related poisonings” = DRP) associated with buprenorphine or methadone OST, “Model estimates suggest that there was a low probability that methadone or buprenorphine reduced the number of DRP in the population: 28 and 21%, respectively.”

Dayton header NYT

Across the U.S., buprenorphine population “dose” has been substantially increasing over past years and would have been increasingly available in any U.S. city to persons needing it as “treatment”, to stop or reduce high-risk opioid use – if not as prescribed in a medically-managed MAT program, then within the bupe diversion economy. We know that because it is so extensively and widely diverted, available illicitly to anyone wanting it. Diverted so widely and extensively that in France – model for the U.S. publicly-funded opioid crisis fix – “sub” diversion fuels illicit opioid economies in other countries.

While availability of the presumed medical fix was widely available either directly or black market, for years, overdose deaths continued to climb . . . and climb in Dayton, until abruptly and concurrently, as in Plumas County, there was an intensive coordinated Naloxone campaign that included distribution, education, and training, was initiated. Then OD deaths dropped.

In Dayton fortuitous (or profit-driven) disappearance from the streets of carfentanil – a dangerous synthetic opioid driving many overdoses – cannot be ruled out as moderating OD deaths. But additional data and evaluation is needed to attribute a role for that change in the OD death outcomes:

Most determinative, were potentially lethal opioid-involved overdoses established and recorded as prevented by administration of Naloxone? If so, those reductions in OD deaths are attributable to Naloxone and cannot reasonably be attributed to changes in carfentanil presence.

Was fentanyl, also dangerous and increasing risk of lethal OD, still on the streets? And figuring in potentially lethal overdoses?

Did opioid-involved overdose decrease in frequency? Or remain largely unchanged, with OD deaths reduced? That would point to effects due to the Naloxone campaign, away from changes in risk of exposure to dangerous opioids on the street, away from “treatment” effects.

In Dayton, new traditional addiction treatment programs became operational the same year – 2018 – that lethal OD deaths decreased – seemingly too late to account for harm-reducing effects gained from successful extended engagement, change, and outcomes for individuals in programs – and there is no evidence, direct or other, to link the reduced deaths to effects of those programs. Those types of effects in any case would not be expected or predicted, because core elements of treatment as usual (TAU) in the U.S. for substance use problems predict at best no benefit, likely harm, one predictive and explanatory factor in continually worsening substance use epidemics.

shutterstock_empty chairs group meeting

Analysis and evaluation of effectiveness of responses in Dayton to the lethal and worsening opioid crisis must be, in any case, revisited and rethought in light of more comprehensive, recent local reporting:

1) opioid-related OD deaths trending back upward in the most recent months and

2) investigative work by the Dayton Daily News revealing – as associated with medical buprenorphine opioid substitution – widespread diversion for abuse; ineffective use of public health care funds constituting apparent Medicaid abuse, especially failure to provide the treatment part of medication assisted treatment (MAT); and criminal behavior by medical providers as commonly described in the U.S.

Misuse of other opioids during and soon after opioid substitute “treatment” remains common and likely underestimated, Because the study data lacked information on patients’ use of illegal opioids like heroin, the results likely underestimate the proportion of patients using opioids during and after buprenorphine treatment. “The statistics are startling,” says Alexander, “but are consistent with studies of patients treated with methadone showing that many patients resume opioid use after treatment.”

shutterstock Suboxone

In France,

where the world’s least restrictive and most intensive “revolutionary” substitute opioid (buprenorphine and methadone) medical dispensing experiment has been underway for decades, among other serious problems, opioid-related overdose deaths have trended upward over the most recent reporting period

French OD death trends 2006-2013

the apparent surge upward again in 2013, interestingly, appearing to follow introduction of Suboxone (bupe plus antagonist naloxone) to longstanding use of Subutex (pure opioid partial agonist buprenorphine).

Medically-disbursed buprenorphine in France seems to serve largely to supply, by diversion, street use of bupe in France and in other countries.

A primary, and telling, outcome of the French decades-long experiment – implemented on the belief that the world’s most developed OST campaign would provide the benefit, at least, of reducing high-risk opioid use – is the recent (2017) finding that France is 5th highest among 20 European nations in high risk opioid use –

France high-risk opioid use