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

by Clark Miller

September 6, 2018

As described here, healthcare industries responsible for the opioid crisis have rushed to claim effectiveness for Medication-Assisted Treatment (MAT) with the substitute opioid Suboxone, a medical fix for a lethal epidemic caused by the unsupportable medicalization of a non-medical problem, popular media tagging along without critical examination of claims and evidence that, on examination, does not support MAT as an effective response to the opioid crisis.

Popular media have followed along with orthodox reinforcement and promotion of medical fixes for the medically-generated opioid crisis, citing reduced overdose deaths due to opioid misuse as strong evidence and support for effectiveness of Medication-Assisted Treatment (MAT) and partial agonist assistance with Suboxone (buprenorphine + the antagonist naloxone) to address problem opioid use and the opioid epidemic.

Numerous print and online news sources are running feature articles and series on the crisis, like at Vox where the appearance of reduced heroin overdose deaths with increased use of “anti-addiction” opioids like subutex in France in the 1980s and 1990s is asserted as establishing buprenorphine-based MAT as both effective and a form of “treatment”, the “gold standard” and fix for the opioid problem. As portrayed by popular addiction writer German Lopez at Vox: “France had a big heroin epidemic in the 1980s and ’90s. Here’s how the country fixed it.

These lines of evidence and research and the confident conclusions drawn from them about effective treatment for a public health crisis are important to examine, analyze, and understand, because they are not supported by the research as described in recent posts.

(BELOW – ADDITIONAL, NEW EVIDENCE POINTING TO LACK OF GAINS OR EFFECTIVENESS ON OPIOID CRISIS WITH OPIOID SUBSTITUTION PROMOTED AS “TREATMENT”)

On Critical Examination, Here

while the results and influential media interpretations of research results helping fuel the rush to identify opioid substitution as the medical “fix” for the medically-generated opioid crisis are at best inconclusive, we can look at available evidence in other ways to evaluate those claims.

In the French experience, increasingly widespread use of overdose death-preventing Naloxone kits coincided with the period over which buprenorphine was increasingly prescribed and OD deaths decreased.

More importantly and to the point, in a recent (2014) paper, French addiction professionals describe, in contrast to a country that has “fixed” its heroin problem, “a major public health care problem in France”, after decades of perhaps the world’s least restrictive buprenorphine prescribing policies, with continued serious problems in France with heroin, other opioids, overdose deaths, abuse of buprenorphine with heroin, and additional diversion (misuse) problems with buprenorphine. Heroin- and methadone-related overdose deaths increased over the most recent period reported, 2006 – 2009.

As noted by the authors, “The situation is still particularly worrying due to psychoactive substance use and misuse of opioid substitution treatments. Since 2003, there has been a persistent increase in the number of deaths and comorbidities related to opioid addiction, principally hepatitis C virus infection, which affects up to 40% of intravenous drug users.”

In an analysis of cohort studies cited by writer Maia Szalavitz, neither concurrent problem substance use nor retention rates are reported, the authors noting this as one of several confounding effects. Any benefit in reduced overdose deaths – whether attributable to MAT as a strategy and benefit, or to associated increase in availability of emergency Naloxone kits, not controlled for – would disappear for individuals leaving the program and engaging in illicit drug use and culture. With retention rates typically low in Suboxone trials (trending toward zero in this naturalistic multisite study) conclusions about significant durable gains are premature.

Additional results for MAT trials are consistent with treatment failure due to retention trending toward zero in the study noted:

Significantly, the 2014 study of MAT trials in natural settings overcomes a number of important design/interpretation problems, with some important results.

 

Take a look here.

The limited, inconclusive nature of evaluation of effectiveness based on overdose rates (attributable to MAT success in treating problem opioid use, or to associated increased training and distribution of naloxone overdose kits?), along with MAT trials that result in treatment failure (e.g. less than 5% treatment retention/success rate; with MAT for prescription opioid abuse, 91% failure over a 12-week trial – links above) point to the status of MAT as currently being an unvalidated approach for problem opioid use and to address the opioid crisis.

More recent reports and evidence

from a California county hard-hit by opioid abuse and overdose deaths provide preliminary indications that the overdose death-reducing drug naloxone, rather than the opioid substitute Suboxone, most likely accounted for reduced overdose deaths.

Those results analyzed and discussed in this recent post.

But perhaps the most direct and powerful evaluation –

of the potential effectiveness and benefit from Suboxone for the opioid crisis – buprenorphine and MAT now having been in use worldwide for more than three decades – would be simply to pose the questions:

1) If effective, why has problem use of illicit and prescription opioids worsened, instead of been moderated, over those decades?

2) If effective, why must proponents of MAT resort to citing what appear to be positive results on only one measure – overdose deaths – unable to provide a body of research pointing to success and benefit by other measures of reduced risks, problems, and harm?

So far –

evidence for the universally accepted medical fix for the medically-generated opioid crisis, Medication-Assisted Treatment, is at best inconclusive, with multiple studies pointing to treatment failure and MAT as a currently unvalidated approach. More fundamentally problematic, the over-focus on medically managed programs prescribing substitute opioids for the crisis appears to have resulted in the actual treatment part of MAT regressing to traditional “addiction treatment”, or treatment as usual (TAU), approaches that have never been evidenced as effective.

Current research does not support confidence in benefit attributable directly to use of prescribed Suboxone or other substitute opioids. Instead, it points strongly to the conclusion that whatever factors are responsible for decreases in lethal overdoses (distinguished from overdoses), Suboxone and MAT are not providing outcomes predicted if those approaches had been over past decades providing significant therapeutic/behavioral/psychosocial benefit to problem opioid users.

NEW EVIDENCE POINTS TO LACK OF GAINS ON OPIOID CRISIS WITH OPIOID SUBSTITUTION PROMOTED AS “TREATMENT”

In the past weeks, additional reporting and evidence have emerged to further invalidate claims around current medically-driven approaches to the opioid crisis with buprenorphine provision constructed not only as a type of “treatment”, but “gold standard” and “fix” for the opioid crisis, the invalidating evidence consistent with outcome failures reported for the decades-old French buprenorphine experiment.

Use of Suboxone (and/or other buprenorphine formulations) has been increasing in the U.S. over past years – reported for the period 2010 to 2015 as increasing in both Medicaid expansion areas and in non-expanding areas.

Yet concurrently, evidence points to a worsening of the opioid “crisis” or “epidemic”, see media reports here and here.

As in the French experiment, buprenorphine and other opioid harm-reduction opioid substitutes are associated with treatment outcome failures including in the U.S. being “increasingly found in overdose deaths”, problems perhaps predicted by early reports of MAT outcomes, approaches, and treatment culture.

No treatment = no benefit? Who knew?