ANOTHER MEDICAL FIX NOT SUPPORTED BY EVIDENCE – SUBOXONE FOR THE OPIOID CRISIS
By Clark Miller
Published July 27, 2018
Updated April 1, 2021
“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.”
– Pierre Bourdieu Outline of a Theory of Practice (1972)
In Bourdieu’s Theory of Practice, heterodoxy is dissent, challenge to what “goes without saying” – the accepted, constructed doxa, “knowledge”, reality, that goes without saying precisely because it “comes without saying”, without real scrutiny, untested, unquestioned. The function of doxa is not knowledge or truth or promotion of the collective good, but to protect and serve the interests of those with the power, the cultural capital, to create it.
Healthcare industries responsible for the opioid crisis have rushed to claim effectiveness for Medication-Assisted Treatment (MAT) with 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.
Media have followed along with orthodox reinforcement and promotion of medical fixes for the medically-generated opioid crisis, citing reduced overdose deaths due to illicit 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.”
Similarly, addiction writer Maia Szalavitz recently cited a 2017 retrospective cohort study of patients provided methadone or buprenorphine for problem opioid use, interpreting and concluding that significant increases in overdose deaths for patients no longer retained in treatment determine that MAT is a first line or sole treatment approach to problem opioid use and the opioid epidemic, advocating for prescription of the opioids to patients for extended or life-long use.
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.
For buprenorphine (Subutex, Suboxone) or methadone substitution to provide benefit and save lives
and health costs, they must effectively provide a period of improved mood, thinking, and functioning in life that supports avoidance of high-risk opioid use and effective participation in the actual (behavioral health, psychotherapy) treatment part of MAT (evidence-based talk therapies for the conditions and stresses driving compulsive substance use, a focus of multiple upcoming posts) by motivated patients, with predicted benefit.
When opioid substitution treatment (OST) fails to support retention in therapy services and patient engagement in effective treatment and change, as it generally does (below), MAT distracts resources and attention from critically needed, fundamental changes to substance use treatment models and methods, from critically needed reformation of the conceptualization of “addiction” itself.
A more general, less research-based look at the problem and how popular media is helping drive it is in this companion post – The False Promise of Medication-Assisted Treatment (MAT) for the Opioid Crisis.
Let’s take a look at the evidence, first with some orientation and context.
Some confounding factors that can qualify or invalidate research conclusions related to MAT include:
It is not legitimate to “cherry pick” published studies that seem to provide positive outcomes and ignore others with poor outcomes (that’s how the pharmaceutical companies falsely inflated effectiveness of antidepressants)
It is not legitimate to rely entirely on “Meta Analyses” type studies – published collections of previously published studies in which conclusions are drawn based on “consensus” or tendencies of those studies to support a type of outcome, like benefits versus no benefit, because in research the devil is always in the details – a collection of studies with similar conclusions and with flaws that prevent or invalidate interpretation of results is no more confident and powerful as evidence than a single inadequate study
Some of numerous factors that can prevent or alter interpretation of research results include 1) can results be applied to real community treatment situations and realistic patient populations? 2) are positive outcomes undermined by factors not measured in the study, like subjects turning to other drugs of abuse? 3) Were the apparent results lasting?
Let’s look at those points (1 – 3) in more detail:
1) external validity – are the study conditions and subjects a reflection of natural (community) conditions to an extent that results can be assumed to hold under real treatment conditions?
2) Are the outcomes being measured meaningful and sufficient to characterize positive results – for example, while study subjects were administered the risk- and harm-reducing man-made opioids (like Suboxone), were they engaging in high-risk or problematic use of other mood-altering substances, compensating for reduced desired effects of prior opioid abuse? Some studies don’t measure for this, others only for other opioids, others for a variety of substances, but not an adequate range, including increasingly commonly abused prescription psychotropic drugs e.g. quetiapine, gabapentin.
3) Were positive results durable, long-lasting, as evidenced by adequate follow-up sampling? Or, for example, at the end of the follow-up period, were retention rates trending down toward zero with longer-term success unestablished (below) ?
Through these very basic (and incomplete) lenses for interpretation of research results and conclusions about results, let’s consider the types of evidence being used to support the rush to provide a medical solution – substitute opioids – as the fix for the opioid crisis.
In Vox, writer German Lopez writes:
Over at the Atlantic, Olga Khazan provided a brief overview of what happened when France responded to its own heroin epidemic in the 1980s and ’90s by massively expanding access to the anti-addiction medication buprenorphine, which reduces withdrawal and cravings for people with an opioid addiction.
The results are fairly persuasive (emphasis mine):
In 1995, France made it so any doctor could prescribe buprenorphine without any special licensing or training. Buprenorphine, a first-line treatment for opioid addiction, is a medication that reduces cravings for opioids without becoming addictive itself.
With the change in policy, the majority of buprenorphine prescribers in France became primary-care doctors, rather than addiction specialists or psychiatrists. Suddenly, about 10 times as many addicted patients began receiving medication-assisted treatment, and half the country’s heroin users were being treated. Within four years, overdose deaths had declined by 79 percent.
As Khazan noted, France also rolled out a needle exchange program and other policies at the time that likely contributed to this drop. And unlike the US, France has a socialized health care system that makes it easy to get to a doctor offering these kinds of addiction services.
But the results are more or less in line with what you would expect to see with a huge expansion of buprenorphine. Studies show that buprenorphine and other anti-addiction medications like it, such as methadone, cut mortality among opioid addiction patients by half or more. That’s why experts consider the medications the gold standard of care for opioid addiction.
Lopez notes that “other policies at the time” may also have accounted for the drop, that is – it is unclear to what extent the increased dispensing of buprenorphine accounted for the decrease in deaths. He does not address the most likely confounding factor: Naloxone, the opioid overdose emergency antidote that became available in France in 1977. French addiction researchers place the reduction of opioid overdose deaths across a slightly different time frame, 1994 to 2002, during a period when Naloxone emergency use in communities in Europe was being promoted and injectable Naloxone was increasingly available to emergency medical personnel in France.
Those factors confuse and confound things,
preventing confident interpretation of results – do overdose deaths decrease because buprenorphine use has therapeutic factors, changing users’ lives in lasting, positive and protective ways that decrease risk of drug abuse and overdose? Or are users, while in buprenorphine programs, more connected to healthy, functional social environments, and socially isolating less – as opposed to “street”, or drug culture life – so that overdoses are more likely to be responded to effectively, preventing death?
Those same confounding factors prevent confident interpretation of possible benefit from use of substitute opioid harm-reducing drugs in the study cited by addiction writer Maia Szalavitz. In that study neither problems with drug use by participants while in the methadone/suboxone programs, nor retention rates (how many subjects actually stayed in the program?) are reported, the study authors noting this as one of several confounding effects limiting confident conclusions. Clearly, any benefit in reduced overdose deaths – whether due to MAT as a strategy and benefit, or to associated increase in availability of emergency Naloxone kits – would disappear or likely diminish for individuals leaving the programs and becoming enmeshed in illegal drug use and culture. With retention rates typically low to very low in Suboxone trials (trending toward zero in this study, results provided, described and discussed below) conclusions about significant lasting benefits from Suboxone and MAT are premature.
A new look at the evidence
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.
The presumed psychosocial mechanisms for reduced overdose deaths attributable to hypothesized benefits of partial agonist (Suboxone) use by subjects would seem necessarily to include: relief from intrapsychic (emotional, mental) stressors driving compulsive opioid use for euphoric relief; strengthened, protective psychosocial integration in a rewarding recovery ecology; intrinsic motivation for and engagement in appropriate services and supports.
Accordingly, reduced overdose deaths attributable to hypothesized benefits of partial agonist (Suboxone) use by subjects motivated for relief from correlates of problem opioid use would predict:
– high retention rates in MAT programs
– reduced concurrent use of drugs of abuse by subjects in MAT
– reduced overdoses/emergency medical contacts in addition to reduced overdose deaths
– reduced measures of psychosocial correlates of problem use of substances
In contrast, if MAT is not providing significant benefit for problem opioid use and diminishing compulsive drive
for euphoric use of opioids and supporting engagement in associated treatments (behavioral and psychotherapy treatment component of MAT), providing gains in emotional and mental health, as well as improved functioning – then predictions would be distinctly different:
– low retention rates in MAT programs
– continued concurrent use of drugs of abuse by subjects in MAT
– continued risk of overdoses/emergency medical contacts apart from overdose deaths- lack of significant change in psychosocial correlates of problem use of substances
These considerations set out a research agenda and need for additional research and interpretation before beneficial effects due to MAT and Suboxone can be asserted.
How do the evidence and research results fit
with these predictions based on benefit versus no benefit from substitute opioid use (MAT)?
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, 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.”
Those 2014 reports stand in marked contrast to American popular media accounts trumpeting that France fixed its heroin problem with MAT.
“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.”(3)
Poloméni, P., & Schwan, R. (2014). Management of opioid addiction with buprenorphine: French history and current management. International Journal of General Medicine, 7, 143–148. http://doi.org/10.2147/IJGM.S53170
In the 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 – see below) 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.
References and links:
1.Sittambalam CD, Vij R, Ferguson RP. Buprenorphine Outpatient Outcomes Project: can Suboxone be a viable outpatient option for heroin addiction? Journal of Community Hospital Internal Medicine Perspectives. 2014;4(2):10.3402/jchimp.v4.22902. doi:10.3402/jchimp.v4.22902.
2. Weiss RD, Potter JS, Fiellin DA, et al. Adjunctive Counseling During Brief and Extended Buprenorphine-Naloxone Treatment for Prescription Opioid Dependence: A 2-Phase Randomized Controlled Trial. Archives of general psychiatry. 2011;68(12):1238-1246. doi:10.1001/archgenpsychiatry.2011.121.
3. Poloméni, P., & Schwan, R. (2014). Management of opioid addiction with buprenorphine: French history and current management. International Journal of General Medicine, 7, 143–148. http://doi.org/10.2147/IJGM.S53170
Take a look.
Some notable features of the study –
- Maintenance treatment clinic setting
- External validity: naturalistic, 34 sites across the U.S.
- Measure of retention over 180 days
- Urine drug screen (UDS) reports through 180 days for: heroin or oxycodone, alcohol, amphetamines, barbiturates, benzodiazepines, cannabinoids, and cocaine
Some key features and outcomes to note about this study:
– Across 34 natural community settings, external validity should be relatively high
– Urine drug screens were provided over the 6-month study period, testing for not only other opioids, also other mood-altering substances
– The large majority of subjects were self-pay, with prediction of relatively high motivation for desired outcomes
At 180 days, retention in programs were 20% and 30% for subutex and Suboxone, respectively, and clearly trending downward. Of the 30% remaining in MAT for Suboxone, 11% were using other opioids, 20% other mood-altering substances. For the 20% retained with subutex those figures were 21% and 45%.
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 the status of MAT as currently being an unvalidated approach for problem opioid use and to address the opioid crisis.
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?
These results and critical discourse raise a critically important question: if at best Suboxone or other substitute opioids can provide a window of improved functioning and potential benefit from the actual Treatment part of Medication-Assisted Treatment for compulsive substance use, what is the status of provision of those effective, evidence-based treatments for substance use as incorporated into MAT programs?
Let’s look at how that’s working in rural Oregon, hard-hit by the opioid crisis, and where a premier clinical MAT program, in a clinic associated with Oregon’s medical research university, is held up by the regional managed care organization as a “model of excellence” and “hub” or model for other programs.
How Effectively is MAT Being Implemented in Rural Oregon Hard-Hit by the Opioid Crisis?
In hard-hit rural Oregon, insurance payers for use of public healthcare dollars for treatment (Coordinated Care Organizations, CCO) have determined that MAT (with provision of the semisynthetic opioid Suboxone) will be the focus of treatment response to the OC, designating and endorsing a MAT program at the OHSU (Oregon Health Sciences University) primary care clinic in Scappoose, Oregon as a model program, a “hub” and “center of excellence” for OC response.
A second MAT program at Rinehart Clinic in Wheeler, Oregon has begun providing partial agonist (Suboxone) MAT under the clinical guidance and support of the CCOs.
Potential problems and limitations with agonist therapy in general and Suboxone have long been recognized.
How effective are the CCOs in using public healthcare funds to provide effective treatment for vulnerable Oregonians trapped in the opioid crisis?
I have been a colleague of professionals directly involved in MAT programs at both OHSU Scappoose and Rinehart Clinic, and have direct descriptions of the nature of programs there based on discussions with them.
At OHSU Scappoose, patients are started on a course of Suboxone, and are provided:
Mandated group “check-ins” in which patients freely discuss how their week went, expressing concerns, status
A voluntary “treatment” group with unknown level of engagement by patients, without a curriculum or defined elements of EBP for substance use
Patients are not provided evidence-based (= individual modality) therapies for substance use disorders
At Rinehart Clinic, patients are started on a course of Suboxone, and are provided:
Participation in a self-help support group (“Smart Recovery”) provided on-site, facilitated by a clinical pharmacologist and a Certified Alcohol and Drug Counselor (CADC). Smart Recovery is not in the registry for evidence-based practices. In a community meeting of SR facilitated by the Rinehart staff member, the facilitator (Richard) was observed to use most of the meeting to talk about himself and his personal history.
Participation in a “process group” in which participants may freely discuss issues related to their involvement in the MAT program
Patients are not provided evidence-based (= individual modality) therapies
Of the two qualified mental health professionals (QMHPs) at Rinehart providing behavioral health services, neither has experience in substance use treatment
The one QMHP at Rinehart potentially available for provision of individual therapy has no experience with Motivational Interviewing, the primary indicated therapy for treatment of substance use disorders, and does not provide MI
None of the above described practices in the two MAT programs with oversight by OHSU and Columbia Pacific CCO constitutes evidence-based practice therapy or treatment for a substance use disorder
– There is no evidence base to support self-help, “process group”, or “check-in” groups as having any benefit.
– Despite the privileged status of group modality (“group treatment”) in the folklore of substance use treatment and popular culture, and appeal to payers of greatly reduced costs of “treatment”, group modality is not supported by evidence as effective with very limited exception (e.g. here; here).
– Evidence-based therapies supported as effective for compulsive substance use are individual modality therapies, provided by advanced level (licensed) behavioral health clinicians (here).
The somewhat dated and limited evidence for any benefit from group modality in substance use treatment is invalidated by established and increasing evidence and practice theory linking problem substance use generally to chronic inner distress and deficits in emotional regulation linked to history of trauma and/or adverse childhood experiences (ACE), participation in such groups inconsistent with trauma-informed care. Key diagnostic features of PTSD include anxiety and hyperarousal with impaired attention and learning in novel and complex social settings. Moreover, very few patients are willing and comfortable working therapeutically on history of trauma in a group setting.
Evidence based therapies for addressing those effects are individual modality therapies provided by licensed mental health therapists, and the common effects of history of ACE and adult trauma – including fearfulness in novel and social settings, with impaired concentration and learning, and avoidance accessing and expressing difficult inner material – all contraindicate group modality.
Further, the presumed value of training for “relapse prevention skills” in group modality is increasingly undermined by the research evidence, which points away from social pressure to use substances and urges to use, per se, as predictors of relapse, and to other factors instead triggering relapse, most strongly: belief in the falsified “disease model” of addiction; deficits in self-efficacy; and situational stressors that are individualized and contextual, requiring individual modality exploration and therapies.
Ineffective and harmful treatment as usual (TAU) is everywhere
At OHSU Scappoose Clinic, patients in the MAT program are routinely referred to TAU outpatient substance use treatment programs in the area, like Columbia County Mental Health (CCMH) and Tillamook Family Counseling Center (TFCC) in Tillamook County, programs also provided clinical oversight by Oregon CCOs, and providing the same elements of traditional substance use TAU provided in residential (“rehab”) programs.
“What we simply need is a a nice bulldozer, so that we could level the entire industry and start from scratch . . . There’s no such thing as an evidence-based rehab. That’s because no matter what you do, the concept of rehab is flawed and unsupported by evidence.”
– Dr. Mark Willenbring, former director of treatment and recovery research at the National Institute of Alcohol Abuse and Alcoholism (NIAAA)
These elements of TAU being incorporated in MAT programs ostensibly addressing the opioid crisis – disease model; 12-Step; group modality; unqualified staff providing treatment – implemented over past decades as “treatment” within the addiction treatment industry predictably have resulted in a steadily worsening and lethal national substance use epidemic.
For a sobering and accurate assessment and characterization of substance use Treatment as Usual in the U.S. – “treatment” most accurately described as a criminal scam and constituting the treatment currently available for Americans trapped in the opioid crisis and other substance use epidemics – see the remarkable documentary film The Business of Recovery.
Under the clinical and medical direction provided by managed healthcare organizations in Oregon the regional “best practice” response to the opioid crisis, including a model MAT program “center of excellence” in fact reflects a profound ignorance of and profound disregard for current research outcomes and evidence-based treatment of substance use disorders, predicting no benefit or harm to individuals trapped in the opioid crisis and seeking competent care.
As designed and implemented by professionals at these clinics and professionals employed by the insurance companies – professionals who are out of scope of competence for evaluation of relevant research and for program development for use of evidence based practice (EBP) MH and SU practices for substance use disorders – neither program is providing any services constituting EBP for substance use disorders or opioid use disorder, instead treatment as usual (TAU), TAU established as predicting no benefit or harm by decades of established research.
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.
Advocacy for MAT and Suboxone as “treatment” approaches are at best premature, possibly disingenuous and ill-informed, in the same way that advocacy for longstanding invalidated benefit from engagement in the religious subculture Alcoholics Anonymous is deceptive and disingenuous.
For AA, retention rates are established as very low – 5% to 15%, results predictable based on the countertherapeutic factors of AA established by decades of research. In AA, 90 to 95% of recruits return to problem alcohol use, a 90% treatment failure, and the small proportion retained in the program disproportionately engaging in misuse of arguably the most lethal and addictive substance known – tobacco.
Similarly for MAT, retention rates are established as very low, trending toward zero here, with predicted concurrent abuse of mood-altering substances by significant proportions of the small proportion of subjects retained in the program, the failed motivation for and retention in treatment predicted based on the absence of provision of and engagement in EBP therapies for problem substance use.
Critically, the at best mixed and inconclusive research base for benefit from Suboxone and other MAT, with short windows of opportunity for treatment engagement, points to the necessary and crucial role of the actual treatment component of MAT to provide benefit and begin to address the opioid crisis. As evidenced and referenced in a series of upcoming posts, therapies supported as effective are psychotherapies in individual, not group modality, (behavioral health therapies delivered by qualified mental health professionals with background in substance use treatment) for substance use, a set of practices that are distinct from those historically and currently provided almost universally in programs and settings providing treatment as usual (TAU) for substance use.
TAU – its core “treatment” components providing no benefit for problem substance use –
has enabled a national substance use epidemic, and is generated and perpetuated by some historical combination of: folklore and popular culture; entitlement; the odd, countertherapeutic, decades-old prescriptions and practices of a religious subculture (AA); and professional, institutional, and cultural abdication of critical thought and critical discourse (upcoming posts).
Substitute opioid medications were originally and accurately conceptualized as potentially providing “harm reduction” rather than “treatment”, and the status of current research affirms that their use may not provide significant benefit let alone “treatment” or a fix for the opioid crisis, expected to kill another 500,000 Americans over the next decade. That predictable harm from the unsupportable medicalization of chronic pain, an entirely non-medical condition, against all available evidence, was created by an abdication of critical thought, critical discourse and of ethical reasoning and accountability.
MAT – the medical industry’s medical fix for the crisis it created – appears to predict perpetuation of that harm and of a public health epidemic.