Opioid Epidemic:

For Worsening Crisis U.S. Medical System Dispenses Addictive, Diverted, Abused Substitute Opioids

With No Evidence-Based Treatments, Predictable Outcomes

by Clark Miller

December 21, 2018

Predictable outcome failures

include U.S., French, and U.S. state-level increases in opioid-related overdose deaths over periods of large increases in population “dose” of the substitute opioid “fix” provided through prescribers in medical care systems.

Note that buprenorphine dispensed medically increased significantly (by about 75%) over the years 2013 – 2016 and over that same period: 1) total opioid related overdose deaths increased notably as well, by about 60 – 70% and 2) overdose deaths appeared to increase or not decrease over the period of expanded bupe provision linked to each of the measured classes of opioids: prescription, synthetic, and heroin.

Results that are mirrored at national levels and in New Jersey, where opioid OD deaths were up 24% in 2017, “even as the number of prescriptions written for opioids fell”.

A treatment directory lists bout 500 programs or doctors in New Jersey prescribing Suboxone, which in any case has been widely available on the street for decades.

Continued reliance on a medical strategy – widespread distribution of substitute addictive, diverted and abused opioids like buprenorphine – for the medically-generated opioid crisis is increasingly invalidated and indicated against by multiple lines of evidence (described with links to research here and related posts here):

retention rate failure (often trending to zero) in buprenorphine (“bupe”) Medication Assisted Treatment (MAT) programs

with high rates of illicit and/or prescribed opioids and other drugs in those programs

lack of evidence for reduced overdose deaths or other gains attributable to MAT, also known as substitute opioid therapy (OST)

widespread diversion and abuse

diversion of clinical focus to perpetuation of compulsive, problem opioid use and away from evidence-based psychosocial treatments for underlying conditions driving compulsive use

failure of the 20-year French experiment with unrestricted buprenorphine substitution to moderate problem opioid use

and reinforcement of patient belief in the long-invalidated biomedical model of addiction, a key predictor of relapse.

That’s not Medication Assisted Treatment – MAT – as Designed

Formulated and designed as informed by research on evidence-based treatments for problem substance use, drugs like buprenorphine serve as the “Assisted” component of Medication Assisted Treatment, supporting evidence-based psychological therapies required to address underlying distress and cognitive distortions driving compulsive substance use.

When buprenorphine (Subutex, Suboxone) substitution works, it can provide a transitional period of 1) tapering off dependence on an opioid and 2) improved mood, thinking, and functioning in life that supports effective participation in the actual treatment part of MAT (evidence-based talk therapies for the conditions and stresses driving compulsive substance use, a focus of multiple Posts) by motivated patients, with predicted benefit.

When it fails to support retention in services and patient engagement in effective treatment and change, as in MAT as currently implemented, it 1) predicts treatment failure and 2) serves to distract resources and attention from critically needed, fundamental changes to substance use treatment models and methods, including critically needed reformation of the conceptualization of “addiction” itself.

The American Society of Addiction Medicine (ASAM) formulated a 6-Dimension standardized assessment approach for treatment formulation and level of care determinations based on decades of practice and research establishing that successful change for persons trapped in compulsive substance use indicates integrated therapies and supports to address the issues driving risk of continued use: emotional/behavioral/belief disturbances; motivational state; environmental stressors; psychosocial and environmental triggers for return to use (“relapse”); acute intoxication/withdrawal; and biomedical conditions (like chronic pain, other stressors) influencing risk.

ASAM 6 dimensions

Astute readers will note that of the six dimensions one is transient (intoxication/withdrawal) and four of the remaining five are addressed by indicated evidence-based psychotherapies and psychosocial supports for gains in emotional and mental health, community and life functioning and security (like relationships, family functioning, housing, employment).

The French experiment with unrestricted substitute opioid provision, indefinitely, increasingly promoted as the “fix” and model for the U.S. to solve its opioid crisis, can be construed to address the transient ASAM dimension of withdrawal, and by intention at least, a second ASAM dimension – risk of medical complications related to compulsive use of opioids. The remaining dimensions understood to be integral and instrumental in treatment of problem substance use? Not so much, by available descriptions of the French experiment.

It hasn’t worked.

Beyond serious problems generated by unrestricted prescribing including widespread diversion, abuse and criminal trafficking: more definitively, overdose deaths in France have INCREASED over recent accounting periods (2006 – 2010), the increase at least partly driven by increases in OD deaths involving heroin and methadone. In 2013, the most recent reporting year, OD deaths remained at a historically high level for the 8-year reporting period, inconsistent with any presumed beneficial trend of protective effects due to bupe OST, despite a 35% increase in French users enrolled in OST over the period 2006 – 2015.

Further, also inconsistent with any presumed causal link between bupe OST and reduced OD deaths (attributable instead to increased availability and use of naloxone) France remained 5th highest among 20 European nations in “high-risk” opioid use despite France’s unique, “revolutionary” campaign to supply users with substitute opioids the most intensive and least restrictive in the world and among those 20 European nations. That data is strongly invalidating of presumed OD death reduction benefits, because attributing OD death reduction to bupe OST requires a psychosocial/behavioral mechanism to account for it – specifically a change in behavior of OST enrollees decreasing high-risk opioid use.

By design and as recognized by inside and external observers, the approach has failed to provide interventions for the condition of compulsive substance use itself – the motivational deficits, inner distress, and environmental/psychosocial needs and stressors driving compulsive use of mood-altering substances. That would require intensive behavioral health services, therapies and supports in integrated programs. Instead, opioid users are primarily seen in medical settings to renew prescriptions for the substitute addictive opioids that are widely diverted, trafficked and abused.

Observations noted in this 2015 report linked widespread diversion, trafficking, and abuse to the “pill mill” characteristics of the French “framework for its prescription”:

“Its wide availability linked to the framework for its prescription and the possibility of injecting it has promoted its misuse,” reveals a study by the French drug and drug addiction observatory Observatoire Français des Drogues et des Toxicomanies.

And, “How can a doctor provide real patient care when dealing with 300 drug addicts? At this stage, all they are doing is renewing prescriptions.”

An earlier look described French doctors as untrained and unprepared to understand the needs of substance users, instead serving as dispensers of the substitute opioids:

“The French system encourages physicians unfamiliar with addiction to prescribe buprenorphine and trusts patients to use it properly. . .”
Including the interviewed doctor who “does not screen patients to ensure that they, in fact, are opiate-dependent and need treatment.”

“Because of its widespread availability, Subutex was serving as a first opiate for some drug users and a re-entry opiate for some who had previously injected heroin. The report found it to be highly addictive and hard to stop. And it was increasingly being used in dangerous combinations with alcohol, benzodiazepines (such as tranquilizers) and even cocaine. . .”

“Many stay in treatment for years, including some who want to quit, prompting criticism that substitution therapy doesn’t address the underlying problem of opiate dependence.”

A more recent report on prescriber practice is consistent with concerns that French model opioid use “treatment” is not so much treatment as it is unregulated and dis-integrated provision of the substitute opioids. Results of the  2015 report on French physician adherence to guidelines aimed at protecting patients and the public from diversion and abuse of a widely-prescribed addictive opioid are troubling and appear explanatory:

“We showed that the physicians we interviewed rarely took into account the guidelines regarding buprenorphine prescription. The actual prescribing of Buprenorphine differed from the guidelines. Only 42% of independent Family Physicians (FPs), working outside the national health care system, had prescribed buprenorphine as a first-time prescription and 40% of FPs do not follow up patients on buprenorphine. In terms of compliance with the guidelines, 55% of FPs gave theoretical answers that only partially complied with the guidelines.” [despite that] “physicians declared a high rate of participation in continuous addiction therapy training. 38% of FPs and more than 80% of Network or Hospital physicians reported having attended continuous medical training (CMT) in addiction therapy.”

And in the U.S. –

Increasingly in the U.S., an alliance of medical and pharmaceutical industries, the Trump administration, and U.S. media continue to promote expanded and less restricted buprenorphine (Suboxone) distribution – following the French model – as the “fix” and a “gold standard” for the crisis. Common among the media pieces and social media messages of medical and other healthcare professionals are calls for reliance on Suboxone provision as a standalone “treatment” for problem opioid use and the opioid crisis.

So far, outcomes for U.S. reliance on the medical fix of a prescribed, addictive and abused opioid for the medically-generated opioid crisis, reported in a series of posts here at A Critical Discourse have mirrored those from France – among other indicators:

1) Consistent evidence that any decreases in OD deaths can be attributed to increased use of naloxone made increasingly available concurrently with developed OST campaigns, not to buprenorphine

2) Increasing, not decreasing, opioid-related OD deaths as the “dose” of Suboxone provided to U.S. populations of Americans trapped in the opioid crisis increases substantially

That was predictable, with the U.S. healthcare/pharmaceutical industry leaving the treatment part of Medication Assisted “Treatment” out of the public health response. Already, dispersal of buprenorphine, with or without provision of actual evidence-based psychotherapy treatments for compulsive substance use has become equated with “treatment” in common public discourse.

That’s the picture that emerges from Dayton, Ohio, recently celebrated in a NY Times piece highlighting a dramatic decrease in opioid-related OD deaths this year breaking a trend of years of increased mortality.

But OD deaths are trending upward again,

with no evidence of benefit from substitute opioid prescriptions – prescribed addictive opioids that are being widely diverted and abused versus the direct effects of an intensive campaign to increase use of the OD death reversing drug naloxone. And years of investigative work by Katie Wedell and others at the Dayton Daily News reveal a less optimistic picture, painted by observations of treatment providers “on the ground” establishing among other problems that the evidence-based treatments required to address the emotional and psychological lives of users compelled to continue problem use of opioids are not being provided.

Can Others Learn From It?

Dayton DN composite 2

Our investigation shows:

  • Clinics or doctors who see fewer than 30 patients at a time don’t have to be state-certified and comply with the stringent standards of those who treat more people and are certified. That also means they aren’t being inspected regularly like the larger providers and the state relies on complaints to police them.
  • Cash or self-pay clinics have opened as demand for addiction treatment has increased. They often charge as much as $250 out-of-pocket for an initial visit, services that would be free to the patient if they qualify for Medicaid, and often don’t provide much counseling or other supportive therapies shown to reduce relapse rates.
  • Widely accepted medical standards say medication treatment should always be done with other methods like counseling, cognitive behavioral therapy and/or peer supports. But there is no requirement that a MAT-licensed doctor do that. They are supposed to refer patients to other providers or support groups and document whether the patient attends. No one routinely checks if doctors are complying with those requirements.

Also from the December 2018  Dayton Daily News Piece:

“The fly-by-night, Medicaid-funded MAT treatment programs that have popped up have terrible track records. They are milking the system and not improving the lives of half the people who need their help because the state isn’t tracking their efficacy,” said Jan Lepore-Jentleson, executive director of East End Community Services. “Treatment programs need to be monitored for effectiveness.”

Other doctors and treatment providers in the area have reported the same story from patients and said they are concerned about the quality of care people are getting when they simply Google Suboxone clinics and find one with walk-in appointments and cash payments.
“It’s often medication without the treatment,” said Wendy Doolittle, CEO of McKinley Hall, a state-certified treatment center in Springfield.
“The prescribing of medication is what got us into this mess,” said Jade Chandler, president of Woodhaven Residential Recovery Center in Dayton, a state-certified facility that uses some MAT for withdrawal management but focuses much more on behavioral therapy.

Montgomery County’s Alcohol Drug Addiction and Mental Health Board recommends that people seeking treatment go to state-certified facilities that offer cognitive behavioral therapy in addition to medication and the board only contracts with those facilities.
“Access to medication will relieve the person of the physical and some of the psychological stress of addiction, but it doesn’t change the person’s long-term thinking and feelings that drive their behaviors,” said Jodi Long, director of treatment and supportive services for the Montgomery County board.

Of course in the response to the crisis driven by the U.S. medical industry, there is proximate precedent for the French model “pill mill” approach to substitute opioid use – in France generating the problems, by prescriber practice, with widespread diversion, criminal trafficking and abuse, and lack of evidence for treatment benefit – precedent in medical prescriber practice creation of the opioid crisis, with runaway dispersal of addictive opioids indicated against by all longstanding, relevant lines of evidence and for the non-medical condition of centralized chronic pain.

As pressure to expand dispersal of the addictive, widely diverted and widely abused substitute opioid Suboxone mounts, vulnerable Americans will depend on the clinical judgment of that same profession responsible for deciding to dispense more opioids versus refer to evidence-based treatments.

TO TREAT OR NOT TO TREAT

EVIDENCE-BASED TREATMENT VERSUS SUBSTITUTE OPIOID DISPENSING FOR A WORSENING OPIOID CRISIS

OREGON’s MANAGED CARE BUSINESS MODEL

In rural Oregon hard-hit by the opioid crisis, insurance payers controlling use of public healthcare dollars for treatment (Coordinated Care Organizations, like Columbia Pacific CCO) have determined that Suboxone MAT will be the focus of treatment response to the crisis, 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”.

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.

I have been a colleague of professionals directly involved in the MAT programs at both OHSU Scappoose and Rinehart Clinic, and have direct descriptions from them 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 evidence-based practice (EBP) for problem 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 a recognized evidence-based practice.

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.

shutterstock_man with pill

As explained at A Critical Discourse with links to primary research, none of the above described practices in the two MAT programs with oversight by and clinical guidance by OHSU and/or 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 (here; here).

Evidence-based therapies supported as effective for compulsive substance use are psychotherapies to address complex, individualized inner distress driving compulsive substance use, provided in individual (one-on-one) sessions by advanced level behavioral health clinicians.

The 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. 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.

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.

Prescription for Dependence?

As reported to me directly by the behavioral health professional dedicated to the Suboxone MAT program at OHSU Scappoose, patients to be inducted (started on Suboxone) were not filtered by severity of opioid use. Instead “anyone who meets DSM 5 criteria for opioid use disorder” would be, with their consent, started.

With significant revisions to the preceding DSM IV, criteria for substance use disorders in the DSM 5 impose a much lower threshold for diagnosis of a SUD. An opioid (or other substance user) would be provided the diagnosis of opioid use disorder (OUD) if the interviewer (most likely a medical professional who is out of scope of competence to assess for substance use or any other behavioral health conditions) finds that the individual affirms as few as two of the 11 DSM criteria:

So, among unlimited realistic case scenarios, consider: a patient who had been prescribed opioids for post-surgery pain or chronic pain by a medical provider at the same clinic, who was motivated to stop understanding the risks, had no history of a substance use disorder, who had been prescribed the opioids longer than medically indicated, and who perhaps had used more than the dose prescribed at times having (predictably) experienced some level of tolerance, along with, for example a) having experienced some related mood disturbance, or b) having driven when feeling sedated by the drug, or c) having had conflicts with family members concerned about the use, or someone wanting the opioids diverted to them, etc., etc. – would be diagnosed with “Opioid Use Disorder” and started on a course of buprenorphine, if desired; perhaps encouraged to in order to enroll patients in the grant-funded model program, a “hub” and “center of excellence”.

From the 2007 Baltimore Sun report on France’s campaign to dispense buprenorphine by essentially unrestricted prescription by primary care doctors:

Buprenorphine has become an entry drug for people who haven’t used opiates before, a re-entry drug for former addicts, and a factor in more than 100 deaths since 1996 when taken in combination with other substances, according to researchers and public health authorities. . .

The drug has created a quandary that no one seemed to anticipate: how to get patients off it. Many stay in treatment for years, including some who want to quit, prompting criticism that substitution therapy doesn’t address the underlying problem of opiate dependence. . .

“It’s overprescribed, and it’s too easily prescribed, without any control,” said Dr. Agnes Lafforgue, who helps recovering addicts at a treatment and assistance center in Toulouse, a university city in southwest France.
She questions treating longtime heroin injectors with Subutex, for fear they will inject it, too, and worries about its addictive qualities. She said she has “practically never” successfully weaned a patient off it, despite having done so many times with methadone.

shutterstock Suboxone

Ineffective 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.

The 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 are each invalidated by longstanding bodies of research as having no therapeutic effects instead no or harmful effects and 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 those 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 therapies and psychosocial supports 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.

To Treat or not to Treat

As propelled by politicians pressured to act to address U.S. public health substance use epidemics, by medical and pharmaceutical industries largely responsible for them, and by mass media rewarded for tagging along – U.S. public healthcare using public healthcare funds is moving toward the failed French model of essentially unrestricted dispersal of addictive, diverted, and abused substitute opioids constructed as “treatment” for the complex psychosocial condition of compulsive substance use, with predictable results.

Medically designed and directed MAT programs or buprenorphine campaigns, as such, provide for the continuation of problem opioid use (dependence) while acting as barriers to public health provision of evidence-based treatments for problem substance use including opioid use by 1) establishing MAT programs with bupe prescribing as a standalone or essentially standalone approach or 2) by providing Treatment as Usual for “addiction” – in the U.S. consisting of practices invalidated by longstanding bodies of research and predicting harm.