What we miss when we focus on opioid treatment and recovery

Fortunately, there’s been growing concern that advocates, policy makers, and media have to narrowly focused on the opioid crisis. Up to this point, it hasn’t reached the level of media coverage.

USA Today is one of the first to publish an article that explores the limitations of the nation’s focus on opioid treatment and recovery:

More than eight years into his opioid-addiction treatment, Paul Moore was shooting cocaine into his arms and legs up to 20 times a day so he could “feel something.”

The buprenorphine he took to quell cravings for opioids couldn’t satisfy his need to get high. Moore said he treated himself like a “garbage can,” ingesting any drug and drink he could get, but soon enough, alcohol and weed had almost no effect unless he vaped the highest-THC medical marijuana available.

Cocaine, however, especially if it was mainlined — now that could jolt him from his lifelong depression to euphoria.

The article provides several important messages:

  • The importance of addiction treatment over opioid use disorder treatment for many (if not most) patients.
  • Along similar lines, messages about opioid recovery can be misleading for patients, families, and communities.
  • These issues raise the importance of clarity about the boundaries of recovery. For example, were these people in recovery when they were in opioid use disorder treatment and reduced or quit using opioids, but were still using cocaine and experiencing poor quality of life due to untreated addiction? (This would have been an uncontroversial and easy question to answer just a few years ago. Today, there are many saying that any movement toward wellness or participation in harm reduction is recovery.)
  • The article also highlights what gets missed when agonist treatments (buprenorphine and methadone) are described as the most highly effective and highly successful treatments without more context. They rarely answer the question, effective at what? (This isn’t saying that these medications aren’t useful or don’t have a place in care. Rather, it’s important that journalists and experts do not oversell their evidence for effectiveness.)

Failure to clarify and communicate these messages are likely to result in increased stigma for addiction and recovery.

Rather than communicating that addiction is a treatable illness, the unintended message will be that addiction more closely resembles a chronic disability than a treatable illness that has a good prognosis when the patient receives treatment of adequate quality, duration, and intensity.

This century’s first wave of recovery advocacy was built upon the message that we can and do recover when we get the right help and support. In this context, recovery meant something resembling the Betty Ford Consensus Panel definition:

Recovery from substance dependence is a voluntarily maintained lifestyle characterized by sobriety, personal health, and citizenship.

The traditional understanding of addiction recovery alludes to the restoration of people in their families, communities, and to a life in alignment with their goals and values.

Adjustments to that understanding are likely to result in readjustments in the public’s attitudes, which are eventually likely to result in readjustments in policy.

NIH takes pharma dollars despite advisory committee recommendations

(Nora Feddal)

Anyone who knows me would know that crossfit.com is not a typical news source for me. In fact, when this story was sent to me, I started from a place of skepticism. However, this story about opioid manufacturers pouring money into NIH provides all the receipts.

The story explains everything clearly and provides lots of direct links to sources to support its statements. Read the whole thing.

Here’s a quick rundown:

  • The Center for Disease Control (CDC) and National Institutes of Health (NIH) both have foundations that support their work.
    • They are supposed to report who donates to the foundations, but they list many donations as “anonymous.”
    • Congress has directed them to stop listing donations “anonymous” but they continue to do so.
  • NIH has an advisory committee that issued 12 ethics recommendations about opioid industry partnerships to NIH’s director.
    • They recommended using only federal dollars (no industry dollars) in their efforts to address the opioid crisis.
    • They recommended that, if they accept industry dollars, that they not accept funding from companies involved in litigation related to the opioid crisis.
    • They also recommended complete transparency.
  • The director of NIH politely rejected these recommendations.
  • NIH has accepted millions from various manufacturers and lobbying organizations.
    • NIH’s foundation accepted a $2.5 to $5 million donation from Johnson & Johnson last year.
    • Johnson & Johnson is represented on the NIH foundation board and on a committee guiding NIH’s efforts to address opioid addiction.
    • An Oklahoma court recently found “Johnson & Johnson and its subsidiaries helped fuel the state’s opioid crisis and ordered the consumer products giant to pay $572 million.”
    • PhRMA, Pfizer and the Sackler family are also represented on NIH boards and committees.

Initiating buprenorphine treatment during short‐term inpatient ‘detoxification’

A new study on initiation of buprenorphine maintenance was just published. The press release describes the intervention as an alternative to “revolving door” detox and relapse cycles:

“patients who start long-term buprenorphine treatment at a detox program, instead of going through detox and getting a referral for such treatment at discharge, are less likely to use opioids illicitly over the following six months, and more likely to keep up treatment”

Study finds alternative to ‘revolving door’ of opioid detox and relapse

The study was recently published in the journal Addiction. Let’s take a closer look at the study.

1) What is the treatment or intervention being studied?

The researchers compared two service models in a short-term inpatient detoxification unit:

  • 5‐day buprenorphine managed withdrawal protocol and passive referral with “a full list of local substance use treatment options as well as primary medical care follow‐up options.”
  • Buprenorphine induction, inpatient dose stabilization and post‐discharge transition to maintenance buprenorphine at an affiliated primary care clinic.

2) Who were the subjects?

Subjects were recruited from a medically supervised treatment facility that provides, as usual care, evaluation and withdrawal management using a methadone taper protocol for those with opioid use disorder, along with individual and group counseling and aftercare case management. On average, patients stay for 5.7 days. The program is also associated with a methadone maintenance program and a primary care‐based buprenorphine program. Within 24 hours of admission individuals were approached by the study team, who described the study and asked permission to complete a brief eligibility screen.

“Study inclusion criteria included age 18 years or older, interested in initiating maintenance buprenorphine/naloxone treatment and willing to establish primary care after discharge with a buprenorphine provider at the nearby SSTAR health center in Fall River. Exclusion criteria included: not able to provide informed consent (due to acute illness, cognitive impairment, psychosis or not able to complete the study in English), having a history of allergic reaction to buprenorphine or naloxone, surgery in the coming 6 months, pregnancy, a current DSM‐IV diagnosis of schizophrenia, 20 or more days of use in the last month of sedative/hypnotic drugs, cocaine or alcohol (because the out‐patient program would not accept direct linkage of high‐levels of non‐opioid substance use), current suicidality, current homelessness or plans to leave the area within the next 6 months.”

3) How long was the study?

6 months.

This is good. 6 months is a relatively long-term study.

4) What outcomes did the study measure? (How did they define success?)

“Our outcomes of interest were (1) mean 30‐day rate of use of illicit opioids and (2) prescribed buprenorphine treatment days at 1, 3 and 6 months’ follow‐up.”

Treatment engagement and retention are important things to evaluation, but treatment is not recovery and may not reflect the goals of people with addiction and their loved ones.

The other outcome was illicit opioid use, which is more directly related to recovery. However, it’s worth noting that this does not include other drugs or prescribed opioids.

5) What were the study methods? What’s the quality of the evidence?

All participants completed follow‐up assessments at the end of their in‐patient stay (day 5), a week following discharge (day 12) and then at 1 (day 35), 3 (day 95) and 6 months (day 185) post‐discharge; all post‐discharge follow‐up assessments included a urine toxicology and compensation (day 12: $40, day 35: $50, day 95: $50, day 185: $50). Participants provided a urine specimen for toxicological testing (instant screens) at each assessment.

6) What did the study find?

Treatment days: By the end of the study:

  • 69% of maintenance patients were still using buprenorphine more than 10 days per month.
  • 39% were using buprenorphine on a daily basis.

Illicit opioid use: When the researches excluded missed drug screens, they found significant less illicit opioid use in the maintenance patients during the study, but these differences shrunk to non-significant levels by the end of the study.

When they treated missed drug screens as positive drug screens, the maintenance patients used illicit opioids 4-5 fewer days per month. The graphs below suggest that the maintenance patients averaged around 12 days of illicit opioid use per month versus around 16 days per month for the detox and passive referral patients.

7) Were any actual or potential conflicts of interest?

“The study medication was supplied by Indivior as an unrestricted, unsolicited grant of non‐financial support. Indivior had no role in study design; collection, or analysis and interpretation of the data; in the writing of the manuscript; or in the decision to submit the manuscript for publication.”

8) What questions does the study not answer?

Note: No study can answer all questions and any study that tries to answer all questions is likely to do so poorly. This is not meant as criticism as much as context.

  • We don’t know anything about use of prescription opioids, illicit drugs (other than opioids), or alcohol use.
  • We don’t know anything about quality of life or restoration of functioning in life domains.
  • We don’t know how this intervention would compare to a decent program. Opioid detoxification with passive referral to ongoing care is very poor care.
  • We don’t know how much (or how little) the subjects look like real-world patients. The study screened out 77% potential subjects. And, of the eligible subjects, 70% chose not to participate and another 13.5% either left the facility or were determined ineligible.
  • The researchers speculate that buprenorphine recipients benefited from protection from overdose. There were no deaths in either group, but the study did not report whether there were differences in nonfatal overdose.

NA and “understanding their reality”

I see professionals and advocates criticize Narcotics Anonymous (NA) on a near daily basis for their views on opioid agonist medications (methadone and buprenorphine), often referring to them as problematic, backwards, and complicit in the opioid overdose crisis.

The published guidance for groups is here and might be summarized as follows:

  • implying that people on agonist treatments may not be “abstinent”;
  • asserting that people on agonist medications should be welcomed in NA meetings; and
  • leaving it to groups to define “abstinent/recovery” and decide the roles people on agonist treatments can play in their group.

In the rush to condemn NA, I don’t see critics trying to understand their reasons.

This brought to mind something Isabel Wilkerson said [emphasis mine], “Empathy means getting inside of them, and understanding their reality, and looking at their situation and saying not, ‘What would I do if I were in their position?’ but, ‘What are they doing? Why are they doing what they’re doing from the perspective of what they have endured?'”

So, if we take Wilkerson’s advice (or Ta-Nehisi’s admonishment to practice a “muscular empathy”), what might we consider?

First, addicts formed NA in the context of neglect/abuse from helping systems that believed they couldn’t recover.

In a recent post, Bill White summarized some of that context:

Such treatment insults span bleeding, purging, and toxic, mercury-laden medicines in the 18th century. They include the fraudulent boxed and bottled home cures and the use of cocaine to treat morphine addiction in the 19th century. And they encompass the oft-lethal withdrawal procedures, prefrontal lobotomies, electro- and chemo-convulsive therapies, prolonged institutionalizations, and the harmful use of stimulants, sedatives, and anti-psychotic medications to treat addiction in the early to mid 20th century.

The Irrationality of Addiction Treatment

Further, many of the groups that are precursors to NA were formed in prisons.

Second, before the emergence of NA, many went to AA but were told that their needs were incompatible with AA’s singleness of purpose.

Simultaneously, another precursor to growth of NA was the experience of addict AA members who felt threatened by the overmedication (stimulants, sedatives and sleep aids) of other AA members.

So, these people who had been abandoned and abused by helping systems, whose cultural ownership had been relegated to criminal justice systems, created their own community to support each other and help others join them in their recovery.

More recently, it’s well-known that agonist misuse is common. (Professionals characterize it as instrumental use to avoid withdrawal. Patients in non-agonist residential treatment paint a more complicated story.)

Given this context, it’s not surprising that NA is relatively uninterested in the opinions of professionals telling them that they are doing it wrong. Particularly since NA members are not professionals and are simply a fellowship of people who have come together to share their path from addiction to recovery.

We might also imagine that this perceived contempt and condescension is experienced by NA members not as a 2019 reaction to a 2019 medical treatment, but as another chapter in a long history of professional neglect, abuse, domination, control, disrespect, and contempt.

Further, if groups like Medication Assisted Recovery Anonymous (MARA) were much more widely available, few would care what NA does or doesn’t do.

Given this, rather than criticize NA, a more productive use of time and energy might be to use NA as inspiration and as a model for facilitating the growth of groups like MARA. (Much like NA did with AA.)

More on that Suboxone settlement

I saw some questions about what it means. Here’s a little more context.

  • 2002 – Reckitt Benckiser introduced Suboxone.
  • 2010 – Suboxone’s patent is expiring and Reckitt Benckiser claimed that Suboxone pills present a safety hazard to children and should be pulled off the market while they introduce a new film version with a new patent.
  • 2014 – Reckitt Benckiser spins off Suboxone into a new company called Indivior.

Here’s some reporting on the implications of the settlement:

Reckitt’s settlement only covers allegations dating to the period before Indivior’s 2014 spinoff, Indivior said in a statement. Reckitt was not directly named in the feds’ criminal investigation, and prosecutors are still investigating Indivior’s own marketing of Suboxone. The company was indicted on criminal charges in April.

Fierce Pharma

So . . . that appears to be a wrap for Reckitt Benckiser.

Here’s the latest with Indivior:

The settlement partly clears the cloud of uncertainty over Indivior. The company sliced its 2019 sales forecast in half in May after the federal indictment and lower-than-expected uptake of its branded Suboxone Film. The company teamed up with Novartis’ generics unit Sandoz to roll out an authorized generic earlier this year.

However, Indivior reversed that revised guidance Thursday, announcing Suboxone’s “outperformance” in the second quarter. The company said its projected revenue on the year is now forecast between $670 million and $720 million—a 25% increase over the previous forecast—thanks to its success at preserving market share

Fierce Pharma

UPDATE: This ABC News article does a good job describing the allegations against Reckitt Benckiser.

Suboxone maker to pay $1.4 billion in largest opioid settlement in US history

From ABC News:

Suboxone maker Reckitt Benckiser Group (RB Group) will pay the U.S. government a record $1.4 billion to end criminal and civil probes into the marketing of its addiction treatment medication, making it the largest settlement related to the opioid crisis in U.S. history, authorities said on Thursday.

This would appear to be tied for the 5th largest pharma settlement ever.

A couple of questions

First, we are currently witnessing rapid change / evolution / destabilization of the conceptual boundaries of recovery. How do these changes affect what it means to call a program or system recovery-oriented? What differentiates a recovery-oriented provider from others?

Second, Bill White frequently shares his epiphany that the orientation of research and service providers was on addiction (pathology) and treatment, to the exclusion of recovery. He called for “a fundamental paradigm shift” from a pathology orientation to a recovery orientation.

There has been a notable shift in locus of recovery advocacy efforts toward drug users rather than people in recovery, often framing communities of recovery as problematic. Additionally, the primary goal(s) of service systems are increasingly organized around death prevention and symptom amelioration. While there are real reasons for these shifts, what risks do they pose? How do they affect the risk of returning to a pathology orientation?

Is calling addiction a disease harmful?

In recent years there’s been a lot of attention and energy devoted to reclassifying addiction from a disease to something else–a “disease” of despair, a lack of social connection, a product of injustice and hardship, a product of deprived environments, a learning disorder, etc.

Now, there’s a recent study getting attention that suggests teaching clients addiction is a disease may be harmful.

Drug addiction is a disease. That has long been the consensus in the medical community, and in recent decades it has filtered down to the general public.

The hope among public-health officials has been that such messaging decreases the moral stigma that traditionally surrounds addiction, and instead will inspire suffering people to stop blaming themselves and get professional help. But newly published research suggests this framework “may have unintended negative consequences.”

The results of a new study suggest that, for many people who need help, “I have a disease” translates to “There’s nothing I can do about it,” or “It’s out of my hands.”

So . . . should we stop talking about it as a disease?

I’d say no, for a couple reasons.

First, it is a disease.

Second, I suspect that the problem is not with addiction being categorized as a disease, it’s the context for that categorization. I’d imagine there are contexts in which it’s harmful and contexts in which it’s helpful.

Off the top of my head, these contexts might revolve around questions like:

  • What treatment outcomes are possible or can be expected for this disease?
  • Who’s responsible for treatment?
  • If the expected outcomes are not achieved, who is responsible for that? And, how should we respond?

What treatment outcomes are possible or can be expected for this disease?

If the patient assumes the prognosis is poor, I’d imagine that diagnosis is likely to have negative consequences, like a loss of agency.

However, I imagine health professionals deal with this situation every day. Patients hear diagnoses like cancer, asthma, or heart disease and assume that the course of their physical well-being is out of their hands.

I hope that, where the prognosis is not poor and active client participation is an essential element to effective treatments, providers have approaches to mitigate the potential loss of agency that may accompany a diagnosis.

What happens if the provider is pessimistic about the prognosis? How does that influence care? How does the provider explain the poor prognosis?

Off the top of my head, I see 4 possible explanations a helper may arrive at:

First, they may conclude that they are not a very good helper. Few providers will give this serious consideration.

Second, they may conclude that we just don’t have good treatments for this disease–the disease is too difficult treat. This is much more common. Whatever the drug crisis of the moment is, that is considered to be particularly difficult to treat. (Crack, then methamphetamine, then opioids.)

Third, they may conclude that the disease is treatable, but the patient is too difficult to treat. They may believe that their clients are too complex, that they don’t want recovery, that they are too chaotic and difficult to engage or retain. This is more common yet. The belief is, “I am competent, we have the knowledge and skills, but these clients won’t/cant cooperate.”

Fourth, they may believe that the disease is treatable but the context makes it impossible to effectively treat the disease. They may believe that these clients can’t be effectively treated because they are too poor, they are homeless, their living environments are too hostile to recovery, they face legal and employment barriers, etc. This may be the most common. With this explanation, like the second and third, the professional experiences a loss of agency.

Who’s responsible for treatment?

Is treatment something that is delivered by a professional who is believe to possess the important knowledge, skills, tools and plan?

Does treatment narrowly focused on pills and procedures? And, is a “good patient” a passive, compliant patient?

Or, is treatment a partnership between the patient and professionals that is based on listening, understanding, shared decision-making, and shared responsibility? Treatment of this kind may involve pills and procedures, but may also involve much more, including behavioral strategies, and interventions to address barriers to treatment.

If the expected outcomes are not achieved, who is responsible for that? And, how should we respond?

When we don’t get the outcome we wanted, who do we ascribe responsibility to?

Is it the patient’s fault for not following the treatment plan? If we share responsibility, there may be some truth to this at times. However, shared responsibility requires that we don’t stop there. If the patient didn’t adequately participate in treatment or didn’t follow the plan, we should consider:

  • Did the patient have sufficient input on the plan?
  • Was the plan aligned with the patient’s goals? (Recognizing that goals often change before and during treatment.)
  • Did we adequately explore and plan for barriers the patient is likely to encounter?
  • Did we approach the patient in a manner that contributed to a loss of agency rather than using approaches then enhance agency?

Do we blame the illness for being too difficult to treat? In this case, we should consider the following:

  • Is the illness really that difficult to treat, or are we unwilling to invest the necessary resources to achieve remission?
  • If there is no silver bullet treatment, informed consent becomes more important. In this case, what combinations might make sense?
  • Is seeking to reduce symptoms and harms while we wait for better treatments the best we can do? If so, do we communicate this to patients?
  • Do combinations of treatments move us closer to, or increase the likelihood

Do we blame the provider?

  • Are they providing treatment in an adequate dose and intensity?
  • Was the treatment of adequate duration?
  • Was the treatment of adequate quality?
  • Is the provider attending to extra-therapeutic factors that are likely to influence outcomes?
  • While some providers are sure to be poor caregivers, others may be under-resourced.

Do we blame the context?

Do we blame the environments that patients are coming from? Where applicable, do we blame criminal justice policy, homelessness, employment opportunities, anomie, health care policy, social determinants of health, etc.?

Of course, all of these things influence what we’re able to do for patients and the outcomes we achieve together. And, of course, many of these needs fall outside the narrow purview of “addiction treatment.”

We can say, “that’s not my system’s/agency’s job” and complain about other systems’ failures to meet or clients’ needs. We can confine our efforts to reimbursable services. That’s a pretty easy position to defend.

While that is an easy position to defend, it indicates the absence of a mission-based commitment to recovery and our patients.

Anecdotally, it appears to be the smaller, community-based programs that develop housing programs (before any funders would considering reimbursement for these services), employment programs, maintain pantries, and provide meaningful linkages with indigenous sources of recovery support.

I routinely encounter patients from corporate providers who received a time-limited, often high-intensity, dose of treatment followed by inadequate continuing care. The continuing care is often a passive referral to an unaffiliated low-intensity outpatient program near their home. (In the worst cases, corporate programs will complain about smaller, community-based programs that do not adapt their services to accommodate the needs of poorly served corporate patients.)

When I’ve reached out on behalf of patients, the help available to them is entirely contingent on funding.

Negative consequences?

If there are negative consequences to receiving a diagnosis of addiction, it’s worth asking whether it’s the diagnosis itself of something else.

Maybe we don’t need to nuance the language for our patients. Maybe we need to do better for our patients.