Residential treatment is still an important piece of the continuum

locations-dawn-farmA newly published study makes a case for residential treatment for opioid addicts:

Opioid users were much more likely to benefit from residential treatment compared to alcohol users. In contrast, the opposite was true for those with marijuana as a primary substance of abuse—the degree of benefit offered by residential treatment was less than that for alcohol abusers. However, for cocaine and methamphetamine users, there was no moderation effect—the effect of treatment setting on treatment completion did not differ from alcohol abusers.

We speculate that for opioid abusers, the increased structure and cloistering of residential treatment provide some protection from the environmental and social triggers for relapse or that otherwise lead to the termination of treatment that outpatient treatment settings do not afford. Indeed, environmental risk characteristics in drug abusers’ residential neighborhoods, such as the presence of liquor stores and indicators of concentrated disadvantage at the neighborhood level, have been found to be associated with treatment non-continuity and relapse (Stahler et al., 2007, Stahler et al., 2009 and Mennis et al., 2012). Such environmental triggers may play a particularly substantial role for those addicted to opioids compared to those seeking treatment for marijuana abuse. Since opioid users have the lowest raw completion rates in general (Table 1), this finding that residential treatment makes a greater positive difference for opioid users than it does for any of the other substances represents an important result that merits further investigation. Given the current epidemic of opioid-related overdoses in the U.S., our results suggest that greater use of residential treatment should be explored for opioid users in particular.

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Substance Use Disorders as a category

Push_vs_Pull_MarketingThere’s been a big change in the way professionals and advocates talk and think about drug and alcohol problems over the last several years.

On one end, we have professionals changing the classifications and mental models for substance use problems.

On the other end, we have recovery advocates changing the definition of recovery.

Before we dig into these changes, let’s start with a little background.

One attempt to classify drinkers

I’ve no doubt that there is a long history of classifying drug and alcohol users and, honestly, I’m not interested in digging into it right now. So . . . one easy to find attempt is AA’s. They were making no attempt to be authoritative–they were just trying to describe what they’d observed.

First, “normal” drinkers:

For most normal folks, drinking means conviviality, companionship and colorful imagination. It means release from care, boredom and worry. It is joyous intimacy with friends and a feeling that life is good.

Next, the various types of heavier drinkers:

Moderate drinkers have little trouble in giving up liquor entirely if they have good reason for it. They can take it or leave it alone.

Then we have a certain type of hard drinker. He may have the habit badly enough to gradually impair him physically and mentally. It may cause him to die a few years before his time. If a sufficiently strong reason – ill health, falling in love, change of environment, or the warning of a doctor – becomes operative, this man can also stop or moderate, although he may find it difficult and troublesome and may even need medical attention.

But what about the real alcoholic? He may start off as a moderate drinker; he may or may not become a continuous hard drinker; but at some stage of his drinking career he begins to lose all control of his liquor consumption, once he starts to drink.

To review, they seemed to identify 4 types of drinkers:

  1. normal drinkers,
  2. people who find that they have been drinking more than they want to and choose to cut back or quit,
  3. people whose drinking gets them into trouble and may need some professional help to moderate or quit, and
  4. alcoholics who have lost control of their drinking for whom abstinence is the only solution.

While these distinctions were observed by lay people in the 1930s, for decades, drug and alcohol professionals too frequently failed to recognize these differences and often treated types 2 and 3 as though they were a type 4.

The DSM – From Abuse/Dependence to a Continuum

apples_aint_oranges_by_tootieofrutyIn 1980, the DSM-III created the diagnosis of substance “abuse” (similar to AA’s type 3, but may include some type 2 drinkers) as separate from substance “dependence” (similar to AA’s type 4 but, unfortunately, still captured many type 3s). These categories continued through the DSM-IV.

Unfortunately, it took too much time for professionals to catch up. (Since Dawn Farm began providing outpatient services in 2000, we have offered 2 “tracks”. The first is for people who meet DSM abuse criteria and/or prefer moderation as a goal. In this track, clients choose moderation or abstinence as their goal. The second track is for people with the more severe and chronic substance problems and abstinence is the goal.)

Over time, it’s my impression* that most professionals did catch up. These categories seemed to become more widely used and shaped care. These were conceptualized as different in kind rather than a difference in severity. Most people meeting “abuse” criteria will never progress into “dependence” and moderation being a perfectly appropriate goal for patients diagnosed with “abuse.” (* My impression is based on professional publications, conference presentations and my admittedly regionally limited interaction with other professionals. This impression is disputed by others and I’m open to the suggestion that many professionals persistently failed to make these distinctions.)

In 2013, the DSM 5 eliminated abuse and dependence, combining them into a single disorder measured on a continuum from mild to severe.

This means that the new diagnostic manual conceptualizes types 2, 3 and 4 as different in severity rather than a difference in kind.

Shifting Definitions of Recovery

This coincides with advocacy efforts that had been seeking to broaden the definition of recovery. In 2001, groups like Faces and Voices of Recovery (FAVOR) formed and sought to include people using non-12 step approaches and people on maintenance medications like methadone under the banner of “recovery.” It was my impression that, at this time, the concept of recovery was confined to those recovering from the disease of addiction.

By 2011, recovery advocates had embraced what has become an important talking point, that 23.5 million Americans are in recovery.

According to the new survey funded by OASAS, 10 percent of adults surveyed said yes to the question, “Did you once have a problem with drugs or alcohol, but no longer do?” – one simple way of describing recovery from drug and alcohol abuse or addiction.

10%? . . . 23.5 million? Those numbers are a powerful advocacy tool. However, to me, this constituted an important transition. This expanded the label of recovery to AA’s type 2 and 3 drinkers, meaning that groups like FAVOR were now applying the label of recovery to people who had short-lived and mild substance use problems, and people who are using substances non-problematically.

To me, the de-coupling of recovery and addiction seems like a very important development.

Not an argument for “dependence”

Dependence was far from perfect. This is not an argument for a return to the abuse/dependence model. (Though I will argue that we should return to conceptualizing as addiction as a different kind of problem from low to moderate SUDs, rather than a different severity.)

Let’s start by stating that addiction/alcoholism is the chronic form of the problem is primary and characterized by functional impairment, craving and loss of control over their use of the substance.

Problems with the categories of abuse and dependence include:

  • Dependence has often been thought of as interchangeable with addiction/alcoholism, but this is not the case.
  • Dependence criteria captured people who are not do not have the chronic form of the problem. We know that relatively large numbers of young adults will meet criteria for alcohol dependence but that something like 60% of them will mature out as they hit milestones like graduating from college, starting a career or starting a family.
  • Dependence criteria captured people who are not experiencing loss of control of their use of the substance.
  • The word dependence leads to overemphasis on physical dependence which, in the case of a pain patient, may not indicate a problem at all.
  • The word abuse is morally laden.
  • For me, there are serious questions about whether abuse should be considered a disorder at all.

Several of these problems are related to doing a poor job in distinguishing which kind of user the patient or subject is.

The abuse/dependence model fell short in distinguishing between kinds of users. Rather than taking a step forward in distinguishing between the kinds of users, the continuum approach implies that there is only one kind with different levels of severity.

Does it really matter?

Reasonable people can disagree, but I find this problematic for a few reasons.

Stigma

I tend to believe that failing to distinguish between kinds of problem users will actually add to stigma. It will perpetuate the conversations that sound something like, “Greg, when your Uncle Bob was in the Navy, he drank too much and got into some trouble. Then he had kids and knocked it off. Why can’t you just do the same?” The reason they can’t do the same was that Uncle Bob was a problem drinker and Greg is an alcoholic.

Non-alcoholics using the drinking experience of non-alcoholics (themselves or others) to understand the experience of alcoholics only increases stigma.

It’s not a different degree of the same thing. It’s a different kind of thing.

In my experience, it’s only when people understand that it’s a different kind of thing—that the experience of the alcoholic cannot be understood by reflecting on your own experience of drinking too much in college—that stigma can be challenged.

Disease and non-disease under the same diagnosis?

The continuum approach becomes especially troubling when you think about the idea of giving people with low severity SUDs and people with the disease of addiction the same diagnosis, only with different severity ratings.

There’s little doubt that large numbers of young people on college campuses meet diagnostic criteria for an alcohol use disorder under the DSM 5. I doubt anyone would argue that all of these young people have a disease process? Even a mild one?

This seems likely to undermine the acceptance of addiction as a disease. Not just by the public, but also by insurers and policy makers.

Others are more concerned, arguing that abuse should be thought of as a behavior and dependence as a disease, and by combining them it becomes easier for payers to deny clinically appropriate care. Even worse, it might signal a shift to the idea that any professional with “behavioral” health training would be eligible.

One frequent example of how this conceptualization undermines the disease model is one of last year’s most popular posts.

In arguing that the causes of addiction are environmental (non-nurturing environments) and social (lack of connection) Johann Hari pointed to returning Vietnam vets discontinuing heroin without treatment as proof that addiction is not a disease.

However, these Vietnam stories often ignore an important fact:

“. . . there was that other cohort, that 5 to 12 per cent of the servicemen in the study, for whom it did not go that way at all. This group of former users could not seem to shake it, except with great difficulty.”

Hmmmm. That range….5 to 12 percent…why, that’s similar to estimates of the portion of the population that experiences addiction to alcohol or other drugs.

To me, the other important lesson is that opiate dependence and opiate addiction are not the same thing. Hospitals and doctors treating patients for pain recreate this experiment on a daily basis. They prescribe opiates to patients, often producing opiate dependence. However, all but a small minority will never develop drug seeking behavior once their pain is resolved and they are detoxed.

My problem with all the references to these vets and addiction, is that I suspect most of them were dependent and not addicted.

So…it certainly has something to offer us about how addictions develops (Or, more specifically, how it does not develop.), but not how it’s resolved.

How useful is it as a diagnostic category?

What’s the purpose of a diagnosis?

Isn’t it to give us a way to think about the causes, course, symptoms and treatments for an illness?

In plain language, a diagnosis is supposed to help us think about, talk about and understand what happened, what’s happening, what’s likely to happen, what will help, what is unlikely to help and what might be harmful.

What do someone with the disease of addiction and someone with a low severity SUD have in common? Do they have anything in common other than some harms (symptoms)? I can think of very little.

When we have one diagnosis that includes problems with radically different causes, courses and treatments, what use is it?

Really, it’s hard for me to see how this category would give helpers any insight into the patient’s experience or help in developing policy responses.

It feels a little like a diagnostic category of “respiratory disease.” It could be acute or chronic; it could be viral, bacterial, congenital, malignant or benign; it could be mild, moderate, severe or terminal; it could require aggressive and invasive treatment or no treatment; it could be progressive, nonprogressive or relapsing and remitting; etc.

Combining addiction and problem use into one continuum seems to like it brings confusion rather than clarity to understanding what happened, what’s happening, what’s likely to happen, what will help, what is unlikely to help and what might be harmful.

Will it eventually undermine advocacy efforts?

Doug Rudolph, of the advocacy group Young People in Recovery, suggested that messaging using SUDs as a category is misleading, undermining integrity and credibility.

I believe that we need to stop merely talking at the public, using the same language, playing to emotions, overgeneralizing data, and commanding them to agree with us, no questions asked. We need to stop using oversimplified, polarizing language that basically characterizes anyone who struggles with drugs and alcohol as suffering from a life-long, incurable, chronic brain disease because that will not, and hasn’t yet, resonated with the silent majority of America. We need to stop skewing statistics to further an agenda, unlike how the above cited statistic is often used, because that calls our integrity and credibility into question. Rather, we need to start digging deeper to develop an effective method that will bridge the gap and reconcile the inconsistencies between messaging and reality. And most difficult of all: we need to be objective.

He added that it risks drawing the attention of advocates away from important questions:

To do this, we need to start asking more nuanced questions that the recovery community has historically glossed over, and which many people believe are taboo to even ask or mention.

For example, while there is a significant difference between a free-of-charge mutual aid, community-driven support group and treatment, should treatment centers be employing and profiting off a method of treatment that a person could receive for free down the street? Should treatment centers be held to a higher, better regulated standard? Do we (as advocates) have a duty to constructively criticize the methods of treatment by which Big Treatment earns profits? While people attending community-driven support groups can do whatever they wish to help themselves maintain recovery (as long as it’s legal), how can we blame Americans at large for not believing that addiction is a bona fide medical disease when the oldest and most popular form of addiction treatment, for which people (or insurance companies) pay big bucks, relies on prayer, character defects, and admitting wrongs? How many other medical diseases or psychiatric disorders are primarily treated this way? Would it be appropriate to treat schizophrenia, PTSD, or diabetes this way? What’s the difference? Do people notice or think about this? Would acknowledging this and incorporating it into our messaging hurt or help our advocacy efforts?

Will it inflate “addiction” rates?

These changes were intended to clear up language problems, specifically the conflation of dependence and addiction leading to “false positives” for addiction. Looks like the DSM-5 is causing its own language problems before it’s even adopted. [emphasis mine]

Many scholars believe that the new manual will increase addiction rates. A study by Australian researchers found, for example, that about 60 percent more people would be considered addicted to alcohol under the new manual’s standards. Association officials expressed doubt, however, that the expanded addiction definitions would sharply increase the number of new patients, and they said that identifying abusers sooner could prevent serious complications and expensive hospitalizations.

What’s the solution?

It’s my opinion that thinking and talking about high severity SUDs and low severity SUDs as different kinds is important for good treatment and good advocacy.

Unfortunately, that means a lot more work for treatment providers and researchers. And, less impressive numbers for recovery advocates.

Why would it be more work for treatment providers and researchers? Because trying to sort type 3 and type 4 is not easy and takes time.

For example, when I have a young adult who meets criteria for alcohol dependence, I have to work with them to figure out if they are a type 3 (Meaning moderation might be a good goal and that might be achieved through education, motivational interviewing, contingencies or help addressing other problems leading to excessive drinking.) or a type 4 (Meaning abstinence should be the eventual goal and they may require specialty treatment followed by long term monitoring and support to achieve that goal.).

I’ll often have a conversation that sounds something like this:

One of the things we’d have to sort through is the kind of alcohol problem you have. There are 2 big categories. The first is the progressive, more severe and chronic type–alcoholism. The second is a lower severity problem that people often mature out of with little or no help, often making the change after some consequence or because of a life transition like graduating or parenthood. Research suggests that something like 60% of young people meeting criteria for alcohol dependence fall into the second category. The kinds of things that suggest someone is likely to fall into the first category are use of other substances, loss of control, euphoric recall of first drug contact, atypical tolerance, continued use despite growing consequences and family history.

Of course, it may take some time and some trial and error to agree on whether the patient is a type 3 or type 4. This conflicts with the goals of DSM writers, researchers, insurers and too many practitioners, but I don’t see a way around it.

Another Vietnam cohort?

This entire issue could be of significant consequence as the current opioid epidemic continues to unfold.

Let’s take a look at comments from the researcher who did the returning veterans study and how it has been misunderstood:

The argument that addiction in Vietnam was a response to war stress, and therefore remitted on exit from the Vietnam war theatre, is still frequently cited as though it were self-evident, because it sounds so plausible. Yet accepting this argument is difficult in the face of the facts. Heroin was so readily available in Vietnam that more than 80% were offered it, and usually within the week following arrival. Those who became addicted had typically begun use early in their Vietnam tour, before they were exposed to combat. Further, the dose-response curve that is such a powerful causal argument did not apply: those who saw more active combat were not more likely to use than veterans who saw less, once one took into account their pre-service histories. (Those with pre-service antisocial behavior both used more drugs and saw more combat. Their greater exposure to combat was presumably because they had none of the skills that kept cooks, typists, and construction workers behind the lines.)

These men were in an environment where it was readily available and presumably less stigmatized, leading to high rates of social/recreational use. This social/recreational use led to high rates of dependence, giving the impression that they had the disease of addiction when, in fact, it appears that only a minority did. This misunderstanding leads to false understandings about the causes, course and treatment required for addiction. These false understandings shape research and public understandings of the problem and solutions.

When one considers this Vietnam story along side what we know about young people meeting criteria for alcohol dependence, it opens the door to some frightening possibilities for this opioid epidemic.

Given the dramatic increases in opioid misuse, is it possible we’ll see a large numbers of people presenting with opioid dependence who are not actually addicted?

If so, will each group get the right treatment for their problem? Will people with opioid-dependence-but-not-addiction be given treatment that focuses on things like maintenance medication, lifelong abstinence and recovery maintenance, when something that looks more like an acute care model would be more appropriate?

Will the research done on treatment provided during this epidemic make any attempt to distinguish between types and each type’s response to various treatment interventions? I wonder if we’ll find that the the opioid-dependent-but-not-addicted group responds well to office-based buprenorphine treatment and are restored to a good quality of life, while addicted groups get stuck or have poor retention and continue to use other substances.

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Should maintenance be the first-line treatment?

Canada1

A recent article in Substance Abuse Treatment, Prevention, and Policy takes a look at the role of maintenance treatments in Canada.

A recent report in the Lancet (2012) concluded that “research into the treatment for [PO] addiction has been chronically neglected. As a result, the evidence base that informs best practice is thin […] The ‘standard treatment’ for [PO] dependence is evolving, and [there is no] single current standard at this time” [10]. Yet, current Canadian treatment system realities seem to suggest the opposite. In Ontario, Canada’s most populous province (~13.6 million pop.), the number of individuals enrolled in methadone maintenance treatment (MMT) has skyrocketed to just under 50,000 in 2014 (from a mere 3000 in 1996, and 29,000 in 2010), with the vast majority of recent enrollments presumed to be PO-related.

Maintenance as the first-line treatment

Not only has MMT enrollment skyrocketed, it’s become the first-line treatment for all stages and types of opioid dependence–not just late stage, treatment-resistance cases.

The above data reflect that OMT – mostly with methadone but some suboxone-based in exceptional cases – has proliferated as the de facto first-line treatment for PO-related disorders in Ontario. This is despite the fact that OMT is designed as long-term – in many cases for life – pharmacotherapy for most patients [18]. The predominant reliance on OMT for PO-disorder treatment is mainly based by research evidence from long-term heroin users, even though substantial, clinically relevant differences between heroin and PO users are documented [1923]. Furthermore, this practice has evolved largely in the absence of an evidence-based stepped-treatment model for PO-disorders, even though evidence exists for benefits of treatment options less intrusive (and potentially less costly) than MMT.

It’s worth noting that this is the direction that that our own government wants to go.

How did Canada’s treatment system get to this point?

While the pharmaceutical industry’s corporate greed and tactics have been popularly blamed – and legally punished – for the PO abuse epidemic (e.g., [32, 33]), economics within the health care system appear to exert an un-desirable dynamic in the realities of treatment for PO disorders. In addition to standard reimbursement for OMT care within Ontario’s public fee-for-service-based health care system, the province introduced additional financial ‘incentives’ in 2011 to entice more community physicians and pharmacies into MMT delivery [34, 35]. In this context, an extensive proliferation of numerous ‘for-profit’ MMT-only clinics occurred focussing on economies-of-scale – i.e., large patient numbers – yet also featuring treatment quality problems (e.g., compromised patient care, inappropriate take-homes or “carries”, excessive urine testing) [3638]. While the MMT-focussed incentives have created a proliferation of MMT clinics and patients in Ontario, there has been no commensurate investment in short- or mid-term treatment interventions, for example with abstinence, where possible, as a main goal for potentially suitable patient sub-groups. While these treatment interventions may potentially be more care effort- or management-intensive in the acute treatment phase, they be less costly for the system – yet also provide less income for OMT providers or medications producers – in the long run.

Again, our government is moving in the direction of major investment and incentives to expand maintenance treatments.

Are the authors “one-wayers”?

No.

Allow us to be perfectly clear: Our position is not ‘anti’-OMT for PO-disorders. In fact, several of the present authors have actively argued for the expansion of OMT availability in Canada when this was still a highly restricted and scarce treatment for the treatment of opioid disorders not so long ago [15, 40]. We believe however that OMT’s proliferation as the first-line-treatment for PO disorders has been propelled to excess by several of the wrong reasons . . .

Why not maintenance as a first-line treatment?

You might ask, “What’s wrong with an aggressive approach?” Well, the writers point to adverse effects that are not mentioned in US policy discussion and advocacy.

While OMT undoubtedly brings therapeutic benefits to many opioid-dependent people, and is the best available therapuetic choice for a large sub-group of patients with PO disorder it also implies the continued exposure of patients to potential correlated adverse effects (e.g., brain structure changes, depression, mortality) of chronic opioid intake – risks that should be minimized especially with young and non-severely dependent patients [4550]. Long-term OMT should thus surely be an available treatment option in a continuum-of-care, but primarily for non-responders to less intrusive alternatives where these seem reasonably indicated as a first treatment option.

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Addressing Criticisms of the Disease Model

Dirk Hanson recently shared an important post summarizing NEJM article offering counterarguments to common criticisms of the disease model. Dirk graciously allowed me to repost his post here.

Please follow him at Addiction Inbox.

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Volkow, Koob, and McLellan on the neurobiology of addiction.

The New England Journal of Medicine recently published a review article, “Neurobiologic Advances from the Brain Disease Model of Addiction,” authored by three prominent figures in the field of addiction research: Nora Volkow, the director of the National Institute of Drug Abuse (NIDA); George Koob, the director of the National Institute of Alcohol Abuse and Alcoholism (NIAAA); and Thomas McLellan, founder and chairman of the Treatment Research Institute in Philadelphia.  The article summarizes the research that has “increasingly supported the view that addiction is a disease of the brain,” and concludes that “neuroscience continues to support the brain disease model of addiction.”

The implications of this, say the authors, are straightforward: “As is the case in other medical conditions in which voluntary, unhealthful behaviors contribute to disease progression (e.g., heart disease, diabetes, chronic pain, and lung cancer), evidence-based interventions aimed at prevention, along with appropriate health policies, are the most effective ways of changing outcomes.”

And some of the implications are immediate: “A more comprehensive understanding of the brain disease model of addiction many help to moderate some of the moral judgement attached to addictive behaviors and foster more scientific and public health-oriented approaches to prevention and treatment.”

In a supplementary appendix, the authors address some of the common criticisms of the disease model of addiction, and offer counter-arguments. The quotes below are excerpted directly from the appendix.

Most people with addiction recover without treatment, which is hard to reconcile with the concept of addiction as a chronic disease.

This reflects the fact that the severity of addiction varies, which is clinically significant for it will determine the type and intensity of the intervention. Individuals with a mild to moderate substance use disorder, which corresponds to the majority of cases, might benefit from a brief intervention or recover without treatment whereas most individuals with a severe disorder will require specialized treatment

—Addicted individuals respond to small financial rewards or incentives (contingency management), which is hard to reconcile with the notion that there is loss of control in addiction.

The demonstrated effectiveness of contingency management shows that financial cues and incentives can compete with drug cues and incentives – especially when those financial incentives are significant and relatively immediate; and when control has been simply eroded rather than lost. Contingency management is increasingly being utilized in the management of other medical disorders to incentivize behavioral changes (i.e., compliance with medications, diets, physical activity).

—Gene alleles associated with addiction only weakly predict risk for addiction, which is hard to reconcile with the importance of genetic vulnerabilities in the Brain Disease Model of Addiction.

This phenomenon is typical of complex medical diseases with high heritability rates for which risk alleles predict only a very small percentage of variance in contrast to a much greater influence of environmental factors (i.e., cirrhosis, diabetes, asthma, cardiovascular disease). This reflects, among other things, that the risk alleles mediate the response to the environment; in the case of addiction, the exposures to drugs and stressful environments.

Overlaps in brain abnormalities between people with addiction and control groups raises questions on the role that brain abnormalities have on addiction.

The overlap is likely to reflect the limitation of currently available brain imaging techniques (spatial and temporal resolutions, chemical sensitivity), our limited understanding of how the human brain works, the complexity of the neurobiological changes triggered by drugs and the heterogeneity of substance use disorders.

Treatment benefits associated with the Brain Disease Model of Addiction have not materialized.

Medications are among the most effective interventions for substance use disorders for which they are available (nicotine, alcohol and opiates). Moreover, progress in the approval of new medications for substance use disorders has been slowed by the reluctance of pharmaceutical companies to invest in drug development for addiction.

Benefits to policy have been minimal.

The Brain Disease Model of Addiction provided the basis for patients to be able to receive treatment for their addiction and for insurances to cover for it. This is a monumental advance in health policy. The Brain Disease Model of Addiction also provides key evidence-based science for retaining the drinking age at 21 years.

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NY Times on Medicines to Keep Addiction Away . . . “these work”

Choose you evidence carefully by rocket ship

Choose you evidence carefully by rocket ship

The NY Times has a new post on “Medicines to Keep Addiction Away“.

The writer makes some pretty strong statements. Here she is on  methadone and buprenorphine:

These work. (See here, here and here, just some of many studies). They reduce illicit drug use and keep people in treatment, compared with recovery programs that don’t include medicine. These medicines also cut the risk of fatal overdose by half. I’ll repeat: People on these medicines were half as likely to die of overdose as those getting psychological or social interventions alone

“These work.”

Let’s pick this apart. “These work.

What does “work” mean? Well, she provides 3 references. Let’s go to her evidence.

Reference 1: Let’s go straight to the author’s conclusion.

Methadone is an effective maintenance therapy intervention for the treatment of heroin dependence as it retains patients in treatment and decreases heroin use better than treatments that do not utilise opioid replacement therapy. It does not show a statistically significant superior effect on criminal activity or mortality.

Reference 2: They looked at studies measuring treatment retention and suppression of illicit opioid use. It appears the medications did improve retention and reduce illicit opioid use. However, methadone was more effective than buprenorphine. Why? Here’s what the authors hypothesized.

It is the authors’ view based on clinical experience that the user misses the “gouch” (the colloquial term in the UK coined by users for the slight “head-nodding” effect of heroin and methadone) associated with methadone compared with the relatively “clear-headed” state associated with buprenorphine, and this plays a significant role in the relative lack of uptake of the latter.

Reference 3: They summarized their findings as follows:

Buprenorphine Maintenance Treatment has a positive impact compared with placebo on:

  • Retention in treatment
  • Illicit opioid use

Evidence is mixed for its impact on:

  • Nonopioid illicit drug use

Retaining people in treatment is a good thing, right? If we can keep them in treatment it gives us the chance to use psychosocial interventions, exposing them to social workers, other helpers and peers that can help them improve their quality of life. Right?

Not so fast. Here’s what reference 3 has to say about that:

The addition of structured psychotherapy to standard treatment—which may include peer support services, 12-step programs, and other psychosocial treatment provided at the facility or office—has not been shown to improve outcomes for patients on opioid maintenance therapy.

So . . . according to the author’s evidence, “works” means:

  • we can expect patients to use fewer illegal opioids;
  • they will keep coming back for their buprenorphine or methadone;
  • a stronger “head-nodding” opioid effect predicts better retention and less illegal opioid use;
  • maybe they’ll use fewer nonopioid illegal drugs; and
  • somehow, they’ll be maintained in a state where they are not helped by additional psychosocial interventions.

Are these outcomes what we want for our opioid addicted loved ones? Would achieving those outcomes for your son/daughter be a success?

half as likely to die

There’s little argument that maintenance drugs reduce risk of overdose. It’s less clear how big that reduction is, especially when asking the questions, “compared to what?” and “over what period of time?”

The author makes a pretty bold claim that these medication reduce death by 50%. That’s huge!

What’s her evidence? She uses an English study with an impressively large n of 191,310 patients. And, it compares methadone (not buprenorphine) to residential treatment. That residential to methadone comparison sounds promising. However, I was unable to find any information about the duration of residential treatment and the kind of recovery support that patients received following residential. (That’s a big gap in the information we’d need to make meaniningful inferences from the study. But, let’s put that aside for now.)

More importantly, there’s one issue that raised my eyebrow. The researchers did indeed find a fatal overdose rate of half for methadone recipients when compared to residential treatment patients. However, if I’m reading the study correctly, the total number of post-treatment fatal overdoses for patients discharged from residential treatment was 10. 

Doesn’t that seem like an awfully small number of fatal overdoses to draw such a strong conclusion from?

And, the evidence she used to support her “that works” argument said this, “[methadone] does not show a statistically significant superior effect on criminal activity or mortality.”

Mortality can include causes of death other than fatal overdose. Interestingly, another study that measured mortality among methadone patients found “6.5 times the rate of mortality than that expected in the population.”

Now, this doesn’t mean that methadone doesn’t reduce death rates. It means that the death rate is still very high.

It also means that quality of life questions shouldn’t be dismissed with snarky quips like, “What kind of QOL do dead people have?“, because methadone patients die in large numbers too.

Also, keep in mind that retention rates for methadone and buprenorphine are not great. And, as noted earlier, methadone has higher retention rates.

I’ll also throw in a reminder from a previous post about were I stand on maintenance treatments:

Just to be sure that my position is understood. I’m not advocating interfering with people having access to maintenance.

Here’s something I wrote in a previous post: “All I want is a day when addicts are offered recovery oriented treatment of an adequate duration and intensity. I have no problem with drug-assisted treatment being offered. Give the client accurate information and let them choose.”

Another: “Once again, I’d welcome a day when addicts are offered recovery oriented treatment of an adequate duration and intensity and have the opportunity to choose for themselves.”

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Recent reporting on the consequences of PHARMA bad behavior

phrma2

There were a couple of articles published this week about bad behavior from PHARMA.

First, Vox looks into the roots of the overdose epidemic and Purdue Pharma’s role in policy changes that set the stage for the explosion in opioid prescribing and addiction. (Of course, Purdue profited from these policy changes.)

Andrew Kolodny and other public health experts explained the history in the Annual Review of Public Health, detailing Purdue Pharma’s involvement after it put OxyContin on the market in the 1990s:

Between 1996 and 2002, Purdue Pharma funded more than 20,000 pain-related educational programs through direct sponsorship or financial grants and launched a multifaceted campaign to encourage long-term use of [opioid painkillers] for chronic non-cancer pain. As part of this campaign, Purdue provided financial support to the American Pain Society, the American Academy of Pain Medicine, the Federation of State Medical Boards, the Joint Commission, pain patient groups, and other organizations. In turn, these groups all advocated for more aggressive identification and treatment of pain, especially use of [opioid painkillers].

Choose you evidence carefully by rocket ship

Choose you evidence carefully by rocket ship

Second, BMJ published an analysis finding that drug manufacturers withheld information about antidepressants and suicidal thoughts and aggression in children.

In the latest and most comprehensive analysis, published last week in BMJ (the British Medical Journal),a group of researchers at the Nordic Cochrane Center in Copenhagen showed that pharmaceutical companies were not presenting the full extent of serious harm in clinical study reports, which are detailed documents sent to regulatory authorities such as the U.S. Food and Drug Administration and the European Medicines Agency (EMA) when applying for approval of a new drug. The researchers examined documents from 70 double-blind, placebo-controlled trials of two common types of antidepressants—selective serotonin reuptake inhibitors (SSRI) and serotonin and norepinephrine reuptake inhibitors (SNRI)—and found that the occurrence of suicidal thoughts and aggressive behavior doubled in children and adolescents who used these medications.

The article correctly frames this a part of a larger pattern.

This paper comes on the heels of disturbing charges about conflicts of interest in reports on antidepressant trials. Last September a study published in the Journal of Clinical Epidemiology revealed that a third of meta-analyses of antidepressant studies were written by pharma employees and that these were 22 times less likely than other meta-studies to include negative statements about the drug. That same month another research group reported that after reanalyzing the data from Study 329, a 2001 clinical trial of Paxil funded by GlaxoSmithKline, they uncovered exaggerated efficacy and undisclosed harm to adolescents.

The author offers this conclusion:

Taken together with other research that raises questions about the pros and cons of this class of drugs—including studies that suggest antidepressants are only marginally better than placebos—some experts say it is time to reevaluate. “My view is that we really don’t have good enough evidence that antidepressants are effective and we have increasing evidence that they can be harmful,” Moncrieff says. “So we need to go into reverse and stop this increasing trend of prescribing [them].”

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Supporting Research for Psychosocial Treatments + Medication is “sparse”

fear_false_evidence_appearing_realYesterday, I told you about the new White House budget proposal for $1,100,000,000 for addiction treatment that places very heavy emphasis on medication assisted treatment (MAT).

A recently published study in Journal of Addiction Medicine, the official journal of the American Society of Addiction Medicine (ASAM), raises questions about the rationale for that budget.

That budget and it’s emphasis on MAT is based on this:

“As the Huffington Post article pointed out, we have highly effective medications, when combined with other behavioral supports, that are the standard of care for the treatment of opiate addiction. And for a long time and what continues to this day is a lack of — a tremendous amount of misunderstanding about these drugs and particularly within our criminal justice system,” drug czar Michael Botticelli said in a briefing with reporters.

You might ask, what medications are they talking about? Spend a little time following this coverage and it’s pretty clear that they are primarily talking about buprenorphine.

Let’s look at the statements, “highly effective” and “when combined with other behavioral supports”.

A recent post addressed the “highly effective” element. I’ll repeat that information below, but let’s start with the other claim, “when combined with behavioral supports.”

“when combined with other behavioral supports”

A summary of the Journal of Addiction Medicine article states:

There are three approved types of medications that work in different ways to treat people with opioid addiction: methadone, buprenorphine, and naltrexone. . . . All three medications are approved for use “within the framework of medical, social, and psychological support,” and ASAM’s guideline recommends psychosocial treatment in conjunction with the use of medications. “However,” Dr. Dugosh and coauthors add, “there is limited research addressing the efficacy of psychosocial interventions used in conjunction with medications to treat opioid addiction.”

What did they find about buprenorphine?

For buprenorphine, the results were “less robust”—only three of eight studies found positive effects of psychosocial interventions.

Of course, this is not news. Our position paper and some other posts pointed this out.

If we’ve known this since 2011, how could the drug czar and these professional reporters writing a long-form article not know?

“highly effective”

A couple months ago, NIDA circulated an article with the headline, “Long-Term Follow-Up of Medication-Assisted Treatment for Addiction to Pain Relievers Yields ‘Cause for Optimism’

Here’s how they summarized the study’s findings:

In the first long-term follow-up of patients treated with buprenorphine/naloxone (Bp/Nx) for addiction to opioid pain relievers, half reported that they were abstinent from the drugs 18 months after starting the therapy. After 3.5 years, the portion who reported being abstinent had risen further, to 61 percent, and fewer than 10 percent met diagnostic criteria for dependence on the drugs.

These studies are important. Long-term outcomes have been a big gap in the research.

This is great news, right? 50% abstinent at 18 months! 61% abstinent at 3.5 years! Fewer than 10% dependent at 5.5 years!

Wow!

Not so fast

Lowering_The_Bar_Cover_2010.09.22There are a couple of problems here.

  • They were only able to do follow-up with 38% of subjects at 18 months and 52% at 3.5 years.
    • So, that 50% abstinent at 18 months is really more like 19%.
    • The 61% abstinent at 3.5 years is more like 32%

Still, 19% abstinent at 18 months and 32% abstinent at 3.5 years might be pretty good, right?

Pump the brakes

There are a couple of problems here too.

  • They are only reporting on abstinence from illicit opioid use, not other drugs.
  • Buried in the article, they mention that they are reporting on being abstinent for the last 30 days. This doesn’t tell us much about how they’ve been doing over the previous 18 months or 3.5 years, does it?
  • Same thing for the reporting on diagnostic criteria for dependence. That was also based only on the previous 30 days.

and . . .

This is a federal study seeking to determine whether adding behavioral support improved outcomes.

Think about it

The headline for the press release summary of the study is “Use of Psychosocial Treatments in Conjunction with Medication for Opioid Addiction—Recommended, But Supporting Research Is Sparse

Recommended . . . but evidence is sparse? Let that headline sink in for a moment.

Remember that next time you hear experts or journalists refer to MAT as THE “evidence-based” treatment, or the “best hope“, or “highly effective” or a “wonder drug“.

Then, ask your self why they mentioned nothing about a model, with admittedly narrow implementation, that really does have outstanding outcomes.

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