Author: anonymous

  • Response to the heroin epidemic: 3. OST, the economics of diversion, and the dangers of naltrexone

    Response to the heroin epidemic: 3. OST, the economics of diversion, and the dangers of naltrexone

    …by Shaun Shelly…

    Percy Menzies’ post has stirred up a lot of controversy! Here, Shaun’s extensive rebuttal gathers some of these arguments, plus many of his own, and launches them in torpedo-like fashion. Shaun’s command of the research landscape is awesome, but let’s take care to keep a balanced perspective.

    …………………………………

    In the previous post on this site Percy Menzies makes what appears to be a persuasive argument for naltrexone as a favourable intervention when addressing heroin use disorders. Where Dr. Menzies and I agree is that people who have a heroin use disorder should have a wide range of options for treatment, all the way from non-pharmaceutical to antagonist to agonist. Having said this, I have some major problems with his argument, and I believe that the promotion of naltrexone as a valid response to the heroin epidemic, compared to agonist and partial agonist therapies, is flawed.

    The first thing we need to know is that opioid substitution therapy (OST) works. It is the gold standard recommended by the World Health Organisation, and for the last 50 years methadone has been proven to reduce mortality, reduce crime, improve health, improve retention in treatment and allow people the space to resolve shootingupmany of the issues that have made drug use so meaningful to them. It also reduces the spread of HIV. Through robust head-to-head clinical trials, buprenorphine has also been shown to be effective, in some cases more so, in some cases less, but it is effective and has a better safety profile.

    Dr. Menzies suggests that the treatment of heroin use disorders is “overwhelmingly dominated” by OST. This is simply not true. According to a 2015 SAMHSA report, only 22% of people between the ages of 22 and 34 accessing treatment for heroin use disorders received OST. Even judges playing doctor are ordering people to stop OST. Further, Dr. Menzies argues that if OST was made more available it would “exacerbate the existing problem, as the pool of opioids will greatly increase along with abuse and diversion.” The data simply do not support this: In Switzerland, where 92% of people in heroin use treatment are receiving agonist therapies, the number of people with a heroin use disorder is dropping by 4% per year and no one has died from a heroin overdose since the programme was started in the early 90s. Similarly in France, where buprenorphine is the norm, 70% of heroin users have access to OST and there has been an 80% reduction in heroin-related deaths and a 75% drop in HIV prevalence among injecting drug users. 20% of French physicians prescribe buprenorphine compared to 3% in the US.

    bupebottlesAs far as diversion is concerned, diversion is a function not of greater availability but of lack of availability. The diversion of methadone and buprenorphine occurs because they have a street value — because people cannot access these medications or because the services that offer them are not attractive to them. This is basic economics, and it has been proven throughout history. Increased access through appropriate services will reduce diversion!

    The most concerning aspect of Dr. Menzies argument is his promotion of naltrexone in lieu of OST. Naltrexone has been available since 1984 in the oral form for treating opioid dependence and XR-NTX, the extended release injectable version, since 2010. Naltrexone is an opioid antagonist. In other words it has affinity with the opioid receptor but has no intrinsic value and therefore no efficacy. Theoretically this blockage causes the dissipation of Pavlovian learning over time. But for this to occur, the naltrexone needs to be taken over time, and retention and compliance are listed as a major problem in all the studies. The 28-day injection (XR-NTX) was developed, and this has improved compliance, but in many studies patients do not complete the course — in a phase four trial only 36% of participants completed the treatment. Dr. Menzies and his organisation, Assisted Recovery Centers of America (ARCA), also describe naltrexone as an anti-craving medication on their website. But what does the data say?

    A Cochrane and other reviews have shown that naltrexone performs no better than placebo in reducing heroin use. Craving has only been shown to be reduced with the XR-NTX formulation, but studies suggest this is linked to period of abstinence independent of the drug. Further, due to the antagonist nature and subsequent upregulation of opioid receptors, once naltrexone is stopped it significantly increases the risk of overdose. Some studies have suggested that this risk can be 7 times higher than with methadone.

    Further, the studies that were used to secure FDA approval for XR-NTX in the treatment of heroin use disorders were done in Russia, where OST is outlawed. It is a basic principle of clinical trial ethics that if there is an existing treatment option, placebo controlled trials are not ethical. There have been no head-to-head trials in the US for naltrexone vs. OST. A Malaysian trial ended prematurely because the difference between buprenorphine and naltrexone was so great that it would not have been ethical to continue!

    Dr. Menzies is suggesting that we use a medication that has: not been through head-to-head clinical trials with a known effective treatment (OST); that performs no better than placebo unless autonomy is taken away and it is given in a 28-day formulation; and that has been shown to significantly increase the risk of mortality on termination. He further suggests that it may be especially useful for “patients who are not well-to-do and who are, as a result, often trapped in a very limited set of choices.” This despite the recommendations of the World Health Organisation and the UK National Institute for Health and Care Excellence (NICE) guidelines recommending that only employed, fully informed, short-term users who want total abstinence and are well informed of the consequences of naltrexone would benefit. Studies looking at retention and efficacy have shown that people who are homeless, injectors, or have co-occurring disorders are not suited to naltrexone. At US$1000 a shot, I wonder how long the “not well-to-do” will be compliant.

    In the interests of autonomy, disclosure and choice, naltrexone should be on the menu, as Dr. Menzies suggests. But based on the evidence, Dr. Menzies’ post promoting naltrexone as the most promising response to the heroin epidemic appears to be less of a reasoned argument and more of a biased stance that capitalises on the fear and stigma so many have towards opioids and those who use them.

    For a more complete argument against the use of naltrexone, complete with references, please see my piece in The Influence.

  • Response to the heroin epidemic: 2. Addiction, access, and the problem of opioid substitution

    Response to the heroin epidemic: 2. Addiction, access, and the problem of opioid substitution

    …by Percy Menzies…

    I met Percy, a treatment provider and policy person, in Minnesota about six months ago. We have had some spirited discussions since then. In his view, the culprit in the opiate crisis is access — drug availability — a position that’s put him in direct opposition to Johann Hari and others who favour decriminalization/legalization. He is also a champion of naltrexone…an evidence-based treatment we don’t hear much about. Here’s what he’s got to say:

    ……………………………………..

    Access to drugs is by far the strongest factor contributing to the spread of addiction. The unprecedented quantity of heroin being produced by Afghanistan, Burma and Mexico is causing a sharp increase in heroin addiction and deaths in bordering countries including the US. Addiction rates are rising in Europe, Asia, Africa and many other countries. The access is almost certain to grow as more opium poppies are grown in these countries. The heroin problem in the US is compounded by the huge increase in the use of prescription opioids to treat chronic pain. Indeed, the US consumes in excess of 80% of the world’s legal opioids! We have not seen a problem this big since the days when morphine was an unregulated drug and used indiscriminately.

    How do we grapple with this growing problem? A little history before we attempt to answer the question. The treatment of opioid addiction is overwhelmingly dominated by opioid substitution treatment (OST) based on a hypothesis that opioid use causes permanent changes to the opiate receptors necessitating prolonged opioid use as a form of harm reduction. Using an opioid to treat an opioid addiction is tricky and works best when access is controlled. It started when President Nixon in the 1970’s reversed the long-standing policy against maintenance treatment with opioids and authorized the opening of methadone clinics. Heroin addicted patients were required to go to the clinic each morning to ingest a carefully controlled dose. This highly restrictive and controversial program was planned as a temporary measure and served a dual purpose. It protected society from the criminal activity of drug addicts and at the same time provided heroin addicts treatment.

    If opiate substitution treatment is the only way to go, could we develop or look at existing opioids that could be administered in a less restrictive environment? Buprenorphine, a powerful, but safer opioid, developed in the 1970’s as an injectable drug for the treatment of acute pain, emerged as the best candidate. The oral formulation as a sublingual tablet was found to be highly effective in curbing the cravings for opioids. Although abuse was an ongoing problem, buprenorphine emerged as a safe, effective medication that could be prescribed by a physician. Researchers believed that adding the opioid antagonist naloxone (better known by the trade name Narcan) would deter patients from injecting the sublingual tablet.

    The introduction of buprenorphine in 2002, better known by the trade names Subutex and Suboxone took a rather convoluted path. The approval occurred when the nation was in the throes of a man-made epidemic of prescription opioid use. To prevent buprenorphine turning into “pill mills,” physicians were required to obtain a DEA-waiver and there were limits on how many patients could be treated at any one time – 30 the first year and 100 thereafter. Too few physicians bothered to get the exemptions, and although the sales of buprenorphine soared to in excess of $2 billion per year, we have not seen a drop in reduction of heroin use or overdoses. Why? Too few physicians with the required exemption and too few treatment slots for buprenorphine, the experts told us. After much debate and lobbying, the compromise is to increase the access by allowing physicians to treat up to 200 patients at a time.

    We are facing an unprecedented epidemic. Why not remove all restrictions on the use of methadone and buprenorphine and throw open the floodgates for OST? Why not treat addictions as we have treated chronic pain in the past? Will this solve the problem? Not by any stretch of the imagination. It will only exacerbate the existing problem as the pool of opioids will greatly increase along with abuse and diversion. We have to offer patients treatment options including non-opioids.

    Marc Lewis in his very thoughtful post on visiting a harm reduction facility in Belgium observed: “Methadone provides a solution to heroin epidemic, but not a great solution. Something is still seriously wrong here, and this form of treatment, connection and care can make it livable. But only just.” Marc’s observation that many patients in the clinic he visited balanced their methadone dose with heroin obtained on the street also applies to buprenorphine. As long as there is access to heroin, treatment options centered on buprenorphine or any other opioid are going to be problematic.

    My clinics have treated thousands of patients addicted to prescription opioids and heroin by offering them clear treatment options. We refer them to methadone clinics when appropriate; offer buprenorphine as a detox and maintenance medication when necessary; and when they want to be completely abstinent from all opioids, we start them on naltrexone. A monthly injection of naltrexone (called Vivitrol) is a highly favorable alternative to continuous opioid addiction, especially when street drugs are mixed with OST. Our patients can always go back on buprenorphine or methadone if they change their minds. For many patients it is refreshing to know that they don’t have an incurable disease, and a spectrum of treatments options gives them a fighting chance to feel empowered and to quit using drugs. Even if only 15-20% of patients are likely to benefit from naltrexone/Vivitrol, is it not ethical to offer it as a treatment option? Especially for patients who are not well-to-do and who are, as a result, often trapped in a very limited set of choices.

    Access is the major culprit in the spread of addiction and a major contributor to relapse. Increasing access to opioids as part of treatment may help some people, but it is only going to worsen the big picture.

    Percy Menzies holds a Master’s degree in pharmacy from India and is the president of Assisted Recovery Centers of America, a clinic based in St Louis, Missouri, that treats in excess of 400 heroin addicts a month through evidence-based treatments.

  • Strong support for opiate substitution treatment…and fixing the bigger picture

    Strong support for opiate substitution treatment…and fixing the bigger picture

    …by Shaun Shelly…

    I just pulled into a lodge in Banff, Canada at 2 AM (roughly noon for me) after a flight delay and missed shuttle. I’m way too tired to introduce this intelligently. All I can say is that I have huge respect for Shaun’s understanding of what goes on in opiate addiction, both above and below the surface we call treatment. See for yourself:

    ……………………………

    Firstly, I think that the most important thing to remember is that OST (either agonists such as methadone or partial-agonists such as Buprenorphine, with or without naloxone) saves lives. There is up to 75% reduction in mortality for those in these programmes as opposed to those who do not have access. That alone should sweep away almost any argument against the utility/ethics/need for OST programmes. OST is well researched and has been shown to work and save lives over many years. (*1 for examples -there are many)

    Secondly, low threshold programmes, such as the one you describe [see last post], that do not insist on abstinence or accessing other services, are a vital part of the continuum of care. The data tells us that psychosocial interventions such as CBT add nothing to the outcomes of these programmes in terms of drug use, retention, other health issues etc. Personally I have some issues with the design of some of these studies, and as with most “addiction” research they are too limited to draw absolute conclusions from, but certainly the lack of availability or the lack of willingness to engage in psychosocial services should NEVER prevent the supply of OST.

    Thirdly; there is plenty of evidence that these programmes improve access to health services; improve compliance on ARVs and TB meds; reduce criminal activity; improve quality of life in some people; can help people become employed; lead to people choosing to engage in other “addiction” treatment programmes, including abstinence based programmes (but this increases risk of mortality in the short-term!) etc etc

    So, it is clear, in my opinion, that we should be offering low-threshold OST programmes. I think it is also very important to note that this type of programme, along with needle and syringe programmes, offers a unique opportunity for drug users who are highly stigmatised to engage with health and other services, and, perhaps vitally, to engage with people who are part of a wider community without stigma or judgement. This interaction can, and sometime does, provide the “scaffolding to construct a vision of future self” (to paraphrase one of my favourite quotes from Marc).

    For some people the simple move from a street opioid to a pharmaceutical opioid with a longer half-life is all that is needed to find some stability and start “living” again. If they have the correct support structures, mental faculties, education, family or alternative family structure, the right lucky break or a guardian angel individually or in any combination, they will be able to build a productive life. I know many such people. They are still dependent on an opioid, but are not addicted – so what! Just the structure of attending the clinic and not having heroin be their all-consuming vocation, can give them the space and the belief  to start making changes, and these are often self-accelerating. Some of these people will eventually down-titrate to zero or close to zero dose, some may not. Their choice. Some may have, as Dr Mark Willenbring has suggested to me, a hypoactive endogenous opioid system that requires a life-long agonist to function optimally.  Either way, they, and many of the rest of the world, except the abstinence Nazis, are happy.

    However, there are many exceptions. While many of the people you saw “weren’t anywhere close to safe and stable in the big picture” I would argue that this has little to do with their drug use. I certainly do not want to paint all street dwelling dependent heroin users as victims – they are often the most resourceful and resilient people I have ever met – but many of them (but not all as Gabor Mate would have us believe) are sufferers of serial trauma and most have been highly stigmatised, ciminalised and ostracised. In this case, they may not have the resources, intrinsic and extrinsic, to build on the new-found structure of methadone or buprenorphine and create a “new life” or find “recovery”. Indeed, for many that may not even be desirable.

    For many of these people heroin is a form of vocation and indeed the thing that binds them to their street family (see the video I have linked at the end of this post). I have worked extensively with these populations, and I find that for many drug use is a supremely logical choice in the face of little chance of finding meaning in what others would call “normal” pursuits. As I stated earlier, this is not a problem of pharmacology, this is a problem that lies beyond the individual and in the structural and systemic issues of modern society – the work of Alexander (his FULL BODY of work!) is very relevant. To expect methadone programs to address these issues is unrealistic!

    This leads me to the one area where I do have a problem with methadone programmes and the reductionist approach that reduces harm reduction to a set of bio-medical interventions. Just because people are being kept alive does not mean we have solved the problem. The other issues that need attention are criminalisation, stigma, inability to address the needs of those with mental health and other issues. These are not (only) drug issues, but societal issues.

    One of the steps towards addressing these wrongs lies in the fact that agonist therapies work – they are the only consistent therapies to work with “addiction” when it comes to health issues. The logical conclusion is that we should make pharmaceutical agonists easily available to all drug users – allow these street users the same benefits that many of us “functional due to privilege” users enjoy – access pharmaceutical quality drugs with the minimum of barriers. That is decriminalise, legalise and regulate all drugs. This will not solve all the problems, but will go a long way to prioritising who does and doesn’t need “treatment”!

    Video on “street families”:
    http://www.featureshoot.com/2015/11/photographer-chris-arnade-on-street-addiction-and-the-devastation-it-leaves-in-its-wake/

    *1 EG :Caplehorn, J. R., Dalton, M. S., Haldar, F., Petrenas, A. M., & Nisbet, J. G. (1996). Methadone maintenance and addicts’ risk of fatal heroin overdose. Substance Use & Misuse, 31(2), 177–196. http://doi.org/10.3109/10826089609045806
    Connock, M., Juarez-Garcia, a., Jowett, S., Frew, E., Liu, Z., Taylor, R. J., … Taylor, R. S. (2007). Methadone and buprenorphine for the management of opioid dependence: a systematic review and economic evaluation. Health Technology Assessment (Winchester, England), 11(9). http://doi.org/10.2165/11632820-000000000-00000

  • Triggers and Tethers

    Triggers and Tethers

    …by Matt Robert…

    longdociThis will be our last post of the season. Not only is it smart and sensitive but it’s also warm hearted and optimistic. An ideal note to end on — until January. In the meantime, I wish you all an incredibly happy or at least reasonably happy holiday, however you define “holiday” and however you define “happy.”

     

    dominoesMost people know the word “trigger” as a cue that can initiate a negative behavior. It can be a person, a place, a familiar situation—anything that may compel somebody to return to a behavior they are trying abstain from. Common triggers include seeing a familiar bar or liquor store, running into a using buddy from the old neighborhood, something that causes undue stress… These are things people spend a lot of time avoiding in early recovery and figuring out strategies to manage more effectively.

    But what do we call the things that help re-engage a person in life—that give life meaning? Exercise, meditation, walking the dog, going to church—the things that help us hold on to sobriety, not threaten to questionmarkwrench it away like triggers do. We don’t have a word for things people try to learn or rediscover in recovery, to fill the gap once filled by using. These things are specific activities or events, just like triggers are, and they vary from person to person. Yet there is no general, generic term for these restorative habits and activities. “When I’m tense, I visit my grandchildren. That helps me stay sober and not want to drink. That’s a real (blank) for me.” That’s a real anchor? Refuge? A lifeline? A solace? That’s a real safety? The thing that stops the trigger? The diversity of what “trigger” connotes would be mirrored by its positive counterpart, although a widely accepted term doesn’t exist.

    “Trigger” is a useful term mostly because it is a salient metaphor for the particular experience of being influenced to do something reflexively that you are trying to avoid. So what are some metaphors for a scenario that aids, or protects, or bolsters one’s recovery? Does it restrain you? Does it shield you? Does it protect you? Does it free you? Does it ground you? Does it support you?

    One possibility is the word “tether.” It has several shades of meaning, all related to connection, protective roped to shorerestraint and safety. For example, a boat tethered to the dock is safe because its mooring prevents it from being carried out into the open sea. A tether can be a lifeline followed to safety in a blinding blizzard. A tether is the air hose of a deep sea diver, connemountaineercting him to the surface, to air, to safety. A tether connects a novice to a more experienced mountain climber. A tether keeps a spacewalking astronaut from floating off into the darkness. A tether keeps a dog close to its home, so it doesn’t run off and harm itself or others.

    spacewalkA tether can be used by an addict to stay attached and close to sobriety, not venturing past unsafe boundaries. And with time, the tether can be lengthened more and more, until it is no longer necessary. A tether is a metaphor for a connection to safety and sobriety. “After work, I always dogonleashtake a run to ease the stress of the day. That’s been a real tether for me.” Having a generic term for these activities or states could facilitate productive, forward-looking dialogue. And it could reinforce the primary importance of this aspect of recovery.

    “Trigger” and “tether” are words that describe the two most important states in recovery—the urge to use and the capacity to abstain. They can be natural partners in our discussions, because they highlight both the negative and the positive aspects of recovery. What to pursue and what to avoid. Such discussions can support a healthier balance and move the focus toward the positive, not just the negative—from the prohibitive to the productive—and eventually the freeing.

    The world of recovery has plenty of negative terms for relapse and its causes. Wouldn’t it be helpful to have a reliable, generic term for the positive stuff we do to keep it together?

    Please contribute to the blog with any preferences, suggestions or recommendations for something to fill this void and enhance our discussions of recovery.

     

     

  • A doctor’s view on what doctors CAN’T do for addicts

    A doctor’s view on what doctors CAN’T do for addicts

    …by Bill Abbott, M.D….

    Bill has been a long-standing member of this blog community and he has contributed his leadership and knowledge to the SMART Recovery movement. Thanks, Bill, for taking the time to share your thoughts here.

    ……….

    I’ve recently completed two books. The first is Marc Lewis’s recent one and it is a winner. In this book Marc describes a “model” to explain addiction that is counter to the prevailing “disease model” and he does so in a very credible and lucid way that is based on neuroscience integrated with personal experiences of people he interviewed. A very effective approach indeed.

    stantonThe second book, republished recently, is entitled Love and Addiction by Stanton Peele, which was first published in 1975 – 40 years ago. In this book (and other books of about the same vintage, such as Diseasing of America) Peele described the problem of addiction in very similar ways – obviously without the neuroscience available today — and showed the similarities between addiction and some forms of love, as Marc does also.

    This has left me both frustrated and somewhat sad – that is, so much was clear forty years ago and yet we seem to have learned so little, and I can only come to conclude the following:

    1. The current way we approach the problem of addiction in the United States is abysmal; it isn’t working because it is wrong.
    2. We have failed to learn from our mistakes.
    3. Much of what we really need to know to understand addiction has been known for a long time, but we haven’t paid attention.
    4. We know enough about the problem to effectively deal with it.
    5. And finally, the disease model is not only wrong; it is harmful.

    Marc suggests that the disease model is harmful to a certain extent, but my purpose here is to expand on that idea. I feel justified perhaps because I am a medical doctor — and in long term recovery from alcohol misuse.

    As a disclaimer, what I describe pertains to the United States, where I live… but probably to some extent to other western countries as well.

    doctor at windowThe harm stems from two sources:

    The first is a practical issue. If addiction is a disease, doctors will be expected to “treat” it. That may not be too bad in theory, but unfortunately the medical profession (in the United States at least) is ill-prepared by virtue of knowledge, training, and — most problematic — insufficient time.

    What about psychiatrists, you say? They are doctors. This is true (although many seem to forget clinical medicine)… but because they are doctors they treat patients by managing their patient’s diseases by prescribing medication, hoping for cure.

    The underscored words lead to the second and greater problem with the brain disease model; and that is that it shifts the focus away from people with a problem to an outside entity, thereby mitigating personal responsibility. This position in essence means looking for an outside solution for an inside problem…that only an inside solution can help.

    Let me expand on that a little.

    Marc brings up two very important concepts in his book: what he calls “now appeal” (officially delay discounting) and ego fatigue or depletion (the depletion of cognitive resources for applying self-control). A related idea is the concept of locus of control.

    This concept has been around for a number of years and has been described a number of ways. In general terms what it refers to is whether an individual believes in or relies on self-management or tends to look to along in doc officoutside resources for problem solving. This is not a fixed or constant trait but rather a tendency that varies with the problems and stresses people face. It often tends to be more on the external side in those encountering hard times – not uncommon in the addicted person. Some incorrectly call it low self-esteem.

    So if addiction is a formerly useful coping strategy, now gone amiss, then one needs to look for other coping strategies that work better and be motivated to put them to use. And these work better if they are self-empowered. They don’t work if you rely on someone or something else. They just can’t.

    The neuroscience points to the same conclusion; it is the “desire” that Marc is talking about that makes recovery work.

    What is needed is a shift toward an internal locus of control. Something which the disease model tends to undermine because it fosters dependence on another power.

    Surely you can and ought to seek help, advice, support, or what have you, if that can help. But ultimately you have to do it—for yourself

    This is why the disease model is so insidious and counterproductive to successful recovery in many people. Although your doctor will encourage your participation, basically he is telling you what to do. This is prescription — be it medication or behavior. “You must stop drinking or you will die,“ my doctor said to me. I went home and poured a drink to think about that.

    The evidence supporting the self-management approach is all over the place.

    Consider so-called natural or spontaneous recovery — statistics show that as many as 80% of those who meet criteria for substance use disorder in the DSM-5 recover with no intervention or support whatsoever.

    This is the epitome of self-management and empowerment.

    For those who do need some help, self-management can be learned or better relearned in any number of ways… but I am skeptical that it will ever be learned in a doctor’s office, where you wait next to people with medical illnesses like hypertension and hemorrhoids.

    waiting roomA disease like cancer needs the doctor to manage it; addiction does not.

    What those of us who solved the problem of addiction share is self-empowerment and then learning the skills to manage life’s many stresses in a different and ultimately less destructive manner.

    doctor thumbThe whole disease model concept is based on some really bad science and that in itself is harmful. But the fallout is potentially more damaging.

    I only hope people start paying attention, because the problem is getting worse and we gotta do better. The people who suffer deserve that much, and if we help them to see what they can do for themselves, they may in fact do it — and feel good about the fact that they did.