Buprenorphine, Not Subbies

I’ve been writing longer and longer posts on SuboxForum so maybe I need to write more here.  This blog archives twelve years of frustration over the ignorance toward buprenorphine, at least until I ran out of steam a year ago.  I grew used doctors refusing to treat people addicted to heroin and other opioids.  I became used to the growth of abstinence-based treatment programs, even as relapse rates and deaths continued to rise.  It isn’t all bad news; I enjoyed the past couple meetings of AATOD, where people openly spoke about medication-assisted treatments without hushed voices.  I feel like I’m the conservative one at those meetings!

I don’t remember where I heard first – maybe in an interview with some reporter about addiction- that I was an ‘influencer’ with buprenorphine.  The comment surprised me, because from here I don’t see the influence.  My supposed influence is from this blog, although I may have changed a couple of minds in my part of my home state among my patients, who had to sit across from me and hear me talk. For an ‘influencer’ I’m not very happy about how many buprenorphine-related things have gone over the years.  I still see the same reckless spending of resources, for example. A couple million people in the US abuse opioids, and only a fraction receive treatment.

Those are big things, and anyone reading my blog knows all the big things.  I want to write about the little things.  The easiest way to have influence is to write about the things that nobody else writes about.  After all, that’s what made me an influencer in the first place, back when I had the only buprenorphine blog out there. Here’s what I want to influence:  If you’re trying to leave opioid addiction behind, do not call buprenorphine ‘subs’ or subbies.

On the forum I try to keep things real – not in a cool way, but in a medical or scientific way.  I want people to use .  I know I sound like some old guy frustrated by all of the new words and acronyms on social media.  YES, dammit, I AM frustrated by those things!  But communication has become so…. careless in the era of Twitter and texting.  Find an old book and notice the words and phrases used by educated people 100 years ago.  Or look in the drawer at your mom’s house where she kept letters from your dad, or from her friends.  Does anyone communicate in sentences anymore?

I’m not crazy (always pay attention when you catch yourself saying that!), so I realize this isn’t the start of a wave (what color would THAT one be?)   But I might show a couple people how loose language is used to take advantage of healthcare consumers. In the next post I’m going to show an example of ‘fad-science’ masquerading as alternative medicine, promoting substances that avoid FDA scrutiny by identifying as nutrients and not drugs.  Some large scams benefit from the informal attitudes toward health and medicine;  attitudes that might encourage more discussion about health, but also lead people to think that medical decisions are as easy as fixing a faulty indicator on the dashboard with the help of a YouTube video.  As in ‘I can treat it myself if I can find the medicines somewhere.’

The point is that common talk about medicines is helpful unless it isn’t.

Many people in my area addicted to opioids treat themselves with buprenorphine, either now and then or in some cases long-term.  Is ‘treat’ the right word?  From my perspective I’d say yes in some cases, and no in others.  Last year I took on 4 patients who were taking buprenorphine medications on their own, paying $30/dose, for more than a year.  They said (and I believe them) that they hadn’t used opioid agonists for at least that long.  I’ve also taken on patients who used buprenorphine but also used heroin, cocaine, and other illicit substances.  There is a big difference between the two groups in regard to level of function, employment, relationship status, emotional stability, dental and general health status, and finances.  Another difference between them is that people in the first group talk about taking buprenorphine or Suboxone or Zubsolv.  Those in the second group talk about finding subbies.

I also have patients in my practice to whom I prescribe buprenorphine, who sometimes talk about subbies, or subs, or ‘vives’, or addies.  I correct them and tell them that I have a hard time trusting patients who talk that way.  After all, those are street terms.  A pharmacist doesn’t say ‘here’s your subs!’

So here’s the rub.  Should I discharge these patients? Should I assume from their language that they are part of the street scene, and maybe selling medication I’m prescribing?  Or should I just watch them closer and be more suspicious, doubling the drug tests and pill counts? Should I tell the police?

No, of course not.  I took it that far to make a point about slippery slopes, and the struggle to find a foothold while sliding.

But I will continue to correct them, and let them know that their words create a certain impression.  Getting that point across would be enough influence for one day!

Ten Gripes of Buprenorphine Doctors

I recently gave a lecture to medical students about opioid dependence and medication assisted treatment using buprenorphine, methadone, or naltrexone. I was happy to see their interest in the topic, in contrast to the utter lack of interest in learning about buprenorphine shown by practicing physicians. In case someone from the latter group comes across this page, I’ll list a few things to do or to avoid when caring for someone on buprenorphine (e.g. Suboxone).

1. Buprenorphine does NOT treat acute pain, so don’t assume that it will. Patients are fully tolerant to the mu-opioid effects of buprenorphine, so they do not walk around in a state of constant analgesia. Acute pain that you would typically treat with opioids should be treated with opioids in buprenorphine patients. Patients on buprenorphine need higher doses of agonist, usually 2-3 times greater than other patients. Reduce risk of overuse/overdose by providing multiple scripts with ‘fill after’ dates. For example if someone needs opioid analgesia for 6 days, use three prescriptions that each cover two days, each with the notation ‘fill on or after’ the date each will be needed.

2. Don’t say ‘since you’re an opioid addict I can’t give you anything’. There are ways to provide analgesia safely. If you do not provide analgesia when indicated, your patient will only crave opioids more, and may seek out illicit opioids for relief. Unfortunately nobody will criticize you for leaving your patient in pain, but they should!

3. Don’t blame the lack of pain control on laws that don’t exist, for example “I’d like to help you but the law won’t let me.” Patients deserve honesty, even when the truth makes us uncomfortable. We get paid ‘the big bucks’ for tolerating the discomfort that sometimes comes from frank discussions with our patients.

4. Don’t assume your patient can or cannot control pain medications. If a patient has been stable on buprenorphine for years, he/she may have a partner or family member who you can trust to control pain medications. Some patients stable on buprenorphine can control agonists used for acute pain, but I wouldn’t stake my life, or theirs, on that ability. A useful compromise is to prescribe enough pain medication to cover 1-2 days of analgesia on each of several prescriptions, each with a ‘fill after’ date, to reduce the amount of agonist controlled by the patient at one time.

5. Don’t tell your patients that ‘opioids don’t work for chronic pain.’ I see stories on such great medical sources as the ‘Huffington Post’ explaining that ‘opioids never help chronic pain’. In reality, your patients know that opioids DO treat chronic pain, so they will consider you a liar or an idiot if you clam they don’t. The challenge is explaining the risk/reward equation to your patients, and explaining why treating chronic pain with opioids often leads to greater problems, as the risk/benefit equation is changed by tolerance.

6. I know this will cause heads to explode, but don’t assume that chronic pain is always less severe than acute pain. What if your patient’s chronic pain is worse than the typical pain after cholecystectomy or ACL repair? Most doctors would gasp at the idea of recovering from major surgery without opioids. What if the pain from failed back syndrome is worse?! I have had a few patients who, I’m certain, experience a great deal of suffering, and have gone so far as to have brain or spinal cord implants to get relief. I’m not arguing that we treat chronic pain in the same way as acute pain. But we shouldn’t jump to the conclusion that chronic pain isn’t severe enough to warrant opioids in order to dismiss those complaints more easily.

7. Don’t tell your patient to stop taking buprenorphine unless you’ve talked with the doctor who is prescribing that medication, and realize that the doctor you are calling knows more about buprenorphine and addiction than you do.

8. Don’t ask patients ‘how long are you going to take that stuff’ or criticize patients’ use of buprenorphine medications. Likewise psychiatrists shouldn’t tell patients scheduled for knee arthroscopy that the procedure is controversial, or talk patients out of hernia surgery.

9. Don’t assume that the doctor prescribing buprenorphine knows what YOU are doing. Too often patients will tell me about surgery that they failed to discuss in advance, even calling about pain hours after getting home from a procedure they failed to mention. Some people seem to believe that doctors regularly collaborate on their care, even though the opposite is closer to the truth.

10. Don’t assume that unusual or atypical symptoms come fromo buprenorphine. One truism of medicine is that doctors tend to blame unexplained symptoms on whatever medication they know the least about. Fevers of unknown origin, mental status changes, or double vision are not ‘from the buprenorphine!’

Those are the gripes at the top of my list. Did I miss one of yours? Or for patients, have you suffered from breakdowns in the system?

Addendum: 11. When treating post-surgical pain in buprenorphine patients, choose one opioid and stick with it. What often happens is that doctors will use one opioid, say morphine… and when nurses call a few hours later to say the patient is still screaming, they change to a different opioid, then another after that. As a result, the patient is placed on insufficient doses of several opioids, rather than an adequate dose of one medication.

There are two critical issues in treating such patients effectively. First, providing pain relief comes down to competition at the mu receptor. A certain concentration of agonist in the brain and spinal fluid will out-compete buprenorphine and provide analgesia. You cannot get there by adding other opioids together. If you use oxycodone for an hour and then change to dilaudid, you are starting over. Instead, choose one drug, preferably something that can be given intravenously, and stick with it. Morphine is not a good option btw, because of the low potency and histamine releasing properties of that drug.

Second, remember that analgesia and respiratory depression travel together, both mediated by the mu receptor. Anesthesiologists know this principle well… opioid medication can be titrated to respiratory rate, providing that the medication is given IM or IV. If a patient is breathing 28 times per minute, he/she is in pain. If the patient is breathing 6 times per minute, pain is not a problem, and the patient should be monitored for respiratory depression and possible overdose. When treating pain, doctors should aim for a respiratory rate of 14-18 breaths per minute, making sure that the medication is actually getting into the bloodstream (the risk comes when patients are given SQ injections or oral doses of narcotic that enter the bloodstream later, causing toxic blood levels).

This Suboxone Doesn’t Work!

Today on SuboxForum people were writing about their experiences with different buprenorphine formulations.  Doctors occasionally have patients who prefer brand medications over generics, but buprenorphine patients push brand-loyalty to a different level.  The current thread includes references to povidone and crospovidone, compounds included in most medications to improve bioavailability.  Some forum members suggested that their buprenorphine product wasn’t working because of the presence of crospovidone or povidone.  Others shared their experiences with different formulations of buprenorphine and questioned whether buprenorphine products are interchangeable, and  whether buprenorphine was always just buprenorphine, or whether some people respond better to one product or another.

My comments, including my observations about patient tolerance of specific buprenorphine products, are posted below.

Just to get some things straight about povidone and crospovidone (which is just another synthetic formulation of povidone),  both compounds are NEVER absorbed, by anyone.   They are part of a group of compounds called ‘excipients’, and are included in many medications to help with their absorption.  They act as ‘disintegrants’– meaning they allow the medication to ‘unclump’ and dissolve in liquids, such as saliva or intestinal secretions.

Molecules tend to clump together, sometimes into crystals, sometimes into other shapes.  A pile of powdered molecules molded, packed, and dried into pill form wouldn’t dissolve in the GI tract if not for povidone or other disintegrants.  I remember reading somewhere about cheap vitamins that could be found in the stool, looking much the same as they did when they were swallowed.  Not sure who admitted to doing the research for that article..

Buprenorphine IS buprenorphine.  Period.  The absorption isn’t affected much by excipients, because nobody ever complains that their Suboxone or buprenorphine won’t dissolve.  Povidone or crospovidone are also added to increase the volume, because an 8 mg tab of buprenorphine would be the size of 100 or so grains of salt.  Excipients like povidone and crospovidone also help some drugs dissolve, especially drugs that are fatty and don’t usually dissolve well in water-based solutions.   This last purpose does NOT apply to buprenorphine, since buprenorphine is very water-soluble.  Zubsolv is supposedly absorbed more efficiently in part because it dissolves very quickly, and maybe that is due to excipients.

I realize that when I write ‘bupe is bupe’ it sounds like I don’t believe those who complain about their medication.  But honest, I work with people over this issue every day…  I have an equal mix of people who insist Suboxone doesn’t work for them and people who insist ONLY Suboxone works for them.    Today I was reading TIP 43–  a guide about medication-assisted treatment put out by SAMHSA and the Feds that is over 300 pages long, very well-cited– in a section that cited studies about the psychological triggers for withdrawal symptoms.  TIP 43 and other TIPs can be downloaded for free… just Google them.  TIP 43 is primarily about methadone, but some of the information applies to methadone and buprenorphine.  The pertinent section was around page 100, if I remember correctly.

The TIP information mirrored what I see in my practice.  For years, I’ve noticed that patients will complain about withdrawal symptoms even at times when their buprenorphine levels are at their highest.  Patients also report that their withdrawal symptoms go away ‘right away’ after dosing, when in fact buprenorphine levels won’t increase significantly for 45-60 minutes.  People who have been addicted to opioids may remember how even severe withdrawal mysteriously disappeared as soon as oxycodone tabs were sitting on the table in front of them.   The bottom lline– withdrawal experiences are remembered, and those memories are ‘replayed’ in response to triggers or other memories.

In my experience as a prescriber, I’ve come to believe that patients with an open mind will learn to tolerate any type of buprenorphine (the exception being the 1 patient I’ve met who developed hives from meds with naloxone– hives that appeared consistently on three distinct occasions).  But withdrawal symptoms seem to be triggered, in many people, by the expectation of withdrawal symptoms.  So someone convinced he will never tolerate Zubsolv, Bunavail, or Suboxone Film will probably never tolerate those medications.

As for buprenorphine, it IS just buprenorphine.  Molecules with a certain name and structure are always identical to each other.  They are not ‘crafted’ products like bookcases or tables;  some buprenorphine molecules aren’t made with a quality inferior to other buprenorphine molecules.  And once a molecule is in solution, I don’t see much role for excipients.  Of course a tablet or strip could contain too much or too little active drug, but that is an FDA issue, not an excipient issue.

Obama and the TREAT Act

I just read an article in the Daily Beast that reads like a better version of something I would write about the value of medication-assisted treatment of opioid dependence.  I appreciate Christopher Moraff telling a story that has been untold far too long, and I hope the story raises questions across the country.

But I have something else on my mind that deserves a story of its own.  I am just a small-town psychiatrist in the Midwest, of course, and so I could be missing something.  I watch Veep and House of Cards, but I assume that the political games in those shows are grossly exaggerated.  I’ll offer a bit of background… but if you already understand why people opposed to increasing the buprenorphine cap are idiots, just skip the next few paragraphs.

The Recover Enhancement for Addiction Treatment Act, a.k.a. TREAT Act, is a Bill with bipartisan support written in response to the epidemic of opioid dependence in the US.  If enacted into law, the TREAT Act (among other things) would increase number of patients that a physician can treat with buprenorphine from 100 to 500 and allow nurse practitioners and other ‘mid-level prescribers’ to treat opioid dependence with buprenorphine medications. For newcomers, treatment professionals debate the wisdom of raising the cap on the number of patients treated by each practioner.  Some people argue against medication treatment entirely and claim that abstinence is the only legitimate goal when treating addiction, despite the fact that abstinence-based treatments rarely work.  ‘Rarely’ is in the eye of the beholder, I guess– but even the most optimistic promoters of abstinence-based treatments claim they fail only 70% of the time– within ONE YEAR.   Other addiction docs advocate using medications that dramatically cut death rates, in concert with counseling.  They demand the counseling despite no evidence– none– that counseling improves outcomes in medication-assisted treatments.  But arguing against counseling is like arguing against… milk, I guess.  Who can argue against milk?

Then there are the extremists like me who argue that addiction is an illness that should be treated like any other illnesses and managed with medications, sometimes over the course of a person’s life.  Maybe counseling is indicated, and maybe not– but the need for counseling should not stand in the way of obtaining a life-sustaining medication.  After all, do we withhold insulin from diabetics who don’t receive nutritional counseling?  We extremists point out that there is no ‘cap’ on patients who are prescribed opioid agonists– the type of practice that started this epidemic in the first place.  We point out that literally no deaths have been caused by buprenorphine in patients who were prescribed the medication.  In all of medicine, THAT is the medication that needs a ‘cap’?  Doctors can treat unlimited numbers of patients with cancers, pain disorders, or complicated surgical procedures, but can’t handle more than 100 of THESE patients?!

I don’t see the point of the other groups, so I won’t try to explain their thought processes– accept one example.  Some docs are Boarded in Addiction Medicine– a secondary certification that can be obtained after certification in primary care or psychiatry.  Full disclosure– I am not Board Certified in Addiction Medicine.  I am Board Certified in Anesthesiology and in Psychiatry, and I worked with narcotics as a pain physician and anesthesiologist for ten years.  And I have a PhD in neurochemistry.  From my perspective, I have enough things on the wall. But the docs who DID get boarded in addiction medicine are angry that they get nothing special for their efforts.  The law that created buprenorphine treatment was intended to increase addiction treatment by primary care practitioners.  But that’s sour grapes to the addiction docs, who want the sole right to treat more than 100 patients.  Never mind that 30,000 people die from overdose each year, and buprenorphine could save many of them.  The addiction-boarded docs are angry that they aren’t given special privileges.  Isn’t THAT a problem!

What does all of this have to do with President Obama?  A bipartisan group of members of Congress of worked on the Treat Act over the past 8 months.  Professional societies have come to compromises over the Bill.  According to Schoolhouse Rock, Congress creates laws and then if passed, the President signs them into law.  The President often pulls opposing factions together, encouraging them to get a Bill to his/her desk.  For most of President Obama’s term, about 20,000-30,000 young Americans have died each year– far more than the total number of Americans killed by war, terrorism, hurricanes, and other natural disasters combined.    Until a month ago, I’ve heard absolutely nothing from the US President– no calls to action, no pressure on lawmakers, no requests to call our congresspersons.  But as the TREAT Act was introduced in the Senate, President Obama announced that he will raise the cap by Executive Order.  A supporter of the President would say (I know, because I’ve heard them) that the important thing is that it got done– so who cares how it happened?

Readers of this blog know that I pretty-much dislike everybody… so it is no surprise that I’m not happy.  We have the TREAT Act sitting in Congress, needing a simple majority to be sent to the President’s desk and signed into law.  During an epidemic of overdose deaths, the support would not be difficult to find for most Presidents, even with an ‘obstructionist Congress’, as our President likes to call them.  A change in the law would be relatively PERMANENT, unlike an Executive order– which can be changed with a new President, or with a new set of political calculations by the same President.   And an Executive Order to change rules at HHS requires hearings for citizen comments, which take more time– time when more patients will die.  Shouldn’t President Obama have used the operations that other Presidents used for far-more controversial issues, and changed the law?  This temporary, delayed Presidential action will get kudos from articles like the one in the Daily Beast.  And Obama gets TV time and headlines to describe how he addressed the opioid epidemic, on his own– in spite of a ‘obstructionist Congress.’

What irks me the most, though, is that an Executive Order didn’t need to take seven years.  By 2010 the overdose epidemic was well-underway, and had already killed a couple hundred thousand young people.  Did President Obama need to wait until the TREAT Act was almost at his doorstep before taking ANY action to stem the surge in overdose deaths?  From the sidelines it looks like the deaths themselves didn’t provoke a response.  But the threat of bipartisan action during an election year?  I guess that’s another story!

Counseling Schmounseling

I just noticed a couple of my recent posts….  these people have it wrong, and that person has it wrong.  One of these days I really need to print something positive and uplifting.  But not today.

Excuse the self-flattery, but I like to think of myself as a physician scientist.  That concept motivated my PhD work, and cost me friend after friend in the years that followed!  A physician scientist isn’t all that difficult to be from an educational standpoint, especially in the age of the internet.  The one thing that is necessary is the willingness, or need, to question every assumption by the media, the government, physicians, laypersons, and other scientists.   Ideally, the questions are guided by a knowledge of p-values, the process by which scientific grants are awarded, an understanding of the peer-review process, and the realization that anyone elected to office knows less about science than most other humans on the planet.

Last night I came across an opinion piece– I think in the Bangor Daily News, but I could be wrong about that– that argued that we will never stem the heroin epidemic without use of medications.  The comment section after the article was filled with the usual angry banter over methadone and buprenorphine that now follows every article about medication assisted treatment.  As an aside, why are the abstinence-based treatment people so angry about medication?  There are people out there who choose to treat cancer using crystals, but they don’t spend time bashing monoclonal antibodies!

Here is the part of this post where I start losing friends…  but let me first say that I know some counselors.  I like counselors.  In fact, some of my best friends are counselors.  But in the comments after that article I read the same thing over and over–   that meds aren’t the important thing, and that counseling is what really makes all the difference.  A couple weeks ago  the person sitting to my right said the same thing during a discussion about  medication-assisted treatments.  And that same phrase is repeated ad nauseum in lecture after lecture in ASAM lectures and policy statements related to addiction.  The phrase has even been codified into some state laws.  And why not?  It is something we all ‘know’, after all.

If we are going so far as writing laws requiring that people have counseling in order to obtain medication, shouldn’t we do one thing first?  Shouldn’t we determine if the comment is really true?

A couple years ago two papers came out– someone help me with the reference if you have them– that looked at abstinence rates after a year on buprenorphine in patients with or without counseling.  Guess what?  The counseling group did not do better!  In fact, the counseled patients did worse; not sigificantly so, but enough to clearly show that there was no ‘trend’ toward better performance in the counseled group (which would have been pointed out, were it true.)

I could hypothesize many reasons why the counseled groups would do worse.  Maybe they were angered by the forced counseling and therefore bonded less effectively with their physician.  Maybe they obtained a false sense of expertise in dealing with addiction, making them more likely to relapse, whereas the non-counseled group learned to just do as they were told.  Or maybe the counselors send out signals, consciously or unconsciously, that interfered with medication treatment.

The thing is, we have no idea which of these things, if any, are going on!  There have been no systematic studies or other attempts to understand what happens during the combination of counseling and medication treatments.  We just have a bunch of people saying ‘do them both!  do them both!–  a comment that apparently feels so good to some people that they just cannot consider things any other way.

For the record, I see ALL my patients for at least 30 minutes for every appointment.  As a Board Certified Psychiatrist, I guess that means I’m counseling them.  And from what I can tell, it seems to be working pretty well.  But even in my own case, I would never draw firm conclusions unless someone does a double-blind study and collects the data.

I encourage all physicians, scientists or not, to question some of what we ‘know’ about addiction treatment.  Is it really all about the counseling?  Maybe— but then again, smart people used to ‘know’ the world was flat, and the Earth was the center of the Universe.

Addiction Treatment Has it ALL WRONG

Today on SuboxForum members discussed how long they have been treated with buprenorphine medications.  Most agreed that buprenorphine turned their lives around, and most are afraid they will eventually be pushed off the medication.  Most buprenorphine patients described a reprieve from a horrible illness when they discovered buprenorphine.  But most have new fears that they never anticipated– that their physician will die or retire, that politicians will place arbitrary limits on buprenorphine treatment, or that insurers will limit coverage for the medication that saved there lives.

I joined the discussion with the following comment:

I give lectures now and then about ‘Addiction, the Medical Illness.’  Once a person thinks through the topic several times with an open mind, the right approach to treating addiction becomes obvious.    After all, doctors ‘manage’ all illnesses save for a few bacterial diseases, and even those will become at best ‘managed’, as greater resistance develops in most bacteria.  We doctors rarely cure illnesses.  We manage illness.

The public’s attitudes toward treating addiction differ from treatments for other diseases.  Avoiding effective medications isn’t  a goal for other illnesses.  In fact, in most cases doctors refer to skipping medication negatively, as ‘noncompliance.’  There are religious orders that don’t believe in medication including Christian Scientists… and there are religions with specific beliefs, e.g. Scientology, that don’t believe in psychiatry, or Jehovah’s Witnesses who don’t accept blood products. I assume that attitudes toward addiction developed over the years when no medical treatments effectively treated addiction.  Doctors and laypersons came to see addiction as untreatable, and the only survivors people who found their rock bottom and in rare cases, saved themselves.  And since nobody could fix addiction, and the only chance at life was to find ‘recovery’, a nebulous concept based on spirituality, adherence to a group identity, and correction of ‘personality defects.’

What an obnoxious attitude– that people with addictions have ‘personality defects’!  Even most of the docs and therapists who ‘get it’ about medication insist that no patient will heal until we ‘fix the underlying cause of his/her addiction’.  What a bunch of crap…  as if all of those people out there WITHOUT addictions have GOOD personalities, and all of those people who got stuck on opioids (mostly because of bad doctors by the way) have BAD personalities.  I call BULL!  Opioids are powerfully-addictive substances, and a percentage of people  exposed to them, regardless of character, become addicted.  My personality was apparently good enough to get a PhD, get married, save a drowning woman, have a family, go to medical school and graduate at the top of my class with multiple honors, become an anesthesiologist and get elected president of my anesthesia group an unprecedented 3 times.  But taking cough medicine that grew into an addiction to fentanyl means I have ‘personality defects’??!!

I’m sure everyone has his/her own story.  But we’ve all heard so often that we have some broken screw at the base of our brains that we’ve started believing it.  And the mistreatment by doctors and pharmacists (and reporters and media and society in general) perpetuates that shame among all of us.

The truth is that our ADDICTIONS caused us to do things that were wrong.  We developed an intense desire to find chemicals because of the activation of addictive centers in our brains.  And THAT caused our ‘character’ problems.

I’ve written before about the ‘dynamic nature of character defects’.  Search my name and that term, and you will find the comments- or just click here.  The character problems so obvious in using addicts are driven by the obsession to find and use opioids.  When you treat that obsession with buprenorphine, those ‘character defects’ disappear.  I’ve seen the process unfold over and over, in patient after patient.  Some doctors perpetuate character problems by treating patients like criminals, and ANY person will develop character problems if treated poorly long enough.  In that way, the defects can become a self-fulfilling prophecy.

The character defect argument is the whole reason for counseling.  But get this– there have been several studies that looked at abstinence after discontinuation of buprenorphine after one year, with or without counseling.   And the counseling group did WORSE in those studies!  Of course, everyone interprets those studies by saying that ‘the counseling must not have been done right’ or it was not intense enough, rather than accept the data with an open mind, as any good scientist would.

Vivitrol (i.e. depot injections of naltrexone) are the biggest example of treatment based on flawed ideology.  The treatment rests on the idea that if we block receptors and counsel the heck out of people, we can fix their character defects and their addictions so they won’t use when Vivitrol is removed.  The travesty is that nobody will look at the results of this vast experiment, mostly played out in drug courts.  When you think about it, we have a long history of experimenting on people caught in the criminal justice system.  Studies in Australia showed a 12-fold higher death rate in addicts maintained on naltrexone and ‘counseled’ compared to people maintained on methadone.   When the people forced onto Vivitrol by the legal system start to die, will anyone keep track?

Deaths after residential treatment are common, but nobody keeps track of them.  So I’m not holding my breath for outcome data from the failures of drug courts!

Every serious chronic illness warrants chronic medical treatment, save one.   All healthcare professionals will say, some reluctantly, that addiction is a disease.   It is time to start TREATING IT LIKE ONE.

Clearbrook President Gets it Wrong

A blurb in the buprenorphine newsfeed (see the bupe news link in the header of this page), has the headline ‘Suboxone challenged by Clearbrook President’.  I followed the link, and after reading the ‘article’ I wanted to comment to that president but the person’s name wasn’t included, let alone an email address or comment section.  So I’ll have to comment here instead.

The article was one of those PR notices that anyone can purchase for about 100 bucks, in this case from ‘PR Newswire’.  It’s a quick and easy way to get a headline into Google News, which pulls headlines for certain keywords like ‘Suboxone’ or ‘addiction’.

The Clearbrook president makes the comment that this 180-degree swing to ‘medication assisted treatment’ is a big mistake.  He says that in his 19 years in the industry he has seen ‘thousands’ of people ‘experience sobriety’.   I’ll cut and paste his conclusion:

There is no coming into treatment and getting cured from the disease of Addiction. There is no pill or remedy that will magically make one better. Those looking for a quick fix to addiction and the treatment modality being used by the vast majority of treatment providers today, will be disappointed with the direction our field is taking when this newest solution doesn’t live up to its claims.

A word to the President of Clearbrook:   I’ve worked in the industry too.  But unlike you, I wasn’t satisfied to see a fraction of the patients who present, desperate for help, ‘experience sobriety’– especially when I read the obituaries of many of those patients months or years later.

The president says that ‘no pill or remedy will magically make one better.’  Addiction, for some reason, has always been considered immune to advances in modern medicine.  We all know that addiction is a disease, just like other psychiatric conditions including depression, bipolar, and schizophrenia.  Why is it that even as medicine makes extraordinary advances in all areas of illness, medications for addiction are considered to be ‘magic’?

Those of us who treat patients with medications, particularly buprenorphine, realize that addiction doesn’t respond to ‘magic’.  But I see a lot more hocus pocus in abstinence-based residential treatment programs than in the medications approved by the FDA for treating addiction.  Residential programs charge tens of thousands of dollars for a variety of treatments–  experiential therapy, art therapy, psychodrama, music therapy, etc.– that have no evidence of efficacy for treating opioid dependence.  Abstinence-based treatments have managed to deflect criticism from their failed treatment models by blaming patients for ‘not wanting recovery enough’.

Buprenorphine finally allows the disease of addiction to be treated like other diseases– by doctors and other health professionals, based on sound scientific and pharmacological principles.   Abstinence-based treatment programs have tried to tarnish medication-assisted treatments, but people are finally recognizing the obvious– that traditional, step-based treatments rarely work.

And that’s just not good enough when dealing with a potentially fatal illness like opioid dependence.

Addiction Recovery Act of 2015

With appreciation to the good folks at BDSI, makers of Bunavail:

Here is the latest news concerning the Comprehensive Addiction Recovery Act of 2015 (aka Heroin Crisis Act):

It has easily passed Committee and is headed to the Senate floor next week.  If approved, the bill is scheduled to go into effect this year. Here are some new highlights:

  • The proposed funding was originally $80 million. It may go to $1.2 billion with a proposal of $600 million in emergency funding (note that this article says ‘billion’, but that is a typo.  Other sources confirm $600 million.
  • Mid-level providers are looking to be added to those who can treat opioid-dependent patients
  • Language addressing regulations around the current marketing, manufacturing and prescribing of prescription opioids (pain meds)

This funding (including any emergency monies) would directly impact every state. Additional federal funding would not only mean additional education and treatment services but could also mean more affordable access to medicated assisted treatment.

Buprenorphine Depression Drug Stumbles

I’ve written a few optimistic lines about ALKS 5461 as a potential solution for people suffering from refractory major depressive disorder.  Those unfortunate will have to keep waiting.

ALKS 5461 is a product in Alkermes’ pipeline that combines buprenorphine with ALKS 33, or Samidorphan.  The combination drug is purported to ‘stabilize opioid pathways’, which is a very simple explanation for a complicated, poorly-understood system.  The results of two late-stage trials were disappointing, in part– according to Alkermes– because the placebo groups did better than usual.  Beating the placebo is a common problem in trials involving antidepressants, because of the high susceptibility to the placebo effect in the patients in such trials.  Over half of patients get better from taking the sugar pill, so a medication that helps half the patients will not move the needle to signal success.

I receive emails now and then from patients treated with buprenorphine for depression.  If the emails are any measure of reality, buprenorphine is not going to cure the world of depression.  While I occasionally read success stories, I just as often read angry descriptions from people complaining that they were never warned of the difficulty of stopping the medication.   I’ve written before that for that reason, I am reluctant to start buprenorphine for depression alone, in patients who are not already opioid-tolerant.  I have patients who struggled with depression before becoming addicted to opioids, and I believe the drug benefits their mood symptoms.  But I continue to hold back in a couple patients who have very severe depression, who have failed traditional treatments.  The news from Alkermes doesn’t push me in either direction.

I’ll take a moment to respond to the angry person who recently commented on one of my other blogs about this topic, who wrote that ‘depressed people are no more likely to get addicted than other people’, and ‘buprenorphine makes people happy and productive’ and therefore should be used for depression.  People with histories of depressive disorders DO have a higher incidence of addiction, but that is not the major issue holding me back from using buprenorphine for depression.  I would also disagree that buprenorphine makes everyone happy and productive.  The mood effects of buprenorphine, like all opioids, are subject to tolerance…  which gets closer to my concern.  I fear that the effects of buprenorphine would fade with tolerance, leaving patients stuck on an ineffective drug.  And we all know what happens to mood during discontinuation of buprenorphine.

ALKS 5461, though, works by a mechanism that may not be susceptible to tolerance.  Buprenorphine is a partial agonist at mu receptors and a kappa-receptor antagonist, and the latter effect is thought responsible for the effects on mood.  Samidorphan selectively blocks mu receptors, so that the combined drug is left with only the kappa effects.  Patients are supposedly spared from mu-receptor activation, tolerance, and withdrawal.   I wonder if it is really all that simple, or if the competition between buprenorphine and Samidorphan at mu receptors will create other problems.    Opioids cause a number of side effects, especially in patients who tend to focus on somatic symptoms, as some depressed patients do.   Starting an antagonist in the presence of an agonist, such as inducing with buprenorphine in patients on methadone or fentanyl, triggers a great deal of misery.  And even stable patients on buprenorphine alone tend to struggle with dry mouth, hot flashes, and GI complaints, most-commonly constipation.  But then again, major depression is a horrible illness.  I’m sure there are many people out there who would make the trade without regret– IF the ALKS 5461 works.

Alkermes continues to study ALKS 5461.  The higher dose ranges in the study, using 2 mg of buprenorphine, appeared to work better than the 0.5 mg dosage, so future studies will focus on buprenorphine doses of 1 and 2 mg per day (paired with equal doses of Samidorphan).  If you’re a believer, the stock is selling pretty cheap these days.  This is not an investment blog…. but I’m betting on Apple instead!

Post-op Pain on Suboxone

Many patients on Suboxone or buprenorphine eventually require pain treatment, just like people who aren’t on buprenorphine products.  I’ve written about post-op pain control several times, but I continue to get emails from patients who haven’t seen my comments and who view an upcoming surgery with the same fear experienced by patients before the early 1900’s, when the OR was correctly seen as a horror-chamber.

These patients are often torn between following the treatment plan vs. doing what they have learned may work better.  In all cases, I tell patients that they cannot act in ways counter to what their physician prescribes.  But I often support their intent to ask their doctors to clarify or modify their treatment plans.

Patients write about ‘the look’– the way doctors, nurses, and pharmacists react when patients ask about pain control.  As a recovering addict myself, I know what they are referring to.   Doctors encourage other patients to discuss concerns about pain control, and as long as they have no piercing or tattoos, patients will usually be comforted with assurances that their doctors will take their pain seriously.  But people on buprenorphine often see their doctors roll their eyes, or even say that the opposite is true– that if they have pain, they had better not bother the doctor about it!    Doctors who act that way are asses, of course, and I urge patients to avoid them if possible.  This post is not for those doctors, as they are not likely to ‘get it’ after reading the comments of another doctor— if they would ever read them in the first place!

I’m writing for the doctors who are open to hearing about new ways to help their patients.  I intend to use this post, going forward, to answer the emails from patients about this topic   If you are a physician who received this from a patient, please consider my comments– as I have found the approach described below far more helpful for surgical patients on buprenorphine products than the alternatives described elsewhere.  There was an NIH consensus paper a few years ago for example that described several alternatives, but mostly focused on discontinuing buprenorphine before surgery, then restarting buprenorphine at some point through a standard induction that includes 24 hours of withdrawal in patients already weakened by surgery.  Standard doses of opioid agonists were recommended for pain.  That approach was also described in a flashy article in one of the throw-away journals a month or two ago (i.e. Autumn of 2015).

There are so many problems with that approach:

  • Patients forced to stop buprenorphine before surgery and enter surgery dehydrated and weakened (IF they even managed to stop, as many patients end up staying on buprenorphine covertly– NOT a good situation for surgery.)
  • Buprenorphine discontinuation not an option for emergency surgeries;
  • Constant opioid levels are necessary to avoid withdrawal, before even considering pain control;
  • Buprenorphine is erroneously considered gone, when the long half-life actually assures that buprenorphine is still present;
  • Patients fret and argue over pain control every time the nurses change shifts;
  • Buprenorphine re-induction at some point after surgery, requiring patients to go through withdrawal symptoms;
  • Agonist treatment alone causes tolerance to rise very rapidly, requiring high doses of narcotic at hospital discharge;
  • An increased risk of overdose from narcotic pain medication in patients off buprenorphine;
  • And many other reasons.  Using the ‘discontinuation’ approach, patients end up on a Hellish roller-coaster ride where pain is grossly under-treated and withdrawal symptoms are only 4 hours away, day after day.

I’ve read emails from people whose buprenorphine doctors recommended taking more buprenorphine for post-op pain, or dosing more often.  I’ve read about suggestions to use Tramadol for pain after major surgery(!)

Earlier today I sent a letter in response to a woman who is planning a series of painful procedures.  I’ll share that letter to spare myself some time:

Dear A,

You’ve been through enough misery, and I hope you convince your physician to consider a different approach to your pain. I’ve had patients on buprenorphine go through many surgeries including thoracotomy, nephrectomy, open cholecystectomy, total knee replacement, and rotator cuff repair– all very painful surgeries.  My experience as an anesthesiologist piques my interest in post-op pain control.

My favored approach is very simple.  Maintain buprenorphine, and use oxycodone or other agonists to out-compete buprenorphine at the mu receptor as needed for pain relief. The benefits of the approach are obvious once the prescriber opens his/her mind to the realities of ligand competition.  There is no need to go through withdrawal, no need for ‘comfort meds’ to tolerate the withdrawal, and no need to enter surgery in an already-weakened state. As you know, even minor withdrawal causes people to feel very depressed, lose their appetites, stop sleeping…. is that really any way to go into surgery?!

As an aside,  buprenorphine alone does not provide ‘real’ pain control in patients who take chronic buprenorphine.   Yes, buprenorphine seems to reduce pain in people with minor pain issues.  But it is of no use for the pain of major surgery.  Of course in theory, why would buprenorphine treat chronic pain in patients with complete mu tolerance to a medication with a ceiling effect?!

A few years ago, an NIH consensus paper described a few approaches to acute pain in patients on buprenorphine. I don’t know who was on that panel, but the paper suggested stopping buprenorphine for several days before surgery and then using agonists. The panel mentioned the approach that I favor near the end of the paper.   I also described my favored approach at an annual meeting of ASAM, in a talk that was very-well received. I was optimistic that the discussion would open enough minds among prescribers to follow the neurochemistry, instead of focusing on the misplaced fear of combining an agonist and a partial agonist.   There are other papers out there– and book chapters– about the effects gained by combining an agonist with a partial agonist. You can find my ASAM slides at www.slideshare.net by searching for ‘junig’ and ‘uncoupling analgesia’.

The ‘uncoupling’ part BTW is what makes my favored approach so valuable, but that gets into the area of chronic pain, which is not entirely relevant to this discussion.  In short, opioid analgesia has always been limited by tolerance and dependence.  I believe that those limits can be removed by combining mu receptor agonists with partial agonists, allowing for pain relief from agonists while partial-agonists prevent euphoria and anchor tolerance at a lower level.

My approach is to reduce buprenorphine to about 4 mg per day.   Higher doses in my experience get in the way of pain control.  I then treat post-op pain as I would in any patient, but using 4 times more agonist (warning– see * below).  I typically prescribe oxycodone, 15 mg tabs,* and direct patients to take one tab every 4 hours as needed. When patients no-longer needs narcotic analgesia, I stop the agonist and have them resume their regular doses of buprenorphine. That’s it.  No tapering, and no withdrawal… just treating patients as I would any other patients, but realizing that mu receptors are competitively blocked, and effective doses of oxycodone must out-compete buprenorphine.

Dilaudid or fentanyl are not necessary. You could approach post-op pain in a very elegant way in a hospital using sublingual buprenorphine, fentanyl infusion, and PCA, but that gets a bit complicated. Oxycodone works fine.   In rare cases my patients required higher doses of oxycodone, but I’ve never had reason to use more than 30 mg.   Oxycodone is typically used every 4 hours.  My buprenorphine patients have found good pain relief from total daily doses of 60-120 mg of oxycodone.  The patients who went to a hospital where I couldn’t control their analgesia, who were told to stop buprenorphine, ended up on much higher doses of oxycodone at discharge.

Advantages of Combined Approach:

There are many advantages to maintaining buprenorphine throughout the perioperative period. The entire process is much simpler, and the patient’s experience is better because there is no euphoria, and no warm rush from oxycodone to rekindle addiction. The pain is relieved, but the reinforcing effects of oxycodone are eliminated.  I assume the that the limits on mu effects by buprenorphine are like a ‘governor’ that limits the speed of fleet vehicles. You can get only so much opioid effect in the presence of buprenorphine, and not enough to cause a ‘high.’

The combined approach also prevents tolerance, which is a greater issue with chronic pain than with post-operative pain. Buprenorphine anchors tolerance at the level yielded by the ceiling effect, allowing agonist effects to continue over time. I’ve treated people with the combination of buprenorphine and oxycodone for over 2 years, and the combination continues to work as well as it did on the first day.

Some prescribers and pharmacists worry about ‘precipitated withdrawal’, but that is not an issue as long as buprenorphine is continued every day. The only way to precipitate withdrawal would be to stop buprenorphine for at least a few days, boost tolerance higher with an agonist, and then give buprenorphine– which would ‘yank’ tolerance back down again. Patients who stay on buprenorphine can add agonists without fear of precipitated withdrawal.

I’ve convinced a few doctors to try this approach, and I’ve received a number of positive reports about the approach.   I’ve described the idea to several pharmaceutical companies as an approach that would revolutionize pain treatment.  Can you imagine pain relief without addiction, without tolerance, and without euphoria?   I realize that the large number of deaths caused by opioid overdose limits interest in opioid analgesia.  But I suspect that a product that combines buprenorphine and an agonist would go a long way to reducing opioid dependence, providing that the two medications were irreversibly bonded together in a combination product.  I have some thoughts about how to do that… but that’s for another day!

It is NEVER safe to prescribe one’s self opioids or other controlled substances, so this discussion is intended to provoke discussion between patients and their doctors.  Patients must realize that there are many things that go into decisions about post-operative analgesia, and NO approach is the right approach for everyone.  Any individual patient may have features to his/her history that make the combination approach inappropriate, or even dangerous.

*Doses described in this post are intended as approximations for consideration by trained and licensed medical professionals.  Doses described may not be safe in some patients, including patients at the extremes of age, patients with respiratory or other chronic illness, patients with central nervous system disorders, or patients on other respiratory depressant medications.

NEVER use opioids except as directed by your own physician.