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.

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.

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.

Opioid Analgesia Without Addiction

I don’t have pull with the addiction-related organizations out there.  I’m never been a joiner, and I tend to notice the problems caused by medical societies over the good things that they supposedly accomplish.    For example PROP, or ‘Physicians for Responsible Opioid Prescribing’, have a specific mission.  Once a group has a mission, any considerations about individual patients go out the window.  PROP has propagated the message that opioids are NEVER beneficial for patients with chronic pain.  Legislators with no knowledge of clinical medicine hear that message, and respond by passing draconian laws that interfere with any considerations of individual patients.  I would guess that the people of PROP pat themselves on the back for encouraging laws that remove physician autonomy.  I’m sure they figure that they are smarter than all the family practice docs out there.  But in reality, they are only destroying the control of doctors over patient care, and handing that care over to politicians.  Way to go, PROP!!
But I digress…
In the same way, the societies that hold meetings about meetings, that elect Secretaries who become Vice Presidents who become Presidents, get to publish the articles that describe clinical protocols.  The doc who spends every day talking with patients has no access to these sources, and little ability to influence those protocols.  Sometimes the societies and organizations get things right… and sometimes they get things wrong.  The latter is the case with post-op pain control in patients on buprenorphine products.
I’ve written about this before, as regular readers know.  Over the past 8 years I’ve had dozens, if not hundreds, of patients on buprenorphine undergo surgery.  The surgeries include coronary bypass, thoracotomy, rotator cuff repair, C-section, nephrectomy, total knee or hip replacement… and a host of minor surgeries with scopes and lasers.  I’ve treated these patients in a number of ways, in part because hospitals that provide emergency care have different ways of dealing with post-op analgesia.  I rarely have control over what they do acutely– but I almost-always take over pain control when patients are discharged.
In the past few months there have been several ‘articles’ stating that the best way to handle surgery, in people on buprenorphine products, is to stop the buprenorphine before surgery, and treat pain using opioid agonists.  This opinion is not supported by any data.  It is someone’s opinion– usually someone who has a title, i.e. someone who spends at least some of his/her time in society meetings.  That time is removed from the amount of time that could be spent treating and speaking with patients.  Frankly, the ‘higher’ a doctor is in society circles, the less time they spend in patient care.  That comment will anger the docs who it applies to.  I can hear them now– saying I’m only full of ‘sour grapes’. But maybe those same docs should look in the mirror, and wonder how they ended up as ‘President’ of a society.
I’ve used the approach claimed as best practice in the society journals– i.e stopping buprenorphine before surgery– and the same thing always happens.  Tolerance to opioid agonists rises very rapidly in the post-op period.  Patients are discharged on huge doses of opioid agonists.  And at some point, agonists must be discontinued for 24 hours to allow for re-induction with buprenorphine agents.  I’ve had several recent patients go through this exact process– and my frustration motivates this post.  One guy shot himself in the femur, and the bullet also passed through his lower leg.  He needed fasciotomy to avoid losing the leg. His Suboxone was discontinued at admission, and ten days later he was discharged on 30 mg of oxycodone every 2-3 hours– i.e. over 200 mg per day.  The other person was in a serious car accident, and had multiple fractures—  femur, pelvis, ribs, wrist– as well as internal injuries.  After 3 weeks he was released on over 300 mg of oxycodone per day!
On the other hand, I’ve had many patients go through the surgeries listed earlier while maintained on buprenorphine, 4-8 mg per day.  In ALL cases, they had excellent analgesia with lower doses of oxycodone than in the people who stopped buprenorphine.  Most patients did well on 15 mg of oxycodone every 3-4 hours– a max of 120 mg of oxycodone per day.  In a few cases– i.e. in the most painful operations, in the most sensitive patients– I had to use 30 mg of oxycodone every 4 hours.
The most amazing thing about the combination of buprenorphine and opioid agonists is the absence of tolerance to agonists, when buprenorphine is present.  I’ve had patients with recurrent injuries that required repeated surgeries, including a woman who tore her rotator cuff and the surgical repair THREE times over three months.  She took the same amount of opioid agonist for three months, with no noticeable decrease in efficacy.  After the final operation, after three months on significant amounts of opioid agonist, she simply stopped the agonist and resumed her full dose (16 mg) of buprenorphine.  She had no withdrawal, and not other complications.  She simply stopped the agonist and resumed buprenorphine treatment.
I’ve come to realize that buprenorphine effectively ‘anchors’ tolerance when patients take opioid agonists, as long as the buprenorphine is continued.  Patients always say the same thing:  that the pain was reduced by the agonist, but that it didn’t ‘feel’ like the agonist they used to take.  In fact, patients who could never control pain pills found that they COULD control agonists if they stayed on buprenorphine(!)
A couple years ago I presented these findings at an annual meeting of ASAM.  The slides can be found here.  I believe that some day, combinations of buprenorphine and opioid agonists will be the standard approach to pain treatment.  The combination allows for opioid analgesia without tolerance, without euphoria, and with little or no risk of addiction.  If THAT doesn’t piqué your interest, you have no business reading about opioid dependence!!
I picture combinations of buprenorphine and fentanyl… especially since both are now FDA-approved as transdermal patches.  Or perhaps a combination of fentanyl lozenges and sublingual buprenorphine.  The possibilities are endless.  Throughout history, the miracle of opioid analgesia has been cursed by the attachment to tolerance, dependence, and addiction.
Imagine if that curse was lifted from opioid analgesia.    Can you even dare to imagine that world?  I’m telling you… it is closer than you think—- and there for the taking.

Menzies Gets it Wrong

In Opioid Addiction Treatment Should Not Last a Lifetime, Percy Menzies resurrects old theories  to tarnish buprenorphine-based addiction treatment.  Methadone maintenance withstood similar attacks over the decades, and remains the gold standard for the most important aspect of treating opioid dependence:  preventing death.
Menzies begins by claiming that a number of ideas that never had the support of modern medicine are somehow similar to buprenorphine treatment.  Replacing beer with benzodiazepines?  Replacing morphine with alcohol?  Replacing opioids with cocaine?  Where, exactly, did these programs exist, that Menzies claims were precursors for methadone maintenance?
Buprenorphine has unique properties as a partial agonist that allows for effects far beyond ‘replacement’.  The ceiling effect of the drug effectively eliminates the desire to use opioids.  Seeing buprenorphine only as ‘replacement therapy’ misses the point, and ignores the unique pharmacology of the medication.
Highly-regulated clinics dispense methadone for addiction treatment., and other physicians prescribe methadone for chronic pain.  Menzies claims ‘it is an axiom of medicine that drugs with an addiction potential are inappropriate for the treatment of chronic conditions.’  For that reason, he claims, methadone treatment is ‘out of the ambit of mainstream medicine.’ The 250,000-plus US patients who benefit from methadone treatment would be amused by his reasoning.    I suspect that the thousands of patients who experience a lifetime of chronic pain—including veterans with crushed spines and traumatic amputations—would likely NOT be amused by his suggestion that ‘opioids… were never intended to be prescribed forever.’   Those of us who treat chronic pain take our patients as they come—often with addictions and other psychiatric baggage.  Pain doesn’t stop from the presence of addiction, neither does the right for some measure of relief from that pain.
Menzies cites the old stories about Vietnam veterans who returned to the US and gave up heroin, as evidence that prolonged treatment for opioid dependence is unnecessary for current addicts.   But there is no similarity between the two samples in his comparison!  US Servicemen forced into a jungle to engage in lethal combat use heroin for different reasons than do teenagers attending high school.   Beyond the different reasons for using, after returning home, soldiers associated heroin with danger and death!  Of course they were able to stop using!  And that has to do with current addicts… how?
Teens in the US have no mainland to take them back.  Their addiction began in their parents’ basement, and without valid treatment, too often ends in the same place.
Menzies refers to buprenorphine treatment as ‘a conundrum’ that has not had any effect on deaths from opioid dependence—a claim impossible to support without an alternative universe and a time machine.  He claims that buprenorphine treatment is unsafe and plagued by diversion.  In reality, most ‘diversion’ consists of self-treatment by addicts who are unable to find a physician able to take new patients under the Federal cap.  In the worst cases, some addicts keep a tablet of buprenorphine in their pockets to prevent the worst of the withdrawal symptoms if heroin is not available.  But even in these cases, buprenorphine inadvertently treats addicts who take the medication, preventing euphoria from heroin for up to several days and more importantly, preventing death from overdose.
Just look at the numbers.  In the past ten years, about 35,000 people have died from overdose each year in the US with no buprenorphine in their bloodstream.  How many people died WITH buprenorphine in their bloodstream?  About 40.  Even in those cases, buprenorphine was almost never the cause of death.  In fact, in many of those 40 cases, the person’s life would have been saved if MORE buprenorphine had been in the bloodstream because buprenorphine blocks the respiratory depression caused by opioid agonists.
Naltrexone is a pure opioid blocker that some favor for addiction treatment because it has no abuse potential.  Naltrexone compliance is very low when the medication is not injected, and naltrexone injections cost well over $1000 per month.   Naltrexone may have some utility in the case of drug courts, where monthly injections are a required condition of probation.  But even in those circumstances, the success of naltrexone likely benefits the most from another fact about the drug, i.e. that the deaths from naltrexone treatment are hidden on the back end.  Fans of naltrexone focus, optimistically, on its ability to block heroin up to a certain dose, up to a certain length of time after taking the medication.  But Australian studies of naltrexone show death rates ten times higher than with methadone when the drug is discontinued, when patients have been discharged from treatment, and short-term treatment professionals have shifted their attention to the next group of desperate but misguided patients.
The physicians who treat addiction with buprenorphine, on the other hand, follow their patients long term because they see, first-hand, the long-term nature of addiction.  Menzies’ claim that ‘the longer you take it, the harder it is to stop’ has no basis in the science of buprenorphine, or in clinical practice.  Patients often get to a point—after several years—when they are ready to discontinue buprenorphine.  And while buprenorphine has discontinuation symptoms, the severity of those symptoms is less than stopping agonists—and unrelated to the duration of taking buprenorphine.   Until that point in time, buprenorphine effectively interrupts the natural progression of the addiction to misery and death.
The physicians who prescribe buprenorphine and the practitioners at methadone clinics are the only addiction professionals who witness the true, long-term nature of opioid dependence. In contrast, too many addiction practitioners see only the front end of addiction, discharging patients after weeks or months, considering them ‘cured’…  and somehow missing the familiar names in the obituary columns months or years later.

The Overdose Report

I set up a new site today that collects newsfeeds related to the epidemic of opioid dependence and posts links to the articles.  Some of the news stories strike a sensational tone, as opposed to the somber nature of the content— and my intention was not to create a website fashioned after an episode of ‘Cops’.   But there is an epidemic going on, and many of the articles refer to efforts to stem the tide through legislation at the state level throughout the country.  Feel free to check it out…  and I hope it doesn’t come across as insensitive because of the title.
Overdose Report

Toward Understanding Ibogaine

First Posted 12/30/2013
Paul Dessauer, Outreach Coordinator at WASUA, the Western Australian Substance Users’ Association, often adds insight to issues that come up on my blog.  He shared a few comments in response to my post about ibogaine, and at my request gave permission to post his remarks here. His comments include a summary of the receptor actions of ibogaine known to date, a description of the legal status of ibogaine ‘down under’, and several links to further information.
The information provides a good example of how knowledge is gained about psychoactive substances through combining research data from different areas of study.  Psychologists  assess the effects of the drug on different aspects of behavior.  Neurochemists identify the actions of the substance at different receptor systems, with an understanding of the anatomy and interconnections of those receptor systems. Neurophysiologists identify the effects of the substance on firing patterns in different brain regions. All of this knowledge is added to the things we already know about brain function, to push our understanding a bit further. Neuroscience is inefficient, as single studies rarely provide significant gains, and some studies yield results counter to the findings of other studies.  But little by little, over years, we gain an understanding of how a substance affects brain function.
I thought it appropriate to share some information about WASUA:
WASUA Vision:
To improve the health and social circumstances of substance users, utilising a framework underpinned by harm reduction and peer education.
Mission Statement:
To provide support, education and advocacy and to reduce transmission of Blood Borne Viruses and the harms and hazards associated with substance use amongst people in Western Australia.
His Comments:
We should always be skeptical in the extreme of any treatment modality that is presented as a universal “cure” or “magic bullet”, but at the same time we must be careful that the blind zeal of enthusiasts doesn’t cause us to dismiss potentially useful tools out of hand.
Pharmacologically, Ibogaine is a very interesting substance, as it’s a psychedelic tryptamine that is an agonist at 5-HT2A (serotonin receptors) but also acts as an antagonist at NMDA receptors, is an agonist for kappa-opioid receptors and also non-competitively inhibits nAChR (nicotinic acetylcholine receptors).
Serotonin agonists include LSD and a great many other hallucinogenic drugs.
Like dopamine and glutamate, NMDA (N-methyl-D-aspartate) is heavily implicated in the development and maintenance of dependence to many drugs.
Nicotine binds to nAChR (nicotinic acetylcholine receptors), and the drug Zyban (bupropion), which is used as a smoking cessation treatment, blocks acetylcholine receptors.
Just to complicate this pharmacological profile further, Ibogaine is metabolized in the liver (via CYP450 2D6) to produce a psychoactive metabolite noribogaine (12-hydroxyibogamine).
Noribogaine is most potent as a serotonin reuptake inhibitor, reinforcing the serotonergic effects of the parent molecule. It also acts as a moderate κ-opioid receptor antagonist and a weak µ-opioid receptor full agonist, (mu-opioid receptors mediate the euphoric effect of opioids).
(Opioid receptors come in three classes- kappa, mu, and delta. Ibogaine binds most strongly to κ- opioid receptors, shows less affinity for μ receptors, and no affinity for δ receptors. Noribogaine binds to all three classes more strongly than Ibogaine does). http://www.ibogaine.desk.nl/ch05.pdf
It is possible that this action of noribogaine at the κ-opioid receptor may contribute to the psychoactive effects; the hallucinogenic plant Salvia divinorum contains the chemical salvinorin A which is a highly selective kappa opioid agonist.
As an opioid receptor agonist, Ibogaine actually potentiates opioids. It’s been demonstrated in a couple of small studies that co-administering Ibogaine with morphine stops the development of tolerance and decreases the chance of dependence- but no-one has used this effect clinically, apparently because the dangers of overdose due to potentiation.
Animal studies show that Ibogaine appears to reduce or repress the urge to self-administer morphine in some, but not all, rats who are morphine-dependent, eg;http://www.sciencedirect.com/science/article/pii/0014299991904745
It also inhibits cocaine self-administration, eg;http://www.sciencedirect.com/science/article/pii/001429999390212Z
Both of those rodent studies show a dose-response relationship, with more of the rats ceasing or reducing self-admin if they were given three doses over a three week period, than from a single dose.
More; http://jpet.aspetjournals.org/content/288/1/88.short andhttp://jpet.aspetjournals.org/content/275/2/753.short
Although Ibogaine treatment is apparently not illegal in Australia, Ibogaine is a very strictly controlled substance.
The import of ibogaine is specifically prohibited under Schedule 4 (import regulations) of the Customs Act. Under the definition of the law ANY material containing the listed substance is deemed to be that substance. Hence, all ibogaine containing material is a drug prohibited import.  However, there are no restrictions on possessing ibogaine containing material, seed or live plants in Australia, except that pure ibogaine may not be sold or possessed as a therapeutic product without prescription.
NOTE: Under customs law the importation of 1g of ibogaine is equivalent to importing 1g of heroin. The importation of 100g of iboga bark is equivalent to importing 100g of heroin. The importation of 1g of ibogaine dissolved in 100ml of water/alcohol (eg a tincture) is equivalent to importing 100g of heroin.
Legal status in Australia; http://shaman-australis.com.au/shop/tabernanthe_spp_cp_110.php  andhttp://www.shaman-australis.com/forum/index.php?showtopic=26958.
New Zealand’s regulators decided to classify Ibogaine and its primary metabolite as a prescription medicine, but this actually makes it more difficult to legally source, as previously it was unregulated. Interestingly, in their review they mention that Ibogaine in NZ as an un-regulated drug was associated with about the same number of deaths per annum as the most strictly regulated prescription drug, methadone.  Here is the decision; http://www.medsafe.govt.nz/Profs/class/mccMin03Nov2009.htm
Scroll all the way down the page to item 10. “General Business”, and you’ll see that Ibogaine is Item 10.1 There is actually a good, concise summary of what we know about this drug at 10.1, – well worth a quick read if you are interested in Ibogaine.
There is a native Australian Ibogaine Shrub, containing extractable quantities of the drug, although there appears to be no surviving tradition of Aboriginal people ever using it. (Although just because there is no surviving evidence of current or pre-European-settlement Aboriginal cultures using it, doesn’t mean none have ever done so during the 60,000 years or more that they’ve populated Australia. Other psychoactive plants, like Pitjuri (contains nicotine and scopolamine) and Psilocybin mushrooms were exploited ritually and recreationally by traditional Aboriginal peoples, and Pitjuri was traded all over the continent).
Australian Ibogaine (or Iodine) Bush ;http://www.somemagneticislandplants.com.au/index.php/plants/87-tabernaemontana-orientalis
I’ve met a handful of people who have used Ibogaine to treat drug dependency, but not a large or broad enough sample to have a strong opinion about its effectiveness. (In a similar fashion, I’ve met a couple of Americans and one Mexican guy who, every six to nine months, go out in the desert with Huicol people and eat peyote, and all three swear this is what has allowed them to overcome serious drug addictions). Because of the ambiguous legal status in Australia, only 1 or two places advertise Ibogaine treatment, I don’t know how many customers they get, and I don’t know how professional these outfits are.
Ibogaine treatment centres in Australia and New Zealand; http://www.ibogaine.co.uk/options.htm#Aus
Testimonials about Ibogaine treatment; http://www.iboga.com.au/testimonials.html
More; http://shaman-australis.com.au/Website/Constituents/Ibogaine.html
Hope this is a useful info.
Regards,
Paul

Addicted to Suboxone

First Published 7/23/2013
I hear from the anti-buprenorphine people now and then, less than I used to.  I also hear from fans of this blog’s early days, when I routinely lost my temper in response to those people.  Their general line was that things on heroin weren’t all that bad, but now, on buprenorphine, things are miserable.  Starting buprenorphine somehow removed an opportunity to be clean that they used to have, that they would have used if not for buprenorphine.
They somehow miss the obvious—that they could ALWAYS go back to the heroin addiction that worked so well for them.  They’ll say they could stop heroin any time they wanted (you know the joke—‘It is so easy to quit that I quit a hundred times!’), but act as if someone is forcing them to take buprenorphine.
If it is so easy to stop heroin, why not go back to heroin and stop?
For the record, I don’t advise people on buprenorphine to change to heroin.  It is difficult to wean off any opioid, including buprenorphine.  But I do have patients who have tapered off buprenorphine; something I’ve never witnessed with agonists like oxycodone or heroin (i.e. tapering outside of a controlled environment).    Most people who read my blog know that I don’t recommend tapering off buprenorphine for most people, an opinion I’ve come to after seeing many people relapse, and some people die, after stopping buprenorphine.
I received a typical anti-bupe message yesterday; the message and my response are below.  There are a few typos that I can’t decipher….
Errors of logic, anyone?
Subutex was the worst mistake I ever made. I was an off and on heroin user for 5 years. I was clean for over a year and relapsed that when I survived Subutex first I was getting it off the streets then my wife ego had the insurance got a script. She was pregnant so the doctor prescribed Subutex. She told her that her brain would never be the same from her opiate use and would need Subutex most likely for the rest of her life. We both were quickly using it IV IT killed our sex life. It made me feel like a woman or something I have no libido at all. I quit using it IV for 9 months then started again which caused me to have a full blown relapse I’m in 12 step recovery. I lost our home shortly after our new born son was born forcing her to move in with her parents and I moved into an sober living house. We are now both trying to taper off this drug that it’s overly prescribed. The doctor put her on 26mg a day mind you we shared but the doctor doesn’t know that. I do believe in short term low dose setting this drug has a therapeutic value. But I believe it’s been designed to get money lost to drug dealers into the pockets of our government. I kicked Heroin and Oxycontin more then once. Getting off Subutex has been the toughest one yet the physical and mental withdraws are horrible. The best bet for addiction treatment is 12 step meetings. All Subutex or Suboxone does is give you a crutch and prolongs actual recovery from the disease of addiction. They don’t tell you about all the terrible side effects behind this medication its marketed as a miracle drug. A wise man once said if it sounds too good to be true then it’s probably not. Rant done hopefully this helps someone. The answer to recovery is the 12 and staying sober 1 day at a time, most important a relationship with a higher power.
My Response:
An interesting comment… You’ve taken heroin for over five years as an ‘off and on user’.  You then illegally obtained buprenorphine, and injected it (!)… illegally shared what a physician prescribed for your wife… but it’s all buprenorphine’s fault that you are experiencing problems?  Part of the 12 steps that you favor includes taking responsibility for what happens in one’s life, yet I don’t hear a lot of that in your narrative.
I don’t know about ‘miracle drug’, although it probably has saved the lives of both you and your wife, since IV heroin addicts don’t tend to do well beyond 5 years.  There is nothing in your history to suggest that your ‘on and off use of heroin’ would have somehow come to an end, had you not changed your drug of choice to buprenorphine.  But one aspect of buprenorphine is the ‘ceiling effect’, which makes overdose much less likely.
Likewise, I don’t see a government conspiracy, and I disagree with your comment about ‘low dose use’.  Buprenorphine HAS been used in low dosage for treating pain for the past 30 years, but everything about buprenorphine that makes it a good addiction treatment relies on the person taking a dose that assures a high blood level, i.e. above the ceiling level for the drug’s effects.  In low doses, buprenorphine acts like any other agonist– i.e. causes the same up/down mood, cravings, and obsessive use pattern.
Your problem is that you became addicted to opioids, and your opioid addiction has cost you a great deal.  You misused buprenorphine by injecting it, but luckily for you the drug has certain safety features that helped keep you from overdosing– something heroin doesn’t have.    But now you blame buprenorphine for all your problems.
I certainly do not suggest that you do this, but for the sake of making a point—-  you could easily go right back to where you were, before you met buprenorphine, if you returned to your addiction to IV heroin.    If you started heroin tomorrow, the buprenorphine would be out of your system in a week or so, and… voila….. you would be ‘cured’ from this horrible affliction that you claim to have, i.e. an addiction to buprenorphine.  Or are you going to suggest that taking sublingual buprenorphine was somehow WORSE for you than doing what you were doing before finding a doctor, when you were injecting foul solutions of heroin into your veins?!  You were FINE with the heroin, but BUPRENORPHINE has ruined your life?
Sorry– I don’t buy it.  Most people who stop ANY opioid– buprenorphine, oxycodone, or heroin— end up using again.  Buprenorphine, as a partial agonist, relieves cravings in a way that opioid agonists can’t.  And taking buprenorphine certainly doesn’t make anything ‘worse’;  a person addicted to heroin, who doesn’t like taking buprenorphine, can always go back to heroin!  I don’t recommend it, as the overdose risk is very high with heroin, and people on heroin suffer from constant obsessions to take more and more– a life far worse than the person properly taking buprenorphine.
This is where I come in… THESE are the patients I see on a regular basis.  The doctors who used to call them ‘good patients’ now call the same people ‘drug addicts.’  And the pain doctors—the ones who create so many addicts—give lectures on ‘how to prescribe opioids.’   I can spare you the need to attend the lecture— the main message is that after you make the patient an addict, you must do everything that you can to separate yourself from the patient before the consequences of that addiction become apparent—so that your hands appear sparkly-clean!

Suboxone Makes Me Fat and Boring and Stupid

Originally posted 3/6/2013
A late post tonight, since my new exercise program has pushed my blogging back by an hour or so each night.  My suspicions about exercise were correct, by the way; it is much easier to suggest exercise to other people than it is to actually exercise.  I’ve been at it since the beginning of the year, and I at least feel a bit less hypocritical.
While I’m on the topic…  I’ve received many comments over the years from people complaining that they’ve been taking Suboxone or buprenorphine for X many years, and they have no energy, they feel stressed, they have gained weight, they don’t sleep well or they sleep TOO well… and concluding that all of the problems are from Suboxone.
Suboxone causes… everything!
They aren’t (from Suboxone).   Not at all.  But I wonder, at this point, if regular readers of my blog know EXACTLY what I’m going to say.  I’m tempted to stop typing and ask people answer so I get a sense of how predictable I’ve become.    But then I’d have to wait and then come back, read, and assess the situation….  I really can’t imagine much positive to come out of THAT experience, so I’ll just finish my thoughts, about the problems that people often blame on Suboxone.
The problems are the result of other things, including things that tend to occur naturally as our lives become less chaotic and more outwardly-secure.  The problems I mentioned above, for example, come from inactivity.  They come from thinking that we’ve ‘paid our dues’ at the age of 30, and it’s time to coast in life.  They come from failing to seek out challenges, and from failing to do our best to tackle those challenges.  They come from letting out minds be idle, smoking pot or watching American Idol  instead of responding to the naggings sense of boredom that ideally pushes people to join basketball, tennis, or bowling leagues.
Our minds and bodies are capable of SO much.  I (honestly) am not a network TV viewer, but I love the contrast of ‘before and after’ scenes on ‘Biggest Loser.’  People magazine (it sits in my waiting room) had a section a while back about people who lost half their body size, by exercise and dieting.  The part I found most interesting was the deeply personal answer that each person had to the question, ‘what was your turning point?’  Each cited an episode of humiliation or shame that lifted the veil of denial, and helped them do what they knew, all along, needed to be done.
We are not all capable of ‘Biggest Loser’ comebacks. But it is important for people to understand that feeling good, physically or mentally, takes work.   That incredible feeling of a ‘sense of accomplishment’ only comes when we accomplish something.  We don’t need to eliminate global hunger or cure cancer; sometimes we just need to shovel the driveway, mow the lawn, or do a crossword puzzle.  I’ve learned, as a psychiatrist, that the people who walk around with smiles on their faces usually did something that made the smile happen.  I’ve learned that ‘feeling happy’ does not just happen for most people.  And I don’t think I’ve ever met a person who answered, when asked about stress, ‘no—I don’t have anxiety.’
Once someone blames Suboxone for their problems, it becomes less likely that the real causes of those problems will become apparent. For example, If I think that my glasses are giving me headaches, I’m less likely to make changes in my diet that might make the headaches better.  Once we have something to blame, our problems become more and more engrained, and the real solutions become less and less evident.
I’m truly sorry if I am coming across as ‘preachy’; understand that I’m just trying to make my way through life like everyone else.  But I now take note of all those people power-walking at 6 AM, and I understand why they do it.  Some of them might be on Suboxone.  Some of them might not be.  But I respect all of them for opening their minds, and for their willingness to do the hard work that brings happiness—or at least points in that general direction.

Reckitt Benckiser is Smarter than I Thought

Originally published 10/14/2012
Regarding a prior post, I carefully read through the entire Citizens Petition’ filed with the FDA by Reckitt-Benckiser.  I have a better understanding of what, exactly, was accomplished by that action by the manufacturer of Suboxone.
The document explains that the company hired an independent group, RADARS (Researched Abuse, Diversion, and Addiction-Related Surveillance), to investigate the exposure of small children to Suboxone tabs and Suboxone Film.  The results are spelled out in detail in the Citizens Petition.
They show an increase in exposure to Suboxone Tabs over the past ten years.  They also show an increased rate of exposure, i.e. number of exposures, divided by the number of tabs prescribed.  Reckitt-Benckiser wrote that they instituted REMS over the past few years to counter that increase. What are REMS, you ask?
From the FDA site:  ‘The Food and Drug Administration Amendments Act of 2007 gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks.’
To meet that requirement, RB claims that they instructed their sales force to be double, extra-especially careful to tell doctors to remind patients to avoid giving Suboxone tablets to their children.  No, I’m not making this stuff up… although the ‘double, extra-especially’ part is my own hyperbole.  I don’t remember exactly how it was worded in the petition.
RB wrote that the warning is actually part of their mitigation strategy—that they expect an impact on pediatric exposure, if their salespeople tell doctors to tell patients to keep the pills out of the hands of children.  Gosh—good thing they did that!  I’m picturing all those people who having their 2-year-old kids managing their Suboxone!
But telling doctors to tell patients this ridiculous bit of information did not solve the problem, so RB claims they needed to do more.  They decided that every dose of Suboxone must be individually packaged.  But they had problems with the stability of naloxone while producing individually-packaged Suboxone Tabs, leading them to make the Film form of the drug.
To read the petition, the expiration of their patent on the tabs had nothing to do with anything.  And the long, new patent on the Film has nothing to do with anything.
I have a couple questions at this point.  First, the obvious one—did RB REALLY have a discussion about having their salespeople remind doctors to remind patients to protect their children?  Do they really think that patients and doctors are that stupid—that their salespeople can make a difference in that regard?
Second, do they really find it necessary to individually wrap each dose of Suboxone, a combination of an opioid partial agonist plus an opioid antagonist, when oxycodone, hydromorphone, hydrocodone, and other potent opioid agonists are sold by the bottle?  I could go on and on about this issue… most patients on Suboxone guard each tablet carefully, as they are prescribed to match up with the number of days in each month… whereas opioid agonists are usually prescribed to take ‘as needed’, meaning the tabs are much more likely to end up in kitchen cupboards or otherwise unaccounted for.
Why would a company hire another company to find fault with their product?  One might think that the manufacturer of a substance would be, if anything, pointing out the safety of their product—not arguing that it is unsafe.  This is where cynicism starts to set in; where I wonoder if they are really just ‘Here to Help.’ I’m supposed to believe that RB discovered a problem with their product, hired a company to assess that problem, and then voluntarily withdrew the product from the market.
To believe the RB line, I have to accept a number of coincidences.  They wrung profits out of the tabs for almost ten years, and just happened to figure out this danger within a year after patent expiration—just when generic pharmaceutical companies were able to manufacture cheaper forms of buprenorphine.  The company has been dreading the flow of generics for years;  heck, their reps spend more time talking about THAT issue than they do about pediatric exposures!  It is also an odd coincidence that RB just happened to be pushing the Film like crazy to insurers and Medicaid agencies, well before their ‘discovery’ of the danger of pediatric exposure to tablets.
To really understand the situation, you must read all the way to the top of page 29 of the Citizens Petition.  There, the attorneys for RB point out to the FDA that if a manufacturer voluntarily withdraws a medication for safety reasons, the FDA is not allowed to approve any new drug application for a generic that is based on the withdrawn medication.
Wow.  They have some darn good attorneys at RB.