Reckitt Benckiser Citizen Petition for Suboxone: DENIED

Posted 2/23/2013
For those who missed my explanation, I’m adding these old posts to reconstruct the archive.  The site’s database was damaged by something, somehow… New posts coming soon.
Find a copy of the response here, or at this url:www.suboxonetalkzone.com/cpresponse.pdf

Suboxone Withdrawal in Newborns

One of the top search terms for Suboxone relates to pregnancy, and fear that the baby will experience withdrawal; official name ‘neonatal abstinence syndrome.’  I wrote this post a couple years ago, and I think it is worth reposting. Since the first time around, several studies have shown that withdrawal symptoms occur in about half of babies born to mothers on buprenorphine. The symptoms, when they do occur, tend to be milder than the symptoms in babies born to mothers on methadone or other opioid agonists.
Headlines grasp for attention with words like ‘addicted babies.’ Realize that there are many differences between physiological dependence and addiction to substances. For example, people who take Effexor are dependent– and will have significant discontinuation-emergent side effects– but they are not ‘addicted’, which consists of a mental obsession for a substance. The same is true of beta-blockers, in that discontinuation results in rebound hypertension, but there is no craving for propranolol when it is stopped abruptly.
We have no idea of the ‘cravings’ experienced by a newborn, but I cannot imagine a newborn having the cortical connections required to experience anything akin to the ‘cravings’ experienced by opiate addicts, which consist of memories of using and positive reinforcement of behavior—things that are NOT part of the experience ‘in utero’.
It is also important to realize that the withdrawal experienced by addicts consists of little actual ‘pain’ (I’ve been there—I know). Addicts talk about this subject often, as in ‘why do we hate withdrawal so much?’ It is not physical pain, but rather the discomfort of involuntary movements of the limbs, depression, and very severe shame and guilt. The normal newborn already has such involuntary movements as the result of incomplete myelination of spinal nerve tracts and immature basal ganglia and cerebellar function in the brain. And the worst part of withdrawal—the shame and guilt and hopelessness—are not experienced in the same degree in a baby who has no understanding of the stigma of addiction!
Finally, if we look at the ‘misery’ experienced by a newborn, we should compare it to the misery experienced by being a newborn in general. I doubt it feels good to have one’s head squeezed so hard that it changes shape—yet nobody gets real excited about THAT discomfort—at least not from the baby’s perspective! I also doubt it feels good to have one’s head squeezed by a pair of forceps, and then be pulled by the head through the birth canal! Many hospitals still do circumcisions without local, instead just tying down the limbs and cutting. Babies having surgery for pyloric stenosis are often intubated ‘awake’, as the standard of care– which anyone who understands intubation knows is not a pleasant experience. And up until a couple decades ago—i.e. the 1980s (!), babies had surgery on the heart, including splitting open the sternum or breaking ribs, with a paralytic agent only, as the belief was that a baby with a heart defect wouldn’t tolerate narcotics or anesthetic. I don’t like making a baby experience the heightened autonomic activity that can be associated with abstinence syndrome, but compared to other elements of the birth experience, I know which I would choose!
My points are twofold, and are not intended to encourage more births of physiogically-dependent babies. But everyone in the field should be aware of the very clear difference between physiological dependence and addiction, as the difference is a basic principle that is not a matter of opinion—but rather the need to get one’s definitions right. Second, the cycle of addiction and shame has been well established, and there is already plenty of shame inside of most addicted mothers. If there are ten babies screaming loudly, only the whimper from the ‘addict baby’ elicits the ‘tsk tsk’ of the nurses and breast feeding consultants. My first child was born to a healthy mom years before my own opiate dependence, and he never took to breast feeding; he his mother been an addict, his trouble surely would have been blamed on ‘addiction’ or ‘withdrawal’. Unfortunately even medical people see what they want to see—and sometimes that view needs to be checked for bias due to undeserved stigma—for EVERYONE’S good, baby included.
Addendum:  Another of my posts, including a response to a mother’s comments and several references, can be found here.

Size Matters?

I’ve received several complaints from patients and readers about one of the current buprenorphine formulations.  The primary complaint is that the tablet is ‘not ‘working as well as the other formulations;’ that it seems to wear off earlier, or that people feel compelled to take more than what is prescribed.

buprenorphine formulations
Buprenorphine 8 mg tabs

My understanding, admittedly based only on what people have told me, is that there are three current formulations of buprenorphine.  The brand form, Subutex, comes as a relatively-large, flat-oval tablet, white or off-white in color.  The Roxanne version is a round white tablet, with a diameter of about 0.5 inch.  The tablet people have complained about is from Teva, and is smaller;  about the size of a tic-tac.
In general, I think that generics are as good as brand name medications.  I have never come across a reliable instance, in my practice, of generics being less potent or less active.  I recognize that particularly for psychiatric medications, the placebo effect accounts for significant portions of the actions of medications—so if a person BELIEVES that generic fluoxetine is less likely to work, it IS less likely to work.  But take away the placebo issue, and a molecule of fluoxetine is a molecule of fluoxetine—regardless of where it comes from.
That said, I realize that the delivery of molecules can be affected by the design of capsules and tablets.  I remember a study, years ago, that showed that many of the vitamins sold in the US passed through the intestinal system without even dissolving, let alone getting into the bloodstream. If the active substance is encased inside insoluble resin, there is little to be gained from taking it.
The delivery issue is less of a concern with a medication that is delivered through the oral mucosa, as with buprenorphine.  There are several factors that affect absorption of buprenorphine;  the concentration of buprenorphine in saliva,  the amount of surface area that buprenorphine is allowed to pass through, and the time allowed for that passage to occur.  If the smaller tablet dissolves more slowly, molecules of buprenorphine may have less actual contact-time with oral mucosa, thereby reducing absorption.
On the other hand, I am well aware of the psychological reward that people describe from taking buprenorphine or buprenorphine-naloxone, even in the absence of any subjective sensation.  The fear of withdrawal is relieved by taking buprenorphine—making the dosing experience ‘rewarding.’  It may be that the smaller tablet provides less reward, as the small size engenders less confidence in those unfelt ‘effects.’
In any case, I invite readers to share their experiences, just in case those who have already written are truly onto something.  Please leave comments below—and thanks for sharing!

Relapse in an Era of Buprenorphine

A recent experience with a patient helped me realize some of the dramatic differences in the treatment of opioid dependence, in an era of buprenorphine.
I drug-test patients who are treated with buprenorphine or Suboxone.  The point of testing is not to catch someone messing up, but rather to determine when a person is in trouble.  It would be great if we could simply rely on the word of our patients, but once a person is using opioids, his/her own ability to know what is true falls apart. All of us who treat addiction have heard patients rationalize relapse as something they ‘had to do’ for one reason or another, for example.  The effects of active using on insight are why I like the use of ‘DENIAL’ as a mnemonic for ‘Don’t Even Notice I Am Lying.’
The effects of relapse on telling the truth are part of the profound impact of using on a person’s insight.  Insight disappears very quickly during active using, as the mind abandons the broad view and becomes focused on one goal. Before buprenorphine, drug testing was in some ways more, and other ways less important.  It was more important because after relapse, the person was immediately thrown back into the world of desperate scrambling, where risks for consequences are high.  On the other hand, testing was less important—or maybe necessary– because experienced addictionologists (and spouses) could see the effects of using, including the loss of insight, in the active addict’s eyes.
I was one of those people who experienced that rapid loss of insight after my relapse, back in 2000. For years I had attended AA and NA; hundreds if not thousands of meetings over seven years.  I remember comforting myself that ‘if I ever get off track, at least I now know where the door is to get back.’  I didn’t realize that at the instant one relapses, that door becomes nowhere to be found.
In retrospect, I don’t know if the door actually disappeared. I suspect that with the right attitude, that same door would have opened for me.  But the honesty and humility that I needed, in order to ask for help in finding and passing through the door, were suddenly replaced by the need for secrets—secrets about everything.  As soon as I relapsed, nobody could be trusted. Nobody would understand me.  I was on my own.
Contrast that with the experiences of patients on buprenorphine who relapse with opioid agonists. As I compare their experiences to mine, I realize that I am using the experiences of a couple people to make broad generalizations.  But I have seen a number of examples that support these generalizations, that have consistently followed the paths that I’m about to describe.
One patient—call him ‘Paul’—told me about his relapse before I even mentioned that I would be asking for a urine test.  In fact, he was eager to tell me about his experience, as if he looked forward to getting it off his conscience.  “I have to tell you that I really screwed up last week,” he said. When I asked him what happened, he said that a friend who he hadn’t seen for several months came through town and stopped by his house.  With little warning, his friend pulled out a bag of heroin and a couple clean needles, tossed them on the table, and said ‘let’s fire up.’
After shooting the heroin, Paul immediately felt disappointed in himself.  Unlike in the old days, he felt nothing from the heroin.  While his old friend nodded off next to him, Paul wondered what the heck happened—and immediately wanted to talk to me about the situation.
His desire to talk is an amazing thing—and worth noting.  Without buprenorphine, a person who relapses is not generally eager to speak to his/her sponsor, let alone counselor or physician.  In those cases, the mind reels from an avalanche of shame, and the need to keep secrets—even from one’s own awareness—becomes paramount.
There are many buprenorphine programs that would discharge a person for one relapse—and in such cases, I would not expect the same type of honesty from patients.  I don’t get the logic of those programs, and I become angry when I think about them.  As I’ve said before, if a person relapses, that person NEEDS help—not abandonment!  I believe that the proper approach to treating addiction can be found in almost all cases simply by considering opioid dependence to be another chronic illness.  And if someone with heart disease overexerts himself and comes in with chest pain, we don’t boot him from treatment!
Paul made an appointment to talk about his experience.  He explained how he felt when his old buddy contacted him, and we discussed ways to avoid meeting up with ‘old friends’ in the future.  He discussed the urge to escape when he saw the paraphernalia—to escape from life’s responsibilities—and we talked about how difficult it can be to simply tolerate life sometimes, and the powerful effects of triggers and cues.  Most interesting to me, as a psychodynamic psychiatrist, he talked about a complicated set of thoughts and feelings that came up when he saw the drugs—questions about who he was, about shame, about the heavy load that comes with doing the right thing, and about the pressure of not letting people down.  Those are all big issues, I said as I agreed with him.  How much easier, at least for a few moments, to just be ‘nothing’—to have no expectations about one’s self!
We talked about the challenge of being ‘someone’– of being proud of one’s self.  It feels good to do the right thing– but it may also feel bad.  Am I letting my old friends down, if I do better? I suggested that he might watch the old movie, Ordinary People, where a younger brother struggles after surviving an accident that claimed the life of his brother.
Before buprenorphine, people struggled with opioid dependence largely on their own.  Yes, we had twelve step groups—and still do—but twelve step groups place the responsibility to get one’s act together squarely on the back of the using addict.  Many people in AA or NA will say that “AA is a selfish program.”  It has to be.  When one relapses, one is left with his own distorted insight, accumulating consequences until, hopefully, he finds his way back to the pathway established by the simple program of the steps.
On buprenorphine, relapse doesn’t necessarily cause instant loss of insight.  I don’t mean to minimize relapse, as bad things can always happen.  For example, I have had patients stuck in a pattern of chronic relapse that was difficult to straighten out, even though there was little or no psychic effect from the drug being abused.  But from an optimistic standpoint, relapse on buprenorphine stimulates a deeper investigation into what is missing from the person’s life, and a renewed effort to gain what is missing.
This assumes, of course, that the person is not simply tossed from treatment for the relapse.  In that case, other people are left trying to figure out what happened—when the obituary appears a few months later.

The Buprenorphine Ceiling Effect

This post is from a couple years ago;  I think it is important for people to have a basic understanding of how buprenorphine removes opioid cravings, so I’m republishing the post.
Note that naloxone has NOTHING to do with the effects of Suboxone.
In this video I explain why the ceiling effect is so important to the effects of buprenorphine for treating opiate dependence.

Can my doc prescribe Subutex? SHOULD he?

Hi all!  Sorry for the lapse in posting… I have been gearing up to blog for Psych Central, an opportunity that I am very excited about, and I have a hard time writing one blog and being excited about a second blog at the same time!  Please be sure to visit my blog at psychcentral.com, called ‘An epidemic of addiction.’ The first few posts will be mostly introducing myself with information that people here already know, so come visit in a couple weeks when I am up to speed.
A question/answer post for tonight:
As you know, generic Subutex is cheaper than Suboxone. I want my doctor to switch me to Subutex, but I am so afraid to ask him.  Even though my doc is nice to me, what if he is one of those doctors….gets mad at me, and discharges me as a patient?  I can’t do something that could possibily send me back on that old course of life that seems more and more distant every day.
Can my doctor legally prescribe me Subutex rather than Suboxone?  What good reason could he have for not agreeing to, once I show him how much money it will save me?   Also, do doctors make extra money by writing a prescription that is filled at a certain pharmacy?
My reply:
Thanks for your question.  Isn’t it sad that people are afraid that their doctors will cut them off of life-saving treatment?  The writer is not paranoid;  there are practices where patients are treated as ‘guilty’ just for asking questions that make the doc uncomfortable.  Such a situation does NOT foster the open communication that keeps addiction out in the open, where it can be treated properly and effectively.  And such a situation is a far cry from treating addiction as the disease that it is, rather than a character deficiency.
Any doctor who can prescribe Suboxone can also prescribe Subutex.  There is no difference in the actions of the two medications when they are taken properly;  Suboxone contains naloxone, that supposedly reduces IV use of Suboxone.  But studies show that most ‘diversion’ of buprenorphine is for ‘self-treatment’ of opioid dependence– not for the sake of getting an opiate high.  I suspect– but have no proof– that the RB reps encourage docs to think that if they prescribe generic Subutex, their patients will be shooting up in their lobbies.  This keeps docs prescribing brand-name Suboxone– at least until the Teva generic becomes available.
The main reason a doc won’t prescribe the generic then is fear of diversion, which in my opinion is overblown– not  because there is no diversion, but because both Suboxone and Subutex are diverted at an equal rate and used for the same thing– for illicit self-treatment.  Some docs probably avoid the generic to avoid a common problem– if the pharmacy doesn’t have the generic they will substitute the very-expensive, name brand Subutex– often resulting in calls to the doctor for prior authorizations or replacement scripts.  It is currently easier for the doctor to simply write for Suboxone.  Docs should realize, though, that the cost difference is quite significant;  in my part of Wisconsin, generic Subutex is lesss than $3.00 per tab, and Suboxone is over twice as costly.
I have heard of places in Florida (sorry Florida– maybe it happens elsewhere too, but you folks have a reputation for this) where docs provide scripts for pain pills with the condition that people use specific pharmacies.  I am surprised that such an arrangement would be legal;  it is clearly unethical to have such a conflict of interest.  That arrangement would violate Medicare law, but if they avoid Medicare patients, perhaps they can get away with it…  But to answer the question, I have never seen such a situation in my part of the country.  Docs– post anonymously if you are willing– has anyone heard of profiting by prescribing certain medications?
To the writer, I would like to just say ‘ask your doc if he/she will prescribe the generic.’  I can tell you that I would certainly not be ‘offended’ in any way, or think poorly of you.  Of course there is always some value in being polite;  no doctor likes being told what he/she ‘has to prescribe!’   But you know your doc and I don’t.  If your gut says tread cautiously, then tread cautiously.  You could always ask your pharmacist if doctor so and so ever prescribes the generic– although pharmacists tend to treat addicts even  more poorly than doctors do!
For the docs out there, maybe it would be appropriate to ask yourselves, ‘is this MY patient writing to the blog?  And if it is, why is he afraid to talk to me?’

Goals of buprenorphine treatment and generic Suboxone

A question in response to a recent article, and my answer.  My primary point is to address what buprenorphine maintenance CAN do– which is far more than simply ‘replace’ opioid agonists.  I recently received a message from an AODA counselor that totally misses the point of buprenorphine;  a message that did what the anti-sub crowd typically does– i.e. present a skewed view of buprenorphine and then tear down that skewed view.  I’m not posting his ‘straw man’ message here, as there is already enough misinformation out there without his contribution. 
Instead I’ll share a different, nicer letter:
Hi– my name is (Julie) and I’m a member of your site however I never post as I usually find answers to my questions.
I too would like to make a donation.
I have been on Suboxone for 3 months. Before that I was on methadone for one year, and tapered down before switching to Suboxone. I am now at one mg per day which I’m doing well with.  How long should I stay at one mg before reducing to 0.5 mg?  And how do I ask for Subutex (since it’s generic) without the doc thinking I’m going to abuse it?  I’ve never been a needle user; sniffing was my thing– oxys but most heroin.    I’m interested in generic buprenorphine because obviously it’s cheaper.
I love your site and have read about the liquid taper and your story. It’s nice to have an addiction psychiatrist who’s been in “our” shoes and who understands addiction.
Also can I mention these drugs you’re talking about to my doctor, BuTrans, Probuphine and proglumide?
Like most addicts the thought of going through withdrawal terrifies me. But I know I can’t stay on this forever. I own a small business and can’t afford to take 3 weeks or more off of work. Also I have prescriptions from a different doc who gives me valium and lorazepam. Will these help with my withdrawals? The diazepam doesn’t seem very strong to me.
Thank you!
Back to me:
Donations are always appreciated– the donation button on the blog site works through PayPal.
The mistake most people make– addicts and their docs– is to stop buprenorphine too early.  Several large studies show very clearly that buprenorphine treatment less than 6-12 months is almost always followed by relapse;  there is now general agreement that buprenorphine should be continued for a year or more, and often indefinitely.  I understand the desire to get off everything, but there is simply no going back to who we were, before we became addicted.  Active addiction permanently changes pathways in our brain, and we cannot erase them any more than we can ‘forget’ how to ride a bike.  What we hope for, during buprenorphine maintenance, is for the pathways that have become engrained in the brain to fade to some extent.  Addicts learn, while using, to constantly gaze inward and focus on how they ‘feel.’  If there are unpleasant sensations or feelings, addicts learn to turn to a chemical to make the feelings go away.  The goal on buprenorphine is for the person to learn the reverse– to stop constantly looking inward and instead direct our minds outward, and to learn to accept life on life’s terms. When we notice unpleasant sensations or feelings, we must learn to tolerate them and ignore them.  Buprenorphine maintenance allows that process to occur– providing it is taken correctly.  If an addict, for example, takes little chips of buprenorphine in response to every unpleasant sensation, that person may as well take an opioid agonist.
Another goal of buprenorphine maintenance is to promote character change. I don’t think that most docs (and certainly few AODA counselors) get this part.  The harm from opioid dependence does not come from ‘taking’ opioids;  the harm comes from the OBSESSION for opioids.  That obsession takes over the addict’s life, replacing interests in work, relationships, hobbies, simple pleasures– everything.  I naively expected a ‘dry drunk’ when I first treated addicts with buprenorphine, but that is not what I discovered.  Instead, I saw that as the obsession for opioids faded away, other interests returned.  It’s almost as if the mind is like a computer hard drive, and has only so much capacity.  If the mind is filled with obsession for opioids, there is no room for other things. I suppose the analogy is a person filling his business computer with porn– so that there is no space, and no time, for what is SUPPOSED to be going on!
One other positive aspect of buprenorphine in regard to character has to do with honesty.  Opioid addicts learn to lie about pretty much everything.  Addicts learn to repress the guilt over those lies and the guilt from their behavior, eventually becoming extremely adept at lying.  All that lying leads to the development of an artificial, shallow personality that allows an addict to put on a fake smile even as life is falling apart.  The fake personality can fool some people, but a fake ‘self’ cannot form real intimate relationships.  So the addict appears happy, giddy, or even goofy… but is intensely alone on the inside.  Eventually that loneliness contributes to the despair that leads, hopefully, to seeking help and recovery.  One reason that taking buprenorphine on the street is foolhardy is because the addict is still leading a life of dishonesty.  The fake veneer remains in place in such cases. The addict fools him/herself by thinking that everything is in order, but deep inside the addict is still separated from society by his lies, and by knowing that he is not who he says he is. With appropriate treatment on the other hand, the addict gains self confidence from knowing that the rest of the world is interacting with his/her true self.  I have testified in court for various purposes, and it always boosts my confidence when I realize that I only need to speak the truth.  If I had to present a version of reality that I was fabricating, I would be a mess!  How much easier to just speak the truth– at least the truth as a person knows it!
Back to your situation… I worry a little that your dose of buprenorphine is too low, but if you going the full 24 hours between doses without withdrawal or cravings, your dose is sufficient.  But I would be in much less of a hurry to get the dose lower.  There is little difference in the opioid tolerance of a person taking 4 mg vs. a person taking 24 mg (because of the ceiling effect).  So the ONLY reason to take such a low dose is for cost considerations– and maybe so that if you needed surgery, it would be a little easier to overcome the block from buprenorphine.
You are free to talk about the things I’ve mentioned with your doctor– about medications to reduce withdrawal symptoms.  Unfortunately, though, it is difficult for people to understand our fear of withdrawal, who have  not experienced it firsthand.  As you know, there are no words that capture the symptoms, so docs think in terms of ‘pain’ or ‘depression;’ neither of which come close to describing the experience of opioid withdrawal.  Society as well has no empathy for THAT type of suffering, instead dismissing it as something brought on by addicts themselves, that on some level they deserve.  Yes, we are VERY far from treating addiction as a disease!!
As for benzos specifically– like Valium (diazepam) and Ativan (lorazepam)– they clearly reduce the misery of withdrawal, but they are themselves almost as addictive as opioids (and probably more addictive in some people).  I support their use for such a purpose only if there are significant measures to make sure that their use stops after a short period of time.  Many, perhaps most, physicians would be reluctant to prescribe them in the setting of opioid withdrawal, and I am not critical of that attitude, as I have seen many patients who have been injured by careless prescribing and use of benzodiazepines.
Finally on the Subutex issue, there is no doubt that the difference between Suboxone and Subutex in reagard to diversion has been overblown.  Most diverted buprenorphine from either formulation is taken sublingually to stave off withdrawal, not intravenously for a ‘high.’  I have wondered aloud if Reckitt-Benckiser perpetuates the misperception purposefully in order to reduce abandonment of brand Suboxone.  Thankfully we now have generic Suboxone from Teva Pharmaceuticals, and hopefully prices for both formulations will fall.  I recently heard about a pharmacy in Appleton, WI that had generic buprenorphine 8 mg tablets for about $2.80 per tablet retail, which is the lowest price I’ve seen for a couple years.  For any physicians reading this, I encourage you to cut your patients some slack if they have no insurance and consider prescribing generics;  I prescribe the generic in such cases and have had no complaints of lower efficacy or other problems.  In Wisconsin most pharmacies do not stock the generic, but they can order it if given a day or two notice.  Although we do NOT yet have the Teva generic available, at least as far as I have heard.
Thank you for your letter.  Please let your doc know about the blog, and particularly about the forum.
JJ

Allergic to Suboxone taste additive/sweetener

Something I haven’t yet come across:

Acesulfame Potassium

Well, i’ve been clean with the help of Suboxone for 14 months now. Throughout my treatment I’d been getting tongue blisters and ulcers at least two at a time. I’ve probably had them six to eight different times in this 14 month period. I realized something wasn’t right, and started investigating, trying to figure out what the problem was. I watched the foods I ate and the things I drank. Nothing seemed to work; they just kept coming back. So, the only thing I could think of was the Suboxone.  I read the pamphlet that comes with the medication. The artificial sweetener in Suboxone (Acesulfame K sweetener) is what I am allergic to. I have been allergic to artificial sweeteners my entire life. I had been taking a medicine I’m allergic to for 14 months! I admit, i should have done more research from the start. But I was so desperate for relief that i would have done anything to get rid of withdrawal. I also checked the ingredients in Subutex. It does not contain Acesulfame K sweetener. I went to my next doctor appt. and told my doctor my findings. My doctor was a complete jerk. When I brought up pretty much the only option I had and asked ‘could you switch me to Subutex?’  He said he usually only uses Suboxone but because of my allergy there wasn’t any other choice.  I said ‘will you write the prescription so that i can get the generic just in case Subutex isn’t covered?’  He said, ‘nah I really don’t want you taking generic.’ I said, ‘do you mind going to check and see if you can find out whether Subutex is covered?’ he leaves for a few minutes, comes back and says ‘nope it doesn’t cover it.’ Then he says, ‘ I’ll go ahead and write it so that you can get generic.’ He was very angry. I can only guess it was because the generic is made by another company.I could take this discussion in any of several different directions.  But instead of getting angry tonight at doctors who may have hostility for addicts (or perhaps addicts who perceive something else as hostility–  I wasn’t there, so I don’t know what happened), let’s look at the issue of allergy to the artificial sweetener in Suboxone, and the issue of prescribing brand vs. generic and Suboxone vs. Subutex.  For people who are interested, I took the discussion in an entirely different direction on the forum, where I took Reckitt-Benckiser to task for their limited number of slots in their patient assistance program.
Some background:  Brand Suboxone and Subutex have been the only bupe game in town until last fall, when a generic version of Subutex appeared on the scene.  Access to the medication has been a constant frustration since then, as distribution gets backed up and the price continues to rise– now almost double the initial price of about $2.50 per 8 mg tablet.  People in Wisconsin can generally find the generic by ordering it ahead of time at Walgreens– a company I am loathe to refer people to, but that at least has been able to get the medication.  That is if one of their pharmacists doesn’t decide to tar and feather you and post you on the wall along with those other darn drug addicts!
The generic version of Suboxone entnered the market about a month ago thanks to Teva pharmaceuticals, a large generic company that SHOULD be able to meet demand, but that so far does not have tablets on the shelves in Wisconsin.  The hope of many people, of course, is that the advent of generics will bring down the price of buprenorphine.  That SHOULD happen, provided that doctors don’t fall for whatever anti-generic nonsense is thrown their way by the sales force for Reckitt-Benckiser.
This is the point, by the way, where a company’s ‘true colors’ show.  Reckitt-Benckiser makes a big deal of talking about how they are NOT about the money– they are all about HELPING ADDICTS, and really don’t hardly notice that their company profits continue to surprise to the upside, pushing the stock price higher.  And I’m sure it is completely by accident that the price of Suboxone is so high, and that the high price has gone higher by about 50% over the past two years, at a time when everything else in the world is getting cheaper.  I figure that somebody accidentally moved a decimal point,  just like that crazy day in the stock market a month ago.  They probably THINK that Suboxone sells for $0.60 per tablet, not $6.00!
I’m sorry for sounding annoyed.  My anger stems from my suspicion that RB ISN’T just about saving lives.  Don’t get me wrong– I love capitalism.  But only when ruled by honesty, especially in the healthcare sector.  I have heard and read comments from the sales reps from Reckitt-Benckiser that suggest a concerted plan to tarnish competitors in a way not done by other companies about other generics.  I do not know what happened to their plan for a listerine-strip type of product, individually packaged, but they clearly planned to attack their own formulation just as soon as they got approval for the new product.  But so far, the dissolving SL tablet in a multi-dose vial appears to be just fine!  Watch for that to change. 
Reckitt-Benckiser is also playing up the diversion-potential of Subutex, even though they know that the vast majority of diversion cases consist of addicts self-treating their addiction, taking the tablet by the usual sublingual route– NOT injecting it.  But it protects the sales of Suboxone if the doctors and pharmacists (and DEA) are under the impression that prescribing Subutex is taking a big risk.  Is Subutex ever injected?  Of course.  But only a small fraction of diverted Subutex ends up used that way.  For the most part, Suboxone and Subutex are the same medication– except until recently one had a generic and the other did not.  I even suspect that some RB reps deliberately allow confusion over how Suboxone works– i.e. not explaining that Subutex contains EVERYTHING necessary to treat opioid dependence that is present in Suboxone.  Some docs think that the naloxone in Suboxone adds to the opioid blockade (it does not, when taken sublingual) or reduces cravings (it does not).
I did some reading on the artificial sweetener in Suboxone, and the writer is on the right track– and I hope he is prescribed the medication that he needs, rather than suffer with mouth sores.
I encourage physicians to take all factors into account as they take on this nasty illness.  On one hand, I resist the complaint that ‘I can’t get help because Suboxone is too expensive’ because active using is always much more costly– even before considering the costs to one’s occupation or to one’s relationships.  But physicians have long-relied on generics to increase availability of life-saving medications that otherwise would be beyond reach for many people– particularly during a nasty recession. 
Makers of generic buprenorphine, please continue your good work, and good luck to the new products entering the market– for example Butrans, which was approved a few days ago, and Probuphine, a long-term injectable form of buprenorphine that I suspect will be a great help for the final stage of buprenorphine remission treatment, i.e. stopping treatment with buprenorphine.  Let’s hope the FDA recognizes the demand for that delivery system.
JJ

Sick from naloxone, maybe?

A person wrote about feeling ill after taking Suboxone, thinking that naloxone is to blame and frustrated that her physician would not prescribe Subutex:
I first read your blog last week as I was going through the despair and misery of withdrawal from Percocet, and considered suicide. I didn’t want to die, or create anymore suffering for my family; I just didn’t see any options or hope. Your well written words (I thank you deeply) about the hell of withdrawal got my attention & brought me to tears. I continued to read, found out about Suboxone, which led me to message boards from others like me. For the first time I felt hopeful. I found a doctor and made an appt, and after the initial, office administered dose I found myself feeling the best I had in years– no withdrawal and no physical pain – wow! At the 2hr follow-up I told (the doctor) that my pain was completely gone, which she disputed, saying it’s not prescribed for pain. What I know now is that she had given me Subutex in the office, and a Suboxone prescription to take home!!I filled the prescription, took the ½ pill dose, and within minutes my stomach hurt/gnawed, and I developed a very strange headache and mild to moderate chest pain. By the evening I’d vomited and the headache worsened. By next morning I had the worst headache ever and started vomiting large amounts of bile, all of which continued throughout the day. My doc insisted I show up for the follow up appt. that day, even though I was too sick to hold my head up. She insisted I was sick from withdrawal.

 


http://suboxonetalkzone.com
Chemical Structure of Naloxone

To date I’m taking 3 Excedrin for migraine within an hour of every Suboxone dose as I get a bad headache every time.  I also wake up with a moderate headache every day. The last few days I’ve noticed I don’t feel emotions, joy, or happiness. I feel depressed & don’t care about things that would typically give me happy goose bumps – my grandkids, my dogs, sunsets.

I asked the sub doc to put me on Subutex which she refused to do. I explained that if someone was this ill from BP or diabetes meds, and there were other options, it would be unethical to not help the patient. I spend $180 for medication that makes me ill- every day.
I’ve spent the day trying to find a doc who will prescribe Subutex, with no success. Ironically, a few years ago my own doc recommended this drug for my back/leg pain.  I don’t know what to do.  I can’t stay on Suboxone or go off. Do you have any suggestions? 
 My answer:
I hope that your weekend is going OK.  I have a few thoughts about your situation, but I don’t know how much help they will be, as ultimately you are dependent on the prescribing doc.  But maybe we will find something that will help.
It sounds like you have a pretty good understanding about buprenorphine and Suboxone, but there are a couple areas that need clarification.  For most people- more than 95% of people in my estimation—there is no difference in the subjective experience from taking Suboxone vs. Subutex.  The active drug, buprenorphine, is present in both, and the naloxone that is present in Suboxone has no significant effect.  The ceiling effect of Suboxone is due to buprenorphine;  naloxone plays no role in that effect.  Both Suboxone and Subutex can be used for pain, and both can be used for ‘induction.’  There are some misguided physicians out there who think that Subutex is a better choice for induction, thinking that naloxone will cause withdrawal during the induction process—but those doctors are wrong.  Both Suboxone and Subutex cause precipitated withdrawal, which comes from buprenorphine, not naloxone.  Naloxone does not pass through the mucous membranes lining the oral cavity, and instead ends up being swallowed, and taken up into the portal vein from the proximal small intestine.  In MOST people, naloxone is then rapidly destroyed by the liver before getting into the systemic circulation.  In a FEW people, though, naloxone causes side effects.  Side effects are of two basic types.  The first type is an allergic reaction to naloxone, causing flushing, wheezing, and perhaps nausea, vomiting, and/or rash.  Allergic reactions can occur from very small amounts of a substance, and so people can have allergic reactions to naloxone even when the drug is essentially cleared by the liver and too little remains to cause symptoms of withdrawal.
A second type of reaction is more common in my experience, and that is where the naloxone is not destroyed well be the liver and instead gets into the systemic circulation and then to the brain and spinal cord, where it blocks the opiate effects of buprenorphine.  In this case the person would have typical symptoms of withdrawal, including headache, depression, anxiety, restlessness, pain, diarrhea, and nausea.  Naloxone is not a long-lasting medication, so I would expect the withdrawal-type symptoms to last only for several hours.
As I mentioned, naloxone is usually destroyed very efficiently by the liver before reaching the systemic circulation, a process called ‘first pass metabolism.’.  There are many medications that interfere with liver enzymes, although I do not know of specific inhibitors of the enzymes that destroy naloxone.  In other cases, people have a genetic background that results in reduced metabolism of certain substances including naloxone.  Your symptoms occur shortly after each dose, which is what we would expect in a person who is not fully metabolizing naloxone.
I do not know why your physician is refusing to prescribe Subutex, but it sounds as if she is concerned about diversion.  In my opinion, concern in this instance is misguided.  Yes, there is a diversion problem with buprenorphine, but there is not a difference between Suboxone and Subutex in this regard—i.e. BOTH are diverted.  Studies suggest that buprenorphine is not generally diverted for the purpose of ‘partying’ or getting high, but rather is taken by addicts who are trying to treat themselves to get off opiates, or who need something to carry them over when heroin or oxycodone are not around.  In either case, the presence of naloxone does nothing to reduce diversion.  As you likely know, naloxone only prevents against intravenous use of Suboxone—a type of diversion that accounts for a very small percentage of cases.
You are welcome to share this with your physician.  Unfortunately there are some thin-skinned doctors out there though, so be careful that you do not get yourself kicked out of treatment!  I have a couple other suggestions that might be safer.  First, you are welcome to send me a list of medications you are taking, and I will check to see if any of them are inhibitors of the liver enzymes that metabolize naloxone.  Prozac, for example, is a potent inhibitor of one group of enzymes, and therefore can affect the half-life of a number of medications.
A second thing you can do has been described in earlier posts.  The idea is to absorb the buprenorphine without absorbing the naloxone.  Since naloxone is taken up only at the intestine, the key is to avoid swallowing the naloxone.  Start with a dry mouth.  Put the tablet in your mouth and bite it into pieces to get it dissolved in a small volume of saliva.  Then use your tongue like a paint brush, and spread the concentrated saliva over the mucous membranes in your mouth for about 10 minutes.   After ten minutes spit out the saliva, which contains the bulk of the naloxone.  Be sure to avoid eating or drinking for about 10 more minutes, as you don’t want to rinse away the buprenorphine that is attached to the surfaces in your mouth.   This method of dosing seems to be more efficient than placing a tablet under the tongue, and allows more control over the absorption of naloxone.   I’ve had a number of patients who initially felt that their dose of buprenorphine was too low, who then felt better dosing this way.  And I have had a few patients who believed they were getting headaches from naloxone, who had fewer headaches after dosing this way and spitting out the naloxone.
One final thought.  I did not address your comments about joy, happiness, passion, or depression because it is usually not a good idea for us addicts to focus on whether we are adequately ‘feeling’ those things.  Opiate addicts tend to spend too much time looking ‘inward,’ thinking about how they feel.  One goal with treatment is to get them thinking about things OUT THERE in the world, rather than about how they are feeling ‘inside’  (Don’t confuse this point, though, with ‘feelings work.’  Addicts tend to have a hard time identifying feelings and recognizing the nuances between one feeling and the next, and there is much to be gained in working on identifying and recognizing feelings during group or one on one psychotherapy.  This work is to be distinguished from the self-obsessed search for happiness that many of us addicts get wrapped up in from time to time).  Once a person decides he/she is not feeling ‘passion,’ the absence of passion becomes a self-fulfilling prophecy.  The same holds for feeling sad, lonely, or depressed.  I do not have an explanation for why Suboxone vs. Subutex would result in a lack of happiness or passion, except perhaps by causing low level withdrawal symptoms that affect mood.  I SUSPECT that those feelings are more ‘psychological’ than anything else.   I also do not know why your symptoms on Suboxone last all day long, although I suppose it is possible that for some reason your body metabolizes naloxone extremely poorly, causing it to sicken you for the entire period of time between doses.
If the ‘spitting technique’ works, that is one more bit of data that you can take to your physician.  Hopefully, if that is the case, she will have a change of heart.

Reckitt-Benckiser's 'Here to Help' Program– What do you think?

Reckitt-Benckiser, the first (but surely not last) manufacturer of orally dissolvable buprenorphine sold under the brand names Suboxone and Subutex, has been aggressively pushing doctors to refer addicts taking buprenorphine into a program called ‘Here to Help’ that they promote as something that will keep patients compliant with buprenorphine maintenance.  Regular readers of STZ know that I have not been impressed by Reckitt-Benckiser over the years, and so I’m not going to just jump on the ‘here to help’ bandwagon unless I see value in the program for my patients.  I have referred SOME patients to the program, but the feedback I have received has not been positive.   Patients have told me that they receive confusing or conflicting information, or that the person on the phone seemed ‘scripted’ and not responsive to the person’s specific needs, or that the information they were given assumed a knowledge level below what the patients already had.
Why am I unhappy with R-B, you ask?  If you go on the web site of any pharmaceutical company– from the smallest, like Dey Pharmaceuticals, distributor of the MAOI patch called Emsam, to the large companies such as Pfizer– you will find a section with procedures and applications for grant support for unrestricted educational programs, investigator-initiated trials, or other purposes.  Little Dey Pharma has released tens of millions of dollars for community educational projects.  Pfizer provides hundreds of millions of dollars for similar purposes.  But try to find a similar web site for Reckitt-Benckiser (the Suboxone division) — let alone any contact info for grant applications!  I have tried for several years to simply get the name of a person to speak to about financial support to expand my efforts, and the result is always the same?  I will receive a phone number of a low-level sales manager who tells me ‘he (she) will look into it and get back to me.’  I’m still waiting.  I would like to apply for assistance for what I do best– educate addicts about opiate dependence, and educate physicians about how addicts feel about treatment and about what their doctors are missing.  I would also like to create a program to address the internalized shame that most addicts on buprenorphine continue to struggle with, no matter how long they are away from active using.  I won’t go into specifics here, but there are so many things that could be done—that SHOULD be done.  I know some of the things the company spends money on; I resent that they do not see the value in my efforts.  And I am annoyed that they don’t even have an application process that would allow them to at least pretend that they are interested!
There are so many ways to become involved with buprenorphine; there are organizations like SAMHSA and CSAT and others that provide education and research into the use of buprenorphine.  I was a ‘mentor’ for physicians with new buprenorphine practices for a short time and I have considered becoming active in SAMHSA or the other agencies.  But if find those types of organizations to be inefficient compared to what I can do speaking to addicts directly, through the blog or forum.  I also know where my strengths lie, and where they don’t.  I do not do well as a ‘consensus builder’, for example—such people must be careful about what they say, whereas I tend to say what I am thinking.  If a meeting is running long because someone is repeating how much he/she wants to do the right thing for all of these poor addicts, I am the person who will stand up and say ‘y’know, that is a given—and this is all a massive waste of time.’  And then for some reason I won’t get invited back again!  Those meetings are not for me.  My favorite recovery ‘saying’ is ‘a good man knows his limitations’—and that is one of my limitations.  My strength comes from the fact that I understand how opiate addicts feel, and how they think.  I always seem to know what an opiate addict is going to say next.  On the other hand, I never have any idea what a government bureaucrat is going to say, or what I should say when speaking to one!
I suspect that R-B would like me to get on board the Here to Help message.  But I have reservations about the program.  I suspect, for example, that it is primarily being supported by R-B in the hopes of somehow using it to maintain their ‘brand’ over buprenorphine.  If that is their intention, good luck to them– it is going to need some awesome content to keep people buying Suboxone for $8 when generic Subutex is selling for $2.55 at Walgreens!
Today I received a brochure describing the results of a ‘study’ that claims that patients in the ‘Here to Help’ program had improved compliance as measured by maintaining appropriate use of prescribed buprenorphine.  As some of you may know I got my PhD in Neurochemistry doing basic science research and I have served as a Peer Reviewer for Academic Psychiatry for a number of years, so I know how to evaluate whether a study is ‘sound’ or is instead misleading. Even in the material that I received today, R-B refers to the findings as coming from a ‘quasi-study design’—so they at least apparently recognize that the findings are biased.  I participated in the data collection for the study, actually;   those of us who participated would invite new patients to participate, and the patients who accepted the invitations would then be randomized so that one group would get the ‘here to help’ info and the other group would not.  R-B found that the here to help group had better compliance and fewer drop-outs than the other group.  One problem I have is that I don’t know what they did for the ‘non-study’ group.  For example if they told the non-here to help group ‘Suboxone will kill you if you keep taking it’, then the difference in compliance would be meaningless!  I’m sure they didn’t say that, but what DID they say?
Second, there was no way to ‘blind’ the study on either side—both the addict and the phone person knew which group the study person was in.  We like studies to be ‘double-blind’, and this one was not even single-blind.
Finally, participation in the study was voluntary, and we don’t know anything about the factors that caused some people to enroll and others to avoid enrolling.  Let me explain how that bias could have affected the results.  Patients were paid to participate in the study, so I would guess that the addicts who were unemployed were more likely to participate.  Likewise, the addicts who were, say, executives from a high-profile company or physicians or attorneys would be less likely to participate, as they would be more concerned about disclosure of their status as addicts.  So at best, the ‘here to help’ study looked at a specific subset of addicts—those who were interested in making $100 by talking on the phone for a half hour.  Would the here to help program be of any value for a person who is still working, making good money, who has not suffered many consequences yet?  We don’t know.
So… I am interested in your feedback.  Have any of you used the ‘Here to Help’ program?  If so, what do you think about it?  If you have NOT used it, why not?  Did your doc tell you about it?  Leave your answers in the comments section—you do NOT have to leave a real name, and I will not use your e-mail for anything (it does not get displayed in your comment either).  Your comment won’t show up immediately; for spam purposes I will approve the messages as I receive them.  But here is your chance to let RB how you feel about that program—or about anything else, for that matter.  Will you use the generic, or stick with the brand?  Why or why not?  Leave your comments and I will be sure to send them at least as far up the chain as I can reach!
Finally, I continue to ask for your support.  I note that our forum is over 1500 registered members strong and growing; the older forum supported by R-B has about 200 registered members.  You must know that your presence just warms my heart!  If you have some money to spare and want to join me in my efforts (a pipe-dream of mine!), let me know and we will truly do some good things out there.  Lest anyone thinks I’m getting rich from this, I have received 3 donations of $50 over the past few years, and a few of $5-$10.  That’s it.  And that’s fine—I just don’t want y’all to think I’m cleaning up with this blog.  Maybe I should start posting each donation—leave a comment if you have an opinion on that as well!  If I help you out or if you care to support my typing away on the blog, or help with the self-publishing of my eventual ‘big book,’ a small financial donation is always greatly appreciated.
The main thing you can do to support me is to spread the word.  Send my links to anyone you know who takes buprenorphine– links for the blog, and for the forum too.  Better yet, print out the link and give it to your doctor and tell him that you like it (if you do!).
Got all that?  I suppose I could have just typed ‘what do you all think about the here to help program’ and gone to bed an hour ago!  As always, thanks for reading.  And I wish you all the best at keeping the scourge at bay.
JJ