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

$uboxone Clinically Identical to Buprenorphine??

As I give my last post more thought….  I wonder if there is ANY clinical difference between $uboxone at $7 per dose, vs. generic buprenorphine at $2.33 per dose?  Researchers out there– can anyone send me a reference?
Read my last post for details– but the essence is that naloxone is destroyed when Suboxone is taken properly (orally, sublingually), and has no action whatsoever– on that issue there is scientifc agreement (although there is a great deal of ignorance among prescribers about this fact).  The ONLY think naloxone does, is to supposedly serve as a deterrent to IV injection of buprenorphine.
Sounds good, but…  we know that people divert Suboxone intravenously, naloxone and all.  Buprenorphine binds opioid receptors very tightly- so tightly that the naloxone doesn’t effectively compete with buprenorphine.
The State of WI requires Medicaid patients to take expensive Suboxone Film, whereas in other cases they require prescribing the generic.  What is the argument for requiring the film?  RB would argue (now that the tablet has lost the luster of being on-patent) that the film is harder to ‘divert’– i.e. to inject.  But frankly, the intravenous diversion of buprenorphine is a tiny issue compared to things like heroin addiction and a budget crisis.  Most of the diversion of buprenorphine, either Suboxone or generic, is not injected, but rather taken orally to ward off withdrawal– and the film makes no difference in that case.
Insurers, likewise, are wasting millions of dollars (literally) by paying for Suboxone— sometimes exclusively(!)  Have the bean counters fallen asleep on this issue?
I have nothing personal against Reckitt-Benckiser, beyond the fact that they refuse to engage in conversation with me.  If the good Brits at RB have discovered a way to suck millions of dollars from the weakest members of society, more power to them.  But I am a big fan of intellectual honesty, particularly in regard to the science behind medical practice.  So if someone has evidence that $uboxone is clinically different than generic buprenorphine, whether used properly or injected, please send it my way.

Generic Subutex, aka buprenorphine– what's the dif?

I’ll take a break from the book to post a question and answer with a reader:
My daughter’s doctor recently started prescribing her a pill called only ‘buprenorphine,’ instead of her usual Suboxone. Should I be concerned about the change?
My answer:
You don’t mention the age of your daughter, but your question raises the issue of how involved should a parent be in the treatment of a child?  Perhaps a more general issue is whether anyone should be closely involved in the treatment of someone with opioid dependence?  After all, I frequently write that opioid addiction should be seen as ‘just another disease,’ and it is hard to make the case that people should share the details of their medical histories with others, at least after reaching adulthood.
But opioid dependence, while being a disease, does have some unique qualities—such as the effect of a worsening of the disease, i.e. relapse, on patients’ ability to make sound judgments.  Over time, I typically want patients to become responsible for their own outcomes; adult children of too-involved parents sometimes seem to be stuck in a state of chronic defiance, where the addict seems to think that a relapse is a statement of independence or a reflection on the parents, rather than the addict’s own problem.  But early on, it can be helpful to have someone monitor the addict’s behavior, and even control the buprenorphine.  Just remember that only the addict him/herself can determine, in the long run, whether a buprenorphine program will work—or whether it will just be one more failed treatment method.
Suboxone and Subutex (generic or brand-name) are interchangeable for the most part— except generic buprenorphine is about half the price of brand-name Suboxone  ($3 per tab vs. $6-$7).  The main chemical difference is the naloxone in Suboxone, which is not present in Subutex or generic Subutex (aka buprenorphine HCL).  Naloxone doesn’t cross mucous membranes; lipid soluble molecules like buprenorphine and fentanyl tend to pass through mucous membranes, and water soluble molecules like naloxone and morphine do not.  When a person takes Suboxone properly the naloxone ends up being swallowed, absorbed from the intestine into the ‘portal vein,’ and then completely metabolized at the liver before getting into the systemic circulation by a process called ‘first pass metabolism.’  The features of buprenorphine that make it effective for treating opioid dependence (for example the ‘ceiling effect’) do NOT require naloxone. Naloxone is added to Suboxone for one reason—to prevent intravenous injection of dissolved Suboxone tablets.  If Suboxone is dissolved and injected, the naloxone would enter the circulation, block opioid receptors, and cause an hour or two of withdrawal symptoms. 
There is not a great amount of injecting of Suboxone going on out there, and so for most people, generic buprenorphine is fine.  Some people who don’t completely metabolize the naloxone (because of genetic variants of liver enzymes, or perhaps because of taking cytochrome inhibitors like certain SSRIs) develop dysphoria for an hour or two after a dose of Suboxone, because the naloxone gets into their systemic circulation and causes withdrawal.
All patients who are pregnant are generally put on Subutex (or generic buprenorphine) because the low chance of injecting is not enough reason to expose the fetus to one more chemical.
I don’t know if your daughter is pregnant, but that would be one reason to take the generic.  Or it may be a cost issue, or perhaps she sometimes felt sick after taking her dose of Suboxone.  The theoretical risk from switching would be that she could then inject the buprenorphine, without the risk of withdrawal.  If she DID inject, she would not get ‘high’ from doing so;  the injected buprenorphine would have the same effects as when it is absorbed through the oral mucosa, only more quickly (i.e. zero effects, more quickly!).  Even for people NOT tolerant to buprenorphine, injecting buprenorphine is not generally a great way to get high;  the person develops a tolerance to buprenorphine very quickly, and within a day or two is ‘on’ buprenorphine going forward–  incapable of feeling opioid effects because of mu receptor tolerance, and vulnerable to withdrawal if the buprenorphine is discontinued.
I’ll be back with another installment of the book in a few days.  Thanks, as always, for reading; please share the site with other addicts and with those who love them.
JJ

Buprenorphine Film: Step Forward or Marketing Gimmick?

It i salways humorous when companies do what Reckitt-Benckiser recently did– make a small change in their product, then trash the old product in favor of the new, more expensive product.  “The OLD formulation is GARBAGE!  It poses huge risks! It is reckless and irresponsible to prescribe that tablet (the one that we’ve been marketing for years, that is…)”

buprenorphine film
The orange rectangle is buprenorphine film

For people who are confused, here is what happened…. Reckitt-Benckiser, the makers of Suboxone and Subutex, used to have a stranglehold on the market for buprenorphine.  Profits poured in from selling buprenorphine at ridiculous prices;  $6 per tablet in the Midwest for Suboxone, and over $11 per tablet for Subutex.  The prices were particularly obnoxious given that the company didn’t invent buprenorphine– in fact, buprenorphine has been around for 30 years, and could be purchased cheaply in bulk quantities.  All that RB did was come up with a sublingual formulation, and from that point forward they were essentially printing money.  Suddenly a cleaning product company is raking in the big bucks!
Of course at some point, patents expire.  Companies often sue to stretch out patents– and profits– as far as possible, but at some point the party comes to an end, and such is now the case with Reckitt-Benckiser and Suboxone.   The generic version of Subutex costs as little as $2.80 in my area;  RB has been stemming the bleeding from that generic by warning doctors that patients will dissolve and inject buprenorphine if naloxone is not mixed in– something that is exceedingly rare, given the long half-life of the medication, the aversion that most addicts have for needles, and the fact that most diversion of buprenorphine is by people seeking a way to stop using– not by people looking for a ‘buzz.’  But more recently Teva, a large manufacturer of branded and generic medications, received approval for their version of sublingual buprenorphine.  I have not seen it in pharmacies in the Midwest, at least not yet, but it will be more difficult for RB to deal with this form of buprenorphine– which will essentially be the same as branded Suboxone, only cheaper.
Some states, including Wisconsin, REQUIRE pharmacists to substitute less-expensive generics unless specifically blocked by the prescriber.  Insurers, both private and government, also require use of generics in the absence of a compelling reason to use the branded product.  That means that to get brand Suboxone, doctors will have to fill out paperwork explaining their reason for requesting the brand.  Doctors, of course, hate paperwork, and so I anticipate a huge shift to the generic product once it appears in pharmacies.
RB, then, is in a pickle.  So some marketing guy gets the idea to put buprenorphine in a listerine-style breath strip, sell it indiviually packaged, and tell everyone that individual tablets of Suboxone are a huge risk to the public.  They tell us that little kids put them in their mouths, that the packaging isn’t safe enough, or that the tablets absorb moisture, making their sublingual dissolution rate unpredictable.  Better use the strips intead, they say.
I tried one of the strips– one that was a ‘dummy strip’ that did not contain buprenorphine.  The instructions are to put it under your tongue, but as I have written here many times, there is nothing special about the under-the-tongue space, and they can be put on top of the tongue if that is easier;  the point is to get the molecule in contact with the mucous membranes that line the mouth.  I like the idea of the strip in theory;  the absorption of buprenorphine is driven by the concentration gradient of the molecule, and the film helps deliver a highly concentrated dose of buprenorphine to the surface of the oral mucosa.  The film could also conceivably be cut into small pieces using an exacto knife, to help with tapering the drug.  But in practice, the film was unpleasant to use.  It was thicker than I expected, sort of like a cross between a Listerine strip and a gummy worm.  It took longer to dissolve than I expected, and the taste was nasty.
So what is the conclusion?  Is the strip a leap forward in safety and convenience?  Or is it just an attempt to hang onto a brand?  I suppose that answer depends on how you see the world, and how you see a cleaning products company from the UK that struck it big on the backs of US opioid addicts.

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

Generic Suboxone i.e. buprenorphine

Great news from SuboxForum.com, a.k.a. buprenorphorum.com, where today Chris55552 posted the following:
Hey everyone, Not sure who all keeps up with pharma news or the reputation/quality of generic drug companies but I recently
discovered that Teva Pharmaceuticals (generics) has their version of generic subutex available. Teva USA is the most dominant generic company in the US and is highly regarded as High grade quality.
Marketing Start Date:05/10/2010
Tablets will be available in the following:
2 mg: White, oval, flat-faced, unscored tablet. Debossed with 798 on one side and stylized b on the other side. Each tablet contains 2.16 mg of buprenorphine HCl, equivalent to 2 mg of buprenorphine base.
Available in bottles of:
30 Tablets NDC 0093-5378-56
100 Tablets NDC 0093-5378-01
8 mg: White, oval, flat-faced, unscored tablet. Debossed with 799 on one side and stylized b on the other side. Each tablet contains 8.64 mg of buprenorphine HCl, equivalent to 8 mg of buprenorphine base.
Available in bottles of:
30 Tablets NDC 0093-5379-56
100 Tablets NDC 0093-5379-01
Please join as at buprenorphorum.com, where you will find loads of info about the treatment of opiate dependence.   And to Chris55552, Thanks for the update!

More on the generic form of buprenorphine

Hey Doc,
I went to Walgreens early this morning and they had the drug on hand. So, if there is anyone who still has doubts as to the drug being available at local pharmacies- this shows the 2nd largest drugstore chain has it available in its pharmacies.
Note: the writer is referring to a Walgreens in Wisconsin.
The tablets themselves are round and white with the imprint of 54 411 on one side and a blank opposite side. Really the best way to describe them, is that they are identical in every feature (minus the imprint code) as the “512 Generic Percocet” tablets. As for taste and texture I found them to be much easier to tolerate than the fake orange Pez flavor laced with formaldehyde that Suboxone leaves in your mouth for hours. To me it was as if chewing a large aspirin and holding it in my mouth. Yes, it was slightly bitter, but the flavor itself was mainly inert and inoffensive.
Now as for price… Walgreens lists the retail cash price for 60 tablets to be $152.99 which translates to $2.55 x tablet. Less than half of what the name brand cost!!!ee
Note: in Wisconsin, Walgreens has always been the costliest place to purchase Suboxone, with prices up to 50% higher than other pharmacies such as Wal-Mart, Pick N Save, ShopKo, and even the smaller mom and pop pharmacies.  I would expect for that reason that the generic could be found for even less money with a bit of calling around.
Hopefully some good news!
-jp
Thanks JP!