Addiction Treatment Has it ALL WRONG

Today on SuboxForum members discussed how long they have been treated with buprenorphine medications.  Most agreed that buprenorphine turned their lives around, and most are afraid they will eventually be pushed off the medication.  Most buprenorphine patients described a reprieve from a horrible illness when they discovered buprenorphine.  But most have new fears that they never anticipated– that their physician will die or retire, that politicians will place arbitrary limits on buprenorphine treatment, or that insurers will limit coverage for the medication that saved there lives.
I joined the discussion with the following comment:
I give lectures now and then about ‘Addiction, the Medical Illness.’  Once a person thinks through the topic several times with an open mind, the right approach to treating addiction becomes obvious.    After all, doctors ‘manage’ all illnesses save for a few bacterial diseases, and even those will become at best ‘managed’, as greater resistance develops in most bacteria.  We doctors rarely cure illnesses.  We manage illness.
The public’s attitudes toward treating addiction differ from treatments for other diseases.  Avoiding effective medications isn’t  a goal for other illnesses.  In fact, in most cases doctors refer to skipping medication negatively, as ‘noncompliance.’  There are religious orders that don’t believe in medication including Christian Scientists… and there are religions with specific beliefs, e.g. Scientology, that don’t believe in psychiatry, or Jehovah’s Witnesses who don’t accept blood products. I assume that attitudes toward addiction developed over the years when no medical treatments effectively treated addiction.  Doctors and laypersons came to see addiction as untreatable, and the only survivors people who found their rock bottom and in rare cases, saved themselves.  And since nobody could fix addiction, and the only chance at life was to find ‘recovery’, a nebulous concept based on spirituality, adherence to a group identity, and correction of ‘personality defects.’
What an obnoxious attitude– that people with addictions have ‘personality defects’!  Even most of the docs and therapists who ‘get it’ about medication insist that no patient will heal until we ‘fix the underlying cause of his/her addiction’.  What a bunch of crap…  as if all of those people out there WITHOUT addictions have GOOD personalities, and all of those people who got stuck on opioids (mostly because of bad doctors by the way) have BAD personalities.  I call BULL!  Opioids are powerfully-addictive substances, and a percentage of people  exposed to them, regardless of character, become addicted.  My personality was apparently good enough to get a PhD, get married, save a drowning woman, have a family, go to medical school and graduate at the top of my class with multiple honors, become an anesthesiologist and get elected president of my anesthesia group an unprecedented 3 times.  But taking cough medicine that grew into an addiction to fentanyl means I have ‘personality defects’??!!
I’m sure everyone has his/her own story.  But we’ve all heard so often that we have some broken screw at the base of our brains that we’ve started believing it.  And the mistreatment by doctors and pharmacists (and reporters and media and society in general) perpetuates that shame among all of us.
The truth is that our ADDICTIONS caused us to do things that were wrong.  We developed an intense desire to find chemicals because of the activation of addictive centers in our brains.  And THAT caused our ‘character’ problems.
I’ve written before about the ‘dynamic nature of character defects’.  Search my name and that term, and you will find the comments- or just click here.  The character problems so obvious in using addicts are driven by the obsession to find and use opioids.  When you treat that obsession with buprenorphine, those ‘character defects’ disappear.  I’ve seen the process unfold over and over, in patient after patient.  Some doctors perpetuate character problems by treating patients like criminals, and ANY person will develop character problems if treated poorly long enough.  In that way, the defects can become a self-fulfilling prophecy.
The character defect argument is the whole reason for counseling.  But get this– there have been several studies that looked at abstinence after discontinuation of buprenorphine after one year, with or without counseling.   And the counseling group did WORSE in those studies!  Of course, everyone interprets those studies by saying that ‘the counseling must not have been done right’ or it was not intense enough, rather than accept the data with an open mind, as any good scientist would.
Vivitrol (i.e. depot injections of naltrexone) are the biggest example of treatment based on flawed ideology.  The treatment rests on the idea that if we block receptors and counsel the heck out of people, we can fix their character defects and their addictions so they won’t use when Vivitrol is removed.  The travesty is that nobody will look at the results of this vast experiment, mostly played out in drug courts.  When you think about it, we have a long history of experimenting on people caught in the criminal justice system.  Studies in Australia showed a 12-fold higher death rate in addicts maintained on naltrexone and ‘counseled’ compared to people maintained on methadone.   When the people forced onto Vivitrol by the legal system start to die, will anyone keep track?
Deaths after residential treatment are common, but nobody keeps track of them.  So I’m not holding my breath for outcome data from the failures of drug courts!
Every serious chronic illness warrants chronic medical treatment, save one.   All healthcare professionals will say, some reluctantly, that addiction is a disease.   It is time to start TREATING IT LIKE ONE.

I am Addicted to Heroin. What Should I Do?

I’ve been spending more time answering questions on SuboxForum, and less time writing blog posts.   I’ll share a comment from today in the hopes that someone looking for help will stumble across this page.
A newcomer to SuboxForum posted this succinct question:
Will someone PLEASE help me take the first steps into the right direction? I have been on opiates and heroin for 10 years and it is starting to ruin my life. I don’t know what to do first?
My less-succinct reply, with minor editing:
Sometimes people get too focused on choosing the right approach and end up doing nothing—sometimes called ‘paralysis by analysis.’  Your options are largely determined by your circumstances– so your first mission is to find out what is available.  There are people who put down medication-assisted treatments like buprenorphine (aka Suboxone) and methadone, saying that they are ‘replacing one drug for another’.  But either of those approaches have much better success rates than residential treatment, and they are both easier to start.
Methadone or buprenorphine will each stabilize your situation fairly quickly, allowing you to step back and weigh your options without the daily search for opioids.  With either buprenorphine or methadone treatments you lose nothing by getting started.  If you start buprenorphine and decide it isn’t right for you, you can simply go back to heroin or oxycodone.  The same is true for methadone.    People rarely make that choice– and when they do, it usually wasn’t a deliberate change, but rather the addiction gained the upper hand and pulled them away.  But the point is worth making that you can always go back– because every now and then someone comes here and complains to be ‘stuck on buprenorphine’.  I try to point out that they are stuck on opioids– and they can always go back to where they were before they started buprenorphine.
The question is whether you have access to either medication in your area.  If you Google ‘find addiction treatment’ or a related search, you will get listings of many outdated web sites.  I’m disappointed to see that even the SAMHSA site is extremely outdated, listing programs that are no longer available and not showing newer treatment programs for either methadone or buprenorphine.
I have a web site that lists a number of buprenorphine doctor directories at SuboxDocs.com.  The site is a ‘directory of directories’, and some of the databases are more current than others.
I’m just now noticing how difficult it must be to find a treatment program.  The last time I really looked at the databases was maybe 5 years ago, and I remember seeing a number of sites that were fairly current.  I assumed that the information was only better now– but it appears to be worse.  If anyone reading this knows of good resources for FINDING treatment, leave a comment!
Another option for someone seeking treatment is to call your county health department.  I would think that most counties would have a list of programs in their area.  Finally, many people hear about a treatment program through word of mouth.  I don’t usually recommend increased contact with people who are actively using, but if you are in contact anyway, you might as well ask!
Buprenorphine treatment will have a higher ‘front end’ cost.  In my area, initial costs are $300-$500.  Ongoing costs include the medication (usually covered by Medicaid or private insurance) and the cost of monthly doctor visits.  Things to consider when choosing a long-term provider:  Are doctor visits covered by Medicaid or insurance?  If not, what will the visits cost?  Who pays for drug testing?  How much does that cost?  If you don’t have any insurance at all, will the doc prescribe plain buprenorphine (which is less costly than combination products)?  Are you required to be in counseling?  If so, how often, and where?  Some docs use buprenorphine to fill their counselors’ time slots, which pushes ethical borders a bit in my opinion.  Other considerations… Does the doctor provide other services such as mental health treatment?  Does the doc allow you to be treated with benzodiazepines?  What is the doc’s attitude toward marijuana?  Will you be kicked out if you test ‘dirty’?  Is the doctor ‘punitive’– i.e. will you be tossed from the program if you struggle a bit?  Or will the doctor work with you, if you don’t get it perfect right away?
Methadone programs in my area are covered by Medicaid, making them essentially free for people with that coverage.  But as people do better and find jobs, they often lose Medicaid and have to pay for methadone out of pocket, which can be costly… although never costlier than active addiction, especially when you factor in all of the related costs that come with actively using.
If you do not have access to medication-assisted treatments, you may need to consider abstinence-based treatment programs.  I’m not a big fan of abstinence programs for opioids because of the high relapse rates with those substances, and the high death rate during relapse.  And of course, an abstinence-based program requires detox and withdrawal.  People who lack an understanding of the usual course of opioid dependence see abstinence-based treatment as the best option.  But the only way to see things that way is by ignoring all of the data, or by assuming that in THIS case, things will go differently than usual.  That thought is very seductive to the parents of addicted young people, and I have known a number of people who died after falling victim to that seduction.
Most people who have been addicted to opioids for a year or more have already learned that detox alone provides little value.  If simple detox works for you, you were probably physically dependent, not addicted.  If you have detoxed and then relapsed several times, another detox is not likely to be helpful.  In fact, detox introduces danger into the equation, as many overdose deaths occur after a person has been through detox, either voluntary at a treatment program, or forcibly through incarceration.  Methadone and buprenorphine are both safer options because they keep tolerance high, reducing the risk of overdose.
My bias toward medication-assisted treatment comes across loud and clear, I know.   I don’t intend to assert that residential programs have NO value; I just think that too-often people enter them without understanding the long odds for finding success.  The people who do best with abstinence-based treatments are those who are monitored for a long time and have a lot to lose, such as people trying to regain professional or occupational licenses, or trying to avoid prison.  In all cases, the treatment is just the beginning of a lifetime of working to maintain sobriety.
An aside to the treatment community:  I often give talks about the need to treat addiction as an illness (and I generally accept requests to speak for a couple hours on the topic, in case anyone has need for a speaker!).  For decades, we all envisioned a paradigm where addiction responded to intensive, months-long abstinence-based treatments, followed by lesser-intense ‘aftercare’ and meetings.  Physicians had minor roles, or no role at all.   There is a growing awareness that things need to change.  I don’t claim that doctors understand addiction better than the current treatment community, and in fact I assume that the opposite is true.  But doctors can prescribe medications with the power to preserve life far more reliably than abstinence-based treatments.
There is a saying–  ‘perfect is the enemy of good’.  We are losing thousands of lives in the search for a ‘perfect’ treatment.  For almost all other illnesses, doctors provide medications and recommendations in order to ‘manage’ the illness.   Now more than ever, addiction warrants the same medical approach.

Questions, Excuses, Krokodil

I’ve been in more of a chatty mood lately, as regular readers have likely noticed.  I find it interesting that weeks will pass when I have little or nothing to say… and at other times, I have all sorts of random thoughts to discuss.
Excuses first– I’ve been tinkering with ads for the past few days, and I apologize to those of you who tried to read a post while I was activating and deactivating Wordpress plug-ins.  After experimenting with different colors I’ve decided that basic grayscale is the best.  For those who don’t blog, ‘plug-ins’ are small, add-on programs that add a range of functions to a blog.  There are literally thousands of them out there;  some free, some for a small charge.  A couple dozen plug-ins are designed to add the code for Google Adsense to a blog, with a range of features including adding ads randomly to old posts, etc.  I’ve found that some work better than others; a couple of them really messed up the other blog functions, causing the top banner to appear at the bottom and vice versa.  I THINK I have things working OK now;  if you are having trouble, please send me an email (drj at Suboxonetalkzone dot com) and tell me the nature of the problen, and the browser and operating system you are using.  Thanks!
Another neat feature of WordPress is that you can review a number of different statistics for a blog, including the keyword that each viewer searched for before arriving at the site.  I see certain questions posted over and over;  I presume those questions are about things that come up often in the lives of people on Suboxone.  I used to do ‘questions and answers’ on a regular basis;  I’ll try to get back to those now and then, using the most popular queries as starting points.
Yesterday, several people searched for phrases related to buprenorphine and workplace drug testing.  I’ve received a number of questions by email about that same topic.  People wonder if Suboxone (buprenorphine) shows up in drug testing, and whether they should disclose that they take the medication before the test.  This is a very tough issue.  I believe that people who take Suboxone properly are NOT impaired by the medication.  There was an article from the Mayo Clinic Proceedings recently that claimed that people ARE impaired by Suboxone, and therefore certain occupations– notably physicians and nurses– should not work at those jobs, if taking Suboxone.
There were at least two things that made their conclusions… ridiculous.  First, the authors wrote that doctors’ work is so uniquely difficult, that it challenges gray matter so much more heavily than other occupations, that doctors should avoid buprenorphine treatment.  To that, I say that a recovering anesthesiologist taking Suboxone is much safer than a recovering anesthesiologist, holding fentanyl in his/her hand, not on Suboxone!  Even if you take away the risk that the non-Suboxone doctor is using, one must consider the effects of cravings on vigilance.  I’ll take the doc on Suboxone, who is placing all of his attention on ME, over the guy reciting the serenity prayer to himself and pondering the decision over what can be ‘changed’ and what can’t!  Of course, that’s just me…
I was also impressed by the ego of the writers, who think that a pediatrician or radiologist has greater need for an ‘unmedicated brain’ than a jet pilot, or a welder ten stories up, or a long-haul trucker, or a nuclear physicist. Yes– doctor jobs are ‘uniquely’ difficult!  (add sarcasm here).
The conclusions were deeply flawed in other ways.  To determine the effects of Suboxone on performance, they looked at studies that gave people opioid agonists or buprenorphine, and concluded that the effects were similar.  I mean really– people who are not on Suboxone regularly, without a tolerance to opioids, taking buprenorphine?  OF COURSE the people were messed up!  Suboxone has potent opioid effects;  there is no argument to that point.  But the unique ceiling effects of buprenorphine allow the subjective effects to go away, as tolerance is established.  That’s the whole point of Suboxone treatment!
I’m off on a tangent, right?  Back  to drug testing…  I do not think that people on Suboxone, who take it properly, are impaired in any way.  So I do not believe that people should have to disclose their treatment, and their history, to their potential employers.  But my opinions on the matter are irrelevant, unless the new/old President-elect appoints me as Attorney General… and odds are not in favor of that happening.
I can say that I’ve received 20-30 emails over the years, asking about employee drug testing.  In each case I asked the writer to follow-up and let me know what happened.  Some ended up disclosing that they were on Suboxone, and most did not.  To date, nobody has written back to say that they were denied the job over the issue.  I therefore conclude that most employers are ignoring buprenorphine, at least at this point.  That’s the best answer I have;  I can’t recommend any specific course of action.
Finally… today I came across an old post on my forum about a drug that was sweeping across Russia last year, called Krokodil.  The drug apparently is made from over-the-counter codeine tablets, in a process that creates a cheap concoction of opioids in a toxic sludge.  Users of the drug describe withdrawal more severe than opioid withdrawal, that includes seizures.  And within days of starting a habit, users slough off large sections of skin and other tissue from their arms, legs, torso– even from the face.  Not for the faint of heart— if you search the name of the drug under Google Images, you will find horrifying photographs of the damage inflicted on people addicted to the substance.
If anyone really thinks that drug addiction is a ‘choice,’ please tell me what, exactly, those tragic people were thinking.

The Suboxone Business Fix

I have shared my thoughts about ‘Suboxone Film,’ a product that serves only one purpose:  to block generic competition from entering the Suboxone market.  Below I’ve copied a Bloomberg article that discusses the current nature of the buprenorphine/naloxone business, and the efforts by RB to prevent market penetration by generics– something that would lead to price reductions for healthcare consumers.

Suboxone Doctors act dumb with buprenorphine
Dumb about naloxone?

Unfortunately, the Bloomberg article overlooks the most significant threat to the profits of Reckitt-Benckiser.  This threat is mitigated only by the ignorance of many of the physicians who prescribe Suboxone.  The threat to profits consists of a simple fact that RB does not want anyone to realize:  that the generic equivalent of Suboxone is already available, in the form of orally-dissolving tablets of buprenorphine.

I encourage physicians who doubt my comments to do their own ‘due diligence’ and break out their old pharmacology textbooks.  I have a hard time understanding how people who graduated from accredited medical schools can get things as wrong as they do with this issue.  I sometimes present opinions, but not with this post.  The facts about buprenorphine and naloxone that I’m about to describe are described in any pharmacology textbook— e.g. Goodman and Gilman—and are not in dispute in any way.

Suboxone consists of buprenorphine plus naloxone.  Naloxone is an opioid antagonist that is added to reduce diversion of Suboxone in the form of intravenous injection of a dissolved tablet.  Naloxone is NOT ACTIVE when not injected.  The molecule is poorly absorbed through the oral mucosa because of the molecule’s size and poor lipid-solubility.  Instead, naloxone is swallowed, absorbed from the small intestine, and totally destroyed at the liver before reaching the systemic circulation through a process called ‘first pass metabolism.’

I suspect that some physicians confuse naloxone with the similarly-named substance naltrexone, an opioid antagonist (blocker) that IS orally active. There is NO naltrexone in Suboxone.

All of the beneficial aspects of Suboxone come from the partial agonist buprenorphine.  The ceiling effect of buprenorphine causes a reduction in cravings through a process that I’ve described in earlier posts.  Naloxone, on the other hand, does absolutely nothing to reduce cravings, to increase safety, to reduce euphoria, etc, provided that the medication is not injected.

The confusion surrounding buprenorphine essentially consists of intellectual laziness or intellectual dishonesty by the physicians who prescribe the medication and the pharmacists who dispense it.  I realize that not all doctors are cut out to be ‘physician scientists’ who understand pharmacology in great detail.  But I am particularly disappointed that the large organizations that supposedly oversee the science of addiction treatment have dropped the ball on this issue. I don’t know why groups like ASAM and SAMHSA don’t get it– whether the problem is ignorance, or whether there are mutually beneficial relationships between these organizations and RB that encourage the organizations to foster ignorance among
patients and doctors.  I don’t belong to the organizations primarily for this reason– and I blame ASAM and SAMHSA for the current status of addiction treatment as the ‘no science zone’ of modern medicine.

 A few examples of intellectual laziness: 

Example 1:  Physicians who prescribe Suboxone often say that one shouldn’t use buprenorphine ‘because it doesn’t have the opioid blocker and therefore….’ (add whatever here– it causes euphoria, it is addictive, it isn’t safe– any or all of these comments). The statement is partially correct. Generic buprenorphine does not have the opioid blocker naloxone— but naloxone is irrelevant to the actions of Suboxone!

There are TWO opioid blockers in Suboxone, but only one is clinically relevant—the one that is in both Suboxone and generic buprenorphine.  What is the relevant ‘opioid blocker’ that IS
in both Suboxone and generic buprenorphine?  Buprenorphine!   As a partial agonist, buprenorphine has antagonist properties that are responsible for ALL of the effective clinical properties of Suboxone.

Example 2:  Refusing to consider the cost of medication as a factor that determines access to treatment.  Some docs make ‘fear of diversion’ the only factor in determining what to prescribe.  Discussions with hundreds of opioid addicts over the years have convinced me that buprenorphine is rarely a drug of choice.  Rather, it is used by addicts who are sick and tired and want a break from using without withdrawal, or by addicts who have no money or access to agonists.  In such cases, buprenorphine or Suboxone are equally effective– and equally diverted.  When I ask addicts new to treatment about their injecting habits, I often ask whether they injected buprenorphine or Suboxone.  The typical response is either ‘can you do that?’ or ‘why would I do that, since heroin is cheaper?’

In my area, an 8 mg tab of buprenorphine costs as low as $2.33.  This low cost should be part of the equation for choice of medication, just as it is for other illnesses.  Does anyone doubt that there are some people kept from treatment by a price differential of 300%?!  Is it ethical to fear diversion so greatly that treatment is effectively withheld– for a condition with the fatality rate of opioid dependence?!   I’m sure readers know my answer, especially when there are effective ways to reduce diversion, such as close monitoring of prescribed doses, a ‘no replacement’ policy, and drug testing, among others.

Example 3:  There is some question whether the naloxone in Suboxone does anything to reduce diversion. Buprenorphine patients on my forum  who have injected Suboxone in the past have claimed that they did not experience withdrawal from either Suboxone or buprenorphine, consistent with what I would expect from combining a low-affinity antagonist with a high-affinity partial agonist.

Note: Injecting ANYTHING is in essence taking your life in your hands, and I strongly encourage anyone in such a position to seek treatment immediately.   Really—don’t do it.

Example 4:  Insurers generally refuse to cover generic buprenorphine (the generic form of the RB drug Subutex), even though it is much cheaper than Suboxone.  The one time they WILL cover Subutex or buprenorphine is for women who are pregnant or nursing.  The argument is that we shouldn’t expose the fetus/infant to one more drug (naloxone), since that drug isn’t necessary to the actions of Suboxone.  I agree with the argument, and wonder why it is extended only to the fetus?  Why does mom or dad have to be exposed to an extra substance(naloxone) that isn’t necessary to the actions of Suboxone?

I struggle to understand the insurance issue, as I would expect that someone at some major insurer would know enough about pharmacology to save money on Suboxone by favoring gen
eric buprenorphine.

The ultimate of silliness is that the State of Wisconsin requires that people on Medicaid use only Suboxone FILM.  Getting Abilify for a patient is virtually impossible without first using a variety of older, cheaper medications… but the squishy arguments in favor of Suboxone Film push the med up the formulary chain past an alternative that sells at a fraction of the cost.  The film/Medicaid situation is doubly dubious, as we have the arguments for buprenorphine over Suboxone, and the even less-sound argument for Suboxone Film being favored over the tablet.

RB apparently convinced the state that for Medicaid patients, only the film was safe– and that the film should be required instead of the tablet form of Suboxone, placing future generics at a great disadvantage.  It is especially impressive that RB accomplished this feat after selling a million units of the tablets themselves!  I can picture the person making the point:  ‘the tablet is unsafe…. Starting NOW!’

I’m going to write all night if I don’t wrap this up.  To summarize, the Bloomberg article below describes why RB is winning the battle with generics, but the writers of the article, along with most doctors, miss the bigger issue– that misplaced fears, intellectual laziness, and misinformation have protected Suboxone sales from a much greater foe-– generic buprenorphine.  If doctors, states, and insurers ever get their acts together and prescribe according to science, brand name Suboxone profits will go down the toilet faster than the cleaning products made by RB.

The Bloomberg piece:

Reckitt Benckiser Kicks Heroin Tablet Habit With Film: Retail

By Clementine Fletcher

Reckitt Benckiser Group Plc may be kicking its heroin problem.

After losing U.S. patent protection in 2009 for its Suboxone tablet, designed to help heroin users quit, Reckitt Benckiser has said that the entrance of a generic competitor could erode pharmaceutical sales and profit by 80 percent (note by JJ:  What a shame?!  Consider the benefit of such a price reduction for addicts in need of treatment!).

Reckitt Benckiser, which gets most of its revenue from selling home and personal-care products like Lysol cleaners and Durex condoms, has faced calls to sell the business before a generic comes to market. Instead, the London-based company aims to divert the showdown by switching users to a film form of the drug — one whose last patent doesn’t run out until 2025 (note by JJ:  NOW do you see why they made the film?!)

To get people to make the switch, Reckitt Benckiser is thinking more like a consumer company than a pharmaceutical one. It’s drawing on a marketing technique first pioneered by Coca- Cola Co. more than 100 years ago: coupons. By offering up to $45 a month toward a user’s co-payment in the U.S., the company is making the film version, which looks like a Listerine Pocketpak, close to free. That offers patients who get part of the bill subsidized by health insurance little incentive to transfer to a generic pill once it appears on the market.

“They’ve done a good job of making a silk purse out of a not very compelling situation,” said Martin Deboo, an analyst at Investec Securities Ltd. in London.

Reckitt Benckiser’s shares have risen 55 percent in the last five years, outpacing Unilever and Procter & Gamble Co. Under Chief Executive Officer Bart Becht, who stepped down last month, the company more than doubled sales in a decade. The stock has dropped 3.7 percent this year, compared with Unilever’s 4.7 percent gain and P&G’s 1.2 percent gain.

Drugs Growth

The company is due to report third-quarter results tomorrow and will probably say revenue adjusted for purchases and asset sales rose 7 percent at the drugs division, analysts led by Andy Smith at MF Global in London estimate, compared with a 3.9 percent increase for the rest of the business. Profit likely rose 0.9 percent to 430 million pounds, they said.

The film version of Suboxone, introduced in September 2010, accounted for 41 percent of the drug’s U.S. sales by the end of the first half (note by JJ:  Thanks, Wisconsin Badgercare!). That surpassed the company’s own expectations, Becht said on an Aug. 30 conference call arranged by Sanford C. Bernstein. Becht was succeeded by Rakesh Kapoor, a company veteran.

Generic Delay

The film “has been a phenomenal success,” Becht said, according to a transcript of his remarks. “To make the business completely sustainable, we would like to have a share which is clearly much higher than where we are.” He added that the company aims to grow that share every month.

Right now, time is on his side. Teva Pharmaceuticals Industries Ltd., the world’s biggest maker of generics, began the year saying it might launch a Suboxone copy in 2011. Now the company has backed off, saying it no longer expects the product to win regulatory approval this year.

Biodelivery Sciences International Inc., another drugmaker going after Suboxone, said a study comparing its own version of the drug to a placebo failed to show a statistical difference in the treatment of chronic pain. A test in patients addicted to opioids, which include heroin and codeine, is scheduled to begin
later this year. Titan Pharmaceuticals Inc. on Aug. 31 said it’s preparing to seek approval of an upper-arm implant that would deliver buprenorphine, one of
the active ingredients in Suboxone, directly into the bloodstream (note by JJ:  the ONLY active ingredient in Suboxone!)

‘Massive Benefit’

“This delay has been a massive benefit,” said Andrew Wood, an analyst at Sanford C. Bernstein. “With every day that goes by, RB has an extra day to convert users.” Suboxone is either harder-than-expected to copy or generic-drug makers are having second thoughts about targeting addicts, according to Bernstein.

About 1 million people in the U.S. are addicted to heroin, the National Institute on Drug Abuse estimates. As many as 325,000 people use Suboxone to quit the drug or painkillers, says Pablo Zuanic, an analyst at Liberum Capital in London.

The medicine combines buprenorphine, a painkiller derived from the opium poppy that shares some of its properties, with naloxone, a chemical that blunts
withdrawal symptoms (note by JJ:  This is simply WRONG.  BLATANTLY WRONG.  Really–  an opioid antagonist BLUNTING withdrawal symptoms?  Shame on the writers!). The film sells for about $4.63 to $8.23 a dose at Walgreens stores, according to Liberum, depending on its strength and pack size. That means the strongest dose costs about $247 a month.  (note by JJ—a pharmacy near my practice sells generic buprenorphine dissolvable tabs, 8 mg, for $2.33 per tablet—a medication that works EXACTLY the same way IF NOT INJECTED INTRAVENOUSLY)

More than half of people on Suboxone use private insurance with co-pay, Zuanic says. Reckitt Benckiser offers $45 towards co-pay for the film, he said, meaning an insured patient who’d contribute $50 to the cost of the drug may end up spending $5.

‘Near Zero’

“The actual cash cost for some patients buying the film with private insurance could be near zero,” Zuanic said in a note to clients this month. (note by
JJ:  but we are all paying the cost in higher insurance premiums, and some insurers, notably Humana, have draconian policies that stop covering—forcing instant withdrawal- if a patient receives a prescription for a sleep medication such as Ambien, so many people are left paying cash).

Meantime, Suboxone is only becoming more important to Reckitt Benckiser. The drugs division, whose sales grew five times as quickly as the main business last year, accounted for almost 9 percent of sales and 24 percent of profit, up from 7.6 percent and 20 percent in 2009. Sales a
t the unit will probably rise 12 percent to 829 million pounds ($1.3 billion) this year, according Nomura International Plc estimates.

The maker of French’s mustard is even considering making an injectable Suboxone and developing new products for cocaine, alcohol and cannabis addicts.
The plan has met skepticism.

“We’re quite a long way from having any visibility on these products,” said Julian Hardwick, an analyst at Royal Bank of Scotland Group Plc in London. “Are they products that will work? Which will get approval?”

Prescription drugs are perceived as a bit of a misfit in the home of Vanish stain removers and Finish dishwasher tablets.

Misfit

“Reckitt Benckiser is basically a home and personal-care company with over-the-counter pharmaceuticals,” said Carl Short, an analyst at Standard & Poor’s in London. The drugs unit is “always going to be something that looks like it doesn’t fit with the rest.”

Reckitt Benckiser may look at selling the unit, which Becht himself has said is “not the No. 1 strategic part” of the company, once a generic form of Suboxone reaches pharmacy shelves, analysts said. (note by JJ:  i.e. after all of the profit has been wrung from suffering addicts).  But the company’s marketing savvy, coupled with delays in the launch of a generic, are giving Kapoor time to settle into his new job.

“This is a big job and he is coming in after someone’s done it for some considerable time and very well,” said Julian Chillingworth, who helps manage about 16 billion pounds in shares at Rathbone Brothers Plc, including Reckitt stock. “You wouldn’t want to come in as a CEO into a very successful business and start selling things off on the cheap.”

Not Time

Analyst valuations range from 2 billion pounds to 6.3 billion pounds, according to four estimates compiled by Bloomberg News. Estimates diverge because it’s hard to value the business without knowing how Suboxone sales will resist the generic challenge and whether the shift to film can counter some of that impact.

“Until you get generic competition for the tablet, I think it’s unlikely that prospective buyers would give you the full value for the business,” said Hardwick of RBS. “Now is not the time to sell.”

–With assistance from Naomi Kresge in Berlin. Editors: Celeste Perri, Marthe Fourcade.

 

 

Stopping Suboxone

Liquefied Suboxone taper methodI recently received a question about stopping Suboxone (buprenorphine)…. I deleted the message but I remember the bulk of it, and I have a copy of my response. I thought that someone else out there may find it useful, so here it is:
The question:
I have decided to go off Suboxone after that was recommended to me by almost everybody. My doctor told me to taper off by going down to 2 mg per day, and then take 2 mg every other day, then every third day, and stopping after I get to every 4th day. I followed those instructions and I am taking it every other day, but I am now getting sick every other day. Is this a good way to stop Suboxone, or do you recommend another way?
My response:

I’m not certain who is giving you advice. More and more, the standard of care is to keep people on buprenorphine for at least a year, and many people stay on ‘remission treatment’ indefinitely– just as we do for other chronic illnesses. There is no evidence or truth to the idea that ‘it is harder to stop buprenorphine the longer you take it’; tolerance does not increase after reaching a plateau, usually in a month or so, and I have found that patients are more successful at stopping buprenorphine the further they get from the period of active use. There is no significant toxicity from the medication when it is taken properly; it is far safer than medications used to treat other illnesses, such as hypertension, elevated cholesterol, asthma, diabetes, or arthritis– let alone other potentially fatal illnesses like cancer.
If you DO go off buprenorphine, the method you described won’t generally work because of the pharmacokinetics of the drug. The plasma half-life of buprenorphine is 2-5 hours, but the elimination half life is over 30 hours. The volume of distribution of the drug increases with dose because of dose-dependent protein binding. Finally, the ceiling effect creates a non-linear relationship between blood level and pharmacologic effect. The practical result of these factors is that larger doses of buprenorphine produce opioid effects that last longer than smaller doses. A typical buprenorphine pain dose of 50-100 micrograms lasts for 6-8 hours, but in the super high doses used for addiction (8 mg equals 8000 micrograms), the opioid effects last much longer- allowing for once per day dosing.
As the dose is lowered, the effects of buprenorphine become shorter in duration. So the person tapering buprenorphine need to not only take smaller amounts each day, but must also divide that daily amount into two, then three, then maybe even four doses to avoid withdrawal symptoms at the end of the dosing interval.
On my forum, SuboxForum, people discuss the ‘liquefied taper method’– a method that I believe I was the first to describe, where a tablet of Suboxone is dissolved in a small amount of water, and doses are administered by drop from a medicine dropper or TB syringe. Any small medicine bottle and the included dropper can be used. I would suggest taking the time to calculate the microgram per milliliter concentration, and using the dropper to dose known amounts.  A TB syringe is more accurate, as it has the amounts marked on the side. For this purpose, a ‘cc’ is the same as an ‘ml’. There are 1000 micrograms per milligram (mg). I’ll leave the rest of the calculations to you!
Another option might be to use ‘Butrans’, a buprenorphine skin patch, after tapering to a low sublingual dose. The biggest patch releases 500 micrograms (or 0.5 mg) per day, and there are a couple smaller sizes with the smallest patch releasing 0.1 mg per day or 100 micrograms. One could taper down to a quarter of an 8 mg tab per day, and then change to the 0.5 mg patch. That sounds like a big drop, but only a small percentage of the sublingual dose of buprenorphine is absorbed– some estimates as low as 15% of the dose. By that estimate, a 2 mg sublingual dose of buprenorphine would be comparable to 0.5 mg of transdermal buprenorphine.
I wrote Butrans might be used because under current law, doctors cannot prescribe Butrans to treat addiction—and I assume that includes tapering off buprenorphine. Federal law that allows for use of controlled substances to treat opioid dependence (DATA 2000)—an exception to the Harrison Act— only allows use of medications that are indicated for opioid dependence. At the present time, Butrans is indicated for treating pain, and not for treating addiction. By my understanding of the law, doctors can use Butrans to taper patients off buprenorphine only if the indicated use for the buprenorphine is any condition other than addiction.
But again, do give some thought to whether you should be stopping buprenorphine, as the relapse rate for opioid dependence is, unfortunately, very high.

Do You Prescribe Buprenorphine?

I’m not sure about the make-up of readers of this blog.  I know that there are about 20,000 page views each month, but I don’t know how many are by people addicted to opioids, people taking buprenorphine, family members of addicts, or physicians who prescribe buprenorphine.  If you fall into that latter category– i.e. if you prescribe buprenorphine, or if you prescribe other medications to treat opioid dependence such as Vivitrol or methadone– consider joining the group at linkedin.com called ‘Buprenorphine and other medication-assisted treatment of opiate dependence.’  If you already belong to LinkedIn, you can simply follow this link to join: http://www.linkedin.com/groupRegistration?gid=2710529
I have always resisted separating those who prescribe buprenorphine from those who are prescribed the medication.  I have avoided, for example, placing a ‘doctors’ section’ at SuboxForum, as I don’t want there to be two separate discussions.  Clearly, each group would benefit from the wisdom of the other.  But there are some physicians who want to discuss prescribing habits, techniques, and science with other docs, who are not comfortable discussing some topics in the ‘presence’ of their patients.
Non-docs, please don’t flame me for this decision;  I’ve wrestled with it, and have made this decision, at least for now.   Frankly, the discussions at SuboxForum are far more interesting than anything that has come up so far at the linked in site!    But some docs who prescribe buprenorphine are isolated out there, perhaps even looked down on by their peers for working with addiction– and that is a crying shame.    I want to get those docs some support.  My goal ultimately is to bring the two sides together, so that docs can talk to addicts and realize that they are the same species as the rest of their patients!
Thanks all,
JJ

User's Guide to Suboxone

Many of you are familiar with my e-book, ‘User’s Guide to Suboxone,’ that has been available for sale on the web.  The copy that is sold through that site is ‘print-protected’ and copy protected;  a password is required to open the document and it cannot be printed– at least not without a bit of digital trickery. 

e-book about buprenorphine

I was just looking through the book, and realized that it ain’t that bad– I’m no Hemingway, but I think that it contains some good ideas, and the words are spelled correctly.   The chapters are listed at the end of this post.
I plan to upgrade ‘the forum’ in the near future, and part of that process includes raising money for a web designer.  My friend Jim will always be the ‘right-hand guy’ with the programming, but I can only ask for so much free help before feeling guilty!  So if anyone out there has considered making a donation, now is the time…. because a $5 donation will get you a copy of the e-book, User’s Guide to Suboxone, sent as an e-mail attachment that unlike prior forms can be printed.  I do ask that you respect the copyright, and if you want a dozen copies for your treatment center, send me a note to work out a discount– rather than simply making 11 copies.
Instead of automating things this time around, if you want a copy of the printable e-book I’ll have you use the donation button on the right side of this web site.  Just make a donation of $5 or more, and I will use the e-mail address that you use for the PayPal or Google Checkout donation to send the book as an attachment.  I’ll get it out within a day or two.  Proceeds will go to the new SuboxForum– the more I raise, the nicer I hope to make it!  As always, thank you all for your support.
List of Chapters:
A Caution
Introduction
Introducing Buprenorphine
Practical considerations
High Tolerance at Induction
Precipitated Withdrawal
Pain control
Surgery
Pregnancy
Length of Maintenance
Tapering
Other Medications While On Buprenorphine
Other Drugs of Abuse
Benzodiazepines
Other Medications
Buprenorphine Side Effects
Twelve Step Meetings
Future trends

Treatments for Opioid Withdrawal

I have written about this topic multiple times, but perhaps a summary is appropriate.  More and more evidence and clinical experience suggest that buprenorphine is best considered a long-term ‘remission agent’ for opioid dependence.  Such a conclusion would have been obvious years ago if not for the hesitancy to do what has been suggested by addictionologists for decades, and treat opioid dependence as a DISEASE.  While many people pay lip service to addiction being a chronic illness, the reluctance, particularly by AODA counselors, to fully accept a medication for the condition is clear evidence of the stigma that continues to force addiction into the realm of ‘character.’   AODA counselors would do well to do some serious soul-searching on this issue– at least in my opinion.
While remission therapy with buprenorphine will likely become the standard treatment for opioid dependence, there will be some cases where tapering off buprenorphine is appropriate.  The problem in such cases is that the taper process causes withdrawal, which stirs up all of the self-disgust, fear, and shame that predispose an addict toward relapse.  As I have discussed, a long-term injectable formulation (such as Probuphine, currently in the FDA approval process) would be useful for tapering off buprenorphine.  The final piece of the equation would be effective treatments for opioid withdrawal. 
A number of medications are rumored to help reduce the symptoms of opioid withdrawal.  I’ll mention a few of the medications that I have used to treat withdrawal, or that I have read about in scientific studies or case reports.
– Clonidine is the ‘standby’ agent for treating opioid withdrawal.  The medication reduces CNS excitation by effects at alpha-2 adrenergic receptors, causing less release of epinephrine and norepinephrine by central and peripheral nerve terminals.  Symptoms of withdrawal are reduced by about a third, and the primary side effect is sedation.
– Some medications target specific components of withdrawal;  Imodium (generic name loperamide) reduces bowel cramping and diarrhea; benzodiazepines reduce anxiety (but are themselves addictive); ibuprofen and acetaminophen reduce muscle aches and headache; stimulants or wellbutrin reduce fatigue (perhaps for severe symptoms, but use of stimulants would be considered controversial at best).
– Proglumide is an antagonist of two classes of receptors for a gastro-intestinal hormone called ‘cholecystokinin’, or CCK.  Proglumide used to be used in the US and elsewhere to treat gastric ulcers, before more effective medications like histamine blockers were developed (e.g. cimetadine).  There are a number of chemicals structurally related to proglumide that have similar actions, that include enhancing analgesia caused by opioids, treating Parkinsons disease, and enhancing the release of growth hormone.  Proglumide appears to ‘reset’ tolerance to opioids in people who are physically dependent, and also to reduce symptoms of withdrawal.  Proglumide appears to have dropped of the face of the planet;  if you search for the medication you will find it available in chemical supply houses in China, but not available through pharmaceutical companies.  I recently received contact from a person claiming that  proglumide is available through a company based in Pakistan, but I have not yet verified the information.  Stay tuned.
– I recently came across an article with some fairly convincing evidence that symptoms of withdrawal are reduced by the anti-anxiety medication buspirone.  A study found that self-reported withdrawal symptoms of opioid addicts were greatly reduced by treatment with buspirone, which is a pretty safe, inexpensive medication that is not itself addictive.
– Ondantreson is an anti-nausea medication used during chemotherapy and surgery.  I have seen several studies demonstrating a reduction in opioid withdrawal from the medication, which like buspirone is fairly safe and is not addictive.  Ondantreson is, however, more costly.
I have treated patients in withdrawal using gabapentin, specifically to reduce sweating and hot flashes.  I do not know if it works, or if the people who liked it were getting a placebo response.  I have not seen reports in the literature showing this benefit.
– I have mentioned the recent approval of transdermal buprenorphine, called ‘BuTrans.’  This formulation provides a lower range of doses of buprenorphine, in the tens to hundreds of micrograms (one tablet of Suboxone contains 8000 micrograms of buprenorphine).  This lower dosed formulation may find usage for tapering.
Do you have other suggestions for treating opioid withdrawal?  If so, please share them in the comments below or over at SuboxForum.  Of course, these medications must NOT be taken ‘on the street,’ but rather should be discussed with your physician if and when the time comes to taper off buprenorphine.
Thanks all,
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

Purdue’s Butrans Approved by FDA

Over a year ago I wrote about the transdermal formulation of buprenorphine available in Europe called ‘Butrans.’  One problem with the treatment of opioid dependence using buprenorphine has been the limited dose options available;  while 2 and 8 mg sublingual tablets are fine for maintenance, they are wholly inadequate when it comes to tapering off buprenorphine.  The ‘wall’ of withdrawal symptoms that people discover as they taper past 2 mg is a product of the ceiling effect of buprenorphine– so useful on the way up, but so challenging on the way down!  At 2 mg, the level part of the dose/response curve ends, and each decrease in dose causes a drop in opiate effect and a drop in tolerance… and so an increase in (albeit temporary) misery.  Smaller doses of buprenorphine would be very useful at that point, say 2 mg of buprenorphine in a scored bar about a cm long, so that people could measure consistently-sized doses like 2 mg, 1.8 mg, 1.6 mg, and so on.  I have described a ‘liquefied taper method’ that some people have used with success, as described on the Forum, to consistently measure smaller and smaller doses for an effective taper.

Of course the remaining problem with any opiate taper is that the person must suffer through some degree of discomfort and craving, while at the same time holding a vial filled with the doses that would make things whole.  Most opioid addicts really struggle at 3 AM under those conditions.

I’ve been excited about the newer products coming down the pipeline, including the transdermal product Butrans and also an injectable form of buprenorphine called Probuphine.  The latter in particular would be useful for tapering, as the addict could get a slowly-dissolving shot of buprenorphine and then go about life as it wears off, without having a vial of more buprenorphine on the nightstand.  I don’t know if Butrans will have any usefulness for tapering buprenorphine– if it did, such use would be ‘off-label’ as the medication is approved for treatment of pain, NOT for addiction treatment.