Obama and the TREAT Act

I just read an article in the Daily Beast that reads like a better version of something I would write about the value of medication-assisted treatment of opioid dependence.  I appreciate Christopher Moraff telling a story that has been untold far too long, and I hope the story raises questions across the country.
But I have something else on my mind that deserves a story of its own.  I am just a small-town psychiatrist in the Midwest, of course, and so I could be missing something.  I watch Veep and House of Cards, but I assume that the political games in those shows are grossly exaggerated.  I’ll offer a bit of background… but if you already understand why people opposed to increasing the buprenorphine cap are idiots, just skip the next few paragraphs.
The Recover Enhancement for Addiction Treatment Act, a.k.a. TREAT Act, is a Bill with bipartisan support written in response to the epidemic of opioid dependence in the US.  If enacted into law, the TREAT Act (among other things) would increase number of patients that a physician can treat with buprenorphine from 100 to 500 and allow nurse practitioners and other ‘mid-level prescribers’ to treat opioid dependence with buprenorphine medications. For newcomers, treatment professionals debate the wisdom of raising the cap on the number of patients treated by each practioner.  Some people argue against medication treatment entirely and claim that abstinence is the only legitimate goal when treating addiction, despite the fact that abstinence-based treatments rarely work.  ‘Rarely’ is in the eye of the beholder, I guess– but even the most optimistic promoters of abstinence-based treatments claim they fail only 70% of the time– within ONE YEAR.   Other addiction docs advocate using medications that dramatically cut death rates, in concert with counseling.  They demand the counseling despite no evidence– none– that counseling improves outcomes in medication-assisted treatments.  But arguing against counseling is like arguing against… milk, I guess.  Who can argue against milk?
Then there are the extremists like me who argue that addiction is an illness that should be treated like any other illnesses and managed with medications, sometimes over the course of a person’s life.  Maybe counseling is indicated, and maybe not– but the need for counseling should not stand in the way of obtaining a life-sustaining medication.  After all, do we withhold insulin from diabetics who don’t receive nutritional counseling?  We extremists point out that there is no ‘cap’ on patients who are prescribed opioid agonists– the type of practice that started this epidemic in the first place.  We point out that literally no deaths have been caused by buprenorphine in patients who were prescribed the medication.  In all of medicine, THAT is the medication that needs a ‘cap’?  Doctors can treat unlimited numbers of patients with cancers, pain disorders, or complicated surgical procedures, but can’t handle more than 100 of THESE patients?!
I don’t see the point of the other groups, so I won’t try to explain their thought processes– accept one example.  Some docs are Boarded in Addiction Medicine– a secondary certification that can be obtained after certification in primary care or psychiatry.  Full disclosure– I am not Board Certified in Addiction Medicine.  I am Board Certified in Anesthesiology and in Psychiatry, and I worked with narcotics as a pain physician and anesthesiologist for ten years.  And I have a PhD in neurochemistry.  From my perspective, I have enough things on the wall. But the docs who DID get boarded in addiction medicine are angry that they get nothing special for their efforts.  The law that created buprenorphine treatment was intended to increase addiction treatment by primary care practitioners.  But that’s sour grapes to the addiction docs, who want the sole right to treat more than 100 patients.  Never mind that 30,000 people die from overdose each year, and buprenorphine could save many of them.  The addiction-boarded docs are angry that they aren’t given special privileges.  Isn’t THAT a problem!
What does all of this have to do with President Obama?  A bipartisan group of members of Congress of worked on the Treat Act over the past 8 months.  Professional societies have come to compromises over the Bill.  According to Schoolhouse Rock, Congress creates laws and then if passed, the President signs them into law.  The President often pulls opposing factions together, encouraging them to get a Bill to his/her desk.  For most of President Obama’s term, about 20,000-30,000 young Americans have died each year– far more than the total number of Americans killed by war, terrorism, hurricanes, and other natural disasters combined.    Until a month ago, I’ve heard absolutely nothing from the US President– no calls to action, no pressure on lawmakers, no requests to call our congresspersons.  But as the TREAT Act was introduced in the Senate, President Obama announced that he will raise the cap by Executive Order.  A supporter of the President would say (I know, because I’ve heard them) that the important thing is that it got done– so who cares how it happened?
Readers of this blog know that I pretty-much dislike everybody… so it is no surprise that I’m not happy.  We have the TREAT Act sitting in Congress, needing a simple majority to be sent to the President’s desk and signed into law.  During an epidemic of overdose deaths, the support would not be difficult to find for most Presidents, even with an ‘obstructionist Congress’, as our President likes to call them.  A change in the law would be relatively PERMANENT, unlike an Executive order– which can be changed with a new President, or with a new set of political calculations by the same President.   And an Executive Order to change rules at HHS requires hearings for citizen comments, which take more time– time when more patients will die.  Shouldn’t President Obama have used the operations that other Presidents used for far-more controversial issues, and changed the law?  This temporary, delayed Presidential action will get kudos from articles like the one in the Daily Beast.  And Obama gets TV time and headlines to describe how he addressed the opioid epidemic, on his own– in spite of a ‘obstructionist Congress.’
What irks me the most, though, is that an Executive Order didn’t need to take seven years.  By 2010 the overdose epidemic was well-underway, and had already killed a couple hundred thousand young people.  Did President Obama need to wait until the TREAT Act was almost at his doorstep before taking ANY action to stem the surge in overdose deaths?  From the sidelines it looks like the deaths themselves didn’t provoke a response.  But the threat of bipartisan action during an election year?  I guess that’s another story!

Prince Missed Suboxone Lifeboat by 12 Hours

One of the links from this page connects to the ‘OD Report‘.  I set up the connection to highlight the epidemic of overdose deaths, not to sensationalize the issue.  But the Prince story is sensational and tragic at the same time. And the connection to buprenorphine only magnifies the tragic circumstances that are wrapped around the use of a potentially-life-saving medication.
I read some time ago about Prince’s chronic pain problems, primarily involving his hips and secondary to years of dancing in high-heeled shoes.  Shortly after his death, TMZ reported that Prince’s plane made an emergency stop in Moline Illinois on his way home from Atlanta.  They reported that he received Narcan at the airport after landing, and then was treated and released at the hospital before flying home to Minneapolis.  TMZ later reported that Prince was taking large amounts of prescription opioids that contributed to his death.
The OD Report contains newsfeeds about opioid overdose.  An article published today describes the circumstances surrounding the discovery of Prince’s body by Andrw Kornfeld, the son of an addiction doc from Mill Valley, California.   According to the article, an emergency addiction treatment plan was arranged with a program called ‘Recovery Without Walls’ based in Mill Valley, California.   The physician who founded and medically directs that program, Dr. Howard Kornfeld, was not able to make it to Prince and instead sent his son, Andrew Kornfeld, a premed student who worked as a ‘spokesman’ for Recovery Without Walls.
Here is where it gets interesting…  Andrew Kornfeld travelled to Prince’s home with a small supply of buprenorphine.  The intent of the people involved cannot be known, of course, but one could surmise that the buprenorphine was provided in order to get Prince started on the medication.  Andrew Kornfeld was the person who reportedly called 911 after he arrived at Paisley Park, prompting security personel to summon the singer and eventually find his body in an elevator.
Putting aside for a moment the legal and ethical lapses of a premed student delivering buprenorphine to a person in another state. one thing is clear:  Had Prince taken the two tablets of buprenorphine found with Andrew Kornfeld, he would never have died from opioids– unless, at some point, he decided to stop taking the medication.  If you have trouble believing that simple fact, then I suggest you do some more research about buprenorphine treatment.  You’ll find that while 30,000 people die each year from opioids without buprenorphine in their bloodstream, only 40 die with buprenorphine in their system– and almost all of those people died from other agonists, and would have lived if more buprenorphine was present.
It is almost impossible to die from opioids if a person is taking buprenorphine or the combination drug, buprenorphine/naloxone.
I don’t know how the media will interpret the story, or who society will hold at fault.  From my perspective, the story is tragic in how predictable things played out.  Prince had the resources to determine the truth about opioid dependence– i.e. that abstinence-based programs rarely work, especially for patients with chronic pain.  He likely learned that his options included 1. a stay in rehab, including a painful withdrawal, followed by a high risk of relapse, or 2. finding a doctor to treat his chronic pain and opioid dependence using buprenorphine or a buprenorphine/naloxone combination medication (as they are essentially identical), which would almost immediately place his ‘opioid problem’ in remission.   It is not clear how much of his problem was ‘addiction’, and how much was ‘pain treatment plus tolerance.’  The difference between the two conditions is often in the eye of the diagnosing physician.  But the good news for such patients is that is doesn’t really matter.  Buprenorphine products provide almost immediate resolution for pain patients tolerant to opioid agonists, removing cravings and providing relief from withdrawal.
In a sane world, Prince would have called the doctor down the street to get started on buprenorphine immediately.  But doctors who prescribe the medication are hard to find, and the few doctors who do prescribe the medication are stuck at the 100-patient cap, waiting for President Obama to make good on his promise to change the rules so that more people can be treated.
Instead, the 100-patient limit remains in place– and patients desperate for help search throughout the country for doctors with openings.  I myself receive several emails and calls every single day from people across the country who are begging for help.  I tell them the same thing I would have told Prince:  I’m stuck at the cap.  I wish I could help.

Counseling Schmounseling

I just noticed a couple of my recent posts….  these people have it wrong, and that person has it wrong.  One of these days I really need to print something positive and uplifting.  But not today.
Excuse the self-flattery, but I like to think of myself as a physician scientist.  That concept motivated my PhD work, and cost me friend after friend in the years that followed!  A physician scientist isn’t all that difficult to be from an educational standpoint, especially in the age of the internet.  The one thing that is necessary is the willingness, or need, to question every assumption by the media, the government, physicians, laypersons, and other scientists.   Ideally, the questions are guided by a knowledge of p-values, the process by which scientific grants are awarded, an understanding of the peer-review process, and the realization that anyone elected to office knows less about science than most other humans on the planet.
Last night I came across an opinion piece– I think in the Bangor Daily News, but I could be wrong about that– that argued that we will never stem the heroin epidemic without use of medications.  The comment section after the article was filled with the usual angry banter over methadone and buprenorphine that now follows every article about medication assisted treatment.  As an aside, why are the abstinence-based treatment people so angry about medication?  There are people out there who choose to treat cancer using crystals, but they don’t spend time bashing monoclonal antibodies!
Here is the part of this post where I start losing friends…  but let me first say that I know some counselors.  I like counselors.  In fact, some of my best friends are counselors.  But in the comments after that article I read the same thing over and over–   that meds aren’t the important thing, and that counseling is what really makes all the difference.  A couple weeks ago  the person sitting to my right said the same thing during a discussion about  medication-assisted treatments.  And that same phrase is repeated ad nauseum in lecture after lecture in ASAM lectures and policy statements related to addiction.  The phrase has even been codified into some state laws.  And why not?  It is something we all ‘know’, after all.
If we are going so far as writing laws requiring that people have counseling in order to obtain medication, shouldn’t we do one thing first?  Shouldn’t we determine if the comment is really true?
A couple years ago two papers came out– someone help me with the reference if you have them– that looked at abstinence rates after a year on buprenorphine in patients with or without counseling.  Guess what?  The counseling group did not do better!  In fact, the counseled patients did worse; not sigificantly so, but enough to clearly show that there was no ‘trend’ toward better performance in the counseled group (which would have been pointed out, were it true.)
I could hypothesize many reasons why the counseled groups would do worse.  Maybe they were angered by the forced counseling and therefore bonded less effectively with their physician.  Maybe they obtained a false sense of expertise in dealing with addiction, making them more likely to relapse, whereas the non-counseled group learned to just do as they were told.  Or maybe the counselors send out signals, consciously or unconsciously, that interfered with medication treatment.
The thing is, we have no idea which of these things, if any, are going on!  There have been no systematic studies or other attempts to understand what happens during the combination of counseling and medication treatments.  We just have a bunch of people saying ‘do them both!  do them both!–  a comment that apparently feels so good to some people that they just cannot consider things any other way.
For the record, I see ALL my patients for at least 30 minutes for every appointment.  As a Board Certified Psychiatrist, I guess that means I’m counseling them.  And from what I can tell, it seems to be working pretty well.  But even in my own case, I would never draw firm conclusions unless someone does a double-blind study and collects the data.
I encourage all physicians, scientists or not, to question some of what we ‘know’ about addiction treatment.  Is it really all about the counseling?  Maybe— but then again, smart people used to ‘know’ the world was flat, and the Earth was the center of the Universe.

Addiction Treatment Has it ALL WRONG

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

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.

Clearbrook President Gets it Wrong

A blurb in the buprenorphine newsfeed (see the bupe news link in the header of this page), has the headline ‘Suboxone challenged by Clearbrook President’.  I followed the link, and after reading the ‘article’ I wanted to comment to that president but the person’s name wasn’t included, let alone an email address or comment section.  So I’ll have to comment here instead.
The article was one of those PR notices that anyone can purchase for about 100 bucks, in this case from ‘PR Newswire’.  It’s a quick and easy way to get a headline into Google News, which pulls headlines for certain keywords like ‘Suboxone’ or ‘addiction’.
The Clearbrook president makes the comment that this 180-degree swing to ‘medication assisted treatment’ is a big mistake.  He says that in his 19 years in the industry he has seen ‘thousands’ of people ‘experience sobriety’.   I’ll cut and paste his conclusion:
There is no coming into treatment and getting cured from the disease of Addiction. There is no pill or remedy that will magically make one better. Those looking for a quick fix to addiction and the treatment modality being used by the vast majority of treatment providers today, will be disappointed with the direction our field is taking when this newest solution doesn’t live up to its claims.
A word to the President of Clearbrook:   I’ve worked in the industry too.  But unlike you, I wasn’t satisfied to see a fraction of the patients who present, desperate for help, ‘experience sobriety’– especially when I read the obituaries of many of those patients months or years later.
The president says that ‘no pill or remedy will magically make one better.’  Addiction, for some reason, has always been considered immune to advances in modern medicine.  We all know that addiction is a disease, just like other psychiatric conditions including depression, bipolar, and schizophrenia.  Why is it that even as medicine makes extraordinary advances in all areas of illness, medications for addiction are considered to be ‘magic’?
Those of us who treat patients with medications, particularly buprenorphine, realize that addiction doesn’t respond to ‘magic’.  But I see a lot more hocus pocus in abstinence-based residential treatment programs than in the medications approved by the FDA for treating addiction.  Residential programs charge tens of thousands of dollars for a variety of treatments–  experiential therapy, art therapy, psychodrama, music therapy, etc.– that have no evidence of efficacy for treating opioid dependence.  Abstinence-based treatments have managed to deflect criticism from their failed treatment models by blaming patients for ‘not wanting recovery enough’.
Buprenorphine finally allows the disease of addiction to be treated like other diseases– by doctors and other health professionals, based on sound scientific and pharmacological principles.   Abstinence-based treatment programs have tried to tarnish medication-assisted treatments, but people are finally recognizing the obvious– that traditional, step-based treatments rarely work.
And that’s just not good enough when dealing with a potentially fatal illness like opioid dependence.

Addiction Recovery Act of 2015

With appreciation to the good folks at BDSI, makers of Bunavail:
Here is the latest news concerning the Comprehensive Addiction Recovery Act of 2015 (aka Heroin Crisis Act):
It has easily passed Committee and is headed to the Senate floor next week.  If approved, the bill is scheduled to go into effect this year. Here are some new highlights:

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

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

Subox Docs: Analyze This!

People on buprenorphine or Suboxone often write to me with complaints about lab testing.  I received an email last week that mirrors my personal experience with lab testing companies.
Here is what it said:
Dr. Junig:
I thought you might find this interesting. I continue to see (name withheld) for addiction treatment using buprenorphine. I see the doctor every three months, and I’m prescribed a low dose of Suboxone film (below 4 mg per day). I recently got an insurance denial for over $2000 in lab charges, for ONE urine test! Evidently someone sent my tests to (lab name withheld for patient privacy) who billed for 23 tests!  This is on a test that was negative for any substances other than the proper amount of buprenorphine.   This is like a license to print money! The same thing happened three or four years ago with (a National lab provider), but that was ‘only’ $600 and it eventually got written off. I have no idea if (withheld) will come after me– but there is no way I’ll pay them a dime.
Is there any wonder health costs are so out of control? How can a company get away with this? I have a feeling this is just routine and someone on the staff sent it by mistake as after the first incident with the other lab.   My doctor doesn’t usually send my tests into a lab, but instead just does the immune point-of-care test in the office.
Have you heard of charges this high? Just thought I’d pass it to you in case it’s good info for a blog post. Talk about crazy–  How in the hell, even seeing a doctor 4 times a year, could I remain in recovery on buprenorphine with total annual costs near $12,000?  Plus, doing these expensive tests on negative samples?  I can maybe see on a positive result – but negative?  This is so wrong.
I wrote this email in response (I’ve edited my remarks for grammar and privacy):
I wrote about this issue a couple of years ago, and I understand your anger.  I used the same lab company a few years ago for about a month, after their salesperson promised they would never charge anything beyond what insurance paid.  But they did charge some patients, and then other patients complained that one lab test used up their entire annual mental health coverage!   Now I only use point-of-care tests (which cost $3 each), unless there is a clear reason for confirmatory testing.
(Note—Wisconsin health insurers used to commonly limit mental health expenses to two or three thousand dollars.  Now, because of mental health parity laws, insurers must provide the same coverage for mental health expenses, including drug testing, as they do for other types of healthcare.  I guess it’s good that the care is no longer treated differently… but one very ugly result has been an explosion in lab testing costs—which increase EVERYONE’S insurance rates).
Back to my email:
In the past few years representatives from two pain clinics asked for meetings, and told me the same thing: that insurers were tightening payments for ‘injections’ by paying only for injections that actually worked (what a concept!).  The pain clinics now make more money from lab testing than from their bogus injections.  The problem?  Insurance would only cover one urine test per month unless an addiction doc was on staff, which would allow them to do unlimited numbers of tests.  They said that lab companies set up turn-key operations for docs providing equipment, technicians, billing codes, etc—and they could bill over $1000 for a test that used $4 in raw materials.   Even Medicaid paid over $500 for one urine test!
I would love to blow the whistle on this garbage, but every agency seems to have the attitude that doctors need to test people more, not less—no matter the cost.  Talk about a situation ripe for abuse!
Comments:
Opioid agonists are a Godsend to patients with severe pain, whether the pain is acute or chronic.  Opioid agonists are also highly-abused, so some degree of monitoring is appropriate.  I wonder about the motives of some doctors, who prescribe ever-increasing doses of potent opioids, and then suddenly stop prescribing when a urine test shows traces of THC.  Those doctors know, or at least should know, that acutely stopping opioids results in severe withdrawal.    About ¾ of my addiction patients turned to street pain pills when a doctor, often the same doc who started them on pain meds, kicked them out of treatment for testing positive for THC or for running out of medicine early after treating a flare-up of their pain.
Even for the sadistic docs who practice that way, it doesn’t take a thousand-dollar test to discover a drug habit.  If society is truly concerned about healthcare costs, is it appropriate to spend $2700 testing for non-existent metabolites of non-existent substances, when one $3 test will detect the presence or absence of cocaine, buprenorphine, oxycodone, hydrocodone, amphetamine, THC, propoxyphene, PCP, heroin, or benzodiazepines?  Is the extra $2697 justified on every routine follow-up visit?  Inexpensive or free measures, such as pill counts or random 3$ point of care tests– are far more useful to determine if someone is selling or sharing a prescription.
Opioid agonists cause tens of thousands of deaths each year, so maybe someone could argue for that type of overkill with those medications. But this degree of drug testing for patients treated with buprenorphine?!   Buprenorphine is identified in fewer than 50 overdose victims per year in the US–  the same number of people killed by lightning.  Even in those few cases, buprenorphine didn’t cause death, but rather was present because the person used a buprenorphine product at some point in the days or weeks before overdose.  In fact, most of those 50 overdose deaths would have been prevented had MORE buprenorphine been present.
I find it bizarre that more and more ‘PA’s’ for buprenorphine products ask the question, ‘are you doing drug testing’?  I’m curious– what do the people who create those forms WANT to happen with their patients?  I’ve thought about writing back…. “Yes, I did drug testing.  He tested positive for marijuana, so I kicked him out of my practice, and he died of a heroin overdose last week.”  Would the insurer see that as a good outcome?  Would I get a pat on the back– “Great job!  That’s some GREAT drug testing you’re doing!”
Why So Much Testing?
When did doctors stop trusting their patients?  Doctors used to provide a confidential refuge for troubled people.  Med school ethics courses questioned whether doctors should take any action that interfered with patient autonomy.  Doctors must go against their patients’ wishes in certain situations, such as cases of child abuse.  But when did we start assuming that people voluntarily seeking treatment were lying?
I wonder why my colleagues are so eager to get behind aggressive testing.  I’ve already suggested one motivator—i.e. greed.  But that doesn’t explain the entire phenomenon, because many docs get just as excited about testing while leaving all the profit for the testing companies.  In those cases I’ve wondered if their willingness to distrust their patients relates to their backgrounds as addiction doctors.
Many addiction docs are psychiatrists, a specialty that attracts the most risk-averse medical students.  Consider the risks that doctors in other specialties accept as a matter of course.  A neurosurgeon speaks with a patient a couple of times, and then opens that person’s skull and removes part of the person’s brain.   Consider the CT surgeon who meets with a patient, reviews the tests, and then splits the sternum to sew grafts into arteries that supply blood to the heart.  Those doctors are entrusted to cut people open, remove diseased tissue, and provide appropriate follow-up care.
But when you talk to addiction docs about drug testing, they all say the same thing:  They have to do the testing ‘or they will lose their license.’   They claim that they don’t have the power or autonomy to decide which patients need to be treated like criminals, and which patients have proven themselves as trustworthy and stable.  They have no choice, they say, other than to test every single patient on every visit.
Then there is the true cynic in me, who wonders of some doctors just ‘get off’ on catching people.  Patients who come in for addiction treatment are in dire straits, and have a lot of work to do.   After living like animals, they are taking on the challenges of giving up their drugs of choice, learning to trust their physicians, giving up self-medicating, and learning to tolerate their emotions.   Many new patients struggle with giving up marijuana, a drug they’ve used to treat withdrawal for years, and a drug associated with mixed signals from a couple states (and from the President).   Kicking a heroin addict out of treatment for smoking marijuana is the worst type of of bullying I can imagine.
I admit that I drug-test patients.  But I don’t use drug tests to kick someone out of my practice, any more than an endocrinologist would stop prescribing insulin for a diabetic patient who can’t stay on a diet.  My patients know that I don’t kick people out for struggling, so I usually hear, at the start of the appointment, if a patient has relapsed.    I’m sure there are docs who think I’m naïve, who believe that patients are getting away with something ‘on my watch’.  But I can live with that.   In return I get to be a doctor who treats people like human beings, not criminals.
If buprenorphine was causing death (it isn’t), serving as a gateway drug (it isn’t), or was used in some nefarious way similar to GHB (it isn’t), I would likely think differently.  But honestly—the docs and DA’s who spout that ‘buprenorphine is just like heroin’ are idiots.  I suggest that they learn a bit of neurochemistry before spreading such nonsense.  In fact, just pay for my travel and I’ll walk you through the science, and show you WHY you’re idiots.
To the doctors who aren’t yet making a profit from lab testing but considering jumping on the bandwagon, reconsider. What type or relationship do you want with your patients?
To the doctors who gave in to the slick sales pitch from a lab company’s salesperson who brought you a nice lunch, and promised to only bill insurance so that ‘nobody loses’, stop kidding yourself.  You are a big part of the problem.
And to the docs who make money from treating all patient like liars, driving up insurance rates for the rest of us…  Shame on you.

Buprenorphine Depression Drug Stumbles

I’ve written a few optimistic lines about ALKS 5461 as a potential solution for people suffering from refractory major depressive disorder.  Those unfortunate will have to keep waiting.
ALKS 5461 is a product in Alkermes’ pipeline that combines buprenorphine with ALKS 33, or Samidorphan.  The combination drug is purported to ‘stabilize opioid pathways’, which is a very simple explanation for a complicated, poorly-understood system.  The results of two late-stage trials were disappointing, in part– according to Alkermes– because the placebo groups did better than usual.  Beating the placebo is a common problem in trials involving antidepressants, because of the high susceptibility to the placebo effect in the patients in such trials.  Over half of patients get better from taking the sugar pill, so a medication that helps half the patients will not move the needle to signal success.
I receive emails now and then from patients treated with buprenorphine for depression.  If the emails are any measure of reality, buprenorphine is not going to cure the world of depression.  While I occasionally read success stories, I just as often read angry descriptions from people complaining that they were never warned of the difficulty of stopping the medication.   I’ve written before that for that reason, I am reluctant to start buprenorphine for depression alone, in patients who are not already opioid-tolerant.  I have patients who struggled with depression before becoming addicted to opioids, and I believe the drug benefits their mood symptoms.  But I continue to hold back in a couple patients who have very severe depression, who have failed traditional treatments.  The news from Alkermes doesn’t push me in either direction.
I’ll take a moment to respond to the angry person who recently commented on one of my other blogs about this topic, who wrote that ‘depressed people are no more likely to get addicted than other people’, and ‘buprenorphine makes people happy and productive’ and therefore should be used for depression.  People with histories of depressive disorders DO have a higher incidence of addiction, but that is not the major issue holding me back from using buprenorphine for depression.  I would also disagree that buprenorphine makes everyone happy and productive.  The mood effects of buprenorphine, like all opioids, are subject to tolerance…  which gets closer to my concern.  I fear that the effects of buprenorphine would fade with tolerance, leaving patients stuck on an ineffective drug.  And we all know what happens to mood during discontinuation of buprenorphine.
ALKS 5461, though, works by a mechanism that may not be susceptible to tolerance.  Buprenorphine is a partial agonist at mu receptors and a kappa-receptor antagonist, and the latter effect is thought responsible for the effects on mood.  Samidorphan selectively blocks mu receptors, so that the combined drug is left with only the kappa effects.  Patients are supposedly spared from mu-receptor activation, tolerance, and withdrawal.   I wonder if it is really all that simple, or if the competition between buprenorphine and Samidorphan at mu receptors will create other problems.    Opioids cause a number of side effects, especially in patients who tend to focus on somatic symptoms, as some depressed patients do.   Starting an antagonist in the presence of an agonist, such as inducing with buprenorphine in patients on methadone or fentanyl, triggers a great deal of misery.  And even stable patients on buprenorphine alone tend to struggle with dry mouth, hot flashes, and GI complaints, most-commonly constipation.  But then again, major depression is a horrible illness.  I’m sure there are many people out there who would make the trade without regret– IF the ALKS 5461 works.
Alkermes continues to study ALKS 5461.  The higher dose ranges in the study, using 2 mg of buprenorphine, appeared to work better than the 0.5 mg dosage, so future studies will focus on buprenorphine doses of 1 and 2 mg per day (paired with equal doses of Samidorphan).  If you’re a believer, the stock is selling pretty cheap these days.  This is not an investment blog…. but I’m betting on Apple instead!

Suboxone and Suicide

Today I came across an article about a study that showed a reduction in suicidal ideation caused by buprenorphine.  The dose of buprenorphine used in the study was lower than doses used for treating opioid dependence, ranging from 100-800 micrograms taken sublingually.   Buprenorphine was administered for up to four weeks in the study.
I haven’t read the full text yet, and I’ll have more to say after I do.  There was also a provocative link on the article’s web page leading to an editorial about treating depression with opioids.  My post is a bit premature, but I want readers to be the first to describe these findings at the water cooler tomorrow morning!
Most people reading this blog are already aware that opioids can elevate mood.  In fact, opioids can serve as an answer to all of life’s problems, making life fulfilling and pleasant… for a little while.    Those effects are part of why it is so hard to leave opioids behind.  Opioids bind to receptors for endorphins– called ‘mu opioid receptors’– and activate the same pathways that light up during life’s most pleasurable moments.
But most of the people reading this post have learned the sad, simple truth that the positive effects of opioids carry a steep cost.  Any pleasure provided from mu-receptor stimulation must be paid back by the absence of activity in those same pleasure pathways.  And like any transfer of energy, the process is not 100% efficient.  Most opioid users discover that they eventually lose far more happiness than they ever gained from opioids.
So my main question, when I see the full article, will be whether patients benefit from buprenorphine in the long run– or if they only get a respite from depression that must be paid back, with interest, after the medication is discontinued.  So far, the requirement for payback has been a fatal flaw in using opioids to treat mood disorders.
There are rare patients who do not respond to any treatments for depression, who receive a short respite from depressive symptoms from opioids.  I’ve considered using opioids in a few select, severely-depressed individuals.  But so far, I’ve decided that the potential cost– a lifetime dependence on opioids– is too great to justify the use of opioids for depressive disorders.  Here’s hoping that at some future date we’ll find a way to harness the benefits of opioids without the high cost of tolerance and dependence.