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!

Drug Court Organization Lobbied Against Suboxone

For years, people familiar with the benefits of buprenorphine have wondered– who is the idiot standing in the way of increasing access to this life-saving treatment?  One of the idiots was recently identified, when an open-records request by the Huffington Post uncovered a letter to HHS Secretary Sylvia Burwell from West Huddleston, then-CEO of the National Association of Drug Court Professionals.
In the letter, Huddleston wrote that allowing doctors to see more than the current limit allows ‘will result in the expanded use of buprenorphine in a manner that is less responsible and presents greater risk to the health and safety of the individuals and communities we both serve.’   The Huffington Post correctly points out that over 28,000 Americans died from opioid overdose in 2014, when the letter was written.
People familiar with buprenorphine know that the medication virtually eliminates the risk of death by overdose– even when taken incorrectly.  The anti-medication lobby, fueled by the large profits of revolving-door ‘abstinence-based’ treatments, has used fear of diversion of buprenorphine as a weapon against greater access to the medication.  But stories about diversion always fail to mention key facts about buprenorphine– for example that of the 30,000 US opioid overdose deaths last year, only about 40 had buprenorphine identified as one of the drugs in the bloodstream at the time of death.  And of those 30,000 deaths, none were CAUSED by buprenorphine.
There have been overdose deaths that were in-part due to buprenorphine or buprenorphine/naloxone medications (i.e. Suboxone, Bunavail, and Zubsolv).  But such deaths are rare.  In order for buprenorphine to contribute to overdose, the victim must 1. Have a low tolerance to opioids, and 2. Have a low tolerance to a second respiratory depressant, taken around the same time in sufficient amount.   In other words, someone physically dependent on opioids cannot overdose on buprenorphine.  In fact, buprenorphine products would precipitate severe withdrawal if taken by opioid addicts within a few hours of heroin, oxycodone, or other opioid use.
Drug courts in my area tend to avoid medication assisted treatments, with the exception of Vivitrol or IM Naltrexone.  There is no evidence that blocking opioid receptors for a year has any effect on death rates from opioids.  Studies have reported that patients who stay compliant with treatment, who return each month for another injection of naltrexone, don’t waste their money on agonists that would have no effect on them.  But what happens 6-12 months later, when probation ends and those patients are no-longer required to take naltrexone?
I wish I could tell you what happens– but I can’t, because nobody has done the studies to find out.  The cynic in me takes it further, wondering if anyone even cares what happens when people are temporarily maintained on naltrexone and then allowed to stop the medication?  I’ve asked physicians, prosecutors, and law enforcement the same question:  what happens to the person when the naltrexone is discontinued?  In response I usually hear ‘what do you mean?’  Or ‘how would I know, since I don’t see them anymore?’, or ‘I assume they do fine… don’t they?’
I don’t see much concern when I explain that people who stop naltrexone are in a state of ‘reverse tolerance’ making them more susceptible to death by overdose.   So I remind them of the large number of overdose deaths in people who were recently released from a controlled environment, such as residential treatment or incarceration, after tolerance dropped to normal levels.  Maybe I’ll point out the Australian studies that show a 12-fold higher death rate in addicts who were maintained on naltrexone.   But by that time I’ve lost the person’s attention– just as their attention leaves each addict when his/her probation expires.  ‘Not my problem anymore.’
Huddleston is no longer the CEO, but the NADCP continues to express a muddled message about buprenorphine medications.   If you have a minute, you might consider educating the NADCP staff about the value of buprenorphine treatment.
Meanwhile, HHS Secretary Burwell says changes to the cap are coming.  I received 12 calls last week from people looking for help.  I’ll keep telling them to try to be patient.

Raising the Suboxone Patient Cap

HHS Secretary Sylvia Burwell announced yesterday that the cap on buprenorphine patients would be raised in the near future.  Details were not released, but she emphasized that measures would be taken to increase availability of this life-saving treatment, while at the same time taking caution to prevent misuse of the medication.   Anyone who works with buprenorphine understands the importance of her announcement.  I only hope that her actions are swift, and not overloaded with regulations that reduce practical implementation of whatever increases are allowed.
I have been at the cap for years, unable to accept new patients for buprenorphine treatment.  My office receives 3-4 calls each day on average from people addicted to heroin, begging for help.  Patients on buprenorphine (the active substance in Suboxone) are much less likely to die from overdose than are patients not taking buprenorphine– even in the absence of perfect compliance.  Some doctors, in my opinion, over-emphasize the ‘diversion’ of buprenorphine medications.  At least in my part of the country, ‘diversion’ of buprenorphine amounts to heroin addicts trying to stop heroin, taking ‘street buprenorphine’ because of the absence of legitimate treatment spots.    Of the few new patients I’ve been able to take this year, almost all have histories of using buprenorphine products on their own, without prescriptions.  They are very happy to finally have a reliable source of the medication– and to have the medication covered by their health insurance!
Let’s hope the increase in the cap happens sooner rather than later.  After all, lives are literally hanging in the balance.

Opioid Dependence Treatment with Ibogaine

First Posted 12/28/2013
I’ve always assumed that stories about ibogaine curing opioid dependence were fabricated or exaggerated.  But I’ve read more about ibogaine since the drug popped up on an episode of Homeland.  The scene made me wonder how and when the hoopla over ibogaine began, and why it ended.  After all, people treat addiction with all sorts of things that don’t work—so why ban ibogaine?
In the era of the internet, the answers are easy to find.  Ibogaine was used for religious rites in Africa for at least 200 years.  Since the 1930’s the drug, brand-named Lambarène, was used to treat depression and improve energy in France.   The usefulness of ibogaine for treating opioid addiction was described by Howard Lotsof in 1962.  But Lambarene was removed from the market in the 1960s, when the World Health Assembly classified ibogaine as ‘a substance likely to cause dependency or endanger human health.’  A few years later the DEA moved ibogaine to Schedule I—a class of drugs deemed to have ‘no value as medicine.’ Marijuana is schedule I, by the way.
In lack of formal study, several authors have recorded clinical outcomes after ibogaine treatment in non-standard environments.  Carl Waltenburg wrote about treating addicts with ibogaine in a squatters’ village in Denmark in the early 1980’s. Lotsof described a series of patients treated for addiction in a patent awarded for that use of ibogaine in 1985.  In the 1990’s the NIDA funded research of ibogaine treatment of opioid dependence, but that funding was cut in 1995 when a review of early outcome data revealed the death of a young woman treated with ibogaine.  The woman’s death was not clearly attributed to ibogaine, since her belongings were found to include heroin paraphernalia after her death.  But as we all know, attitudes toward medications in the addiction field are subject to emotion and politics, and the death of a young woman during study of a schedule I drug was all it took for NIDA to pull the grant and spend the money elsewhere.
Reports of the efficacy of ibogaine for treating addiction are interesting, and I encourage readers to dig into discussions about the drug with a healthy dose of skepticism.  Remember that scientific truth never comes from one study, or even from a few studies.  Rather, results must be replicated by a number of scientists, preferably with a wide range of bias and perspectives.  In the 1985 patent application for the use of Ibogaine for opioid dependence, Lotsof summarized impressive findings (which are in the public domain and copied below).  Keep in mind, though, that someone applying for a patent is not going to use the application to report their failures!
It is a principal object of the present invention to provide an improved method for the treatment of opiate addiction.
Another object of the present invention is to provide an improved method for interrupting the physiological and psychological aspects of the heroin addiction syndrome.
Still another object of the present invention is to provide a method of the above nature characterized by its high degree of success, the absence of the great pain and discomfort accompanying earlier treatments, the ease and convenience of application the absence of undesirable or persistent side effects and the persistent effectiveness of the treatment.
The above and other objects of the present invention will become apparent from a reading of the following description which sets forth preferred embodiments thereof.
A feature of the present invention is based on the discovery that an alkaloid of the family Apocynaceae and its therapeutically active derivatives and salts, particularly, ibogaine and its therapeutically active, non-toxic derivatives and salts for example, ibogaine hydrochloride and other non-toxic salts of ibogaine, possess the unexpected unique ability to disrupt the heroin addiction syndrome. Examples of other salts of ibogaine which may be used are ibogaine hydrobromide, and any other non-toxic salt of ibogaine.
For the purpose of definition, the heroin addiction syndrome is meant to consist of all the symptomology demonstrated by addicts in their use of and search for heroin. The interruption of the syndrome was accomplished in five out of seven (71%) of the test subjects who were addicted to heroin. None of the test subjects were seeking to terminate their habits, and all seven were enamored with narcotics.
A single treatment with ibogaine or ibogaine HCl of doses ranging from 6 mg/kg to 19 mg/kg administered orally, disrupted the subject’s use of heroin for about six months.
A treatment lasts about thirty hours during which time ibogaine exerts a stimulant effect. Apparently, an abreactive process is involved during ibogaine therapy but is not noticeable until the patient wakes from natural sleep occurring after primary and secondary effects of ibogaine are diminished. When effective, ibogaine left the addict with no desire to use heroin and no noticeable signs of physical withdrawal. Subjects appeared relaxed, coherent, with a sense of direction and feelings of confidence. 
(Note: abreaction is defined as ‘the release of emotional tension achieved through recalling a repressed traumatic experience.)
Ibogaine was one of five substances we studied. The other four–mescaline, psilocybin, LSD and DMT though different in duration of action and intensity–have similar psychotropic effects that are well documented and will not be discussed here. Ibogaine, unlike the others, is not a euphoriant hallucinogen and did not leave the subjects open to swells of emotion. While under the influence of ibogaine, emotional responses to traumatic repressed thoughts and feelings appeared to be negated.
Another effect of ibogaine administration that was found interesting was that even after twenty-six to thirty hours of wakefulness, subjects slept three to four hours and awoke fully rested. This pattern continued, diminishing slowly, over a three to four month period.
The effects of oral administration of ibogaine are first noticed in fifteen to twenty minutes. Initially, a numbing of the skin is accompanied by an auditory buzzing or oscillating sound. Within twenty-five to thirty-five minutes the auditory transcends across the sensory mechanisms to include the visual: objects appear to vibrate with great intensity. It is at this time that the dream enhancement or hallucinatory effects begin. In many cases an acute stage of nausea follows the hallucinatory phase. The visions end abruptly and the numbness of the skin begins to abate.
This is followed by six to eight hours of a high energy state during which the subjects see “lightening” or flashes of light dance about them. Thoughts which seem to amplify the meaning of the visions seen during the primary phase of ibogaine intoxication continue during this period.
Between twenty-six and thirty-six hours, the level of stimulation diminishes and the test subject falls asleep.
Thus, three stages of ibogaine intoxication have been observed. First, a hallucinatory period lasting for three to four hours during which time the person receiving ibogaine manifests repressed material visually. Second, a high energy period accompanied by flashes of light, the appearance of a vibration to all objects, and the awareness of thoughts appropriate to the visual material seen by the subject. Third, a diminishing energy period free of vibration or light flashes and culminating in sleep.
In the administration of acceptable dosage forms, any one of a variety of preparations may be compounded, for example: capsules, tablets, pills, powders, solutions, etc. In addition to the active agent, there may be present additional substances used in the manufacture of pharmaceutical preparations such as binders, fillers and other inert ingredients.
The entire patent application, including case reports, can be found at the web site of the US Patent Office, or at this site entirely dedicated to ibogaine.
Assignment of a substance to Schedule I creates significant barriers to formal study, at least in the United States.  But US Schedule I status has not prevented the establishment of ibogaine treatment centers in other parts of the world, including Mexico and Canada.  The data pieced together over the years suggests that ibogaine could be a remarkable medication for some people.  But like any medical treatment, there are significant risks to ibogaine treatment.  One particular concern is cerebellar damage in rats treated with doses of ibogaine greater than 100 mg/kg.  Proponents of ibogaine point out that the dose used for treating human opioid dependence is about 50% lower, hardly a reassuring margin of safety.  Best estimates, taken from limited data, suggest an overall fatality rate of 1 in 300 people treated with ibogaine for opioid dependence, with higher death rates in people with certain comorbid conditions.
I’m skeptical of the claims of permanent, positive treatment outcomes from ibogaine.  Addiction to opioids creates a complicated, interconnected collection of physical and psychological dispositions that favor eventual relapse.  I have a hard time believing that one dose of abreactive insight, no matter how profound or intense, can selectively eliminate the desire to use opioids…. while leaving unaffected the desires for all of the normal, good things that humans enjoy.   But then again, opioid dependence is an often-fatal condition.  The significant risks in the risk/reward equation create scenarios where Ibogaine treatment may be appropriate.  I’d be interested in hearing and sharing first-hand accounts from anyone who has been through ibogaine treatment—without need to share your personal identity, of course.

Quantitative Urine Drug Testing and Buprenorphine: Tainted Motives?

First Posted 11/23/2013
As fear of buprenorphine diversion sweeps the nation, some states have passed legislation adding more rules for practices that treat addiction using buprenorphine. Never mind that buprenorphine is linked to about 400 deaths over ten years, one tenth of the number of deaths from acetaminophen during that same time, and 0.1% of the number of overdose deaths overall.

Many parts of the country have seen a reduction in number of buprenorphine-certified physicians over the past few years. Many rural areas have no buprenorphine prescribers at all. The lack of prescribers, combined with the limit of 100 patients per prescriber, leaves opioid addicts with one legitimate treatment option— the early morning line for methadone or buprenorphine at methadone clinics. I’m not against the clinics, but the need to report each morning is a significant barrier to employment in many patients who would do just as well with a prescription for the medication—and a first-shift job. Their other option is to do what all the news stories have been reporting—use buprenorphine without a doctor’s supervision and attempt to stop heroin or pain pills on their own, aka diversion.

One clue about your own state’s buprenorphine policies is whether your doctor is still prescribing buprenorphine products, or has instead moved to an area of medicine where doctors make decisions according to clinical judgment. As the number of buprenorphine/naloxone prescribers in my part of the country has decreased, the amount of diversion has increased. I predict that policies that discourage doctors from treating opioid dependence will increase the number of addicted people trying to treat themselves.

Sometimes it is easy to predict unintended consequences.

Regulatory agencies of at least one state prevent insurers from covering specific, FDA-approved medications. Other states require doctors to follow specific practice patterns instead of their best clinical judgment. One example of oversight that demonstrates the folly of lawmakers playing doctor is the push to require ‘quantitative urine testing’ in all patients at frequencies determined at the state capital, rather than by the doctors treating the patients. The expectation is for quantitative testing to reduce diversion. Note that 30,000 overdose deaths per year from non-buprenorphine products never prompted such oversight, nor did the well-known ‘pill-mill’ pain clinics that have flourished for the past decade. But an average of 40 deaths per year related to buprenorphine has demanded action by lawmakers!
There are times when quantitative testing is useful, but I suspect that legislators who voted to require such testing heard only the half of the story told by people with vested interests. After all, quantitative testing is one of the more lucrative areas in all of healthcare. Even Medicaid agencies that pay pennies on the dollar for office visits pay generously for testing with the right billing codes. Turn-key testing businesses can be purchased by entrepreneurial doctors to grow revenue at pain clinics, leasing out testing equipment and training techs in return for a piece of the action.

What legislators SHOULD know:

Quantitative urine tests for standard drugs of abuse in just one patient can cost well over $1000. Costs over $500 per test are the norm. The costs are paid by insurers, Medicaid, or patients, increasing insurance premiums and taxes and blocking treatment for some patients.

‘Point of care’ test strips that use immunoassay methodology are sensitive and accurate. A standard test kit shows the presence/absence of trace amounts of specific opioids (methadone, oxycodone, or heroin/morphine derivatives), amphetamine, benzodiazepines, cannabinoids, cocaine, PCP, barbiturates, and buprenorphine. Typical test kits give all the results for a total price of $5-$10.

Almost all the decisions related to testing rely on the presence or absence of substances—not the number of nanograms of a substance. The point is whether a patient used heroin or cocaine—not how many milligrams of heroin or cocaine were used. Test companies claim that measurement of buprenorphine’s first breakdown product, norbuprenorphine, can determine if a patient took buprenorphine only recently to fool the doctor. But I receive dozens of emails each year from patients with nothing to gain by describing their experience in those cases, swearing that they were taking the medication correctly, and asking how they can prove their truthfulness after what is called ‘flipped levels’ in such testing. Besides, anyone with knowledge of addiction knows how difficult it would be to pull of such a scam. The scammer’s urine would still contain the drug of abuse, unless we suppose the unlikely scenario where scammers successfully stop all opioids for a week each month and experience withdrawal each time, all for the sake of a script for Suboxone. Beyond the misery, few addicts would be able to control use of narcotics to that extent. That’s why they are addicted in the first place!

‘Quantitative urine testing’ measures the concentrations of substances in a patient’s urine. But urine concentrations of substances are not accurate reflections of blood concentrations of the substances. The first part of kidneys (the glomeruli) act like sieves with very large pores, spilling gallons of dilute liquid that contains drug metabolites and other molecules. The largest parts of our kidneys consist of tubules that reabsorb water and reabsorb or secrete other molecules and ions. When that liquid finally reaches the exit from the kidneys at the ureters, the original filtrate has been concentrated by several orders of magnitude, and has had a range of molecules removed from or secreted into it. Water reabsorption depends on hydration status, circadian rhythms, diuretic and other medications, stress hormones, diet, and other factors. As a result, concentration of a substance in the urine is not related to concentration in the blood—let alone to the use of the substance. Blood levels provide far-more-accurate information, but even blood levels vary from differences in metabolism of substances between individuals.
Quantitative testing tries to overcome the gap between blood and urine levels by using levels of other substances, such as creatinine or urea, to estimate the extent of concentration performed by the kidneys. But there are enough variables to make the results far from reliable. But frankly, the inaccuracies don’t really matter—since in most cases the presence or absence of a chemical is the issue, not the concentration.

In an era when costs are a concern, why would states become involved in testing processes that force a dramatic increase in treatment costs? Doctors who know their patients are in better position to decide when such testing is valuable. In medical school 25 years ago, I learned about the inefficiency of shotgun approaches to lab testing—that instead of ordering routine chemistry panels for every patient, doctors should decide which specific tests are necessary and order accordingly. To mandate such expensive testing, someone is deciding ‘yes that’s true, but….’. The annual climb in the cost of healthcare is largely due to those and other ‘buts.’

The only reason the state would think that they know better—from hundreds of miles away, without meeting the patients—is if they assume that doctors treating addiction don’t care what their patients are doing, or are inept. But if the same inept doctors are the people interpreting the results of mandated quantitative testing, what does the mandate add, exactly? And why the selective oversight of doctors who treat addiction, when most of the harm from drug diversion comes from opioid agonists prescribed by doctors who don’t work in the addiction field?

Other mandates include the rules found on standard opioid treatment contracts. The rules themselves are not unreasonable. But I take issue with the double standard applied to addiction physicians. Expensive residential treatment programs have abysmal success rates. Should they be regulated? People who have too much plastic surgery look ridiculous—should that be regulated? Everybody talks about the epidemic of opioid overdose deaths— deaths caused 99.9% of the time by something other than buprenorphine, the most effective treatment for opioid dependence. But it’s buprenorphine that needs regulating?