Archive for the ‘Evidence-based Treatments’ Category

Continuum of Care for Opioid Use Disorder

 

 

 

 

 

 

“Continuum of care is a concept involving an integrated system of care that guides and tracks patient over time through a comprehensive array of health services spanning all levels of intensity of care.” (Evashwick, 1989)

Continuum of care isn’t a new concept. It’s a pattern of care that we use to treat patients with all sorts of chronic medical illnesses. For mild forms of a chronic illness, primary care providers manage patients’ illnesses. For more severe forms of the same illness, patients are referred to specialists, with more experience and training in that area of medicine. Ideally these shared patients flow back and forth between specialists and primary care providers as needed based on the severity of illness as it may fluctuate over time.

We ought to apply this same concept for the management of opioid use disorder. It’s a chronic illness which can have exacerbations and remissions over time, just like diabetes and asthma.

I try to follow this concept at the opioid treatment program where I work. Patients new to treatment often are ill, not only from the drug use, but also from neglected physical and mental health issues. They need more intense care. An opioid treatment program offers more structure and supervision than an office-based practice, so it’s a level of care that’s appropriate for such patients.

At the opioid treatment program, we can do daily observed dosing, to make sure patients take the dose I prescribe. We assess the adequacy of the dose by asking about withdrawal symptoms and observing withdrawal physical signs. We can monitor for side effects. We can do frequent drug screens, to provide information about the proper level of counseling needed. Counseling, both group and individual, are built into the system at opioid treatment programs.

At the other end of the spectrum, stable patients with years of recovery in medication-assisted treatment need less care. We still need to monitor for relapses, but they usually don’t need as much counseling, and no longer require observed dosing. They need the freedom that office-based practices provide.

Stable patients on methadone get more take home doses, but opioid treatment programs are their only option for treatment setting. Stable patients on methadone can’t get their treatment in primary care settings. It’s illegal for office-based physicians to prescribe methadone for the purpose of treating opioid use disorder. Primary care doctors can prescribe methadone to treat pain, but not if the patient also has opioid use disorder.

It’s different for patients on buprenorphine (Suboxone, Subutex, Zubsolv, Bunavail). Since 2000, it’s been legal to prescribe this medication from office-based settings for patients with opioid use disorder.

But that doesn’t mean this is the right setting for all patients with opioid use disorder.

I have an advantage, since I see patients in both settings, both opioid treatment program and an office-based practice. I have the luxury of being able to treat new patients in the opioid treatment program, and after they stabilize, talk to them about transitioning to the office-based practice. If a patient encounters a rough patch, I can ask them to return to the opioid treatment program for more intense treatment until they again stabilize.

I can use the same concept as used with other chronic medical illnesses.

Sometimes a new patient can safely be treated in an office-based program. This all depends on individual patient circumstances. One patient may have a fantastic support system at home, while another may have to put up with active drug use in his home. Obviously, the latter patient needs more support from treatment staff.

Sometimes patients on buprenorphine aren’t appropriate for office-based treatment, even after months of treatment.

Unfortunately, most patients with opioid use disorder aren’t placed in a treatment setting based on their needs. Most patients end up in whatever facility they enter for the duration of their treatment, which may not be the best thing for the patients.

It’s rare for an office-based practice to refer their patients who are struggling to opioid treatment programs. Many office-based providers, enthusiastic about treating patients with opioid use disorder, still regard opioid treatment programs with great suspicion. It’s partly due to lack of knowledge about OTPs. It’s also partly due to that old bugaboo that blocks so much of appropriate treatment for people with substance abuse disorders: stigma. Some providers believe all sorts of outlandish things about what takes place at opioid treatment programs.

It’s painful to admit, but some providers’ opinions are formed based on the actions of poorly run opioid treatment programs. Some opioid treatment programs provide little more than daily dosing of medication. In our business, those programs are referred to derisively as “juice bars,” meaning patients get a daily dose of methadone, which looks like red juice, and little more.

These programs taint the reputation of good opioid treatment programs which offer an array of services all meant to help the patient. This is a real shame.

So, what about me? Do I refer stable buprenorphine patients at our opioid treatment program to other office-based buprenorphine practices? Well…not so often.

I know plenty of excellent office-based buprenorphine providers across the state who are diligent and painstaking about the care they deliver. And I know some providers in my area who don’t meet that standard. I’m hesitant to refer to them.

For example, one nearby provider charts extensive patient visits. These notes include everything from history of present illness, complete review of systems, and complete physical exam for each visit. Yet I was troubled about how similar each visit was, and suspected there was a whole lot of “cut and paste” going on, and that the charted care wasn’t actually being delivered.

Recently a patient transferred from this practice back to me, at the opioid treatment program, for purely financial reasons. We requested a copy of her charts, as we do for all patients who have been seeing other practitioners. This is good medical practice, even if it hasn’t been all that helpful with this particular provider in the past.

I was reading the records, and was confused. I read in the exam section of her last visit, “Abdomen consistent with eight month pregnancy.”

How had I missed this, I thought. I’m no obstetrician, but even I should pick up an advanced pregnancy on exam.

I slid my eyes back to the patient, sitting on a chair near the corner of my desk. Her abdomen looked flat.

“Um, so…are you pregnant?”

“No! Why?”

“Well you don’t look pregnant,” I added, not wishing to offend her. “It’s just that this last note says you’re eight months pregnant.”

She sighed and rolled her eyes. “The baby is seventeen months old. I guess they just never changed it in my chart.”

I looked back at each note. Sure enough, the exams for each date all read, “Abdomen consistent with eight month pregnancy.” For many months. Clearly, this was cut and paste charting. It’s not quality care, and may be illegal if the provider charged for services not delivered.

This confirmed my worst suspicions about the level of care provided at that practice, so I don’t think I will be referring patients to them.

In this country, we do have obstacles to providing a continuum of care for patients with opioid use disorders. We have some office-based practices that aren’t well-run and have little oversight. We have substandard opioid treatment programs providing little more than medication dosing, and we have undeserved stigma against opioid treatment programs that have been providing quality care for many years.

In fact, opioid use disorder may have the least organized continuum of care of all chronic diseases.

What’s the answer? Better communication and better education among medical providers.

I’m doing my part.

I go to many conferences, to learn the latest data and standards in my field. I also meet other providers at these conferences, even though by nature I’m a bit of a recluse. I’ve given talks, both to community groups and at medical meetings, to do my part to pass on what I know. I don’t enjoy public speaking, but find that once I get involved in my topic, I lose my fears.

All providers of care for people with opioid use disorders need to do this – we must meet each other, talk to each other, and learn from each other.

Here are a few wonderful opportunities to interact and learn:

ASAM conferences: the American Society of Addiction Medicine holds several conferences per year at the national level, and these are excellent for learning and meeting the leaders in the field. You can read more at their web site: www.asam.org

 

In my state of North Carolina, you can get some valuable information from the Governor’s Institute, at https://governorsinstitute.org/ and also their blog: http://www.sa4docs.org/

You can attend webinars, get clinical tools, and obtain mentoring from the Providers’ Clinical Support System MAT, at https://pcssmat.org/

If you are a provider in North Carolina and want CME hours while you teleconference with peers and mentors, you can participate in the UNC ECHO project. You can read more about that here: https://uncnews.unc.edu/2017/02/15/unc-chapel-hill-initiative-will-combat-opioid-use-disorders-overdose-deaths/

Write to me if you want to participate and I can forward you to the people that can make that happen.

Advertisements

Media Maintains Methadone is Menacing Mountains

 

NEWS CAT

Last week, a colleague of mine directed my attention to local news coverage of the opioid use disorder epidemic. It’s a four-part series titled “Paths to Recovery.”

Anytime the press covers opioid use disorder and its treatments, I feel hope and dread. I hope the report will be fair and unbiased, and give the public much-needed information. And I dread the more likely stigmatization and perpetuation of tired stereotypes about methadone as a treatment for opioid use disorder.

Overall, the four segments of this news report had some good parts, and some biased parts. It was not a particularly well-done series, and could have benefitted from better editing. It was disjointed and contained non-sequiturs, which I suspect confused viewers.

In the introduction to the first segment, the report says their investigators have spent months digging into treatment options in the area. Their conclusion: there’s a variety of options and treatment is not one-size-fits-all. The report goes on to give statistics about how bad the opioid use disorder situation has become, and they interviewed a treatment worker who says we’re two years in to this, and the community doesn’t grasp the seriousness of the situation. They also interviewed some harm reduction workers, and discussed naloxone rescue for overdoses and needle exchange.

So far, so good, except that of course we are more like two decades into the opioid crisis, not two years.

Part two of this series was “Mountain methadone clinics.” As soon as I saw the dreadful alliteration, I cringed, fearing the content of the segment.

This report didn’t say good things about methadone. In fact, one physician, supposedly the medical director of a new opioid treatment program in the area, says on camera, “Methadone is very dangerous. It has some effects on the heart. The rhythm of the heart, it has some drug interactions.” He went on to say that at the right dose, people could feel normal, and that it replaced the endorphins that were lacking, but I worry people will remember only that a doctor said methadone was a very dangerous drug.

Methadone can be dangerous, if you don’t know how to prescribe it, or if you give a person with opioid use disorder unfettered access to methadone. But in the hands of a skilled and experienced physician, at an opioid treatment program with observed dosing, methadone can be life-saving.

The news report outlined the failings of existing methadone programs in the area, saying staff had inadequate training, and failed to provide enough counseling for patients. It said one program made a dosing error and killed a patient, while another program had excessive lab errors.

All of that sounds very bad.

No positive aspects were presented as a counterpoint to that bleak picture. I felt myself yearning for an interview with a patient on methadone who has gotten his family back, works every day, and is leading a happy and productive life. Of course, those people are hard to find, since they are at work and harder to find by the media, even reporters who have supposedly been “working for months” on this story.

And then…of course they interviewed patients who had misused methadone. One person criticized his opioid treatment program because they allowed him to increase his dose to 160mg per day, and he said “…that’s a lot. I didn’t need that much…” and goes on to admitting to selling his take home medication. Another patient said the methadone made him “sleep all the time.” Another patient said methadone made him “high all the time.”

There will always be such patients…ready to lie to treatment providers to get more medication than needed, break the law by selling that medication, and then blame it all on the people trying to help them. Unable to see their own errors, they blame it all on someone else, or on the evil drug methadone.

Every program has such patients. But these people can also be helped, if they can safely be retained in treatment long enough, and get enough counseling.

Even though these patients are few, they get far more media attention compared to the many patients who want help and are willing to abide by the multitude of rules and regulations laid on opioid treatment programs by state and federal authorities. These latter patients are why I love my job. I see them get their lives back while on methadone. They become the moms and dads that they want to be. They go back to school. They get good jobs and they live normal lives. They don’t “sleep all the time,” as the patients on this report said.

But not one such patient was interviewed for this report.

As I watched this segment, I thought back to an interview the A. T. Forum did with Dr. Vincent Dole, one of the original researchers to study methadone for the treatment of opioid use disorders. This was in 1996, before our present opioid crisis gained momentum.

A.T. FORUM: It seems that, over the years, methadone has been more thoroughly researched and written about than almost any other medication; yet, it’s still not completely accepted. How do you feel about that?

  1. VINCENT DOLE:It’s an extraordinary phenomenon and it has come to me as a surprise. From the beginning of our research with methadone we were able to rehabilitate otherwise hopeless addicts that had been through all of the other treatments available. I expected methadone would be taken up very carefully by the addiction treatment community, but with some enthusiasm. Instead of that, we’ve had endless moral and other types of objections which are really irrelevant to the scientific data.

I was surprised, because my background in research had led me to expect that the medical community was a very critical but nonetheless objective group that would respond to solid, reproducible data. Instead I find that we still get the anti-methadone argument of substituting one addictive drug for another.

This is ignoring the scientific data showing that, as a result of methadone treatment, people who have been hopelessly addicted and anti-social and excluded from any normal life or family, are in a wonderful way becoming responsive to social rehabilitation and today constitute a very large number of people who are living normal lives. The fact that people, especially medical practitioners, would dismiss that as unimportant simply staggers me!

[http://atforum.com/interview-dr-vincent-dole-methadone-next-30-years ]

 

What would Dr. Dole think now, twenty more years later, during a terrible wave of death from opioid use disorders, about the continued stigmatization of methadone?

Then next segment was about buprenorphine, and how it can be prescribed in a doctor’s office, making it a better choice for patients. It wasn’t a bad segment, and contained some useful information. Physicians who were interviewed had nothing but good things to say about buprenorphine.

Or rather, they had good things to say about Suboxone.

The brand Suboxone was heavily promoted by this piece. Not once did the reporter use the drug’s generic name, buprenorphine. Every time, the medication was called by its brand name, Suboxone, and every picture of the medication was of Suboxone film. No mention was made of the other brands: Zubsolv, Bunavail, Probuphine, or even that there are generic combination buprenorphine/naloxone equivalents for Suboxone film, for less than half the price.

I know buprenorphine is kind of a mouthful for non-medical reporters, but still, I thought it was odd to use only the name of one brand: Suboxone. It’s as if this was a commercial for that drug company. Indivior, the manufacturer of Suboxone, must be delighted with this coverage. To me, it felt like an advertisement rather than journalism.

Another segment was about sober recovery homes. The investigative reporter talked to owners of sober recovery houses and the tenants at those homes. She said NC has no regulations or standards for recovery homes. She talked on screen to a patient advocate who says patient brokering is going on in Asheville, as well as lab scams at recovery homes where the patients’ best interests aren’t at the heart of the way these homes function.

She talked to Josh Stein, NC Attorney General, about passing laws to better regulate these sober homes, and he agreed that if these laws were needed, they should be passed.

No controversy with that one.

There was a segment about how there’s not enough beds in residential facilities for patients with opioid use disorder who want help. I agree, though I’m not sure this is breaking news for anyone. I don’t think there’s ever been enough beds to meet the treatment need.

Overall, I was left with a bitter taste after this reportage. The news program missed an opportunity to educate viewers about all evidence-based treatments for opioid use disorder, but ended up doing an advertisement for Suboxone and denigrating methadone.

Buprenorphine and methadone both work under the same principle: they are long-acting opioids which, when dosed properly, prevent withdrawal and craving while also blocking illicit opioids. While buprenorphine is a safer drug with fewer drug interactions, it isn’t strong enough for everyone. Methadone has countless studies to support its use to treat opioid use disorder, showing it reduces death, increases employment, decreases crime… but why go on, since facts don’t seem to matter as much as sound bites.

In my opinion, WLOS bungled an opportunity.

News You Can Use

 

 

 

 

 

 

 

 

New ACOG Recommendations:

The American College of Obstetrics and Gynecology (ACOG) just released an updated recommendation about the treatment of opioid use disorder in pregnant women: https://www.acog.org/Resources-And-Publications/Committee-Opinions/Committee-on-Obstetric-Practice/Opioid-Use-and-Opioid-Use-Disorder-in-Pregnancy

Their last statement was issued in 2012, in cooperation with the American Society of Addiction Medicine (ASAM). This newer statement was released earlier this month, also in cooperation with ASAM.

By my reading, this update is more direct about recommending medication-assisted treatment for pregnant women with opioid use disorder, and specifically discouraged medically supervised withdrawal from opioids during pregnancy.

This statement was in the update’s conclusions: “For pregnant women with an opioid use disorder, opioid agonist pharmacotherapy is the recommended therapy and is preferable to medically supervised withdrawal because withdrawal is associated with high relapse rates, which lead to worse outcomes. More research is needed to assess the safety (particularly regarding maternal relapse), efficacy, and long-term outcomes of medically supervised withdrawal.”

I suspect this released update may have been prompted by the actions of obstetricians in certain locations (Tennessee, for example), where medically supervised withdrawal is routinely recommended by obstetricians. As you recall in a blog earlier this summer, I showed you a letter written by OBs from TN, recommending “medically supervised withdrawal” for patients on medication-assisted treatment of opioid use disorders.

As the ACOG update emphasizes, there’s scant evidence to show medically supervised withdrawal provides any better outcomes for the baby, but certainly places the mother at risk for relapse.

I am pleased to see this update, and plan to mail it to a few obstetrics practices in my own area. Some OBs may be giving patients recommendations not supported by their own professional organization out of ignorance, in which case more information can help. Other OBs do it for ideological reasons, in which case I doubt any amount of information can help, but at least I’ll know I’ve tried to do something.

Screening for substance use disorders was also strongly emphasized in the new document, with specific recommendations about how this should be done. In other words, asking a pregnant patient, “You don’t take any drugs, do you?” is not considered to be adequate or recommended screening.

Increased Risk for Death in Patients with Opioid Use Disorder who Leave Buprenorphine Treatment

We have multiple studies, dating back decades, showing patients with opioid use disorder who leave treatment with methadone have higher risks of overdose deaths. We believe the same thing is true with buprenorphine treatment, but now we have more data to support that assumption.

A French study of 713 buprenorphine patients showed that being out of buprenorphine treatment was associated with a 30-fold increase in death, compared with patients who stay on buprenorphine treatment.

Now that’s impressive.

This was a study done in France, where most patients with opioid use disorder are treated by general practitioners in private practice. This would be roughly equivalent to what physicians do now in the U.S. in their office-based buprenorphine practices, often called OBOT treatment.

The study was published in the July/August 2017 issue of the Annals of Family Medicine, by Dupouy et al. It looked at new patients admitted onto buprenorphine treatment from early 2007 until the end of 2011, and covered over 3,000 person -years of treatment.

The authors say that the data showed, “…being out of treatment was associated with sharply elevated mortality risk.”

We already knew that people with opioid use disorder have an increased risk of death. Early in this article, the authors state that the accepted mortality rate of untreated heroin use disorder is around 2 people per 100 patient years. This means that if you follow 100 heroin users for a year, it is likely that 2 will be dead at the end of the year. An older study, by Hser et al., followed people with opioid use disorder over time, and found that around 50% were dead at 30 years.

We’ve had other studies that show being in treatment with buprenorphine or methadone decreases risk of death, but this may be the first study showing that getting help in a primary care setting reduces the risk of death so remarkably.

This was a very large study, so the data is more impressive to me All this data supports the conclusion that opioid use disorder is a serious and potentially fatal disease, and that being in medication-assisted treatment markedly reduces the risk of death.

 

What’s a Doctor To Do?

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Above, you will see two documents which illustrate the problem.

The second is a letter sent to North Carolina opioid treatment program (OTP) physicians from the preeminent OB/GYN group at the University of Tennessee. The first is a letter sent last month to obstetrical providers and opioid use disorder treatment providers from the Center for Substance Abuse Treatment, an arm of SAMHSA (Substance Abuse and Mental Health Services Administration).

You will note they recommend polar opposite approaches to the management of opioid use disorder in pregnant women. The obstetricians at University of Tennessee recommend that pregnant women with “chronic narcotic use” be offered the option of taper from opioids, to avoid neonatal abstinence syndrome and to avoid microcephaly.

In contrast, the letter to providers from CSAT division of SAMHSA recommends, “Pregnant women with opioid use disorder should be advised that medically supervised withdrawal from opioids is associated with high rates of relapse and is not the recommended course of treatment during pregnancy.”

That mention of microcephaly in the U of T letter baffles me. The resources cited in their letter referred to one study of head circumference in babies with neonatal abstinence syndrome (NAS). There’s no mention whether the moms are on illicit opioids or MAT. The second study looked at head circumference in babies born to moms with polysubstance use. None of the studies looked at head circumference of infants born to moms on MAT and compared them with controls. Using microcephaly as an argument against MAT is a misuse of data.

Why on earth would Tennessee obstetricians send their letter to NC opioid treatment program providers? Because, as I have ranted about so often in the past, there are no opioid treatment programs in Eastern Tennessee. Because that portion of Tennessee still has no methadone programs, patients are forced to drive across the border to get the gold standard of treatment for opioid use disorder. True, there are some buprenorphine prescribers in that area, and that’s a great thing as far as it goes, but as we know, not all patients do well with buprenorphine, and we have around six decades worth of data about methadone in pregnancy.

So not only does Tennessee refuse to allow the most evidence-based treatment for opioid use disorder to exist in that part of their state, but their physicians seek to control the actions of opioid treatment physicians in North Carolina, and ask us to adopt treatment approaches discouraged by all other expert organizations.

The study touted by Dr. Towers in their above letter was published by Bell, Towers, et al. in September 2016 issue of the American Journal of Obstetrics and Gynecology: http://www.ajog.org/article/S0002-9378(16)00477-4/abstract

After reading this study in some detail, I’m surprised by the authors’ conclusions. I find their conclusions to be based on some very thin evidence.

This study was a retrospective analysis of four groups of pregnant women with opioid use disorder. The first group consisted of incarcerated women, allowed to go through opioid withdrawal without the standard of care, buprenorphine or methadone. How this is even legal is beyond me.

The study says that jail programs in east Tennessee have “no ability to provide opiates to prevent or perform an opiate-assisted withdrawal medical withdrawal.” It went on to say that the jail doctor can treat symptoms with anti-nausea meds, clonidine, and anti-diarrheal meds. They also lack the ability to perform fetal monitoring while incarcerated.

Of the 108 women in group 1, two suffered intrauterine fetal death, one at 34 weeks and one at 18 weeks. The authors don’t say what the expected rate of fetal death would be, and I don’t know either. Apparently the authors didn’t consider these two deaths to be outside the range of normal.

Group 2 consisted of 23 pregnant women with opioid use disorder who were sent to inpatient opioid detoxification followed by long-term follow-up behavioral health programs. These women did well, with only 17% relapsing while in treatment. This group had a 17% rate of neonatal abstinence syndrome in the newborns.

I guess that means all of the four women who relapsed had babies with NAS. That’s 100%, much higher than the 50% rate nationwide. That seems odd to me.

Group 3 did the worst. These 77 women had inpatient detoxification but then did not have the long-term treatment that group 2 were given. Of the infants born to these women, 22% needed admission to the neonatal intensive care unit. Of these 77 women, 74% relapsed, and NAS was present in 70% of those infants. Again, this gives a NAS rate of 95%, which is a great deal higher than most other studies of NAS in babies born to moms using opioids of any kind. Even with methadone, studies give estimates of 50% to 80% at the highest.

Group 4 consisted of 93 women on buprenorphine prescribed by office-based physicians who agreed to taper the women’s doses during pregnancy. The rate of relapse in this group was noted to be 22%, and 17% of all the babies had NAS. Again, this gives a relatively higher NAS rate than has been found in other studies. In this Bell study, NAS occurred in 76% of the women who relapsed, up from 50% of women on buprenorphine in the MOTHER trial who were not tapered.

A little sentence in the articles table of demographics and outcomes gives the clue to why their NAS rates were so high. The way this study determined relapse was by drug screen at the time of admission to the hospital for delivery, or an admission by the pregnant woman, or positive meconium screen, or treatment of NAS in the newborn.

I think relapses could have gone undetected very easily, so that only the women with a relapse close enough to the time of delivery were detected to have used opioids.

Other problems with this study have been pointed out by much smarter people than me. Dr. Hendree Jones, author of the landmark MOTHER trial comparing methadone and buprenorphine during pregnancy, commented in the Journal of Addiction Medicine in the March/April 2017 issue: Her conclusions after a review of the Bell article plus a handful of other similar studies is: “Evidence of fetal safety to support the equivalence of medically assisted withdrawal to opioid agonist pharmacotherapy is insufficient.”

Of course, pregnant patients have one big concern: “What can I do to keep my baby from having withdrawal?” and that’s what they focus on. They are willing to do anything, including coming off methadone or buprenorphine or other opioids, if it will keep their baby from withdrawal. As Doctor Jones cogently points out in the above referenced article, there’s lack of data to show medically-supervised withdrawal from opioids results in less risk of NAS.

In other words, if prevention of NAS is our only goal, there’s not enough evidence to show that reducing opioids during pregnancy will achieve this. In part, that’s due to the high risk of relapse in the mother, and in part due to other factors.

This is the state of the situation right now. Things could change in the future. We do need new studies, done with closer attention to fetal monitoring and drug testing throughout pregnancy to help us determine the ideal treatment of pregnant women with opioid use disorder.

But for right now, maintenance on buprenorphine or methadone is still the treatment of choice.

It’s not only SAMHSA that’s recommending MAT as the treatment of choice for pregnant patients with opioid use disorder. Even the American College of Obstetrics & Gynecology (ACOG), the professional organization of OB/GYNs in the U.S., in a position statement from 2012, says:

  • “The current standard of care for pregnant women with opioid dependence is referral for opioid-assisted therapy with methadone, but emerging evidence suggests that buprenorphine also should be considered.”
  • “Medically supervised tapered doses of opioids during pregnancy often result in relapse to former use.”
  • “The rationale for opioid-assisted therapy during pregnancy is to prevent complications of illicit opioid use and narcotic withdrawal, encourage prenatal care and drug treatment, reduce criminal activity, and avoid risks to the patient of associating with a drug culture.”

The World Health Organization says, in its guidelines from 2014:

  • “Pregnant women dependent on opioids should be encouraged to use opioid maintenance treatment whenever available rather than to attempt opioid detoxification. Opioid maintenance treatment in this context refers to either methadone maintenance treatment or buprenorphine maintenance treatment.”

A new statement from the American Society of Addiction Medicine earlier this year, titled, “Substance Use, Misuse, and Use Disorders During and Following Pregnancy, with an Emphasis on Opioids” said:

  • “For pregnant women with opioid use disorder, opioid agonist pharmacotherapy is the standard of care; the ASAM National Practice Guideline for the Use of Medications in the Treatment of Addiction Involving Opioid Use recommends that pregnant women who are physically dependent on opioids receive treatment using methadone or buprenorphine monoproduct rather than withdrawal management to abstinence.

So the experts agree. Medication-assisted treatment is the gold standard for pregnant women with opioid use disorder.

Why are some OB/GYNs in Tennessee and other areas recommending the opposite, based on evidence that most of us consider preliminary at best, and flimsy at worst?

I don’t know for sure, but I think these physicians suffer from the same biases as other non-medical people. I would like for these physicians to base their actions on the best scientific data, but that’s not happening in some areas. I believe these doctors, with the best of intentions, have been swayed by the political climates of their areas. Rather than challenge long-held beliefs about medication-assisted therapies that have been based on ideology rather than fact, they have stayed inside the comfort zone of believing pregnant women shouldn’t be on methadone or buprenorphine.

This leaves addiction medicine physicians in the middle. We know what the standard of care is, but our patients are told we are wrong, and that they should taper off maintenance medication, or not start it in the first place.

I’ve tried, one OB at a time, to educate gently about what I see as the standard of care. I’ve sent studies and position papers and other data to the OBs with whom I share patients. I’ve blogged about the negative experiences I’ve had. In short, many of these obstetricians say something to the effect of: “Who are you to tell me how to care for this pregnant patient?” After all, I’m not an obstetrician. But I do read, and I do keep my fund of knowledge up to date in the field of addiction medicine, which overlaps with obstetrics at times.

I’m terribly frustrated by the situation, and I know my colleagues at other opioid treatment programs feel the same way. I’m fortunate that there is one group of OBs who are somewhat supportive of my pregnant patients on MAT, and I appreciate that. But often these pregnant ladies using opioids are already going to one of the anti-MAT OBs, and that creates real problems.

If it’s difficult for physicians, just think how the pregnant patients feel. They are given polar opposite recommendations by their OB and their physician at the OTP. They sought help in order to do the best thing for their babies, wanting to be good mothers. In most situations, they have tried desperately to quit opioid on their own, and couldn’t. Now the OB is telling them they must taper off their medication during pregnancy, and the OTP physician is recommending they stay on it, even recommending they increase their dose if needed.

At a difficult time in their lives, these mothers-to-be aren’t sure if they are doing the right thing by being in treatment with MAT or not. They second guess themselves, and their families also recommend, with the best of intentions, that they follow the OB’s directions.

I think this won’t change unless professional organizations like ACOG reach out more directly to obstetricians in the field. Perhaps SAMHSA can organize educational lectures, given by obstetricians who know the data and know the best practice recommendations. Perhaps state medical societies or state medical boards can contact these obstetricians with statements of best practices, if more are needed. With WHO, ACOG, SAMHSA, and ASAM all recommending MAT for opioid-dependent pregnant women, you wouldn’t think further statements of best practice would be needed…yet they are.

All I know is that I don’t seem to be making any headway at all. I need help, and my patients need help.

 

 

 

New Treatment for Neonatal Abstinence Syndrome

 

 

 

 

 

 

 

 

 

 

The June 15, 2017 issue of the New England Journal of Medicine contained an article of great interest. Written by Kraft et al., this article titled, “Buprenorphine for the Treatment of the Neonatal Abstinence Syndrome,” described a study comparing buprenorphine with morphine solution to treat opioid withdrawal in the newborn. This study showed significantly shorter duration of treatment and shorter median length of hospitalization for babies with neonatal abstinence syndrome when treated with sublingual buprenorphine compared to traditional treatment with morphine oral solution.

This study covers a hot topic. Many people are alarmed at the rising rate of NAS in our nation’s hospitals. The incidence of NAS has risen four-fold from 2003 to 2012, and cost $316 million in care for those babies just in 2012. [1] Any new treatment that can reduce the duration of withdrawal in newborns, and thus reduce treatment costs and parental anxiety, is an exciting new development.

The NEJM study described was done at Thomas Jefferson University in Philadelphia, Pennsylvania, with subjects enrolled from late 2011 until mid-2016. To qualify for the study, the babies had to be born full-term, defined as more than 37 weeks of gestation, and had to have been exposed to opioids during the pregnancy. The infants had to have signs and symptoms of neonatal abstinence syndrome (NAS), and parental consent to participate in the study.

The study, abbreviated BBORN, for “blinded buprenorphine or neonatal morphine solution,” excluded babies with low birth weight, exposure to benzodiazepines within 30 days of delivery, or serious other medical conditions. For the first part of patient enrollment, breast fed babies were excluded, but this restriction was lifted by 2013, with the national trend of that encouraged these mothers to breast feed. Nearly all of the mothers were on methadone maintenance, with doses ranging from 25 to 265 in the group assigned to buprenorphine treatment, and 30-260 in the group assigned to morphine oral solution, regarded as treatment as usual.

The design of this study was very strong, since it was doubly blinded, which means the providers caring for these infants didn’t know which were randomized to buprenorphine and which were randomized to morphine.

This double-blind approach is important in general, but especially important when dealing with the evaluation of babies in withdrawal. Sometimes nurses and other medical professionals who are evaluating withdrawal in babies have an emotional reactions. Some of these people can overestimate the degree of withdrawal, leading to longer hospitalization and over-medication.

If you are wondering “How do they get the babies to keep the medication under their tongue?” I wondered the same thing. The study explained that after getting a buprenorphine dose (or placebo, if their active drug was morphine solution), the babies were given a pacifier to extend the time the medication is in contact with the sublingual mucosa.

How clever. When my cat Yoshi was prescribed buprenorphine for urethritis, I had to dose him with buprenorphine, but there’s no way he kept it under his tongue. I thought some had to have gotten absorbed just from the oral mucosa. He definitely had a response to the medication, being opioid-naïve…he fell asleep, which gave him respite from frantic over-grooming of his urethra…

But I digress.

Anyway, this study showed buprenorphine significant decreased the duration of treatment for NAS, by an average of thirteen days, with no increase in adverse events, as compared to treatment as usual with morphine oral solution. The study authors postulate that the long half-life of buprenorphine levels the peaks and troughs seen with the shorter-acting morphine solution.

The study was limited by its small sample size. The authors wanted to get at least 40 subjects in each treatment arm, but had a hard time recruiting parents willing to enter their newborn into a treatment trial. They ended up with 30 patients in the buprenorphine treatment arm, and 28 in the morphine treatment as usual arm.

I can only imagine how hard it was to convince nervous mothers-to-be to enter their babies in this study. They were likely already worried about NAS in their infants, and perhaps feeling guilty about being pregnant while having the disease of opioid use disorder. Asking a mom – or dad – to then enroll in a study using a new medication (new for this use, at least) would be a hard sell.

Thankfully even with fewer test subjects than desired, the data still reached statistical significance. If future studies can replicate these outcomes, we will have a new medication with which to treat NAS, which will reduce the length of stay in the hospital for babies, reduce medical costs, and get these babies home sooner.

  1. Corr et al., “The Economic Burden of Neonatal Abstinence Syndrome in the United States,” Addiction, 6/13/17 http://onlinelibrary.wiley.com/doi/10.1111/add.13842/abstract

Bad Science: “Miracle” Cures for Addiction

snake oil

 

 

Addiction is hard to treat. Like other chronic illnesses, relapses are common, and frustrating to both the patient and the family. Substance use disorders cause considerable disability and even death. Treatments do help many people, especially medication-assisted treatment for opioid use disorder, but still aren’t as successful as we’d like.

Scoundrels looking to make a quick buck often prey on patients with diseases that are difficult to treat, like cancer, multiple sclerosis, substance use disorders, and the like. Sometimes bogus treatments have no basis in science at all. Sometimes minimally helpful treatments are touted as being more successful than science shows that they are. In all these cases, bad science is used to cover questionable, usually financial, motives.

I hate bad science. For the purposes of this blog post, I’m defining bad science as when people attempt to give their treatment, or method, or viewpoint, a sheen of scientific validity by using or misusing data, or by having no relevant data at all.

Some examples are more outrageous than others, and bad science has been used for decades.

Charles B. Towns, together with Dr. Alexander Lambert, declared the Towns-Lambert cure for alcohol and drug addiction to be 90% effective. The Towns-Lambert cure was a mixture of belladonna, hyoscyamine, and herb called prickly ash, castor oil, and mercury. Patients were also given chloral hydrate, a sedative similar to a barbiturate, along with morphine and paraldehyde. It fact, it was while he was a patient in Towns’ New York hospital that Bill Wilson, co-founder of Alcoholics Anonymous, had his vision that lead to his spiritual awakening, which in turn lead to the formulation of the Twelve Step program of AA.

Eventually, the number of repeat patients undermined claims of the cure rates of the Towns-Lambert method. Despite his lack of evidence, Towns’ claims became ever more extravagant, leading Dr. Lambert eventually to disassociate himself from Townes. Eventually, the Towns cure was discredited and disappeared.

This wasn’t the first treatment with better marketing than science, and it certainly wasn’t the last.

I had the displeasure of seeing a product being promoted at a recent conference I attended. This device, and I’m not going to give the name since I don’t want to give the promoter any free publicity, generates electrical pulses to the head. Three electrodes are placed just under the skin, and the device is worn for five days while the patient receives intermittent electrical stimulation. This supposedly gets rid of opioid withdrawal symptoms.

The person peddling this new invention shot himself in the foot in my view as soon as he said this device worked 100% of the time. When I asked for studies which had been published in peer-reviewed journals, he said they had loads of studies. Sadly, none were yet published that had been done in humans. He did have human data, but it wasn’t published yet, since an IRB (internal review board) hadn’t approved the study design before they undertook the study, so they had to find someone to approve the study after it was done.

Huh? No, that’s not the way review boards work. Review boards review studies before they are done, to assure no patient will be put in danger needlessly. I’ve never heard of a post-study review board.

So anyway, their human data hadn’t yet been published.

I hinted (oh OK, I came right out and said it) that perhaps it was a bit unethical to promote and expensive treatment ($500, not covered by insurance) unless they had human data, approved and reviewed by the research community, showing efficacy. The promoter of the item countered by saying it was unethical NOT to provide this device, given the benefit it provides.

He didn’t understand that my objection was to the lack of scientific process that all new treatments should undergo, to show they are of at least some benefit prior to use in clinical practice. This should be done before the treatment is marketed. But he pointed to all the success stories on their website, testimonials by patients of how effective this treatment was at preventing opioid withdrawal.

These testimonials are called anecdotal data in the scientific community. Anecdotal data isn’t nothing. It is a type of information that can suggest a potential effective treatment. But anecdotal data alone isn’t sufficient to claim efficacy. It’s only a potential starting point.

People tend to give testimonial type of anecdotal information more credence than they deserve. Hearing a story of miraculous healing touches our hearts. If we are also desperate for a similar cure, we risk making emotional decisions rather than rational ones.

I wasn’t trying to tell this salesman his product didn’t work. For all I know it will be the greatest breakthrough in addiction medicine in the last one hundred years. What I’m saying is that we don’t yet know if it works, because it hasn’t yet been properly tested. And therefore, I thought it was unethical to sell it before testing it.

Does anyone remember Prometa? It was all the rage ten years ago. News articles asked if it was the big breakthrough in addiction treatment. Anecdotal stories from former methamphetamine addicts were heart-warming. The company that supplies Prometa, Hythiam, was created by a former junk bond salesman, which could have been a red flag. That salesman heavily promoted Prometa with the anecdotal stories from addicts who had lost everything but were now drug free and happy.

The medications that made up Prometa are hydroxyzine (an antihistamine with sedating properties), gabapentin (an anti-seizure medication also used for neuropathy) and flumazenil ( a benzodiazepine antagonist). All three are FDA approved for uses other than addiction, but the proprietary combination of these made up Prometa, and it was sold as an addiction treatment cure without FDA approval. This is perfectly legal, by the way.

One drug treatment court, in Tacoma, Washington, paid $400,000 to buy Prometa for its participants. When it was discovered that several of the people making decisions for the drug court also owned stock in Hythiam, it left some people believing there was a conflict of interest. And after results from that drug treatment court were available, Prometa performed no better than traditional (and much cheaper!) treatments. [1]

Ten years later, I rarely hear the word Prometa. Hythiam changed its name to Catasys. Dr. Walter Ling, a very respected scientist in the addiction treatment world, completed a double-blind placebo-controlled studies showed Prometa to be no more effective than placebo.

But all this happened after that former junk bond trader made up to $15,000 for every Prometa patient treated. All those patients and their families were disappointed by another treatment that promised much and delivered nothing better than placebo.

I think it’s unethical for a company to bring a product to market before there’s adequate science to prove that it works. This rather rigorous process is what makes a product or procedure or methadone evidence-based.

Until you’ve got something that’s evidence-based, please don’t waste my time by trying to sell it to me.

When the marketing of a medication outpaces the research supporting it, watch out. We are in snake oil territory.

If a salesman blathers about how good his product is, but can’t hand you a good study published in a peer-reviewed journal, beware. With science, you’re supposed to do the studies first, then present at a conference of your peers, or in a peer-reviewed journal. The data should be able to be replicated by other facilities before we can see it is an evidence-based treatment. Barring that, it’s only a possible treatment among many possible treatments.

  1. “Prescription for Addiction,” 60 Minutes, CBS News, December 9, 2007 http://www.cbsnews.com/news/prescription-for-addiction/3/
  2. Ling et. al., “Double-blind placebo-controlled evaluation of the PROMETA program,” Addiction, 2012 Feb;107(2):361-9

Art Therapy as Treatment for Substance Use Disorders

 

Mural at our opioid treatment program

Mural at our opioid treatment program

 

 

 

We have a bunch of really creative people enrolled in our opioid addiction treatment program, skilled in arts of all kinds. We have an art therapy group, and I love looking at their creations.

As a special project, a group of patients made a beautiful mural on one wall of our facility, seen above. On the far left, scenery is dark and foreboding, with tombstones and other images of bleakness. Gradually there’s a transition as you look to the right. At the far right, the imagery is more cheerful, with pretty flowering trees and green grass. In the middle, signposts direct the viewer to the left, labeled “addiction,” and to the right, labelled “recovery.”

I started to wonder about whether art therapy was evidence-based, probably because I wanted it to be, because I like the idea of art therapy.

I found studies showing art therapy can decrease denial, reduce opposition to treatment, and give people with substance use disorders a means of communication. (Cox & Price, 1990, Allen et al, 1985, Moore, 1983) Some studies show that art can help lessen shame, and be an aid to group discussions for people with substance use disorders. (Johnson, 1990). Art can also help patients feel more motivated about making changes. (Holt & Kaiser, 2009, Matto et al, 2003)

So it appears there’s some evidence to show that art therapy can be of help to recovering people.

I have two posters framed in my office. They aren’t the usual inspiration posters of “teamwork” and “dream big,” etc. They don’t have any writing at all, and I picked them because they both inspired me personally. It’s interesting how patients interpret them

One is a print of a representational image of a colorful mountain, topped with praying hands, with a river appearing to flow from the mountain.

I’ve had numerous intriguing comments from patients about this print. Most just say “I like it.” Others say it reminds them that prayer can help them, or that prayer can create beautiful things.

I had one patient look at it for a long while, then back at me, and he said, “You’re a lesbian, aren’t you?” I had to laugh. I have no idea how he got that from my picture. When I told him no, I’m not a lesbian, he seemed disappointed. This illustrates how art can be interpreted differently by different people.

My other poster is a print of a painting that is so realistic that it looks like a photo. It shows a mountain goat in mid-leap between two narrow, snow covered peaks. A deep crevasse separates the two mountains. I’m intrigued by how differently patients react to that one. Many say that they like that one too, and I ask them, “Do you think he makes it?” meaning does the goat land safely? Most patients say something like, “I don’t know…” and others say, “No way. That goat falls.” And still others say, “Of course he does. He’s a mountain goat; that’s what he’s made for.”

Again, interesting perspectives from different people.

Do patients’ reactions to my art prints tell me anything useful for patient treatment? I don’t think it’s that easy. I’m tempted to assume the patient who says the mountain goat will fall is a pessimist, and the patient who says the goat will make it is an optimist, but I don’t know about that. For now, it’s just interesting.

Art is like that. It can help us understand the world in subtle, unique ways.

aaaaaaaaaaaaaaaaaaaaaaleapoffaith