Probuphine Implants: Impractical?

Probuphine

The more I learn about Probuphine, the less I think it will be practical for use in the average office-based opioid use disorder treatment setting. I predict it will be a specialty medication implanted by a few practitioners who take referrals from other doctors.

Braeburn Pharmaceuticals is sponsoring conferences for doctors to learn how to insert Probuphine, the form of buprenorphine that’s implanted under the skin like Norplant, the birth control medication. This medication is marketed by Titan Pharmaceuticals. Probuphine consists of four slender rods that are inserted just under the skin at the upper arm. These rods release buprenorphine over six months, when they have to be removed, and new rods implanted.

I wasn’t sure I wanted to do Probuphine implants, but I liked the idea of being able to do it, so I asked to attend one of their conferences to learn the procedure.

Alas, the company says only doctors who have performed minor surgical procedures over the past ninety days are eligible to learn to be an implanter of Probuphine. I can still prescribe it if I take the course, their letter says, but I’d have to refer to someone else to implant Probuphine.

Huh? I thought I could prescribe it already, since I have an “X” number. Maybe not.

If I can prescribe it but I can’t administer it, why would the patient see me at all? Why not just go directly to the doctor who can prescribe and implant?

I looked around the room during my recent addiction medicine conference and tried to imagine how many of these specialists had done surgical procedures over the past three months. There was one surgeon, and a few obstetricians, so I decided three out of sixty or so of the doctors who presently prescribe buprenorphine.

Even if the FDA approves Probuphine in May, I have a hard time imagining how Probuphine could be used in a typical office-based buprenorphine practice.

Because besides the implantation conundrum, who pays for it? Drug company representatives were unable to answer questions about the cost.

And how does the implant, the implanting physician, and the patient all arrive at the appointment time? Is the doctor expected to order the implant, store it in her office, and hope the patient shows up for the implantation? Surely we couldn’t give a prescription to the patient to take to a pharmacy for the implant, so I’m not sure how that’s going to work.

Won’t this medication need prior approval? Representatives from the drug’s manufacturer say “no,” but I have a hard time believing that.

I picture one or two sites in North Carolina that will have the resources to do the implants and probably keep them in stock, perhaps at a hospital pharmacy. Maybe the teaching hospitals will have the resources to do this.

Also, the Probuphine delivers drug levels equivalent to six to eight milligrams of sublingual buprenorphine, so patients at higher probably won’t be considered.

I’m starting to doubt the practicality of Probuphine at an average addiction medicine physician’s office.

Buprenorphine: Current Practices

NCSAM

I just got back from the NC Society of Addiction Medicine annual conference. (Yes, I’ve been to several conferences lately.) One of the sessions I attended was a lively discussion of the current practices in office-based prescribing of buprenorphine, for opioid addiction.

The session was run by two experienced, knowledgeable addictionologists, who mediated topics and shepherded the dialogue. One physician works in North Carolina and the other in Tennessee. The room was packed with at least fifty people, most of us doctors who prescribe buprenorphine for addiction.

Deliberations were collegial but we didn’t agree on all issues, of course. Dissenting opinions were respected and debated.

The first topic I can recall was about how often buprenorphine patients need to be seen. Most practitioners agreed that new patients needed to be seen at least weekly initially. As stability develops, we gradually extend the time between visits to one month. One doctor opined that no patient should be allowed to go any more than one month between physician visits. When the moderator asked if anyone disagreed, I raised my hand, and the moderator asked me to explain.

With some trepidation, I told the audience that I had a super-stable group of patients in my practice. I inherited most of them from another physician who was one of the first in the area to prescribe buprenorphine. This group of patients all have over five years of stable and relapse-free recovery. A few have been in stable recovery for nearly ten years. These people work, and have happy and productive lives.

So yes, I do allow these patients to go two months between visits.

No one booed or hissed me, but I got the feeling I’m doing something with my patients outside the realm of normal for most doctors prescribing buprenorphine. Thankfully, the moderator made the point that we should use our clinical judgment and adjust treatment to best fit each situation, which made me feel better.

I was mulling this over later, and maybe I do have an unusual group of patients, who have been stable on MAT for so long. Some of these patients elected to stay on sublingual buprenorphine because they are doing so well on it, and they fear relapse if they taper off of it. Others plan to stay on buprenorphine because they developed addiction as a complication of chronic pain treatment. Happily, the buprenorphine works as well for their pain as it does for their addiction, so we get the two birds with the one stone.

There’s another unusual thing about these super-stable patients: almost all of them are deeply involved in 12-step recovery. Many were in Alcoholics Anonymous prior to their opioid addiction. They developed addiction to opioid pain pills after receiving prescription opioids for an acute or chronic pain condition. Once they started on buprenorphine to treat the opioid addiction, they continued going to Alcoholics Anonymous (a few go to Narcotics Anonymous).. Other patients didn’t start going to AA until after they entered MAT on buprenorphine.

I’ve had many people write comments to my blog, furious when I even mention 12-step recovery and MAT in the same sentence. But I have living proof in my practice of multiple patients on medication-assisted treatment of opioid addiction who have been able to make 12-step programs work for them.

Getting back to the conference…we spent much time discussing the monoproduct buprenorphine versus the combination product buprenorphine/naloxone. All of us agreed there’s a need for caution with prospective patients who insist they can take only the monoproduct (this is the equivalent of the brand name Subutex), because it does have a higher street value than the combination product.

Of course, there are people who inject the combination product (Suboxone film, Zubsolv, etc.), but overall, people seeking to inject buprenorphine are much more likely to prefer plain buprenorphine. Black market prices are higher for the monoproduct than the combination product, underscoring the preference for monoproduct.

One outspoken doctor said the monoproduct should rarely if ever be prescribed. Another doctor echoed my feelings on the matter when he said something to the effect that some patients really do have a bad reaction to the naloxone in the combination products, and if we are cautious, we can prescribe the monoproduct. However, the general opinion was that financial reasons weren’t sufficient to take the risk of prescribing the monoproduct.

I disagree with that, but kept quiet, already feeling like maybe I’m a bit too liberal.

I have had patients, stable on a buprenorphine combination product (usually brand name Suboxone films), who suddenly lost their health insurance. If such patients had negative drug screens for years, and no history of intravenous use, I switched them to the generic monoproduct because it’s the cheapest buprenorphine product on the market. These patients could not have stayed in treatment if I’d made them stay on the much more expensive brand names. Most of those patients prefer the films, and when they got new insurance, asked to switch back to the films.

I did not suspect these patients would sell their medication for profit. You have to know them, but these patients had stable jobs and no leanings toward criminality. And I am by no means a gullible person.

Since then, a generic combination product came onto the market. Still more expensive than the monoproduct, it’s less expensive than all the name brands.

Next we discussed how to deal with patients who say they are allergic to naloxone, and thus can’t take the combination product (Suboxone, Zubsolv) but only the monoproduct (Subutex).. Patients usually don’t mean an actual allergy, but rather intolerance to naloxone. These patients report headache, nausea, etc. when they ask their physician to prescribe the monoproduct. Of course, this raises suspicion with physicians that such patients plan to misuse the medication by injecting or snorting.

Should physicians just accept what patients say at face value, or should we say sorry, I only prescribe buprenorphine in combination with naloxone? After all, there’s no way to “prove” a headache or nausea. There’s no test we can order that will give any useful information. One doctor said he sent such patients to a neurologist for evaluation of the headache, or to a gastroenterologist to decide the cause of nausea. He says most patients fail to follow through, and so he weeds such prospective patients out of his practice that way.

An audience member suitably questioned this habit, asking how could a specialist be expected to determine if a medication caused headache or nausea? I think it’s kind of a sneaky way to get rid of patients who want buprenorphine monoproduct.

I have the same fears when fielding new calls from prospective patients. I’ve instructed my patient contact representative (who is also my office’s licensed professional counselor, after-hours contact person, pharmacy liaison, licensed clinical addiction specialist, prior approval wrangler, and fiancé) to tell these people that I do not prescribe the monoproduct to new patients. I have no problems saying “no” upfront to these patients, and try to explain why I’ve made this decision for my private practice (even though, as above, I have prescribed it for patients I know very well).

I use the monoproduct in the opioid treatment program where I work, because those patients dose with us every day until they have a period of stability. The dosing nurses roughly chop the tablets, to minimize diversion, and patients stay on-premises until the medication has dissolved, also to make diversion more difficult. These patients don’t get any take home doses until we feel they have stabilized.

We also discussed how long to keep patients on buprenorphine. The bottom line is that no one knows. Best outcomes are seen in patients who stay on buprenorphine, since there’s still a high relapse rate back to opioids in patients who stop buprenorphine. I ask my patients periodically if they wish to start a slow taper, if they’ve been stable for over a year. I don’t push them to taper if they’re not ready, but if they are, I recommend they taper slowly. From the discussion at this meeting, it sounds like most of my colleagues do the same.

We discussed the maximum daily dose of buprenorphine. According to studies, a daily dose of 16mg saturates most of a patient’s opioid receptors, and increasing the dose to 24mg only gives about a 4% increase in the number of covered opioid receptors. Some doctors say this shows buprenorphine should never be dosed more than 16mg per day.

However, about a third of the doctors in the room raised their hands when the moderator asked if they had any patients who seemed to require 24mg per day to stabilize.

I didn’t interject anything into the discussion, but I just went to a session at the national ASAM meeting where this same topic was discussed. While it’s true that basic pharmacology would indicate 16mg is probably the just as effective as 24mg in most patients, several studies have shown better patient retention in treatment when higher doses (24-32mg per day) are used.

It’s possible this isn’t a physiologic effect, but more of a mental process. We can’t be sure. But for whatever reason, if my patient does best at 24mg, I’ll allow her to stay on that dose.

For patients on higher doses, we need to make sure they aren’t diverting some of their medication. Patients sometimes ask for a higher dose than they need, in order to get enough medication to treat a friend, family member, or significant other. Some doctors call this “piggy-backing.” Even though it means a suffering addict is getting treatment, the piggy-backer won’t get any counseling. Also, law enforcement types use examples of diversion to demonstrate that buprenorphine is a bad street drug, contributing to the stigma against patients doing well in their treatment. Diversion threatens the whole concept of office-based treatment program.

All in all, we had two hours of lively interaction on the finer points of office-based prescribing of buprenorphine. I don’t think all doctors will agree about everything, but it’s nice to hear what other physicians are doing, to make sure I am not too far out of line with the standard of care.

Conference

asam logo

I just got back from the yearly American Society of Addiction Medicine conference. As always, it was a treat. It’s so refreshing to be surrounding by other physicians who know addiction is a treatable illness and not a moral shortcoming. I feel revitalized from being around people who also love treating people with substance use disorders, and who also love seeing people get well and get back to being themselves.

This conference was huge. Over 1800 people attended. When I went to my first ASAM meeting in 2004, I think there were around 300 attendees. What a difference!

This year, I sensed even more hopefulness and enthusiasm than in past years. Last month, Addiction Medicine was finally recognized as a legitimate specialty of medicine. Finally, we got recognition that we have a substantial body of science with data that supports the work we do.

Recently, there’s more conversation about treating people with opioid addiction. We see television shows, online articles, and blog posts about the opioid addiction epidemic and the death toll it’s exacting on our nation. Even President Obama recently emphasized the importance of treating people with opioid addiction, and the obligation of incorporating medication-assisted treatment. More federal and state grants are available to start programs to help people with substance use disorders.

All of these recent changes encouraged me, but the speakers at the ASAM conference pushed my enthusiasm further.

On the first session of the first day, Dr. Nora Volkow, director of NIDA (National Institute on Drug Abuse), spoke. She was her usual brilliant self, giving a concise summary of this nation’s present opioid addiction situation. She discussed many of the same studies I’ve highlighted in my blog over this past year, so I felt good about that.

Next to speak was Dr. William Miller, the “father” of Motivational Interviewing. His lecture, titled “The Power of Empathy in Addiction Treatment,” was a gift. It reminded me of why I love what I do, and how I can continue to improve as a clinician.

I also went to his ninety-minute session about the basics of Motivational Interviewing. I’ve read all three editions of his book, “Motivational Interviewing,” and I’ve seen videos of therapists using MI as a counseling technique. Motivational Interviewing is an evidence-based method of counseling people in order to help them change.

MI sounds much easier than it is. It also looks easy when I watch other people do it, but it’s much more difficult than it looks. Fortunately, my fiancé is a “MINTee,” meaning he’s one of the Motivational Interviewing Network of Trainers for Motivational Interviewing. I figure that can’t help but rub off on me. Plus, he helps train the counselors at our local opioid treatment program. In my obviously biased opinion, he’s helped our counselors become much better at their jobs, which ultimately benefits our patients.

I went to many other ASAM sessions – from a lecture on contingency management techniques to a discussion about buprenorphine doses above 16mg. All were excellent. Even though it’s impossible to attend all the sessions, since many times there were four of five going on at the same time in different rooms, I plan to listen to the recordings of them all on ASAM’s website when they become available.

And I will return to work a better, more enthusiastic doctor.

 

Vivitrol Treatment for Opioid-addicted Criminal Justice Offenders

Vivitrol

Naltrexone, an oral opioid blocker, is now available as an extended-release monthly injection, under the brand name Vivitrol. Initially marketed for alcohol addiction, it also treats opioid addiction. This medication is an opioid antagonist, which means that though it attaches to opioid receptors, it does not stimulate the receptor. Since naltrexone has a higher affinity for the receptor than opioid agonists (like oxycodone, heroin, and methadone) it can’t be displaced. This means it blocks opioid effects, including euphoria. Vivitrol is used for alcohol addiction because part of the pleasure from alcohol consumption is thought to be mediated through opioid receptors.

Some patients say Vivitrol blocks opioid cravings. From a purely biological view, that would be surprising, since it does not stimulate the opioid receptor. Yet some studies suggest it reduces opioid cravings, and some patients claim it reduces opioid cravings. It’s hard to know if this is due to a physiologic effect, or a mental process. If a patient who has just been given an opioid blocker believes he then is unable to feel any euphoria from opioids, maybe his cravings diminish.

I haven’t used Vivitrol much. I had one patient who came two months in a row for his injection, then was lost to follow up. I’ve had about three prospective Vivitrol patients scheduled to see me in my office and all three were no-shows for their appointments, very irritating.

This medication is expensive, at over a thousand dollars for one monthly injection.

In short, from the studies I’ve read and my own experience, I’m not convinced naltrexone will ever be as effective as methadone or buprenorphine in the treatment of opioid addiction.

When I saw an article in the New England Journal of Medicine, titled “Extended-release Naltrexone to Prevent Opioid Relapse in Criminal Justice Offenders,” I read it with interest. This article was in the March 31, 2016 issue, describing a study of 308 subjects, done by Lee et al., at five sites in the Northeast.

The study subjects were recruited from volunteers with histories of opioid dependence who were involved with the criminal justice system, but not incarcerated. These people agreed to be randomized to the treatment with Vivitrol or treatment as usual. Subjects were excluded if they had elevated liver function tests, were pregnant or trying to become pregnant, or had serious physical or mental health problems. They were also excluded if they had a chronic pain diagnosis for which opioids were prescribed, or if they had been hospitalized with a drug overdose within the past 3 years. They were excluded from the study if they preferred addiction treatment with buprenorphine or methadone medications, since obviously naltrexone can’t be given with those two medications.

The test subjects randomized to the Vivitrol group received injections every 4 weeks with counseling around medication side effects. Beyond that, both the Vivitrol group and the treatment as usual group had similar counseling schedules. People in the treatment as usual group were referred to treatment programs in the community, including providers of methadone and buprenorphine. Test subjects were seen every two weeks for 24 weeks, then at week 27, 52, and 78. Urine toxicology was obtained at each visit, as was self-report of drug use. Researchers also collected subject-reported data about criminal activity, re-arrest and incarceration.

The study examined how long it took subjects in each group to relapse to opioid use. The researchers defined relapse as ten or more days of opioid use out of the preceding four weeks. The rate of opioid-free drug screens was also evaluated for each group.

The treatment lasted 24 weeks. During this time, this study found that subjects randomized to receive naltrexone had significantly longer time until relapse to opioids than the group randomized to treatment as usual: 10 weeks for Vivitrol subjects compared to 5 weeks for treatment as usual group. The naltrexone group had higher rates of opioid-negative drug screens, and lower percentage of self-reported days with opioid use.

The groups didn’t differ significantly on rates of other, non-opioid drug use or the rates of re-incarceration.

This study also examined relapses in both groups after treatment ended, at week 52 and week 78, and found both groups had similar rates of opioid-negative urine samples. Surprisingly, in both groups, about half the subjects had negative drug screens for opioids.

In summary, this study showed that extended-release naltrexone by injection helped people addicted to opioids refrain from using opioids for much longer, and helped them have fewer days of opioid use. However, once the medication was stopped, the rate of drug use for these subjects was the same as treatment as usual group.

I have a few thoughts about the study.

  1. This data nicely fits with our present disease model of addiction as a chronic illness. Just as with diseases like high blood pressure and diabetes, when the treatment medication stopped, the disease returned.
  2. Out of the 153 subjects randomized to receive naltrexone, only 91 got all six of the planned injections. Authors state various reasons for the drop-outs, and indicated only five dropped out due to an adverse reaction to Vivitrol.
    Really? This interests me. Naltrexone has significant side effects in some people. Since naltrexone is an opioid blocker, it probably blocks the opioids made by the human body, called endorphins. Yet only one patient dropped out due to side effects?
    The authors said 39% of the Vivitrol group had adverse events related to the drug, and listed injection site reaction as most common, occurring in nearly a third; next most common were headache, and gastrointestinal upset. Is it possible some subjects in the Vivitrol group dropped out due to side effects but didn’t tell the researchers? I don’t know.
  3. Compliance was much better in this study of extended-release injection than with daily oral medication. That makes sense. With oral naltrexone, the person with opioid addiction has to decide to take medication every day, as opposed to once a month with Vivitrol.
  4. None of the naltrexone patients died, either during treatment or after. This is important, since after a period of abstinence from opioids, overdose risk is thought to be increased. But we didn’t see that effect after the medication was stopped. None of the patients died in an attempt to “override” the blockade of Vivitrol either.

Two subjects in the treatment as usual group died. I don’t think those numbers are nearly large enough to draw statistical conclusions, though.

  1. The authors acknowledge the lack of blinding – with a medication like depot naltrexone, it would be hard to give a sham injection to control subjects. This medication is thick and not an easy shot to give. It would feel much different than a placebo shot of sterile saline, for example. Perhaps the idea of getting an active medication helped subjects in that group believe it was helping, giving better results not due to the actual medication. That’s the problem with no placebo control – there’s no way to know.
  2. More study subjects in the treatment-as-usual group sought help from opioid-agonist treatments with buprenorphine and methadone than did the naltrexone group, at 37% versus 11%.

Thirty-sever percent?? That’s over a third. That tidbit is thrown in with little explanation, other than they subjects went to MAT “primarily after resumed illicit opioid use and relapse.”

From the article, I can’t tell if these subjects were counted as having relapsed or not. The number of subjects was likely too small to do any meaningful analysis, but I am very curious about their outcome.

  1. I find the high rate of opioid-negative drug screens in both groups to be surprising. Each had about half the subjects test negative for opioids at one year after treatment and a year and a half after treatment. That’s good…but just a little too good, perhaps.

So, in this study of opioid-addicted people involved with the criminal justice system, extended-release injected naltrexone prolonged the time to first opioid use compared with treatment as usual. Vivitrol also increased the rate of opioid-free days.

Of course, the big question isn’t IF naltrexone works…the question is how well it works, compared with methadone and buprenorphine?

Ongoing studies will hopefully give us that information soon.

 

DATA 2000: I’m Not Bitter!

Denial

Recently discussion of expansion of the one hundred patient limit has been in the news. I lost interest in this topic several years ago, when I saw DATA 2000 standards being violated with impunity in my community. Given lack of adherence to DATA 2000 requirements, people who want buprenorphine have no problem getting it.

Is this good or bad? Maybe a bit of both.

At least three physician extenders in my area prescribe buprenorphine for patients with addiction on a regular basis, despite having no “X” number. I don’t know how this happens, but I do know the North Carolina Medical Board investigated this practice, took no action, and these same extenders, still with no “X” number, continue to prescribe buprenorphine for addiction.

Since present DATA 2000 regulations are being ignored, changes in those regulations are moot in my state, or at least in my area.

Do I sound bitter? Yes, I am, or at least I am intermittently. On most days, I’ve got my own patient challenges to deal with, so I don’t have time to worry about other doctors’ practices. But occasionally I do feel some resentment. It’s hard not to fret when other practices get away with things, while I follow regulations.

I also grumble when I’ve got to pick up the pieces for patients expelled from other buprenorphine practices for doing exactly what people with addiction do – take drugs.

I’ve had multiple patients seek admission to our opioid treatment program after they were “fired’ by these other practices. Now, I know I’ll do a better job than they ever did, but it’s a real pain in the ass to try to find out exactly what went wrong. I’ve been hesitant to believe patients’ versions, since they sound incredible, but so far, my patients have told the absolute truth.

Recently I admitted several patients after they were dismissed from the other practice for misuse of their opioids. These patients had been prescribed buprenorphine by the physician extenders, and were apparently doing well. Then on one visit, the nurse practitioner or physician assistant asked the patient about pain, and after being told some pain did remain, these patients were taken off buprenorphine and prescribed powerful opioids instead.

Even the patients thought this action was odd. These patients said they knew they would relapse, but due to their disease of addiction, were unable to refuse this jackpot of opioids when offered.

Events unfolded in a predictable manner. The patients went back into active addiction, and injected the oxymorphone they were prescribed. They ran out early, and when a pill count was demanded, they of course failed. Dismissed for being a bad patient, the confused patients came to the opioid treatment program where I’m left to try to figure out what the hell has gone on.

Thankfully, the people I’ve seen survived their relapses, and were able to re-stabilize on either buprenorphine or methadone. But I wonder how many other people have had worse outcomes.

Perhaps if buprenorphine prescribers had better education about addiction, such relapses could be avoided. That’s one big downside of ignoring DATA 2000 requirements.

You Can Find My Office Next to the Restroom

bathroom break

Warning: this is one of those fluffy entries, not much substances, lots of musings…

A few weeks ago, I ushered a new patient to my office for her initial history and physical. Once in my office, she looked around and said, “Wow, they don’t think much of you, do they?” At first I was puzzled, but then figured out she meant that my office is small and undesirably positioned right next to the patients’ restroom. It’s not furnished lavishly, only with the essentials: desk, exam table, and two chairs. I also have a file cabinet containing some species of records.

Perhaps in the business world, one’s value to a company is reflected in the lavishness of one’s office. It is not like that in the doctor world, or at least not in the doctor world I inhabit. I don’t think about the size of my office, the location, or the furnishings. As long as I have everything I need to do my job, I don’t care or even notice other amenities. But some of the patients notice.

I’ve had some patients ask how I can stand the smell. On intake days, with eight or so new patients in varying stages of opioid withdrawal, my office can sometimes take on a certain redolence from the restroom next door.

It doesn’t bother me. I became immune to bad odors in 1985, roughly when I started my clinical rotations in medical school. By the time I got to my residency program, any sense of smell I still had was burnt out during my two-month rotation through the emergency department. I’ve been exposed to massive burdens of every type of stench emitted from the human body. As a result, I reflexively start mouth-breathing in the presence of unpleasant smells. It’s automatic.

I’ve worked for five opioid treatment program companies, in fifteen separate facilities. In many of them, the doctor’s office was next to the restroom, but I’m sure that’s just coincidence.

The worst was in an old building shaped like a “U”, with the pharmacy in the center. My office was at one end of the “u” and directly across from…you guessed it…the patient bathroom. That wasn’t the worst thing, though. Unfortunately my office had an inch and a half gap between the floor and the wall, and it appeared to be a major thoroughfare for bug travel. It was not uncommon for a roach to emerge from the gap, waving antennae like he was a pageant queen.

I usually had my back to this area, so the patients would be the first to see the invader. Almost without exception, the male patients would jump to their feet and stomp the intruder into bug heaven. I would smile and say, “Thank you, my dragon slayer.” We would share a laugh and get back to business.

Why are the physicians’ offices less luxurious in the opioid treatment programs than the rest of the doctor world? I think for the same reason some OTPs are in run-down buildings in the worst part of town. The stigma against medication-assisted treatment makes it more difficult to get regular medical office space. For all I know, maybe only the buggiest places were rentable. It’s also possible that some opioid treatment programs don’t think it’s worth spending money for a nice facility.

Doctors’ offices at OTPs may tend to be shabby because doctors aren’t in the opioid treatment program every day. Obviously, the counselors who are there every day should get the nicest offices because they will be using them more hours per week. Often when the facilities are cramped for space, the program doctor has to share an office with one or more other people. I know where I work now, two or three other people work in my office when they need space. As a result, a variety of detritus comes and goes.

One day a patient asked, “Are those your shoes under the exam table?” I didn’t have to look up. I knew he meant the pair of espadrilles that appeared one day without any explanation. I said “No, I don’t know whose those are.” He looked at me oddly, as if that were a strange answer, so I told him, “That’s nothing; there are other random things. I just don’t ask anymore.” One day my office was filled with balloons, and on another day, with hot dog buns.

The shoes were gone a month or so later, as quietly as they had appeared.

At my other program, my office is so small that literally we have to ask the patient to leave the room so that we can wheel in the EKG machine, then come back in. It is very cramped, but what I really mind is the heat. This OTP is in the mountains, but as cold as it may be outside, it’s always summer in my office.

This office has no vents and no overhead lights. When I complained about the lack of proper lighting, the program manager brought in floor lamps. One gives a puny little light, and the other throws enough heat to keep French fries warm. I have to remember to dress for summer even in the middle of winter.

It would be easy to take shabby offices personally, but I don’t think that’s generally what is behind it. OTPs take a more utilitarian approach towards facilities than other branches of medicine. I think OTPs get so used to being the red-headed stepchild that they forget to take pride in their surroundings.

Having nice facilities may not feel like a high priority, but it should be. We need to provide space as nice as other medical offices. We provide an intensely important service, with literally decades of data to support what we do for patients. Maybe our surroundings should reflect the importance of what we do, and the significance of what we do.

Addiction Medicine: News Briefs

News Briefs

Following are several short news updates I thought might interest readers:

Heroin Vaccine

In a blog I posted in 2013, I mentioned a new heroin vaccine being developed. Last fall, the researcher got a 1.6 million dollar grant to continue research studies on the vaccine.

Kim Janda, researcher at the Scripps Institute in California, created the vaccine. The idea behind the vaccine is that it tricks the body into making antibodies against a substance, in this case heroin. After the person has formed these antibodies, if heroin is used, antibodies bind to the drug and keep it from attaching to brain receptors. Since heroin can’t bind to the brain’s pleasure receptors, the person has no euphoric effect from heroin.

Every type of opioid needs a specific antibody to be created, so Dr. Janda plans to try to create a vaccine against oxycodone and hydrocodone, too.

Such vaccines could be another tool with which to fight opioid addiction, but would need to be combined with psychosocial counseling for maximum effectiveness. The vaccine prohibits the opioid from attaching to mu opioid receptors, but would not alleviate cravings for opioids. It would have no effect on withdrawal symptoms, either.

Thus far, the vaccine looks promising in rat studies. We have no human data, and researchers in Virginia Commonwealth University will be helping with primate studies. If these are as successful, human trials could then begin, meaning it would take years to come to market, if it is successful.

I wonder if the vaccine can be overridden. In other words, is it possible to inject so much heroin that all the antibodies are used? If so, could extra heroin still cross the blood-brain-barrier to cause euphoria? I don’t know. Stay tuned for more data.

Frontline: Chasing Heroin

Did everyone get a chance to watch the PBS Frontline segment about opioid addiction and its treatment? You can watch the entire show at: http://www.pbs.org/wgbh/frontline/film/chasing-heroin/

I missed this program when it originally aired on 2/23/16, but watched it last weekend, and I’m glad I did. It was very good.

The program started by giving the history of opioid addiction in our country, and the factors that lead to the over-prescribing of opioids starting in the late 1990’s. The program described the inappropriate marketing of OxyContin, the pain management movement, and mistakes about assumed rates of opioid addiction in patients prescribed opioids long-term.

The program showed how many people who were addicted to prescription opioids eventually switched to cheaper and more potent heroin. They described the usual progression from snorting or smoking heroin to injecting it.

Heroin addiction currently disproportionately affects the white middle class, unlike past decades, when heroin was seen as an inner-city, minority problem. Some of the people interviewed rightfully pointed out possible racism of our current focus on the problem of opioid addiction. Since the white middle class got addicted, people are talking about how to fix this epidemic. When minorities were affected, not so much attention was lavished upon the affected population.

The show interviewed key people in this nation who know much about addiction and its treatment. Barry Meier, who wrote the book “Pain Killer” back when it was not considered proper to criticize Purdue Pharma, was interviewed, as was Sam Quinones, who wrote, “Dreamland.” (I reviewed this book recently on my blog, saying it did a great job of explaining how heroin has quietly swept across the U.S.)

Dr. Thomas McLellan, former deputy director of the ONDCP (Office of National Drug Control Policy) spoke about addiction, and Nora Volkow, from NIDA, was interviewed about the disease aspect of addiction. She explained how addicting drugs damage the brain, making it harder to stop using drugs once they’ve been started.

Robert DuPont, our first Drug Czar, was interviewed and he gave some historical perspective.

Facts from experts are helpful, but real stories from affected people have more emotional power. The program followed several opioid-addicted people as they sought help. Their paths through addiction and attempts at treatment illustrate many of the problems of our present treatment system, or rather lack of system.

I was mostly pleased with how the program handled medication-assisted treatment with methadone and buprenorphine (Suboxone/Subutex, etc.). The program showed the story of a community in Washington State, hard hit with heroin addiction, which voted not to allow a methadone clinic to become established, a classic example of the NIMBY attitude. One of the people who objected to the methadone clinic then had a son who became addicted, and the program showed his gradual change of mind about addition treatment programs.

The program said what we in the field know too well: MAT is an evidence-based and proven form of treatment, yet it remains “controversial” to many people working in addiction treatment.

I felt that issue could have been pushed farther and examined in more depth, but of course that’s my bias.

Toward the end of the show, an interviewer asks a doctor something to the effect of, “…so you can prescribe OxyContin to as many patients as you want, but you can only prescribe Suboxone to one hundred people???” The doctor answers yes, that’s what the law says.

Touché.

Also towards the end of the show, they discussed Seattle’s LEAD program. I liked to hear a law enforcement officer say, “We can’t arrest our way out of this problem.” Given that LEAD is based on harm-reduction principles, the program showed that though LEAD helps a great many people, other people don’t choose to participate in drug addiction treatment.

Thank God that law enforcement is starting to admit law enforcement can’t fix addiction.

Addiction Medicine Finally Recognized as a Medical Specialty

Earlier this month, the American Board of Medical Specialties (ABMS) announced that Addiction Medicine achieved specialty status.

It’s hard to explain quite what this means, but I’ll try. Addiction Medicine is now formally recognized as a specialty field of medicine with a distinct arena of clinical knowledge, grounded in evidence-based information. Board certified Addiction Medicine physicians should now be recognized as experts in this field.

It is also hoped that recognition of Addiction Medicine as a specialty will result in medical students and residents getting more training about drug use and abuse, and addiction prevention and treatment. We already have fellowship training programs for Addiction Medicine, and hopefully these will expand, to train more physicians in this specialty.

According to the information sent by the American Board of Addiction Medicine, addiction and risky substance use accounts for about a third of all hospital costs, and is responsible for twenty percent of all deaths in the United States. Slightly fewer than four thousand of us are certified by the American Board of Addiction Medicine, so more doctors are needed in this important field of medicine.

I am so grateful to all of the people who worked so hard to get this recognition of Addiction Medicine. I know this is something the members of the American Society of Addiction Medicine have been striving toward for over a decade. Thanks to all of you!

 

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