Archive for the ‘American Society of Addiction Medicine’ Category

U-47700

Illicit U-47700

Illicit U-47700

 

 

 

My patients are sometimes my best teachers, so when one of them mentioned a new opioid drug, I searched for information online. This new drug is called Pink, or Pinky, but its chemical name is U 47700.

This drug was first developed in the 1970’s by a scientist at Upjohn, a pharmaceutical company. This drug has never been studied in humans, but produces a strong opioid-type effect due to its action at the mu opioid receptor. It’s quite powerful, with estimated potency at seven or eight times that of morphine.

Last year, forty to eighty overdose deaths in the U.S. were attributed to this drug, depending on which source you read. As a man-made research drug, it was legal to obtain until late last year, when the DEA placed U-47700 on Schedule 1 status. This means it is no longer legal to buy online, and that it has a high potential for causing addiction and harm.

Rolling Stone did an article on this drug last fall, saying it was one of the drugs that contributed to Prince’s death, found in his blood at autopsy along with fentanyl. When Rolling Stone published their article, it was still an unscheduled drug. According to that report, there had been around 80 deaths attributable to U 47700, which is usually combined with fentanyl or other drugs. [1]

In some areas, fake Norco tablets were peddled by drug dealers. These pills actually contained U-47700, or a combination of U-47700 and fentanyl. At least a dozen people died from these fake pills, because they believed they were buying hydrocodone, but actually ingested the much more powerful opioids U-47700 and/or fentanyl.

When I listened to an online lecture from last year’s American Society of Addiction Medicine’s fall conference, one of the speakers, Robert DuPont M.D., said the drugs of the future will be synthetics. We’ve already seen this in the rise of synthetic marijuana products, and now it appears we are seeing synthetic, novel opioids hit the streets.

These drugs are cheaper to make by the big drug labs in China and Mexico than traditional heroin, as I said in a former blog post.

It’s impossible to tell how big a problem U-47700 is at this time. Routine toxicology may not detect this substance, unless the lab is told to test for it specifically. It’s quite possible this drug could be a component of much of what is sold as heroin. We already know heroin is frequently mixed with fentanyl because it’s cheaper to manufacture. If U- 47700 is cheap to make, it’s also likely to become a common component.

Synthetic drugs present legal problems. A chemist who is experimenting may come up with a new psychoactive product, and it can hit the market before any law can be passed against its use.

These novel drugs aren’t illegal until after they appear on the streets and cause harm. Then governmental agencies like the DEA rush to change laws to cover these drugs.

There’s another big danger to synthetics. Sometimes the chemists making drugs aren’t that careful. Not all chemists are Walter White, the character on “Breaking Bad.” Walter was an educated chemist who wanted to make the purest product possible, in order to please his customers and maintain his reputation. I dare say most chemists aren’t as educated as Walter, and aren’t as meticulous with details.

There’s always the risk that these people will inadvertently make a similar drug with completely different properties and side effects.

MPTP is a great example of a drug manufacturing error.

MPTP, chemically known as 1-Methyl-4-phenyl-1,2,3,6-tetrahydrophyridine, can be accidently manufactured instead of MPPP, a closely related drug with opioid-like effects. In the 1980’s a handful of people injected what they thought was MPPP, and developed severe Parkinson’s disease. This happened because the chemist accidently made MPTP, which destroys cells in the brain that control movement of the body. MPTP caused Parkinson’s disease in these drug users. This error, though tragic for the people affected, led to useful information to better understands Parkinson’s disease and its treatments.

And some of what I read online seemed overblown. For example, one section of the Rolling Stone article said the drug could cause rectal bleeding. Upon closer reading of the article, the rectal bleeding was reported by people who had used the drug rectally. So yeah, that might cause problems down there.

In another online article, the police chief of Park City, Utah, is quoted as saying, “This stuff is so powerful that if you touch it, you could go into cardiac arrest.” [2]

I am skeptical about that statement. Unless there’s something in it allowing it to pass through the barrier of the skin, that’s doubtful.

Making speculative statements without proof can lead to hysteria, and can undermine the credibility of people who are trying to inform drug users of some very real dangers.

For me, the message is “buyer beware” with heroin. It may or may not be heroin. It could be fentanyl, it could be U-47700, and it could be a whole lot of other things.

This means it’s even more important for drug users to try “tester shots,” meaning use a fraction of drug to assess its potency. It’s important not to use alone, and to stagger injection times, so that there’s always someone able to call for help if needed. Drug users of opioids should have up-to-date naloxone kits on hand in case the worst happens and someone overdoses.

And above all, consider getting into opioid use disorder treatment: https://findtreatment.samhsa.gov/

  1. http://www.rollingstone.com/culture/news/u-47700-everything-you-need-to-know-about-deadly-new-drug-w443344
  2. http://www.inquisitr.com/3600359/new-drug-pink-causing-deaths-nationwide-opioid-u-47700-easily-purchased-online-despite-federal-ban/

Raising the Patient Limit on Buprenorphine Physicians: HHS’s New Proposed Rule

Expanding access

Last month, the Health and Human Services (HHS) department of the U.S. government posted new proposed regulations for doctors who prescribe buprenorphine (better known as Suboxone, Subutex, or Zubsolv) from office-based practices. This rule proposes to raise the number of patients that physicians can treat in their office practice from one hundred to two hundred. They did this to make more treatment available for people with opioid addiction, to combat opioid overdose deaths in our country,

This new proposed rule is now posted online at: https://www.federalregister.gov/articles/2016/03/30/2016-07128/medication-assisted-treatment-for-opioid-use-disorders#h-63

Anyone can submit a comment about this proposed rule, until May 31, 2016.

I studied this proposed rule at length, and thought I’d give my blog readers my interpretation and my opinion of it.

First of all, I approve of the idea behind the proposed regulation. Too many people with opioid use disorder want treatment and can’t get it. Many doctors are at their one hundred patient limit and have been for some time.

I haven’t taken a new patient in months. And as I’ve grumbled about in previous posts, several practitioners in my area already have well over one hundred buprenorphine office patients. Rogue doctors are going to do what they do no matter what, but us law-abiding doctors would like permission to treat more patients.

This new proposed rule would allow physicians who have had a one hundred patient limit for at least one year to request permission to treat up to two hundred patients at one time.

However, this proposed rule is a little more complicated than it would appear on the surface. Medical practitioners have to meet certain criteria to get approval to treat up to two hundred patients.

First of all, as the regulation is written now, some physicians believe that physicians who are board-certified by the American Board of Addiction Medicine won’t qualify for approval to treat up to two hundred patients. The proposed new regulation says the physician must have “subspecialty board certification.” Apparently, some physicians feel that an exact interpretation of this means only psychiatrists with subspecialty certification in addiction medicine would qualify. I read on the American Society of Addiction Medicine’s website that they want members to protest this wording to allow ABAM-certified doctors to qualify too. Thirty-six hundred doctors, including me, are board certified by ABAM, while only about a thousand psychiatrists have subspecialty board certification in Addiction Psychiatry in this country.

I read the entire DHHS document online, but the way I read it, I thought ABAM certified doctors would definitely qualify, but then maybe I’m a little fuzzy about what, exactly, “subspecialty” means. I think HHS’s intention was to include ASAM/ABAM doctors.

Practitioners seeking approval to treat up to two hundred patients must meet other criteria. In simplified terms, they need to, among other things:

  1. Have professional coverage for after-hours emergencies.
  2. Provide case management services
  3. Have electronic medical records
  4. Use that practitioner’s state prescription monitoring program
  5. Accept third-party insurance
  6. Have a plan to address possible diversion of prescribed buprenorphine medication
  7. Re-apply for permission to treat up to two hundred patients every three years
  8. Supply yearly reports about their practice and their buprenorphine patients

Several of these requirements are fairly obvious and should be standard of care anyway. For example, coverage after hours should be provided no matter if the practitioner has one patient, two-hundred, or a thousand. And I can’t imagine any doctor would prescribe buprenorphine for a patient with opioid use disorder without checking the state prescription monitoring program.

Personally, every night before I see my office-based patients, I look at their data on the prescription monitoring program. That way, if I get any surprises, I can discuss this with my patient at their visit.

All practices should have a plan to detect diversion. In my patient agreement, patients understand they may be asked to do a pill count at any time. I’ve lost some patients who failed pill counts.

Yearly reporting requirements seem reasonable, depending on what the government intends to do with this data. I assume DHH intends to monitor the quality of the care that a buprenorphine physician is delivering, and monitor the results of this care. Such monitoring is to include: average monthly case load of the physician, percentage of patients who are receiving either psychosocial counseling or case management services; number of patients being checked on the state prescription monitoring program; sending year-end reports about the number of patients who have completed treatment, number who have been referred elsewhere, and the number of patients who no longer want this form of treatment.

Physicians can collect that data without too much problem, I think.

However, I worry about how this information could be misinterpreted. For example, if the people who will review these reports expect patients to “complete” treatment for a chronic disease such as opioid addiction, they may mistakenly conclude that doctors with higher numbers of patients who complete treatment provide better care than doctors with lower numbers of patients who complete treatment. In reality, the opposite may well be true, since the standard of care with medication-assisted treatment is maintenance, not detox.

I’m also concerned about submitting the number of patients getting counseling. For maintenance patients, how long should they receive counseling? To me, the answer should be “as long as they need it.” This should be highly individualized.

If patients have been stable on buprenorphine for more than three years, with relapse-free recovery, do they still need counseling? Some of my patients are in relapse-free recovery for longer than that, and they have productive jobs, happy home lives, and no mental health issues. Should I still insist they still go to counseling? I don’t think so, unless counseling can improve the quality of their lives.

I’m not talking about new patients, fresh into treatment. Nearly all of those patients need counseling. But what if they have no insurance, and can’t afford “official” counseling? Is 12-step attendance good enough to meet counseling requirements?

There’s no way to know how people evaluating yearly physician reports will view such topics.

Now let’s talk about some of the requirements which may be deal-breakers for me.

When I read about practitioners having to accept third-party payers, I thought nope, not gonna do it.

My practice is bare-bones. I have three employees: me, my fiancé, and a man who works my front desk for about six hours per week. It’s kind of a mom-and-pop practice. Patients pay me, and I give them receipts with the needed codes to fill with their insurance company so they can be paid back. Since I don’t mess with insurance, I can keep my office costs down, because I don’t have to pay for another person to file insurance. Technically it is not a cash-only practice, since I’m set up to take credit and debit cards, but I am cautious about accepting checks. I have learned the hard way not to accept a check from a new patient.

My fiancé, who is a licensed professional counselor and also a licensed clinical addiction specialist, does the counseling for some of my office patients. He also answers the 24-hour phone, and since we are together most of the time, it’s easy for him to talk to me about whatever is going on. He screens new patients and does scheduling. He also handles most of the prior authorizations for buprenorphine medications (since I tend to get angry and swear).

My other employee, Daniel, works in my office on the one day per week that I’m open. He is terribly overqualified for his job, since he is just finishing his Master’s degree in addiction counseling. He checks patients in, performs drug screens, records the results, checks patients out and takes their money, and schedules their next visit. Besides being smart and savvy, he also knows my patients are sick people getting well.

I have few expenses. My fiancé does all the computer work that I need, and the only bills I have are rent, electricity, and various office expenses.

If I decided to accept third party insurance, I’d have to add another employee. I’ve seen the nightmares that come with billing insurance, having worked in primary care for ten years. Insurance companies deny claims for frivolous and stupid reasons, and take their time paying doctors. I heard this year from a few colleagues that BlueCross/BlueShield, the primary payer in my state, in some cases waits longer than six months to pay doctors, and still denies many claims. I’d have to raise my rates to make up for this, making it more difficult for my patients with no insurance.

Right now I charge $85 to $100 per 20-minute visit. I feel strongly that people with addiction shouldn’t have to pay more to see their doctor than people with other chronic illnesses, so I keep my rates low, relative to other providers. About half of my patients are the working poor, who don’t qualify for Medicaid in my state, and also don’t qualify for Obamacare. They can still afford treatment, because I’m also willing to prescribe generic buprenorphine/naloxone, which is quite a bit cheaper than name brand medication.

Am I willing to take on the headache of accepting insurance in order to be able to treat a hundred more patients? I don’t know if I am. I plan to investigate it further, maybe talk to some other doctors who take insurance currently, to see how big a hassle it is to get paid.

Next let’s talk about electronic medical records (EMRs). EMRs sound better in theory than they work in practice. My doctor friends complain that they cost much money, are not designed to be physician-friendly, and take up more time than they save. They aren’t interoperable, so each practice has a different electronic record. To coordinate care with a provider outside of one specific system means the record still has to be printed out on paper to be faxed or mailed.

Do electronic records provide better care? I have my doubts. I’ve bitched about EMRs in prior blogs, describing how I’ve requested records on my patients from the local hospital. Those records show on the front page, without fail, that the patient has been screened for Ebola. But I have to look at many pages to try to find a final diagnosis and treatment plan from the emergency department physician. Sometimes I find it… and sometimes not.

Privacy is a big issue to some of my patients. I treat several people, prominent in their communities, who see me specifically because I don’t have electronic medical records. They are willing to travel more than an hour one-way to see me, both because they know their records aren’t computerized, and because my office is very private, in the back on a non-descript realty building. Some of these patients may be a little paranoid about their records, but maybe not.

If I worked in an office owned by a big hospital system, how many people could get access to read my records? We all know stigma against substance use disorders and mental health diagnoses exist. It could cause damage to patients with substance abuse issues if details about addiction treatment were leaked. Ironically, my patients who work in healthcare are the ones most concerned about their privacy, and maybe for good reason.

Besides, EMRs are expensive, and probably I couldn’t afford one for my small practice.

Those are my specific objections to the proposed rule. I understand why the authors of the rule included these requirements. HHS doesn’t want bad doctors, running buprenorphine pill-mills, to be able to qualify to treat more patients. But as I’ve complained about at length and repeatedly in my blog…those doctors already thumb their nose at patient limits. So this proposed rule is likely to be followed only by the doctors who are already conscientious about following rules and guidelines.

I’m glad and grateful the HHS proposed this new rule. But I’m not yet sure I will want to increase my patient limit, for the reasons described.

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.

 

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!

 

The Disease of Addiction, Explained

addicted brain

 

 

The New England Journal of Medicine published an excellent review article explaining the neuroscience of addiction in their January 28, 2016 issue. It was written by three heavy-hitters in the addiction field: Dr. Nora Volkow, the director of NIDA, Dr. George Koob, the director of NIAAA; and Dr. Thomas McLellan, founder of the Treatment Research Institute.

This article should lay to rest any debate about whether addiction is a disease of the brain.

http://www.nejm.org/doi/pdf/10.1056/NEJMra1511480

Updates

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Prisoner death from drug withdrawal:

In my blog entry on October 20, 2015, I discussed the horrible death from drug withdrawal suffered by David Stojcevski in the Macomb County, Michigan, jail. I’ve been scouring the internet looking for updates on the lawsuit the family has filed against the county, but haven’t found anything. However, I’m pleased to find many news stories about this awful incident, which helps to keep the issue of medical treatment of prisoners in the news. This is something we must change. Incarcerated people should not be allowed to die from drug withdrawal!

http://www.newsjs.com/ca/cops-arresting-man-in-murder-probe-leave-him-locked-on-bus-with-passengers/diV1CbLR9C6B0bMHAlNf4Wk68k_mM&authuser=0/

Bad legislation:

On April 12, 2015, I blogged about NC bill S297, which is legislature intended to make drug use by a pregnant woman a criminal act. Regrettably, this sorry and misguided piece of legislation was passed on its first reading in the NC senate. It’s now been referred to the Committee on Rules and Operations of the Senate. If you live in NC, when you vote, remember that Republican Brent Jackson presented this bill, which I believe will keep pregnant women from seeking medical care during pregnancy if they have the disease of addiction. This bill is not good for society, pregnant women, and especially not good for fetuses.

Probuphine:

I’ve written a few blog entries (September 2, 2011; March 30, 2013; May 21, 2013; and November 7, 2015), about Probuphine, implantable small rods that deliver buprenorphine into a patient’s bloodstream over six months.

In January of 2016, an advisory committee to the FDA voted to recommend Probuphine for approval by the FDA for the treatment of opioid addiction. The FDA is expected to hold its vote at the end of this month. You will recall that despite a similar recommendation last year, the FDA did not approve this implant, stating more study was needed, especially on patients who were stable at lower dose of buprenorphine.

This time, Titan Pharmaceuticals is seeking approval in patients who are stable on 8mg of the sublingual buprenorphine or less per day.

Of the minority of people on the advisory panel who voted no to the recommendation, concerns were expressed about identifying appropriate patients for this medication, and risks of both implantation and removal of the rods.

I’m still not clear if there will be changes to the rules for implantation and removal of the Probuphine rods. For a buprenorphine prescriber to be able to offer Probuphine, she would have to take a training class for the procedures for implantation and removal. This requires time away from work, to meet an uncertain demand for this product. Not all doctors who prescribe buprenorphine will want do this procedure anyway.

If I want to do this procedure in my office, how to I get the implants? Do I have to buy them, and wait for the patient to pay me back? Do I write a prescription and have the patient pick them up at the pharmacy? Will insurance cover the medication and the procedure? If yes, how long would I have to wait for payment from these companies? I’ve been able to stay in business at my private office by keeping overhead pared to a minimum, so if Probuphine requires an investment by me, I may decide it’s not worth my time and effort.

Hepatitis C treatment

As described in my July 3, 2015 blog entry, the CDC recently reported a surge in the numbers of U.S. citizens who have contracted Hepatitis C. Now another drug has entered the market to treat Hep C, but remains extremely expensive. Earlier this year, Merck pharmaceutical company launched a new Hep C drug called Zepatier. It’s an oral drug that costs an estimated $54,000 for a twelve week course, compared to $80,000 for a similar course of Harvoni. However, early reports say Zepatier cure rates may not be as high as Harvoni’s, so we await more information.

Many health insurance systems can’t afford to pay this much money for treatment of their insured, and so many people infected with Hep C have found their insurer refuses to pay for this new treatment that cures Hep C in most patients. Without insurance, few people could shoulder that expense themselves.

So we have another treatment option, and a little bit less expensive. Let’s hope this trend continues.

ALKS 5461

In my blog post from January 17.2015, I reported a new drug on the horizon that was hoped to be a novel treatment for resistant depression. This medication, known as ALKS 5461, contains buprenorphine (just like Suboxone, Subutex) and samidorphan, a new opioid receptor blocker. The medication was theorized to treat depression by the buprenorphine’s antagonistic action on the kappa receptors, and the samidorphan would serve to block the effect of buprenorphine on opioid receptors, so that the patient would not develop an opioid dependency.

Unfortunately, ALKS 5461 failed to show benefit in two phase III clinical trials, leading Alkermes stock to fall when this data was announced in January of 2016. Despite these results, Alkermes is reported to be continuing research into this potential new medication for depression.