Tag Archives: buprenorphine

Optimism? Or, is it low expectations?

Lowering_The_Bar_Cover_2010.09.22The feds recently published an article touting the long-term success of buprenorphine:

In the first long-term follow-up of patients treated with buprenorphine/naloxone (Bp/Nx) for addiction to opioid pain relievers, half reported that they were abstinent from the drugs 18 months after starting the therapy. After 3.5 years, the portion who reported being abstinent had risen further, to 61 percent, and fewer than 10 percent met diagnostic criteria for dependence on the drugs.

These studies are important. Long-term outcomes have been a big gap in the research.

This is great news, right? 50% abstinent at 18 months! 61% abstinent at 3.5 years! Fewer than 10% dependent at 5.5 years!

Wow!

Not so fast

There are a couple of problems here.

  • They were only able to do follow-up with 38% of subjects at 18 months and 52% at 3.5 years.
    • So, that 50% abstinent at 18 months is really more like 19%.
    • The 61% abstinent at 3.5 years is more like 32%

Still, 19% abstinent at 18 months and 32% abstinent at 3.5 years is pretty good, right?

Pump the brakes

There are a couple of problems here too.

  • They are only reporting on abstinence from illicit opioid use, not other drugs.
  • Buried in the article, they mention that they are reporting on being abstinent for the last 30 days. This doesn’t tell us much about how they’ve been doing over the previous 18 months or 3.5 years, does it?
  • Same thing for the reporting on diagnostic criteria for dependence. That was also based only on the previous 30 days.

Taking their conclusions at face value

Further, their conclusions open the door to some interesting questions:

In the first study examining long-term treatment outcomes of patients with prescription opioid dependence, our results were more encouraging than short-term outcomes from POATS suggested. As reported in our 18-month follow-up study (Potter et al., 2014), and consistent with other literature (Moore et al., 2007, Nielsen et al., 2013 and Potter et al., 2013), patients with prescription opioid dependence may have a more promising long-term course, compared with expectations based on long-term follow-up studies of heroin users (Darke et al., 2007, Flynn et al., 2003, Grella and Lovinger, 2011, Hser et al., 2001 and Vaillant, 1973). Indeed, a history of occasional heroin use at POATS entry was the only prognostic indicator 42 months later, associated with a higher likelihood of meeting symptomatic criteria for current opioid dependence. Our results are consistent with research on heroin dependence in supporting the value of opioid agonist therapy for prescription opioid dependence; however, half of the follow-up participants reported good outcomes without agonist therapy.

This begs a couple of important questions.

  • First, many medication assisted treatment advocates have argued that opioid addiction is unique in that it creates long-term or permanent brain dysfunction that requires opioid replacement. Do these findings undermine this theory?
  • Second, half of their follow-up subjects doing well without opioid replacement. Can we assume that opioid replacement is responsible for their good outcomes?

This is the basis for the federal and media push for MAT?

It would appear so.

This not quite what you imagined when they reported 61% abstinent, is it? Why would they present it in a manner that many of us would consider misleading?

It’s also hard to understand their certainty, isn’t it?

I mean, when they talk about this being “treatment that works”, “evidence-based treatment” or “science-based treatment”, don’t most member of the public assume that expressions like “works”, “evidence-based” and “science-based” mean that there’s a body of research indicating that these treatments provide a good chance of getting well?

Instead, these studies suggest that these treatments help make people less sick.

If that’s what patients and their families want, there’s nothing wrong with that. But, they ought to know what they’re getting. (The same goes for communicating the limitations or gaps in evidence for other treatments.)

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Don’t believe the hype

hype-marketing

About that Huffington Post article covering Obama’s addiction speech a few weeks ago.

ALLEGATION FACT FACT
A Huffington Post investigation published in January found that the treatment industry overwhelmingly resists a medication-assisted model based on decades-old beliefs about sobriety that have been passed down by those in recovery, but have never been rigorously tested. Suboxone is the number 39 drug in the US and has sales of more than $1.4 billion.* Federal surveys find that opioid replacement treatment (one form of medication assisted treatment) admissions accounted for 27.8%** of all admissions. [Not 27.8% of opioid addiction admissions. 27.8% of ALL addiction treatment admissions.]

More on the Huffington Post’s drug policy reporting here.

* note that this is only for the brand Suboxone and does not include Subutex and generics.

** This post originally reported that maintenance admissions accounted for 26%. It was 26% in 2009. More recent numbers are now available and the updated reports says that maintenance admission accounted for 27.8% of all admission in 2011.

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2014’s top posts: #2

“He’d still be alive”

CANADA TORONTO FILM FESTIVALMuch has been said this week about the death of Phillip Seymour Hoffman.

I’ve heard two recurring themes. First, that he might still be alive if he had been “treated with an evidence-based” treatment, like buprenorphine. Second, that he might still be alive if he hadn’t been inculcated with the disease model, which purportedly fosters learned helplessness.

The buprenorphine argument

I know nothing of the treatment he received and most of these people admit that they don’t either.

Let’s assume, for a moment, that their assumptions are correct.

One problems is that most of these writers fail to deal with the issue of falling buprenorphine compliance ratesThis recent study of 6 month study found a dropout rate of 76% for those without chronic pain and described the compliance rates as consistent with other studies.

Early studies of buprenorphine reported outstanding compliance rates. Those numbers need to be viewed with suspicion and one should wonder whether the promulgation of those numbers is a success of science or marketing.

Their premise seems to be that people prescribed buprenorphine don’t OD. I don’t doubt that people currently taking buprenorhine are at lower risk for OD. However, I’m not aware of any good studies of survival rates that consider real world compliance rates.

Now, we learn that buprenorphine was reportedly found in his apartment. I have no idea whether it was prescribed to him or whether he bought it on the street. If it was prescribed to him, it suggests that prescribing the drug may not have the protective properties that advocates claim. If he bought it on the street, it points to the issue of diversion, which raises questions about patient compliance with the drug.

Besides, this was someone who had maintained some sort of remission for 23 years, had been in relapse for one year and had only one, brief detox episode during that period of time. Seems a little rash to assume that that path that had worked for 23 years would be a bad path to try to get him back to.

The disease argument

There’s ample evidence that addiction is a disease and, kind of like the climate change debate, though there is a noisy group of dissenters with high visibility, there is widespread agreement among experts that it’s a brain disease characterized by loss of control.

One of the most common arguments to question the disease model is the existence of natural recovery–that fact that large numbers of “addicts” recovery without any help.

The quotation marks in the previous sentence signal my response. Vietnam vets who returned with heroin problems are a frequently cited example. Most came back to the states and quit heroin on their own. Reports indicate that only 5% to 12% were unable to quit or moderate.

Hmmmm. That range….5 to 12 percent…why, that’s similar to estimates of the portion of the population that experiences addiction to alcohol or other drugs.

To me, the other important lesson is that opiate dependence and opiate addiction are not the same thing. Hospitals and doctors treating patients for pain recreate this experiment on a daily basis. They prescribe opiates to patients, often producing opiate dependence. However, all but a small minority will never develop drug seeking behavior once their pain is resolved and they are detoxed.

My problem with all the references to these vets and addiction, is that I suspect most of them were dependent and not addicted.

So…it certainly has something to offer us about how addictions develops (Or, more specifically, how it does not develop.), but not how it’s resolved.

Why is it so frequently cited and presented without any attempt to distinguish between dependence and addiction? Probably because it fits the preferred narrative of the writer.

It’s worth noting that this can cut in both directions. There’s a tendency to respond to problem users (people who drink too much, but are not alcoholics.) and dependent non-addicts (most pain patients or these returning vets) as though they are addicts. This results in bad treatment for those people, bad research and it manufactures resentment toward treatment, mutual aid groups and recovery advocates.

We run into the same problem when recovery advocates (who I love and generally agree with) report that there are 23 million Americans in recovery. These kinds of statements tend to be based on surveys asking people something to effect of, “Have you previously had a problem with drugs or alcohol and no longer have one?” That kind of question is going to get a lot of false-positives for what we think of as recovery. It’s a little like asking people if they once had a chronic cough and no longer have one, then inferring that all of those people are in recovery from TB.

We know that relatively large numbers of young adults will meet criteria for alcohol dependence but that something like 60% of them will mature out as they hit milestones like graduating from college, starting a career or starting a family. Are these people addicts in recovery? Or, were they people with a problem of an entirely different kindan acute alcohol problem rather than the chronic brain disease of addiction?

We need to do a better job distinguishing addiction/alcoholism from dependence and look at improving DSM criteria to help with this distinction. Loss of control, over an extended period of time that returns after periods of abstinence is the key to me. Addicts/alcoholics are not people making poor decisions about their drug and alcohol use, they are people who have lost the ability to make execute decisions related to drug and alcohol use.

It’s apples and oranges and these statements about the prevalence of recovery do real damage to the cause. People with addiction shouldn’t be treated with expectations constructed around the experience and pathways of people who do not have the same disease. AND, people who do not have addiction should not be subjected to treatments for people who do have the disease.

A better argument

I’ve spent a lot of time on this blog responding to arguments that pharmacological treatments are better than drug-free treatment. And, I’ll admit that I feel defensive when I hear treatment being attacked. However, when I step back, I have to admit that there’s a lot of bad treatment out there. With and without medications.

These arguments about drug-free vs. drug maintenance miss one really big and really important point. Whichever kind of treatment a person ends up receiving, there’s a really good chance that they will not get the long term monitoring and support that is appropriate for a life-threatening and chronic disease.

Two models that have outstanding outcomes are treatment programs for health professionals and programs for pilots. Both have long term success rates in 90% range. Both of them happen to be drug-free, but the point I want to focus on is that they both provide intensive long term monitoring and support with rapid re-intervention in the event of relapse.

Shouldn’t we have a system that monitored Philip Seymour Hoffman in the same way we monitor people with heart disease? One other example that comes to mind is my dentist. I mean, I don’t even get cavities–there’s nothing urgent going on in my mouth. BUT, my dentist corners me into scheduling another appointment before I leave the office and they start calling and texting me to remind me AND even ask me to reply that I will make my appointment.

If my dentist can deploy the strategies to promote continuity of care, why can’t addiction treatment programs?

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ASAM president also medical director for drug company

phrma2I missed this a while back. Turns out that ASAM’s president works for a buprenorphine manufacturer.

Stuart Gitlow, M.D., is the president of the American Society of Addiction Medicine (ASAM) and also medical director — as a consultant — for Orexo, which makes Zubsolv, a newly approved buprenorphine-naloxone medication (see ADAW, July 15).

The first public charge of a conflict of interest was made last month via Twitter by Mark Willenbring, M.D., former director of treatment and recovery research at the National Institute on Alcohol Abuse and Alcoholism. In the tweet, Willenbring suggested that ASAM should examine its policies about conflicts of interest. While the connection with Orexo doesn’t mean that Gitlow’s beliefs and statements about buprenorphine are incorrect, it does raise questions, said Willenbring, now in private practice in St. Paul, Minnesota, where he provides treatment for substance use disorders and is a strong proponent of medication-assisted treatment. “At the same time, how can someone who is employed by the drug company have any credibility when his financial interest is in selling the drug?” Willenbring told ADAW. “My concern is with the increasing public perception, especially in psychiatry and addiction treatment, that financial interests taint and discredit professional opinions.” Gitlow’s dual roles, said Willenbring, raise this question: “Is he speaking for ASAM as a professional or for the pharmaceutical company as a salesman?”

While I don’t follow ASAM closely, I’ve seen no evidence of Gitlow advocating for any policy that would not receive broad agreement among ASAM membership.

However, as ASAM engages in advocacy around prescribing limits for buprenorphine, is it a conflict that the organization’s president gets a paycheck from a manufacturer?

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Addiction research funding focused on “abstinence only”?

Federal grant search for active projects with the terms methadone, buprenorphine and naloxone

Federal grant search for active projects with the terms methadone, buprenorphine and naloxone

DJ Mac picks up on a story that also caught my eye and catches a line moaning about research bias in favor of abstinence-based programs. He pulled this quote.

The gorilla in the room around this question turns out to be the ideology of the decision makers. “There are ideological constraints tied to what gets funded,” says Ethan Nadelmann, founder and executive director of the Drug Policy Alliance in New York City. An example? The tendency to fund “abstinence only” programs and the war on drugs at the expense of drug prevention research. “There is not a lot of evidence of what works because it does not get studied. Today, kids lose their drug virginity before their sexual virginity. What’s the needle exchange of today?”

This struck me as odd, because NIDA seems to be heavily invested in promoting buprenorphine. So, I went to projectreporter.nih.gov and looked up active projects with the search terms “methadone OR buprenorphine OR naloxone”. It’s not a perfect method, but it tells you something, right?

Here’s what I found:

  • 220 active projects
  • $103,152,353 in total funding for these projects
  • These projects have generated 2028 publications that are now part of the evidence-base

“What’s the needle exchange of today?” It’s obviously naloxone, right? If you limit the search to just naloxone, you still get over $35,000,000. A search for “opioid AND abstinence” returns $41,450,238 in funding.

These results are consistent with the articles theme of research being oriented toward PhRMA, but not with Nadelmann’s argument that “abstinence only” rules the playground.

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Another buprenorphine study with poor outcomes for young patients

 

ordinary statistics by jayjizzle

ordinary statistics by jayjizzle

A recent study looks at buprenorphine retention and frames young adult retention as a problem.

Emerging adults (18-25 years old) are often poorly retained in substance use disorder treatment. Office-based buprenorphine often enhances treatment retention among people with opioid dependence. In this study, we examined the records of a collaborative care buprenorphine treatment program to compare the treatment retention rates of emerging adults vs. older adults. Subjects were 294 adults, 71 (24%) aged 18-25, followed in treatment with buprenorphine, nurse care management, and an intensive outpatient program followed by weekly psychosocial treatment. Compared to older adults, emerging adults remained in treatment at a significantly lower rate at 3 months (56% vs. 78%) and 12 months (17% vs. 45%), and were significantly more likely to test positive for illicit opioids, relapse, or drop out of treatment. Further research into factors associated with buprenorphine treatment retention among emerging adults is needed to improve treatment and long-term outcomes in this group.

Further:

During the first three months of treatment, emerging adults were more likely than older adults to test positive for illicit use of opioids (p < 0.0001; OR: 2.20 [1.53-3.15]). Specifically, during month 1, 47.9% of emerging adults vs. 31.0% of older adults tested positive for illicit use of opioids, with similar group differences during Month 2 (28.3% vs. 13.3%) and Month 3 (28.6% vs. 15.4%) ( Fig. 4a).

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not what one might hope for

Probuphine-3-25-13Somehow, I missed the buprenorphine implant until a comment on yesterday’s post.

Yesterday’s post pointed to dropout issues with buprenorphine. Of course, an implant would address that issue. However, the outcomes for the implants are, “not what one might hope for”.

Probuphine was evaluated in two placebo-controlled trials. In terms of efficacy, researchers found that patients on the active implant were more likely than those given a placebo implant to have opioid-negative urine samples on more occasions, and were less likely to need sublingual buprenorphine for treating of symptoms of withdrawal or craving.

But the response “was not what one might hope for, given that the product ensures compliance with medication for 6 months,” the researchers wrote. “It prompts speculation that the dose is simply not high enough.”

For instance, only 32% and 27% of patients in the respective trials had opioid-negative samples for half of all their urine tests, and 40% to 62% needed supplemental buprenorphine.

Of course, their theory is that the dose is too low.

The drug was rejected by the FDA. Here is one advocate’s case for the drug:

“If these patients could just start each day without having to decide whether or not to take a pill, I firmly believe we could help a greater number of patients achieve long-term sobriety.”

I see his point, but these outcomes make me wonder if this cuts both ways. What if their outcomes suffered because patient’s role is passive and they don’t make that decision on a daily basis?

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