Congress is hyperfocused on opioids. Is it focusing enough on addiction?

There’s actually an interesting discussion happening in congress right now:

A question some lawmakers and journalists often ask is whether Congress is too closely targeting opioids, as the epidemic is a problem of polydrug misuse. Bloomberg’s editorial board warned “lawmakers need to take benzodiazepines seriously, before it’s too late.” (Overdose deaths associated with benzodiazepines are fewer than opioids, but still eight times what it was in 1999.)

“I’m concerned that here in Congress we’re so focused on opiates as the drug de jure, if you will, and that in five years or so when this crisis ends or abates or tapers that we’re going to have a bunch of federal programs that are specifically aimed at a problem that may not be as significant,” said Sen. Lisa Murkowski (R-AK) in April.

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Effects of MAT on functional outcomes

Recovery from opioid addiction is also more than remission, with remission defined as the sustained cessation or deceleration of opioid and other drug use/problems to a subclinical level—no longer meeting diagnostic criteria for opioid dependence or another substance use disorder. Remission is about the subtraction of pathology; recovery is ultimately about the achievement of global (physical, emotional, relational, spiritual) health, social functioning, and quality of life in the community.

William White

I have frequently posted about the importance of research looking at the quality of life of treatment patients.

When you hear or read someone say something like, “this treatment approach is the most evidence-based,” we should follow-up with the question, “evidence-based for what outcome?”

Statements like this are frequently made about MAT and follow-up questions are rarely asked and answered.

Unfortunately, the evidence-base says very little about the quality of life of the research subjects. Most studies focus on measures like reduced days of illicit drug use, reduced criminal activity, reduced disease transmission, and reduced overdose rates. Of course, these are important outcomes, but they fall far short of the outcomes desired by most patients and families.

A recently published study looks at what they call “functional outcomes.” These include “cognitive (e.g., memory), physical (e.g., fatigue), occupational (e.g., return to work), social/behavioral (e.g., criminal activity), and neurological (e.g., balance) function.”

These are moving in the direction of quality of life measures. Good!

They did not conduct a study with patients, instead they reviewed existing research to see what can be learned.

So . . . how much research had anything to say about these kinds of measures?

A comprehensive search followed by 1411 full text publication screenings yielded 30 randomized controlled trials (RCTs) and 10 observational studies meeting inclusion criteria.

Only 40? That’s disappointing, but how useful were those 40?

Functional measures were primary outcomes in only six RCTs; it is unclear if the other trials, which were powered statistically to detect differences in illicit drug use or treatment retention, had adequate power to detect differences in functional effects.

They summarized findings addressing the following areas:

  • memory
  • attention
  • cognitive speed
  • vision
  • driving
  • employment
  • fatigue
  • insomnia
  • family functioning
  • psychological function
  • aggression
  • criminal activity
  • arrests and incarceration
  • legal status
  • stress

The researchers summarized their findings this way:

Several of the individual studies that compared OUD patients who received MAT to those who did not reported significant positive effects of MAT on functional outcomes. However, in several studies, MAT patients performed significantly worse than matched healthy controls. Because of the limited number and quality of the studies, the quality of evidence supporting significant differences is low or very low. The only exception is moderate quality evidence supporting a lower prevalence of fatigue with buprenorphine compared to methadone.

There are legitimate questions to be raised about the comparisons. For example, are healthy controls the right comparison group? Is placebo the right comparison group. We might also ask if the researchers’ standards for inclusion were too high.

Whatever opinions one holds on those questions, it seems pretty clear that there is a disconnect between the way the evidence is frequently discussed and what we can actually conclude from it.

This doesn’t mean MAT is bad or should not be available. It simply means the research doesn’t speak to outcomes most patients are seeking. We should acknowledge this when we discuss the evidence and researchers should seek answers to quality of life questions.

Here’s what I’ve said repeatedly in this blog:

People with addiction should be told about the treatments that exist, and the evidence for them. When discussing the evidence for an approach, they ought to be informed about the extent to which the evidence aligns with their goals.

Then, they should be told about the treatments that are available to them. And, they ought to be told why some treatments aren’t available to them—not covered, too expensive, no provider available, policy barriers, etc.

Then, they should be free to choose the treatment they prefer. And, within reason, they should be free to change their mind.

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Sentences to ponder

“We’ve been wrong about what our job is in medicine. We think our job is to ensure health and survival. But really it is larger than that. It is to enable well-being. And well-being is about the reasons one wishes to be alive. . . . whatever we can offer, our interventions, and the risks and sacrifices they entail, are justified only if they serve the larger aims of a person’s life.”

Atul Gawande

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Overdose crisis? Or, addiction crisis?

British Columbia has long been cited as a model for North American drug policy and harm reduction implementation.

BC has established a Death Review Panel in response to the overdose crisis. The panel recently issued a report with 3 recommendations. The first recommendation to regulate recovery homes, which currently require only a simple inspection of the facility. (The other 2 were for more maintenance treatments and more harm reduction.)

The chair of the panel cited the abstinence orientation of houses as a concern.

A columnist at the Vancouver Sun pushes back against the argument that BC is suffering from insufficient harm reduction:

This is, after all, a city and a province that for nearly 20 years has been at the forefront of harm-reduction with needle exchange programs, safe injection sites, methadone and suboxone treatment programs, a prescription heroin program and, more recently, free naloxone kits, free-standing naloxone stations and training for first-responders and even teachers in how to use it as an antidote for fentanyl overdoses.

We’ve gone from crisis to crisis, each one sucking up incredible resources. Currently, a quarter of a million dollars a day goes into the Downtown Eastside alone for methadone treatment. This year, the B.C. government expects the number of British Columbians receiving replacement drug therapy to rise to 30,000 and then nearly double to 58,000 by 2020-21.

In 2006 when Vancouver updated its four pillars approach, it noted that there were 8,319 British Columbians being treated with methadone.

By 2020-21, the province also expects to be supplying 55,000 “free” take-home naloxone kits, up from 45,000 this year.

We keep hearing about an overdose crisis, but what we have is an addictions crisis. Solving it will require a lot more than simply reducing harm.

What’s needed is a recovery orientation. (Which does not rule out harm reduction.)

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“safely discharged”?

hand drowningFrom a press release about newly published research. The title of the press release is Fentanyl overdose survivors require little if any hospital treatment

“Our protocol should give emergency physicians and nurses the confidence to allocate the appropriate resources to the patients who truly need them, especially when there is a wave of fentanyl overdoses that threaten to overwhelm the hospital,” Scheuermeyer said. “If the patients meet our definition of low-risk, physicians and nurses should also feel comfortable letting patients leave if they want to.”

Number of times the following words appear:

  • referral = 0
  • continuing care = 0
  • linkage = 0
  • treatment = 2 (the context is as follows)
    • “don’t need prolonged hospital treatment”
    • ” leading to unnecessary treatment that strains hospital resources”

The only reference to trying to address the disorder that nearly killed the patient is this:

Patients also received visits from a social worker who asked them about their need for housing and detoxification programs.

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Exhibit A

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Pharma, Pharma, Pharma

MedPage Today reports on a recent NIH, NIDA, HHS press briefing.

HHS Secretary Alex Azar, JD, NIH Director Francis Collins, MD, PhD, and Nora Volkow, MD, director of the National Institute on Drug Abuse (NIDA) pitched the president’s opioid initiative to reporters during a press briefing on Wednesday afternoon.

So, how did they describe their priorities?

  • Improve understanding of the “neurobiology of pain and to locate new drug targets.” (They note that Collins said “private industry is eager to leverage” this knowledge.
  • Testing for biomarkers for pain that would guide treatment.
  • To “create public-private partnerships and incentivize industry to come up with medications for opioid use disorder that don’t need to be taken every day” because “half of all patients relapse in 6 months.”
  • “partnering with pharmaceuticals for the development of alternative formulation devices… of naloxone or another antagonists”
  • Developing opioid vaccines.

Industry dollars part of the plan

That sounds like a lot of opportunities for new patents.

Is the industry interested in this plan?

At least 33 companies have shown interest in partnering with the NIH, said Collins, and a “scientific work plan” that involves an “unprecedented” level of information sharing is underway.

He also spoke of efforts to set up a clinical trial network, so that new treatments could be quickly tested.

“All of that seems to have received wide enthusiasm from both the public and the private sectors. It is now a matter of figuring out how we would put the funding and the governance together,” Collins said.

This prompted Keith Humphreys to tweet:

 

And the head of the Academy of Integrative Pain Management to tweet this:

Best practices (“best” for who?)

The story added this:

Azar reiterated President Trump’s goal of cutting legal opioid prescriptions by one-third in three years, and ensuring that all federal programs operate according to best practices when it comes to opioids.

Of course, this begs questions about the role of industry dollars shaping those “best” practices.

These concerns are heightened by the recent coverage of NIAAA and NIH offering the beverage alcohol industry an opportunity to invest in research on the grounds that the findings would benefit the industry before the research began.

The death penalty

The president’s inclusion of the death penalty for big drug dealers came up in the briefing.

Asked about the president’s repeated mentions of capital punishment for drug traffickers, Azar called it one piece of a “comprehensive plan.”

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