Recent reporting on the consequences of PHARMA bad behavior

phrma2

There were a couple of articles published this week about bad behavior from PHARMA.

First, Vox looks into the roots of the overdose epidemic and Purdue Pharma’s role in policy changes that set the stage for the explosion in opioid prescribing and addiction. (Of course, Purdue profited from these policy changes.)

Andrew Kolodny and other public health experts explained the history in the Annual Review of Public Health, detailing Purdue Pharma’s involvement after it put OxyContin on the market in the 1990s:

Between 1996 and 2002, Purdue Pharma funded more than 20,000 pain-related educational programs through direct sponsorship or financial grants and launched a multifaceted campaign to encourage long-term use of [opioid painkillers] for chronic non-cancer pain. As part of this campaign, Purdue provided financial support to the American Pain Society, the American Academy of Pain Medicine, the Federation of State Medical Boards, the Joint Commission, pain patient groups, and other organizations. In turn, these groups all advocated for more aggressive identification and treatment of pain, especially use of [opioid painkillers].

Choose you evidence carefully by rocket ship

Choose you evidence carefully by rocket ship

Second, BMJ published an analysis finding that drug manufacturers withheld information about antidepressants and suicidal thoughts and aggression in children.

In the latest and most comprehensive analysis, published last week in BMJ (the British Medical Journal),a group of researchers at the Nordic Cochrane Center in Copenhagen showed that pharmaceutical companies were not presenting the full extent of serious harm in clinical study reports, which are detailed documents sent to regulatory authorities such as the U.S. Food and Drug Administration and the European Medicines Agency (EMA) when applying for approval of a new drug. The researchers examined documents from 70 double-blind, placebo-controlled trials of two common types of antidepressants—selective serotonin reuptake inhibitors (SSRI) and serotonin and norepinephrine reuptake inhibitors (SNRI)—and found that the occurrence of suicidal thoughts and aggressive behavior doubled in children and adolescents who used these medications.

The article correctly frames this a part of a larger pattern.

This paper comes on the heels of disturbing charges about conflicts of interest in reports on antidepressant trials. Last September a study published in the Journal of Clinical Epidemiology revealed that a third of meta-analyses of antidepressant studies were written by pharma employees and that these were 22 times less likely than other meta-studies to include negative statements about the drug. That same month another research group reported that after reanalyzing the data from Study 329, a 2001 clinical trial of Paxil funded by GlaxoSmithKline, they uncovered exaggerated efficacy and undisclosed harm to adolescents.

The author offers this conclusion:

Taken together with other research that raises questions about the pros and cons of this class of drugs—including studies that suggest antidepressants are only marginally better than placebos—some experts say it is time to reevaluate. “My view is that we really don’t have good enough evidence that antidepressants are effective and we have increasing evidence that they can be harmful,” Moncrieff says. “So we need to go into reverse and stop this increasing trend of prescribing [them].”

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Supporting Research for Psychosocial Treatments + Medication is “sparse”

fear_false_evidence_appearing_realYesterday, I told you about the new White House budget proposal for $1,100,000,000 for addiction treatment that places very heavy emphasis on medication assisted treatment (MAT).

A recently published study in Journal of Addiction Medicine, the official journal of the American Society of Addiction Medicine (ASAM), raises questions about the rationale for that budget.

That budget and it’s emphasis on MAT is based on this:

“As the Huffington Post article pointed out, we have highly effective medications, when combined with other behavioral supports, that are the standard of care for the treatment of opiate addiction. And for a long time and what continues to this day is a lack of — a tremendous amount of misunderstanding about these drugs and particularly within our criminal justice system,” drug czar Michael Botticelli said in a briefing with reporters.

You might ask, what medications are they talking about? Spend a little time following this coverage and it’s pretty clear that they are primarily talking about buprenorphine.

Let’s look at the statements, “highly effective” and “when combined with other behavioral supports”.

A recent post addressed the “highly effective” element. I’ll repeat that information below, but let’s start with the other claim, “when combined with behavioral supports.”

“when combined with other behavioral supports”

A summary of the Journal of Addiction Medicine article states:

There are three approved types of medications that work in different ways to treat people with opioid addiction: methadone, buprenorphine, and naltrexone. . . . All three medications are approved for use “within the framework of medical, social, and psychological support,” and ASAM’s guideline recommends psychosocial treatment in conjunction with the use of medications. “However,” Dr. Dugosh and coauthors add, “there is limited research addressing the efficacy of psychosocial interventions used in conjunction with medications to treat opioid addiction.”

What did they find about buprenorphine?

For buprenorphine, the results were “less robust”—only three of eight studies found positive effects of psychosocial interventions.

Of course, this is not news. Our position paper and some other posts pointed this out.

If we’ve known this since 2011, how could the drug czar and these professional reporters writing a long-form article not know?

“highly effective”

A couple months ago, NIDA circulated an article with the headline, “Long-Term Follow-Up of Medication-Assisted Treatment for Addiction to Pain Relievers Yields ‘Cause for Optimism’

Here’s how they summarized the study’s findings:

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

Lowering_The_Bar_Cover_2010.09.22There 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 might be 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.

and . . .

This is a federal study seeking to determine whether adding behavioral support improved outcomes.

Think about it

The headline for the press release summary of the study is “Use of Psychosocial Treatments in Conjunction with Medication for Opioid Addiction—Recommended, But Supporting Research Is Sparse

Recommended . . . but evidence is sparse? Let that headline sink in for a moment.

Remember that next time you hear experts or journalists refer to MAT as THE “evidence-based” treatment, or the “best hope“, or “highly effective” or a “wonder drug“.

Then, ask your self why they mentioned nothing about a model, with admittedly narrow implementation, that really does have outstanding outcomes.

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Something to celebrate?

The White House announced $1.1 for addiction treatment in the 2017 budget proposal it just introduced.

Good news, right?

Some advocacy groups are pretty excited about it, “They’re hearing us!”

If approved, here’s how the money would be spent:

  • $920 million to support cooperative agreements with States to expand access to medication-assisted treatment for opioid use disorders. States will receive funds based on the severity of the epidemic and on the strength of their strategy to respond to it.  States can use these funds to expand treatment capacity and make services more affordable.
  • $50 million in National Health Service Corps funding to expand access to substance use treatment providers.  This funding will help support approximately 700 providers able to provide substance use disorder treatment services, including medication-assisted treatment, in areas across the country most in need of behavioral health providers.
  • $30 million to evaluate the effectiveness of treatment programs employing medication-assisted treatment under real-world conditions and help identify opportunities to improve treatment for patients with opioid use disorders.

faust-1006416_960_720The celebration over a budget that places such a lopsided emphasis on MAT is exactly why I am ambivalent about embracing this latest wave of recovery adovocacy.

This is a disappointment, not a victory.

The overemphasis on these particular treatments will not be good for addicts. It’s the subtle bigotry of low expectations.

Look at the actual research behind NIDA’s own advocacy for MAT.

A couple months ago, NIDA circulated an article with the headline, “Long-Term Follow-Up of Medication-Assisted Treatment for Addiction to Pain Relievers Yields ‘Cause for Optimism’

Behind the headline

Here’s how they summarized the study’s findings:

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

Lowering_The_Bar_Cover_2010.09.22There 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.)

Unintended Consequences

16071861920_0735216aef_bThis isn’t meant to suggest that these treatments don’t work for some people, even many people. Or, that they shouldn’t be available to addicts who want them. It’s about creating high expectations about treatments that don’t deliver as promised. (Or the evidence for their effectiveness doesn’t match the desired outcomes for most addicts and their families.)

As this plays out, I suspect recovering people and the public are going to end up feeling like they were sold a bill of goods and be more suspicious of recovery advocacy and treatment.

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Dangerous Treatment and the Science of Safety

We are concerned about the dangers of addiction as never before. For good reason–the opioid epidemic has become an overdose epidemic.

One undercurrent in the coverage of the issue is the implication that abstinence-based treatment contributes to overdose deaths. (There’s no question maintenance drugs reduce overdose risk and short term abstinence-based treatment of opioid addiction is irresponsible. However, there’s a lot more to the story. I’ve addressed this in several previous posts.)

A recent Addiction Professional article includes a sidebar entitled, “Dangers of drug-free treatment“.

This is pretty frustrating when the gold standard is abstinence-based and is restricted to a few elite groups.

Then, right on time, comes Kevin McCauley with his new video, Memo to Self: Protecting Sobriety with the Science of Safety.


McCauley introduces us to the Swiss Cheese Model of safety that he borrows from his background in aviation.

He uses this safety framework to propose a plan for protecting recovery. He proposes 10 protective layers. (Or, if you prefer, layers of cheese.)

His 10 layers are as follows:

  1. Treatment (residential or inpatient)
  2. A therapist, coach, and/or advocate (for regular recovery maintenance check-ups)
  3. Recovery residences
  4. Mutual support groups
  5. A relapse plan
  6. Drug testing (frequent and prolonged)
  7. Job or school (for meaning and purpose)
  8. An addiction medicine specialist
  9. Medication
  10. Hedonic rehabilitation (learning to have fun in recovery)

sw_not_aligned

Within this frame each layer provides a layer of protection and choosing to remove a layer increases the risk of relapse. This safety frame provides a way to make these risk increasing decisions more concrete and less emotionally charged. If there’s good reason to remove a particular layer, it also sets up exploration of what might be done to add another layer to replace it.

Unlike most educational videos, it’s not boring, preachy and tedious. McCauley gets us to laugh at his story and, in doing so, gets us to reflect on our own experiences with the distorted thinking of early recovery and see the importance of building protective layers to get the very precarious early months of recovery.

Further, one of the limitations of all lifestyle medicine approaches has been the dearth of knowledge about maintaining change over years and decades. This safety model provides a way of thinking through what layers are needed, not just to achieve stable recovery, but also to maintain stable recovery over years and decades.

The too-frequently and simplistically proposed solution (prescription?) for the overdose epidemic is opioid replacement medication, like buprenorphine or methadone. This model makes plain that, at best, these medications (or others, like vivitrol) compose only one layer of a safety plan. Of course, going to inpatient treatment is also only one layer.

Unfortunately, the treatment system does not deliver anything resembling this model for anyone other than doctors, pilots and possibly lawyers. This makes the video and model especially important for programs that want to improve their services as well as families and addicts that want to piece together these layers of protection on their own.

This video is a real service to treatment providers, advocates, families and addicts. It is highly recommended.

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Most popular posts of 2015 – #1 – Why so irrational about AA?

AA isn't the only way to recover, but no reasonable person can say it's ineffective.

AA isn’t the only way to recover, but no reasonable person can say it’s ineffective.

Gabrielle Glaser has gotten another AA bashing article published and it’s getting a lot of attention. Of course she doesn’t really offer a tangible alternative.

I’m not going to write another piece rebutting it, but I’ll point you to a few relevant posts.

First, in New York magazine, Jesse Singal dismantles Glaser’s arguments.

As with any story about a complicated social-science issue, there are aspects of Glaser’s argument with which one could easily quibble. For one thing, she repeatedly conflates and switches between discussing AA, a program that, whatever one thinks about it, is clearly defined and has been studied, in one form or another, for decades, and the broader world of for-profit addiction-recovery programs, which is indeed an underregulated Wild West of snake-oil salesman offering treatments that haven’t been sufficiently tested in clinical settings. Her argument also leans too heavily on the work of Lance Dodes, a former Harvard Medical School psychiatrist. He has estimated, as Glaser puts it, that “AA’s actual success rate [is] somewhere between 5 and 8 percent,” but this is a very controversial figure among addiction researchers. (I should admit here that I recently passed along this number much too credulously.)

But on Glaser’s central claim that there’s no rigorous scientific evidence that AA and other 12-step programs work, there’s no quibbling: It’s wrong.

Next, one of my previous posts lays out the evidence for the use of 12 step groups.

Then, here are some of my responses to Dodes.

Finally, some posts on addiction treatment and recovery being made a front in the culture wars, including a response to a previous Glaser article.

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Most popular posts of 2015 – #2 – We all wish love was enough

fear_false_evidence_appearing_realThis article, claiming to have discovered the long suppressed cause of addiction, has been making the rounds and has been recommended by a lot of people.

Like a lot of things, it contains some truth but is not the Truth.

People generally bring up rat park and returning Vietnam vets to advance 2 arguments.

  1. That you can’t catch addiction by just being exposed to the drug.
  2. That environment is the real problem. If you put people in bad environments, they’ll look like addicts. If you enrich addicts’ environments, they’ll stop being addicted.

I whole-heartedly agree with argument #1. You can expose 100 people to drugs like cocaine and heroin and a relatively small minority will develop chronic problems–5 to 23, depending on the study you look at. So, even if the outlier studies were true, we’re still talking about 77% not becoming addicted.

Every field has its goofballs, but in my two decades in the field I have not heard any serious practitioners or researchers argue that simple exposure (even to large doses over an extended period) causes addiction.

Argument #2 is much weaker. It’s my understanding that follow-up studies with rats have failed to reproduce these findings and suggested genetic factors were important. The strongest statement you can make about environment is that it is a risk factor, but not anything approaching a cause.

As for returning Vietnam vets, this is from a post I wrote a few years ago:

These stories often ignore the fact that:

“. . . there was that other cohort, that 5 to 12 per cent of the servicemen in the study, for whom it did not go that way at all. This group of former users could not seem to shake it, except with great difficulty.”

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.

So. . . rat park and returning Vietnam vets are not quite what he describes. Let’s continue.

I do appreciate the article’s call for compassion and I am a believer that purpose, meaning and connection are important elements of stable recovery. However, as I continue reading the article, I am reminded of Ralph Waldo Emerson:

Their every truth is not quite true. Their two is not the real two, their four not the real four; so that every word they say chagrins us, and we know not where to begin to set them right.

mencken-complex-problemHe says that addiction that begins with  prescribed pain medication “virtually never happens.” Well, it’s hard to pin down exactly how often it happens, due to chicken and egg questions related to how many pain patients have pre-existing substance use problems. However, reported estimates range from  “from 2.8% (Cowan et al., 2003) to 50% ( Saper et al., 2004).”

What about the Portugal miracle? We’ll a few things to keep in mind. First, the decriminalization approach is focused on getting addicts into treatment. Housing and treatment may be addressed, but it’s clear the focus is on treatment. Second, Portugal was starting from the position of a terrible heroin problem. They’ve gone from 1% addicted to 0.5% addicted. That’s great, but to provide a little context, the National Survey on Drug Use and Health pegs current heroin users at 0.1% of the U.S. population.

So . . . the article doesn’t tell the whole story, it oversimplifies some very complex issues and presents us with straw man arguments. (Who says that anyone who uses heroin is going to get hooked for life? [Note that he had to go back to a commercial from the 1980s and that a search for the reported text of the commercial only produces references to his article.] Or, that behavioral, environmental, social and other factors are unimportant in the development, course and recovery from addiction?)

I also worry about the implied message that we just love them enough, they’ll get well. I see countless families that provide housing, jobs, connection and love–only with watch their loved one slip further and further into addiction.

Addiction is a complex problem. Multiple factors influence it’s development, course and resolution. This is always the case with chronic disease. There’s a cultural narrative out there that addiction is not a disease, that it is rational, that it’s a product of environment, that it’s a learning disorder, that framing it as a disease is a foundation for violating individual liberties and that recovery needs to be redefined. Intended, or not, stories like this are part of that narrative.

I don’t engage in ad hominem arguments, but, while we’re on the topic of narratives, it would seem strange to not point out that this author has a history of playing fast and loose to advance a narrative.

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Most popular posts of 2015 – #3 – The treatment system is failing opiate addicts

Doha15Stories like this are getting a lot of attention lately:

State Sen. Chris Eaton is planning to introduce legislation to encourage opiate treatment providers and doctors to break with an abstinence-based model and embrace evidence-based practices for treating addiction, the Minnesota Democrat told The Huffington Post.

I want to make it clear that I know nothing of Senator Eaton and am not questioning her motives.

If this was really motivated by a desire to spread evidence-based treatments, there’d be another, more interesting debate brewing.

That debate would be whether Senator Eaton should introduce legislation requiring that Physician Health Programs (PHP) start treating addicted health professionals with maintenance medications.

I doubt Senator Eaton wants that. I doubt she even knows much about Physician Health Programs. Her source of information about opioid addiction treatment was the Huffington Post article that painted abstinence-based treatment as hopelessly anti-evidence and ineffective while painting maintenance medications as THE answer to this problems that’s been with us for ages.

Why would she want to change opiate addiction treatment for the general population, but not for doctors? Because the treatment system for the general population is failing addicts and their families while the Physician Health Programs are producing outstanding outcomes.

Is the difference that one is abstinence-based while the other uses maintenance medications? No.

The difference is that PHPs get treatment and recovery support of an adequate quality, intensity and duration while the general population does not.

Debra Jay identified 8 essential ingredients in PHPs:

  1. Positive rewards and negative consequences
  2. Frequent random drug testing
  3. 12 step involvement and an abstinence expectation
  4. Viable role models and recovery mentors
  5. Modified lifestyles
  6. Active and sustained monitoring
  7. Active management of relapse
  8. Continuing care approach

PHPs provide treatment, recovery support and monitoring for up to 5 years and 85% of participants have no relapses. Of the 15% who relapse, most of them have only one relapse over that 5 year period.

Will maintenance medications improve treatment for the general population? It’s hard to imagine they will when they have the same retention problems that abstinence-based treatments have. Further, most of the treatment delivered with maintenance medications suffers from the same problem as abstinence-based treatment– inadequate quality, intensity and duration. (By duration, I mean the accompanying behavioral support as well as retention on the medication.)

So . . . this solution really focuses on the wrong problem.

The problem isn’t that treatment is abstinence-based. The problem is that abstinence-based and maintenance treatments too often do not provide adequate quality, intensity and duration.

So, why advocate to spread access to a treatment we won’t use on addicted physicians rather than spread access the gold standard of care that addicted physicians receive? That’s the danger of advocacy journalism that is dressed up as objective reporting.

I’m grateful to work in a place the works so hard to increase access to treatment and recovery support of an adequate quality, intensity and duration.

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