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Follow up – Responses to charges against Invidior

So . . . a week and a half ago, Indivior, the manufacturer of Suboxone, was charged with conspiracy, health care fraud, mail fraud and wire fraud.

Prosecutors said:

Indivior misled doctors and government health programs into believing that the drug, Suboxone Film, was safer and less likely to be abused than rivals, the Justice Department said in a statement Tuesday.

. . .

Federal prosecutors in the Western District of Virginia said Indivior’s deceptions had contributed to an epidemic that has killed thousands of people.

I posted the story, along with discussion about SAMHSA’s proposed guidelines for recovery homes. The proposed guidelines acknowledge diversion as a reality and a risk to be managed. This acknowledgement is important, though I worry that their attitude may be cavalier.

The problem of diverted maintenance medications has been well-known by people with addictions and practitioners for at least a decade. However, in public treatment and recovery advocacy forums, the problem has been taboo and raising the issue often resulted in having one’s judgement and motives questioned. (I was actually in a forum with a high level official from the Office of Drug Control Policy where an attendee very diplomatically raised the concern. That attendee was politely advised that discussion of the matter is likely to complicate accomplishing the goals of his office. He, therefore, discouraged discussing those concerns in public forums.)

About 9 days after news of the charges against Indivior were made public, an organization called the Addiction Policy Forum posted an article by an esteemed addiction scholar. The article used a recent study about the diversion of buprenorphine to argue that diverted buprenorphine is typically used in ways that are consistent with therapeutic purposes.

This article was widely circulated in treatment/research/advocacy circles in response to the concerns raised by the Indivior charges. The implication was that the evidence-base doesn’t support concerns about non-therapeutic misuse.

What was not mentioned in these tweets and posts is that the Addiction Policy Forum is funded by drug makers, including Indivior. These tweets and posts also failed to note that the study referenced in the article was funded by Indivior.

Disclosures from: Cicero, T., Ellis, M., & Chilcoat, H. (2018). Understanding the use of diverted buprenorphine. Drug And Alcohol Dependence, 193, 117-123. doi:10.1016/j.drugalcdep.2018.09.007

The study found that diversion was pretty common, with  58% of subjects reported having used diverted buprenorphine. It also found that 52% of subjects reported having used buprenorphine to get high.

It seems strange to defend Indivior’s medication from allegations that Indivior has been deceptive by circulating an article published by an Indivior funded organization that cites an Indivior funded study without acknowledging Indivior’s role in the study.

So, if Indivior funded and promulgated research finds high rates of diversion and that “52% reported using buprenorphine to get high or alter mood”, what does other research say?

Well, another post referenced a study that also found misuse of buprenorphine to be very common. One of the authors summarized their findings as follows:

Some claims for buprenorphine products have proven not to be true. People bluntly report ability to get a “high” within clinically approved doses despite early claims otherwise. Buprenorphine is commonly diverted and misused, despite early claims that the drug would not lend itself to such patterns. . . . this study looks at the real-world conditions and experiences collected on 1,674 people who report themselves as having a history of disordered use of many different drugs (including alcohol) and who have recently engaged in a recovery program to become abstinent from all substances that cause a “high,” or which mask unpleasant emotions.

Key Findings for those reporting prior use of buprenorphine products in the prior 6 months:

  • 4.2% had only obtained buprenorphine by legal prescription
  • 60% had only obtained buprenorphine by illegal means
  • 35.9% had obtained buprenorphine by both illegal and illegal means
  • 10% had overdosed with buprenorphine while taking other drugs or alcohol
  • No matter how obtained, 56.1 % to 81.2% report getting a good “high” on buprenorphine
  • Efficacy: 25.2% = helped // 31.5% = no effect // 43.3% = made problems worse

Now, it’s important to note that the subjects in this study were participants in drug-free treatment, which likely creates a selection bias.

With that in mind, one way to read that is that maintenance medications may be unhelpful, bad, or risky for a significant number of people with opioid addiction, many of them know it, many of them find their way to non-maintenance treatment (if available), and that it will not be helpful to push these patients into maintenance treatments or environments with maintenance medications.

I should add that I am open to the inverse being true too. None of this is an argument that maintenance treatments should not be available to any patient that wants them. As I’ve repeatedly stated in this blog, it’s just a push for good informed consent that empowers patients to advocate and choose for themselves.

Bill White’s recent post on chaos and recovery speaks to the variability in what helps some and harms others:

Unique service combinations that are transformative for one individual may exert no effects, minimal effects, or even harmful effects on others. This proposition affirms the need for expansive menus of recovery support elements (as opposed to a fixed “program”) and rapid adaptations in such offerings based on individual responses to services over time. It also suggests that any single pathway model of addiction and recovery will only result in sustained recovery for a limited subset of the total population of AOD-affected individuals and that those outside that subset could be injured when subjected to mismatched interventions. In medicine, such injuries are referred to as iatrogenic illnesses (e.g., treatment-caused harm).

. . .

Suggesting such complex interactions within the recovery process is not an invitation to therapeutic nihilism or abandonment of science, e.g., the suggestion that all treatment and recovery frameworks are worthy and only need their elements combined. (Some may be ineffective or harmful.) It is instead an invitation to bring ALL of  evidence-based, practice-informed ingredients into our service and support milieus, mixing and matching them as we draw from the experiential knowledge of people in recovery, while closely monitoring and adapting personal responses to various service clusters that are chosen. It further calls for a heightened level of professional humility and personal awe that unseen forces may be at work in providing a detonation point for these combustible ingredients.

Again, none of this is an argument to reduce access to any kind of treatment. Rather, it’s a call to talk more openly about what the evidence says and doesn’t say about the benefits, what we know and don’t know about the harms and risks, as well as the limitations.

I should add that non-maintenance treatments are not exempt from ethical concerns, as this week’s news and previous posts indicate.

UPDATE: One other theme in some of the reactions paint diversion as a product of a shortage of prescribers, citing reports that only 5% of US physicians have a waiver to prescribe buprenorphine.

To me, that seemed like an unhelpful statistic. I don’t know what percentage of US physicians are specialists like ophthalmologists, oncologists, nephrologists, surgeons, etc. I wouldn’t expect most specialists to prescribe something like buprenorphine under any regulatory circumstance.

So . . . I did a little googling.

That number of waivered physicians constitutes the equivalent of 27.8% of all primary care and psychiatrists in the US.

That seems substantial to me.

Further, a post from 3 years ago addressed concerns about access to maintenance medications. One would assume that buprenorphine sales and utilization have increased since these numbers were generated in 2010 and 2013.

 

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Recovery Celebrities?

gut-check-image2

This post is a couple years old. Re-upping.

================================

A couple of days ago, I had a chance to catch up with a friend and recovery advocate. Turns out we share a concern about the emergence of a kind of celebrity culture within recovery advocacy efforts.

It seems like a good time to revisit a post from Bill White that addresses the topic. The post focuses on anonymity and advocacy, examining the changing cultural context for anonymity and its functions.

On anonymity as a spiritual principle [emphasis mine]:

When AA literature speaks of anonymity as a “spiritual principle,” it does so out of a profound understanding of the importance of self-transcendence as the vehicle for sobriety and serenity. You can hear people depicting AA as a “selfish program” to mean that the alcoholic must get sober for self and not for others, but you find a quite different orientation on the issue of anonymity. The “spiritual substance” of anonymity according to AA’s core literature is not selfishness but “sacrifice.” (AA, 1952/1981, p. 184). What is sacrificed in AA (and in acts of heroism) are one’s “natural desires for personal distinction,” which in AA are eschewed in favor of “humility, expressed by anonymity” (AA, 1952/1981, p. 87). Applying this understanding, one could see how an AA or NA member choosing public recovery advocacy could technically meet the letter of Tradition Eleven (not disclosing AA affiliation at the level of press), but violate the pervading spirit of the Traditions (Tradition Twelve). This could occur when advocacy is used as a stage for assertion of self (flowing from ego / narcissism / pride and the desire for personal recognition) rather than as a platform for acts of service, which flow from remorse, gratitude, humility, and a commitment to service. (2013)

He closes with a call for a gut check on our advocacy efforts:

There is a purity—perhaps even a nobility—to recovery advocacy when it meets the heroism criteria. There is a zone of service and connection to community within advocacy work, and I think we must do a regular gut check to make sure we remain within that zone and not drift into advocacy as an assertion of ego. The intensity of camera lights, the proffered microphone, and seeing our published words and images can be as intoxicating and destructive as any drug if we allow ourselves to be seduced by them. If we shift our focus from the power of the message to our power as a messenger, we risk, like Icarus of myth, flying towards the sun and our own self-destruction. To avoid that, we have to speak as a community of recovering people and avoid becoming recovery celebrities—even on the smallest of stages. We must stay closely connected to diverse communities of recovery and speak publicly not as an individual or representative of one path of recovery, but on behalf of all people in recovery. The fact that no one is fully qualified to do that helps us maintain a sense of humility even as we embrace the very real importance of the work to be done. The spirit of anonymity—that suppression of self-centeredness—can be respected when we speak by embracing the wonderful varieties of recovery experience rather than as individuals competing for attention and superiority. (2013)

We stand on the shoulders of others

I’m grateful for Bill’s reminder. Personally, I’m bothered be some of the slogans coming out of the newest generation of advocates. “Silent no more”, “I am not anonymous” and “The silence ends” are just a few examples.

First of all, anonymity, as practiced within communities of recovery, never demanded silence. All one needs to do is read AA’s chapter on the 12th tradition, published in 1952.

When opportunities to be helpful came along, he found he could talk easily about A.A. to almost anyone. These quiet disclosures helped him to lose his fear of the alcoholic stigma, and spread the news of A.A.’s existence in his community. Many a new man and woman came to A.A. because of such conversations. Though not in the strict letter of anonymity, such communications were well within its spirit.

But it became apparent that the word-of-mouth method was too limited. Our work, as such, needed to be publicized. The A.A. groups would have to reach quickly as many despairing alcoholics as they could. Consequently, many groups began to hold meetings which were open to interested friends and the public, so that the average citizen could see for himself just what A.A. was all about. The response to these meetings was warmly sympathetic. Soon, groups began to receive requests for A.A. speakers to appear before civic organizations, church groups, and medical societies. Provided anonymity was maintained on these platforms, and reporters present were cautioned against the use of names or pictures, the result was fine.

We may not have organized recovering people into a national advocacy movement, but we’ve never been silent. As a community, we haven’t cowered in shame. Communities of recovery are so frequently painted as “secretive”, with all of it’s pejorative connotations–implying shame, hiding, cultishness, etc. Why are we reinforcing this?

“I am not anonymous” seems dismissive of anonymity as a spiritual principle.

The issue isn’t advocacy. The first wave of this advocacy movement was much more respectful of tradition and the people who blazed the trail for building a recovering community capable of engaging in this level of advocacy. They made the case for “advocacy with anonymity” rather than dismissing it as quaint.

There’s nothing wrong with evolving. There’s nothing wrong with questioning the confines of tradition. We don’t have to be bound by tradition, but we should respect the traditions, principles and values that brought us this far.

I hope this movement grows, matures and succeeds in reducing stigma and improving access to help of adequate quality, intensity and duration.

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“full recovery or amplified recovery” — toward typologies of recovery?

Recently proposed definitions of recovery could be characterized as defining it downward (or expanding the boundaries outward).

I’ve expressed concern that these proposed boundaries are so broad that most people who currently self-identify as in recovery will not feel a shared identity with the people that advocates are trying to expand the boundaries to include.

I believe, if these new definitions take root, recovering people will feel a need to establish typologies of recovery or select a new word to convey the identity they share.

Bill White and Galen Tinder describe what might be one of those typologies—”full” or “amplified” recovery.

Addiction recovery is far more than the removal of drugs from an otherwise unchanged life. Recent definitions of recovery transcend radical changes in the person-drug relationship and encompass enhanced global health and social functioning. The authors have carried on a decades-long interest in what has been christened full recovery or amplified recovery—a state of enhanced quality of life and personal character in long-term recovery.

First, note that they begin by describing recovery as more than the removal of drugs. (Removal of drugs is more like a floor than a ceiling.) Bill has previously described something he calls “precovery“, which would apply to many of the behaviors that the proposed more diffuse conceptual boundaries seek to include.

Second, some of the rhetoric around recovery advocacy might make a productive discussion challenging. The need for typologies stems from the desire to distinguish one type from another, and use them. How might they be used? They would likely be used to organize research and programming around each type. This means these typologies would be used in inclusion/exclusion criteria for everything from research to treatment to recovery housing to collegiate recovery programs to physician health programs to state or unstated hiring practices.

There are serious and important equity issues that include problems related to access to care, incarceration and privilege. The social justice framing has the potential to illuminate and clarify these inequities. It also has the potential to complicate discussion and disagreement because positions get cast as just vs unjust, moral vs immoral, and valid vs invalid.

I’ve been increasingly concerned that addiction treatment and policy has become a new battleground for the culture wars without many of us even realizing it was happening or conceiving that treatment belonged on any “side” of a culture war. Some good may come of it, but it’s hard to imagine that there would not be a lot damage, polarization, contempt and fragmentation accompanying it. There’s also the question of how patients will respond to a field that’s a front in a culture war.

UPDATE: The FDA’s proposed alternative endpoints are also germane to this discussion and increases the need for productive discussion. Are they appropriate endpoints? Are they recovery?

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Comments on SAMHSA recovery housing guidelines

Below are my comments for SAMHSA in response to their request for comments on your proposed recovery housing guidelines. The deadline is 5pm today. Send your comments, whatever they are.


To whom it may concern:

I am writing in response to your request for comments on your proposed recovery housing guidelines.

I commend your efforts to provide guidance for recovery housing. Recovery housing is a long-neglected and critical element in the treatment and recovery support continuum.

I strongly urge guidelines that maintain options for recovery housing where agonist MAT substances are excluded.

I offer the following as a rationale for this request.

First, there has been relatively little research on the diversion of opioid agonists in the US. The research that exists suggests that diversion is common.

For example, Walker, Logan, Chipley & Miller (2018), in the peer-reviewed journal The American Journal of Drug and Alcohol Abuse, found misuse of buprenorphone to be very common. One of the authors summarized their findings as follows:

Buprenorphine is an opioid that, like other opioid drugs, can produce effects such as pain reduction, a pleasurable “high,” sleepiness, physical dependence and addiction. It has become a street-trafficked drug. . . . Some claims for buprenorphine products have proven not to be true. People bluntly report ability to get a “high” within clinically approved doses despite early claims otherwise. Buprenorphine is commonly diverted and abused, despite early claims that the drug would not lend itself to such patterns. Most of the research studies by developers and marketers carefully selected subjects who only had opioid use disorder, mostly those only with prescription opioid-use disorder and, rarely, those only with heroin-use disorders. In contrast, this study looks at the real-world conditions and experiences collected on 1,674 people who report themselves as having a history of disordered use of many different drugs (including alcohol) and who have recently engaged in a recovery program to become abstinent from all substances that cause a “high,” or which mask unpleasant emotions.

Key Findings for those reporting prior use of buprenorphine products in the prior 6 months:

  • 4.2% had only obtained buprenorphine by legal prescription
  • 60% had only obtained buprenorphine by illegal means
  • 35.9% had obtained buprenorphine by both illegal and illegal means
  • 10% had overdosed with buprenorphine while taking other drugs or alcohol
  • No matter how obtained, 56.1 % to 81.2% report getting a good “high” on buprenorphine
  • Efficacy: 25.2% = helped 31.5% = no effect 43.3% = made problems worse

This is supported by this week’s, Department of Justice charges against Indivior for “deceiving health-care providers and health-care benefit programs into believing that Suboxone Film was safer, less divertible, and less abusable than other opioid-addiction treatment drugs”

Secondly, while there is a large evidence-base for the effectiveness of agonists in reducing illicit opioid use, overdose deaths, criminal activity, and disease transmission, those outcomes only partially overlap with the goals of most recovery housing programs. Most recovery housing programs seek abstinence from alcohol and commonly misused drugs—licit and illicit.

Hettema and Sorensen (2008), in the peer reviewed journal International journal of mental health and addiction, reported the following:

While much of the stigma against the use MMT does not seem grounded in evidence, some important arguments against the integration of MMT and residential treatment have been put forth. Residential treatment programs are faced with a complex context for their clinical decision making (Zemore & Kaskutas, 2008). Unlike methadone clinics, in which the behavior of one client has little effect on others, patients within residential treatment programs are highly dependent on one another. Here the behavior of one individual can have a huge effect on the overall environment and, consequently, what may be beneficial to one client may be harmful to the community as a whole.

The proposed guidelines themselves discuss the potential for diversion and misuse and outline actions provides can consider to manage these risks. If mandatory, this would be a considerable burden to place on providers and many residents.

Thirdly, the guidelines call for access to FDA approved medications. It’s worth noting and considering that legally prescribed medication played a key role in raising the opioid problem to the crisis level and sustaining it. It’s also worth noting that legally prescribed, FDA approved medications can include opioids, benzodiazepines, muscle relaxers, and many other frequently misused drugs.

Finally, if large portions of recovery housing residents have agonist medications, isn’t it reasonable for residents to think of a “safe” recovery environment as one that excludes those commonly misused medications?

It is undoubtedly true that agonist patients do not have adequate access to recovery housing. One could explain this gap by accusing housing providers of stigmatization and discriminating. Another way to explain this is that agonist treatment providers have failed to deliver this kind of recovery support. Seen this way, the problem is not that many providers prohibit opioids, rather that there is a need to establish recovery housing that allows agonist medications.

The need for both agonist-friendly programs and opioid-free programs is clear. By all means, encourage and support the establishment of agonist-friendly recovery housing programs. However, please do so in a manner that assures we do not pit the needs of one group of patients/residents against the other.

Thank you for your consideration.

 

Sincerely,

Jason Schwartz

 

References:

Hettema, J. E., & Sorensen, J. L. (2009). Access to Care for Methadone Maintenance Patients in the United States. International journal of mental health and addiction, 7(3), 468–474. doi:10.1007/s11469-009-9204-6

Robert Walker, TK Logan, Quintin T. Chipley & Jaime Miller (2018) Characteristics and experiences of buprenorphine-naloxone use among polysubstance users, The American Journal of Drug and Alcohol Abuse, 44:6, 595-603, DOI: 10.1080/00952990.2018.1461876

White, W.L. & Torres, L. (2010). Recovery-oriented Methadone Maintenance. Chicago, IL: Great Lakes Addiction Technology Transfer Center, Philadelphia Department of Behavioral Health and Mental Retardation Services and Northeast Addiction Technology Transfer Center.

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billions from deceptions that “Suboxone Film was safer, less divertible, and less abusable”

From Bloomberg:

Indivior misled doctors and government health programs into believing that the drug, Suboxone Film, was safer and less likely to be abused than rivals, the Justice Department said in a statement Tuesday.

. . .

Federal prosecutors in the Western District of Virginia said Indivior’s deceptions had contributed to an epidemic that has killed thousands of people.

“Indivior obtained billions of dollars in revenue from Suboxone Film prescriptions by deceiving health-care providers and health-care benefit programs into believing that Suboxone Film was safer, less divertible, and less abusable than other opioid-addiction treatment drugs,” said the prosecutors.

Interestingly, SAMHSA has recently issued proposed recovery housing guidelines. (They are seeking feedback. Please send yours, whatever it is.) SAMHSA has previously published materials that stated the Fair Housing Act and Americans with Disabilities Act require transitional housing programs to allow legally prescribed medications.

In the past, concern about diversion of medications like buprenorphine was treated as an imagined problem (it’s not), or that it’s only diverted for instrumental use to avoid withdrawal in the context of barriers to access.

These guidelines speak to the issue of diversion in a new manner:

According the NSDUH (2017) the intentional misuse of buprenorphine increased over 30%, making it the fastest growing abused prescription opioid in the country. There are still other prescription opioids that are intentionally misused or abused more than buprenorphine, but this drug has witnessed the largest percentage uptick in popularity. In July 2018, SAMHSA conducted a technical expert panel on the inclusion of MAT into the recovery model of care. Our expert panelists described the diversion of mood-altering (partial and full agonist) MAT drugs as the act of diverting an appropriate prescribed medication from the intended recipient to another recipient. Also equally problematic is the intentional abuse of these medications such as mixing with other drugs or alcohol and/or injecting medications for the sole purpose of achieving intoxication. Since the abuse of mood-altering substances can have detrimental effects on other people’s sobriety living in close quarters such as a recovery house, our experts recommended several courses of action listed below to help ensure client safety.

  • Medication counts with staff and client
  • Increase drug testing (if suspected of diversion)
  • Communication between stakeholders, providers & staff (releases of information)
  • Distribution of lock boxes
  • Maintain proper documentation
  • Monitor specific residents
  • Open discussion of medications (e.g., group topic, potential triggers, etc.)

They also still appear to require the inclusion of any FDA approved medication. (That specifier, “FDA approved medication” does not appear to be limited to medications for SUDs.)

“Substance-free does not prohibit prescribed medications taken as directed by a licensed physician, such as Medication Assisted Treatment, and other FDA approved medications.”

For purposes of this document, SAMHSA’s official definition will serve as the benchmark from which to ascribe best practices and suggested minimum standards. The utilization of this definition is because it encompasses the basic tenets as set forth in the statute and it stipulates the inclusion of medication assisted treatment and other FDA approved pharmacological interventions.

It’s worth noting that legally prescribed medication played a key role in raising the opioid problem to the crisis level and sustaining it.

It’s also worth noting that legally prescribed, FDA approved medications can include opioids, benzos, muscle relaxers, and many other frequently misused drugs.

Implementation of these expectations are likely to result in very troubled programs, in an already troubled industry, and result in more stigma and NIMBY pushback that makes it harder for conscientious and recovery-oriented providers to establish programs.

The question isn’t whether maintenance patients should have access to long term recovery support, like sober housing. They absolutely should. The question that’s never discussed is, who should take responsibility for providing these patients with access to this kind of support? When you look at existing housing programs, they are generally started by people in recovery who want to help others succeed on their pathway or by treatment providers that committed their time and resources to extending recovery support for their patients.

Maintenance patients do not have adequate access to recovery housing. One way to explain this gap is that housing providers are discriminating. Another way to explain this is that maintenance treatment providers have failed to deliver this kind of recovery support. Of course, there are other possible explanations, and it might be a combination of explanations.

Another question is this, if large portions of recovery housing residents have misused maintenance medications, is it wrong to want an environment that does not allow those misused medications? If that’s a legitimate want, is it wrong to provide that? (And, under the FHA argument, what about benzos, gabapentin, stimulants, etc.?)

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On self-identification, recovery advocacy and identity

I recently became aware of the blog, Tenured Addict. He has a great new post on addiction, recovery, advocacy and language. It’s a thorough and challenging post on a potentially thorny issue but it’s written in a personal and generous spirit. Here are a couple of pull quotes, but take the time to read the whole thing.

There are important reasons to challenge stigmatizing language. It’s wounding and it can affect people’s decisions in key settings. But the wide-spread notion that language policing helps to eliminate or transform broader social prejudice is pretty dubious. On the second question, many activists have adopted a vocabulary that originated not in our own history and communities, but in the field of psychiatry. Whether wise or not (clearly I have qualms), it is striking that this strategy goes in the opposite direction of other traditions of social justice, such as the LGBTQ movement, which mobilized terms like Gay and Queer to challenge the term “homosexual.” A significant tradition of activism and scholarship warns against the limitations of an individualizing, biomedical model of addiction. Why would we then adopt this same discourse for our self-designation?

On SUDs as a container for recovery advocacy:

I simply wish that we would be far more careful in identifying what we are speaking about and whom we are claiming to represent. Some of our assertions erase the experiences of people that we claim to champion—in some cases, our own experiences. However, I think there is a strain of recovery advocacy where the folding of addiction into SUD coincides with a potentially dangerous and divisive power dynamic. The constituency of SUDs plus “sippers” and their relatives is the perfect vehicle for a self-empowering discourse. It has no sociological unity. It has no epidemiological unity. It has no statistical unity other than the tenuous numbers produced by the fact of agglomeration itself. It certainly has no political unity. In other words, it cannot contest the self-empowering claim to represent it because it does not actually exist outside some dubious statistical slapstick. When groups raise questions about the current discourse of recovery advocacy or observe that their experience is not well captured by its framing, they can be ignored or marginalized. They can be dismissed as—for example—grizzled twelve steppers whose understanding is imprisoned by out-of-date dogma.

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“bad doctors are not going to become good doctors because you give them more rules”

I’ve posted before about maintenance medications, like buprenorphine, that are frequently referred to as the gold standard.

I’ve also posted about how there may be a discrepancy between the kinds of outcomes people with opioid addiction are seeking and the outcomes found in the evidence-base for maintenance treatments.

I’ve also pointed out that, while many institutional advocates for maintenance treatments claim that maintenance medications are “highly effective when combined with other behavioral supports,” their own evidence cast doubt on their advocacy.

Ohio has had serious problems with ethically dubious buprenorphine prescribers.

One policy response to these kinds of practices is to require that buprenorphine patients receive counseling. It is consistent with the institutional advocacy mentioned above and constitutes a standard of care that is thought to be incongruent with the practices of a “pill mill.”

Apparently, Ohio already requires counseling for buprenorphine patients and their medical board is considering rule changes to be more prescriptive about the counseling required.

Unfortunately, the article doesn’t say much about the proposed changes. The only relevant proposed changes are these, so I’m assuming they are the proposed rules.

The state business impact analysis offers the following rationale:

The need for regulation is urgent, as there are reports that some prescribers are setting up “pill mills” for specifically approved buprenorphine products, similar to the “pill mills” where prescription opiates such as OxyContin and Vicodin were prescribed for other than legitimate medical purposes (see http://www.nytimes.com/2013/11/17/health/in-demand-in-clinics-and-on-the-street-bupe-can-be-savior-or-menace.html?_r=1&). Recognizing the constellation of factors related to opiate addiction, treatment, and illegal activity, the rules attempt to strike a proper balance between access to opiate addiction treatment and diversion of specifically approved buprenorphine products by setting forth the requirements for treating opiate addiction in a non-institutional setting so that the treatment can be performed in a safe manner for the patient and reduce the risk of unlawful behavior of patients, practitioners, and others.

However, the counseling requirement is getting pushback:

Several doctors have raised issues with the requirement to get counseling, saying it isn’t medically necessary and limits the number of doctors offering MAT and number of patients getting help.

. . .

The Ohio Society of Addiction Medicine has objected to the counseling requirement, citing a 2018 Substance Abuse and Mental Health Services Administration document called Treatment Improvement Protocol 63.

“Four randomized trials found no extra benefit to adding adjunctive counseling to well-conducted medical management visits delivered by the buprenorphine prescriber,” it says.

Gregory Boehm, the Ohio society’s president, wrote the group agrees. “Counseling does not improve outcomes,” he said.

The article addresses some of the issues identified in the rulemaking rationale:

. . . some doctors . . .  in Dayton who are operating cash-only clinics, giving out Suboxone with no other services or referrals to further treatment. For about $200 a client can get a 90-day prescription, which he said they can turn around and sell on the street for $2,000.

And while they paid cash to the doctor for the visit, they may have used Medicaid to fill the prescription, meaning tax money is funding street drug trade . . .

“I understand the State Medical Board of Ohio’s desire to put these doctors out of business,” she said. “The issue is bad doctors are not going to become good doctors because you give them more rules.”

Gold Standard?

All of this should invite questions about why this approach is so frequently referred to as the gold standard.

Bill White, who is an advocate for maintenance treatment, wrote the following in 2010:

As a professional field, we know a great deal about what methadone maintenance treatment can eliminate from the lives of patients, but we know very little from the standpoint of science about what it adds. In fact, we know very little about the stages and styles of long-term medication-assisted recovery.

In the midst of this, we have the FDA and federal agencies lowering the bar by promoting what they refer to as “alternative endpoints” that would make reduced drug use an acceptable endpoint for drug trials.

And, we’ve heard an oft repeated mantra of “maintenance medications reduce overdose deaths by half” for several years. Yet, I’ve pointed out that it doesn’t appear to be that simple–communities and countries that have emphasized harm reduction and maintenance treatments do not seem to be getting spared.

Now, this doesn’t mean that methadone doesn’t reduce death rates. It means that the death rate is still very high.

One observation that might help makes sense of this is the following:

This seems plausible, but I haven’t seen the data. (I’ve requested a source and will share it here, if provided.)

It’s worth mentioning that there is a highly effective treatment model that doesn’t have to be too expensive and might be adapted to other populations. Unfortunately, it does not fit the popular narratives and does not get any attention from the press.

I’ll also throw in a reminder from a previous post about were I stand on maintenance treatments:

Just to be sure that my position is understood. I’m not advocating the abolition of maintenance treatments.

Here’s something I wrote in a previous post: “All I want is a day when addicts are offered recovery oriented treatment of an adequate duration and intensity. I have no problem with drug-assisted treatment being offered. Give the client accurate information and let them choose.”

Another: “Once again, I’d welcome a day when addicts are offered recovery oriented treatment of an adequate duration and intensity and have the opportunity to choose for themselves.”

It’s also worth noting that there is a link between AA and methadone.

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