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.