12.2.1 Drug Court Staff Beliefs Regarding Treatment for Substance Use Disorder

Drug courts typically do not provide treatment directly, but rather set treatment policies, establish relationships with community substance use disorder (SUD) treatment providers to whom they refer clients, and monitor treatment adherence. Participant noncompliance with drug court policies can result in program expulsion and incarceration. Drug courts are operated by teams headed by a judge.Footnote ¹³ Court teams may also include a program coordinator, court case manager, prosecutor, probation/parole officer, law enforcement official, counselor, and clinical case manager.Footnote ¹⁴ Most team members lack medical training, most teams lack physicians, and counselors and clinical case managers engaged on treatment teams typically are employed by a partnering health care organization, and not the court. To date, little is known about how drug court teams set treatment policies, especially with respect to opioid use disorder (OUD) treatment.

The gold standard of care for OUD is MOUD with methadone, buprenorphine, or naltrexone.Footnote ¹⁵ Methadone and buprenorphine (including but not limited to Suboxone) are opioid agonists that activate the brain’s mu opioid receptors, decreasing opioid cravings and preventing painful withdrawal symptoms. Agonist treatment is associated with as much as a 50 percent decrease in mortality from overdose.Footnote ¹⁶ In contrast, naltrexone is a non-opioid antagonist that blocks opioids from activating the brain’s mu opioid receptors. Vivitrol, approved for OUD treatment in 2010, is an intramuscular injectable extended-release version of naltrexone that is more effective than a placebo at preventing return to drug use, including for criminal justice system participants.Footnote ¹⁷

While few studies to date have directly compared the efficacy of buprenorphine or methadone to Vivitrol, buprenorphine and methadone appear more effective at preventing overdose deaths, do not necessitate complete detoxification, and are more cost-effective.Footnote ¹⁸ Additionally, Vivitrol is harder to start because it requires complete detoxification from opioids.Footnote ¹⁹ According to one randomized controlled comparative study, it was harder to initiate patients onto Vivitrol than oral buprenorphine, creating a relatively higher rate of return to drug use for patients randomized to Vivitrol as compared to oral buprenorphine; however, patients who successfully initiated onto Vivitrol had comparable rates of return to drug use as those on oral buprenorphine.Footnote ²⁰ Therefore, patients may need detoxification support and/or high motivation levels to successfully start Vivitrol.Footnote ²¹ Two more recent studies found that agonists were more protective against opioid overdose than Vivitrol.Footnote ²² Lastly, at approximately $1,300 per thirty-day dose, Vivitrol is significantly more expensive, and far less cost-effective, than other OUD medications.Footnote ²³

Unfortunately, drug court OUD treatment policies may run contrary to best practices. A 2013 study found that up to 50 percent of adult drug courts prohibit methadone and buprenorphine; and a 2021 study found that judges are more likely to have favourable policies toward Vivitrol as compared to buprenorphine or methadone.Footnote ²⁴ The substance and accuracy of court teams’ treatment policies relate to program member beliefs about treatment safety, efficacy, and diversion potential.Footnote ²⁵ Compared to agonist treatments, court staff appear to have relatively more positive beliefs about Vivitrol,Footnote ²⁶ despite emerging data suggesting that agonist treatments are comparatively more effective at preventing overdose death.Footnote ²⁷

Device and pharmaceutical manufacturers (Industry) may directly inform court staff beliefs about MOUD. From 2010 to 2017, as the opioid epidemic exploded, few OUD treatment education options were available to courts beyond industry representatives.Footnote ²⁸ Media articles,Footnote ²⁹ a qualitative study of Indiana courts,Footnote ³⁰ and a quantitative study of Florida courtsFootnote ³¹ suggest that many court staff receive information about OUD treatments directly from pharmaceutical companies, especially Alkermes. For example, in a convenience sample of 121 Florida court staff, 36 percent reported receiving training from Alkermes, 24 percent from a buprenorphine manufacturer, and 11 percent from a methadone manufacturer. Among those who received training from a medication manufacturer, 55 percent received training from at least two companies. Another recent study found that, after controlling for opioid overdose deaths in an area, drug courts’ location was significantly and positively associated with pharmaceutical payments to physicians for MOUD (tracked under sunshine laws),Footnote ³² suggesting that pharmaceutical companies may target physicians in areas where they know drug courts make referrals.

Some court staff’s understanding of substance use may reflect cultural and personal perspectives about addiction, “viewing it as moral weakness that call[s] for tough paternalism.”Footnote ³³ According to Andraka-Christou, judges have differing conceptions of sobriety, from living life without any substances (including medications) to living life without misusing substances.Footnote ³⁴ Some court staff view agonists merely as “trading one drug for another” or “not really quitting.”Footnote ³⁵ Court staff beliefs about MOUD may also reflect beliefs and practices of the treatment providers with whom they collaborate, with one study of a convenience sample of court staff finding that half felt their collaborating provider did not encourage agonist MOUD.Footnote ³⁶

Despite the effectiveness of agonist MOUD at decreasing overdose death and return to drug use, several studies have documented hostile court staff attitudes towards agonist treatment,Footnote ³⁷ particularly methadone,Footnote ³⁸ due to its perceived diversion and misuse potential, distrust of methadone providers (often located in high-crime areas), and misunderstandings about medication safety and efficacy.Footnote ³⁹ Court staff view buprenorphine slightly more favorably, but may require or strongly encourage clients to transition off upon entering the programFootnote ⁴⁰ despite medical studies indicating that longer-term buprenorphine use is more effective than shorter-term use.Footnote ⁴¹ As with methadone, court staff appear to distrust providers and worry about potential client misuse or diversion of buprenorphine.Footnote ⁴² One Ohio drug court judge stated, “the Suboxone zombies aren’t getting better … The people who want the Vivitrol are the ones who want to get healthy and get better.”Footnote ⁴³

Court staff have more favorable beliefs about Vivitrol because it cannot be misused or diverted and lacks an opioid ingredient.Footnote ⁴⁴ Judges are critical of its cost, however, even though clients can get free samples or discounts through state-funded programs or Alkermes. One judge stated, “we work really closely with the drug rep from Alkermes … and they ‘ve been very supportive in finding us, giving us discounts for some of our people, even providing a month or two of free doses.”Footnote ⁴⁵

12.2.2 Examples of Direct-to-Court Marketing: the Bridge and Vivitrol

Medical device manufacturers market their products directly to drug courts. The National Association of Drug Court Professionals (NADCP) is the primary standard-setting organization for adult drug courts, and heavily influences court staff education. Innovative Health Solutions, the manufacturers of the Bridge, have been a regular presence promoting their product as an adjunct to Vivitrol-based treatment at the NADCP national conference. Even though the device received FDA approval, that status rested solely upon a heavily criticized study that lacked a control group, reported no dropout rate, and lacked IRB oversight. IHS also marketed the Bridge as early as 2016, over a year before receiving FDA approval, engaging in off-label promotion and violating FDA regulations.Footnote ⁴⁶

As compared to other MOUD manufacturers, Alkermes is most widely known for engaging and “educating” drug court judges. Alkermes initially found that conventional marketing practices were ineffective for VivitrolFootnote ⁴⁷ and began to cultivate new markets by reaching out to criminal justice officials, drug court judges, and professional associations.Footnote ⁴⁸ In 2014, Alkermes paid $50,000 to become a “champion” sponsor of the NADCP.Footnote ⁴⁹ Alkermes also detailed its strategic targeting of drug court judges and criminal justice institutions at a 2016 analyst and investor event,Footnote ⁵⁰ where CEO Richard Pops described “priming” state “ecosystems” to shape and penetrate markets by aligning messaging to court staff opinions.Footnote ⁵¹ Alkermes’ “road map for future growth” included both a “traditional commercial approach (MD, patient, payer)” and “generat[ing] organic conversations among [a] broad range of stakeholders (criminal justice, policy, caregivers, etc.)”Footnote ⁵² These strategies directly positioned Vivitrol as a novel and superior drug; Alkermes’ Vice President of Marketing described “stimulat[ing] organic conversations about ‘deserving to know all options’ and the potential to end dependence on opioids.”Footnote ⁵³

12.3.1 Applying a Conflict-of-Interest Framework

A conflict-of-interest (COI) framework can structure our understanding of relationships between industry and drug court treatment teams, especially since, as shown above, we know: 1) industry representatives already serve either as significant sponsors or appear as vendors at drug court conferences, and 2) industry has been engaged in court team members education and detailing.

As described by Stark,Footnote ⁶⁷ whose work examined COI as it applied to public officials, and has since been applied to health professionals,Footnote ⁶⁸ motivated bias is a process (FN69), and COIs are broken down into three behavioral stages.Footnote ⁶⁹ First, antecedent acts prepare the target of influence’s state of mind for partiality or bias, making the target more likely to exercise responsibility for private or personal interests instead of the interests of the public (or patient/program enrolee).Footnote ⁷⁰ Second, antecedent acts influence the target towards certain perspectives, biases, or affinities.Footnote ⁷¹ Third, the target behaves in ways influenced by antecedent factors.Footnote ⁷² Industry interactions with court team members are, at minimum, antecedent acts toward more favorable arrangements for the industry (in this case prioritizing one MOUD in court treatment referrals or in court policies).

Stark also distinguishes external influences from internal convictions, differentiating between an internal “genuinely subjective belief or commitment” that might become “an encumbrance when its proximate cause lies without, in the importunings of a litigant, the ministrations of a lobbyist or the pressure of a campaign contributor.”Footnote ⁷³ For example, lobbying is an external attempt to “mobilize the bias,” or “strengthen the commitment members have to an already established position on a given question.”Footnote ⁷⁴ Internal convictions are difficult or impossible to disclose and divest; there is no disclosure form, and disclosure itself only suggests “an irremediable capacity to make an unencumbered decision.”Footnote ⁷⁵ Someone who discloses beliefs might “develop an encumbering interest” in maintaining them.Footnote ⁷⁶

12.3.2 Judges as Moral Entrepreneurs

Sociologist Howard Becker coined the term “moral entrepreneurs” to describe individuals in power who work to construct systems that reinforce their beliefs about deviancy (often through criminalization).Footnote ⁷⁷ For example, a moral entrepreneur who believes that all people who use medications with misuse potential are morally deviant would punish and/or exclude people who utilize these products and develop systems that prioritize the use of medications/devices without misuse potential.

For years, judges and drug court treatment teams have been forging ahead in the opioid epidemic, handling massive increases in the proportion of clients with opioid use disorder, including treatment referrals, without much organized guidance. More research must be conducted on the mechanics underlying the selection of treatment providers for drug court teams. That said, our research has found that program managers, as well as judges, are receiving education from industry representatives.Footnote ⁷⁸

According to Stark, “in law, business, and medicine, the professional (lawyer, manager, doctor) is thought to have fiduciary or ‘role-moral’ obligations … to pursue and protect certain interests possessed by a defined, identifiable set of principles: clients, shareholders, patients.”Footnote ⁷⁹ Because drug courts are structured to facilitate opportunities for program enrolees (clients) to access treatment services that effectively address their SUD and help them avoid incarceration and recidivism, judges and treatment team members, as the creators and managers of these systems of care, are charged with the role-moral obligation to act in clients’ best interests. This section focuses explicitly on drug court judges because, in the unique setting of the drug court, they lead teams that select and engage treatment providers, are fiduciaries, and must adhere to ethics codes. Even if a manufacturer communicates directly with other team members, such as court program coordinators, judges will have the final say about court policies.

Industry education from antagonist manufacturers and device companies position their products as morally superior to agonist treatments. In this way, antagonist manufacturers motivate bias against the moral entrepreneur – in this case, the judge – and their existing negative beliefs regarding opioids.

Some external standards exist to determine clients’ best interests as to MOUD, including medical standards of care or best practices and professional guidance.Footnote ⁸⁰

A judge who supports recovery should follow medical standards for recovery support, rather than engage as moral entrepreneurs. Narrowing treatment options to Vivitrol and/or the Bridge ignores patients for whom these interventions are contraindicated, including pregnant women. Because Vivitrol is costlier, requires detoxification, and is less protective against overdose, judges preferencing Vivitrol in their systems also create a more difficult recovery road for court clients with limited financial means. As the former head of SAMHSA’s Center for Substance Abuse Treatment commented, “what we continue to have is a political philosophy colliding with therapeutic strategies, and that political philosophy has less to do with the individual and more to do with moral views about drug abuse.”Footnote ⁸¹

Because of the unique nature of the relationship between courts and MOUD manufacturers, it would be difficult to regulate these decisions based upon extant judicial conduct rules. American Bar Association Model Code of Judicial Conduct Rule 2.2 requires judges to “uphold the law” when deciding cases; an accompanying comment states, “[a]lthough each judge comes to the bench with a unique background and personal philosophy, a judge must interpret and interpret the law without regard to whether the judge approves or disapproves or the law in question.” Yet, there is no law compelling judges to use the highest and best scientific and medical evidence in judicial decision making. In fact, one might argue that this is not the type of “decision making” the model code envisaged.