"Benefits, Limitations, and Value of Abuse-Deterrent Opioids" in JAMA Internal Medicine

Two members of our team - Dr. Gregory Curfman and Professor Leo Beletsky - and friend of PHLW Ameet Sarpatwari have an important new piece out in JAMA Internal Medicine entitled "Benefits, Limitations, and Value of Abuse Deterrent Opioids."  "Abuse deterrent opioids" are formulations of the drugs meant to be tamper-resistant, "intended to make manipulation more difficult or to make abuse of the manipulated product less attractive or less rewarding." Looking at the Institute for Clinical and Economic Review report on Abuse-Deterrent Formulations of Opioids: Effectiveness and Value and adding independent analysis, the authors found that the selective use of abuse deterrent opioids may mitigate opioid abuse and diversion. However, the use may also promote switching to more dangerous opioids (like heroin). Finally, they found no evidence that abuse deterrent opioid use reduces overdose deaths. 

Read the entire article here.

"Graham-Cassidy" Provides Zero Funding to Address the "Opioid Crisis"

By Elisabeth J. Ryan

One of the few positive provisions of the summer’s Senate “health care” bills was the inclusion of funding to states to “support substance use disorder treatment and recovery support services.”  With more than 30,000 people dying from heroin and painkiller overdoses in the United States every year, sufficient funding to address and effectively treat this issue is crucial.  Yet the latest Republican version of the “health care” bill has omitted this funding entirely.

The original Better Care Reconciliation Act included a $2B fund to distribute grants to states for fighting the “opioid crisis” and other substance use disorder issues; the “Cruz amendment” version significantly increased that amount to nearly $45B over nine years.  While even that amount would likely not have been sufficient to cover needs, the increase was hailed as a key provision aimed specifically at some Republican Senators still wavering in their support.  Yet the latest iteration – “Graham-Cassidy” – includes absolutely no such funding.  This glaring omission has received little attention, but it contributes to the bill’s overall potential to actually harm public health.  The bill would also make alarming cuts to Medicaid (which is one of the top insurers for substance use disorder services) and would also allow states to waive the current requirements that insurance companies not only cover substance use disorder treatment but also that they cover it without charging people higher premiums.  One analysis estimates that a person with "drug dependence" could face a premium surcharge of $20,000 per year.  

Without any funding added to the bill to offset those potentially devastating losses, treatment for substance use disorder will become either financially or practically impossible for the millions of people who may need it.  This lack of adequate, evidence-based, available treatment already constitutes a public health crisis - Congress may be poised to make it even worse.  

Briefly: Massachusetts Governor Proposes New Crime of Manslaughter for 'Drug Dealers'

By Elisabeth J. Ryan

Massachusetts Governor Charlie Baker filed legislation yesterday which would, among other things, create a new crime of manslaughter for drug dealers if a person dies from using their drugs.  Specifically, anyone who "manufactures, distributes, or dispenses" any controlled substance would be "strictly liable" if "a death...results from the injection, inhalation, or ingestion of that substance."  The punishment would be a mandatory minimum of 5 years to a maximum of life in state prison.  

The Governor presented this proposal as a new way to fight the opioid epidemic, saying, “[W]e should ensure that those who cause our citizens the most harm by illegally selling drugs that kill people are held accountable for their actions.”  The law, however, doesn’t apply to just opioids; it covers all controlled substances except marijuana. 

Similar laws and prosecutions in Canada and other states have faced significant backlash.

The Wrong Path: Involuntary Treatment and the Opioid Crisis [from The Crime Report]

PHLW's Leo Beletsky and Elisabeth Ryan wrote about the increasing use of "Section 35" commitments in Massachusetts over at The Crime Report.  This law allows people with substance use disorders to be committed involuntarily to a secure facility for up to 90 days.  This is not the way to handle the opioid crisis.

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In May, nine people committed to the Massachusetts Alcohol and Substance Abuse Center in Plymouth briefly walked out from the minimum-security facility. State authorities mounted a manhunt, using helicopters and dogs to apprehend these treatment “patients.”

The episode illustrates a dangerously-blurred line between substance use treatment and prison, based on a statute that allows for involuntary commitment of “alcoholics or substance abusers.”

In this case, the facilities housing criminals and patients were, in fact, one and the same.

The Massachusetts provision—Section 35—allows family members, doctors and police to petition a judge to civilly commit an individual with substance use disorder, where the condition creates a “likelihood of serious harm.”

Across the US, at least 33 states have similar statutes, though their precise parameters and level of deployment vary widely. In Massachusetts, an individual can be ordered to a course of treatment for up to 90 days.

The use of this mechanism has rapidly expanded as the opioid crisis has worsened, used primarily by desperate families seeking to get help for their loved ones.

In some of the over 8,000 Section 35 commitments a year in the state, the mechanism is being invoked by the very individual who is to be committed. This is because many see Section 35 as the only—or the most expedient and cheapest—way to access treatment.

That highlights the perversion of our drug treatment system.

It’s easier to voluntarily submit oneself to “involuntary” treatment, just to receive rapid and free access to assistance. This is despite the fact that the path is through a coercive, criminal justice-based structure, rather than through normal health care navigation channels.

Drug users committed under this provision have committed no crime. Treating them as criminals and depriving them of agency and liberty without adequate justification violates basic constitutional and ethical principles, as recent and previous litigation has posited. To make matters worse, these individuals are now subject to being physically restrained in treatment facilities, raising concerns about possible physical abuse.

The parallel provision in Massachusetts law applying to mental health cases, such as cases of suicide risk, imposes only a three-day commitment and requires authorization from a mental health clinician. In contrast, Section 35 authorizes a person to be held for up to 90 days and considers clinical judgment non-binding.

Further, the rules of evidence do not apply to Section 35 hearings. And, for police and physicians, “committing” individuals through Section 35 recently became easier because a standing order in some courts now allows those petitioners to simply fax the petition rather than appearing in person.

In the meantime, police, family support groups, and others are disseminating information and instructions on how to “section” SUD-affected individuals.

As it turns out, coerced and involuntary treatment is actually less effective in terms of long-term substance use outcomes, and more dangerous in terms of overdose risk.

Mandated evaluation of overdose data in Massachusetts has found that people who were involuntarily committed were more than twice as likely to experience a fatal overdose as those who completed voluntary treatment. (See page 48-49 inthis preliminary analysis.)

Though further research is needed to confirm these findings, there are several possible reasons for this. One is that recovery is much more likely when it is driven by internal motivation, not by coercion or force (i.e. the person must “want to change”).

Second, the state may actually route individuals to less evidence-driven programs on average (e.g. “detox”) than the kind of treatment accessed voluntarily (i.e. outpatient methadone or buprenorphine treatment).

Finally, those receiving care in outpatient settings may also receive services that help address underlying physical or mental health needs, which are often at the root of problematic substance use.

Another important concern is that mechanisms like Section 35 massively shift financial responsibility for substance use treatment from insurers directly to taxpayers. In Massachusetts, care provided under Section 35 has to be paid for by state public health dollars (or criminal justice dollars, depending on the location of commitment). In contrast, care received voluntarily is paid for by health insurers.

This is in addition to the fact that the gold standard for most people with opioid use disorder is outpatient treatment, which does not require “beds.” In other words, taxpayers are left holding the bag for something that is more costly, less effective, and more traumatizing. Misuse of those resources also raises questions about what alternative evidence-based investments could be made with those resources.

Despite these and other weighty concerns, policymakers in Massachusetts and elsewhere have looked to expand the scope of mechanisms like Section 35, because they seem them as a key tool in addressing the opioid crisis. The recent federal announcement of a public health emergency will likely accelerate this trend.

Though involuntary commitment represents an attractively decisive policy option, it is in fact the wrong solution to the crisis.

Across Massachusetts and throughout the U.S., families are desperate for solutions, but increased reliance on Section 35 is not the way to go. Many individuals who are in crisis are unable or unwilling to access help. There are formidable logistical, financial, and other barriers to receiving on-demand treatment and related services.

The way services are currently rendered is also a barrier.

Many users do not want to engage in existing programs because those programs use unproven methods and approach care in ways that traumatizes and denigrates patients. Others may simply not be ready to enter treatment.

Currently, there is no alternative mechanism that would trigger timely assistance and intensive case management of the kind that is necessary to support people in crisis and their families in non-coercive, evidence-driven way.

Any conversation about reducing over-reliance on involuntary commitment provisions like Section 35 must include a discussion of such alternatives.

See also: Leo Beletsky, Law Enforcement, Drugs and the ‘Public Health’ Approach

Leo Beletsky is an Associate Professor of Law and Health Sciences at Northeastern University. He’s on Twitter at @leobeletsky. Elisabeth Ryan is a Legal Fellow at the Center for Health Policy and Law, Northeastern University School of Law. She runs publichealthlawwatch.org, on Twitter at @phlawwatch. They welcome comments from readers.

Law Enforcement, Drugs, and the 'Public Health' Approach [from The Crime Report]

Leo Beletsky, George Consortium founding member and Associate Professor of Law and Health Sciences at Northeastern University School of Law, wrote "Law Enforcement, Drugs, and the 'Public Health' Approach," for The Crime Report in April 2016.  Watch tomorrow for a new piece about the law in Massachusetts that allows individuals with substance use disorders to be involuntarily committed to secure facilities for up to three months.  

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In a recent high-profile speech at the National Prescription Drug Abuse and Heroin Summit in Atlanta, President Barack Obama reaffirmed his Administration’s approach to addiction as a “public health problem, and not just a criminal problem.”

In its various iterations, the adage that “we can’t arrest our way out” of raging opioid overdose and addiction crisis now figures prominently in policy discussions at all levels of government.

This is, a welcome—and overdue—development. Opioid overdose, including deaths resulting from prescription drugs like Oxycontin as well as their chemical cousin heroin, is now killing as many as 80 Americans daily.

The precipitous rise in opioid misuse and overdose has occurred despite extraordinary financial and human investments in drug law enforcement, mass incarceration for drug-related crimes, and other criminal justice approaches. But the emerging rhetoric that an alternative, “public health” approach is necessary to curb the opioid crisis has yielded few actionable specifics for those on its front lines—police and other law enforcement officers.

As often happens, innovation has come from the bottom up.

One of the most widespread initiatives has been to equip police officers with the overdose antidote naloxone. First introduced as a tool for law enforcement in New Mexico in 2004, it has recently expanded to police forces across the country, on the principle that police are often the first to arrive at the scene of an overdose. (This is especially true in rural locales and other settings like tribal areas, where emergency medical service response times can be substantially longer than those of law enforcement personnel.)

Nationwide, law enforcement officers outnumber medical first responders by approximately a factor of three. Several hundred police agencies have now trained and equipped officers to resuscitate overdose victims, reversing over one thousand overdose events.

Aside from this direct role in rescue operations, law enforcement can also contribute to overdose prevention through other activities. These could include disseminating information about signs and symptoms of overdose, advice on accessing naloxone, promoting Good Samaritan (criminal amnesty for overdose victims and witnesses who call for help) policies, and referral to available addiction treatment programs.

A growing number of departments are embracing these kinds of outreach activities. For instance, Boston PD has recently formed an Opioid Response Unit, which provides education and resources to overdose victims and their families.

Another effort introduced in Gloucester, MA offers amnesty to anyone who presents at the police station seeking help to access substance use treatment. The so-called “Gloucester Angel Initiative” program has helped to launch a national movement: More than two dozen police departments have adopted similar policies, and recently formed The Police Assisted Addiction and Recovery Initiative (PAARI).

Finally, Law Enforcement Assisted Diversion (LEAD) programs offer a structure for pre-arrest diversion available to drug users and other non-violent offenders. First introduced in Seattle, LEAD provides access to a broad range of housing, job training, and other social services.

These efforts can offer unique benefits. Police professionals often have close interaction with hard-to-reach groups that are most at risk for substance abuse and overdose. They also promote operational collaboration with public health agencies, resulting in improved information sharing and other synergies.

In addition to direct public health benefits, police overdose response, public education, and referral programs can help both police agencies and the communities they serve.

A closer understanding of drug misuse, its root causes, and evidence-based prevention and treatment tools can empower criminal justice professionals and institutions to achieve better results. At the same time, a shift in police attitudes towards addiction can increase trust and communication with drug users and their families, as well as in the community at large. At a time of serious challenges to community-police relations, reaffirming law enforcement’s dedication to public wellbeing can strengthen collaboration with civil society, promote officer job satisfaction, and ultimately help police in their core public safety mission.

But a number of challenges remain before the “public health approach” rhetoric can be translated into evidence-based policing practice.

With the exception of Seattle’s LEAD program, the impact of these public health-oriented policing initiatives remains unclear. As we struggle to contain this crisis, their rapid dissemination has proceeded organically in the near-absence of robust evaluation that could inform their design and tailoring.

For example, it is not clear whether training and equipping police to conduct overdose rescues is equally cost-effective in urban areas already well-served by professional medical response, as it is in rural or tribal locales where medical first responders arrive with substantial delay.

While these innovations have certainly expanded the traditional law enforcement toolkit, they have yet to challenge our reliance on the more traditional drug law enforcement. Conducting interrogations at the scene of an overdose, using prescription drug monitoring data for investigative purposes, and charging small-time dealers with homicide for supplying drugs to overdose victims may be perceived by law enforcement officers as deterrents to substance misuse.

Unfortunately, rather than promoting public health, these actions can inadvertently fuel the very problems they seek to address.

Treating every overdose event as a crime scene and charging overdose witnesses with drug-induced homicide can deter help-seeking during overdose emergencies. Using prescription drug data to identify and prosecute patients can undermine trust between people with substance use problems and their providers, pushing vulnerable patients away from getting help at a time when they need it most.

At the policy level, proposals for higher-intensity enforcement measures and a renewed focus on legislation extending drug trafficking sentences run at cross purposes to 911 Good Samaritan laws and other amnesty measures.

To be clear, we do need accurate and timely information about dangerous street drugs and prescription drug patterns. But the work of gathering and applying this information must be done with a clear vision for the life-saving goal in our effort to mount an effective response to the opioid crisis. We must acknowledge what we have learned by now from experience: that wielding the stick of criminal justice against street-level drug use does little to stem it, while also driving users underground, away from helping hands.

To make a real impact in curbing the current crisis, police agencies can benefit most from evidence-driven guidance to translate the “public health” approach heralded by policymakers and community leaders into street-level operations. This is the real opportunity before us for shared innovation and exchange.

Leo Beletsky is an Associate Professor of Law and Health Sciences at Northeastern University. He’s on Twitter at @leobeletsky