COVID Law Briefing: Protecting the Vulnerable Substance Use Disorder Population During COVID-19- Summary

Earlier this year, Public Health Law Watch, in collaboration with members of the George Consortium and other partner organizations, hosted a series of legal briefings related to COVID-19 and legal and policy issues associated with the global pandemic. Experts and scholars joined us for bi-weekly livestreamed discussions on these issues. We invite you to read the summaries of selected episodes below! And, enjoy relistening to the series (linked below and archived on our #COVIDLawBriefing webpage).

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4/9/20: Protecting the Vulnerable Substance Use Disorder Population During COVID-19

Mod: Leo Beletsky 

Speaker: Nicolas Terry 

Professor Beletsky moderated a discussion with Professor Terry on protecting the vulnerable substance use disorder (sud) population on this #COVIDLawBriefing. The panelists get into the nuances of substance use disorder that makes it unique from any other illness. Most obviously, you can get arrested for sud. What people may not know is how important privacy is to this population. As the professors pointed out, you can lose employment, or even your children, if you are part of the sud population. This means that loosening privacy rights is a huge concern. Before COVID-19 hit, people were already not getting adequate treatment due to both lack of healthcare and the huge stigma that still surrounds this disorder. Next the discussion pivoted to how COVID-19 has exposed our public health system for not protecting its most vulnerable populations including the “disproportionate deaths in black and brown communities.” Especially with some states not participating in the recent expansion of Medicaid, many front line people from health care providers to delivery drivers have been left without health insurance. The Cares Act has also left the sud population more vulnerable to their personal information getting out. For health care operations, disclosures go to non-patient care functions which means that many more people will have access to personal information. This will be especially problematic in more rural areas where communities are smaller and the leaking of personal information could have a negative impact on many aspects of a person's life. They finished with a discussion of how the healthcare delivery systems have been “more creative” as a result of this crisis. This has been especially true in the expanded use of telehealth for a variety of issues including mental health. The professors hoped to see some of these advances that have come as a result of COVID-19 continue once this has passed. To learn more about this issue check out the rest of this law briefing here. 

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Public Health Law Watch’s COVID Law Briefings are co-sponsored by the Center for Health Policy and Law at Northeastern University School of Law, the Center for Public Health Law Research at Temple University Beasley School of Law, the Network for Public Health Law, and the APHA Law Section.

2020 Presidential Candidates: Policies for Addressing the Opioid Overdose Crisis.

This post is first in a series aimed at identifying and exploring some of the public health issues and policies under consideration by candidates in the 2020 Presidential Election.

The goal of this series is to provide a deeper look at the ways in which candidates may or may not be including a public health framework in their healthcare reform policies, and encourage candidates to thoughtfully and purposefully develop nuanced, evidence-based, impactful policies. We also hope to inform the public as they continue to evaluate each candidate’s efforts to articulate plans that address healthcare and public health challenges in the U.S. Our goal is not endorse a particular candidate or political party; rather, our goal, as always, is to research, analyze, inform, and equip people with the knowledge they need to be engaged and thoughtful members of their communities and this nation.

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Each day, over 130 people die from opioid-related overdoses. This includes both prescription and illicit opioids. The National Institute on Drug Abuse attributes the opioid overdose crisis to unscrupulous pharmaceutical companies, who misled healthcare providers to believe opioid pain relievers were not addictive. Other researchers, while agreeing that increased drug supply was an important factor, argue that economic and social issues fueled the crisis, viewing the issue through the lens of a structural and social determinants of health framework.   

Public health experts and practitioners are increasingly pursuing support for and implementation of evidence-based harm reduction policies and programs to reduce harmful outcomes related to substance use disorders (SUD) and opioid use disorders (OUD). Our colleagues at the Health in Justice Action Lab (HIJAL) have identified a series of proven hard reduction programs. Below we offer a description for a few such programs and identify which of the 2020 Democratic Presidential Candidates support each program:

• Safe injection facilities

• Buprenorphine deregulation

• Increased access to SUD treatment in prisons and jails

• Decriminalization of opiates for personal use

Safe injection facilities

Safe injection facilities, also known as supervised consumption services (SCS), are legal facilities in which people can bring in and consume illicit drugs under the supervision of trained staff. The facilities provide clients with sterile injection supplies and a safe place to consume drugs, as staff members monitor for overdose and provide first aid as needed. Additionally, staff members are available to provide clients with referrals to drug treatment and other support programs. Although many studies have identified myriad public health benefits of safe injection sites, they remain controversial. Safe injection sites exist around the world, but due to legal issues (and specifically the Controlled Substance Act), not yet in the United States. However, that may be changing soon; a federal judge recently ruled that the Controlled Substance Act does not apply to Safehouse, a Philadelphia group seeking to open a safe injection facility

Candidates who have expressed support for safe injection facilities:

• Pete Buttigieg

• Bernie Sanders

• Elizabeth Warren

• Andrew Yang

Buprenorphine deregulation

Buprenorphine is an opioid partial agonist used in treating opioid use disorder (OUD). Under the Drug Addiction Treatment Act of 2000, prescribers must complete an approved training, attest to their referral capacity, and submit an application to SAMHSA in order to receive what is known as an “X-waiver.” As noted by Kevin Fiscella et al, “X-waivered prescribers face heightened scrutiny by federal and state law enforcement officials, including periodic audits that are intended to minimize diversion and misuse.” Fiscella articulates four reasons for deregulating buprenorphine:

“First, buprenorphine’s comparative safety undermines a critical rationale for regulation. Buprenorphine, regardless of prescribing intent, is safer than commonly prescribed full-opioid agonists.

Second, deregulation would improve access to buprenorphine during the opioid national emergency. Despite promotion and training initiatives by SAMHSA and legislation that has expanded patient limits and waivers to nurse practitioners and physician assistants, access to buprenorphine has not kept pace with the current epidemic, particularly in rural communities.

Third, buprenorphine regulation is premised on the faulty assumption that buprenorphine diversion is driven by a desire to “get high.” Yet, buprenorphine obtained illicitly is mostly used for self-medication to relieve withdrawal symptoms rather than for euphoria… This suggests that regulations constraining access to buprenorphine may paradoxically contribute to a market for illicit buprenorphine among those who seek treatment.

Lastly, deregulation could help integrate opioid disorder treatment into primary care. Regulations reinforce the stigma surrounding buprenorphine prescribers and patients who receive it while constraining access and discouraging patient engagement and retention in treatment.”

Candidates who have expressed support for buprenorphine deregulation:

• Michael Bloomberg

• Pete Buttigieg

• Amy Klobuchar

• Bernie Sanders

• Andrew Yang

Increased access to SUD treatment in prisons and jails

A federal report found that 58% of people in prison and 63% of people in jail suffer from drug use disorders (SUD) based on criteria from the Diagnostic and Statistical Manual of Mental Disorders. However, only 28% of people in prison who met this criteria and 22% of people in jail participated in any type of SUD treatment.

Candidates who have expressed support for increased access to SUD treatment in prisons and jails:

• Joe Biden

• Mike Bloomberg

• Pete Buttigieg

• Tulsi Gabbard

• Amy Klobuchar

• Bernie Sanders

• Elizabeth Warren

Decriminalization of opiates for personal use

Some advocates have proposed decriminalization as a measure to improve public health. The Drug Policy Alliance lists several benefits of decriminalization on their website:

 “Removing criminal penalties for drug possession and low-level sales would:

• Save money by reducing prison and especially jail costs and population size

• Free up law enforcement resources to be used in more appropriate ways

• Prioritize health and safety over punishment for people who use drugs

• Reduce the stigma associated with drug use so that problematic drug users are encouraged to come out of the shadows and seek treatment and other support

• Remove barriers to evidence-based harm reduction practices such as drug checking, heroin-assisted treatment, and medical marijuana.”

Candidates who have expressed support for decriminalization of opiates for personal use:

• Pete Buttigieg

• Andrew Yang

On Ending Physician Health Program Bans on Opioid-Agonist Therapy

By Nadia Halder

When thinking about the opioid crisis, the typical narrative is a patient who may have developed an opioid use disorder (OUD) after being prescribed medication for a shoulder surgery, or perhaps someone who is struggling with socioeconomic stress and turns to opioids as a way to cope. These stories are important, and we must know them in order to fight the ongoing crisis. However, we must also remember that the opioid epidemic spans all demographics and professions, including the health care professionals who are tasked with treating OUD patients.

“Practicing What We Preach – Ending Physician Health Program Bans on Opioid-Agonist Therapy”, written by Leo Beletsky, Sarah E. Wakeman, and Kevin Fiscella, opens with the report of two nurses found dead from opioid overdoses in hospital bathrooms, occurring at the same hospital just 16 months apart. The number of deaths due to opioid use disorder and overdose among health care professionals is unknown precisely because of lack of oversight on the issue.

While opioid-agonist therapy is a standard treatment for OUD and is very successful in reducing the risks of overdose, death, and relapse, it is greatly underutilized due to stigmatization of the nature of the treatment. Physicians have been pushing the increased usage of opioid-agonist therapy as a way to combat the increasing epidemic, and despite their work in destigmatizing the practice, practitioners themselves often remain barred from receiving this treatment.

When a practitioner self-identifies or is identified as having an opioid-use disorder, they are often required to enroll in a state-level physician health program (PHP). These programs push abstinence-based models of treatment “as a condition of maintaining professional licensure.” Due to the nature of a physician’s work, there are very rare exceptions to this rule, thus implying “a blanket ban on opioid-agonist therapy.”

In 1973, the American Medical Association endorsed the state-run model, and all but three states (California, Nebraska, and Wisconsin) have adopted PHPs. This model encourages early detection and diagnosis with “abstinence-oriented residential treatment for 60 to 90 days, followed by random urine toxicology screening for roughly 5 years.”

There are two reasons for restricting opioid-agonist therapy in physician health programs. The first is that physicians are viewed as exceptional individuals whose rigorous routines and intrinsic motivation to practice their professions yield significantly higher success rates in abstinence only-programs. Long-term monitoring and the threat of sanction also contribute to these supposed success rates. However, due to the uncertainty around the number of physicians with OUD and a lack of studies that carefully scrutinize the physician health programs, no conclusions can be drawn. Even when the existing data from these programs is analyzed, it shows that 25% of physicians are unsuccessful in their recovery.

Secondly, the ban against opioid-agonist therapy relies on concerns about impairment. However, the authors write that “available evidence doesn’t show that people receiving opioid-agonist therapy show meaningful differences in performance as compared with those receiving nonmedication treatment for OUD.” The logic that opioid-agonist therapy impairs an individual more than abstinence-only treatment ignores the notion that medications for other conditions may also have neurocognitive effects. In fact, there is a growing body of evidence showing that factors such as fatigue, stress, and sleep deprivation lead to physician impairment and patient harm. These stressors, combined with the readily available access to psychoactive substances, lead to an elevated risk of substance use disorder among physicians. Those who oppose opioid-agonist therapy for physicians place more importance on regulating the type of treatment rather than fixing the underlying factors that may cause an individual to develop OUD.

Restricting opioid-agonist therapy for physicians cements the stigma that they have been working so hard to fight. It creates a narrative that this treatment is not worthy of health care practitioners, and those who seek opioid-agonist therapy cannot be trusted with their profession. The article closes with the authors calling on the health care sector to “practice what it preaches by discarding this antiquated norm in all its policy and practice variants.”

Nadia is a fourth year student studying chemical engineering and global health at Northeastern University. She is interested in health policy and law, and she recently spent a month in South America studying various public health care systems. She is an intern at PHLW.

Opioid litigation updates

Opioid Multi-District Litigation (MDL)

Over 1,500 federal court cases have been consolidated into the opiate multi-district litigation in the Northern District of Ohio. Cities, counties, tribes, hospitals, and others are suing opioid makers and distributors in the MDL overseen by Judge Dan Aaron Polster. During the MDL’s first hearing in January 2018, Judge Polster said he wanted a settlement within a year. The bellwether cases, Cuyahoga County, Ohio v. Purdue Pharma and Summit County, Ohio v. Purdue Pharma are slated to begin trial on October 21, 2019.

State Lawsuits

At least 39 states have filed lawsuits against Purdue Pharma, seeking to hold them responsible for their role in the opioid addiction and overdose crisis. A few notable cases:

• Oklahoma

  • In March 2019, Purdue Pharma settled its case with Oklahoma for $270 million. According to the settlement, $102.5 million will go to establish a national addiction treatment and research center at Oklahoma State University, with an additional $15 million per year for five years; $20 million will go to addiction treatment and overdose reversal medications; $12.5 million will go to help cities and counties with the opioid crisis.

  • On May 26, 2019, Teva announced a settlement with Oklahoma for $85 million.

  • On May 28, 2019, the nation’s first opioid trial began, as Oklahoma lawyers accused Johnson & Johnson of oversupplying its drugs and misrepresenting the safety of opioids.

• North Dakota

  • On May 10, 2019, a district judge dismissed North Dakota’s suit against Purdue Pharma, reasoning the company does not have control over the drug after it enters the market. The state has said they will appeal the dismissal.

PHLW files amicus brief in opiate MDL

By Faith Khalik, Legal Fellow at Public Health Law Watch at Northeastern Univ. School of Law

On May 3, 2019, Public Health Law Watch and six other amici filed an amicus brief in the national prescription opiate litigation in the northern district of Ohio.

During the case’s first hearing in January 2018, Judge Dan Aaron Polster told lawyers that he expected to see a settlement that would reduce the adverse public health impact of the opioid crisis, instead of just “moving money around.” The amicus brief submitted by PHLW et al. proposes just that: a settlement that includes a framework for addressing the opioid crisis and has a meaningful positive impact on public health.

Specifically, the brief proposes the creation of a nonprofit foundation to monitor the settlement’s implementation, participate in development and implementation of evidence-based programmatic initiatives, and administer funding for local treatment and prevention resources.

Amici believe that establishing such a foundation would result in better public health outcomes, as it would ensure that settlement funds go directly toward public health interventions and related initiatives, rather than being redirected toward non-health related priorities the plaintiffs may have. This was an important lesson learned from the 1998 tobacco Master Settlement Agreement (MSA). As discussed in the amicus brief, one of the major failings of the MSA was the fact that it mostly moved money from the defendants to the plaintiffs without any requirement for the funds to address public health issues resulting from tobacco use. Although the plaintiffs in the MSA initially stated their intent was to use the settlement funds for public health purposes, other budgetary needs competed for priority and won; in 2019, states will collect over $27 billion from MSA proceeds and tobacco taxes but allocate only 2.4% of that income to tobacco prevention and related efforts.

Despite this gap in the settlement’s design, the foundation created by the MSA (truth initiative, formerly American Legacy Foundation) is regarded as a public health success. Researchers have concluded that truth’s counter-marketing campaign accounted for a significant decline in youth smoking prevalence.

Based on combined decades of research, subject-matter expertise, and lessons learned from the MSA, amici proffer an outline for a similarly-structured foundation to combat the opioid crisis.

It could be argued that due to differences between tobacco and opioids, a specialized foundation is even more necessary for the opiate litigation than it was for the MSA. Differences include that a) tobacco use is always harmful, while opioid use constitutes an important health care tool; b) the harms from tobacco were caused mainly by defendant’s own products, while there is a large, uncontrolled market for illicit opioids; c) price increases in tobacco directly increased costs to individual users, reducing consumption, while price increases in opioids would likely increase costs to insurance companies, plaintiffs, and the federal government. Because of these differences, a more nuanced approach is necessary in this case.

To remediate the crisis, any approach must factor in four issues. First, it must improve access to evidence-based addiction and overdose treatment, including medication-assisted treatment and overdose reversal drugs. Second, it must improve access to effective pain management. Third, it must address the root causes of substance use and overdose, and refer back to them when constructing and implementing its plan. Finally, it should publicize defendants’ internal documents. The approach should allow for adaptability as further evidence on approach efficacy accumulates.

Poorly calibrated responses that have slashed access to prescription opioids have in some cases exacerbated the problem they were attempting to fix. A nonprofit foundation developed and led by those with public health expertise, specifically opioid use disorder expertise, would be best positioned to navigate these and other issues.

 (Amici include The Center for Public Health Law Research at Temple University, ChangeLab Solutions, Health in Justice Action Lab, The Network for Public Health Law, Northeastern University’s Center for Health Policy and Law, and The Public Health Advocacy Institute)

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Faith is the Legal Fellow responsible for overseeing the Public Health Law Watch, a collaborative initiative between the Center for Health Policy and Law and the George Consortium, a network of academics, scholars, and practitioners in the field of public health law. 

Philadelphia’s City Council could have fought opioids by placing limits on pharma reps

By Robert I. Field, Ph.D., J.D., M.P.H.

Does the over-prescribing of opioids lie at the heart of the addiction crisis? Some members of Philadelphia City Council along with many public health experts think so. The Philadelphia City Council recently considered a bill to limit the activities of pharmaceutical sales representatives, also known as detailers, who promote prescription drugs to physicians.

The bill would have required detailers to register with the city for a fee of up to $250, wear identification badges, refrain from giving even small gifts like free lunches to doctors and their staffs, and submit the sales materials they use to the city for review.

Philadelphia is fertile ground for selling pharmaceuticals. It is home to several major academic health systems and physician organizations, and the region contains the headquarters of numerous pharmaceutical and biotechnology companies. It also plays host to a large number of medical conventions that generate business for local restaurants and hotels. Opponents of the bill warned it would have encouraged convention sponsors to look elsewhere, driving away the industry, and the jobs and tax revenue that go with it.

In the end, opponents carried the day, and the bill was defeated by a vote of 9-5.

Would the bill have worked? Recent research suggests that it could have.

A study published in 2017 by researchers at UCLA and Carnegie Mellon examined the effects of limits on drug detailing at 19 academic medical centers around the country. It found that the restrictions resulted in fewer prescriptions for brand-name drugs that detailers promoted. The reduction in prescriptions was modest, but clear.

There is every reason to believe that the proposed limits in Philadelphia would have had a similar effect. And fewer patients receiving prescriptions for opioids could have led to fewer becoming addicted. For a plague as serious as opioid addition, even a small reduction in the number of new victims would prevent a tremendous amount of human suffering, not to mention medical and law enforcement costs that go with it.

With the bill’s defeat, Philadelphia’s risk of losing convention business has faded. At the same time, the opioid epidemic continues unabated. The City is left to wonder which threat is the greatest.

This blog post first appeared in the Health Cents blog on Philly.com.

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About the author: Robert I. Field is a member of the Inquirer’s Health Advisory Panel, and nationally known expert in health care regulation and its role in implementing public policy. He holds a joint appointment as professor of law at the School of Law and professor of health management and policy at the School of Public Health at Drexel University.

Reports on the Opioid Crisis are Full of Misidentified Problems and Poorly Calibrated Solutions [from Bill of Health]

In April, our Center for Health Policy and Law hosted a two-day conference entitled "Diseases of Despair: The Role of Policy and Law." Our friends at Harvard Law School's Petrie-Flom Center is now hosting a blog symposium from that conference on Bill of Health. 

The third piece is from Professor Nicolas P. Terry.  For the full post, please visit Bill of Health.  

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The epidemic associated with Opioid Use Disorder (OUD) has birthed a proliferation of reports, many with notable provenance. They include the Surgeon General’s Report(2016), the President’s Commission on Combating Drug Addiction and the Opioid Crisis(2017),  and the National Governors Association Recommendations for Federal Action to End the Nation’s Opioid Crisis (2018). We can add innumerable regional and statereports to that list.

Placed next to each other, their recommendations are broadly similar. While they may differ somewhat to the extent that they emphasize criminalization versus medicalization, overall, they tend to coalesce around harm reduction (such as broad naloxone availability and syringe exchanges), upstream opioid reduction strategies (such as prescription limits and prescription drug monitoring programs), and increased public health surveillance based on improved data collection and analysis.

Most reports endorse healthcare and public health initiatives such as broader availability of all three types of FDA-approved medication-assisted treatment (MAT) in multiple treatment settings, including jails, as well as the provision of wrap-around services, and tackling social determinants of health.

However, these proposals often are more diffuse, the strategies unclear, and the funding (if any) of dubious sustainability.  

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Please visit Bill of Health for the remaining full article

Policy Pathways to Address Provider Workforce Barriers to Buprenorphine Treatment [from American Journal of Preventive Medicine]

George Consortium member Rebecca L. Haffajee has a new article in the American Journal of Preventive Medicine focusing on some of the reasons why only 40% of people with opioid use disorder actually receive medication-assisted treatment. One major reason is that so few physicians are licensed to even prescribe buprenorphine (such as Suboxone). As the article details, numerous workplace barriers contribute to this lack of licensing, including insufficient training, lack of peer support, inadequate reimbursement, and regulatory hurdles. 

For complete article with footnotes, please see:  https://www.sciencedirect.com/science/article/pii/S0749379718300746

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Introduction

Opioid misuse and overdose continue to escalate, contributing to the growing population with opioid use disorders (OUDs) in need of treatment. The opioid-related overdose death rate increased from 6.1 to 16.3 deaths per 100,000 people from 1999 to 2015, totaling 33,091 deaths in the U.S. in 2015. Rates of opioid-related substance use treatment admissions have followed a similar trajectory. Despite recent abatements in prescription opioid dispensing and use,4 prescribing contributes heavily to those who are misusing opioids.  Moreover, overdoses and infectious diseases resulting from opioid injection drug use continue to climb, and are increasingly attributed to heroin and potent synthetic opioids, such as fentanyl.

Meeting the clinical criteria for an OUD—or a “problematic pattern of opioid use leading to clinically significant impairments or distress,”—increases a person’s risk of early death (typically from overdose, trauma, suicide, or infectious disease transmission) by a factor of 20.The prevalence of OUDs has increased significantly over time, from approximately 1.5 million in 2003 to more than 2.3 million in 2015. Despite the risks of untreated OUD, the gap between OUD prevalence and evidence-based medication-assisted treatment (MAT) capacity was close to 1 million in 2012.

Buprenorphine, one of three medications used as part of MAT, has high potential to address the persistent OUD treatment gap. Buprenorphine is approved for use in non-specialty outpatient settings, has demonstrated effectiveness at promoting abstinence and reducing opioid-related overdoses, and is cost effective. However, according to the Substance Abuse and Mental Health Services Administration (SAMHSA), less than 4% of licensed physicians were approved to prescribe buprenorphine in 2017. In 2016, overall 47% of counties—and 72% of rural counties—lacked a buprenorphine-waivered physician.26 Although buprenorphine capacity has increased since 2002—when it was first approved for OUD treatment in office-based settings—the treatment gap has not significantly narrowed because of the increasing population with OUDs. Moreover, many buprenorphine-approved prescribers treat far fewer than the number of patients allowed by regulations.17; 27 ;  28 Estimates range, but suggest that only 20%–40% of people with OUDs are receiving MAT.

Despite some recent policy successes in expanding buprenorphine treatment insurance coverage, funding, and provider capacity, significant provider and policy barriers remain and must be addressed to capitalize on this promising treatment at a time of dire public health need. This article provides a brief history of MAT and the factors contributing to buprenorphine’s promise. It then outlines persistent provider workforce barriers to buprenorphine provision in the U.S. and policy recommendations to address them.

The rest of the article (including footnotes) is available here: Policy Pathways to Address Provider Workforce Barriers to Buprenorphine Treatment

It's Time for Uncomfortable Solutions to the Opioid Epidemic [from The Fix]

We are thrilled to present some work from brand new George Consortium member Abraham Gutman! This piece from The Fix discusses the fact that we need to get creative, and uncomfortable, in addressing the opioid crisis. Be sure to follow Av's great Twitter feed at @abgutman.

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The results of the War on Drugs: an America that is the most incarcerated nation in the world, a sharp decrease in the price of heroin, and a new Jim Crow for Black communities.

Not every problem has a solution that we are comfortable with. The opioid epidemic and the overdose crisis are two examples of such problems. There has been a lot of work by states and cities to tackle the epidemic and mitigate harm. Laws limiting opioid prescriptions have been enacted (controversially), DEA regulations on who can administer treatment were laxed, Prescription Drug Monitoring Programs were founded, and states of emergency were declared.

“The United States has seen a vigorous legislative response to the opioid epidemic,” writes Scott Burris, the Director of the Center for Public Health Law Research at Temple University, in a recent article, “but legislators are running out of easy targets as the most popular ideas are adopted in all the states.

With no more low-hanging fruits left on the tree, and with the epidemic still raging, it is time to confront the solutions that we are less comfortable with. Philadelphia found itself in the middle of this conversation after city officials announced that they would encourage private organizations to operate comprehensive-user engagement sites, commonly known as safe-consumption sites.

While Philadelphia is the first city in which officials gave their blessing to open a safe-consumption site, other cities—including Denver, Seattle, and New York—are currently considering opening such sites. Two weeks after Philadelphia’s announcement, San-Francisco announced that the city is expecting to be the first city with a site coming July 1st of this year.

Safe-consumption sites are a harm reduction measure that has been shown to enhance access to primary health care for people who use drugs, reduce overdose mortality, and reduce transmission of disease such as HIV/AIDS. The evidence further suggests that the sites reduce the level of public consumption of drugs and dropped syringes without causing an increase in drug use, drug trafficking or crime in the vicinity of the site. Last summer the American Medical Association voted to support the development of pilot safe consumption facilities.

The debate about safe-consumption sites is mostly not about the evidence that supports the efficacy of the practice but about whether it is the right path to take. One opponent in Philadelphia wrote, “we don’t need to enable drug addiction. We need to keep kids off drugs in the first place. We need to help addicts who want to stop using.”

The truth is: we don’t know how keep kids off drugs in the first place. Furthermore, medication assisted treatment, the gold standard treatment for opioid use disorder, is heavily regulated on the state and federal level leading to barriers in access.

America spent billions of dollars in an attempt to convince the nation’s youth to “just say no” to drugs. The phrase that was first used by First Lady Nancy Reagan to respond to an elementary school girl in Oakland in 1982 became a national and international campaign, and a myth. Telling kids to “just say no” doesn’t work. In fact, it might have the exact opposite effect.

If we can’t make kids say no, maybe we can prevent anyone from offering them drug in the first place. This was the logic of Donald Trump in his first State of the Union when he declared that “we must get much tougher on drug dealers and pushers” and that “open borders have allowed drugs” to enter the country. In a recent speech in New Hampshire, Trump doubled down on this line of thinking and called for the death penalty for some dealers.

Getting tough on drugs is in no way a new idea, in fact it is almost 100 years old. America conducted a horrifying policy experiment to see if this idea works. This experiment, known as the War on Drugs, was conducted with communities of color as the subjects. The results are an America that is the most incarcerated nation in the world, a sharp decrease in the price of heroin with virtually no change in the number of high school seniors using illicit drugs, and a new Jim Crow for Black communities. Renewed calls to get tough on crime are either driven by blindness to the realities of the War on Drugs, racism, or a combination of both.

Tightening the border is not doing much to prevent drug abuse either. While Trump believes that a wall will prevent drugs from entering the US, most drugs that cross the southern border do so through legal entry ports to the U.S., according to the Drug Enforcement Administration. In fact, some argue that the tightened border security gave rise to proliferation of Fentanyl, a deadly synthetic opioid much stronger than heroin, because drug traffickers can make profits from very small volumes. Executing drug dealers as a means to reduce the supply of illicit drugs is dehumanizing and racist, unconstitutional, and won't work.

If we can’t completely stop illicit drug use, we can at least provide easily accessible treatment. When it comes to opioid use disorder we even have effective treatment to offer: medication-assisted treatment using methadone, buprenorphine, and naltrexone. But access to medication-assisted treatment is far from sufficient to meet the growing need, with some in rural areas having no providers within a 350 mile radius. Investing in treatment is extremely important, however stigma and regulatory barriers from federal law and DEA regulations make increasing access very difficult.

The fight over increasing access to medication assisted treatment is a worthy and necessary fight that we should engage in with full force. That said, we need to be realistic about how long it will take to change established laws, regulations, and hearts and minds. Meanwhile people who use drugs are actively dying from overdose, suffering from injection related wounds, and contracting bloodborne diseases such as Hepatitis B and C and HIV/AIDS.

Safe-consumption sites are in no way a silver bullet that will defeat the opioid epidemic. They are a strong tool that should be utilized to end the overdose crisis. More than 64,000 Americans died in 2016 from drug overdose. Not taking action on evidence-based practices because the solution doesn't feel intuitive should not be an option.

Some still view safe-consumption sites as “enabling” drug use (even though that is not supported by the evidence). “If the current epidemic can teach us anything, it’s that drug use is soaring unassisted,” writes Dr. Sarah Wakeman, the Medical Director of the Substance Use Disorder Initiative at Mass General Hospital. “The time has come to think instead about how we can enable people to stay alive.”

The effort to end the opioid epidemic is a marathon and not a sprint. As a society our goal must be to ensure that as many people who are currently using drugs cross the finish line with us - alive and with the least irreversible damage. The next steps to do that might go against many of our gut instincts but at the end of the day we must trust the evidence and embrace harm reduction measures.

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The original article can be found here. 

Q&A: Holding Drugmakers Accountable for Opioid Crisis

Recently, George Consortium member and University of Michigan professor Rebecca Haffajee gave an interview to the Associated Press, addressing issues around opioid companies and litigation:

“Q: Why didn’t early lawsuits filed against opioid drugmakers have much success?

A: The earlier lawsuits were typically brought by individuals and were vulnerable to a number of defenses from the manufacturers. The companies could argue that individuals misused the prescription drugs or prescribers weren’t providing adequate medical advice about the products. Companies also argued that they were marketing and selling their products in accordance with Food and Drug Administration rules for these FDA-approved products.

Many of those cases were dismissed. Sometimes the individuals bringing the suits simply ran out of resources to pay for the litigation.

Q: Why are these newer lawsuits different?

A: Governments are bringing these more recent lawsuits, and they are alleging harms to their overall social systems that (acknowledge) misuse was happening, but regardless, are trying to hold companies accountable.

The idea is that these companies must have known, based on their own records and information, that the mass selling and distribution of opioids had gone beyond their appropriate medical use. The defense that people misused these drugs doesn’t hold as much weight in these cases.

Q: People have compared this litigation to the lawsuits against Big Tobacco in the 1990s that resulted in a nearly $250 billion financial settlement for state governments. What are some of the differences?

A: Part of the idea with tobacco was to get this product off the market altogether. With opioids we don’t want that. We want to be limiting the amount of opioids prescribed and misuse, but we recognize these are FDA-approved products that have a medical use and can be appropriate and effective, particularly for acute pain. The idea here is to try and thread the needle and allow appropriate use, but rid the market of inappropriate use.

Q: Beyond a financial settlement, many government officials say they want to change how this industry does business. Is that likely to happen?

A: That certainly can be a byproduct of the litigation, changing marketing practices and behavior. If it’s a penalty that’s big enough, it could have a deterrent effect.

Some of the recent settlements we’ve seen with drug distributors and manufacturers have required that they report certain information or refrain from certain conduct going forward.”