Introduction to “Diseases of Despair: The Role of Policy and Law”

By Wendy E. Parmet and Jennifer Lea Huer

We are pleased to host this symposium featuring commentary from speakers and participants of Northeastern University School of Law’s annual health law conference, Diseases of Despair: The Role of Policy and Law, organized by the Center for Health Policy and Law.

All the posts in the series will be available here.

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Promoting Health Equity Through Health in all Policies Programs: A Health Law Perspective

Scholars and public health advocates are optimistic about Health in All Policies initiatives.

This post is part of a symposium from speakers and participants of Northeastern University School of Law’s annual health law conference, Diseases of Despair: The Role of Policy and Law, organized by the Center for Health Policy and Law.

All the posts in the series are available here.

By Peter D. Jacobson

Scholars and public health advocates have expressed optimism about the potential for Health in All Policies (HiAP) initiatives to improve both health equity and population health. HiAP is a collaborative approach across all sectors, involving both public and private decision-makers, to integrate health and equity during the development, implementation, and evaluation of policies and services. Braveman and colleagues define health equity to mean that “that everyone has a fair and just opportunity to be as healthy as possible.”

I suspect the vast majority of health law scholars support the concept of health equity. But what does the concept mean in practice and how can it be implemented? From a public health law perspective, does implementation require a legal imprimatur or can it be effectively designed and implemented absent some sort of legal mandate?

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Global Patient Safety and Health Quality

By John Tingle

The WHO (World Health Organization), the World Bank Group and OECD (Organization for Economic Co-operation and Development) have jointly produced a report which states that poor quality health services are holding back progress on improving health in countries at all income levels.

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The Healing Potential of Medical-Legal Partnerships

This post is part of a symposium from speakers and participants of Northeastern University School of Law’s annual health law conference, Diseases of Despair: The Role of Policy and Law, organized by the Center for Health Policy and Law.

All the posts in the series are available here.

By Tamar Ezer

As we grapple with today’s social ills and Diseases of Despair such as the opioid crisis, violence and suicide, medical-legal partnerships (MLPs), can potentially provide a powerful healing combination.

MLPs, which integrate legal services into health care, have several important strengths.

They embrace a holistic approach to health, addressing not just biological factors, but also social determinants, such as access to housing or freedom from violence. They bring access to justice to communities. People need not go out to seek legal support, but can find services at a one-stop shop for multiple, intersecting needs. MLPs help address legal issues early, preventing problems and intervening before there is an eviction or utilities are shut off.

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Resiliency as Prevention against Diseases of Despair and Structural Violence

This post is part of a symposium from speakers and participants of Northeastern University School of Law’s annual health law conference, Diseases of Despair: The Role of Policy and Law, organized by the Center for Health Policy and Law.

All the posts in the series are available here.

By JoHanna Flacks

If despair is the disease, what is the remedy? I was privileged to participate in a panel with colleagues from the medical-legal partnership (MLP) movement at a Diseases of Despair conference convened by Northeastern University’s School of Lawn in April. We were invited to share how MLP approaches can answer this question broadly by helping to identify and implement interventions that show promise as despair antidotes to or – better yet – antibodies that can prevent despair’s onset.

While hope is despair’s antonym in common usage, the idea of “resiliency” has taken root among healthcare and human service teams as a key quality to cultivate among, for example, survivors of adverse childhood experiences (ACES) who are at risk of poorer health and well-being in the absence of buffers from the toxic stress of these traumas.

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Many State Laws Undermine Harm Reduction Strategies in the Opioid Crisis

A protest sign seen at an ACT UP demonstration. Syringe exchange programs are a harm reduction policy that could have an impact on the opioid crisis. (Photo by riekhavoc/flickr)

This post is part of a symposium from speakers and participants of Northeastern University School of Law’s annual health law conference, Diseases of Despair: The Role of Policy and Law, organized by the Center for Health Policy and Law.

All the posts in the series are available here.

By Aila Hoss

Despite the increase in rates of opioid overdose death since 1999, the Opioid Use Disorder crisis shows little signs of abating. Recent reports from the Centers for Disease Control and Prevention indicate that overdose death rates have continued to climb in recent years. These sobering reports, along with others highlighting the impact of the crisis on children and families, the increase in methamphetamine and cocaine use, and the economic costs to businesses, communities and our healthcare system remind us that “opioid addiction isn’t the disease; it’s the symptom.”

There is “no easy fix” to the social and economic determinants of health, such as poverty and housing insecurity, that are fueling this crisis. However, there are actionable, discrete, evidence-based policy measures that can be taken to reduce the rates of overdose deaths via harm reduction strategies.

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Reports on the Opioid Crisis are Full of Misidentified Problems and Poorly Calibrated Solutions

Photo by striatic/flickr

This post is part of a symposium from speakers and participants of Northeastern University School of Law’s annual health law conference, Diseases of Despair: The Role of Policy and Law, organized by the Center for Health Policy and Law.

All the posts in the series are available here.

By Nicolas Terry

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 state reports 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.

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Physicians and Firearms: Finding a Duty to Talk to Patients About Guns

Sixty-one percent of gun deaths in 2015 were suicides. Physicians should be empowered to speak to patients about guns.

By Elisabeth J. Ryan

This post is part of a symposium from speakers and participants of Northeastern University School of Law’s annual health law conference, Diseases of Despair: The Role of Policy and Law, organized by the Center for Health Policy and Law.

All the posts in the series are available here.

Florida enacted a statute in 2011 entitled the “Firearms Owners’ Privacy Act,” which quickly became known nationwide as simply the “Docs v. Glocks” law.

This law essentially forbade doctors from asking their patients about gun ownership, recording information about guns in the home, and “unnecessarily harassing” patients for being gun owners. The penalty was potential medical license sanctions and a fine up to $10,000.

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Meditation? There’s an (almost FDA-approved) app for that

By Gali Katznelson

Headspace is paving the way for the first FDA-approved prescription meditation app.

Developers behind the mindfulness smartphone app, which has over 30 million users, are creating a new product under Headspace Health that will begin clinical trials this summer, in hopes of clearing FDA approval by 2020. The team is investigating how the app can help treat 12 mental and physical conditions.

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Could user-generated licensing models clear a path through IP thickets in gene-editing?

By Timo MinssenEsther van Zimmeren & Jakob Wested 

An earlier version of this contribution had been published in Life Science Intellectual Property Review (LSIPR).

A voluntary pool or clearinghouse model may give rise to a robust commercial ecosystem for CRISPR and could include special provisions for royalty-free research use by academics. Hence, there may be a path through the CRISPR patent jungle. But, there are many obstacles still in the way.

The revocation of Broad Institute’s patent EP2771468 reported and discussed here, marks the latest major development in a series of patent battles over the revolutionary and highly lucrative CRISPR-Cas9 technology (and other gene editing technologies) in the US and Europe.

While this is the first EPO decision in an opposition procedure concerning the Broad patent portfolio, the outcome may have implications for other related patents as the rationale for the revocation reflects a larger, systemic challenge based on the different rules regarding priority claims in different jurisdictions.

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Will the EPO’s Enlarged Board of Appeal step into the CRISPR patent battle?

By  Jakob Wested, Timo Minssen & Esther van Zimmeren

Another version of this contribution has been published in Life Science Intellectual Property Review (LSIPR).

The Broad Institute is facing a formidable task in defending the revoked CRISPR patent claims in their pending appeal at the European Patent Office (EPO). Ultimately, some of the issues might still be referred to the Enlarged Board of Appeal. However, this might require a significant amount of legal and rhetorical agility.

“The Opposition Division’s interpretation of the EPC [European Patent Convention] is inconsistent with treaties designed to harmonize the international patent process, including that of the United States and Europe.”

This was the rather strong reaction of the Broad Institute after the EPO’s Opposition Division’s (OD) decision to revoke one of their CRISPR patents. It could, however, also be argued that the case presents a simple failure of the patent applicants to comply with the long-standing European practice to apply an “all applicants” approach when claiming priority under article 87 of the European Patent Convention.

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CMS Abandonment of Outcomes-Based Payment Deal with Novartis is a Missed Opportunity

The Centers for Medicare and Medicaid Services have cancelled an outcomes-based price plan with drug maker Novartis. (Wikimedia Commons)

By Rachel Sachs

Earlier this week, Politico broke the news that the Centers for Medicare and Medicaid Services (CMS) had withdrawn its outcomes-based payment deal for Novartis’ CAR-T therapy, Kymriah, without public acknowledgement.

The Food and Drug Administration’s approval of Kymriah in August of last year was accompanied by the announcement of a novel outcomes-based agreement with CMS, in which CMS would pay for Kymriah only if patients had responded to it by the end of the first month. Now, CMS has quietly backed away from that agreement. What does the deal – and its subsequent abandonment – tell us about CMS’ involvement in outcomes-based contracts going forward?

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Don’t Expect Brett Kavanaugh To Protect The Affordable Care Act

Thanks to Brett Kavanaugh’s 12 years as a judge on the D.C. Court of Appeals, we have a well-developed record of the Supreme Court nominee’s positions on key issues, including his views on American health care policy.

In two high profile cases in 2011 and 2015, Kavanaugh upheld key parts of the Affordable Care Act (ACA). But these cases, taken out of context, are misleading. They should not distract anyone evaluating his long record, nor overly inform how he might decide in future cases when it comes to health care.

Besides his record on reproductive health — which is controversial and is already creating significant opposition to his confirmation — Kavanaugh has exhibited strongly-held ideas about the relationship of the courts to government agencies and bureaucracies that carry out most of American public policy, also known as “the administrative state.”

Read more at WBUR’s Cognoscenti

How the New York Court of Appeals Applied the Soda Cap Criteria to Vaccines

By Dorit Reiss

(Photo by pahowho/Flickr)

New York’s Court of Appeals reversed an Appellate Division decision and reinstated New York City’s influenza mandate for city daycares in Garcia v. New York City Department of Health and Mental Hygiene in June. Applying the same criteria the court used in 2014 to overturn the city’s controversial Soda Cap, the court found that the rules are well within the Board’s authority.

We can suspect that the recent influenza season influenced the decision, but it was also based on a more explicit delegation of authority, and a history of vaccination programs by the Board.

Also, it’s likely good news for at least some of New York’s youngest, who will be better protected from a dangerous disease, and for the public.

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Buprenorphine and Naloxone Legislative Restrictions: A Compromise Towards Harm Reduction

Limiting access to MAT can result in patient harm. Improving access using a bridge therapy model may help save lives.

There were approximately 64,000 deaths from opioid overdose in 2016, including deaths from both prescription and illicit drugs. The incidence of opioid overdose has continued to escalate despite a number of efforts. Increasing treatment beds, limiting opioid prescriptions, distribution of naloxone and other efforts have not demonstrated a significant impact on non-medical opioid use or on opioid-related deaths.

The continuing rise in opioid overdose and overdose death has resulted in the declaration by the current executive administration of the opioid epidemic as a “Public Health Emergency”.

Medication assisted treatment (MAT) with agents such as methadone or buprenorphine/naloxone has been demonstrated to be one of the more effective measures in the reduction in high-risk opioid use among individuals with substance abuse disorder. Specifically, treatment with buprenorphine/naloxone has demonstrated efficacy in harm reduction with the advantage of a reduced potential for abuse, a safer therapeutic profile than alternatives, and it can be safely prescribed in the outpatient setting. Use of this therapeutic however, is currently restricted to only certain licensed providers in certain clinical settings, limiting access to this important life-saving intervention.

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Setting Hard Limits: A Federal District Court Puts up Major Hurdle to the Reworking of Medicaid in Stewart v. Azar

Health and Human Services Secretary Alex Azar testifying in front of Congress in June. HHS has come under scrutiny for its use of 1115 waivers.

By Carmel Shachar

Since the Republican controlled Congress failed to repeal the Affordable Care Act in 2017, the Trump administration has been trying to implement its more conservative vision of Medicaid through waivers. On June 29, 2018, however, the D.C. federal district court issued a decision in Stewart v. Azar which would make it significantly more difficult for an administration to rework Medicaid without a congressional mandate.

This case, should it survive subsequent appeals, will represent an important turning point in the ability the Department of Health and Human Services has to shrink or undermine Medicaid through the use of administrative waivers.

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When All You Have is a DALY, Everything Looks Like Disease

Govind persad

Govind Persad discusses priority-setting at the Petrie-Flom Center annual conference

By John Hylton

Recently the Petrie-Flom Center’s annual conference brought together medical experts, bioethics scholars, and disability advocates to rethink how medical systems and public health policies can engage with disability.

During the many fascinating panels at “Beyond Disadvantage: Disability, Law, and Bioethics” one idea that sparked some debate was whether we should use quality/disability adjusted life years (QALY/DALY) to set priorities for who gets access to healthcare resources. Prof. Govind Persad, a bioethicist at Johns Hopkins and blogger for Bill of Health, suggested in his presentation that we should dramatically reduce the role of such utilitarian calculations in priority setting, instead focusing on the genesis of the disadvantage.

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Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari, Michael S. Sinha, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the division.

Below are the abstracts/summaries for papers identified from the month of June. The selections feature topics ranging from the utilization of medical devices necessary to detect post-approval safety differences, to evidentiary standards and regulatory tradeoffs in the FDA’s expedited approval programs, to the president’s plan to address high drug prices. A full posting of abstracts/summaries of these articles may be found on our website.

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The Need for Institutional, Individual and Community Based Responses to the Opioid Crisis

By John Alexander Short

Panelists discussed responses to the opioid crisis during a recent webinar.

Dr. Monica Bharel, the Commissioner of the Massachusetts Department of Health, recently hosted a webinar panel to discuss the many consequences of the modern opioid epidemic on families.

Hosted jointly by the Association of State and Territorial Health Officials (ASTHO) and The Forum at the Harvard T.H. Chan School of Public Health, the event also included Dr. Stephen Patrick, Dr. Karen Remley, and Dr. Michael Warren who joined Bharel for a talk titled “State Health Leadership: Understanding & Responding to the Lifelong Effects of Opioid Exposure for Infants, Children & Families.”

The discussion offered insight into the complex nature of addiction and the need to understand the disease to craft effective solutions.

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What is in America’s Medicine Cabinet? Everything.

By Stephen P. Wood

pills

Prescriptions should never be the first option for healtcare providers. (mpcaphotos/Flickr)

There were 240 million opioid prescriptions in the U.S. in 2016, a number that accounts for about 30 percent of the world’s opioid prescriptions, and is enough for one opioid prescription for every adult American.

Experts believe the overprescribing of opioids is at least somewhat responsible for the current opioid crisis. This led to a national discussion around prescribing stewardship, as well as the development of policy and regulation with regard to opioid prescribing. Included among this have been limits on the duration of therapy, partial fills, and requirements that providers access their state’s prescription monitoring program before prescribing. These policies have had some success and there has been a decline in the number of opioid prescriptions in the last several years.

This should be good news, but unfortunately, opioids aren’t the only thing filling America’s medicine cabinets. Looking again at 2016, there were more than 190,000 kilos of amphetamines, drugs like Adderall and Ritalin, produced for consumption in the United States. The estimates are that about 16 million adults and more than 3.5 million children are taking these stimulants.

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