Paper or Plastic: How would you like your IV fluids today?

By Stephen Wood

The patient was a very pleasant 45-year-old woman who came into the emergency department with fever, headache and neck pain; all signs and symptoms concerning for meningitis or possibly encephalitis. Both are often an infectious, sometimes inflammatory diseases of either the meninges, the thin membrane that covers the brain, or the brain itself. The diagnosis is considered clinically, based on signs and symptoms as well as some clinical exam, and often confirmed by a lumbar puncture or spinal tap.

I discussed this with the patient and she agreed to the procedure. I had her positioned and had opened the prepackaged kit to get started. The kit is wrapped in plastic, a necessity to keep equipment sterile, especially for a procedure that will involve instrumenting a space that communicates with the central nervous system; the brain and spinal cord.

Off came the plastic, and into the trash. There are also some stickers for labeling the syringes used to inject the anesthetic, but I didn’t need those either, so they also went into the trash. There are extra plastic syringes that you don’t need, as well as a plastic straw to draw up the anesthetic if you choose to use that instead of a needle. Into the trash. There are several more items in the kit that are destined for the trash as well: a small circular piece of foam for sticking used needles into, as well as unused needles. By the end of the procedure, I had become a one-man wrecking ball of plastic waste.

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“TrumpCare” with Huberfeld, Buck, Bard, & Terry on ‘The Week in Health Law’ Podcast

By Nicolas Terry

Subscribe to TWIHL here!

The next four episodes were recorded at the 2018 SEALS conference. Four of us got together as a panel to discuss Healthcare in the Era of the Trump Administration. I was joined by:

  • Nicole Huberfeld, Professor of Health Law, Ethics & Human Rights at the Boston University School of Public Health and Professor of Law at the School of Law there.
  • Zack Buck, Associate Professor of Law and Wilkinson Junior Research Professor at The University of Tennessee, Knoxville.
  • Jennifer Bard, Professor of Law in the College of Law at the University of Cincinnati with an appointment as Professor, Department of Internal Medicine at the College of Medicine.

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What to Read on Pharma Law and Policy this Month

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.

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Hastening Death to Avoid Prolonged Dementia

By Norman L. Cantor

The scourge of Alzheimer’s is daunting. For me, the specter of being mired in progressively degenerative dementia is an intolerably degrading prospect. One avoidance tactic — suicide while still competent — risks a premature demise while still enjoying a tolerable lifestyle.

The question arises whether an alternative tactic — an advance directive declining all life-sustaining intervention once a certain point of debilitation is reached — might be preferable as a device to avert a prolonged, unwanted limbo.

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End of year report cards from NHS Resolution and the Care Quality Commission

By John Tingle

Two key NHS (National Health Service) organisations have recently produced reports. NHS Resolution has produced its annual report and accounts.The Care Quality Commission (CQC) has produced a report on the experiences of adult in -patients in NHS hospitals.These reports are excellent for real-time trend analysis and important patient safety and clinical negligence trends are identified.

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Recreational Genetics or Research Enterprise? Cloudy Consent Issues Arising from Direct-to-Consumer Genetic Testing

23andme genetic testing kit

23andMe has partnered with GlaxoSmithKline, creating a flurry of questions around customer consent to how their data is used in research. (Phobo via imran/Flickr)

By Valerie Gutmann Koch

23andMe announced its $300 million partnership with GlaxoSmithKline late last month, a move that will allow the drug behemoth to develop drugs based on “deidentified” DNA and other information collected from the direct-to-consumer (DTC) genetic testing company’s five million customers.

Over the last decade, 23andMe has confrontedand survived – various challenges and existential threats to its existence. However, this announcement, while representing an incredible success for 23andMe’s business, presents potential obstacles for informed consent and the research enterprise.

It may also undermine public trust in the company.

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Public Health Law Research Book Club: “The New Public Health Law”

Cover of new textbook, The New Public Health LawThe newest textbook in public health law comes from Scott Burris, Micah Berman, Matthew Penn and Tara Ramanathan Holiday. The New Public Health Law is an effort to equip students in law, public health, social work and other fields in the public health and social policy realms with the tools to fully exploit the potential of law to improve public health. It takes a transdisciplinary approach, breaking down complex legal processes into discrete and understandable stages, using examples from the field.

We asked authors Micah Berman and Scott Burris about the textbook’s new approach to teaching and learning public health law.

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US Legislators Take a Scattered Approach to Neonatal Abstinence Syndrome

 woman holding newborn

By J. Alexander Short

Pennsylvania is the latest state to enact legislation in reaction to the growing impact the opioid epidemic has on infants. Governor Tom Wolf signed H.B. 1232 in June, effectively requiring hospital officials to notify child protective services when children are born affected by the mother’s substance abuse or affected by withdrawal symptoms as a result of prenatal drug exposure.

Such outcomes generally fall within the parameters of neonatal abstinence syndrome (“NAS”), a group of health problems that occur in newborns who were exposed to drugs while in the mother’s womb.  This legislation brings Pennsylvania into full compliance with the 2003 Federal Child Abuse Prevention and Treatment Act.

This legislative response makes sense.

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California Court of Appeal Rejects Challenge to Vaccine Law

Vaccines are now mandatory for school age children in California.

By Dorit Reiss

The Second Appellate District’s Court of Appeal upheld the California law that removed California’s Personal Belief Exemption (PBE) from school immunization requirements earlier this month.

The decision is a strong endorsement of immunization mandates and is binding on all state courts until another appellate decision is handed down, or the Supreme Court of California addresses the question.

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Ontario’s Sex-Ed Curriculum: A Step Back for Health and Safety

Teens in Ontatio, Canada could be put at risk by a change in the public school sex-ed curriculum that omits LGBT relationships.

By Gali Katznelson

Come September, it seems Ontario students in grades 1-8 will follow the same sexual education curriculum that was taught in schools in 1998.tse

Days after the Progressive Conservative Party’s win in Ontario, premier Doug Ford has announced that he will scrap the province’s elementary school sex-ed curriculum and replace it with one that is twenty years old.

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Cottage Food and Food Freedom Laws – New LawAtlas data

The newest map on LawAtlas.org analyzes state laws governing the production, sale, and regulation of cottage food operations.

Typically, commercial food production is required to take place in certified commercial kitchens that are heavily regulated. Cottage foods laws regulate the production and sale of certain foods (foods less likely to cause foodborne illness, such as jams and baked goods) made in home kitchens, rather than a licensed commercial kitchen, and a person’s ability sell them in venues like farm stands or retail stores. Similar state laws, called “food freedom laws,” expand upon cottage food laws to include potentially hazardous products like meat and poultry.

These laws are quickly becoming an increasing area of debate at the state level.  Part of this debate centers on the economic rights of “small-batch” home bakers and cooks versus public health and safety concerns. These private bakers, canners, and cooks want the liberty to sell their products to consumers free from the onerous licensing requirements required of their larger commercial counterparts, restaurants and food processing plants, are subject to.  At the same time, there is concern that this individual economic interest is riding roughshod over existing regulations designed to protect consumers from foodborne illnesses that can be caused by improperly prepared foods.

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After Julie Eldred, Considering Addiction as Disease or Choice

The Massachusetts Supreme Judicial Court ruled that relapse could be a violation of parole.

By Chris Hutchison-Jones

Is substance addiction a choice or a disease?

In the recent ruling by the Massachusetts Supreme Court in the case of the Commonwealth vs. Julie A Eldred judges had to consider this question.

But they came to the wrong conclusion.

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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 Law 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 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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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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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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