bioIP Faculty Workshop Call for Abstracts

The American Society for Law, Medicine & Ethics (ASLME) is pleased to announce the 4th annual bioIP Faculty Workshop on Friday April 26, 2019, at Boston University.

The Workshop offers a unique opportunity for three scholars in their first decade of teaching to present their work in progress for in-depth critique and commentary by respected senior scholars in the field.

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Health Law Scholar Citation Rankings: A Better Picture This Year

By Scott Burris

Glenn and Mark have done their bit for benchmarking our field with another round of health law professor rankings. It is a largely thankless task, so thank you professors.  Last year, I responded to their list with the observation that any count based on law review publication alone was problematic in assessing the contributions of those in our field whose scholarship is primarily empirical or aimed at the health world.  I offered a suggestive “top scholars list” based on Google Scholar profiles.  Using Google Scholar, which captures articles in all fields, plus books and gray literature, brought a number of different names into the top 20.  Since Google Scholar depends on individuals to create and clean their profiles, my list missed a lot of top scholars without profiles (I am talking about you, Michelle Mello and George Annas,  etc. etc.), but it was enough to suggest that some very productive and much-cited scholars were missed in the Hall-Cohen list.

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The cost of drug monopolies in the United States

By James Love

The United States, like other countries, uses the grant of legal monopolies as the incentive to reward successful R&D investments. The legal mechanisms are varied, and include most importantly patents on medical inventions, but also a variety of regulatory exclusivities in a patchwork of programs that address (for example) delays in regulatory approval, testing for pediatric patients, development of treatments for rare diseases, rights in test data used to provide new drugs and vaccines, and the development of new antibiotic drugs.

Each of these legal mechanisms that are used to block competition can be evaluated separately, but it is also useful to look at the big picture, and ask – what is the cost of the drug monopolies in the United States?

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Running healthcare, research and public trust up the flag pole

By Paul C. McLean

While I was aghast earlier this week that the White House struggled over whether to fly the flag at half-mast or full for the death of John McCain, and relieved that it was still the American flag, I distracted myself from the drama in Washington with other news:

Item: In Europe, there were 5,000 cases of the measles in all of 2016, 24,000 in 2017, and already 41,000 halfway through 2018, including 37 deaths, according to the World Health Organization. Globally, measles remains a leading cause of death among young children even though a safe and cost-effective vaccine is available.

Item: In the bizarre case of a convicted murdered claiming his victim wouldn’t have died had he stayed on life support, the Georgia Supreme Court rejected that argument because the patient “was basically brain dead.” [PDF]

Item: Twenty-five years later, gene therapy finally got a common-sense definition: “the intentional, expected permanent, and specific alteration of the DNA sequence of the cellular genome, for a clinical purpose.”

Bioethicists, policymakers, and clinicians tend not to lump brain death, gene therapy and the anti-vaccine movement together. And why should they? Though fate management is central to each, they are perplexing enough to the public (i.e. me) when considered separately.

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Machine Learning as the Enemy of Science? Not Really.

By Cansu Canca

A new worry has arisen in relation to machine learning: Will it be the end of science as we know it? The quick answer is, no, it will not. And here is why.

Let’s start by recapping what the problem seems to be. Using machine learning, we are increasingly more able to make better predictions than we can by using the tools of traditional scientific method, so to speak. However, these predictions do not come with causal explanation. In fact, the more complex the algorithms become—as we move deeper into deep neural networks—the better are the predictions and the worse are the explicability. And thus “if prediction is […] the primary goal of science” as some argue, then the pillar of scientific method—understanding of phenomena—becomes superfluous and machine learning seems to be a better tool for science than scientific method.

But is this really the case? This argument makes two assumptions: (1) The primary goal of science is prediction and once a system is able to make accurate predictions, the goal of science is achieved; and (2) machine learning conflicts with and replaces the scientific method. I argue that neither of these assumptions hold. The primary goal of science is more than just prediction—it certainly includes explanation of how things work. And moreover, machine learning in a way makes use of and complements the scientific method, not conflicts with it.

Here is an example to explain what I mean. Prediction through machine learning is used extensively in healthcare. Algorithms are developed to predict hospital readmissions at the time of discharge or to predict when a patient’s condition will take a turn for worse. This is fantastic because these are certainly valuable pieces of information and it has been immensely difficult to make accurate predictions in these areas. In that sense, machine learning methodology indeed surpasses the traditional scientific method in predicting these outcomes. However, this is neither the whole story nor the end of the story. Continue reading

Can a national conscience be gene edited?

By Paul C. McLean

Gene editing is at once promising and perilous. Or, as John Oliver said in a recent episode of his news show, it is ”either going to kill all disease or kill every last one of us.”

The Nuffield Council on Bioethics is not as amusing as John Oliver, and unlike the summer film “Rampage,” its new gene editing report features neither The Rock nor a genetically modified, 30-foot wolf.

But if you want to understand what we may actually be getting ourselves into, England’s de facto national bioethics commission has produced a useful roadmap for educating the public and addressing concerns. It may the summer read you’ve been looking for.

And if there’s a gene splicer for envy, I’m ready to be CRISPR’d.

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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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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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Are we speaking the same language? An alphabet soup of acronyms in the opioid epidemic

By Stephen Wood

Medication Replacement Therapy (MRT), Medication Assisted Therapy (MAT). Opioid Substitution Treatment (OST). Opioid Replacement Therapy (ORT). Opioid Agonist Therapy (OAT). This confusing array of acronyms are all terms that have made their way into the dictum of patients, healthcare providers, policy leaders, politicians and journalists —and new ones pop up every day.

Buprenorphine Enabled Recovery Pathway (BERP) is one I just came up with but could just as easily make its way into the menagerie of acceptable buzzwords for using an agonist-antagonist (or other drug) for the treatment of substance use disorder.

It doesn’t stop there.

Safe Consumption Facilities (SCF), Safer Injection Facilities (SIF), another SIF in Supervised Injection Facilities, Supervised Injection Sites (SIS), Medically Supervised Injection Sites (MSIS), and Drug Consumption Sites (DCS) only begin to round out the list of areas that people who use intravenous drugs can go to use in a safe, clean and supported environment.

We see these terms bantered about in the media, among healthcare providers, legislators and policy makers. We hear them from patients with SUD, their families as well as advocate organizations. These terms are in published research reports and clinical studies. To even the savviest person though, it is a confusing alphabet soup of acronyms that are all trying to describe an array of programs, possibly something similar or maybe even the same.

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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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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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Opportunities and challenges for user-generated licensing models 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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