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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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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Childhood Flu Vaccination and Home Rule in the Big Apple

Baby was receiving his scheduled vaccine injection in his right

The New York City Board of Health requires children between 6 months and 5 years to receive a flu shot. (Amanda Mills/USCDCP)

By Nicholas J. Diamond

On June 28, the State of New York Court of Appeals upheld a New York City Board of Health requirement that children between the ages of 6 months and 5 years old attending city-regulated child care or school-based programs receive flu vaccinations.

While New York City is no stranger to progressive public health initiatives, this ruling in particular is significant on at least two accounts. First, it strengthens New York City’s ability to confer the public health benefits of flu vaccination to a wider segment of the adolescent population, consistent with current recommendations. Second, it stands as a reminder of the important role that local health authorities, like boards of health, can play in improving population health, if granted sufficient authority under state law.

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NIMBYism continues to factor into supervised injection site policies

supervised injection site

Insite, in Vancouver, Canada, is a supervised injection facility. (Screengrab via HCLU/Vimeo)

By Daniel Goldberg

As a major tool in harm reduction policy connected to opioid and substance misuse, more than 30 states have implemented syringe exchange programs, or SEPs.

Surmounting or, in many cases, bypassing the considerable legal and political obstacles has proved a challenge for states, whether they succeeded in enacting SEPs or not. While, given the opioid crisis, SEPs are more important than ever, they do have limitations.

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The Intersection of Human Trafficking and Immigration

By Stephen P. Wood

57,000.

That is the appalling number of individuals estimated to be involved in human trafficking in the United States, and it is more than likely a relatively conservative estimate.

Even more appalling is that there are approximately 50 million people who are victims of human trafficking worldwide. This is an industry driven by sex, with 80 percent of trafficked individuals engaged in sex trafficking of some form.

Woman account for about 80 percent of individuals involved in sex-trafficking, with some estimates stating that a quarter of these cases involve minor children. The average age for females at the time of entry into sex-trafficking is thought to be between 17–19 years old.

Victims of both sex and labor trafficking include United States citizens, but also many foreign nationals, mostly from Mexico, Central and South America, as well as the Caribbean. Now more than ever, these victims of a horrific crime are at significant risk, not just from their traffickers but from something else that can cause significant harm: the fear of deportation.

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The non-capture capture of “patient voice.” Isn’t it ironic?

doctor and patient talk

One challenge of Patient Centered Outcomes Research is to make sure the patient voice isn’t “captured.”

 

Register here for this weeks’s event, “Putting Patients at the Center of Research: Opportunities and Challenges for Ethical and Regulatory Oversight”

By Paul McLean

In a previous life I was a headline writer, so I have to give props for the title of this Friday’s Petrie-Flom panel: “Patients and Conflict of Interest: How Can We Keep the Patient’s Voice from Being ‘Captured’?

That is, how do you avoid “capturing” the patient voice when “capturing” the patient voice is the whole point of Patient Centered Outcomes Research? And yet this is a central challenge to bringing expertise unique to the receiving end of medicine and research into all levels of the process.

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