hospital equipment, including heart rate monitor and oxygen monitor functioning at bedside.

Why COVID-19 is a Chronic Health Concern for the US

By Daniel Aaron

The U.S. government has ratified a record-breaking $2 trillion stimulus package just as it has soared past 100,000 coronavirus cases and 1,500 deaths (as of March 27). The U.S. now has the most cases of any country—this despite undercounting due to continuing problems in testing Americans on account of various scientific and policy failures.

Coronavirus has scared Americans. Public health officials and physicians are urging people to stay at home because this disease kills. Many have invoked the language of war, implying a temporary battle against a foreign foe. This framing, though it may galvanize quick support, disregards our own systematic policy failures to prevent, test, and trace coronavirus, and the more general need to solve important policy problems.

Coronavirus is an acute problem at the individual level, but nationally it represents a chronic concern. No doubt, developing innovative ways to increase the number of ventilators, recruit health care workers, and improve hospital capacity will save lives in the short-term — despite mixed messages from the federal government. But a long-term perspective is needed to address the serious problems underlying our country’s systemic failures across public health.

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When it comes to opioids, it’s all about turf.

By Stephen Wood

When it comes to selling opioids, turf matters. Access to customers and geography play a role in the day to day sales of opioids. This often means selling in areas where there is a wanting and willing customer base with funds to spare. It also means picking a spot, a corner, where enforcement is low or where corruption can overcome most legal problems. The delivery can’t be too conspicuous. It needs to be hidden from plain sight, done in the shadows or alleyways where no one is looking. It’s a craft and when done right can lead to fistfuls of cash in the hands of the distributor, the dealer.

This may sound like a street-level drug deal, but it isn’t. It’s the tactic many American pharmaceutical companies are taking in response to increased regulation on prescription opioids. Like the stealth and shadowy moves of a street-level dealer, American pharmaceutical companies have moved their turf to new, mostly naïve markets to sell their wares. They have done this to escape the federal regulations that have limited their market; a response to the opioid crisis that has seen hundreds of thousands of lives affected by substance use disorder or lost to overdose.

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

By Ameet Sarpatwari, Charlie Lee, Frazer Tessema, 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 December. The selections feature topics ranging from potential Medicare savings on inhaler prescriptions through use of negotiated prices and a defined formulary, to evaluation of the REMS for extended-release/long-acting opioids, to the costs of medication non-adherence in adults with atherosclerotic cardiovascular disease in the US. A full posting of abstracts/summaries of these articles may be found on our website. Read More

Several vaping devices on a table

E-Cigarette Laws that Work for Everyone

By Daniel Aaron

The Trump Administration has retreated from proposed tobacco regulations that experts generally agree would benefit public health. The regulations would have included a ban on flavored e-cigarettes, a favorite of children who use e-cigarettes. Currently millions of youth are estimated to be addicted to e-cigarettes.

The rules also could have reduced nicotine in cigarettes to non-addictive levels. Nicotine is the addicting substance largely responsible for continued smoking. If nicotine were “decoupled” from smoking, smokers might turn to other sources of nicotine, rather than continuing to smoke. Smoking is the leading cause of preventable death in the U.S., killing about 500,000 Americans each year, or just about the number of Americans who died in World War I and World War II combined.

Part of the difficulty in regulating e-cigarettes is that, unlike cigarettes, they offer benefits and harms that differ across generations. This concern is called intergenerational equity. How can a solution be crafted that serves all Americans?

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Pile of colorful pills in blister packs

Promises and Perils of Prescription Drug Monitoring Programs: Workshop Report

This piece was part of a symposium featuring commentary from participants in the Center for Health Policy and Law’s annual conference, Promises and Perils of Emerging Health Innovations, held on April 11-12, 2019 at Northeastern University School of Law. The symposium was originally posted through the Northeastern University Law Review Online Forum.

Promises and Perils of Emerging Health Innovations Blog Symposium

We are pleased to present this symposium featuring commentary from participants in the Center for Health Policy and Law’s annual conference, Promises and Perils of Emerging Health Innovations, held on April 11-12, 2019 at Northeastern University School of Law. As a note, additional detailed analyses of issues discussed during the conference will be published in the upcoming Winter Issue of the Northeastern University Law Review.

Throughout the two-day conference, speakers and attendees discussed how innovations, including artificial intelligence, robotics, mobile technology, gene therapies, pharmaceuticals, big data analytics, tele- and virtual health care delivery, and new models of delivery, such as accountable care organizations (ACOs), retail clinics, and medical-legal partnerships (MLPs), have entered and changed the healthcare market. More dramatic innovations and market disruptions are likely in the years to come. These new technologies and market disruptions offer immense promise to advance health care quality and efficiency, as well as improve provider and patient engagement. Success will depend, however, on careful consideration of potential perils and well-planned interventions to ensure new methods ultimately further, rather than diminish, the health of patients, especially those who are the most vulnerable.

In the final post of the Promises and Perils of Emerging Health Innovations blog symposium, Leo Beletsky and the team from Health in Justice Action Lab provide a summary of an event held in conjunction with the Center for Health Policy and Law’s 2019 annual health law conference. The Promises and Perils of Prescription Drug Monitoring Programs (PDMPs) workshop was held on April 13, 2019 and convened experts, practitioners, experts, and other stakeholders to brainstorm strategies with the goal to “maximize the benefits of PDMPs, while minimizing harms.” Visit the Health in Justice Action Lab website (linked below) for information on this and other projects underway. 

Promises and Perils of Prescription Drug Monitoring Programs: Workshop Report

By Health in Justice Action Lab

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New TWIHL with Melissa Keyes, Heather Walter-McCabe, Stacey Tovino, & Ruqaiijah Yearby

By Nicolas Terry

This episode was recorded at our recent conference entitled Getting Real About Health Care for All. An outstanding panel at the conference was asked the question, “Can We Make Health Care Inclusive?” To answer that question we welcomed Melissa Keyes, Heather Walter-McCabe, Stacey Tovino, and Ruqaiijah Yearby. They approached the question from the perspective of those commonly excluded from quality healthcare; those along the capacity spectrum, members of the LGBTQ communities, those suffering from mental health or substance use disorders, and those requiring home or facility-based long-term care.

The Week in Health Law Podcast from Nicolas Terry is a commuting-length discussion about some of the more thorny issues in health law and policy. Subscribe at Apple Podcasts or Google Play, listen at Stitcher Radio, SpotifyTunein or Podbean.

Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find me on Twitter @nicolasterry or @WeekInHealthLaw.

Subscribe to TWIHL here!

Close up of the Lady of Justice statue

The Privatization of Opioid Litigation

By Dan Aaron

As the opioid litigation continues over the shadow of one of our nation’s most pressing public health crises, some criticism has been levied at private lawyers representing the cities, counties, states, and individuals harmed by the crisis. For example, see the following tweet:

Let’s work out tax and healthcare financing policy county by county, with private lawyers taking a 25% cut every time. Judge Polster seems to like this idea.

The critiques are many, but can be summarized: (1) private lawyers are being enriched; (2) private lawyers are setting opioid policy; (3) private lawyers have misaligned incentives; and (4) private lawyers will not support public health.

Arguably, all these arguments bear some truth. However, do they suggest that the opioid litigation is incorrigibly tainted and tort litigation the improper avenue to address mass torts such as the opioid crisis?

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Ohio state flags waving in front of the Ohio State House

Ohio’s Efforts to Centralize Control Over Opioid Claims

By Daniel Aaron

On October 21, two Ohio counties are slated to present their opioid claims in a federal trial. However, last week, 13 states and the District of Columbia signed onto a brief requesting that the 6th Circuit Court of Appeals stay the upcoming trials. Their reasoning? States should control lawsuits for harms within the state; cities and counties do not have authority to sue on their own. While it makes sense that Ohio’s attorney general, spearheading this effort, would want more power and control over opioid claims, the move has the potential to harm public health by disempowering local governments from addressing public health crises. Ohio’s three main arguments will be discussed in turn.

Argument 1: Violation of State Sovereignty

First, Ohio argues that the county lawsuits violate state sovereignty and disrupt the “federal dual-sovereign structure” of the United States:

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Big Ruling in Philadelphia: The Controlled Substances Act does not forbid a safe drug consumption room

By Scott Burris

Federal District Judge Gerald McHugh of the Eastern District of Pennsylvania ruled today that the operation of a safe injection site to prevent overdose, HIV, and other harms associated with drug injection would not violate the federal Controlled Substances Act.  The ruling came in an action for declaratory and injunctive relief brought by the local U.S. Attorney, seeking to prevent the opening of “Safehouse” by a private group led by former Pennsylvania Governor and Philadelphia Mayor Edward G. Rendell. The judge denied the requested relief.

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Photograph of Purdue Pharma headquarters

The Role of Attorneys General in the Opioid Litigation

By Daniel Aaron

People following the opioid lawsuits might have noticed some strange headlines as of late. Virtually every state’s attorney general (AG) is suing Purdue Pharmaceuticals, maker of the blockbuster drug OxyContin. Purdue filed for bankruptcy and is hoping to settle for “$10 billion.” However, the deal only includes $4.4 billion in cash, which is less than the Sackler family, owners of Purdue, transferred to personal accounts over the past decade. In other words, the amount of money the Sacklers made from the opioid epidemic is more than what they will pay more than forty states to help abate the crisis. Is anyone supporting this deal?

Yes, in fact, and this is where the plot thickens. With several exceptions, support for the deal falls along party lines: Republican AGs support the deal, and Democratic AGs oppose it. Why does a decision about settling with an opioid company appear to be political? What is the role of an attorney general? And are they supposed to defend public health?

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