close up of an open book

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

Illustration of four people helping each other climb progressively taller stacks of books

What’s Missing From Biotech Graduate Education? With Free Course, RA Capital Attempts to Fill the Gaps

By Jessica Sagers

As a PhD student in the life sciences at Harvard, I attended almost every career seminar that came through my inbox. I had no idea what I wanted to do after finishing my research doctorate, but I was certain that it wasn’t more cell culture.

The walls of my academic bubble were so thick that even as a budding cell biologist, I’d managed to hear almost nothing about Boston’s booming biotech industry. “Going into industry” was regarded as an “alternative career,” to the point where it sounded like taking a job outside of academia was tantamount to abandoning science. Besides, all my training had been in basic science. The coursework I’d excelled in, from neurobiology to biophysics, did not equip me to translate what I’d learned to the business world.

During my final PhD year, curiosity about the biotech sector drove me to accept an internship at RA Capital Management, a life science-focused investment firm in Boston. Dr. Peter Kolchinsky (Harvard Program in Virology, ’01), Founder and Managing Partner of RA Capital, brought me and a group of fellow PhD students on board to help achieve his vision of providing more pragmatic, focused training to scientists and professionals interested in working in biotechnology. Together, we designed a short, advanced course on the business of biotech designed to fit the practical needs of late-stage graduate students and early-career professionals.

Read More

Uncertainty and Immutability: Arguments for Genetic Nondiscrimination

By Kaitlyn Dowling, based on research by the Cyberlaw Clinic at the Berkman Klein Center for Internet & Society

Illustration of a gavel made out of a DNA helixIn a year-long series on Bill of Health, we’ll be exploring the legal scholarship on genetic non- discrimination. We’ll talk more about GINA and state laws protecting citizens from genetic discrimination. We hope these posts help shed light on this complex and ever-more-relevant area for legal scholars, policymakers, and the public at large. Read the previous posts in the series.

We’ve covered the history of genetic non-discrimination legislation and the potential risks of being discriminated against in housing and lending and education based on genetic data. Those risks are clear: there are many reasons why a bank, landlord, or school might want to take a person’s genetic information (and, thus, their potential future health) into account. Let’s take a deeper dive into two broad arguments in favor of strong privacy protections for genetic information and their consequences.

 

Uncertainty

A common policy argument in favor of genetic non-discrimination legislation is that genetic discrimination is unjust because the outcomes implicated by one’s genes may never manifest. In 2001, President George W. Bush stated that “[g]enetic discrimination is unfair to workers and their families. It is unjustified – among other reasons, because it involves little more than medical speculation. A genetic predisposition toward cancer or heart disease does not mean the condition will develop.” Read More

Soft-focus photograph of wheelchairs lined up in a hospital hallway

Toward a Safer NHS in 2020

By John Tingle

As the New Year begins its important to reflect on the previous year’s National Health Service (NHS) patient safety milestones in England. We should ask also whether the NHS patient safety agenda will make major advances in 2020.

The year 2019 was another bumper year for NHS patient safety policy developments and crises. Some major patient safety publications were produced, and stories of NHS patient safety crisis continued to regularly hit the headlines. The NHS is no sloth when it comes to patient safety policy report writing and the number patient safety adverse incidents happening. Read More

U.S.-Mexico border wall in Texas near a dirt road

Targeting Health: How Anti-Immigrant Policies Threaten Our Health & Our Humanity

By Patricia Illingworth and Wendy E. Parmet

On May 19th of last year, Carlos Gregorio Hernandez Vasquez died of the flu while being held in a cell by U.S. Customs and Border Protection (CBP) in south Texas. He was just 16, a migrant from Guatemala. Hours before his death, when his fever spiked to 103, a nurse suggested that he be checked again in a few hours and taken to the emergency room if he got any worse. Instead, Carlos was moved to a cell and isolated. By morning, he was dead.

Sadly, Carlos’s substandard medical treatment was not an isolated case. Between December 2018 and May 20, 2019, five migrant children died while in federal custody. All of them were from Guatemala. Their deaths were not accidental. Rather, they died as a consequence of harsh policies that are designed to deter immigration, in part, by making life itself precarious for migrants.

Since taking office, the Trump administration has instituted a wide-ranging crackdown on immigration. A surprising number of the policies the administration has instituted as part of that crackdown relate directly or indirectly to health. For example, in addition to providing inadequate treatment to sick migrants, CBP has refused to provide flu shots to detainees, despite the fact that influenza, like other infectious diseases, can spread rapidly in overcrowded detention facilities. In dismissing a CDC recommendation to provide the vaccines, CBP cited the complexity of administering vaccines and the fact that most migrants spend less than 72 hours in its custody before being transferred to other agencies, or returned to Mexico. These explanations lack credibility given how easy it is to administer flu vaccines. Read More

Large pile of amber prescription pill bottles

Recent Litigation Developments Regarding Drug Pricing and Access

This post originally appeared on SLS Blogs and is reposted with permission of the author. You can read the piece in its entirety here.

By Rebecca Wolitz

With multi-million dollar treatments entering the market, prescription drug costs accounting for between 15-17% of healthcare expenditures, and nearly 1 in 4 Americans unable to afford a prescription medication in the past 12 months, it is no wonder that prescription drug costs remain an important topic of national discussion. There has been a flurry of legislative proposals at both the federal and state levels this year, with Nancy Pelosi’s H.R. 3 recently passing the House. And, within the executive branch, HHS just issued its drug importation proposal. Both of these developments have been within the past few weeks; there is a lot going on. Not to mention we are heading into an election year. Read More

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Naughty or Nice 2019? Guests, Zack Buck, John Cogan, and Jennifer Oliva

Ho-ho-ho! It’s the return of “Who’s Been Naughty or Nice?,” TWIHL’s infamous Holiday show. This year’s festive appreciation of those who work in the health care law and policy workshop features the seasonal vocalizations of Zack Buck, John Cogan, and Jennifer Oliva. Nominees for both naughty and nice include a wealth of administration players and policies, plenty of good and bad Medicaid news, drug pricing, and a whole lot more to fill our stockings and remind us that the consumption of prodigious amounts of egg nog is increasingly a quid pro quo for health law and policy work.

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.

A frustrated woman sits at her desk, staring at her computer. Her head is resting in her hand

Patient-Directed Uses vs. The Platform

By Adrian Gropper, MD

This post originally appeared on The Health Care Blog.

This piece is part of the series “The Health Data Goldilocks Dilemma: Sharing? Privacy? Both?” which explores whether it’s possible to advance interoperability while maintaining privacy. Check out other pieces in the series here.

It’s 2023. Alice, a patient at Ascension Seton Medical Center Austin, decides to get a second opinion at Mayo Clinic. She’s heard great things about Mayo’s collaboration with Google that everyone calls “The Platform”. Alice is worried, and hoping Mayo’s version of Dr. Google says something more than Ascension’s version of Dr. Google. Is her Ascension doctor also using The Platform?

Alice makes an appointment in the breast cancer practice using the Mayo patient portal. Mayo asks permission to access her health records. Alice is offered two choices, one uses HIPAA without her consent and the other is under her control. Her choice is: 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?

Read More

Stacks of books against a burgundy wall

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 November. The selections feature topics ranging from the impact of state laws restricting opioid duration, to Medicare spending on drugs and biologics not recommended by the international health technology assessment agencies, to a randomized study of providing evidence context to mitigate physician misinterpretation from off-label drug promotion. A full posting of abstracts/summaries of these articles may be found on our website. Read More