a pill in place of a model globe

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

By Ameet SarpatwariBeatrice Brown, Neeraj Patel, 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.

Below are the citations for papers identified from the month of August. The selections feature topics ranging from a commentary on the need for rigorous scientific evaluation of COVID-19 vaccine candidates in the face of political and economic pressures, to an evaluation of patients’ and pharmacists’ experiences with pill appearance changes, to an examination of the extent and cost of potentially inappropriate prescription drug prescriptions for older adults. A full posting of abstracts/summaries of these articles may be found on our website.

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Syringe and vials of vaccine.

How Does Moderna’s COVID-19 Vaccine Work, and Who Is Funding Its Development?

Cross-posted from Written Description, where it originally appeared on August 19, 2020. 

By Jacob S. Sherkow, Lisa Larrimore Ouellette, Nicholson Price, and Rachel Sachs

Moderna, Inc., a Cambridge, MA-based biotech company, is a leading contender in the race to develop a SARS-CoV-2 vaccine. Moderna’s vaccine, however, works using a completely novel mechanism, unlike any other vaccine currently approved anywhere in the world. Despite this, the U.S. government—and two agencies in particular, the NIH and Biomedical Advanced Research and Development Authority (BARDA)—has invested, heavily, in the vaccine’s development. This week, we explore how these investments interact through different forms of research partnerships, and what this says about IP, novel technologies, and innovation policy.

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a pile of vaccine vials and a needle

COVID-19 Vaccine Advance Purchases Explained

Cross-posted from Written Description, where it originally appeared on August 5, 2020. 

By Nicholson PriceRachel SachsJacob S. Sherkow, and Lisa Larrimore Ouellette

No vaccine for the novel coronavirus has been approved anywhere. Nevertheless, governments and international organizations around the world are announcing deals for billions of dollars to procure tens of millions of doses of vaccines from companies that are still running clinical trials, including a $2.1 billion deal with Sanofi and GSK announced by the US on Friday. What’s going on? And what do these deals tell us about innovation policy for COVID-19 vaccines? In this post, we lay out the landscape of COVID-19 vaccine pre-purchases; we then turn to the innovation impact of these commitments, and finish by asking what role patents and compulsory licensing have to play.
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a covid 19 swab test being inserted into a vile

Maintaining Healthy Skepticism About Reported COVID-19 Findings

By Andy Podgurski and Sharona Hoffman

The COVID-19 pandemic presents special challenges to even well-informed and well-intentioned promulgators and consumers of medical research findings, including the legal community.

The stakes in the debate about handling the pandemic are extremely high in terms of lives, jobs, wealth, and political power. In addition, there are tremendous opportunities for researchers to receive attention and notoriety for influencing the debate.

All this means that perverse incentives exist to publicize initial scientific findings that are dubious, poorly vetted, and possibly dangerous to public welfare. The risk of promulgating false or misleading scientific claims is substantial, even when they are made by well-respected scientists affiliated with prestigious institutions. Government authorities must be extremely cautious about basing public policy decisions on inadequately vetted findings, no matter how much hype they get.

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Photograph of colorful academic journals on a library shelf

Making an Impact: Journal of Law and the Biosciences Scores High

The Journal of Law and the Biosciences is the first fully open-access, peer-reviewed, legal journal focused on the advances at the intersection of law and the biosciences. JLB is co-edited by Profs. I. Glenn Cohen (Harvard Law School), Nita Farahany (Duke University School of Law), and Hank Greely (Stanford Law School). JLB contains original and response articles, essays, and commentaries on a wide range of topics, including bioethics, neuroethics, genetics, reproductive technologies, stem cells, enhancement, patent law, and food and drug regulation. JLB is published as one volume with three issues per year, with new articles posted online on an ongoing basis.

The Journal of Law and the Biosciences recently received a journal impact factor of 2.431, making it one of the most cited, influential journals in its fields. In fact, JLB ranks 14 out of 148 law journals and is ranked third out of sixteen in the areas of both medical ethics and legal medicine.

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Picture of doctor neck down using an ipad with digital health graphics superimposed

Is Data Sharing Caring Enough About Patient Privacy? Part II: Potential Impact on US Data Sharing Regulations

A recent US lawsuit highlights crucial challenges at the interface of data utility, patient privacy & data misuse

By Timo Minssen (CeBIL, UCPH), Sara Gerke & Carmel Shachar

Earlier, we discussed the new suit filed against Google, the University of Chicago (UC), and UChicago Medicine, focusing on the disclosure of patient data from UC to Google. This piece goes beyond the background to consider the potential impact of this lawsuit, in the U.S., as well as placing the lawsuit in the context of other trends in data privacy and security.

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Image of binary and dna

Is Data Sharing Caring Enough About Patient Privacy? Part I: The Background

By Timo Minssen (CeBIL, UCPH), Sara Gerke & Carmel Shachar

A recent US lawsuit highlights crucial challenges at the interface of data utility, patient privacy & data misuse

The huge prospects of artificial intelligence and machine learning (ML), as well as the increasing trend toward public-private partnerships in biomedical innovation, stress the importance of an effective governance and regulation of data sharing in the health and life sciences. Cutting-edge biomedical research strongly demands high-quality data to ensure safe and effective health products. It is often argued that greater access to individual patient data collections stored in hospitals’ medical records systems may considerably advance medical science and improve patient care. However, as public and private actors attempt to gain access to such high-quality data to train their advanced algorithms, a number of sensitive ethical and legal aspects also need to be carefully considered. Besides giving rise to safety, antitrust, trade secrets, and intellectual property issues, such practices have resulted in serious concerns with regard to patient privacy, confidentiality, and the commitments made to patients via appropriate informed consent processes.

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Group of people of various ages and ethnicities sitting in a circle talking. At least one of the people is in a wheelchair.

Rethinking Inclusivity in Precision Medicine Research: The Disability Experience and Barriers to Participation

By Maya Sabatello and Paul S. Appelbaum

One of the most important aspects of precision medicine research is its focus on inclusion of diverse groups. The reality is that without cohort diversity, it will be impossible for precision medicine research to deliver on its promise to provide prevention and therapeutic options that are tailored to each individual’s genetic makeup, environment, and lifestyle choices across diverse groups. And, as the scientific community, including the national All of Us Research Program, increasingly has come to realize, for precision medicine to reduce—rather than magnify—health disparities, it is critical to ensure that historically marginalized communities are included in this research endeavor. Read More

close up of human eye

The Luxturna Debate: Why Ethics Needs a Seat at the Drug Pricing Table

By Clio Sophia Koller

Jack Hogan can now ride his bike home at dusk after an afternoon of playing with his friends. Is that childhood rite-of-passage worth $850,000?

Recently, the Health Policy and Bioethics Consortium convened by Harvard Medical School’s Center for Bioethics and the Program on Regulation, Therapeutics, and Law (PORTAL) at Brigham and Women’s Hospital met to discuss the implications of Spark Therapeutics’ new gene therapy treatment—along with its staggering price tag.

Luxturna, a novel therapy approved by the FDA last year, treats a rare form of inherited blindness known as retinitis pigmentosa. The therapeutic agent targets the RPE65 gene, associated with the disorder, and is shown to improve vision in a population with progressive vision-loss and an inability to see in dim light. Read More