Learn more about Peltz-Steele v. UMass Faculty Federation at Court Listener (complaint) and the Liberty Justice Center. The case is now on appeal in the First Circuit as no. 22-1466 (PACER paywall). Please direct media inquiries to Kristen Williamson.
Showing posts with label genetics. Show all posts
Showing posts with label genetics. Show all posts

Saturday, July 30, 2022

Rats reveal human history, sometimes set its course

RJ Peltz-Steele CC BY-NC-SA 4.0
A rat extermination program is well signed on the islands of the Azores.

As a tort lawyer, I can be a little obsessed with signs, especially warnings. So I was struck by the abundance of these signs on the islands of the Azores, specifically São Miguel, Terceira, and Pico, where I spent some time this month. The signs warn not to remove bait traps loaded with lethal rodenticide and not to litter, such as might provide food for rats.

Being a key port in the European age of discovery, the Azores are inextricably bound up with the history of human exploration and expansion. A remarkably successful species, rats are a part of that history, because they go where we go. The Azorean bat is the only native land mammal of the Azores. But people long ago brought more, including hedgehogs, rabbits, cats, and the islands' iconic cows, all besides, of course, rats.

The Azorean bat is found in dry forests. In contrast,
I am found here in the much wetter Reserva Florestal
Natural Parcial do Biscoito da Ferraria, on Terceira.
(Photo © Emma Falk, licensed exclusively.)
Unfortunately, the rats are now spreading a potentially fatal pathogen, leptospira, which threatens people and animals in the Azores. So officials have set about efforts to reduce the rat population.

There's been an abundance of research sequencing rat DNA to study the history of human exploration. For example, Gabriel, Mathias, & Searle (2014) studied rats in the Azores specifically. There are books on the history that rats and people share: Anthony Barnett's The Story of Rats (2002) and the New York City-focused Rats (2005) by New Yorker contributor Robert Sullivan. As the latter book suggests, rat research also informs contemporary urban development. Canadian "rat detective" Kaylee Byers wrote a fun first-person narrative for The Conversation (2019) on the value of "23andme" for rats.

Rats have a fan club.

The signs in the Azores reminded me in particular of a superb episode of the Throughline podcast in the spring, "Of Rats and Men," which well summarized the subject.

Monday, July 18, 2022

In law symposium, Enríquez follows up genetics book

CRISPR-Cas9 editing of the genome
(NIH Image Gallery CC BY-NC 2.0 via Flickr)
My friend and once-upon-a-time law student Paul Enríquez, J.D., LL.M., Ph.D. (LinkedIn, SSRN), in the spring published The Law, Science, and Policy of Genome Editing in the Boston University Law Review Online (2022).

Dr. Enríquez published the remarkable book Rewriting Nature: The Future of Genome Editing and How to Bridge the Gap Between Law and Science with Cambridge University Press last year. The BU Law Review then invited him to discuss his work as the centerpiece of a Zoom symposium, which I was privileged to attend, in the fall.

In the present article, Enríquez engages with and responds to the dialog of the symposium. Other contributors are Dana Carroll, Katherine Drabiak, Henry T. Greely, Jacob S. Sherkow, Sonia M. Suter, Naomi R. Cahn, Allison M. Whelan, and Michele Goodwin.

Here is the introduction.

Genome editing is the most significant breakthrough of our generation. Rewriting Nature explores the intersection of science, law, and policy as it relates to this powerful technology. Since the manuscript went to press, genome-editing developments have continued apace. Researchers have reported encouraging results from the first clinical trials to treat β-thalassemia and Sickle-Cell Disease, the first wheat-crop variety that is resistant to a crippling fungal disease and features no growth or yield deficits, and proof-of-concept data establishing the therapeutic effects of the first clinical trial involving the injection of a therapy directly into the bloodstream of patients suffering from a genetic, neurological disease. Chinese regulators promulgated rules to approve gene-edited crops. These and other developments are testament to the expansive reach and promise of genome editing. Rewriting Nature showcases the technology’s power to transform what we eat, how we provide healthcare, how we confront the challenges of global climate change, who we are as human beings, and more.

One of my goals in writing the book was to help spur robust dialogue and debate about the future of genome editing and the synergistic roles that law, science and public policy can play in promoting or hindering specific uses of the technology. I am grateful to the Boston University Law Review for organizing this symposium on Rewriting Nature and bringing together an extraordinary group of gifted scholars, academics, entrepreneurs, and thinkers, including several members of the National Academy of Sciences, as well as scientists and lawyers to engage in diverse discussions of my book.... I am encouraged by the consonance on a vast range of ideas among participants but even more so by the disagreement, as it presents opportunities for engagement and progress. My Essay, thus, focuses on the hard questions and challenges that spring from our disagreements, which allowed me to clarify, refine, and expand on ideas presented in Rewriting Nature and to articulate new ones that point towards future work.

Thursday, November 4, 2021

BU journal features Enríquez book on genome editing

Tomorrow, Friday, November 5, beginning at 10 a.m., the Boston University Law Review Online hosts an online symposium on the book, Rewriting Nature: The Future of Genome Editing and How to Bridge the Gap Between Law and Science.

The symposium features author Paul Enríquez, a law student of mine once upon a long time ago.  Dr. Enríquez's fascinating book was featured here on The Savory Tort in July. Here is the symposium précis (which is drawn from the book jacket):

History will mark the twenty-first century as the dawn of the age of precise genetic manipulation. Breakthroughs in genome editing are poised to enable humankind to fundamentally transform life on Earth. Those familiar with genome editing understand its potential to revolutionize civilization in ways that surpass the impact of the discovery of electricity and the development of gunpowder, the atomic bomb, or the Internet. Significant questions regarding how society should promote or hinder genome editing loom large in the horizon. And it is up to humans to decide the fate of this powerful technology. Please join the Boston University Law Review Online for a virtual and thought-provoking, interdisciplinary symposium on Rewriting Nature: The Future of Genome Editing and How to Bridge the Gap Between Law and Science (... 2021) to discuss the complex legal, scientific, policy, ethical, political, economic, and social issues concerning this emerging technology.

The book is available from Cambridge University Press and popular retailers.

Thursday, July 1, 2021

Genetic manipulation will transform humankind; Enríquez book aims to keep law, science in pace

Paul Enríquez, J.D., LL.M., Ph.D. (LinkedIn, SSRN) has published a must-have book for readers interested in the cutting-edge juncture of law and science.  A superb writer, Dr. Enríquez has geared the book for general audiences, while also offering plenty of thought-provoking flesh for lawyers and scientists alike to sink their teeth into.  And that's before science accidentally turns us into zombies.

Here is the précis of Rewriting Nature: The Future of Genome Editing and How to Bridge the Gap Between Law and Science from Cambridge University Press (2021).

History will mark the twenty-first century as the dawn of the age of precise genetic manipulation. Breakthroughs in genome editing are poised to enable humankind to fundamentally transform life on Earth. Those familiar with genome editing understand its potential to revolutionize civilization in ways that surpass the impact of the discovery of electricity and the development of gunpowder, the atomic bomb, or the Internet. Significant questions regarding how society should promote or hinder genome editing loom large in the horizon. And it is up to humans to decide the fate of this powerful technology. Rewriting Nature is a compelling, thought-provoking interdisciplinary exploration of the law, science, and policy of genome editing. The book guides readers through complex legal, scientific, ethical, political, economic, and social issues concerning this emerging technology, and challenges the conventional false dichotomy often associated with science and law, which contributes to a growing divide between both fields.

Besides being a family friend, Dr. Enríquez was, many moons ago, a student in one of my law classes: a rather impertinent fact I mention only to boast.  In truth, the student already had surpassed the mentor.  Nevertheless, he generously asked my feedback on some points of constitutional law for this book.  So I weaseled my way into the acknowledgments, and you can blame me if anything is wrong in the relevant chapter.

Here is the impressive About the Author:

Paul Enríquez, J.D., LL.M., Ph.D., is an intellectual property attorney and scientist who researches and writes at the intersection of law, science, and policy. He holds doctoral degrees in law and structural and molecular biochemistry. His research on law, science, and technology, genome editing, biochemistry, and the regulation of biotechnology, has been published in numerous scientific, legal, and popular-media publications, and has been presented at national and international conferences. He currently serves as a judicial clerk at the U.S. Court of Appeals for the Federal Circuit.

Buy yours now in hardback, paperback, or Kindle from Amazon.

Monday, July 15, 2019

'Genetically modified humans are among us'

An alum of my constitutional law class, Paul Enríquez, J.D., LL.M., Ph.D.—Structural and Molecular Biochemistry, is doing some stellar academic work at the cutting edge of genetic science and law and policy.  He privileged me with a sneak peak at his latest contribution to the legal literature, now available on SSRN, Editing Humanity: On the Precise Manipulation of DNA in Human Embryos, forthcoming in 97 N.C. L. Rev. Here is the abstract:

Genetically modified humans are among us. Emerging technologies for genome editing have launched humanity into the uncharted territory of modifying the human germline—namely, the reproductive cells and embryos that carry our genetic ancestry. Reports of the first live births of humans with edited genomes in China recently confirmed that the power to manipulate our genes at an embryonic stage is no longer theoretical. In the wake of enormous scientific progress, questions regarding how the law will treat this technological breakthrough abound.

This Article examines the legality of human genome editing, specifically germline genome editing (“GGE”), from administrative and constitutional law perspectives. It argues that the Food and Drug Administration’s (“FDA” or “Agency”) forbearance in claiming jurisdiction over GGE is creating a perilous void for an emerging field of law. At the same time, the contemporary de facto legislative ban on GGE clinical applications, which categorically prohibits the Agency from evaluating the safety and efficacy of any investigational new drug or biological product application derived from the technology, is unnecessary and creates more societal costs than benefits. On a broad scale, the ban embodies poor public policy because it prevents the FDA from exercising jurisdiction over matters that constitute extensions of the Agency’s traditional regulatory scope. An analysis of the law reveals salient regulatory gaps that could be viewed as rendering some types of GGE beyond the FDA’s regulatory reach. Notwithstanding those gaps, this Article argues that the FDA can work within the existing statutory framework to cure regulatory deficits and promulgate rules to regulate the technology and, thus, urges the FDA to exercise that jurisdiction. This Article ultimately demonstrates how law and policy converge into a proposed new regulatory paradigm for human GGE that flows from the D.C. Circuit’s ruling in United States v. Regenerative Sciences, LLC, which held that specific stem cell mixtures can be regulated as drugs or biological products within the meaning of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act.

This Article further contends that efforts to ban GGE technologies cannot withstand constitutional scrutiny in the long run because they impinge on a cognizable fundamental right that protects select uses of GGE. This fundamental right flows from jurisprudence in the areas of procreative, parental, and—to some extent—privacy rights, but it is not absolute. The Article presents an interpretive model for this body of jurisprudence in the GGE context, which promotes extrapolation of applicable legal principles that can guide and promote coherent public policy. Launching from this jurisprudential departing point, this Article introduces a novel legal- and science-based normative framework to delineate primary limits for a right to perform GGE based upon four distinct categories: (1) therapeutic uses to remedy disease; (2) prophylactic purposes, which may or may not be therapeutic; (3) cosmetic or enhancement purposes; and (4) uses involving modification of traits that raise concerns of discrimination already prohibited by the law. This conceptual and structural approach outlines a legal blueprint for GGE clinical interventions, but more importantly it circumvents problems that dominate the existing literature, which arise from the conventional tendency to group GGE applications into therapeutic uses on one hand, and enhancements on the other.