On June 20th, the Petrie-Flom Center welcomed Susannah Baruch on board as its new Executive Director.
Susannah comes to the Petrie-Flom Center with expertise in reproductive health law policy, genetics, and genomics, and a wealth of experience in nonprofits, academia, and government. We asked Susannah to share a bit about herself and her past work by way of introduction to Bill of Health’s readers.
The following interview has been edited and condensed.
By Matthew Chun
He Jiankui — a high-profile Chinese scientist convicted for conducting unethical gene-editing experiments — has been released from prison and is currently fundraising for his new gene therapy endeavor. As the scientific community grapples with how to respond, theories of criminal justice can provide important perspectives to better inform the conversation surrounding Dr. He’s return to research.
By Myrisha S. Lewis
Despite religious and ethical objections, assisted reproductive technology (ART), including in vitro fertilization and egg freezing, manages to flourish in the United States, with some states and companies even creating regimes for its insurance coverage. However, reproductive genetic innovation — a term I use to refer to the combination of assisted reproduction with genetic modification or substitution — has yet to receive the same acceptance. Examples of reproductive genetic innovation include mitochondrial transfer, cytoplasmic transfer, and germline gene editing.
Moreover, while many scientists, regulators, and members of the public have called for societal discourse or consensus related to individual reproductive genetic innovation techniques, these calls rarely include an explanation as to how these discourses would be conducted. In a recent article, Normalizing Reproductive Genetic Innovation, I offer four potential avenues for structuring a societal discourse in the U.S. on the topic.
By Emily Michiko Morris
Professor Jorge Contreras’ commentary on the Patent Eligibility Restoration Act of 2022 objects to Senator Thom Tillis’ recently introduced bill. Specifically, he argues that proposed inclusion of isolated and purified human genes and other naturally occurring substances as patent eligible subject matter is unnecessary and would both stymie research and obstruct access to medicine. But the truth is these criticisms rely mostly on narrative and anecdote rather than rigorous empirical evidence. (Professor Contreras has written an article acknowledging the many narratives behind the gene patenting debate: see Narratives of Gene Patenting, 43 Fla. St. U. L. Rev. 1133 (2016)).
By Jorge Contreras
In its unanimous 2013 decision in Association for Molecular Pathology v. Myriad Genetics (569 U.S. 576) the U.S. Supreme Court held that naturally occurring genomic sequences are not eligible for patent protection. Not surprisingly, some representatives of the biotechnology industry, and many patent lawyers, reacted negatively to the decision, and have steadily lobbied Congress to restore patent protection for isolated and purified genomic sequences. On August 2, 2022, Senator Thom Tillis (R-NC) accommodated them with the Patent Eligibility Restoration Act of 2022, a bill that, if enacted into law, would reverse the Myriad decision and a decade of subsequent legal developments. Such a reversal would have serious implications not only for access to healthcare, but also the ability to respond rapidly and effectively to new viral outbreaks.
By James Toomey
Researchers believe that gene drives could eliminate vector-borne diseases such as malaria, by modifying mosquito species or eradicating those that carry disease, kill off invasive species, and combat the growing problem of pesticide resistance.
A gene drive is a technique for genetically modifying entire species of wild organisms. Genetically modified individuals of the species are released into the wild, so as to raise the probability that a particular gene will be passed onto the species’ progeny via reproduction.
Over the course of many generations, the gene — even if detrimental — can spread to an entire population.
But as of now, this is all hypothetical. No gene drive has been tested in the wild, and many people are skeptical that they should ever be used.
The GeneConvene Global Collaborative, a project of the Foundation for the National Institutes of Health, was started this past July to promote the responsible development and regulation of gene drive technologies. It brings together researchers, regulators and stakeholders around the world to develop best practices for gene drive research and implementation.
Because of my prior writing on this topic, I participated in GeneConvene’s fall webinar series and spoke with scientists there about the project. Read More
By Shelly Simana
Gene editing technologies enable people to directly change their DNA sequence by adding, removing, or replacing DNA bases. Today, for the first time, as Jennifer Doudna and Samuel Sternberg announced in their book, A Crack in Creation: Gene Editing and the Unthinkable Power to Control Evolution, people “possess the ability to edit not only the DNA of every living human but also the DNA of future generations” (p. xvi). The emergence of new gene editing tools, such as CRISPR-Cas9, prime editing, and dubbed SATI, has led to momentous advances in biotechnology as the new tools make gene editing faster, easier, less expensive, and more precise than ever before.
While gene editing technologies offer great promise, they may also introduce risks with far-reaching consequences. This post focuses on the possible “dark side” of gene editing technologies and addresses some threats that the technologies might pose to human lives. While nowadays some of those risks would be deemed “science fiction,” they should be in the back of our minds as we ponder the potential impact of gene editing technologies.
This post is part of our Eighth Annual Health Law Year in P/Review symposium. You can read all of the posts in the series here. Review the conference’s full agenda and register for the event on the Petrie-Flom Center’s website.
By Prof. I. Glenn Cohen and Kaitlyn Dowling
The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics is excited to host the Eighth Annual Health Law Year in P/Review to be held at Harvard Law School December 6, 2019. This one-day conference is free and open to the public and will convene leading experts across health law policy, health sciences, technology, and ethics to discuss major developments in the field over the past year and invites them to contemplate what 2020 may hold. This year’s event will focus on developments in health information technology, the challenge of increasing health care coverage, immigration, the 2020 election, gene editing, and drug pricing, among other topic areas.
As we come to the end of another year in health law, the event will give us both a post-mortem on the biggest trends in 2019 and also some predictions on what’s to come in 2020.
Among the topics we will discuss: Read More
By Phebe Hong
Nine months have passed since the startling news broke in November 2018 that Chinese researcher He Jiankui had used CRISPR/Cas9 to genetically modify the embryos of twin girls. The controversial news spurred the scientific and regulatory community into action. In late August 2019, two influential organizations — one from the private sector and one from the public sector — independently released statements announcing their efforts to establish standards for the nascent field of gene editing.
First, the Alliance for Regenerative Medicine (ARM), the advocacy organization representing cell and gene therapy companies, released its “Therapeutic Developers’ Statement of Principles,” offering an industry perspective on the use of gene editing technologies. Shortly thereafter, the World Health Organization (WHO) announced its plans to build a new registry and governance framework to track and regulate human gene editing trials. The statements symbolize an initial step by both private and public organizations to build consensus around responsible stewardship principles to prevent future scientific and ethical transgressions. It remains to be seen how such statements and plans will be implemented and how they will influence the field of genome editing research going forward.
By Marnie Gelbart and Nadine Vincenten
Direct-to-consumer (DTC) genetic testing has entered our world with a big splash and opened the flood gates of genetic information. For over a decade, we have been out talking with people from all walks of life and listening to their stories. Whether we are speaking with scientists or non-scientists, we hear excitement, concerns, ambivalence – sometimes all three at the same time – and not surprisingly, many many questions as people try to make sense of it all.
Susan Domchek, executive director of the Basser Center for BRCA, recalls counseling a patient with a family history of breast, ovarian, and colon cancer. This patient had taken a DTC genetic test that looked at her BRCA genes, and the results led her to conclude that she was not at risk for the cancers that had burdened her family. However, the patient did not realize that the test only looked at 3 of the over 1,000 BRCA variants linked to an increased cancer risk. And because the test did not look at other genes implicated in cancer, the physician recognized that it may have underestimated her patient’s risk. What if the patient had seen a doctor who did not understand the limitations of the test? Might she have avoided taking potentially life-saving precautions? Read More
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