Black and white photo of a line of dominoes toppling over

The (Possible) “Dark Side” of Gene Editing Technologies

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-Cas9prime 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.

Gene Editing as a Weapon of Mass Destruction Read More

Eighth Annual Health Law Year in P/Review: Looking Back & Reaching Ahead

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

Illustration of a scientist editing a DNA strand

Establishing Standards for Gene Editing: Initial Steps from Private and Public Actors

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.

Read More

Consumer Genetics: To Test or Not to Test?

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 storiesWhether we are speaking with scientists or non-scientists, whear 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

image of a genetic screen

How Might we Approach Discussions on the Implications of Using Genetic Data from a Human Rights or Social Justice Perspective?

By Alicia Ely Yamin and Jonathan Chernoguz

To complement the Petrie-Flom Center’s annual conference this year, Consuming Genetics, the Global Health and Rights Project at Petrie-Flom (GHRP) convened a small meeting of feminists, students, and other activists. On May 16, Harvard University’s Global Health Education and Learning Incubator , which co-sponsors GHRP, hosted the forum in conjunction with Marcy Darnovsky and Katie Hasson of Center for Genetics and Society (CGS).

Focusing on “Gene Editing, Ethics, Rights and Health Equity Issues,” and in particular the irrevocability of germline gene editing, the meeting began with Marcy Darnovsky, Executive Director of CGS asking, “How might we begin the discussion from [the perspective of] human rights, feminism, equity, and social justice, rather than from the science and biotechnology?”

This question echoed some of those posed during the Consuming Genetics conference, for example, by Jonathan Kahn in interrogating the equivocation of social diversity and empirical diversity in genomic research.  Read More

Cartoon image of a protein attached to a DNA double helix that has been spliced

Regulation of Human Genome Editing in the Dawn of the CRISPR Era

By Scott J. Schweikart

With the advent of CRISPR and the first babies born with edited genomes, gene editing technology is now cheaper and more accurate than it has been. And there is now a verifiable occurrence of heritable genome modification using CRISPR.

As such, human genome editing is naturally (and quite rightly) receiving world-wide attention. Scientists, bioethicists, lawyers, and policy makers are questioning what is the best course of action in the face of this new technology that promises great medicinal benefits, but also poses great and unknown risks. Read More

Dna test infographic. Genome sequence map, chromosome architecture and genetic sequencing chart abstract data. Molecule structure genetic test.

Ethnic Identity and Genomics Research: Toward Creating Culturally Sensitive Policies and Practices

By Erin Turbitt and Megan C Roberts

Genomic discoveries are rapidly entering healthcare, further propelled by large nationally funded initiatives such as the “All of Us” program. However, minority groups risk not benefiting from these discoveries to the same degree as individuals of European descent. This is because most genomics research involves European descended individuals and genomic databases largely consist of data from these studies. Read More

Image of Normal blood cells next to a sickle blood cell, colored scanning electron microscope image.

Recharting the Course of Sickle Cell Disease – Who will Benefit?

By Vence L. Bonham and Anitra Persaud

Scientific advancements in gene therapy and the implications of leveraging this technology to develop new curative therapies are at the forefront of medical research. Sickle cell disease (SCD), the most common genetic blood disorder, stands center stage. Last month, 60 Minutes aired a segment showcasing the story of a patient at the NIH Clinical Center who is on her journey to a cure of sickle cell disease (SCD) with the help of an experimental gene therapy.

Preliminary clinical trial findings suggest that gene therapy has an acceptable level of safety and can help individuals with the disease produce normal red blood cells instead of the sickle-shaped ones that underlie the physiological basis of the disease and its complications. Given these promising results, there is hope that gene therapy may catalyze a turning point for the SCD population, a community that has long suffered the debilitating effects of not only their disease, but of longstanding neglect within the medical system and research enterprise. Read More