In February, the news broke that the Food and Drug Administration (FDA) had approved a “first of its kind” new cancer therapy. Iovance’s AMTAGVITM, the subject of the approval, is a personalized immunotherapy for advanced melanoma. To be treated, adult patients who are ineligible for surgery or have metastatic disease provide their tumor cells to their medical team. Tumor-attacking T-cells are isolated from the sample, grown and multiplied in-lab, and re-infused into the patients for a turbo-charged immune response that, according to clinical trial data, have shown promise in shrinking patients’ tumors. This drug joins a list of others that work something like this: Patients provide cell samples, which are then isolated and modified or expanded in-lab, and then eventually infused back into their bodies. This general patient experience, though, indicates a different model from what we have seen before. These “living drugs” use your own cells, but better, to fight these daunting battles.
Category: CRISPR
Responding to the Comeback of He Jiankui, ‘The CRISPR Baby Scientist’: Lessons from Criminal Justice Theory
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.
Lessons Learned from the COVID-19 Pandemic: The Future for Diagnostics
By Matthew Bauer and Nicole Welch
Diagnostic tests have changed in the eyes of many Americans across the COVID-19 pandemic.
The traditional site of diagnostic testing, the doctor’s office, has taken a back seat during the COVID-19 pandemic. We can now receive at-home antigen tests in the mail, drive through PCR tests at local sports stadiums, and our workplace cafeteria may serve as a de facto COVID-19 testing site.
The new paradigm of fast, easily accessible, and user-based diagnostics helps to reduce barriers for people to test for COVID-19.
However, nearly all these tests give binary results of yes or no for detecting a specific piece of the SARS-CoV-2 virus. As we look ahead, both the ongoing COVID-19 pandemic and future pandemics will require binary tests, but also tests that give us more granular information about the disease. These changes should be integrated into future diagnostic paradigms, empowering clinical diagnostics to meet both the needs of patients and the broader public health community. Read More
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-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.
Gene Editing as a Weapon of Mass Destruction Read More
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.
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 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
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
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
Malaria Eradication: For Africa as America
There is a page in the history books waiting to be written for the eradication of malaria. In recent years, malaria has killed more people globally than war—it’s killed predominately children, and predominately in sub-Saharan Africa. Despite being curable, and eliminated from most developed countries, malaria is the fifth deadliest infectious disease in the world.
A team of scientists in Italy is looking to write that history. Read More
Gene Editing and Intellectual Property: A Useful Mix?
The Health Policy and Bioethics Consortia is a monthly series that convenes two international experts from different fields or vantage points to discuss how biomedical innovation and health care delivery are affected by various ethical norms, laws, and regulations.
They are organized by the Harvard Medical School Center for Bioethics and the Program on Regulation, Therapeutics, and Law (PORTAL) at Brigham and Women’s Hospital, in collaboration with the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. Support provided by the Oswald DeN. Cammann Fund at Harvard University.
A light lunch will be provided. This event is free and open to the public, but space is limited and registration is required. Please note that attendees will need to show ID in order to enter the venue. Register now!
One way of thinking about genome editing is through the lens of the legal and ethical obligations of ensuring the technology is deployed safely and accurately, for the betterment of human society.
Or, if that’s a mouthful for you, genome editing’s rights—and wrongs. Which brings me to a talk I’ll* be giving at Harvard Medical School on March 8: “Genome Editing: Rights and Wrongs” I feel obligated, however, to asterisk the personal pronoun (“I”) because, in truth, what I’ll be doing is sharing the stage with one the world’s most celebrated scientists, George Church, world-renowned bioethicist, Jeantine Lunshof, and moderated by health policy guru, Aaron Kesselheim. Read More
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