Considerations of risk have equally to do with societal risk. Patent rights are different from ownership rights, and do not confer ownership on anything, patenting must be distinguished from owning. There are 20,000 to 25,000 genes in the human genome, located in various chromosomes. There is a difference between ‘governance’ and ‘self-governance.’ Where government uses law, the scientific community uses peer review, public censure, promotions, university affiliations, and funding to regulate themselves. Society needs to figure out if we all want to do this, if this is good for society, and that takes time. Can we demonstrate that we can fix a mutation that will cause a terrible health problem, accurately and without the risk of harming their potential child? Somatic gene editing compared to germline gene editing. Currently, treatments are focused on somatic cells, that is, cells in the body. That doesn’t mean you should halt research being done by everyone who’s law-abiding. This project was supported by the Department of Genetics, Stanford School of Medicine. Before we could ever move toward the clinic, the scientific community must come to a consensus on how to measure success, and how to measure off-target effects in animal models. There’s no question that gene editing technologies are potentially transformative and are the ultimate precision medicine. Companies argue that without patents, they are left with no guarantee that they can recoup their investment when they discover key genes. Why Genetic Testing May Lead to Ethical Dilemmas . Currently, treatments are focused on somatic cells, that is, cells in the body. Until we can come to agreement about what the results of animal experiments mean, how could we possibly move forward with people? But so-called germ line gene therapy is certainly possible. There are 20,000 to 25,000 genes in the human … Asked about public dialogue around germline human genome editing, George Church, Robert Winthrop Professor of Genetics at HMS, said: “With in vitro fertilization (IVF), ‘test tube babies’ was an intentionally scary term. An example: genetic testing is, for now, optional. We need to specify what the hurdles would be if one were to move forward responsibly and ethically. Those include targeting the wrong gene; off-target impacts, in which editing a gene might fix one problem but cause another; and mosaicism, in which only some copies of the gene are altered. San Jose, CA 95113 So, are we going to decide that it’s OK to edit as-yet-to-be children to cater to this particular idea of a society? A diagnosis or a finding of inherited predisposition in a family member has implications for other family members. Sign up for daily emails to get the latest Harvard news. Ethics flipped 180 degrees, from it being a horrifying idea to being unacceptable to prevent parents from having children by this new method. Human genome editing: somatic vs. germline. For example, is a rate of 900,000 deaths from HIV infection per year a greater risk than West Nile virus, or influenza? That has to be done with great care in terms of ethics.”. http://europepmc.org/abstract/MED/29891181, Glenn Cohen’s blog: How Scott Gottlieb is Wrong on the Gene Edited Baby Debacle. When the average person expresses reservations about patenting DNA, they are often reacting to the idea of owning something fundamental to human personhood. Progress in this field has been so rapid that the dialogue around potential ethical, societal, and safety issues is scrambling to catch up. A lot of companies are getting venture funding for interesting gene therapies, but they’re all going after tough medical conditions where there is an unmet need — [where] nothing is working — and they’re trying to find gene therapies to cure those diseases. This disconnect was brought into stark relief at the Second International Summit on Human Genome Editing, held in Hong Kong in November, when exciting updates about emerging therapies were eclipsed by a disturbing announcement. But at this point, it would be impossible to make a risk-benefit calculation in a responsible manner for that couple. “As happened in England with mitochondrial replacement therapy, we should be able to come to both a scientific and a societal consensus of when and how this approach should be used. For these and other reasons, the scientific community approaches germline editing with caution, and the U.S. and many other countries have substantial policy and regulatory restrictions on using germline human genome editing in people. But after Louise Brown, the first IVF baby, was born healthy 40 years ago, attitudes changed radically. “Public policy or ethical discussion that’s divorced from how science is progressing is problematic. Yet as I. Glenn Cohen, faculty director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, has said, gene editing comes in many varieties, with many consequences. Should insurance companies or employers have access to the results? Human genome editing: somatic vs. germline. Humanity doesn’t lack the will, intelligence, or creativity to come up with ways for using technology for good and not ill. “We don’t require students to learn the moral dimensions of science and technology, and that has to change. The only way we’re going to be able to determine that these standards are met is to proceed cautiously, with reassessments of the societal and health benefits and the risks.”. Native leaders discuss holiday harvest feast and how they mark a day of loss, Outbreak forced changes big and small, some of which are here to stay, Experts say smooth rollout possible although highly complex, Chan School’s Barry Bloom puts vaccine news into context, © 2020 The President and Fellows of Harvard College, By Mary Todd Bergman Harvard Correspondent. The genetic modification of plants for food is a hot-button issue around the world. That does not mean that we’re ready to go into the clinic — we are not. It is not clear that the U.S. needs to react to Dr. He’s announcement with regulation. There is disagreement about both the quality of the data and how to interpret it. It would be so transformative for people with diseases caused by a single gene mutation, like sickle cell anemia and cystic fibrosis. How effective is each vaccine?”. This may affect every cell, which means it has an impact not only on the person who may result, but possibly on his or her descendants.