CMDA's The Point

Will Anyone Consider the Ethics of Genetically Engineered Humans?

January 9, 2020
Oil Bubbles July 31, 2018

by David Prentice, PhD

The story of the gene-edited babies birthed in China continues to reverberate around the world. To review, the Chinese scientist He Jiankui disclosed in late 2018 that he had used gene editing tools to create genetically-modified human embryos, and he then gestated the embryos to birth. He discussed his experiments on the twin girls at an international genetics meeting co-sponsored by the U.S. National Academy of Sciences. While most of the scientific community condemned the experiments, some of the outrage seemed feigned. Nonetheless, in the months following his announcement, there were calls from leading scientists and ethicists for a global moratorium on human heritable genome editing and wide-ranging discussions on the ethics of manipulating the human genome. Over 60 global leaders wrote to U.S. Department of Health and Human Services (HHS) Secretary Alex Azar, saying “We write as scientific, industry, and bioethics leaders who are committed to translating the promise of gene editing into medicines to help patients in need, to express our views strongly condemning the recent reports of the birth of CRISPR-edited infants in China and to urge you to take action.”

Two groups were formed to study the issue: one an international commission partnered by the U.S. National Academies of Science and the U.K. Royal Society, and the second a working group sponsored by WHO. But the National Academies commission is focused on how to move human germline genome editing forward, as all seven of its tasks are aimed at facilitating heritable genome editing experiments. While elite scientists’ opinions are eagerly sought, there is little to no input from the public. The WHO committee has called for a registry to monitor gene editing experiments, but has also not addressed the ethical question of whether heritable genome editing of humans should move forward, and they have admitted that they, too, have no authority and are not working toward any moratorium. At a recent genetics meeting, the running joke was that neither elite group seemed able to say the “M” word (moratorium).

It’s important to distinguish use of “gene editing into medicines to help patients in need” from the use of such techniques for heritable genome engineering. The former (also called somatic genetic engineering) does show great promise for therapies, with a number of clinical trials currently running, and does not raise ethical questions beyond those usually associated with clinical trials. But heritable, or germline, genome editing raises deep concerns. It is not a therapeutic intervention, not a cure. One key question yet to be discussed in any depth is whether such experiments, with potential for such fundamental change in the human genome and future generations, should be attempted. This distinction was made by NIH Director Francis Collins in his own call for a global moratorium (a speech in which he took to task the WHO and NAS for their lack of movement on this issue.)

Jennifer Doudna, one of the co-discoverers of the CRISPR/Cas gene editing system, in a November 2019 Nature editorial urged “active discussion and debate” about heritable genome editing, and she added: “Consequences for defying established restrictions should include, at a minimum, loss of funding and publication privileges.” Certainly, there must be some accountability, and in the case of the Chinese scientist, there has now been a penalty levied. Dr. He has been sentenced to three years in prison and fined approximately US$430,000; also, two research collaborators received prison sentences and fines. The researchers are also apparently banned from ever working with human reproductive technology again, as well as applying for research funding from the Chinese science ministry. These are definitely strong measures, though whether they are strong enough is unsure. Would a global regulation with these penalties be sufficient to deter a scientist from undertaking such experiments? Under the current U.S. prohibitions, through FDA, someone who does what Dr. He did would receive criminal penalties of up to $250,000 and imprisonment for up to 10 years.

Baylis, in her recent book Altered Inheritance, says, “Decisions about the use of genetic technology are too important to be left to scientists.” In other words, this discussion should include many more viewpoints than just those of scientists. The 60-plus global scientists and gene editing leaders put it this way, that “it is vital that extensive discussions and engagement take place among all major stakeholders, including members of the scientific, medical, patient, caregiver, policy, legal, ethical, and faith communities.” A letter to Nature pointed out that, since human eggs are used to create the gene-edited embryos, egg donors should be included in the ethical discussions on heritable genome editing. And a number of gene editing groups associated with the Alliance for Regenerative Medicine (which represents companies involved in cell and gene therapy and regenerative medicine) released a Statement of Principles on Genome Editing noting their support for therapeutic uses but not for germline genome editing.

There is a great need, as well as significant support, for a global moratorium on heritable genome engineering. What is lacking is a concerted effort to put such a moratorium into place, and leadership in that effort as well as in fostering the wide-ranging discussions on the future of such research, covering all of the stakeholders. In 2005, the United Nations passed a Declaration against human cloning, which also encouraged member nations to adopt prohibitions against the “application of genetic engineering techniques that may be contrary to human dignity.” In November 2019, the American Society of Gene & Cell Therapy (ASGCT) held a policy forum on the Ethical, Societal, and Policy Issues in Germline Gene Editing, which provided an excellent start at trying to include a diverse group of stakeholders. These are the types of engagement, and potential leaders, that we need on the weighty issue of heritable genome engineering and future humanity.

David Prentice, PhD

About David Prentice, PhD

David A. Prentice is Vice President and Research Director for the Charlotte Lozier Institute. He is also Adjunct Professor of Molecular Genetics at the John Paul II Institute, The Catholic University of America and was a Founding Advisory Board Member for the Midwest Stem Cell Therapy Center, a unique comprehensive stem cell center in Kansas that he was instrumental in creating. In 2020, he was appointed by the Secretary of HHS to the federal Human Fetal Tissue Ethics Advisory Board. Dr. Prentice has over 40 years’ experience as a scientific researcher and professor, including previous service as senior fellow for life sciences at the Family Research Council, Professor of Life Sciences at Indiana State University, and Adjunct Professor of Medical and Molecular Genetics, Indiana University School of Medicine. He established Stem Cell Research Facts, an educational website providing scientific facts and patient-centered videos about adult stem cells, and is a founding member of Do No Harm: The Coalition of Americans for Research Ethics, and an advisory board member for the Center for Bioethics and Human Dignity. He has provided scientific advice for numerous medical professionals, legislators, policymakers and organizations at the state, federal, and international levels. Dr. Prentice received his Ph.D. in biochemistry from the University of Kansas, and was at Los Alamos National Laboratory and the University of Texas Medical School-Houston before joining Indiana State University where in addition to his research and teaching, he served as Acting Associate Dean of Arts and Sciences and Assistant Chair of Life Sciences. He was recognized with the University’s Caleb Mills Distinguished Teaching Award and Faculty Distinguished Service Award. He has taught courses ranging from non-majors biology to advanced and graduate courses including developmental biology, embryology, cell and tissue culture, history of biology, science and politics, pathophysiology, medical genetics, and medical biochemistry. Several of his courses were also taught on-line. He received the 2007 Walter C. Randall Award in Biomedical Ethics from the American Physiological Society, given for promoting the honor and integrity of biomedical science through example and mentoring in the classroom and laboratory. Dr. Prentice’s research interests encompass various aspects of cell growth control, cell and developmental biology; one major focus is adult stem cells. He has reviewed for various professional publications including The Journal of the American Medical Association. He is an internationally-recognized expert on stem cell research, cell biology and bioethics, and has provided scientific lectures and policy briefings in 40 states and 21 countries, including testimony before the U.S. Congress and numerous state legislatures, the U.S. National Academy of Sciences, the President’s Council on Bioethics, European Parliament, British Parliament, Canadian Parliament, Australian Parliament, German Bundestag, French Senate, Swedish Parliament, the United Nations, and the Vatican. He was selected by President George W. Bush’s U.S. President’s Council on Bioethics to write the comprehensive review of adult stem cell research for the Council’s 2004 publication “Monitoring Stem Cell Research.” Dr. Prentice has published numerous scientific and bioethics articles, including a recent review of stem cell science and adult stem cell treatments published in Circulation Research. He has also published numerous commentaries and op-eds, and travels nationally and internationally to give frequent invited lectures regarding stem cell research, fetal tissue research, gene editing, cloning, embryology, cell culture and vaccines, bioethics, and public policy. He has been interviewed in virtually all major electronic and print media outlets, including CNN, ABC, NBC, CBS, Fox, CSPAN, Reuters, AP, NPR, USA Today, BBC, The Washington Post, The Los Angeles Times, and The New York Times.