A Global Call to Ban the Creation of Gene-Edited Babies
Last November, Chinese scientist He Jiankui shocked the world when he revealed that he had used the gene-editing tool CRISPR to modify human embryos during in vitro fertilization, resulting in the birth of twin girls with edited genomes. It was the first known time CRISPR had been used in this way.
Now, scientists and ethicists from seven countries are calling for a worldwide moratorium that would temporarily ban the editing of human eggs, sperm, or embryos — known as germline editing — with the purpose of making genetically-modified children.
The proposal, which appears March 13 in the major scientific journal Nature, endorses “an initial period of fixed duration during which no clinical uses of germline editing whatsoever should be allowed.” The authors suggest that five years might be appropriate. After that, any nation could choose whether to permit specific applications of gene-editing on viable embryos intended to cause a pregnancy. Countries would then be able to approve applications that meet certain conditions, including giving public notice of the planned experiment to make sure there is what the authors term a “broad societal consensus” about the appropriateness of the experiment.
“The governance framework we are calling for will place major speed bumps in front of the most adventurous plans to reengineer the human species,” write the authors, which include two of CRISPR’s inventors, Feng Zhang, of the Broad Institute of the Massachusetts Institute of Technology and Harvard University, and Emmanuelle Charpentier, director of the Max Planck Institute of Infection Biology in Berlin. (Another one of CRISPR’s inventors, Jennifer Doudna of the University of California, Berkeley, has condemned He’s actions but isn’t one of the signatories on the proposed moratorium, though she called for a pause on such work back in 2015.)
The proposal asks governments to make a voluntary pledge, rather than a formal treaty that would be legally binding if broken. The authors say this approach would be more transparent and less rigid than a treaty. Separately, the World Health Organization has formed an expert advisory committee that will make governance recommendations on human genome editing. The first committee meeting is scheduled for March 18 and 19 at the UN agency’s headquarters in Geneva.
The National Institutes of Health, the single biggest funder of biomedical research worldwide, said it supports the proposed ban. “Until nations can commit to international guiding principles to help determine whether and under what conditions such research should ever proceed, NIH strongly agrees that an international moratorium should be put into effect immediately,” NIH Director Francis Collins said in a statement.
In an accompanying editorial, the Nature staff says a global framework for approving germline editing trials could look something like the Human Fertilisation and Embryology Authority, an independent body in the U.K. that regulates IVF clinics and human embryo research. Researchers wanting to conduct germline editing trials would apply for permission to such an organization before being able to carry out their work.
“I think the moratorium is essential,” Fyodor Urnov, a gene editing pioneer and deputy director at the Altius Institute of Biomedical Sciences in Seattle, tells OneZero. “Now is the time to pull out the regulatory equivalent of a taser.”
The proposed moratorium would not apply to germline editing for research uses — cases in which edited embryos are created and studied in a lab and not transferred to a person’s uterus. A few such studies in China and the U.S. have already been carried out.
About 30 countries, including the U.S., already have legislation in place that directly or indirectly prohibits gene-edited babies. A provision passed by the U.S. Congress in December 2015 prohibits the Food and Drug Administration from even considering human studies in which a human embryo is intentionally created or modified to cause a pregnancy. The amendment has been renewed every year since.
Germline editing is so contentious because any changes made in eggs, sperm, or embryos can be passed on for generations. That sets it apart from somatic gene editing for diseases, which only changes cells in the person it’s designed to treat — changes that can’t be passed onto the next generation. A handful of human clinical trials for somatic gene editing are already underway in the U.S., China and Europe. Ethicists have argued that patients undergoing somatic gene editing can provide informed consent for treatment, whereas babies born with edited genomes cannot.
He’s experiment was further decried by scientists because he had tweaked a gene called CCR5, not to cure or treat disease in utero in the resulting babies, but to make the twins resistant to HIV. It’s established that some people of northern European descent have genetic mutations in the CCR5 gene that make them naturally immune to HIV infection.
But even germline editing to cure a disease in an embryo is hotly debated by ethicists, in part because preimplantation genetic testing is already in use. The technology identifies genetic mutations in embryos, allowing prospective parents to choose unaffected ones to use in IVF. The authors of the Nature commentary point out that sperm and egg donors can be used as an alternative if parents know they’re a carrier of a genetic disease. Adoption, too, is an option.
The idea of a moratorium on germline editing isn’t new. Similar calls were made after the first International Summit on Human Genome Editing in 2015 and after a 2017 study released by the by the National Academies of Sciences, Engineering, and Medicine. The study said germline editing would be ethically defensible in certain situations, such as when both parents have a serious genetic disease and embryo editing is the last option for having biological children.
Not every expert is in favor of a global ban. In an article published earlier this month in the New England Journal of Medicine, R. Alta Charo, a bioethicist at the University of Wisconsin who’s serving on the WHO panel, argued against such a moratorium, saying what’s needed is a “road map for responsible translational research.”
“As has been seen in the rise of businesses selling unproven, often illegal stem cell ‘therapies’ for everything from neurologic disease to stiff knees, top-down regulation has its limitations and cannot completely control the rogues,” Charo writes. “Regulating rogues may well take more than a central agency that grants or denies permission for the sale or use of a product or technique.”
A Global Call to Ban the Creation of Gene-Edited Babies
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