Q&A on scientist's bombshell claim of gene- edited babies 26 November 2018, by Lauran Neergaard And Malcolm Ritter

noted U.S. bioethicist Henry Greely of characterized the claim.

The researcher, Jiankui of , said he altered embryos when parents were undergoing fertility treatments to change a gene so that it might provide the resulting babies with a trait few people naturally have—protection against future infection with the AIDS virus.

"This is probably the worst gene you would choose" to test in pregnancy because it doesn't fix a disease the children were destined to get, said Shoukhrat Mitalipov of the Oregon Health & University, who in laboratory-only experiments In this Oct. 9, 2018 photo, Zhou Xiaoqin, left, loads Cas9 studies how to repair gene defects in embryos. protein and PCSK9 sgRNA molecules into a fine glass pipette as Qin Jinzhou watches at a laboratory in "Where is the assurance this mutation now will Shenzhen in southern China's Guangdong province. result in resistance to HIV?" Mitalipov added. "He's Chinese scientist He Jiankui claims he helped make testing his hypothesis on babies." world's first genetically edited babies: twin girls whose DNA he said he altered. He revealed it Monday, Nov. 26, Here are questions and answers about Monday's in Hong Kong to one of the organizers of an international conference on gene editing. (AP Photo/Mark claim and the state of gene editing: Schiefelbein) WHAT IS GENE EDITING?

Designer babies might be here sooner than anyone reckoned. A Chinese researcher who says he created gene-edited babies crossed what most scientists consider a forbidden line.

It's not clear if the claim is true and if so, how the twin girls whose DNA reportedly was altered will fare as they grow.

There is wide scientific agreement that rewriting DNA before birth—to prevent an inherited disease or to give a baby some "designer" trait—isn't yet safe to try outside laboratory experiments that do not lead to human births. In this Oct. 10, 2018 photo, He Jiankui, left, and Zhou "Grossly premature and deeply unethical," is how Xiaoqin work a computer at a laboratory in Shenzhen in southern China's Guangdong province. Chinese scientist

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He claims he helped make world's first genetically edited work was conducted. babies: twin girls whose DNA he said he altered. He revealed it Monday, Nov. 26, in Hong Kong to one of the WHY IS MONDAY'S NEWS SO organizers of an international conference on gene CONTROVERSIAL? editing. (AP Photo/Mark Schiefelbein)

It's a technology that lets scientists alter the DNA of living cells—from plants, animals, even humans—more precisely than ever before. It's like a biological cut-and-paste program: An enzyme that acts like molecular scissors snips a section of a gene, allowing scientists to delete, repair or replace it.

HOW IS IT USED?

Researchers routinely use gene-editing tools in labs to study diseases in cells or animals, and they're altering crops and food animals for better agriculture. In this Oct. 9, 2018 photo, a microplate containing embryos that have been injected with Cas9 protein and PCSK9 sgRNA is seen in a laboratory in Shenzhen in But in people, gene editing still is highly southern China's Guangdong province. Chinese scientist experimental. One first-in-human study is testing He Jiankui claims he helped make world's first genetically intravenous infusion of gene-editing ingredients to edited babies: twin girls whose DNA he said he altered. fight a killer metabolic disease. Other researchers He revealed it Monday, Nov. 26, in Hong Kong to one of are developing ways to gene-edit damaged cells the organizers of an international conference on gene and return them, repaired, into patients with sickle editing. (AP Photo/Mark Schiefelbein) cell disease and other disorders. But unlike Monday's announcement, none of those experiments would alter DNA in a way that patients would pass to their own children. Altering genes in sperm, eggs or embryos means those changes can be passed down to future WHAT DID THE CHINESE SCIENTIST DO? generations—people who would have no way to consent to those changes. Plus, long-term negative The researcher said he used the gene-editing tool effects might not become apparent for years. CRISPR to alter a gene named CCR5 in embryos for seven couples during their fertility treatments; In 2017, the U.S. National Academies of Science, one pregnancy resulted. A particular mutation in Engineering and Medicine said lab-only research to that CCR5 gene is thought to confer some learn how to alter embryos is ethical—but said it's resistance to HIV by making it harder for that virus not ready for pregnancies yet. The academy said if to enter cells. it is ever allowed, it should be reserved to treat or prevent serious diseases with no good alternatives. Today's medications have turned HIV from a death sentence into a manageable disease in much of the That lab-only research is going on, by Mitalipov and world, but He said he chose that gene because HIV others. remains a big problem in China. But critics said Monday's announcement opens the But He's claims have not been verified by outside door to "designer babies." scientists, and there are questions about how the

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"If this goes unchallenged, other rogue actors will embryos, said Columbia University cell biologist soon offer wealthy parents purported genetic Dietrich Egli, who called it "essentially genome enhancements for their children," said Marcy vandalism." Darnovsky of the Center for Genetics and Society. WHAT ARE THE DANGERS? WHAT HAPPENED TO THE BABIES? The biggest concern: That precision, or lack of it. No independent outsiders know yet, which is partly Unintended mutations could harm health rather why scientists are so disturbed. than help it.

He, the Chinese researcher, said one twin had both IS GENE-EDITING FOR PREGNANCY LEGAL? copies of the intended gene altered while the other had just one altered. People with one copy of the Where you live determines if, or what kind of, mutation can still get HIV. research can be performed on human embryos. In the U.S., scientists can perform laboratory embryo Scientists who reviewed his claims said the research only with private funding, not with federal alterations aren't an exact match to natural CCR5 taxpayer money. Any pregnancy attempt would mutations, and that a big question is whether the require permission from the Food and Drug gene is altered in every cell. Administration, which is currently prohibited by Congress from even reviewing such a request—a de facto ban.

ARE THERE OTHER WAYS TO PREVENT INHERITED DISEASES?

People undergoing fertility treatments that include IVF can have embryos tested for deadly gene mutations that run in the family, such as Huntington's disease, and then implant only the embryos that lack such mutations. Also, some so- called mitochondrial disorders can be addressed by using some genetic material from mom and some from a donor egg, along with dad's sperm.

© 2018 The . All rights reserved. In this Oct. 9, 2018 photo, Zhou Xiaoqin adjusts a monitor showing a video feed of Qin Jinzhou moving a fine glass pipette containing Cas9 protein and PCSK9 sgRNA to an embryo under a microscope at a laboratory in Shenzhen in southern China's Guangdong province. Chinese scientist He Jiankui claims he helped make world's first genetically edited babies: twin girls whose DNA he said he altered. He revealed it Monday, Nov. 26, in Hong Kong to one of the organizers of an international conference on gene editing. (AP Photo/Mark Schiefelbein)

The particular method used is common in lab research but not precise or controlled enough for

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