The safety and efficacy of the technologies scientist He Jiankui used are unreliable and creating gene-edited babies for reproduction is banned by national decree.
Beijing: A Chinese scientist who said he made the world’s first “gene-edited” babies intentionally evaded oversight and broke national guidelines in a quest for fame and fortune, according to a government investigation quoted in state media on Monday.
Scientist He Jiankui said in November that he used a gene-editing technology known as CRISPR-Cas9 to alter the embryonic genes of twin girls born that month, sparking an international outcry about the ethics and safety of such research.
Hundreds of Chinese and international scientists condemned He and said any application of gene editing on human embryos for reproductive purposes was unethical.
Chinese authorities also denounced He and issued a temporary halt to research activities involving the editing of human genes.
He had “deliberately evaded oversight” with the intent of creating a gene-edited baby “for the purpose of reproduction”, according to the initial findings of an investigating team set up by the Health Commission of China in southern Guangdong province, Xinhua news agency reported.
He had raised funds himself and privately organised a team of people to carry out the procedure in order to “seek personal fame and profit,” Xinhua said, adding that he had forged ethical review papers in order to enlist volunteers for the procedure.
The safety and efficacy of the technologies He used are unreliable and creating gene-edited babies for reproduction is banned by national decree, the report said.
The case files of those involved who are suspected of committing crimes have been sent to the ministry of public security, an unnamed spokesperson for the investigation team was quoted by Xinhua as saying.
Neither he nor a representative could be reached for comment on Monday.
He defended his actions at a conference in Hong Kong in November, saying that he was “proud” of what he had done and that gene editing would help protect the girls from being infected with HIV, the virus that causes AIDS.
His announcement sparked a debate among Chinese legal scholars over which laws he had technically broken by carrying out the procedure, as well as whether he could be held criminally responsible or not.
Many scholars pointed to a 2003 guideline that bans altered human embryos from being implanted for the purpose of reproduction and says altered embryos cannot be developed for more than 14 days.
Forecasts of designer babies followed the announcement of the gene-edited twins, just as they have for any reproductive technology since 1978. This signals the public must learn more about genetics.
When Adam Nash was still an embryo, living in a dish in the lab, scientists tested his DNA to make sure it was free of Fanconi anemia, the rare inherited blood disease from which his sister Molly suffered. They also checked his DNA for a marker that would reveal whether he shared the same tissue type. Molly needed a donor match for stem cell therapy, and her parents were determined to find one. Adam was conceived so the stem cells in his umbilical cord could be the lifesaving treatment for his sister.
Adam Nash is considered to be the first designer baby, born in 2000 using in vitro fertilisaton with pre-implantation genetic diagnosis, a technique used to choose desired characteristics. The media covered the story with empathy for the parents’ motives but not without reminding the reader that “eye colour, athletic ability, beauty, intelligence, height, stopping a propensity towards obesity, guaranteeing freedom from certain mental and physical illnesses, all of these could in the future be available to parents deciding to have a designer baby.”
The designer babies have thus been called the “future-we-should-not-want” for each new reproductive technology or intervention. But the babies never came and are nowhere close. I am not surprised.
I study the prediction of complex diseases and human traits that result from interactions between multiple genes and lifestyle factors. This research shows that geneticists cannot read the genetic code and know who will be above average in intelligence and athleticism. Such traits and diseases that result from multiple genes and lifestyle factors cannot be predicted using just DNA, and cannot be designed. Not now. And very unlikely ever.
Designer babies are next
The inevitable rise of designer babies was proclaimed in 1978 after the birth of Louise Brown, the first IVF baby, as the next step toward “a brave world where parents can select their child’s gender and traits.” The same situation occurred in 1994 when a 59-year-old British woman stretched the limits of nature by giving birth to twins using donated eggs that were implanted in her womb at a fertility clinic in Italy.
The response was the same in 1999, when a fertility clinic in Fairfax, Virginia, offered sex selection of embryos to screen against diseases that only happen in boys. In 2013, when 23andMe was granted a patent for a tool that predicts the likelihood of traits in babies based on DNA of two parents, the question of patenting designer babies was raised. In 2016, when the UK permitted a woman to donate her healthy mitochondria to a couple using IVF to conceive a child, raising the number of parents to three, fears of unnatural children rose again. Last month, when Genomic Prediction, a New Jersey company, announced its DNA screening panel for embryos would also assess the risk for complex diseases such as Type 2 diabetes and heart disease that are caused by multiple genes, fears of engineering babies with high IQ or athletic prowess emerged.
The same issues arose on November 26 when He Jiankui reported at the Second International Summit on Human Genome Editing in Hong Kong that he had successfully edited the DNA of twin baby girls born last month.
The designer baby doom scenarios have not evolved with the technology. It’s been the same story for decades. It’s the same “desirable” traits and the same assumption that parents want to select these traits if technology allowed. But no one seems to be questioning whether these traits are solely a product of our genes such that they can be selected or edited in embryos.
Wondering about designer babies was understandable in the early days, but a repetition of these supposed fears now suggests lack of understanding of how DNA, and the genes they encode, work.
Designing favourable traits in babies is not simple
Although there are exceptions, DNA generally differs between people in two ways: There are DNA mutations and DNA variations.
Mutations cause rare diseases like Huntington’s disease and cystic fibrosis, which are caused by a single gene. Mutations in the BRCA genes substantially increase the risk of breast and ovarian cancer. Selecting embryos that do not have these mutations removes the entire or main cause of disease – women who don’t have BRCA mutations can still develop breast cancer through other causes, like all women.
Variations are changes in the genetic code that are more common than mutations and associated with common traits and diseases. DNA variants increase the likelihood that you may have a trait or develop a disease but do not determine or cause it. Association means that in several large study populations, a DNA variant was more frequent among people with the trait than those without, often only slightly more frequent.
These variants don’t determine a trait, but increase its likelihood by interacting with other DNA variants and nongenetic influences such as upbringing, lifestyle and environment. To design such traits in embryos would require multiple DNA changes in multiple genes and orchestrating or controlling relevant environment and lifestyle influences too.
Let’s compare it to driving a car. DNA mutations are like the flat tires and the failing brakes: technical problems that make driving problematic, no matter where you drive. DNA variations are like the colour and the type of car, or other features of the car that may affect the driving experience and even might create problems over time. For example, a convertible is a delight when driving on Hollywood’s Sunset Boulevard on a breezy summer evening, but cruel when crossing a high mountain pass in midwinter. Whether features of the car are an asset or a liability depends on the context and that context might change – they are never ideal all the time.
Most DNA mutations do nothing else other than cause the disease, but DNA variations may play a role in many diseases and traits. Take variations in the MC1R “red hair” gene, which not only increases the chance that your child will have red hair, but also increases their risk of skin cancer. Or variations in the OCA2 and HERC2 “eye colour” genes that are also associated with the risk of various cancers, Parkinson’s and Alzheimer’s disease. To be sure, these are statistical associations, reported in the scientific literature, some may be confirmed; others may not. But the message is clear: Editing DNA variations for “desirable” traits may have adverse consequences, including many that scientists don’t know about yet.
To be sure, even though complex traits such as intelligence, athletics and musicality cannot be selected or designed, there will be opportunists who will try to offer these traits, even if totally premature and unsupported by science. Like Stephen Hsu, the co-founder of Genomic Prediction who said about his offer to test embryos for polygenic risk, the risk of a disease based on multiple genes, “I think people are going to demand that. If we don’t do it, some other company will.” And also He said: “There will be someone, somewhere, who is doing this. If it’s not me, it’s someone else.” People need to be protected against this irresponsible and unethical use of DNA testing and editing.
Science brought incredible progress in reproductive technology but didn’t bring designer babies one step closer. The creation of designer babies is not limited by technology, but by biology: The origins of common traits and diseases are too complex and intertwined to modify the DNA without introducing unwanted effects.
A Cecile JW Janssens is a Research Professor of Epidemiology at Emory University.
The research is believed to have demonstrated it is possible to safely and efficiently correct defective genes that cause inherited diseases.
A CRISPR graphic illustrating gene editing. Credit: Wikimedia
Technology that allows alteration of genes in a human embryo has been used for the first time in the United States, according to Oregon Health and Science University (OHSU) in Portland, which carried out the research.
The OHSU research is believed to have broken new ground both in the number of embryos experimented upon and by demonstrating it is possible to safely and efficiently correct defective genes that cause inherited diseases, according to Technology Review, which first reported the news.
None of the embryos were allowed to develop for more than a few days, according to the report.
Some countries have signed a convention prohibiting the practice on concerns it could be used to create so-called designer babies.
Results of the peer-reviewed study are expected to be published soon in a scientific journal, according to OHSU spokesman Eric Robinson.
The research, led by Shoukhrat Mitalipov, head of OHSU’s Center for Embryonic Cell and Gene Therapy, involves a technology known as CRISPR that has opened up new frontiers in genetic medicine because of its ability to modify genes quickly and efficiently.
CRISPR works as a type of molecular scissors that can selectively trim away unwanted parts of the genome, and replace it with new stretches of DNA.
Scientists in China have published similar studies with mixed results.
In December 2015, scientists and ethicists at an international meeting held at the National Academy of Sciences (NAS) in Washington said it would be “irresponsible” to use gene editing technology in human embryos for therapeutic purposes, such as to correct genetic diseases, until safety and efficacy issues are resolved.
But earlier this year, NAS and the National Academy of Medicine said scientific advances make gene editing in human reproductive cells “a realistic possibility that deserves serious consideration.”
(Reporting By Deena Beasley; Editing by Michael Perry)
