(Robert Sepehr) Designer babies, anti-aging, and bringing back extinct species. Gene editing, or genetic modification, is a type of genetic engineering in which DNA is inserted, deleted, modified or replaced in the genome of a living organism. Unlike early genetic engineering techniques that randomly inserts genetic material into a host genome, genome editing targets the insertions to site-specific locations.
(Sequoyah Kennedy) In November, 2018, a Chinese biophysicist named He Jiankui came into the international spotlight after reports that he used the CRISPR gene editing technology to create the first genetically modified humans.
The Chinese scientist who announced to the world in November 2018 that he had created a pair of gene-edited twin girlscould face the death penalty for corruption and bribery charges, a British geneticist fears.
News of the birth of twin baby girls whose DNA had been edited using CRISPR technology to resist HIV broke on November 26. He Jiankui, the scientist who purported to have created the gene-edited babies, said at the time that a possible 3rd pregnancy was underway. The announcements sparked outrage among the scientific community.
In December, Jiankui went missing, providing the first indication that his work amounted to a monumental and costly blunder. And, it seems, the decision could cost the man his life.
Jiankui is now thought to be living under armed guard at a state-owned apartment in Shenzhen, China, geneticist Robin Lovell-Badge of the Francis Crick Institute in London, says.
In November 2018, Lovell-Badge organized the Second International Summit on Human Genome Editing at the University of Hong Kong. When rumors started to spread about Jiankui’s work, Lovell-Badge decided to invite the 34-year-old scientist to attend the summit. The goal was not to give Jiankui a platform or to encourage his work, but to try and make him shy away from it. Or, as Lovell-Badge puts it, “to control his urges.”
It was during the summit that Jiankui admitted to using the CRISPR-Cas9 gene-editing technology to modify human embryos.
Though Jiankui expressed pride in his work, the scientific community was horrified that the scientist had chosen to conduct his work in secret and failed to go through the proper channels.
“He really thought that he was doing good, that what we has doing was the next big thing, and really important for the good of mankind.
Pretty much everyone he talked to had said ‘don’t do it.’ We’d heard he had ethical approval, so we were getting scared. But clearly it was all too late.”
Now, Lovell-Badge and other scientists in the UK say Jiankui could very well face bribery and corruption charges, both of which carry the death penalty in China. When he implanted the genetically modified embryos into the mother instead of destroying them, as per convention, he violated established research guidelines. Those guidelines carry the same legal weight as established laws in China. 
“There is an official investigation led by the ministries of science and health. Lots of people are probably going to lose their jobs, he wasn’t the only one involved in this, obviously. So how has he got them to do all this work? He could be had up on all sorts of charges of corruption and being guilty of corruption in China these days is not something you want to be. Quite a few people have lost their heads for corruption.”
China doesn’t take corruption lightly these days. Early last year, new reforms were introduced by the government, including a list of offenders. As a result of their misdeeds, scientists who step outside the boundaries of research guidelines could be barred from receiving grants or research positions. Then, in December 2018, the government announced it would use its controversial social credit system to target scientists who break from convention.
Jiankui was in the unique position of being flush with his own cash, which allowed him to personally fund the research and hire lab technicians and IVF doctors to conduct the experiments.
“Here you have a physicist who knows very little biology, is very rich, has a huge ego, wants to be the first at doing something that will change the world.”
Chinese investigators will have to decide how much of a role Jiankui’s collaborators played in the research, and whether they were fully aware of the illegality of the work.
As the process plays out, researchers associated with Jiankui are trying to distance themselves from the shamed scientist. Professor Michael Deem from Rice University was Jiankui’s PhD advisor in 2010 when he received his doctorate in biophysics. 
Deem has said through lawyers that he and Jiankui have kept in touch over the years, with initial reports showing the 2 worked closely together on the CRISPR-baby project. Deem was reportedly present for the consent meetings with the parents, which scientists worldwide have called “insufficient.”
Gene editing has the potential to save lives and prevent devastating diseases, but the technology is still new and the ramifications of such experiments remain largely unknown. So, when a patient’s DNA has been edited using CRISPR-Cas9, researchers keep a close eye on them to track their progress and any problems that may arise. Or, at least, they’re supposed to. That has not been happening in China.
An undisclosed number of cancer patients in China who underwent experimental gene therapies have managed to escape the watchful eye of scientists. In at least one trial where patients’ genes were modified using CRISPR to treat cancer, the scientists tasked with tracking their progress and conducting follow-up examinations haven’t been doing their job.
Editing DNA can lead to autoimmune disorders and other problems later on. It’s important to know how patients are doing so important tweaks can be made.
Jennifer Doudna, a biochemist at the University of California, Berkeley, and a co-inventor of CRISPR, said:
“Since we do not fully understand the human genome and are still developing knowledge of [CRISPR-Cas9 and related technologies], we need to monitor the intended and unintended consequences over the lifespan of patients.”
Recent History: Creating the First Gene-Edited Babies
Controversial scientific experiments are not new to China. In November 2018, Chinese scientist He Jiankui claimed to have created the world’s first gene-edited babies – twin girls born with immunity to HIV, the virus that causes AIDS. Jiankui said that a third pregnancy involving gene-edited embryos may be in the process.
The announcement sparked fear and outrage among the global scientific community, and shortly after the news broke, the Chinese government expanded its social credit system to include infractions made by researchers in an effort to crack down on scientific misconduct in that country. The Chinese government also ordered Jiankui’s medical team to shut down the trial.  
Jiankui doesn’t even have the support of scientists in his own country, despite the lax laws governing gene-editing. China’s Vice Minister of Science and Technology called the experiment “unacceptable” and said the ministry is strongly opposed to such research. 
What Jiankui claims to have accomplished is not legal in China, nor is it legal anywhere else in the world. In both China and the U.S., it is legal to edit human embryos, but they must be destroyed after a few days and may not lead to pregnancy. 
It is also legal in both countries to alter a living person’s DNA (called “somatic gene-editing”) to treat diseases like cancer and the blood disease hemophilia. That is because, unlike embryonic gene-editing, somatic gene-editing does not lead to heritable genetic changes.
Yet, these treatments are still in their infancy, too, which is why responsible oversight and an abundance of caution is so important.
While China and the U.S. share similar laws regarding gene-editing, they do not share the same governmental oversight. There is no equivalent to the U.S. Food and Drug Administration (FDA) in China, and doctors can proceed with a clinical trial based on approval from their hospital’s ethics board alone.
As of January 2018, at least 86 patients in China have had their DNA edited with CRISPR, and the private startup Anhui Kedgene Biotechnology Co. is behind most of them.
“One of Kedgene’s projects has lost touch with patients whose DNA was altered, according to a person familiar with the matter. Kedgene founder Mandy Zhou said one trial didn’t complete the research as planned, and as a result lost touch with patients. No patients died during treatment in that trial, she added.
Another Kedgene trial, at the Anhui Provincial Hospital, treated 18 patients, according to Wang Yong, who ran it. Many participants died as their cancer grew, Dr. Wang said, without giving a specific number. Dr. Wang said he was asked by the science ministry this month to send a report on the trial, the first time authorities in Beijing sought information about it since it began more than a year ago.”
According to the South China Morning Post, China is requesting that hospitals and universities submit detailed reports on all human gene-editing trials conducted since 2013. 
Such irresponsibility not only endangers lives, but puts humanity at the cusp of realizing frightening possibilities, including so-called “designer babies,” in which embryos are edited to make the resulting human superior to others in various ways, including intelligence, looks, and talent.
Following the news that a set of gene-edited twin girls had been born in China in November, the World Health Organization (WHO) announced that it was creating a working group to study gene-editing and the many ethical, social, and safety issues surrounding the process.
The panel’s job will be to develop “agreed norms and standards for the governance of human gene-editing,” the WHO said.
Dr. Tedros Adhanom Ghebreyesus, the WHO’s director-general, warned of the potential for “unintended consequences” of gene-editing during a conference on December 4th.
“This is uncharted water and it has to be taken seriously.
WHO is putting together experts. We will work with member states to do everything we can to make sure of all issues – be it ethical, social, safety – before any manipulation is done.”
Chinese scientist He Jiankui announced November 26 that he had created the world’s first gene-edited babies, twin girls, by altering their DNA to resist HIV, the virus that causes AIDS. The announcement immediately sparked outrage and concern among the scientific community.
Two days later, the researcher said that a second pregnancy had possibly occurred.
While acknowledging that gene-editing holds the potential to rid humanity of horrific maladies, the WHO warned that the technique – which is conducted using CRISPR-Cas9 – also comes with many issues that need to be addressed before the technology can be deployed to potentially benefit people.
“The use of these technologies must be regulated through ethics oversight and human rights standards.
WHO is committed to working with member states to and the wider global health and research community to establish the mechanisms and dialogue needed to effectively govern these technologies.”
Jiankui’s claims have yet to be verified by a scientific journal or any other independent source. The scientist, an associate professor at Shenzhen’s Southern University of Science and Technology in China, made his claims to an organizer of an international gene-editing conference in Hong Kong. 
Gene-editing is controversial for a number of reasons. There is concern that the technique could ignite unintended consequences that could be passed down from generation to generation. In fact, last year, researchers at Columbia University said that when they used CRISPR-Cas9 to correct blindness in mice, they inadvertently caused mutations to more than 1,000 other genes.
One of the scariest possibilities associated with gene-editing is that it could be used to create “designer babies” – children genetically modified to be superior to children created traditionally. Imagine a world in which wealthy parents have the option of making babies that are better-looking, more intelligent, and more resistant to diseases than other children and you may understand why the idea could be so terrifying.
It seems that this science will continue to move forward; let’s just hope that minimal issues unfold in the future.
Just days after a Chinese scientist announced the birth of the world’s first gene-edited babies and a possible 2nd pregnancy, the Chinese government ordered a halt to the highly controversial experiments.
According to Chinese Vice Minister of Science and Technology Xu Nanping, an investigation has also been ordered into the research that led to the birth of twin girls in November, 2018. Just a week prior, researcher He Jiankui claimed to have altered the DNA of the twins in an attempt to make them resistant to HIV, the virus which causes AIDS.
Nanping said Jiankui’s research “crossed the line of morality and ethics adhered to by the academic community and was shocking and unacceptable.”
As soon as Jiankui announced the twins’ birth at a conference on gene-editing in Hong Kong, scientists around the world immediately condemned the research.
In a statement, the 14 leaders of the conference called Jiankui’s attempts to genetically alter sperm, eggs, or embryos “irresponsible,” except in the case of lab research, because the gene-editing technology Jiankui used, CRISPR-Cas9, is still new and not much is known about its risks or safety.
Furthermore, the conference leaders called for independent confirmation of Jiankui’s claim.
So far, no one has even seen a photo of the girls, who Jiankui claims are named Lulu and Nana. 
Through a spokesperson, Jiankui said that he plans to fully cooperate with the investigation and will make his raw data available for 3rd-party review. However, he claims that the twins’ parents wish to remain anonymous.  
A researcher in China claims to have created the world’s first gene-edited babies, sparking deep discussion, along with some harsh criticisms and outrage among some of the world’s leading scientists.
The highly-controversial news that a set of twin girls was born in November with genetically altered DNA broke on November 26. The girls’ DNA was edited using a powerful new tool with the capacity to rewrite the human genome, known as CRISPR-Cas9.
A U.S. scientist reportedly took part in the research, which had to take place in China because this type of gene-editing is not currently legal in the U.S. The primary concern associated with the technology is that it has the potential to pass genetic changes on to future generations and harm other genes – largely making up what we would call ‘unforeseeable consequences.’
Researcher He Jiankui of Shenzhen said he edited embryos for 7 couples who were being treated for fertility problems. He said he wasn’t trying to cure or prevent any inherited diseases; the goal of the experiments was to give the babies the ability to resist possible infection to HIV, the virus that causes AIDS.
Jiankui revealed his work on November 26 in Hong Kong at an international conference on gene-editing that began November 27. So far, his claims have not been confirmed, nor have they been published in a peer-reviewed scientific journal.
“I feel a strong responsibility that it’s not just to make a first, but also make it an example.”
He added that “society will know what to do next” in terms of whether his work should move forward.
In the U.S., CRISPR-Cas9 may only be used for lab research. The technology cannot be used for editing sperm, eggs, or embryos. China outlaws human cloning, but not gene-editing.
Tinkering With Humanity’s Blueprint
Jiankui said he chose HIV as his focus because China has a serious problem with HIV infections. He worked to disable a gene called CCR5 which forms a protein ‘doorway’ that allows HIV to enter a cell.
All of the men in the project had HIV, while all of the women were free of infection. Jiankui aimed to offer couples affected by HIV the opportunity to have a child that might be protected from suffering the same fate.
The babies’ genes were edited during in-vitro fertilization (IVF) treatment. First, the sperm was separated from the semen, which is where the HIV virus tends to hide out. Then, a single sperm was placed into a single egg to create an embryo. Finally, the gene-editing tool was added.
Jiankui removed a few cells from the embryos once they reached 3 to 5 days old and checked them for editing. Couples had the option of using edited or unedited embryos for implantation. In total, 16 of 22 embryos were used in 6 implant attempts before the twin pregnancy was achieved.
Tests showed that 1 twin had both copies of the altered gene, while the other twin had just 1. There was no evidence that the experiment caused harm to any other genes. People with a single copy of the gene can still acquire HIV, but some very limited research suggests the health of those individuals will decline more slowly once they do.
On November 28, Jiankui announced that a 2nd pregnancy may be underway, but it is in its very early stages and needs more time to be monitored to see if it will “take.”
Concern and Outrage Among Leading Scientists
Leading scientists were quick to condemn the experiments, saying there were more questions than answers following Jiankui’s talk. The leader of the conference himself called the experiments “irresponsible” and said that they were evidence that the scientific community had failed to regulate itself to prevent premature DNA-altering efforts.
Jiankui defended his attempts, saying that the genetically-modified twins “need this protection since a vaccine is not available.”
But his colleagues dismissed his argument – including the very people behind the technology used to alter the genes.
Following Jiankui’s talk, Jennifer Doudna, a University of California-Berkeley scientist and one of the inventors of the CRISPR gene-editing tool, said:
“This is a truly unacceptable development. I’m grateful that he appeared today, but I don’t think that we heard answers. We still need to understand the motivation for this.”
David Liu of Harvard and MIT’s Broad Institute, and inventor of a variation of the gene-editing tool, added:
“I feel more disturbed now. It’s an appalling example of what not to do about a promising technology that has great potential to benefit society. I hope it never happens again.”
But it probably will happen again.
China has a history of performing controversial scientific experiments. For example, in 2016, scientists in that country became the first to inject humans with genes edited using CRISPR. In that experiment, genetically modified cells were delivered into a patient with aggressive lung cancer. The patient’s own immune cells were modified to make them more efficient at combating cancer cells.
In 2015, researchers in China announced plans to create a genetically modified “micro pig” which would stay forever small in an effort to help scientists study and resolve human health problems. However, the DNA-editing company responsible for the pig decided to sell the Franken-swine as pets for $1,600.
And gene-editing experiments for the purpose of making people immune to HIV – or at least less likely to contract the virus – are nothing new. In 2015, scientists in China said they had successfully added mutations to human embryos which made them HIV-proof. The experiment resulted in the creation of 4 embryos, but none of them were used to induce pregnancy.
Note: The article’s featured image is merely to represent the story and is not one of the actual twins born through CRISPR.
Europe’s highest court ruled July 25 that crops edited with CRISPR technology should face the same tough scrutiny as conventional genetically modified (GM) organisms. 
The decision, handed down by the Court of Justice of the European Union (ECJ), is a blow to many scientists and other proponents of gene-editing who had hoped that gene-editing technologies such as CRISPR-Cas9 would be exempted from existing European law limiting the planting and sale of GM crops.
Under the ECJ ruling, crops edited with CRISPR and similar technologies are subject to a 2001 directive that was intended for older breeding methods.
Kai Purnhagen, a legal scholar at Wageningen University and Research in the Netherlands who specializes in European and international law, explained:
“It is an important judgment, and it’s a very rigid judgment. It means for all the new inventions such as CRISPR-Cas9 food, you would need to go through the lengthy approval process of the European Union.”
CRISPR-Cas9 was designed to “snip away” bits of undesirable genetic code and replace them with more desirable ones. The 2001 ECJ directive was intended to apply to the insertion of entire genes, or long stretches of DNA, into organisms. It is supposed to be a very precise technology, but a 2017 study found the gene-editing technique can cause a plethora of unintentional genetic mutations.
Monsanto’s “Roundup ready” corn is an example of a GMO produced using transgenesis, an ‘older’ breeding method. The corn contains genes from a bacteria resistant to the herbicide glyphosate, the active ingredient in Monsanto’s Roundup herbicide. Roundup ready corn is designed to withstand being doused with glyphosate even as surrounding weeds are killed off. (Though in many cases, glyphosate fails to actually kill the weeds.) 
The law exempts organisms whose genomes were modified using mutagenesis techniques, such as irradiation, which introduce changes to an organism’s DNA but doesn’t add foreign genetic material. 
The ECJ’s recent decision was made at the request of the French government which, in 2016, asked the high court to interpret the 2001 directive in light of new and emerging plant-breeding techniques.
Mute Schimpf, a food and farming campaigner at Friends of the Earth Europe, one of the anti-gene-editing groups involved in the court case, said:
“These new ‘GMO 2.0’ genetic engineering techniques must be fully tested before they are let out in the countryside and into our food. We welcome this landmark ruling which defeats the biotech industry’s latest attempt to push unwanted genetically modified products onto our fields and plates.”