China orders halt to gene-editing after outcry over babies

Scientist He Jiankui attends the International Summit on Human Genome Editing at the University of Hong Kong in Hong Kong, China November 28, 2018. REUTERS/Stringer

By Alexandra Harney

SHANGHAI (Reuters) – The Chinese government on Thursday ordered a temporary halt to research activities for people involved in the editing of human genes after a Chinese scientist said he had edited the genes of twin babies.

Scientist He Jiankui said this week that he used a gene-editing technology known as CRISPR-Cas9 to alter the embryonic genes of the twin girls born this month.

He’s announcement, which has not been verified, sparked an international outcry about the ethics and safety of such research.

“The nature of this incident is extremely nasty, and relevant bodies have been ordered to temporarily halt the scientific research activities of relevant personnel,” the state news agency Xinhua said, citing the health ministry, science and technology ministry and China Association for Science and Technology.

The organizers of a conference where He claimed to have edited the genes also condemned the work on Thursday, calling it “deeply disturbing” and “irresponsible”.

“Even if the modifications are verified, the procedure was irresponsible and failed to conform with international norms,” the organizing committee of the Second International Summit on Human Genome Editing, being held in Hong Kong this week, said in a statement.

The committee called for an independent assessment of He’s claims.

He said gene editing would help protect the girls from infection with HIV, the virus that causes AIDS.

Chinese scientists have also condemned the work and the Southern University of Science and Technology, where He is on leave from his position as an associate professor, has announced an investigation.

The Guangdong province Health Commission said on its website on Wednesday it and Shenzhen city had set up a team to investigate the case.

He’s filing to a Chinese clinical trials database indicates that a hospital did an ethical review of the project, but the hospital involved denied that its ethics review committee ever met to discuss the work.

He said after his presentation on Wednesday he was proud of what he had done.

The presidents of the U.S. National Academy of Sciences (NAS) and the U.S. National Academy of Medicine (NAM) also expressed concern about He’s work.

“The events in Hong Kong this week clearly demonstrate the need for us to develop more specific standards and principles that can be agreed upon by the international scientific community,” NAS president Marcia McNutt and NAM president Victor Dzau said in a statement.

(This story fixes typo in first paragraph)

(Reporting By Alexandra Harney; Additional reporting by Ben Blanchard in Beijing; Editing by Paul Tait, Robert Birsel)

Gene Editing in cattle, pigs, super crops; poses new EU dilemma

Professor Wendy Harwood poses for a photograph in a plant breeding incubator room with barley plants that have undergone gene editing at the John Innes Centre in Norwich

By Ben Hirschler

LONDON (Reuters) – Heat-tolerant Angus beef cattle designed for the tropics with white coats instead of black or red. A button mushroom that doesn’t turn brown. Pigs that don’t fall sick.

These are all ideas thrown up by gene editing, the new technology taking the biomedical world by storm, and one which also promises a revolution down on the farm.

It poses a thorny problem for European policymakers wary of new molecular manipulation in agriculture after a quarter century of conflict over genetically modified food.

In a research lab in Norwich, 100 miles northeast of London, Wendy Harwood is making exact DNA tweaks in barley plants to produce better-germinating grain, with higher yield and quality.

“We’ve never been able to go in and make such a precise change as we can now with gene editing,” said the John Innes Centre scientist. “This gives you exactly the change you want without anything you don’t want.”

Further to the south of England in Basingstoke, animal genetics firm Genus has tapped the same “CRISPR-Cas9” technique to develop the world’s first pigs resistant to a devastating and common viral disease, in a tie-up with U.S. researchers.

Agricultural scientists and companies worldwide are joining the gene editing race, including seeds giant Monsanto, now the target of a $62 billion takeover attempt by Germany’s Bayer.

Rival DuPont, which is merging with Dow Chemical, hopes to have CRISPR-edited corn and wheat on the market in five to 10 years.

Bright ideas from others include improved varieties of rice, soybeans and tomatoes, as well as hornless cattle and the heat-tolerant breed of Angus.

Using “molecular scissors” to cut DNA means scientists can edit genomes more precisely and rapidly than ever before, and agricultural products – which don’t need the same clinical trials as human drugs – could get to market relatively quickly.

U.S. GREEN LIGHT

Last month, a non-browning button mushroom became the first CRISPR-edited organism to get a green light from the U.S. government – and several crops developed with two older, less efficient editing tools have already been waved through.

But whether such products will ever arrive on European farms is another matter, since the European Commission has so far not made a decision on how they will be regulated, leaving the new science in limbo.

The EU executive had been due to decide by the end of 2015 whether to class gene-edited products as genetically modified organisms (GMOs), subjecting them to the same stringent restrictions that have curbed GMO use in Europe.

This deadline was missed, as was a second one of end-March 2016, and there is now no new timeline for a decision.

Both sides in the debate are worried.

Greenpeace wants the EU’s GMO law to be fully applied to “new breeding techniques” (NBT) like gene editing, because of potential environmental and health impacts, and it fears Brussels is dithering under pressure from Washington.

“We are concerned that we would get products that are risky but could arrive on the market without any risk assessment or labeling or detection methods,” said spokeswoman Franziska Achterberg.

She believes the EU has delayed regulation to pave the way for a transatlantic trade deal, citing a document in which a U.S. official warned that “different regulatory approaches between governments to NBT classification would lead to potentially significant trade disruptions”.

A Commission spokesman denied the delays had anything to do with the Transatlantic Trade and Investment Partnership trade pact talks, but could not say when the EU would make a ruling.

Biotechnology companies, meanwhile, argue their gene-edited products are “non-GMO”, since they do not contain foreign DNA from a different species.

“We fundamentally see gene editing as being very distinct from GMO,” said Genus Chief Executive Karim Bitar. “It’s a very precise cut and there is no movement of genes from one species to another. That’s a major attraction.”

FIND-AND-REPLACE FUNCTION

The argument is complex.

Unlike traditional GMOs, in which a gene is added from another organism, gene-editing works like the find-and-replace function on a word processor. It finds a gene and then makes changes by amending or deleting it.

Proponents argue this makes it similar to conventional selective breeding, which is freely allowed in the EU, since such mutations within the same species can – and do – also occur naturally.

Rene Smulders, a plant breeder at Wageningen University in the Netherlands, says the current uncertainty is affecting research. His group had a grant application turned down last year because of concerns about the legal situation.

He wants Europe to follow the lead of Canada, which decides on new products based on their traits, not how those traits were produced. “Europe’s process-based legislation creates problems and is not suitable for the future,” Smulders said.

Cellectis CEO Andre Choulika, whose Calyxt unit has used older forms of gene editing to improve potatoes, wheat and soybeans, thinks the odds are 50:50 that gene-editing will end up being classified as GMO in Europe.

“If Europe does that, I think they will probably send themselves into the stone age of agricultural biotechnology,” he said.

(Additional reporting by Barbara Lewis in Brussels; Editing by Pravin Char)

Groups call human embryo editing ‘a line we must not cross’

Scientists, scholars and advocates are among those calling for a worldwide ban on the genetic manipulation of human embryos, warning the practice would “irrevocably alter the nature of the human species and society.”

The words appeared in an open letter on the website of the Center for Genetics and Society on Monday, a day before the International Summit on Human Gene Editing began in Washington.
The letter accompanied a report that the Center for Genetics and Society jointly released with the Friends of the Earth, in which the groups call for a ban on editing genes in human embryos.

Modern advancements have brought humans close than ever to creating “genetically modified humans,” but those who signed the open letter agree that humans should not engineer genes that will be passed on to their children, particularly with so little known about long-term effects.

“Genetic modification of children was recently the stuff of science fiction,” Pete Shanks, a consulting researcher with the Center for Genetics and Society and the report’s lead author, said in a statement. “But now, with new technology, the fantasy could become reality. Once the process begins, there will be no going back. This is a line we must not cross.”

The most pertinent technological advancement in the field is CRISPR/Cas9, a cost-effective tool that allows researchers to search for a specific DNA sequence in a cell. Once it finds what it’s looking for, the tool can be used to cut out the DNA strand and paste a different one into its spot.

While those who signed the open letter acknowledge that human gene editing could have some potentially good applications, like treating damaged tissues in a grown person, they wrote there isn’t any justification for tweaking the genes of future children. They wrote that parents who want to prevent their children from inheriting genetic diseases, one of the major arguments used in favor of gene editing, can usually do that another way — like a traditional embryo screening.

The letter also states that allowing any kind of reproductive cell editing “would open the door to an era of high-tech consumer eugenics in which affluent parents seek to choose socially preferred qualities for their children,” or so-called designer babies.

“At a time when economic inequality is surging worldwide, heritable genetic modification could inscribe new forms of inequality and discrimination onto the human genome,” the letter states.

Scientists are expected to discuss recent developments and technologies in human gene editing at this week’s summit. They’re also slated to discuss potential ethical and legal concerns, weigh the risks and benefits of research and examine regulations, according to the summit’s website.