Houston, Texas, USA : He Jiankui, the Chinese researcher who claimed to have created the world’s first gene-edited babies, has been suspended from any scientific activities amid mounting questions from Chinese government agencies and academicians about the experiment.
In a fertilized human egg cell, He sought to disable a gene that forms a protein doorway that allows the HIV virus to enter, intending to make the resulting person resistant to HIV.
“The case, as media have reported, is a blatant violation of China’s laws and regulations, and it breaks the bottom line of academic morality and ethics,” Xu Nanping, China’s vice-minister of science and technology, said on Thursday in an interview with China Central Television. “It’s shocking and unacceptable.”
Xu said the ministry has ordered relevant authorities to suspend all scientific activity of people involved with the case, and will mete out punishments together with other authorities based on the results of the investigation.
Zeng Yixin, vice-minister of the National Health Commission, said on Thursday that the commission has paid close attention to the reports and has sent a working group to assist in the probe.
He Jiankui is based in Shen-zhen, whose government joined Guangdong provincial authorities in an investigative group on Tuesday.
With the rapid development of science and technology, the research and application of science must be more responsible and follow technical and ethical norms, Zeng said.
He, an associate professor at the Shenzhen-based Southern University of Science and Technology, announced on Monday that twin girls, Lulu and Nana, were born healthy earlier this month after in vitro fertilization. Gene editing technology had been used to immunize them from HIV, he said. The news shocked the world and aroused widespread criticism both for its ethics, technical flaws and the necessity of such a procedure to prevent AIDS.
‘Proud’ of work
Attending the Second International Summit on Human Genome Editing in Hong Kong on Wednesday, He announced that he was “proud” of his work and believed he was helping people with HIV (the twins’ father is HIV positive) but declined to reveal the babies’ identities, citing China’s policy regarding privacy in cases involving HIV/AIDS.
Many scholars spoke against the research, saying it violated ethical norms and was unnecessary because couples where the male is HIV-positive can have virus-free children through the application of existing medical technology.
On Thursday, the organizing committee of the summit released a statement saying that the experiment was “irresponsible and failed to conform with international norms”.
“Its flaws include an inadequate medical indication, a poorly designed study protocol, a failure to meet ethical standards for protecting the welfare of research subjects, and lack of transparency in the development, review and conduct of the clinical procedures,” it said.
The organizing committee concluded that because the scientific understanding and technical requirements for clinical practice are uncertain, the risks are too great at this time to permit clinical trials of germ line editing — which can be passed down to offspring.
In an open letter, more than 300 Chinese scientists raised 10 questions for He and his team related to safety, effectiveness and purpose of the research, and whether he has concealed other related experiments from the public.
A top academic body in the country, the Chinese Academy of Engineering, in a statement late on Wednesday, called for the public to strictly guard the privacy of the twins and for the development of a detailed care plan for the babies as they grow “to guard against possible health damage resulting from the gene editing”.
“We care deeply about the two babies and appeal for the research and formulation of detailed medical and ethical care plans,” it said.
The academy said it hopes the babies will grow up happy and healthy, both physically and psychologically, with “the most care possible that can be provided by society”.
Concern for future
Many experts attending the summit in Hong Kong also expressed concern for the babies’ future. Robin Lovell-Badge, head of the Laboratory of Stem Cell Biology and Developmental Genetics at the Francis Crick Institute in the United Kingdom, said the twins’ identities should be kept secret to protect them from any social stigma involving HIV/AIDS.
“We hope we will learn from proper clinical studies as they grow up — if that is possible,” Lovell-Badge said. He added that “we must not know their identity because that would be very unfair”.
There was also debate about the extent of government supervision of the family. Some scientists argued that lifelong institutional study of the girls and their families should be conducted.
Qiu Renzong, a professor at the Chinese Academy of Social Sciences, said that as the twins pass down their altered genetic code, the human gene pool could be affected. Close monitoring of the twins and their offspring will therefore be necessary, Qiu said.
Ethics of baby gene-editing
A Chinese scientist’s stunning claim he has pioneered the world’s first genetically modified baby has suddenly made the eternal debate over ethics and emerging scientific capabilities pressing and real.
Should everything that becomes technically possible be carried out? For most ethicists the answer is no—but the tricky part is whether it can be prevented.
“It’s obvious that everything that is technically feasible is not ethically desirable,” said Cynthia Fleury, a member of the French Ethics Committee.
“But to resist that, in a context of deregulated scientific competition, is structurally destined for failure.”
It’s a question as old as science: Are ethics condemned to constantly nip at the heels of advances that burst forth and take a head start?
Certainly the case in China has brought the debate to the fore.
That country’s National Health Commission has ordered a probe into the baby gene-editing announced by scientist He Jiankui, in which he claimed to have tinkered with the DNA of twin girls born a few weeks ago to prevent them contracting HIV. China’s government said it was opposed to the experiment, while the scientific world erupted in uproar.
The alleged breakthrough has not been verified. And, after a backlash, He said his trial has been suspended and he has disappeared from public view.
“Good science is not just about generating knowledge in a vacuum. Context and consequences are vitally important, and the consequences of this irresponsible action may be dire indeed,” said Dr Sarah Chan, of the University of Edinburgh.
For all the condemnation, however, it is important to note that many objections were not over the principle of human genetic modification as such, but rather over the way the experiment was carried out.
For instance: it was conducted outside of typical institutional structures, by a lone scientist acting in a way seen by many as premature given the technology used.
He said he employed CRISPR, a technique which allows scientists to remove and replace a strand with pinpoint precision.
But the consequences of the technique are not yet fully known—particularly whether genetic slicing and splicing like that carried over from one generation to the next, with unpredictable effects. The fear is that reckless application of CRISPR might create “monsters”.
Another ethical violation raised is that the aim of He’s experiment was to protect the babies against AIDS and not to try to cure them of a life-threatening disease.
“Trying to rush the technology”
The concern of the scientific community is that by stepping across established ethical red lines, ensuing public suspicion could crush a field of very promising research.
While CRISPR might spark unease of a future for humanity straight out of an Aldous Huxley novel, it also bears enormous hopes of being able to treat genetic infirmities.
“Trying to rush the technology forwards, skipping vital scientific and ethical steps, could end up setting us all back,” warned Dr Kathy Niakan, a biologist at the Francis Crick Institute in London.
Yet that view in itself shows just how far ethics have evolved to the pace of scientific change.
For many decades, the idea of modifying human genomes was simply unthinkable. Now, several international scientific organisations conceive of it being possible, within a rigorous framework.
“You can’t just say that something is taboo and that’s that, you can’t ever think about it again,” Anne Cambon-Thomsen, a specialist in immunogenetics and health ethics, and emeritus head of research at France’s CNRS national scientific research centre said.
“An essential point of our humanity is to be able to react by thinking about what is made possible by our technical abilities,” said Cambon-Thomsen, who is part of a European Group on Ethics in Science and New Technologies that advises the EU.
Such a shift in acceptance has already been seen, for example, in the field of organ transplants.
Yet human cloning, at present, still remains an intolerable premise. According to Cambon-Thomsen, that’s because “we have difficulty in showing some sort of (medical) advantage in cloning”.
Following the storm sparked by He Jiankui’s announcement, scientists are calling for an international treaty on gene-editing.
But agreeing global regulation “isn’t easy because cultures are different—we don’t think of human beings in the same way in China as in the West,” observed Thierry Magnin, rector at the Catholic University of Lyon.
Magnin, a theologist and physicist, said: “Ethics must be integrated right from the start when technologies are developed, and not come in the end.”
Image : He Jiankui, a Chinese researcher, speaks during the Human Genome Editing Conference in Hong Kong, Wednesday, Nov. 28, 2018. He made his first public comments about his claim to have helped make the world’s first gene-edited babies.