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Genomics scientists from around the world have called for an immediate halt to any clinical use of gene editing in human embryos and have sharply reprimanded a Chinese researcher who had conducted a secret experiment that would have produced the first babies in the world genetically modified.
This statement was delivered at the end of the Second International Summit on the Human Genome Publishing in Hong Kong. Later, the Chinese government announced that it had suspended and initiated an investigation into the clinical project led by researcher He Jiankui in southern China.
The two announcements from the main scientific body and the Chinese authorities closed a dramatic week for the world of genomics. He made the amazing revelation that a mother had given birth to Lulu and Nana, twins whose genes had been modified to make them resistant to HIV.
A few hours after the summit closes on Thursday, a senior Chinese official told a state broadcaster that his project was suspended following a government investigation. He did not say he was accused of any crime.
"This is a flagrant violation of our national regulations and a flagrant violation of the ethical goals of the scientific world," said Xu Nanping, vice minister of Science and Technology, during an interview with CCTV . "It's shocking, unacceptable and we strongly oppose it."
The summit organizers also played a critical role in an eagerly awaited consensus statement issued on the last day of the event.
"At this summit, we heard an unexpected and deeply troubling assertion that human embryos had been modified and implanted, resulting in pregnancy and the birth of twins," said the summit's organizing committee, which said called for an independent verification of He's claims that have been up to here not been published in a peer-reviewed journal.
"Even if the changes were verified, the procedure was irresponsible and did not comply with international standards," said the organizers in a consensus statement that is generally seen as setting the tone and direction for the meeting. a rapidly evolving field.
The committee, which represents leading researchers from the United States, Britain and Hong Kong, has not called for a total ban on gene editing.
Instead, he acknowledged that the field was evolving toward a future where procedures would be the subject of much research in clinical trials and that researchers would need a rigorous framework for establish ethical standards and guidelines. But in the meantime, the panel asked for a stop.
"The organizing committee concludes that scientific understanding and technical requirements of clinical practice remain too uncertain and that the risks are too great to allow for clinical trials of germ line modification at this time," says closing communiqué.
His work was widely criticized this week by peer researchers and ethicists as a dubious demonstration of a gene editing tool called CRISPR-Cas9, which opened a world of new possibilities for biomedical research. these last years. Supporters predict a time when lethal genetic diseases without treatment could be eradicated, while critics fear that the technology will be used for occasional genetic improvements, to alter features such as intelligence or size.
But until this week, such debates were largely theoretical because no one was known to have delivered a pregnancy from a genetically modified human embryo. He claimed that the experience was a rude awakening for scientists at the summit and an urgent reminder that discussions on the responsible use of a technology that could transform the health and character of future generations might not be enough.
"The need to reach a binding international consensus on setting limits for this type of research … has never been so obvious.For these limits, the world will run the serious risk of a deluge of projects as unethical and unethical ", Francis Collins, director of the National Institutes of Health, said in a statement. "If such epic scientific mishaps continue, an extremely promising technology for the prevention and treatment of the disease would be overshadowed by a public scandal, fear and disgust."
Many countries prohibit such experiments and in the United States, the law effectively prohibits the use of genetically engineered human embryos for reproductive purposes.
After the news of the He project was leaked in the news, the scientists criticized this effort, considering it irresponsible and premature. Investigations were opened on the latter 's work by the South China University of Science and Technology, which stated that the university was not informed of the latest news. experience. He appeared before a large public, in person and online, to defend his work at Wednesday's summit, but the presentation was far from convincing for the experts.
The summit organizers concluded that his work was deeply problematic. "His defects include inadequate medical indication, a poorly designed study protocol, non-compliance with ethical standards for protecting the welfare of research subjects, and a lack of transparency in the development, revision, and conducting clinical procedures, "they said.
Scientists and external ethicists said that the experiment was medically unnecessary because babies would not be born infected with the virus, which can also be prevented by existing low-risk interventions. They wondered whether the effort had even achieved its goal of protecting both girls against HIV after learning from He's data. And they warned that the research had failed to rule out potentially harmful unexpected effects that could afflict twins and spread through the human lineage if they have children.
"After listening to Dr. He, I can only conclude that this was wrong, premature, useless and largely useless," said R. Alta Charo, bioethicist at the University of Wisconsin-Madison.
For years, renowned scientists have avoided pleading for a ban on gene editing technology for human reproduction, preferring instead a cautious approach that such research should not be pursued before certain conditions are met.
At the last meeting of the summit in 2015, the scientists concluded by stating that it would be "irresponsible" to continue until the safety issues were thoroughly examined and that a social consensus was reached. has developed. However, a report published two years later by the National Academies of Science indicated that inheritable genome modifications "could be allowed" if, for example, there was transparency and an unmet need, among other criteria. A report published this summer by the Nuffield Council on Bioethics in the UK concluded that editing genes to influence future generations "could be ethically acceptable under certain circumstances".
These recommendations suggested that technology could be useful, which could have emboldened He. When he presented his research on Wednesday, he said "proud" of his work.
"My initial thought was based on a survey of the United States … or on the British statement of ethics or on a Chinese study that gave us the signal that the majority of the public is supportive of the". use of editing the human genome for treatment, including HIV prevention, "he said.
Mathew Porteus, a pediatric scientist specializing in stem cells at Stanford University, said that in February, he had informed Porteus of his animal studies and an open trial at the University of California. ;man.
"I told him that it was irresponsible and irresponsible to proceed for many reasons and that he had to discuss his plans with the highest Chinese authorities before continuing his work," Porteus said.
Several scientists said that a ban would be premature, but added that the technology was not ready to be used. Others said that a clear message should be sent.
"My feeling would be, given the circumstances, that anything below a moratorium would be insufficient," said Paul Knoepfler, a stem cell biologist at the University of California at Davis. "This indicated that almost everyone could try this, this guy is not a doctor, he is a physicist.It seems that it is necessary to clarify things."
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