Chinese genetic-editing scientist has kept much of his secret work



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SHENZHEN, China – The Chinese scientist who says he helped make the world's first genetically engineered baby deviated from a traditional career by keeping much of his research secret in pursuit of a larger goal – making history.

He Jiankui's great aspirations began to take shape in 2016, a year after another team of Chinese researchers unleashed a global debate with the revelation that they had altered the DNA of human embryos in the laboratory. He soon set his mind on pushing the limits of medical ethics further.

The China-born, US-trained scientist once confided to his former Stanford University advisor his interest in genetically modified babies. He told the Associated Press last month that he had been working on the experiment for more than two years – a period in which, on his own account, he concealed information from some medical team involved in the research, as well as apparently from his own staff. bosses.

It took advantage of the loosely drafted and irregularly enforced regulations and the generous funding available today in China, in some cases circumventing local protocols and possibly laws.

"The enormous ambition in China, the desire to be the first, collides with the desire to create and enforce standards," said Jing-Bao Nie, a Chinese bioethics expert at the University of Otago in New Zealand.

On the eve of an international gene-editing summit in Hong Kong this week, the 34-year-old scientist surprised the world by saying he had used the powerful CRISPR gene-editing tool to alter the DNA of twin girls born earlier this month. His claim could not be independently confirmed, and was not published in a journal, but sparked rapid indignation from researchers and regulators.

Scientists from China and globally said the experiment should never have been tried.

"They chose to short-circuit the whole process. They were dishonest, "said Dr. Kiran Musunuru, a geneticist at the University of Pennsylvania.

China's state broadcaster CCTV said on Tuesday that it could be investigated by the Ministry of Science and Technology if the births were confirmed.

His career path did not follow the expected roadmap. He did not publish most of his previous research on mouse modification and monkey DNA, as most scientists would have done. And the way he advanced in his latest study included questionable decisions about confidentiality and medical ethics.

"If you're going to do something so controversial and so early, and you want to be the leader of this movement, you want to do it in an exemplary way," said Dr. Eric Topol, who heads the Scripps Research Translational Institute. In California.

He, who says his parents were farmers, was born in 1984 in southern China. At the time, the country was only beginning to emerge from the isolation of the Mao era, and the average annual income was only $ 300. Telephones were rare. Many villages were not yet connected by paved roads.

Initially, it followed a common path for the scientists of its generation. After graduating from the University of Science and Technology of China, he moved to the United States for postgraduate studies.

There he earned a Ph.D. in biophysics from Rice University in 2010, spent a year as a postdoctoral researcher at Stanford. His Stanford advisor, Stephen Quake, described it as "super bright" and "at the forefront of trying to apply new technologies to biology."

In 2012, he returned to China to hold a post at the South University of Science and Technology – an institution that opened just a year earlier and is partially funded by the government of Shenzhen, a southern Chinese city known for its technology companies.

"He was really interested in the notion of editing the human genome," and what situation would be appropriate, Quake said, recalling one of He's visits. Quake gave feedback, but did not oversee the study.

His research could not have been legally carried out in the US or most of Europe.

China has banned human cloning for reproduction. In 2003, its Ministry of Health released a guideline for in vitro clinics that prevented "clinical experiments that violate ethical or moral principles."

The young scientist saw this ambiguity as an opportunity. Sometimes researchers – Chinese or foreign – who can not guarantee funding or permission for unconventional projects in the US or Europe find financial support and vacancies in China.

Ren Xiaoping, a surgeon who plans to perform the first human head transplant, worked for many years in American hospitals but returned to China because a medical institute in his hometown of Shenyang agreed to support his research.

Guoping Feng, a neuroscientist at the Massachusetts Institute of Technology, works with a research facility in Guangdong province, where his associates genetically manipulate monkeys with brain disorders to study the development of autism-like symptoms. China has fewer restrictions on the use of laboratory animals.

In 2016, he contacted an AIDS advocacy group in Beijing to help him recruit potential study participants – couples who try to have children where the man is HIV-positive. There are already well-tested ways to protect against the transmission of the Aids virus in in vitro fertilization. Instead, his goal was to rewrite DNA before birth so that children were less likely to get HIV after they were born.

Other scientists have tested similar gene-editing techniques in cells in a laboratory to prevent heritable diseases, but not leading to live births.

For his work CRISPR, he did not seek the prior approval of the federal regulators. He listed his study in an online registry of Chinese clinical trials on November 8, long after it began.

His laboratory circumvented the standards that many of his Chinese counterparts have advocated.

For example, the laboratory did not inform all medical staff that directly aided couples who expected the study to involve genetic editing. They believed they were aiding in standard in vitro fertilization attempts, with an additional step of mapping the genomes, not manipulating the embryo, according to one of the embryologists involved in the research, Qin Jinzhou.

Patient consent forms referred to the study inaccurately as an "AIDS vaccine development" program.

He also sought consultation from an ethics committee outside the hospitals involved in the research. Lin Zhitong, founder of Shenzhen's Harmonicare Women & Children Hospital, told the AP in October that his hospital's ethics committee advised He but had no other involvement.

Withdrawing information from the medical team about genetic editing was acceptable because some fertility doctors may not agree to help HIV-positive couples, said Lin, who also said he did not work as a doctor or scientist but comes from a family of hospital property developers.

Misleading or circumventing any study participant is not standard practice in China, "and violates the broad spirit of informed consent," said Nie, the bioethics expert. "In some cases, ethics committees are just rubber stamps."

Following He's statement, Harmonicare issued a statement condemning the editing of human genes and announced an investigation into any links to He's laboratory.

The Shenzhen scientist has unveiled some discoveries in YouTube videos. He announced his feat in English, not Chinese.

"He wanted to attract the attention of the international community. Now he got what he really wanted, "said Nie.

His own university was kept in the dark. The University of Southern Science and Technology said in a statement that it was not informed about He's work, and that it "seriously violated academic ethics and standards."

His research team includes his former Rice consultant, physics professor Michael Deem, who is on the scientific boards of He's two genetics companies. Rice said she initiated an investigation into Deem's involvement.

In an interview last month at his Shenzhen lab, he said that baby-edited genes were inevitable. He wanted to be the first.

"There will be someone, somewhere, who is doing it," he said. "If it's not me, it's somebody else."

Follow Christina Larson on Twitter at https://twitter.com/larsonchristina .

AP Medical writer Marilynn Marchione in Hong Kong, researcher Fu Ting and videojournalist Emily Wang in Beijing contributed to this report.

This Associated Press series was produced in partnership with the Department of Scientific Education of the Howard Hughes Medical Institute. The AP is solely responsible for all content.

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