The next day, Regalado interviewed Huang as scheduled and duly wrote up a story for his magazine, but this wasn’t where the puck was going—he was desperate to find out what was going on in Shenzhen. Back in the United States, Regalado dug into JK’s story, hoping it would be the centerpiece in his article that would be the curtain-raiser before the Hong Kong summit. With one week to go, Regalado checked in with Kiani: Ferrell had told her that JK was planning on recruiting women in the New Year for trials targeting two genes—CCR5 and PCSK9.
On the Sunday morning of Thanksgiving weekend, November 25, two days before the Hong Kong conference started, Regalado finally hit the mother lode. Searching “He Jiankui” and “CCR5,” Google finally served up an entry in the Chinese Clinical Trial Registry—helpfully listed in Mandarin and English—that was backdated to November 8. The study leader was He Jiankui and the title said it alclass="underline" “Evaluation of the safety and efficacy of gene editing with human embryo CCR5 gene.”
The trial inception date was listed as March 2017. The applicant was Qin Jinzhou, JK’s embryologist. The study rationale cited the Berlin patient as creating “a new medical model for HIV elimination.” JK would recruit HIV-positive patients with infertility, seek informed consent and ethical approval from the hospital. It went on: “Through the CCR5 gene editing of the human embryo in a comprehensive test system, we set to obtain healthy children to avoid HIV providing new insights for the future elimination of major genetic diseases in early human embryos.”14
And there was more. There were two documents linked to the registration. One was an ethics statement (in Mandarin) dated March 7, 2017, submitted to the Harmonicare Shenzhen Women and Children’s Hospital, entitled simply “CCR5 gene editing.” Seizing on the just-published National Academies of Sciences (NAS) report on genome editing, which “for the first time approved the ethics application for a major disease in an embryonic editing study,” JK outlined his plans to target CCR5 in embryos at risk of HIV. The use of CRISPR editing “will bring a new dawn for the treatment of untold numbers of serious genetic diseases.” And then:
We ardently expect that… [the project] will occupy the commanding elevation of the entire field of gene-editing technologies. Like the point of an awl sticking out through a bag, the project will stand out in the increasingly intense international competition of gene editing technologies. This innovative research will be more significant than the IVF technique which won the 2010 Nobel Prize and bring about the dawn of the cure for untold severe genetic diseases.15
But the real smoking gun, Regalado found, was in of all things an Excel spreadsheet. It was a table in Chinese but there was a familiar scientific term in the title: “cfDNA.” Now Regalado got goosebumps. cfDNA stands for circulating free DNA, the raw material for noninvasive prenatal testing (NIPT), the new standard procedure for performing genetic analysis on pregnant women. The table reported DNA analysis in maternal blood at three timepoints: 12, 19, and 24 weeks. NIPT was developed independently by Dennis Lo in Hong Kong and Stanford’s Stephen Quake—JK’s postdoc supervisor. JK’s expertise was in precisely this type of next-gen sequencing analysis that would be used to perform NIPT. Regalado concluded that JK was monitoring a pregnancy in a genome-editing trial. That could only mean one thing.
Regalado called Shadid in China, unconcerned it was the middle of the night in Shanghai. “Is this what I think it is?” he asked. Shadid said yes. Over the next few hours, Shadid worked on translating the ethics document. Next Regalado called JK and asked if any gene-edited babies had been born. JK declined to answer and referred him to Ferrell. Shadid alerted Kiani that Regalado was planning to publish his explosive story “as soon as people are awake in China.” Kiani called Ferrell, who had been asleep. Ferrell scanned his phone to find multiple messages from Regalado. When they finally spoke, Ferrell wouldn’t confirm anything but urged Regalado to delay his story while offering more access to JK.
But Regalado wasn’t interested. For about four hours, he’d been more or less the only person in the world who knew what JK had done and was ready to publish it. As he reviewed the story one last time, he thought: This is either the best story I’ve ever written, or it’s the last! But here it was—Weekly World News meets Tech Review.
China was waking up. Regalado clicked publish.
The term “exclusive” is hopelessly overused in the popular media, where every story and sound bite is tagged as breaking news. But in case anyone was in any doubt, Regalado prefaced his bombshell story with the word in all caps—and included it in the URL for good measure:
EXCLUSIVE: Chinese scientists are creating CRISPR babies16
At 7:15 P.M. (Eastern time) on Sunday, Regalado tweeted: “BREAKING: Chinese scientists making CRISPR babies.” The trial registration news was a bombshell, and while Regalado couldn’t say unequivocally that gene-edited babies had been born, there was an excellent chance that one or more had been conceived.
Regalado’s scoop left Marchione and the AP with an unforeseen dilemma. She had been stealthily preparing her own exclusive, waiting to release her story at the right time, either when JK presented on stage in Hong Kong, or when his Nature manuscript was finally published. After consulting her editors, she posted her own story, just a few hours after Regalado. The AP story contained two crucial exclusive details: the births of Lulu and Nana, genetically edited twins.17
Few people reading either story knew who JK was, but suddenly we could see and hear him in his own words. JK uploaded five short videos onto YouTube—a site ironically banned in China—in which he revealed the names of the twins and defended his decision to carry germline editing to term. Beaming like a proud parent, JK announced the birth of “two beautiful Chinese girls, Lulu and Nana.”18 The twins were safe and healthy, the gene surgery had worked with no off-target effects. “As a father of two girls, I can’t think of a gift more beautiful and wholesome for society than giving another couple the chance to start a family,” JK said.
Gene surgery should only be used to alleviate disease, JK insisted; any desire to deploy the technology cosmetically or to try to enhance a child’s IQ should be banned, as it is “not what a loving parent does.” He closed with the understatement of the year: “I understand my work will be controversial, but I believe families need this technology, and I’m willing to take the criticism for them.”
One of the few people who was not shocked by the sensational headlines was Doudna. Since 2015, she had galvanized the scientific community and led the ethical debate about CRISPR and its potential misuse on human embryos. She thought human germline editing was almost inevitable although she had resisted calls for a moratorium, fearing it could drive the research underground. In fact, she all but predicted the CRISPR baby saga. During an informal interview in 2017, she revisited her efforts to encourage ethical debate: “I didn’t want to see someone giving birth to a ‘CRISPR baby’ so that they could be famous and then having that lead to all kinds of health problems for that child that would then cause a backlash,” she said. “You could imagine this scenario.”19