January 8, 2020

The 'CRISPR baby' scientist is going to jail. What does that mean for CRISPR's future?

Daily Briefing

    He Jiankui, a Chinese scientist who announced in November 2018 that he used the gene-editing technology CRISPR to create the world's first genetically modified human babies, has been sentenced to three years in prison for "illegal medical practice."

    Your cheat sheets for understanding health care's legal landscape

    Background

    In November 2018, Jiankui announced he had altered the DNA of twin girls born earlier. Clinical trial documents posted before the announcement suggested He's research used the gene-editing tool CRISPR to modify human embryos before they were implanted into the women's uteruses.

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    In a 2018 interview with the Associated Press, He said the clinical trial aimed to create a child who would be immune from HIV. He told AP his team edited 16 embryos to disable a gene called CCR5 that allows the HIV virus to enter human cells. He said 11 embryos were used in six implant attempts before the twins were conceived. He said tests suggest one of the twins has both copies of her CCR5 gene disabled while the other has just one copy of CCR5 disabled, which means the latter twin could still contract HIV.

    Since the announcement, nothing has been made public about the health and wellbeing of the twins.

    Research into editing human embryos is highly controversial and has divided the scientific community since 2015, when a separate team in China first edited a human embryo's genes in a laboratory. That earlier line of research did not lead to live human births.

    Given the controversy, He's announcement sent shockwaves throughout the scientific community and triggered investigations by local authorities and universities in China and the United States.

    He sentenced to prison

    On Dec. 30, 2019, the People's Court of Nanshan District of Shenzhen announced that He and two of his colleagues had deliberately violated regulations and research and medical ethics in pursuit of "fame and profit." Authorities also said He's team falsified regulatory paperwork. According to STAT News, the Chinese court ultimately charged He with "illegal medical practice."

    He was sentenced to three years in prison and fined three million yuan, or $430,000. Meanwhile, one of He's collaborators, Zhang Renli, was sentenced to two years in prison and fined one million yuan, or $143,000, while He's other collaborator, Qin Jinzhou, received a suspended sentence of one year and six months in prison and was fined 500,000 yuan, or $71,600.

     All three researchers were also permanently banned from working with human reproductive technology again and from applying for research funding from the science ministry.

    What the sentence means for the future of CRISPR research

    At the time of the announcement, there was speculation as to whether other scientists would perform similar research to He's, Nature reports.

    Some geneticists, including George Church of Harvard University, argued that He's attempt to edit the genes to prevent HIV is "justifiable," because HIV is "a major and growing public health threat." However, Church and other researchers questioned the decision to allow the embryo with the unaltered CCR5 gene to be implanted.

    But others, such as Fyodor Urnov, associate director of the Seattle-based Altius Institute for Biomedical Sciences, argued that there was no justification for the embryo experiment because researchers already are experimenting with modifying the same gene in adults with HIV. "It is a hard-to-explain foray into human germ-line genetic engineering that may overshadow in the mind of the public a decade of progress in gene editing of adults and children to treat existing disease," Urnov said

    But according to Wei Wensheng, a gene-editing researcher at Peking University, He's sentence is "definitely a deterrent to similar misconduct in China."

    Other Chinese scientists currently using CRISPR said they're afraid He's actions could have an effect on their work as well, Nature reports.

    In the United States, human germline editing was effectively outlawed by Congress in December 2015 through a provision in a budget appropriations bill, STAT News reports.

    FDA has jurisdiction over any clinical use of human cells that have been genetically modified, meaning anyone wanting to use gene-edited cells in humans needs to apply for an investigational new drug (IND) waiver from FDA.

    However, Congress' provision bars FDA from considering any IND application that involves transferring a genetically modified human embryo for gestation. Any U.S. scientist who was to conduct an experiment like He's would be subject to administrative actions such as  being disqualified from conducting any ongoing or future FDA-funded research.

    In addition, STAT News reports such research would violate the Federal Food, Drug and Cosmetics Act, which means scientists who conduct such research could face criminal penalties, including fines of up to $250,000 and up to 10 years in prison.

    The House last year opened discussions on whether the language barring germline editing should be modified, but to date the ban remains in full effect in the United States (Cyranoski, Nature, 1/3; Johnston, "First Opinion," STAT News, 12/31/19; Joseph, "In the Lab," STAT News, 12/30/19; Hollingsworth/Yee, CNN, 12/30/19).

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