Thursday, 13 December, 2018

'Of course it's not ethical': shock at gene-edited baby claims

First Gene-edited Babies Claimed in China Investigation launched into 'monstrous' claims scientist has genetically edited humans
Elijah Vega | 28 November, 2018, 02:00

China's National Health Commission ordered an investigation into He's work, which defied a global scientific consensus banning the use of genetic editing on human embryos. All of the men in the project had HIV, the women did not. Those babies were born earlier in November.

The Shenzhen Health and Family Planning Commission denounced the legitimacy of the hospital ethics committee and the review process that approved the application.

Pablo Tebas, a clinical researcher at the University of Pennsylvania who led a small study that crippled CCR5 in HIV-infected adults using what's known as zinc finger technology, similarly denounced the embryo adjustment.

The Southern University of Science and Technology, where He works, said he had been on unpaid leave since February and his research is a "serious violation of academic ethics and norms".

But other factors such as a larger population providing a larger pool of potential patients, as well as regulatory support from the government also played a role, Donovan said. He did not report to the school and the department of biology, and the school and the biology department did not know about it.

Annas also faulted He for conducting his research on "twins instead of one baby" and said scientists should "never endanger two children with a first of its kind experiment-but should do one and not add others until safety (and efficacy) are confirmed in the first".

"I think this just shows the time is now that you have to talk about the ethics of genome editing, because the world may not wait", said Insoo Hyun, a bioethicist at Case Western Reserve University.

To edit the embryos, He says, his team injected a single sperm into each egg to create an embryo and then added the CRISPR construct to some with the instructions for precisely editing the CCR5 gene. In the United Kingdom, editing of embryos may be permitted for research purposes with strict regulatory approval. It is unknown whether the procedure is safe or, if used in pregnancy, whether it can have unintended consequences for the babies later in life or for future generations. "The underlying goal of doing the experiment was obviously to show that they could do gene editing on an embryo, but the objective for the party involved does not make any sense", says Anthony Fauci, an HIV/AIDS researcher who heads the U.S. National Institute of Allergy and Infectious Diseases in Bethesda, Maryland. "It's extremely unfair to Chinese scientist who are diligent, innovative and defending the bottom line of scientific ethics".

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Julian Savulescu, director of the Oxford Uehiro Centre for Practical Ethics at the University of Oxford, described the alleged births as "genetic Russian Roulette".

He says that he practiced CRISPR editing on mice, monkey, and human embryos for several years before applying his techniques to human embryos. "The embryos were healthy". He revealed it Monday in Hong Kong to one of the organizers of an global conference on gene editing that is set to begin Tuesday, and earlier in exclusive interviews with The Associated Press. "Fundamentally, there's nothing different in making [genome] edits in adult humans versus the embryo", said one conference attendee, Eben Kirksey, an associate professor of anthropology at Deakin University in Victoria, Australia.

"I understand my work will be controversial", he said.

China's Genetics Society and the Chinese Society for Stem Cell Research said in a statement He had acted as an "individual" and his work posed "tremendous safety risks for the research subjects".

Baylis said it was also ethically questionable that He chose to address an HIV gene, when there are other less risky ways to prevent HIV. "All these questions need to be looked into when we hear what he's actually done", Hynes says. We don't need genome editing to prevent HIV-we need to make existing preventive measures and treatments more widely available.

On Thursday, the organising committee of the summit will present a report summarising on how to carry forward the development of gene editing.

The mother of the babies, who has not been identified, began with a standard IVF pregnancy.

"(Chinese people) have a high willingness to use of gene in disease prevention and treatment", Liang Chen, a professor at Sun Yat-Sen University is quoted as saying. Although China has no laws explicitly banning gene editing in babies, using the procedure does violate guidelines published by China's health ministry in 2003, and goes against worldwide guidelines agreed to at a summit on the issue in 2015.

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