The brave new world for the edition of human DNA begins in China



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(Bloomberg) – Researchers have expressed surprise at the November 26 report on the birth of the first babies in the world with modified genes – binoculars. It is not surprising that the scientist who made this statement came from China. As part of its efforts to dominate scientific spheres, including biotechnology, the country has taken the initiative to test the uses of Crispr, a tool recently made available to researchers, allowing them to modify the codes of the DNA in a simple and inexpensive way. Chinese scientists were the first to test Crispr on monkey embryos, on non-viable human embryos, on adult humans – and now, that. The announcement of the first baby designer revived the debate over whether the Chinese regulatory system adequately addressed the ethical and medical risks of Crispr.

1. What is the controversy?

This is the first reported case in which genes were manipulated in embryos that were subsequently used to produce babies. The modification of an embryo's genes alters the DNA of each cell, including the eggs or sperm, of a resultant person who had no say, and these modifications will be pbaded on to the offspring. This blurs the principle that clinical research participants must give informed consent. This is important because editing with Crispr is experimental in humans and carries risks. The technique works by making cuts in the DNA. Sometimes they can be involuntary and have unknown effects.

Some researchers were outraged that these risks were taken for purposes that were considered insufficient. The Chinese investigator, He Jiankui, said his goal was to produce babies immune to HIV, the virus that causes AIDS. He says he has modified a gene in embryos that makes a protein called the CCR5 receptor, which HIV uses to enter cells. Critics point out that HIV infection is relatively rare in China, there are other ways to prevent it and it is treatable. Even though gene editing has worked, twins will not be invulnerable to HIV, which can also enter cells via a receptor called CXCR4. In addition, studies suggest that CCR5 deficiency increases vulnerability to West Nile virus and influenza. Reports published by the US National Academies of Science, Engineering and Medicine in 2017 and by the UK's Nuffield Council on Bioethics in 2018 concluded that human reproductive-gene editing badays , or germ cells, should only be used to meet unmet medical needs and benefit the genes are altered.

3. Has the gene editing test been approved?

It is not clear. The researcher said that he had obtained approval from the Medical Ethics Committee of Shenzhen Harmonicare Hospital. The company's owner of the hospital said in a paper that she thought that the signatures on a request made to the committee had been falsified and that she was investigating.

4. What are the relevant rules in China?

According to the guidelines of the National Commission for Health and Family Planning in 2003, the editing of embryo genes is not prohibited, but the use of eggs, sperm and embryos genetically modified is prohibited. These are not laws and they are enforced through the commission's ability to withdraw licenses from fertility clinics.

5. What are the rules elsewhere?

Twenty-nine of the 47 member states of the Council of Europe – including France, Denmark, Switzerland, and Spain – have ratified the Oveido Convention of 1997, which prohibits gene modification of the germ line. In the United States, Congress has banned the Food and Drug Administration from considering such tests. An Australian law of 2002 provides for a 15-year prison sentence for anyone who intentionally modifies a human cell.

6. Does lax regulation explain China's advance?

Certainly not everything. China wants to be a leader in 21st century technology and has spent billions of dollars on research funding. As a participant selected for his prestigious Thousand Talent program – a plan to attract talented Chinese overseas – he would have received at least a starting bonus of about $ 143,000 for his research, along with the possibility of additional research grants of about $ 700,000. He also founded a start-up called Direct Genomics that manufactures DNA sequencing equipment, which also received government funding, according to his website. According to the clinicaltrials.gov database, China has 12 human trials involving the Crispr method. One of them is active, eight are in the recruitment stage. In the United States, there are six Crispr-related trials, four of which are under recruitment and none in operation.

7. China's answer?

Biotechnology companies and universities across the country have made considerable efforts to counter the suspicions that their efforts are fraught with fraud and under-supervised experimentation. The China Genetics Society and the Chinese Society of Cell Biology have quickly condemned the work of gene editing, calling it a serious violation of ethics. A group of 122 Chinese researchers issued a letter Monday saying the project was unfair to the vast majority of Chinese scholars who work conscientiously and respect ethical boundaries. The Chinese Union of Life Sciences Societies, grouping 22 national badociations, said it strongly opposed any research going against the spirit of the science and ethics, and that his case had "seriously disrupted the order of scientific research and seriously damaged Chinese international law". reputation in the field of life sciences. "

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