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China tightens its regulation of some human gene editing, labeling it ‘high-risk’ – Science (Dennis Normile | February 2019)0

Posted by Admin in on May 19, 2019
 

In the wake of the shocking news that one of its scientists had produced genetically altered babies, the Chinese government this week issued draft regulations that would require national approval for clinical research involving gene editing and other “high-risk biomedical technologies.” Although some Chinese researchers welcome the move to tighten oversight, there are worries that the rules could impose a burden on areas of genetic research that are not so controversial.

“I am happy to see the national regulations regarding new biomedical technologies; I think this makes relevant policy more clear,” says Wei Jia, a medical oncologist who is involved with an ongoing trial using gene editing to modify cancer patient T-cells at the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School in China.

The regulations are in response to the late November 2018 claim by He Jiankui, then of Southern University of Science and Technology in Shenzhen, China, that he had altered the DNA embryos in a way that would give the babies and their descendants resistance to HIV. This approach is called germline engineering—it can involve changing DNA in embryos or sperm or eggs—and is banned in many countries, by law or regulation. He’s effort, using a technique called CRISPR, resulted in twin girls born last fall; one more baby, he said, is on the way. The experiment earned He worldwide condemnation for prematurely using a still glitchy technique that might negatively affect the babies’ development and health in a medically unnecessary and unjustified intervention.

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Chinese government funding may have been used for ‘CRISPR babies’ project, documents suggest – STAT (Jane Qiu | February 2019)0

Posted by Admin in on May 19, 2019
 

BEIJING — Three government institutions in China, including the nation’s science ministry, may have funded the “CRISPR babies” study that led to the birth last November of two genetically modified twin girls, according to documents reviewed by STAT.

These findings appear to support what many researchers inside and outside China have suspected since scientist He Jiankui revealed the births in late November, sparking international condemnation for violating scientific guidelines against the use of gene-edited human embryos to start pregnancies. “I don’t think He Jiankui could have done it without the government encouragement to press ahead” with research they thought would merit a Nobel Prize, said Jing-Bao Nie, a bioethicist at the University of Otago in New Zealand.

If the documents are correct, they would suggest China is supporting research that the U.S. and other countries consider unethical, and raise doubts about the preliminary conclusion of a government investigation that He acted mostly on his own. That inquiry, which was led by the Guangdong provincial health commission and involved the science ministry and the National Health Commission, determined that He raised funding for the experiment on his own without official endorsement. It also concluded that He forged an informed-consent form and violated scientific ethics and Chinese regulations, according to the official Xinhua News Agency.

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Remains of dissected Nazi prisoners to be laid to rest in Berlin – The Guardian (Philip Oltermann | May 2019)0

Posted by Admin in on May 16, 2019
 

Microscopic tissue samples, kept by controversial anatomist, were found in 2016

The microscopic remains of political prisoners executed by the Nazis and dissected by a controversial anatomist are to be buried in Berlin on Monday, more than seven decades after the end of the second world war.

About 300 tissue samples, each one no more than a hundredth of a millimetre thin and one square centimetre in size, were discovered in 2016 by descendants of Hermann Stieve, a former director of the Berlin Institute of Anatomy who specialised in research into the female reproductive system.

Though Stieve was not a member of the Nazi party, he developed a relationship with the regime whereby he was allowed to do research on recently executed political prisoners in return for helping to obliterate any traces of their remains.

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Prominent UCSD eye doctor ‘on leave’ after inewsource investigation – inewsource (Jill Castellano & Brad Racino | April 2019)0

Posted by Admin in on May 14, 2019
 

Dr. Kang Zhang, chief of eye genetics at the University of California San Diego, is “on leave” after an inewsource investigation exposed how the doctor put medical research subjects in harm’s way for years while pulling in millions of federal dollars for the institution.

This case demonstrates why an institution’s monitoring arrangements need to escalate consistent nonadherence and include random audits

In a new development, inewsource obtained an inspection report from the U.S. Food and Drug Administration that detailed more problems with one of Zhang’s studies. The report, compiled in 2016, described one incident in which Zhang poked a hole in a study participant’s eye with a needle, causing a cataract that had to be fixed with surgery.
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The person wasn’t supposed to be enrolled in the study, according to the report, and the injury allegedly occurred because Zhang was in a hurry to take a trip to China.
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