Clinical OMICS

JAN-FEB 2019

Healthcare magazine for research scientists, labs, pathologists, hospitals, cancer centers, physicians and biopharma companies providing news articles, expert interviews and videos about molecular diagnostics in precision medicine

Issue link: https://clinicalomics.epubxp.com/i/1071882

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42 Clinical OMICs January/February 2019 www.clinicalomics.com the Associated Press confirmed those rumors: twin girls, Lulu and Nana, had been born earlier that month. He's presentation in Hong Kong raised more questions than answers, even though he fielded questions for 40 minutes. Criticisms of his work were fast and furious—calling it abhor- rent, disgusting, even criminal—and ran the gamut from the choice of gene target (CCR5), the informed consent, the cloak of secrecy, and the medical necessity. He's goal was to edit human embryos to make them resistant to HIV. But as David Liu (HHMI/ Broad Institute) pointed out, He's protocol already included sperm washing to generate uninfected embryos. "What was the unmet medical need?" he asked. He sidestepped the question by stressing the public health menace of HIV affecting mil- lions of patients. NIH Director Francis Collins accused He of trampling on ethical norms, while reiterating that NIH does not support the use of gene-edit- ing technologies in human embryos. But George Daley, Dean of Harvard Medical School, sought a more measured response. "Just because the first steps [in germline editing] are missteps, doesn't mean we shouldn't step back, restart, and think about plausible and responsible pathway for clinical translation," he said. Perhaps Chinese bioethicist Qiu Renzong put it best: "How could Dr. He and [his] team change the gene pool of the human species without con- sidering the need to consult other parts of the human species?" The organizing committee's closing statement said, "The scientific understanding and tech- nical requirements for clinical practice remain too uncertain and the risks too great to permit clinical trials of germline editing at this time." But the committee held out that germline edit- ing could become acceptable in the future with strict independent oversight, a compelling medical need, a translational pathway, plans for long-term patient follow-up, and attention to societal effects. U.S. FDA commissioner Scott Gottlieb warned ominously that, "Governments will now have to react," adding that "the scientific community failed to convincingly assert, in this case, that certain conduct must simply be judged as over the line." CRISPR leaders are hoping that the reckless manner in which germline editing came into being will not negatively impact the promise of CRISPR gene editing for somatic gene therapy, as the first CRISPR clinical trials get underway. "It's an appalling example of what not to do with a new technology that has incredible potential to benefit society," Liu said. "The actions of one rogue scientist could undermine public trust in science and set back responsible research," said Kathy Niakan, a leading embryo researcher at the Crick Institute in London. Liu's Broad Institute colleague, CRISPR pio- neer Feng Zhang, called for a moratorium on germline editing until the field has "a thought- ful set of safety requirements." But George Church's concerns were primarily with the chil- dren. "As long as these are healthy, normal kids, it's going to be fine for the family and for the field," he said. (continued from previous page) "How could Dr. He and [his] team change the gene pool of the human species without considering the need to consult other parts of the human species?" —Chinese bioethicist Qiu Renzong vchal / iStock Getty Images

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