In the latest example of regulations not keeping up with technology, on November 25, 2018, Marilynn Marchione of the AP published a report regarding He Jiankui’s claim that he had helped create the world’s first gene-edited babies using CRISPR-Cas9 technology. He said, twin girls, Lulu and Nana, had been born weeks earlier, with their CCR5 gene edited so that they would be resistant to HIV infection.
Soon after the AP article was released, He published videos on YouTube, where he announced the twin girls were “as healthy as any other babies.” In the videos, He presented what he believes should be the five ethical principles for reproductive technologies (including gene editing) and used the term “gene surgery” instead of “gene editing”.
While there have been numerous examples of fraudulent studies coming out of Asia (e.g., Hwang Woosuk in the field of stem-cell research), the consensus is that He’s claims are likely to be legitimate. The reason why ethicists are so worried about the CRISPR twins is that, technically, CRISPR is pretty easy to do. In fact, a new biotech company is currently developing an at-home CRISPR diagnostics kit.
However, if He has committed fraud, he could be outcast from the scientific community and his young career finished. For example, Hwang was fired from his university job and served prison time for bioethical violations and embezzlement of government funds. If He’s study is accurate, the experiment would likely anger numerous scientists. The unethical experiment that caused the death of Jesse Gelsinger set back the field of gene therapy light years. In fact, Marchione’s article mentioned that individuals with mutated CCR5 genes may have higher risk for infections from other viruses, such as Zika or West Nile. He’s arrogant conduct could increase the arguments of those who have called for a freeze on the gene-editing of human embryos, bringing basic studies to a halt.
The second Human Genome Editing Summit organizing committee issued a statement this past week criticizing He’s study and calling for a suspension of any further germline editing clinical trials. David Baltimore, the 1975 Nobel laureate in Physiology or Medicine, stated “The scientific understanding and technical requirements for clinical practice remain too uncertain and the risks too great to permit clinical trials of germline editing at this time.
“Even if the modifications are verified, the procedure was irresponsible and failed to conform with international norms. Its flaws include an inadequate medical indication, a poorly designed study protocol, a failure to meet ethical standards for protecting the welfare of research subjects, and a lack of transparency in the development, review, and conduct of the clinical procedures.”
Similarly, Francis Collins, director of the National Institutes of Health, called for “a binding international consensus on setting limits for this kind of research. Without such limits, the world will face the serious risk of a deluge of similarly ill-considered and unethical projects. Should such epic scientific misadventures proceed, a technology with enormous promise for prevention and treatment of disease will be overshadowed by justifiable public outrage, fear, and disgust.”
The AP Report: https://www.apnews.com/61291010ca0a4204855c46089ed1d0dd