Creation of first genetically edited twins requires more detailed investigation
6 February 2019. PenzaNews. An American biophysicist from Rice University Michael Deem played an instrumental role in the experiment by the Chinese scientist He Jiankui, who tried to create children protected from HIV infection by gene modification. This information appeared at the scientific and medical portal STAT News.
According to the article, the US scientist was He’s Ph.D. adviser and co-author of many of his works dedicated to the topic of study, including the paper titled “Birth of twins after genome editing for HIV resistance,” which presents the results of experiments.
According to some observers, involvement of a well-known and respected American bio-engineer could not only lend credibility to the project but also encourage the twins’ parents to join the experiment.
Meanwhile, the Chinese authorities officially confirmed the birth of children with altered DNA as a result of He Jiankui's manipulations.
“The scientist had organised a project team that included foreign staff that deliberately evaded supervision and used technology of uncertain safety and effectiveness for illegal human embryo gene-editing,” the investigators stated.
Professor Tetsuya Ishii, Office of Health and Safety, Hokkaido University, Associated editor at Japan Medical Association Journal (JMA-J), who attended the summit in Hong Kong, during which He Jiankui first presented his experiment, noted that the twins “must be followed up due to risky experimental reproductive medicine.”
“The responsibility of follow-up lies in the both the scientist and the parents,” he told PenzaNews.
However, it will be difficult for He Jiankui to perform follow-up because of the State order, according to which he can no longer do research it in China, the expert stressed.
“Moreover, the parents can withdraw the consent on follow-up even if they consented it. Nonetheless, the follow-up must be done for ensuring the health and human right for the twins. Maybe, it is up to the He’s university or the State,” the Japanese scientist suggested.
Commenting on the information that He Jiankui could face the death penalty, Tetsuya Ishii noted that it would be difficult to impose the death on him just because of the experiment.
“If He Jiankui’s assertion is true and the twins were born healthy, obviously it does not constitute the death penalty despite risky human experimentation,” Tetsuya Ishii said.
According to him, now WHO is forming expert panel to address the issues surrounding human gene editing.
“It will likely lead to some declarations demanding more stringent regulations for such uses of gene editing. In reality, it is difficult to globally regulate human gene editing because the viewpoint of human lives or reproduction varies in cultures, traditions, countries. Nonetheless, the efforts to create regulatory framework is important for our future children in the world,” he explained.
In turn, Professor Merlin Crossley, Deputy Vice-Chancellor Academic, Division of Education, the University of New South Wales in Sydney, said the experiment was premature.
“The risks were not known. The efficacy and efficiency of the procedure was not known. It is not clear that it worked,” the expert stressed.
Meanwhile, in her opinion, the babies are likely to be OK.
“It is possible they may have acquired an additional mutation but mutations occur every generation due to natural processes. Adding CRISPR would have increased the risk but the fact that the babies were born indicates no life threatening mutation occurred,” Merlin Crossley said.
The girls would not need any particular extra monitoring, she said.
“In fact, it may be best to avoid undue attention as the psychological impacts of being the first modified babies and in the world’s view may be the most serious side effect,” Deputy Vice-Chancellor Academic said.
According to her, the researcher must take responsibility for doing this work.
“I believe the penalty should fit the crime. If this broke Chinese law – and I do not know Chinese law – then it should be treated according to that law. I cannot comment further other than to say in my country the penalty would be severe and might include a custodial sentence,” Merlin Crossley added.
However, in her opinion, scientists won’t leave the ideas of genetic enhancement, so this direction will gradually develop.
“I believe it will be done with animals for generations and then maybe, if it is safe, it may become acceptable in humans, for limited conditions. But it should not happen before we know the risks and the views of society,” the Australian scientist said.
“This research will not spread around the world. Humans are cautious and slow in terms of reproduction. There will be time to discuss this. It is not like a nuclear explosion, an oil leak, or even like the effects of climate change. This can be contained and is being contained. No one is going to make an army of genetically modified babies, unless they can first command control over an army of willing mothers. I doubt the women of the world would be foolish enough to ever let that happen,” she added.
Meanwhile, Kathy Niakan, Group Leader, Francis Crick Institute, said that conducting the experience at this stage of development of genetic engineering was “irresponsible, unethical and dangerous.”
“He’s presentation did nothing to assuage my scientific, moral or ethical concerns about the work. There was a worrying lack of oversight or scrutiny of his clinical plans before he started human experiments and a complete lack of transparency throughout the process. I found it highly troubling that He avoided questions about approval processes and his answers on patient recruitment and consent did not reassure me. The team don’t seem to have had adequate training on proper consent processes, and offering vulnerable patients free IVF treatment presents a clear conflict of interest,” Kathy Niakan noted.
“He also failed to address the question of why he went ahead with the experiments despite strong international consensus against such procedures. There is a real danger that the actions of one rogue scientist could undermine public trust in science and set back responsible research,” the scientist stressed.
In turn, Dana Carroll, Distinguished Professor, Department of Biochemistry, University of Utah School of Medicine, Salt Lake City, pointed out that we have no independent evidence that the experiments were actually carried out as He Jiankui described.
“Until we have verification of the CCR5 sequence modifications in the two children, it remains possible that he has fabricated the whole story. If the editing is verified, then yes, the children should be monitored closely, and I would think the Chinese authorities should take over at this stage,” the professor said.
According to her, the scientist deserves a certain punishment, since he endangered the children with no medical justification.
“There are two possible reactions that I hope will not occur. First, other people will see the door to human germline editing as open and will proceed with similar attempts before the technology is sufficiently safe and effective. Second, authorities in various countries will react by banning all germline editing experiments and possibly even experiments aimed at developing somatic therapies,” Dana Carroll said.
She expressed hope that therapeutic germline editing will be developed and ultimately offered to families in the future.
“However, a lot of careful research is needed to make this approach safe and effective. In the meantime, a number of somatic therapies are making their way to clinical trials using genome editing with CRISPR, TALENs and zinc-finger nucleases. These have considerable promise and do not involve modifying the human germline. Even the somatic therapies must be tested very thoroughly before they can be offered to patients generally, and this will take several years,” the scientist said.
“The public is eager to enjoy the benefits of medical genome editing, but these are still some distance in the future and apply to a limited range of diseases and conditions,” Dana Carroll concluded.