An international commission has stated that we need more research before gene editing can be used in babies and for now, the technique is too risky.
First gene-edited babies
In 2018, He Jiankui and colleagues, used CRISPR/Cas9 technology to create the first gene-edited babies. The group disabled the CCR5 gene in embryos, making these babies naturally immune to HIV. News of this project led to fierce backlash and widespread concern, with the three scientists responsible jailed. Scientists globally condemned Jiankui work as being unethical and damaging the reputation of Chinese biomedical research. The affair resulted in legal and ethical controversies. As a result, the US National Academy of Medicine, the US National Academy of Sciences and the UK’s Royal Society established the International Commission on the Clinical Use of Human Germline Genome Editing. While most countries have strict regulations in place that limit gene editing approaches to research, this incident led to calls for strong international consensus.
A recent report, produced by experts in ten countries, provided recommendations about the clinical applications of human germline genome editing.
Their recommendations included:
- Extensive conversations in society are essential before countries allow this form of gene-editing.
- Once proven safe and effective, the initial uses should be limited to serious and life-shortening monogenic disorders. This includes cystic fibrosis. Even then, it should only be used when alternative avenues for having an unaffected biologically related child have been exhausted.
- Rigorous checks at every stage of the process are critical to ensure that there are no unintended consequences.
- Investigators should monitor each pregnancy and subsequent children long-term. This includes understanding the mental and physical health effects of the procedure for generations to come.
- Leaders must establish an international scientific advisory panel to regularly assess the evidence on safety and effectiveness.
A key concern about gene-editing technologies is their precision. Current CRISPR/Cas9 technologies generate some unwanted changes, which can outcomes different to those originally intended. Richard Lifton, President of the Rockefeller University in New York City and co-chair of the commission stated:
“The technology is not presently ready for clinical application.
If you are going to be creating human beings, you want to know that you can reliably make the edits you’re intending. If you can’t do it reliably, without introducing unintended effects, you shouldn’t be going forwards.’”
Comments of both support and criticism have emerged since this report, with some arguing that the recommendations are too strict.
Some individuals supported the report’s cautious approach, including Professor Dame Anne Johnson of the Academy of Medical Sciences who stated:
“This area of science could help a group of patients with no other options, but it is not one to be fast-tracked behind closed doors.
It must be based on strong clinical data showing safety and efficacy, alongside thoughtful public debate that is clearly informed by the best possible scientific evidence.”
However, others felt that while me must learn from the world’s first genome-edited babies, the report went too far in the other direction. Sarah Norcross, at Progress Educational Trust, stated:
“The criteria the report sets out, for the first acceptable clinical use of germline genome editing in humans, are far too narrow.
Furthermore, the report strays beyond its scientific remit. Much of the report – including a third of its recommendations – concerns governance, which is the focus of a separate genome editing project by the World Health Organisation.”
The World Health Organisation plans to release their report at the end of 2020. The report intends to deal with more issues of ethics and governance.
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