Pharma, R&D

Incensed by China CRISPR scandal, US consortium amplify global call to suspend human embryo editing

Inspired by his biologist brother, Aldous Huxley laid out his dystopian vision — replete with genetically modified citizens stratified by an intelligence-based social hierarchy — in his 1932 book Brave New World. The emergence of mitochondrial replacement therapy or ‘three-parent IVF’ and one rogue Chinese scientist later, fears that unbridled human embryo editing could be dangerous from a scientific, ethical, and societal perspective have reignited. On Wednesday, a consortium of scientists, bioethicists, and biotech executives wrote to US HHS secretary Alex Azar, calling for a collaboration on a binding global moratorium on human clinical germline experimentation.

Alex Azar

Globally, guidelines vary widely about the extent (or lack thereof) of germline research — introducing heritable changes to sperm, eggs or embryos — is permitted. Some regions ban it altogether; some allow lab research but not pregnancies (like in the UK); while others have no policies. In the US, the NIH does not fund germline research, but private funding is sanctioned.

Last month, an international group of ethicists and researchers, including experts who originally developed CRISPR–Cas9 as a gene-editing tool, called for a moratorium on clinical use of human germline editing until the safety of the technique has been established and a consensus on acceptable use has been reached.

(W)e call for the establishment of an international framework in which nations, while retaining the right to make their own decisions, voluntarily commit to not approve any use of clinical germline editing unless certain conditions are met.

The NIH supported the call.

The move followed last year’s news that controversial Shenzhen-based researcher Jiankui He genetically edited embryos using CRISPR/Cas9 tools — with intention of inducing HIV resistance —  which were implanted and resulted in the birth of twin infant girls, triggering a tempest in scientific circles the world over. In the wake of the scandal, the Chinese government tightened its oversight of gene editing and other “high-risk biomedical technologies” in March.

“He proceeded without clear medical need, in a surreptitious manner lacking any meaningful public or scientific community discussion or consensus, and without any regulatory approval,” the group of 62 decried in the letter, condemning such human germline clinical experimentation as irresponsible.

Feng Zhang

“Such human genetic manipulation should be considered unacceptable and support a binding global moratorium until serious scientific, societal, and ethical concerns are fully addressed,” the experts, including CRISPR/Cas9 co-inventor Feng Zhang, said.

They underscored a myriad of issues such as off-target effects and mutations, which apart from the medical impact could pose major ethical concerns, because research subjects would include, and not only be limited, to embryos and children, but also future generations of descendants.

Clinical germline gene editing is appropriately prohibited in the United States, across much of Europe, in China, and in many other countries…Before this status quo is revisited, it is vital that extensive discussions and engagement take place among all major stakeholders, including members of the scientific, medical, patient, caregiver, policy, legal, ethical, and faith communities.

But the group was clear that the moratorium should be limited to germline editing, not somatic (cells in the body except sperm and egg cells) cells, which have significant repercussions in the understanding and treatment of human disease.

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VP Oncology Biology
Skyhawk Therapeutics Waltham, MA
Associate Director CMC
Elektroki Boston, MA
Director Process Development
Elektroki Boston, MA
Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT

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