by Arthur Caplan
A scientist named He Jiankui at the Southern University of Science and Technology in Shenzhen, China, shocked the world on November 25 when he announced — via YouTube — that he had created the first genetically modified babies. A smiling He reported that the twin girls, Lulu and Nana, were now home with their mom, Grace, and dad, Mark. “Grace started her pregnancy by regular IVF (in vitro fertilization) with one difference,” He said. “Right after we sent her husband’s sperm into her eggs, we also sent in a little bit of protein and instructions for a gene surgery.” The surgery, He explained, “removed the doorway through which HIV enters to infect people.”
He’s “gene surgery” on the embryo involved the gene editing tool CRISPR. He said his aim was to make it harder for HIV to infect the babies by creating a genetic message associated with enhanced resistance to acquiring AIDS in some long-infected adults. The girls, he claims, needed this protection since their father carried the HIV virus. More genetically altered children are, He said, on the way. He later said at the Second International Summit on Human Genome Editing in Hong Kong that he was proud of the achievement. That pride was not reciprocated by his peers and other commentators.
While there was a tiny bit of tolerance expressed for this monumental experiment, most of the scientific community expressed outrage over the first known claim of germline genetic engineering. Chinese authorities, long criticized for their relative reticence to speak out against germline engineering in humans, were quick to make their displeasure known. China’s government ordered a halt to He’s work. Chinese Vice Minister of Science and Technology Xu Nanping told CCTV News that his ministry is strongly opposed to the experiment, labeling the research illegal and unacceptable. A group of 100 prominent Chinese scientists declared He’s work outside the boundaries of acceptable science.
Those who condemned his announcement were right to do so. The state of gene editing does not support this first leap into human germline engineering. What’s more, the manner in which it was done merits condemnation as an ethical fiasco.
Presenting the results of such a groundbreaking, albeit unethical, experimental procedure — with potential consequences for future generations — by press conference is highly irregular. The lack of a peer-reviewed paper, which would require proof of institutional review board approval, has prompted some to question that he actually did what he claimed. Yet, given his failure to meet minimal standards of informed consent and research ethics committee review — his own university claimed no knowledge of what Professor He said he had done — no reputable journal could ethically publish his work. Still, that should not have stopped him from putting a paper online rather than conducting important medical research via the internet, press release and conference chatter. It is also unclear whether the media, particularly MIT Technology Review, where it was first reported (followed the next day by the Associated Press), had advanced knowledge of He’s work due to a prior agreement with him for an exclusive. Showing more concern about press coverage than disseminating details of the work amounts to nothing less than culpable grandstanding by He and his team.
Some have also questioned whether He and his team have the expertise to undertake the editing effort. Professor He trained at Rice University and Stanford and has been invited to many conferences of elite scientists who are perfecting gene editing technologies. Yet this concern overlooks even more pressing questions: Does He have a team in place capable of adequately monitoring the health of the babies for years to come? Has any provision been made to do so? That is, unacceptably, not clear.
He and colleagues published an ethics paper (unbelievably) to coincide with the YouTube announcement called “Draft Ethical Principles for Therapeutic Assisted Reproductive Technologies.” The authors did not disclose the “gene surgery” they’d performed on human embryos in the publication. Nondisclosure of that sort amounts to research misconduct.
And it appears that undisclosed conflict of interests may have tainted this first use of gene editing. Patents were allegedly being sought and clients recruited to the infertility program by an investigator seeking to profit from his work.
He said his aim was to prevent HIV infection in the children created at the fertility clinic where he did the gene editing. But it is not clear that standard methods of reducing transmission risk such as sperm washing would not have achieved equivalent protection.
Even more troubling is the issue of consent. Unborn children obviously cannot consent to an embryo-altering procedure. And putting them at risk when that procedure is still evolving and so much remains unknown about the potential unintended and poorly understood genetic changes that could result is simply immoral.
And the consent form given to the parents was utterly inadequate. It’s 23 complex pages, but it spends more time on who controls baby pictures than on risks. And there appears to have been relatively little effort made to ensure parental comprehension even though the consent is more focused on parental rather than on the child’s interests.
Furthermore, no provisions appear to have been made in the event of something going wrong. What if the twins do contract HIV? What if the gene tweak causes a birth defect or premature aging or vulnerability to other diseases and viruses? Is the research team liable? Their clinic? Their university? Who will pay the costs for the children if they need medical care or support?
No independent group or person appears to have signed off on the protocol. Having the lead investigator — who seeks to achieve a major first in the field of gene editing — be the person who secures consent to a very complex medical intervention makes no ethical sense whatsoever. And conducting the experiment mostly in secret, aside apparently from seeking advice from experts where the lead investigator had trained, is totally incompatible with gaining the public’s confidence that this technology can be implemented in a responsible manner.
Much of the condemnation of the world’s first human germline editing effort has focused on concerns that the science is still in its infancy. But historically, public concerns about germline engineering center less around the science than on the ethics of modifying our descendants. The scorecard on He’s experiment from an ethics point of view is pretty close to zero. For those who see the potential of germline gene editing in wiping out genetic disease — in a transparent and responsible manner — that is nothing short of tragic.
Arthur L. Caplan is the Drs. William F. and Virginia Connolly Mitty Professor and founding head of the Division of Medical Ethics at NYU School of Medicine in New York City
Featured image credit: NIH