Françoise Baylis responds to the recently announced birth of the world’s first genome edited babies and raises concerns about the scientific practice and ethical accountability.
A few days before the scheduled Second International Summit on Human Genome Editing in Hong Kong, scientist Jiankui He announced the birth of twin girls following genome editing. According to He, the goal was to improve resistance to HIV, the virus that causes AIDS, and to allow HIV-infected adults to have unaffected children. However, critics describe this announcement as nothing more than a crass publicity stunt clearly calculated to pre-empt the International Summit.
The recently publicized research involves a Chinese couple where the male partner was infected with HIV. In this case, embryos were created using in vitro fertilization and, at the single-cell stage, genetically modified so that the CCR5 gene was disabled (this gene produces a receptor that allows HIV into cells). This type of heritable genome editing involves making changes to embryos or gametes (eggs and sperm) that are passed down from parents to children through the generations.
As reported by He, twin girls were born following an uneventful pregnancy: “Two beautiful little Chinese girls, named Lulu and Nana, came crying into this world as healthy as any other babies a few weeks ago. The girls are home now.” Lulu and Nana are pseudonyms. He claims that the CCR5 gene was successfully disabled in one of the girls. The other twin appears to have a mix of genetically altered and unaltered cells, something well known in experiments in mice and referred to as mosaicism. The long-term consequences for either girl are unknown.
Within 24 hours of He’s announcement, a statement was issued by the Southern University of Science and Technology clarifying that He had done this gene editing work off campus, while on leave. And, the research ethics review committee has denied having granted ethics approval for the research. As this story unfolds, I expect we will learn more about the as yet unverified claims.
To date, a number of ethical objections have been raised to He’s research, by individuals and organizations, including the Center for Genetics and Society. According to many, heritable human genome editing to provide resistance to HIV is unnecessary because there are other, more effective ways of preventing HIV transmission.
Moreover, there is no favourable harm-benefit ratio with this research. Among the potential harms of heritable genome editing are off-target mutations, which can cause unwanted changes to the DNA and may have serious negative consequences, including cancer. These potential harms outweigh the potential benefit of genome editing to ensure resistance to HIV infection. Indeed, if the girls never come into contact with HIV, there is no benefit whatsoever to having been genetically modified to improve their resistance to HIV.
Furthermore, He seems to have recruited couples through a Beijing-based AIDS advocacy group called Baihualin. This raises ethical questions about how couples were recruited to the study and about informed consent.
In addition to these worries, I have concerns about He’s hubris in thinking that it is for him alone (or in concert with other scientists) to decide that it is ethically appropriate to modify human embryos and make changes that will be passed down through the generations. I, and others, have long argued that the human genome belongs to all of us, and it is not for scientific or corporate elites to decide the future of humanity. In my view, “We should all have a say.”
I first met He in January 2017 at a meeting in Berkeley hosted by Jennifer Doudna and William Hurlbut. At the time, I was surprised at his naiveté when proudly describing his work with human embryos. I don’t think any of us at the meeting imagined that He would soon be attempting to initiate pregnancies using genetically modified embryos. Several of us, however, were left with the impression that He seemed quite cavalier. Should we have said or done something? In thinking about this question, I have tried to imagine what that something might have been and I don’t have an easy answer. What does this say about how we do science and how we hold the scientific community accountable?
In this regard, the non-committal Statement on He’s research from the Organizing Committee of the Second International Summit is a disappointment. At the very least, the Organizing Committee could have referenced the On Human Gene Editing Statement issued in December 2015 by the Organizing Committee of the First International Summit. It stipulated two criteria for ethical heritable human genome editing: “(i) the relevant safety and efficacy issues have been resolved, based on appropriate understanding and balancing of risks, potential benefits, and alternatives, and (ii) there is broad societal consensus about the appropriateness of the proposed application.” He’s research met neither of these criteria. It would not have taken much courage to object to the clear disregard for these minimal criteria. In sharp contrast, the Southern University of Science and Technology has stated unequivocally that it: “believes that Dr. Jiankui He’s conduct in utilizing CRISPR/Cas9 to edit human embryos has seriously violated academic ethics and codes of conduct.”