By, Katie B. ’21
In late November, Chinese scientist He Jiankui announced via YouTube video an attempted implantation of CRISPR genetically edited twins, claiming to have made the first to genetically engineered humans. CRISPR: Clustered Regularly Interspaced Short Palindromic Repeat, is a molecular tool patented by MIT and Harvard’s Broad Institute, and first invented in 1993. The natural role of CRISP is to serve as a bacterial defense system but it has been engineered to be the foundation of modern genome editing technology that targets specific stretches of genetic code and edits the DNA to permanently alter genes in living cells. Currently, research of CRISPR’s uses is focused on at determining whether CRISPR could successfully correct genetic mutations of specific locations in the human genome so as to preemptively “treat” genetic diseases by repairing flaws in DNA.
He Jiankui, a researcher in China who studied at Stanford, has publicly announced that he has altered a gene in the embryos of two twin girls. Dr. He reported via online video that he used the CRISPR program to disable the gene for a protein that allows HIV to enter cells, claiming to have prevented HIV infection while having no adverse effect on other genes of human development. Dr. He’s experiment has faced harsh criticism from global health organizations for violations of standards of ethical research in humans. He has been faulted by the scientific community both for failing to follow research ethics, and for failing to provide scientific details to prove whether he had in fact accomplished what he claimed. Dr. He is currently under investigation by China’s health commission, and the Chinese federal government has halted the research.
The potential use of CRISPR to alter human DNA was recognized early, and following the development of more accurate CRISPR editing tools, the American Society of Human Genetics and eleven international health organizations published a reevaluation of medical ethics surrounding gene editing. These guidelines were firmly opposed to genome editing that culminates in human pregnancy, described both the scientific and social changes required before proper implementation of CRISPR technologies in humans, and recommended specific measures for when the application of CRISPR to human pregnancy could be done, including; compelling medical rationale, evidence, ethical justification, and a transparent public process (American Society Of Human Genetics).
Many Boston based experts in medical ethics that I communicated with expressed shock at the report, and the failure to follow ethical guidelines for human research. According to Louise King, a professor at Harvard Medical School’s Center for Bioethics, “what [Dr. He] has done was not ethical for a multitude of reasons.” Dr. He’s experiment lacked appropriate oversight by the hospital, was not clearly based on informed consent, lacked transparency in its scientific and ethical procedures, and misused the technology in a non-life threatening situation. Robert Truog, director of the Center for Bioethics at Harvard Medical School, suggested that the experiments were “more of a scientific stunt, focused more on building notoriety for the scientist, rather than for advancing knowledge or promoting care.” Truog noted the nature of medical notoriety in the experiment: “the experiments conferred little, if any, benefit to the twins, and exposed them to unknown risks.”
The failure of both the doctor and the hospital to follow ethical norms prompted other experts to call for an end to this type of research for now. George Annas, director of the center for Health Law and Ethics at Boston University Medical School, went further and stated that the experiment “did not follow either basic scientific norms or research ethics. It should provoke a global moratorium on the implantation of genetically-edited embryos.”
National organizations and international collaborations have denounced the experiment, hospitals have publicly rescinded their cooperation with Dr. He, and individuals have directly addressed him in the press, suggesting a collective medical body opposed to the use of CRISPR in human genes. However, despite this surge of demands for halting gene editing,”no country has the ability to demand regulation occurs in another country or the ability to enforce international agreements,” Dr. King reminded me. The United States has an explicitly clear ban on CRISPR research in people, but there is no way to enforce a similar law in other countries or to expect that all countries will follow the US policies.
Concerns surrounding gene editing reach beyond Dr. He’s singular experiment. CRISPR is efficient in removing specific genes, but the breadth of effect a single gene has on the development of a human embryo is at this moment unknown. The worry is that “off-target” effects, while byproducts of beneficial changes, could have other negative effects at the same time that could be devastating or cause illness. There are additional concerns that successful CRISPR editing will stimulate an increased interest in genetic engineering of “designer babies,” that go far beyond addressing illness but seek to craft people to have or lack specific traits such as eye color, height, or appearance. The worldwide availability of CRISPR technology has created a scientific opportunity that many may seek to exploit in order to claim to be the “first” to engineer a “better” person.
The opportunity to use CRISPR to address diseases like sickle cell anemia or congenital disorders had prompted many nations to reconsider previous rules on genetic engineering. The Nuffield Council on Bioethics, a leading ethics body in the UK, had stated that genetic editing is “morally permissible…there is no reason to rule it out in principle,” and that “we need to have as wide a discussion about this as possible.” Nonetheless, the general public still holds vast fears of “designer babies” and gene editing. In a poll from Pew Research Center, 72% of respondents would support gene editing to treat a condition the baby would face at birth, only 19% would support genetic engineering to make a baby more intelligent. While the general public may support moderate uses of gene editing, it is clear that He’s experiment has created a firestorm of academic, medical and public criticism. It raised disturbing questions and reminded people of lingering fears of overuse of the technology and drastic social change. Many scholars and organizations have now pointed out the lack of ethical norms in Dr. He’s experiment, but the international backlash extends further than a failure to follow guidelines. Gene editing technology and international opinion and expertise are at a standoff; technology is advancing with or without public support, but whether society and social norms go with it is simply a guessing game.