A recent article in Science News[1] illustrates the differing views and sometimes internal struggles of scientists undertaking research in the area of gene editing. According to the article, many in the scientific community were outraged and the term “rogue scientist” was invoked when it was learned that a laboratory overseen by Dr. Jiankui He, at the Southern University of Science and Technology in Shenzhen, China, had performed experiments that resulted in the editing of the genomes of two babies nick-named LuLu and NaNa. The edits, accomplished by the use of the CRISPR-Cas9 protein, resulted in the attenuation of the CCR5 gene which is involved in the HIV infection process. Theoretically this should make the two girls immune to HIV infection, which was the goal of the gene therapy. Dr. Jiankui He assured the public that the girls were healthy[2] and that the gene edit had successfully edited only the CCR5 gene throughout the genome of the girls.
Previous gene editing experiments using the same CRISPR technology have typically shown less than perfect specificity of the editing process leading to mosaicism. Mosaicism is where some genes targeted by the CRISPR process contain the edit and some targeted genes remain untouched. Another notable difficulty with CRISPR gene editing has been non-specific editing whereby other sections of DNA not targeted by the researchers have been edited leading to unwanted effects on other genes and body systems. This is why previous CRISPR experiments have been done on animal models or human cell-culture models that do not affect the lives or reproductive cells of viable human beings. Some scientists have assumed a wait-and-see posture as they consider the health and growth of the two girls and have stated that they are skeptical of the specificity claimed by Dr. He.
Jiankui He and his two collaborators were fired, charged with criminal offences, sentenced to time in prison, and given significant fines for gene editing without authorisation and for misleading ethics board members. Prior to the conviction and sentencing Dr. He was listed as one of the 100 most influential people of 2019 by Time Magazine[3] (albeit as one whose research was deemed reckless by the inventor of CRISPR technology). Perhaps we have not heard the last from Dr. He but this controversial research has led to a pronouncement from a newly formed International Commission on the Clinical Use of Human Germline Genome Editing. The group has pronounced strict scientific criteria that would need to be met before heritable gene editing could be tried clinically and have warned that this type of research should not be attempted if the criteria cannot be met.
Yet, such pronouncements will likely not prevent all genetic editing of the human genome. Some suggest that “The science should wait until society decides whether to allow gene editing that can affect future generations.” Other researchers suggest that the best way forward is to continue the research into gene editing without taking it to the point of clinical trials that would result in the birth of gene-edited babies. Nobel Laureate David Baltimore suggests that,
“There are couples today who would like to have a child that inherits their genes, but among their genes, there is one [mutated gene] they would not like their offspring to inherit. If we could guarantee that the offspring would not inherit a mutated gene, they would then be able to have the child they want to have. They would be able to say to a physician, “Is there a procedure that could safely give us the child we want?” I think when the answer to that question is “yes,” there will be tremendous pressure on the medical community to carry out gene modification.”[4]
To return to the former statement, how does one “wait until society decides whether to allow gene editing that can affect future generations”? How does the medical community or society in general make such decisions? What if a genetic edit were to provide enhancement for the individual? Would society or the scientific community view the procedure differently? We do know that in the mouse genome, mice whose equivalent to CCR5 gene had been “knocked out” showed a tendency toward better memory than those whose CCR5 gene was intact. Thus, removing this gene in mice can in fact be considered an enhancement. It is uncertain what this might mean for LuLu and NaNa, but we do know that Dr. He had read the papers that pointed toward memory enhancement in mice without an intact CCR5 gene?[5]
This particular incident in one research lab raises many ethical questions for society at large. How has humanity fared at answering these big questions in the past? Certainly, there are some principles that have been used to determine ethical priorities in medicine. Let’s take a look at just two of these principles and the further questions they engender.
1. First, there is the principle of patient autonomy. For centuries doctors have been trained to work for the health and well-being of the patient. More recently, the World Medical Association was established after World War II to give guidance to physicians with the ethical problems presented by modern medicine. The International Code of Medical ethics and the “Declaration of Geneva were written as 20th century restatements of the medical profession’s commitment to the sovereignty of the patient-care norm.”[6] This declaration states that “a physician shall act in the patient’s best interest when providing medical care”[7] and means that most often the physician will assent to what the patient believes is right for them. This is what makes it so difficult for researchers and physicians to turn away a parent who is desperate to pass on their genes to a child of their own and to ensure that the child is healthy. This principle of the patient’s best interest is even more difficult when a parent is advocating for a procedure that is to be performed on a child or embryo.
In a recent study at the University of Toronto, “The top challenge ranked by the group was disagreement between patients/families and health care professionals about treatment decisions.”[8] In many cases, patients or their families wanted treatments that went beyond what health care professionals would choose to do. In many circumstances, it can be extremely difficult to distinguish between “elective” and “duty-bound” procedures when it comes to the best interests of the patient. In many cases, the wishes of the patient win out over the professional recommendations of clinical specialists and in some situations a clinician may feel compelled to a certain measure of conscientious objection.
2. At some point, a physician or medical researcher must also ask questions about justice. Justice connects a physician or researcher to the broader concepts of the good of society and the needs of society. A medical practitioner may have a great deal of sympathy for the plight of an individual family or patient and they must also recognize the limitations of funding for such procedures in any of a universal healthcare, not-for-profit, or in a for-profit hospital (where case-loads must be juggled to provide the greatest care for the greatest number of patients) context. How does one resolve such tensions?
If only every patient was right about the best treatment for them; if only there was some medical book to which we could refer and find the perfect answer; if only there was some grand meta-narrative that would answer our big questions about life, ethics, and the purpose of human thriving. For some of these most vexing questions, would it ever be helpful to refer to a metanarrative that included a creator, a creation, and a purpose? Of course, a few Catholic theologians and Christians in general might want to look in that direction but for much of the majority culture, that has long ceased to be a common opinion. Yet, in a post-modern world with few boundaries and no absolutes, medical ethics for routine treatment procedures and CRISPR gene editing has no simple answers. Those of us who pray would do well to pray for better answers to the ethical questions of a post-modern and post-Christian world.
[1] “Strict new guidelines lay out a path to heritable human gene editing,” Science News, Tina Hesman Saey, 2020-09-03, https://www.sciencenews.org/article/human-germline-gene-editing-crispr-strict-new-guidelines.
[2] About Lulu and Nana: Twin Girls Born Healthy After Gene Surgery As Single-Cell Embryos; November 25, 2018; https://www.youtube.com/watch?v=th0vnOmFltc
[3] “100 Most Influential People – He Jiankui.” Time. https://time.com/collection/100-most-influential-people-2019/5567707/he-jiankui/ Retrieved 2020-09-08.
[4] “A Nobel Prize winner argues banning CRISPR babies won’t work,” Science News, Tina Hesman Saey, 2019-04-02.
[5] MIT Technology Review, “China’s CRISPR twins might have had their brains inadvertently enhanced,” Antonio Regalado, 2019-02-21 https://www.technologyreview.com/2019/02/21/137309/the-crispr-twins-had-their-brains-altered/
[6] Codes of medical ethics: Traditional foundations and contemporary practice; P.Sohl, H.A.Bassford; Social Science & Medicine,Volume 22, Issue 11, 1986, Pages 1175-1179; https://doi.org/10.1016/0277-9536(86)90184-X
[7] WMA Declaration of Helsinki – ethical principles for medical research involving human subjects; https://wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/
[8] Top 10 health care ethics challenges facing the public: views of Toronto bioethicists, Jonathan M Breslin, Susan K MacRae, Jennifer Bell, Peter A Singer, University of Toronto Joint Centre for Bioethics Clinical Ethics Group, BMC Med Ethics, 2005 Jun 26; 6:E5. doi: 10.1186/1472-6939, https://pubmed.ncbi.nlm.nih.gov/15978136/