While COVID-19 has consumed the attention and energies of the world for the last year, other bioethical and scientific challenges have not gone away and are set to burst back to the forefront this year. Significant advances were made in 2020 to move away from the antiquated science using human fetal tissue from abortion and toward development of modern techniques and biological models that do not use fetal tissue. However, a resurgence of research using trafficked aborted fetal body parts is likely with the new White House Administration. Calls have already been made to gut the current ethical regulations on federal funding of fetal tissue research. The drumbeat for taxpayer dollars to pay for experiments using fetal organs and tissues from abortion continues, trying to make use of the crisis to justify unethical research, e.g., making humanized “lung-only mice” to investigate COVID-19. In the meantime, adult stem cells have made “mini-lungs” in the lab that faithfully model normal lungs, and they are already being used to study COVID-19 infections and therapies.
It’s in fact dismaying how supposedly science-oriented organizations can blatantly put out such anti-science, false rhetoric and claims about fetal tissue, claims that have repeatedly been shown to be false. One medical society seems especially confused on the simple difference between a cell and a body organ or tissue, claiming that there are current federal funding restrictions on fetal cell lines (current regulations exclude cell lines from oversight and are only focused on funding of fetal tissue and organs from ongoing abortion.) Perhaps they need a basic biology reminder of the difference, or maybe a detailed scientific review article on the facts about fetal tissue research and its alternatives? It seems clear this is intentional obfuscation, aimed at hiding support for fetal tissue research from ongoing abortion. In fact, in its document, this society also advocates for dropping all federal prohibitions on human embryo research, increasing embryonic stem cell research, and removal of the current prohibition on heritable (germline) gene editing (which involves creating genetically engineered embryos and babies, and affects not just one individual but subsequent human generations as well.)
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The push for gene-edited embryos and babies has also come from prestigious groups such as the U.S. National Academies of Science, the U.K. Royal Society and the World Health Organization (WHO.) Over a year ago, these organizations were already aimed at moving heritable gene editing forward. Sadly, the COVID-19 crisis has not been a hindrance to their agenda. Despite the numerous calls noted over a year ago for an international moratorium on heritable gene editing, from distinguished scientists and ethicists around the globe, there is no plan to put such a moratorium into place, and no one has worked to foster the necessary discussions with all stakeholders on the future of heritable genome editing research. Instead, the International Commission on the Clinical Use of Human Germline Genome Editing released a report on the “potential benefits, harms, and uncertainties” of heritable genome editing on human embryos. Their recommendations outline a path and steps needed to make human heritable genome editing a reality.
One of their recommendations was for countries to have a regulatory body to assess safety and ethics of heritable gene editing uses. As one writer notes, this puts the U.S. in a particularly vulnerable spot for abuse of heritable gene editing technology and ethics, because current likely candidates are professional organizations whose “guidance is voluntary and notoriously permissive, allowing procedures that other countries ban.”
The focus of concern for these groups is only what can be done under the limits of current law and technology, not whether heritable gene editing on human embryos should be done at all. Paving the way for application to human beings in the clinic, the International Commission acknowledged there was absolutely no suggestion of prohibiting this research despite the huge numbers of human embryos that would be used as experimental fodder. In a recent online discussion of their report and where this technology might proceed, members of the International Commission again admitted they did not consider a moratorium and did not suggest prohibiting research in this area, but they did think the technology is not ready…yet.
Great benefits could be derived from a patient-centered focus on gene editing, rather than an embryo-centered focus. Just one example is a recent report where genetic engineering strategies have repaired gene defects in two blood disorders. While these are early results and should be interpreted with caution, these and other trials using genetic techniques show great potential for ameliorating diseases.
Another reason for concern with the push for heritable gene editing and embryo research is the hubris shown by researchers who think they will easily rid the world of disease and death, if only they have enough embryos on which they can experiment. Yet the “practice runs” haven’t turned out well; definitely not for the embryos, who die in the experiments, but also for the experimenters. While it may sound easy to target specific genes and make genetic changes, published reports show it has deadly effect. Several papers now document “off-target” cutting (meaning that various other places in the genome are snipped), DNA deletions and chromosome rearrangements after attempts at embryo gene editing. One research group in particular, led by Shoukhrat Mitalipov, specifically created 175 human embryos with mutations in order to show they could fix the mutated genes. However, they discovered their attempts resulted in significant genetic alterations in the DNA of the experimental embryos. As a reminder, Mitalipov has stated his desire to gestate and birth some of these gene-edited children, and he is also the researcher who used his techniques to create cloned human embryos, created three-parent human embryos using cloning techniques and advocated for gestation and birth of three-parent embryos. One can only hope the disastrous results of these experiments will dampen his enthusiasm for embryo manipulation.
Another area about which to be concerned is attempts to create embryos and embryo-like models from stem cells, as well as the desire to grow embryos for longer times in the laboratory. Researchers have complained they are not receiving what they consider adequate taxpayer dollars for these areas and need clear guidelines so they can be funded and move the research forward. Of course, one key question is whether what is created is actually an embryo, or an embryo-like artifact that falls short of the definition, and whether that matters. At the request of the National Institutes of Health, the National Academies of Science quietly convened another panel to consider issues regarding ethical, legal and regulatory issues regarding embryoids and organoids. They also resurrected consideration of expanded creation of human-animal chimeras, a proposal made by NIH in 2016 which received numerous critical comments but was left undecided. It may be that this expansion of chimera research funding needed to wait for a more favorable federal climate, more positive reviews and a recommendation to proceed from a national scientific panel. It may not be long before the door opens wide for human-animal chimeras, human clones and their three-parent cousins, lab-created embryos and wholesale embryo experiments.