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02/15/2017

The National Academy of Sciences Expands its Approval for Gene Editing

by Keisha Ray, Ph.D.

This week the National Academy of Sciences (NAS) released a report giving their support for altering heritable genes when previously the NAS only supported altering uninheritable genes. Although it gave very special conditions in which altering human eggs, sperm, and embryos would be acceptable, giving their seal of approval to any alteration of the human germline is a revolutionary move for the current and future status of genetic engineering for a few reasons:

  1. Expanding Clinical Research

Genetic engineering is already practiced for non-heritable genes. Genes that are known to cause chronic and debilitating diseases are the subject of clinical trials all across the world. However, with the advancement of affordable gene editing technology like CRISPR, some bioethicists, physicians, and scientists have changed their stance on what was once seen as an unethical use of genetic engineering—altering genes that could be passed down to offspring. Now the NAS endorses extending the benefits of gene editing to preventing, curing, and treating chronic, deadly, and heritable diseases, when there is no alternative intervention. Changing their ethical stance on gene editing will expand clinical research and change how research funds are allocated. It will give laboratories new avenues in which to pursue cures for diseases that were once thought incurable. Inevitably, there will be also be an increase in lively debate among bioethicists about what the NAS’s new report means for the relationship between science, ethics, and patient care.

  1. Research Arms-Race

The release of this report, for better or for worse, puts the United States on the same playing field as other countries who have already begun to use gene editing tools to alter the germline, particularly in embryos. For example, China was the first to try gene-editing in monkeys and human embryos and they were also the first to announce clinical trials in which CRISPR was used in a human subject. In late 2016 as a part of a clinical trial, researchers at Sichuan University in China announced that they had injected genes that were edited using CRISPR into a patient with severe lung cancer. The researchers removed immune cells from the patient’s blood, then used CRISPR to disable a gene in the cells that code for a protein which alters a cell’s immune response. The researchers then cultured the edited cells, increased their number and injected the patient with the altered cells in hopes that the new, edited cells would attack the cancer. Chinese researchers plan for multiple other patients to be a part of the clinical trial. For various confidentiality reasons, the results of this trial are yet to be known, but that did not stop ethicists from other countries from voicing their concerns, namely concerns about efficacy and its ethical nature, despite the Chinese researchers receiving approval from a hospital ethics review board.

But American researchers at University of Pennsylvania received approval from the National Institutes of Health for CRISPR trials in humans before the Chinese began their human clinical trials. But the American researchers did not receive approval from their institution, nor from the FDA because of its prohibitions on using federal funds to review research that involves germline alterations. In the past Dr. Lu, who is a part of the Chinese clinical trials has said “I hope we are first” in response to the clinical trials at University of Pennsylvania, and in fact Dr. Lu’s hopes came true.

Dr. Lu’s comments represent a real concern for researchers around the world—a desire to compete with other researchers and hopefully be the first to conduct research and release the results of that research. Without the newly given support for gene editing uses from the NAS, the United States couldn’t possibly hope to keep up with the expanding gene editing clinical trials that are happening across the world. Whether bioethicists like it or not there is a sort of gene editing arms races that is happening across the world and without the NAS’s support we could never hope to keep up with other countries. This would mean that other countries would have technology to treat and prevent diseases that we would not have and ultimately, the American people would not have or at least have a harder time accessing. To keep up with other countries, the FDA would also have to change its policies on germline research and perhaps the NAS’s report could facilitate this change.

  1. Genetic Enhancement

The NAS’s new report is also noteworthy because it is changing the relationship between therapy and enhancement. In the past, policies and recommendations seemed fear driven—fears of off-label uses of gene editing to enhance human capabilities outweighed and prevented gene editing for therapeutic uses. The fear was always that similar to pharmaceuticals that were approved for therapy but used to enhance cognition, physical ability, or even morality, gene editing would be used to give people specific traits. A specific worry was that parents would choose to genetically alter embryos in hopes of designing their ideal child perhaps giving them levels of beauty or intelligence that they would not have without genetic intervention. The new report released by the NAS puts fears about genetic enhancement secondary to the promise of genetic therapy, although they explicitly do not condone genetic enhancement. This is perhaps because some members of the NAS involved in creating the report do not think that genetic enhancement is something that we need to worry about just yet.

Like some members of the NAS many enhancement scholars tend to fall back on the idea that the level of human enhancement that ours fears are based on are unlikely to happen in the near future and the types of enhancement interventions that are currently possible can only minimally alter humans. Advances in gene editing have changed what once seemed like far-fetched interventions and made the possibility of creating humans with specific traits very real in ways that pharmaceuticals will never be able. This also means that concerns that typically accompany enhancement will be magnified and reimagined to fit gene editing. These concerns include developing criteria to determine who will have access to enhancement interventions and will enhancement interventions increase the gap between the rich and the poor assuming the high cost of genetic enhancement will give only the rich access to interventions that could be socially and economically lucrative. Additionally, concerns that specifically focus on the individuals being enhanced such as the subject’s autonomy and the freedom to be authentic or the person they would have been if not for the intervention will also be magnified because of the powerfully altering nature of genetic enhancement.

  1. Hope

Lastly, the new National Academy of Sciences reports offers a lot of hope to people with genes for deadly chronic diseases who are concerned about passing these genes on to their children. This new NAS report could give hope to couples who have decided to not have biological children in fears of passing on their potentially deadly genes. The promise of new scientific interventions and biotechnology should be balanced with safety and ethics, however, the ways in which science and biotechnology can transform lives should not be bogged down by ethicists and researchers’ fears and the new NAS report embodies this sentiment.

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