Big Picture
CRISPR–Cas9 is an emerging gene editing technology that can be used in the treatment of chronic diseases and cancers. Early research has shown that the technology is effective, and patients involved in clinical trials have seen improved outcomes. Other uses include engineering plants to withstand the effects of climate change and mutating malaria-spreading mosquitos to be less transmissible. However, ethical controversies arise when considering the technology’s use in human early germ lines (sex cells). Though it is not fully feasible today to use this technology for genetic enhancement, such as designer babies, the ethical questions this technology generates remain an issue. Equity and accessibility are the primary potential ethical implications of the usage of CRISPR-Cas9. Because CRISPR-Cas9 is such a new technology, with the landmark paper having been published in Science in 2012, the potential for off-target effects and unintended consequences emerging in later years poses an issue. In the case of gene enhancement, it is necessary to make sure that introducing these enhancements will not put the embryo at greater risk. As research and clinical trials involving the usage of CRISPR-Cas9 technology continue, further scientific, medical and ethical implications will likely emerge. It is important to note that this technology has developed quickly and is even available to the average person via the internet who, equipped with the necessary biological knowledge, can perform basic CRISPR experimentation. This information would suggest that there are less serious implications that arise from CRISPR-Cas9 experimentation. Rather, the ethical questions of CRISPR emerge at the therapeutic and human embryonic levels. The question remains whether regulation over or legislation against this technology is necessary to address these implications at such an early period in its development.
Operative Definitions
Gene Therapy: Any process that allows scientists or physicians to treat or prevent a disorder by inactivating a problem gene or by inserting a new gene. CRISPR-Cas9 is considered a form of gene therapy.
Germline Gene Enhancement: A process by which the characteristics or traits of an organism are chosen according to the interests of the agents involved during its gestation.
Principle of Procreative Beneficence: Parents or single reproducers are on first impression obliged to choose out of a range of children the child that will lead the best life, leading to societal benefit. Furthermore, parents or single reproducers will feel morally obligated to discard an embryo with potentially ‘criminal’ genes. This is not a legally governed principle, but rather an observation put forth by Savulescu, et. al. in the early 2000s.
CRISPR-Cas9: A gene editing technology that involves using clustered regularly interspaced short palindromic repeats (CRISPR), sequences often found in bacteria, to introduce, edit or delete the DNA sequence of an organism, during or after its gestation.
Important Statistics and Facts
According to a survey conducted by Science in 2016, the countries with the most restrictive legislation governing gene editing include Australia, Canada, France and Germany, while China has more permissive regulations. The United States and the United Kingdom retain more intermediate legislation.
According to McKinsey Global Institute (MGI), a bio-revolution has emerged in the last few decades, with advancements in both biological technology and data science. The scope of this wave of innovation suggests that 60% of the world economy’s physical outputs are already biological or could become produced by biological processes in the future.
As much as 70% of the bio-innovation wave’s output falls under strict regulation, according to MGI.
MGI also estimates that 70% of the reduction of disease in the next 10-20 years will be in higher-income countries, though they only make up 30% of the worldwide disease burden.
Emergen Research found that the global gene editing market size was $5.20 billion in 2020 and is forecasted to reach $18.50 billion by 2028.
Three-Point Plan
The federal government, alongside private institutions, should continue to allocate funding towards further CRISPR-Cas9 or other genetic editing research, especially to determine the severity of off-target effects, if any. The FDA, the CRISPR-Cas9 and other gene editing technology regulating bodies should consider the findings of such research in their regulation of this emerging technology. A novel technology like CRISPR-Cas9 presents many potential benefits to society. However, it must be thoroughly evaluated to ensure its safety for use in human populations. Research institutions like Universities, private laboratories and even pharmaceutical companies, require high levels of funding to conduct such research. This cost burden must be met in part by federal and state governments, for research on both animal models and humans. Clinical trials, which are overseen by the federal government, should be sure to meet ethical requirements so that there are no setbacks in assessing and regulating these technologies.
Therapeutic use of CRISPR-Cas9 in humans should remain at the clinical trial level until 2025, at the least. There are several conditions currently being treated with CRISPR-Cas9 in clinical trials. For research to reach the point of being done on human participants, animal models must have been conducted and have met certain safety criteria. The potential for off-target effects, however, remains an issue, especially when considering the broad range of diseases being studied and their genetic nature. CRISPR research needs to remain in clinical trials until at least 2025 to address this issue. Such a measure is especially supported by the Covid-19 pandemic’s disruption of research. Though this might set back the development and treatment timeline that currently exists, and though some might be ready to move forward to regulating treatment using CRISPR, scientists and physicians must be confident in this treatment’s efficacy and safety.
Experts of medical ethics, scientists, physicians and lawmakers should work together to inform any regulation or legislation that might in the future govern CRISPR-Cas9 use or research at the federal or state levels. They should especially consider the ethical implications of using gene editing technologies for genetic enhancement purposes. When a technology as novel and monumental as CRISPR-Cas9 emerges, a variety of stakeholders also emerge. These can include research institutions (colleges and universities, for example), scientists and physicians, manufacturers and the pharmaceutical industry, ethicists and legislators. It is essential to ensure that all bodies have a place at the regulatory table and that any regulation is informed scientifically, ethically and economically. This is especially important in considering the technology’s use on germ lines and genetic enhancement, which could be a powerful tool that could allow individuals with greater wealth to have a high advantage over the rest of the population. The government should not make a strict or lenient decision until research has adequately informed such legislation.
Why This Initiative is Important
When a treatment is developed for a single disease or condition, it must be thoroughly evaluated for its efficacy. When a technology like CRISPR-Cas9, which has the potential to treat a multitude of conditions, emerges, it is essential to make sure that it is efficacious at all levels and in all patients. The use of CRISPR technology as a therapy to treat genetic diseases is commonly accepted; however, its use as a means of genetic enhancement - especially in the case of the ethical question of designer babies - remains to be seen. There exist several ethical, scientific, technological and economic implications that could arise from the use of this technology for genetic enhancement reasons that do not exist when using the treatment as a gene therapy for a genetic disease. A potential low-to-moderate risk for off-target effects might be justified in a patient with malignant or fatal cancer, but not for an embryo for which parents would like to choose certain characteristics or traits (blue eyes, intelligence, athleticism, etc.). It is necessary to evaluate the potential risks this technology poses and also to determine the ethical implications of genetic enhancement.
Acknowledgment: The opinions expressed in this article are those of the individual author.
The following student worked on this nonpartisan proposal: Sahiti R. Karnati, Columbia University, Mailman School of Public Health.
Sources
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