Gene Editing from a Global Perspective: The Ethical Battle

Photo by Sangharsh Lohakare on Unsplash.

The concern with our food remains in the fact that it is being genetically modified, but how do we feel about genetically modified human beings?

What is Gene Editing?

Now, with gene editing, this is a possibility.  Gene editing is a way to make specific changes to a cell or organism’s DNA. It is used to alter, remove, or add DNA in the genome makeup.  Gene editing technologies can be used on non-heritable cells (somatic cells not used for reproduction) and germline cells purposed for reproduction.  Gene editing comes in multiple forms and is now becoming a risky intensive blight to human genetics and reproduction.  Gene editing types come in primarily four types: Crispr, zinc-finger nucleases (ZFNs), transcription activator-like effector nucleases (TALENs), and mega nucleases.

The editing of genome cells is used in a number of ways, including treating and preventing hereditary diseases.  A first case look includes a “brave” scientist by the name of He Jiankui of Shenzhen, China’s Southern University of Science and Technology, shocked the world by unveiling his unique experiment where he secretly modified the embryos of nine different couples who had biological fathers with HIV positive genes and mothers with HIV negative genes.  The modifications resulted in Jiankui genetically modifying a set of twin baby girls born with a hereditary genome immune to HIV.  The modification to the twins’ genes was a heredity gene which will pass on to future generations.

Scientists across the world are investigating the use mainly of CRISPR-Cas9, the same genetic modification type used on the twins as a treatment for many genetic diseases, such as sickle cell anemia, muscular dystrophy, cystic fibrosis, Alzheimer’s, and more.  But the United States has since employed legal confines to restrain the use of federal funding in germline or gene editing research and projects.  But nothing is stopping the privately funded and non-clinical research.  Although this has slowed the rate of genetic engineering in the United States, there has been successful research of embryonic genome editing, including two distinct United States projects, where researchers at Columbia University used CRISPR to eliminate the gene for an inherited form of blindness called retinitis pigmentosa.  Further researchers at the Oregon Health & Science University used CRISPR to eliminate a gene that causes a potentially fatal heart condition, known as cardiomyopathy.   Additionally, scientists used CRISPR to genetically target cells linked to cancer through a research initiative where the scientists modified T cells so that the cells could better contact and kill the cancer.  CRISPR was used to remove three genes during the cancer study: two that can interfere with the cells and one that limits the cells’ cancer-killing abilities.  The case had results that were not completely telling as one of the subjects’ gene modifications did not work at all yet the other two were successful in modification but not completely in preventing or killing cancer.

The rate of gene editing is specific to the type of gene editing occurring, including the drastically different view by the scientist world and ethicists on somatic cell (non-reproductive cells) editing versus genome editing (reproductive cells).  Anne W. T. Muigai from the School of Biological Sciences in Nairobi, Kenya states that, “somatic gene editing therapies, by contrast, do not present the same risks and challenges, promising to provide treatments for a wide range of diseases and conditions, including cancers, blindness, and hemophilia.”  Therefore, the discrepancy in the popularity of gene editing varies by gene or cell type, for instance, there are around 156 clinical trials registered with the World Health Organization regarding Human Genome Editing.  Currently, heritable genome editing is far less used and banned through legislation or legal action in some countries due to the various ethical concerns.

The Ethical Battle

Many of these successful gene editing stories are indicative of genome editing or editing embryonic cells yet this process is not widely accepted according to many faith-based groups, advocacy organizations, and bioethicists.  Some argue there is a serious ethical and moral implication thus pressuring the narrowness of this sort of research.  The argument is that it’s critical for the research facilities as they implement new technologies that are becoming popular to fully disclose the information to potential clinical trials.  Further, researchers suggest that the population most likely to voluntarily participate in  CRISPR psychiatric clinical trials is a combination of treatment-resistant and risk-takers due to their vulnerability and experiencing feelings of hopelessness and helplessness, or a risk of suicide.  Therefore, treatment-resistant patients and their physicians are more willing to take the risk of newly invented clinical trials. Early issues in gene-therapy trials have taught us that the lack of public awareness of the risks impairs the relationship with researchers to inform subjects of potential risks and to follow the proper precautions.  When clinical researchers fail to report unfavorable events and results, other research sites cannot adjust their safety protocols and informed consent procedures relationship with their patients; thus important patterns in the reported side effects go unreported and unreferenced.  Further, patients are lacking a full understanding of the risks and benefits the trials encompass.  An early case started with the case of Jesse Gelsinger, a young patient enrolled in a gene-therapy clinical trial, where a plethora of events occurred, including the preclinical data that is unable to track the long-term effects.

Some instances of heritable genome editing, aimed at eliminating disease-causing genetic variations, have prompted inquiries into the potential impact on the overall human gene pool.  It has been suggested that any heritable genome editing should consider alterations naturally occurring in the human population simultaneously.  Specifically, the focus would be on converting harmful disease-causing variant alleles into common non-pathogenic DNA sequences, thereby minimizing the risk of unforeseen consequences in future generations.  This approach, which involves editing a disease-causing mutation to an already existing non-pathogenic sequence, lines up with the anticipated therapeutic applications.  Consequently, the anticipated impact of such heritable genome-editing changes for therapeutic purposes is expected to be a minimal alteration to the human gene pool.

Legislative Action and Legal Implications

Legislatures across the globe have either banned or implemented a moratorium on genome editing.  The United States FDA takes the position that genetically modified human embryos are comparable to drugs and biological products.  Thus, the continuation of the trials is illegal because it is illegal to distribute a new drug without FDA approval.  Accordingly, the FDA has not supported or passed any exception of genome editing for embryos even during clinical trial use.  The FDA does permit research usage sometimes through an application to an IND exemption.  With an Investigation New Drug (IND) exemption, researchers need to show the FDA in their application that there is a good non-human research reason, but Congress later identified and amended the FDA funding, prohibiting the application of an IND from supporting any human germline editing, thus making it illegal in the US as an illegal drug distribution.  In many other countries, in Europe, any germline human genome editing is illegal by specific statute, unlike the United States.  In most countries, there are no laws on genome editing, so it is legal for the sake of it being the least of their concern.  The current state of the world is that the reclusive ban based on legislation is the current legislation in 25 countries; the ban based on guidelines is the sentiment among four countries. China, India, Ireland, and Japan forbid genome-editing based on guidelines, thus less enforceable than laws and can be amended.

Court Involvement

In the case of the twin baby girls in China, the medical team was convicted of the crime of “Illegal Medical Practice.”  The court concluded the doctors deliberately violated the National Regulations on Scientific Research and Medical Management, impaired any ethical considerations, and prematurely used genome-editing technology.  Moreover, their genome-editing behavior may cause irreversible damage to the entire human genome chain.  Therefore, Jianku’s case is a way to warn other scientists not to commit similar misconducts in China.  In the United States, the broad interpretation of parental autonomy rights stemmed from the Constitutional rights in which parents have a fundamental right to direct the care, custody, and control of their children.  The discussion of a Constitutional breach revolves around the desire for genetically related children and the potential limitations on parental autonomy if access to gene editing technology is restricted.  Some individuals view the right to genetically related children as a fundamental aspect of parental autonomy, citing reasons ranging from a desire to see traits in the offspring to fulfilling a sense of lineage and continuity.  In the United States, procreative liberty, as established in legal cases, such as Griswold v. Connecticut, Eisenstadt v. Baird, and Obergefell v. Hodges which emphasize the right to have children at the parents’ desired time and with considerable latitude in rearing practices.  However, these cases do not directly address the destruction of ex utero embryos, preimplantation genetic diagnosis (PGD), or the legality of in vitro fertilization (IVF).  The United States’ expansive view of procreative liberty remains unproven regarding how broadly it construes the right to reproductive choices.  It emphasizes that procreative liberty can be viewed either as a negative right protecting individuals from governmental prohibitions and interception or as a positive right obligating the government to facilitate choices or provide services.  But reasonable regulation of reproductive technologies for health and well-being is permitted, even when constitutional rights are involved.  The concept of procreative liberty in the United States has not been extended to a right for citizens to demand government funding or approval of new reproductive technologies, including gene editing technologies for designer babies.

Where Are We Going in the World of Gene Editing?

The Chinese scientist He Jianku, infamous for gene-editing babies, is now proposing a new experiment to prevent Alzheimer’s disease.  Jianku plans to test whether a specific genetic mutation can protect against dementia.  The experiment will initially be conducted on mice, with no intention of creating pregnancies.  Although criticized for his controversial gene-editing work, the proposed genetic mutation can reduce the formation of Alzheimer’s-related brain regions in humans. Despite government permits and ethical approvals being required now that Jianku is banned from the use of reproductive technology, he has set up a new lab in China and asserts that the new approach, utilizing base editing instead of CRISPR, is safer and allowed.

The Effects

In conclusion, gene editing has emerged as a powerful tool with the potential to make specific changes to the DNA of cells or organisms.  The diversity of gene editing technologies, such as CRISPR, ZFNs, TALENs, and meganucleases, has opened avenues for treating and preventing hereditary diseases.  The controversial case of He Jiankui, who genetically modified embryos to confer immunity to HIV, ignited the interglobal debates on the ethical implications of heritable genome editing.  While some successful cases of gene editing for therapeutic purposes have been reported, ethical concerns and moral implications persist, particularly regarding embryonic cells and germline editing.

The ethical battle surrounding gene editing involves complex considerations, including transparency in research, the vulnerability of clinical trial participants, and public awareness of potential risks.  Legislative actions globally reflect a range of approaches, with some countries imposing bans or moratoriums on genome editing, while others rely on guidelines that may be less enforceable.  The United States, for instance, restricts federal funding for germline or gene editing research, contributing to a varied landscape of regulatory responses across the globe.

Legislative and regulatory bodies worldwide have responded differently to the ethical challenges posed by gene editing.  The case of He Jiankui in China resulted in convictions for “Illegal Medical Practice,” highlighting the need for legal consequences in cases of ethical breaches such as editing human embryos without consent or knowledge of the patients.  China has since implemented regulations on the administration of human genetic resources to safeguard public health and national interests.  However, the global landscape remains diverse, with varying degrees of legislative and regulatory frameworks governing gene editing and more to come as new technology develops.

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About Sommer Arena (2 Articles)
Sommer is a second year student at Campbell University School of Law and is a staff writer for the Campbell Law Observer. Originally from Thomaston, CT Sommer attended University of North Carolina Charlotte and earned a Bachelor's degree in Political Science and minors in Journalism, Criminal Justice, and American Studies. Sommer enjoys recording for her podcast, Legally Blondish, spending time with her husband making homemade recipes, shopping at local thrift shops, and writing for her online blog. Sommer’s areas of interest are bankruptcy law and politics.