A Time to Make Ethical Decisions

Indian regulation will have to make a decision to either toe the line on gene editing or turn to options that could address its huge healthcare problem.

A couple checks into a clinic and looks up a menu of options: blue eyes, fair skin, excellent hand-eye co-ordination, good runner, team player. They are opting for the “sportsman” package with a few cosmetic perks for their future child. Having made their choices, they walk away. A few weeks later, their desirable embryo is implanted and nine months later, they welcome the child who they want to be the future captain of the Indian cricket team. Let us look elsewhere in the world: In a hidden laboratory, an evil scientist is creating a super-race with characteristics like immense muscular strength, obedience, quick healing – basically your standard “Wolverine” with the added feature of inherent loyalty. Is this the futuristic scenario that pops in your head when you hear the word ‘germline gene editing’? Some find the power to control our own genes fascinating; others find it repulsive but primarily many fear what this power could do to the human race. But as we worry about whether gene editing will be the bane of humanity, we turn a blind eye to gene editing – the savior of humanity.

The truth is, as fantastic as the above two scenarios sound, neither is remotely possibly in our current state of knowledge. A more realistic probability is the use of gene editing to develop targeted solutions for diseases. Non-CRISPR technologies for gene editing in humans have been trialed for many years. Perhaps the most successful of these is the story of young Layla Richards – a baby with Leukemia, who was declared cancer-free following successful gene-editing therapy. Layla received immune cells which were genetically edited in the laboratory and then injected into her. In a further stride, the first in vivo (inside body) gene therapy for alleviation of Hunter syndrome began last year.

In the past few months, the US FDA has approved CRISPR trials for treatment in adults. Dr He, the Chinese scientist took this further and trialed germline gene editing for achieving HIV immunity in embryos. While the scientific community debates on the ethics of his experiments, the crux of the subject is that all these applications are for disease alleviation.

Many diseases have underlying genetic causes – thalassemia, sickle cell anemia, Duchenne muscular dystrophy, cancer, the list goes on. India has a significant genetic disease burden that is accentuated by a tradition of endogamous marriages. Further the cost of healthcare to manage or treat diseases is high and comprehensive healthcare is not affordable to all economic classes. Thus, prophylactic tools that remedy genetic disorders would aid in a healthy Indian population. While India remains a partner in the international debate on the ethics of gene editing, we should also take cognizance of our unique genetic history and apparent requirement for affordable healthcare solutions.

India needs to look at ethics from the lens of her national interest. Many of the countries debating the ethics of germline editing have access to better healthcare than Indian citizens. As Dr He pointed out, HIV is prevalent in African countries and in the absence of disease management, germline gene editing may be a suitable alternative. Given our own disease burden, should we wait for the Western world to get onboard with the idea of germline editing or should we have the conversation ourselves?

Of course crafting even the most basic of these applications, such as gene editing tool for sickle cell anemia, will take rigorous research and experimentation. The perils of conducting such as experiment with embryos will be harsher. We need to identify the standards at which we can allow studies involving gene editing to proceed. Consent is an important aspect that requires exhaustive discussion. The Chinese study has received much criticism in the face of comparison with US and European consenting procedures. Consenting processes should ensure that the trial participants have full awareness of the experiment’s protocols, potential risks and benefits.

However, the exact content of the process and its application depends on the circumstances. In India, the diversity of languages, educational backgrounds of participants and varying trust on doctors makes the consent process complex. In addition, the severity of disease and associated suffering would make participants vulnerable to easy consenting. A comprehensive consenting process would need to consider all these factors. It may be ambitious to straddle such a process with the constraint of international acceptance. Instead of seeking international blessing, it is time to consider a consent process that promotes trials for decreasing India’s genetic disease burden while also protecting our citizens of any abuse.

India has a strong research foundation, trained scientists and a growing need for healthcare solutions. We also possess genetic diversity and an opportunity to be able to craft tailored solutions. The time is ripe to advance this cause; however, if India continues to toe the line of international opinion, we will not even display the intent of encouraging indigenous solutions. It is India’s choice – and one we have to make soon. The race is on, we can either be a part of this or stay back at the start line gazing as other countries power ahead.

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About the author

Shambhavi Naik

Shambhavi Naik is a Research Analyst at the Technology and Policy Programme, the Takshashila Institution. She has a PhD in Cancer Biology from University of Leicester and has worked as a Post-Doctoral Fellow at the MRC Toxicology Unit, National Centre for Biological Sciences and Institute for Stem Cell Biology and Regenerative Medicine in the past.