Public Access Evolution: Global Action Needed to Maintain the Stability of The Human Genome

Photo Credit: NHGRI

By Bennett Batten
Contributing Writer

In November 2018 the scientific community was stunned when the guest speaker to the second International Summit on Human Genome Editing, He Jiankui, decided to share a fun surprise. He had successfully edited the embryonic DNA of twin girls! He deactivated a gene called CCR5 with the goal of  decreasing the risk of acquiring HIV. In reaction to this event an international body of scientists called for a temporary global moratorium on heritable genome editing, and the World Health Organization (WHO) formed an advisory committee on “Developing Global Standards for Governance and Oversight of Human Genome Editing”. While both of those developments are positive, they do not fix the problem that was highlighted.  

Advancements in genetic engineering have far surpassed our global institutions’ ability to regulate them. With the development of genetic engineering tools such as CRISPR and gene drives, paired with the growing popularity of DIY labs, access to bioweapon creation or human enhancement has become open to the public.

Back in 2014 a scientist at Vanderbilt University stated that experiments that previously required 18 months and $20,000 now only take 3 weeks and $3,000. It’s been 6 years since that statement, so it’s safe to assume that prices have fallen farther. Entrepreneurs have met these falling prices with DIY biohacker labs. The first of their kind opened in 2010. By 2017 there were more than 50 in the USA alone. Lack of regulation and security at these private biolabs have concerned the FDA and FBI, but no cohesive protocol has been put in place by the federal government to address safety and ethical concerns. 

A vulnerability from open access genetic engineering is an inability to contain negative side effects. Most genes affect and are affected by others. When Jiankui “deleted” the gene CCR5 in the twin girls, he knowingly increased their likelihood of health complications from viral infections and improved their cognitive abilities. The study of how genes interact with one another is complex and incomplete. How these side effects will manifest in the twins is unknown. If a germline genetic alteration is made unbeknownst to governments or academia, a containment crisis to the alteration could occur.  

Unlike the threat of nuclearization, creating a bioweapon doesn’t have its own version of a radiation footprint. Even with detectable signs of nuclearization, misguided wars of suspicion have destabilized parts of the globe. “Gene editing could allow scientists to develop biological weapons capable of discriminating among target populations based on ethnic, racial, or other genetically defined characteristics.” Having the capacity to carry out genocide by use of bioweapns is a threat of equal concern to having nuclear capabilities. Since the creation process of bioweapons has no obvious tells built in, paranoia on the weapons capacity of enemy groups could rise.

So, what tools do we have to prevent illegal bioengineering? The Bioweapons Convention (BWC) of 1975 resulted in the multilateral disarmament of treaty member states. Members agreed to ban the development, production, and stockpiling of these weapons. Currently the BWC holds a review conference every five years, and one annual week-long meeting of government experts. The annual meeting is intended to track progress and raise issues. Attendee, Malcolm Dando, and Professor of international security at the University  of Bradford, UK raised concerns that the goal of these meetings are not being accomplished. “In 2013, for example the experts’ meeting scheduled a mere six hours of discussions on science and technology — less than a day. That is not enough time for complex science to be presented, digested and discussed, and not enough to consider its implications and suggest revisions to the BWC.”  

The World Health Organization committee on Developing Global Standards for Governance and Oversight of Human Genome Editing has been actively responding to the problem. In March, 2019 they called for a temporary ban on clinical application of human germline genome editing (heritable changes to genes), while developing a mandatory registry for all planned and ongoing research relevant to gene editing. 

The main objectives of any new policy need to ensure global security by preventing unregistered experiments from contaminating the public gene pool, or privately used for human enhancement. Another objective is the protection of human rights. No unborn person should be subjected to genetic experimentation without the endorsement of the scientific community, its guardians, and society. This will ensure the safety of the child, and that social morality associated with editing human DNA is not violated.  

A focal concern about He Jiankui’s experiment on the twins is how easy it was for him to keep it under wraps. An international registry for all genome editing studies will serve as a deterrent to ambitious scientists, if unregistered studies are prohibited from accessing funding, and barred from publication. This does not deter private moneyed interests that have no desire in publication. Jiaunkui kept his experiment under wraps by lying to, and concealing information from staff, as well as exploiting “… loosely worded and irregularly enforced regulations…” in China. This is exemplary of how one person under current protocol has the ability to shirk regulations and laws by mislabeling actions, and misinforming staff. 

To prevent unsanctioned bioengineering, awareness of humanity’s growing ability to control the future of our species’ evolution needs to be raised. From as early as elementary school, we should instill in the coming generations a humble and almost sacred approach to gene editing. Requiring all DIY labs to host a security guard and in-house lab technician to monitor what is being conducted is low hanging fruit, but still impactful. 

All the necessary materials to perform genetic experiments is basic lab equipment, and since the Cas9 enzyme (the key tool used in CRISPR) is a protein, controlling distribution is not logical. Currently there is no way to detect at home laboratories.  Modifying a centrifuges energy footprint, or frequency discharge into a pattern that identifies itself could provide a way to locate unregistered experiments. 

The BWC has been successful so far in its mission of keeping bioweapons from being developed and utilized in warfare. For it to be successful in preventing the weaponization of gene editing, it should quadruple the time it’s experts and delegates meet yearly in order to dedicate adequate time to policy development. How the BWC evolves is up to debate. Two main paths are available: – one that prioritizes state sovereignty and holds that each state is responsible for all bioterrorism threats within its borders, and another that prioritizes the global genetic stability of the species over state sovereignty. However, many states do not have the capacity to fund programs of surveillance and security to prohibit extremist groups from using their territory

Article 39 in The Charter of the United Nations gives The Security Council (UNSC)  authority to label threats to international peace, and the duty of deciding what actions to take to restore/protect peace. Any action taken requires approval of all five permanent member states (US, GB, FR, CHN, RU). To facilitate productive policy development that would address ranking the priorities of sovereignty and genetic stability, the BWC should request annual discussions with the five permanent member states of the UNSC. 

It is the duty of our global institutions to be predictive of future threats to international peace. To minimize the occurrence of genetic crisis events, effective deterrents must be developed. It is time now to raise cultural awareness of this issue and to pressure our global institutions to take action. 

PRECISION MEDICINE: INVESTING IN THE FUTURE OF GENETIC RESEARCH

Vitamin supplements

By Aarushi Gupta
Staff Writer

The now-famous Human Genome Project (HGP) sequenced the human genetic code in 2003 and effectively ‘mapped’ the human genome, allowing scientists around the world to localize the codes of distinct proteins that are necessary to human life (and some that are not). The results of the HGP told scientists where specific genes were located, but the particular genetic susceptibility or immunity of certain people to genetically linked diseases like Alzheimer’s, cancer and diabetes is still not understood. In a greater effort to better elucidate the mechanism by which some people contract these diseases, President Obama has introduced the Precision Medicine Initiative, which proposes collecting health information from approximately 1 million volunteers to better understand the underlying causes of genetic and metabolic diseases and therefore develop personalized therapeutic treatments based on a patients genetic information.

A task as daunting as this does not come cheap; the President estimates that this endeavor will cost approximately $215 million; 60 percent will go towards the National Institutes of Health’s work on deciphering the nuances of the human genome, and the other 40 percent will be dispersed among the Food and Drug Administration (FDA) and the Office of the National Coordinator for Health Information Technology (ONC) to support the logistics of this operation, including patient confidentiality as well as creation of a database to promote the accessibility of the information.

‘Precision medicine’ refers to the use of patient genetic information to better understand the underlying causes of varying diseases and develop personalized therapeutic treatments in an effort of the medical community to move away from the ‘one-size-fits-all’ approach to medicine; while the symptoms and physiological manifestations of diabetes, cancer and other metabolic diseases are similar across different patients, the causes of these diseases are not fully understood by medical professionals and scientists. What is becoming more apparent is that different people react differently to varying treatment options, based on their genetic susceptibility to specific metabolic processes. The precision medicine effort seeks to increase the availability of customized care and targeted treatments. However, the only way to understand the fundamental causes of these widespread diseases is through the analysis of a large pool of affected and non-affected patients, looking at how the genetic differences manifest into varying physiological outcomes. This work will be performed by the NIH, who will collect and analyze samples from 1 million volunteers to determine the genetic bases for better treatment options.

It is important to understand that this initiative relies on making the data more available to scientists – they already know how to analyze these samples, but suffer from a lack of data. Not only will the initiative play a role in gathering information, it will also make the results available to scientists all over the country, enabling academic researchers to team up and provide molecular explanations for these afflictions. The PMI would increase funding to chemistry, biophysics and molecular biology programs in universities across the country, which would be extremely beneficial for the scientific community. As stated by Gina Kolata in the New York Times, “If the precision medicine initiative supplies genetic and clinical data in a form that is easy to use, it would speed such studies, scientists say.”

Many people, including scientists and medical professionals, believe that this initiative is not a good idea. These detractors cite that precision medicine would not affect the numbers of people affected by generic diseases. Michael Joyner, an anesthesiologist and physiologist at Mayo Clinic, does not put his faith in what he calls “moonshot medicine”, or far-reaching medical initiatives like this one. He believes that there is “no clear genetic story” behind widespread diseases like cardiovascular failure, diabetes, and cancer, and that precision medicine could lead to unintended consequences. In response to his editorial, published in the International New York Times, several researchers have refuted Joyner’s claims with the simple premise of the entire study: collecting data from a large population set will shed light on the genetic tendencies of certain diseases. A 2011 report published in the Proceedings of the National Academy of Sciences, gives an example illustrating the current differences in treatment options between breast cancer, which has become personalized, and Type 2 diabetes, which is defined by its symptoms and unpredictability.

Similar ‘biobanks’ have been explored in other countries; the United Kingdom and Japan both have databanks with amassed data that is now being used to evaluate treatments for cancer. These studies have lead to use of cancer gene testing to guide the treatment of patients with certain mutations, which would not have been known without the large data set made available to researchers. The effects of biobanks have been beneficial for both societies, and has lead to significant strides in medical advancements.

Image by Caris Life Sciences

GMO CROPS IN EUROPE AND THE UNITED STATES

Crops growing in the English countryside

By Jubilee Cheung
Staff Writer

Ever since their introduction, the use of genetically modified organisms (GMOs) in agriculture has always met with mixed feelings from the American populace at best. The term GMO, in the more specific context of produce, most commonly refers to crop items that have had their genes modified in a laboratory setting. Traditionally, farmers have practiced selective breeding but to a lesser extent, hence the subtle distinction. There has been a decidedly less ambiguous response to genetically modified organisms in Europe, where their implementation has been consistently condemned and met with open skepticism.

In Europe, there is currently only one GM crop, MON 810 – a type of corn – that is commercially grown. MON 810’s appeal is in its capacity to repel insects, most notably the European Corn Borer (Ostrinia nubilalis). Even given that, MON 810 is only grown in five countries: Spain, Portugal, the Czech Republic, Slovakia, and Romania. It is fair to say that the stigma associated, perhaps unfairly, with GM crops is very evident in European countries. A new law relevant to the matter is expected to be passed in the European Union, which allows member nations more power to impose restrictions on the growth of genetically modified crops.

Under the proposed law, nations would be able to more readily hinder the production of GMO crops through an increased ability to oppose their introduction. Nations’ governments, for example, would have the right to ban the growth of GMO crops on the basis of the preservation of an ecosystem. Causes that could be cited in a justified ban include “environmental reasons, socioeconomic reasons, land use and town planning, agricultural policy objectives and public policy issues.” Under the European Food Safety Authority (EFSA), Europe has always endorsed strict regulations in regards to GM crops; under the proposed law, regulations would be no less rigorous and would also serve to give countries more choice in their terms of what they decide to grow. By giving countries broader grounds on which to challenge the proliferation of GMOs, the proposed law effectively endows them with the ability to decide for themselves if they want to raise GM crops at all; in this manner, the processes of both cultivating and banning GM crops have been greatly facilitated in Europe.

Similar trends can be observed in the United States, where food items that have been labeled as GMO free have seen incredible profits in recent years: products in this category reportedly raked in sales totaling $10 billion in 2014. Globally, sales of non-GMO food items are expected to increase twofold by 2017, indicating a strong upward trend. In this regard, it appears that the term GMO now has a decidedly more negative connotation now than in the past – at least in the sense that products lacking what the public considers genetic modification have evidently been deemed more desirable.

However, it may well be that GMOs do not deserve their bad reputation or, at least not to such an extreme degree. Genetically modified food items have yet to produce any conclusively ill effects in the populace that consumes them, and have shown in evaluations that they “are not likely to present risks for human health.” The World Health Organization further states that “no effects on human health have been shown as a result of the consumption of such foods by the general population in the countries where they have been approved.” Bearing in mind that GM food items do not appear to adversely affect their consumers, it is a worthwhile endeavor to take account of the advantages associated with cultivating them. GM seeds were originally developed with the purpose of maximizing efficiency; they are engineered to have high yield and heightened resistance to pests and disease. GM seeds’ apparent biological superiority enables farmers to reduce the resources required to maintain their crops, thereby increasing their profits. The economic benefits of employing GM seeds are bolstered by the fact that there have been no confirmed consequences of using them where consumer health is concerned.

The various new approaches to discourage the growth of genetically modified crops serve to reinforce the somewhat exaggerated, if not altogether misconstrued, idea that they are in any way harmful. Labeling food items as GMO-free suggests that there is something fundamentally wrong with products that are comprised of GMO content – the irony of the matter being that such labels are often both unclear and less than trustworthy. While the new law to be passed in Europe also seems to be mostly a nod in favor of more traditional agricultural practices, some European countries – namely the United Kingdom and Netherlands – have governments that endorse GM crops. With the law in place, the United Kingdom is expected to increase its production of GM crops, now having the power to choose whether or not it wants to grow GMOs.

While GM crops have yet to produce any visible ill effects, they represent a relatively new agriculture practice whose effects are not yet fully understood. The skepticism with which they are met is understandable; not only is the idea of ingesting food items that have been tampered with somewhat unsettling, there are some that have argued that GM crops threaten natural biodiversity. It is difficult to make definitive conclusions regarding how GMOs should be viewed as a whole by society, but it is worth taking note of both their political and economic influence as a commodity of sorts.

Image by dommylive