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The Germline Dilemma: How a Controversial Gene-Editing Practice Will Shape Our Future - Georgia BioEd Institute

The Germline Dilemma: How a Controversial Gene-Editing Practice Will Shape Our Future

The Germline Dilemma: How a Controversial Gene-Editing Practice Will Shape Our Future

Guest post by Zachary Banov, an undergraduate student in the College of Pharmacy at University of Georgia. Mr. Banov is pursuing a career in health and science policy.

On February 14, 2017, an international committee convened by the U.S. National Academy of Sciences (NAS) and the National Academy of Medicine released a widely anticipated report regarding a controversial practice called germline editing. The report opened the door for the possibility of permitting germline editing clinical trials to take place in the United States. Since its discovery, the research in this area has remained stagnant compared to other scientific innovations. Despite this groundbreaking report, germline research in the United States does not seem to be advancing, predominantly because of the ethical ramifications of such technology. There is a hotly contested debate as to how the United States government can regulate this technology and whether it should be funded. Can the government balance the far reaching ethical downsides of gene editing with the potential benefits?  Furthermore, what are the consequences if the United States abdicates the technology to other countries who may not have the same moral compass and who can gain from the scientific advances generated by such research?

Germline editing involves making genetic changes to embryos rather than grown adults. As the embryo grows, these modifications are found ubiquitously throughout the organism. The changes develop in sex cells as well, leaving a permanent footprint in future generations. It has recently reentered the public sphere after the discovery of a new gene-editing tool called CRISPR. CRISPR has rapidly accelerated gene-editing research in the past five years, bringing new life to previously dormant ethical questions.

The concerns regarding germline editing are clear. It’s easy to picture a dystopia reminiscent of Aldous Huxley’s A Brave New World. People have had long standing concerns that safely manipulating the genetic code is beyond human capability and could have devastating consequences to the human species. Additionally, some have expressed concerns that genetic modification will benefit only an elite class that has access to this technology, improving their  longevity and upward mobility while other groups fall behind. It is a terrifying image and plays well on the pathos of the public. The reality is that traits like height, strength, and intelligence are already products of an interconnected network of genes that are manipulated and expressed based on external forces such as stress, environment, and diet – factors that already favor certain groups of people.

Treatments to make “super babies” are far beyond our reach for the foreseeable future. Banning research to prevent these treatments is not only jumping the gun, but irresponsible. If and when non-therapeutic treatments begin to arise, it is important to have a well-tested regulatory system in place. By banning any form of this practice, the government is ignoring the inevitable necessity of regulation in the future. Of course, germline editing has immediate, proximate benefits as well. The treatments have the potential to not only cure but permanently eradicate genetic disorders like Huntington’s disease or Rett syndrome. These devastating disorders have simple, known genetic basis which could easily targeted by a germline editing treatment.

A commonly cited concern regarding germline editing is the ethical issue with “playing god.” The idea relies on the assumption that human genes are a sacred code and by making changes, humans are toying the very nature of what they are. The issue with this argument is that it is perfectly natural for humans to change their genes. DNA is flexible and constantly mutates and adapts. In fact, almost everything a person does plays a role on the chemistry of their DNA. If germline editing is “playing god” so is smoking cigarettes and changing one’s diet to name a few. These are epigenetic factors, environmental changes that make changes to DNA.

Epigenetics, or the ability to turn genes off and on, refutes the idea that changing future generations is unnatural or unethical. Research has proven that these epigenetic changes can be passed down to offspring. What one eats, where one lives, even how one feels can cause genetic manipulations that permeate generations. In fact, evidence has even suggested that the traumatic experiences of a parent leave lasting genetic scars that can be traced down to the children.

The public outcry against germline editing has cultivated a self-destructive U.S. policy towards germline funding. The United States’ written policy regarding germline editing is undeveloped and unclear. While the FDA currently prohibits all clinical research related to germline editing, a genetically modified embryo only falls under FDA regulation when it is intended to be placed back into the body of a woman. Because of this loophole, researchers can legally explore germline-editing research if the embryo is not intended to reenter a human being.

Though scientists in the United States are technically able to pursue germline research, the government will not fund the research. The government provides the bulk of early stage research funding and can essentially dictate the movement of scientific research. In appropriations bills passed over the last three years, there has been a small pro-life provision included. The provision bans government funding of any research related to fetuses, which includes genetic alterations. In the White House’s 2018 budget request to congress, the administration called for cuts across the board for scientific entities. If approved, the budget would cut NIH’s spending around 22%, a decrease of 7.7 billion dollars. The government has demonstrated direct opposition to the practice.

From a policy perspective, banning germline research and treatments alone is a fruitless effort. History is littered with examples regarding the futility of prohibition. A ban in the United States does nothing to reduce the spread of information around the world. Banning otherwise available treatments would open the door for black-market treatments and medical tourism. By encouraging travelers and researchers to visit other countries to obtain treatments or conduct research, the prohibition of germline editing will only stimulate competing economies while stunting the United States scientific and medical growth.

The director of the NIH, Francis Collins, declared publicly that the NIH will not fund any germline editing as it is “…almost universally [viewed] as a line that should not be crossed.”

This “universal” view has not been as widely accepted on a global scale. It was a previously unspoken agreement in the scientific community to avoid germline editing. In 2015, Chinese scientists begun a study exploring CRISPR-Cas gene editing on a non-viable human zygote. The experiment, funded by the Chinese government, was the first use of CRISPR-Cas as a tool for germline editing on a human. At first, the decision sent shockwaves through the scientific world. Months later, studies in UK and Sweden were approved to explore germline editing in non-viable humans.

The willingness of international governments to fund and explore this potentially dangerous and unethical practice has begun a race to control the scientific landscape of the future. Medicine is moving away from small compounds and turning towards gene-therapy and biologics. The countries that are most willing to explore and practice germline-editing will gain a significant edge in their knowledge, experience, and, possibly most importantly, global reputation in this arena.

A serious consequence of our apprehension to germline editing is the loss of foreign talent. The United States maintains its’ status as a scientific power through its’ ability to attract foreign students. While US students ranked 19th in science scores and 30th in math scores on a cross-national test called PISA, countries like China, Singapore, and Japan continue to remain dominant across the board. The National Science Board reported that only 33% of bachelor’s degrees in the United States were related to science or engineering, compared to 49% in China.

The decline in STEM (science, technology, engineering, and math) students has been so significant that Georgia’s House of Representatives recently passed a bill, House Bill 801, which adds a half-point to the final grades of students in their STEM courses. The measure is intended to keep Georgia students from dropping out of STEM majors as the rigorous course load continues to deter American students from obtaining these degrees.

In the reputation-dependent world of academia, the quality of one’s degree defines their value to the scientific community. In 2008, China became the first country to surpass the United States as the world leader in the number of PhDs awarded per year. Often, Chinese degrees are met with international skepticism as China’s huge boom in Ph.D. awards has caused many to question the quality of these degrees. The United States has benefitted significantly by attracting top Chinese students to our programs.

As countries like Germany and Singapore continue to develop their Ph.D. programs to better recruit, train, and employ students, the appeal of the Western Ph.D. has begun to decline. By limiting research in budding scientific areas, the United States government has hastened the diminishing reputation of US academia in budding areas like genetics.

Scientific progress moves with a distinct force of its own. To progress safely, it requires global cooperation and regulation. A prohibition on germline research does little other than bury heads in the sand. Instead of fighting the inevitable movement of science, the government should be using this time to develop sound regulatory guidelines and processes. Many fear an international agreement of this magnitude and complexity is impossible in such a divisive political climate, citing the United States’ withdrawal from the Paris Climate Accords. On the other hand, the ICH, a council comprised of pharmaceutical regulatory bodies from Europe, the United States, and Japan, has demonstrated the possibility of an international health science agreement. The world must take on this significant step in scientific history with responsibility and foresight.