Running head: GENETIC ENGINEERING IN ONCOLOGY 1

Genetic Engineering use in Modern Oncology

Tanner Shull

Legal Studies Academy

First Colonial High School

GENETIC ENGINEERING IN ONCOLOGY 2

Abstract

Cancer is the second leading cause of death in the United States, and with current and past

treatments of the disease being so barbaric, the medical community has been searching for a cure

of sorts, or at least a preventative tactic. The recent advancements in genetic engineering

technology have lent to the question of whether it is worth modifying the human genome to save

the almost six-hundred-thousand patients who die every year because of the disease. To this

question, I unequivocally say yes, there is absolutely a place in American oncological medicine

for genetic engineering; Be it immune system therapies or prenatal modifications to the genome

that would prevent the disease. Unfortunately, at this point in time, the federal government is not

so forward thinking, with a regulatory body that is effectively not allowed to invest into research

on the technology. That is the point of this research paper: To evaluate the positive aspects to a

controversial technology that are more often than not overlooked.

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Genetic Engineering's use in Modern Oncology: Genome Editing and Cancer Relation

Genetic engineering is at the forefront of biology and medicine, and its uses are nearly

boundless, but the FDA and Congress have failed to be so forward thinking. Clinical trials are

currently being worked on in the search for certain genetic edits that could drastically change the

course of cancer treatment in the United States. To understand the practical use of genetic

engineering, one needs to understand the methods by which it can be done. CRISPR, the single

most promising advancement in the understanding of life as we know it, is an immune response

in bacteria that sends the Cas9 protein to cut up the DNA of the intruding lifeform. Biologists

can use this reaction to send Cas9 to cut out and remove certain genes that they have found to be

problematic. With twenty-thousand to thirty-thousand genes, there is bound to be a kink in the

human system somewhere, which can disrupt homeostasis, (in this case cancer) and reap pure

havoc on the body (Beavo, 2002). Cancer, after all, is rooted in DNA. It is the uncontrolled

division of cells which eventually disrupts the major functions of the body. Cells do what DNA

tells them to do, so if one’s own DNA is being problematic, doctors need to kill some cells and

hope for the best; at least that’s how it used to be.

In the past, cancer treatment was quite literally poisoning oneself in hopes that the growth

would die before the patient did. Now that biologists have the technology to edit genes, the

problem is finding the specific DNA sequence(s) causing the division and removing the coding

from the genome while also reactivating the immune system. In theory, it is possible to modify

the genome to tell the cells to not only stop dividing, but to commit what is called apoptosis, a

term for programmed cell death after a problem is recognised (Luo, 2010). This would (in
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theory) reduce the need for chemotherapy and radiation, reducing not only suffering in the

patient, but also by promoting technology that could prevent an assortment of genetic disorders.

This is the next step for medicine, no longer relying on the use of poisons to treat cancer, which

would increase the quality of life and decrease the possibility of descendents suffering the same

disease.

Genetic Engineering Basics

Historical Roots

Genetic engineering, in essence, is the modern iteration of what was once selective

breeding. As far back as 12,000 BC, humans were interfering with nature by choosing the best

individuals from a domesticated population and making them breed in hopes of creating

offspring with both traits, benefiting humans. For example, if there is a population of horses, and

one individual may have exceedingly preferable traits, such as being the fastest in the group, a

person may choose to have the first horse breed with the strongest horse in the population.

Ideally, the offspring would possess both the speed and strength of the parents, creating a more

useful horse. In nineteen seventy three, the first successful cloning experiment took place.

Following this, the first genetically modified mouse was produced in nineteen eighty. Seventeen

years later, the infamous sheep, Dolly, was cloned (Biology wise, 1994). Two thousand and ten

had the largest advancement in genetic engineering since the concepts inception through the

discovery and development of CRISPR/Cas9, the single cheapest and most accurate variant of

genetic engineering. This allowed scientists to specifically target genes to be removed from the

DNA sequence. New genes may be inserted or the sequence may be left alone to exist with one

less code. This is simply an evolution of what humans have been doing for thousands of years,
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though this time we can choose specific genes as opposed to genetic sets. CRISPR is incredibly

accurate and can be used in a variety of procedures; It is only matter of time before this

technology becomes mainstream in modern medicine, which will save thousands of lives and

countless suffering.

Case Law

Before CRISPR use in humans becomes mainstream, the issue of GMOs needs to be

tackled. Can life be patented? According the the Supreme Court, yes. ​Diamond v. Chakrabarty

was a landmark case for the world of genetic engineering. This case reached the Supreme Court

and discussed if genetically engineered organisms are covered under patent law and are able to

be profited from. In this case, Mr. Chakrabarty genetically engineered a new type of bacteria that

could be used to break down crude oil in the event of an oil spill, an ability that had not

previously presented in bacteria. Because the bacteria was manufactured and did not occur in

nature, it was deemed to be a product which could be patented. The ruling was 5-4 in favor of

Chakrabarty.This can be used to show that genetic engineering can be profited from, and that it

can have its access limited by the creator in the eyes of the law, and although technology has

advanced much further since the decision, the outcome would still be the same. The dissenting

opinion was that Congress had not ruled that living organisms could be patented. The case shows

that entities can now own life and may manipulate it as they see fit, potentially disregarding the

consequences in the process ​(Diamond v. Chakrabarty, 1980). ​Medical technology is certainly

patentable and is made to be profitable; currently the Broad Institute (a joint venture between

Harvard and MIT) owns the patent to CRISPR use in multicellular organisms, which it licenses

out to companies regularly and indiscriminately providing its use is for the betterment of
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mankind and will be used responsibly (McGuire, 2018). While it is not specifically stated in the

patent that CRISPR is for medical use, it is implied that the technology would be used in a

eukaryote, which is covered under the patent.

​Using Genetic Engineering in Modern Medicine

Conceptual Application

CRISPR, the bacterial tool used to edit genetic coding, has made some big advancements

recently, and it opens up the possibility of huge advancements in medicine. For example,

scientists have cured hypertrophic cardiomyopathy in human embryos, furthering the chances of

seeing genetically modified humans walking the streets with someone in their lifetime (Plumer,

2018). For example, alzheimer's is likely caused by a single gene (APOE on chromosome 19), so

if geneticists snip it and put in a gene that isn’t prone to cause deterioration of brain cells,

scientists can prevent the disease in theory. And while reversing it may be a stretch, we can edit

in those who would be prone to have the disease, stopping it before it starts. While controversial,

fetal modifications could save thousands of lives, entirely preventing predetermined disorders.

This function has many outlets where it is useful, so we should put more research and

development into it. The possibilities are almost endless, not to mention the technology is

relatively cheap considering the circumstances. CRISPR is simple in its function, reducing costs

while also being more accurate than previous methods of genome modification.

Peer Review of CRISPR Potential

In a peer reviewed paper published by the Journal of Medical Genetics,

Biologist/Oncology researcher Xiao-Jie (2015) and their geneticist colleagues explore the
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potential use for CRISPR technology in the therapeutic setting as stated in the abstract, which

says the following:

In cell lines or animal models, CRISPR-Cas9 can be applied for therapeutic purposes in

several ways. It can correct the causal mutations in monogenic disorders and thus rescue

the disease phenotypes, which currently represents the most translatable field in

CRISPR-Cas9-mediated gene therapy. CRISPR-Cas9 can also engineer pathogen genome

such as HIV for therapeutic purposes, or induce protective or therapeutic mutations in

host tissues. Moreover, CRISPR-Cas9 has shown potentials in cancer gene therapy such

as deactivating oncogenic virus and inducing oncosuppressor expressions. Herein, we

review the research on CRISPR-mediated gene therapy, discuss its advantages,

limitations and possible solutions, and propose directions for future research, with an

emphasis on the opportunities and challenges of CRISPR-Cas9 in cancer gene therapy.

(Xaio, 2015)

The aforementioned paper explained the specific biological processes that take place in the

edited genome at great lengths. What it shows is that genetic engineering as a whole is not nearly

as imprecise as the technology once was. Under the correct circumstances and proper supervision

of medical professionals, CRISPR could cure many conditions in a more cost effective manner

than traditional cancer treatments while reducing suffering and the likelihood of a relapse (Xaio,

2015).

Application to Oncology

Dr. Shixiu Wu, The President of Hangzhou Cancer Hospital, is pioneering a study on

how CRISPR use on the immune system of advanced esophageal cancer patients affects the
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spread of the disease (Stein, 2018). Blood is taken from the patient, which is sent to a laboratory

where T-cells can be isolated and modified. CRISPR removes a gene known as PD-1(an

immunosuppressive gene). The newly modified white blood cells are given the chance to divide

before they are re-inserted into the patient (Stein, 2018). The result is a more active immune

system that recognises the rogue cells and dispatches them, with the goal of curing what

advanced chemotherapy and radiation could not. The criteria for patients to undergo the

experimental treatment basically states that they must have severe esophageal cancer that has not

responded to chemotherapy or radiation therapy. As of the most recent update, there is roughly a

40% success rate, which is significant considering that the majority of the cases would be

considered terminal before clinical trials began. The only side effect of the treatment is an

“occasional fever” claims Dr. Wu, with monthly T-cell infusions happening a few days prior.

Most of the patients conditions were stable or in remission after their treatments (Stein, 2018).

UPenn researchers have referred to China as the “Wild West” due to the lack of regulation of

these tests, despite the legislation and guidelines in place. Dr. June is involved with the first

clinical trials at the University of Pennsylvania, which seeks to apply CRISPR to treat cancer in

The United States. The trials were practically put through the ringer of the FDA for two years

before a single test subject was contacted.

A landmark drug has been approved for use in acute leukemia. Kymriah, as the drug is

known, reprograms the immune systems of patients with an 83% success rate after three months

in dozens of test subjects (Zhang, 2017). It allows the immune system to recognize cancer cells

in the blood that were previously invisible, allowing the immune system to do its job. The

trouble with many cancers is that because the cells share lots of DNA with the host, they are
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unable to be recognized by the immune system as threats, so the patient has to seek out external

medicine such a chemotherapy and radiation. This manor of genetic engineering is known as

CAR T-cell therapy, and this is the first of its kind to be approved by the FDA. It is far from

perfect; the immune system can be overactivated, causing a more aggressive response than is

necessary. Also, it takes time to even manufacture each patients individual T-cells, the process

takes about three weeks from blood sampling to administration of the new cells. Novartis, the

company that owns the therapy, has stated they will charge $475,000 for their therapy, a steep

price for sure, but the technology is breaking ground in the United States (Zhang, 2017). This

opens the doors to more genetic engineering to treat medical conditions. Clearly the FDA has

some wiggle room when it comes to regulating genetic engineering, so it is only a matter of time

before we start fixing disorders in the prenatal phase. There is a clear need to help patients

suffering from disorders such as Down’s Syndrome, and seeing as CRISPR can delete entire

chromosomes, there is a huge potential for medical use other than in oncology (Yang, 2017).

Ethical And Legal Discrepancies

Philosophical Evaluation

John Harris, a scientific ethicist at the University of Manchester, co-wrote an article

taking the pro human-germline-editing stance. His platform started with the subject of “playing

God” and the way of nature. In essence, he claimed that if humans were really concerned about

interfering with nature, we would not have developed things like antibiotics, which kill bacteria.

Practicing medicine and combating disease would be unethical, as it disrupts nature. He then

touches on consent, as the embryo did not “consent” to being modified. The flaw that Mr. Harris

points out is that embryos don’t consent to being born, yet children are born every day. John
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wraps up his argument by referencing the “risk” of being genetically modified and the potential

unexpected effects. According to the ethicist, two thirds of all embryos fail to develop past the

first month, and six percent of all births worldwide are affected by a substantial birth defect

related to the genes of the child. While scientists should be responsible with the technology,

restraining oneself from using this technology only increases the amount of suffering and death

endured (Harris, 2018).

Eugenics

As a society, the issue of eugenics and the idea of genetic preferability should be

addressed. Certainly a cell with controlled fission is preferable to a cell with uncontrolled

division for the sake of being alive, but the misnomer that entire genomes are superior should not

take hold in society. If that were to happen, a dystopian future for ourselves that mirrors the

eugenics movement of the early 20th century (a movement that greatly influenced Adolf Hitler

and the nazi agenda) would be created. So to be clear, yes, certain traits are more preferable in

regards to being healthy and at homeostasis in the biological mindset, but entire sets of genomes

should all be regarded as equal. The ADA basically states that a person cannot be discriminated

against for an impairment, be it physical or mental, that he or she has acquired or inherited.

Should someone decide to follow through with inheritable human modification, this would

prevent the patient from being treated differently than any other American (Americans With

Disabilities Act of 1990). Discrimination and thoughts of superiority are a real threat to

American liberty, so legislation is absolutely necessary to protect society from emulating the

past.

Consequences of Inaction
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Certain forms of cancer are practically genetically predetermined. For example, women

who have at least one of the two BRCA genes have an 80% chance of developing breast cancer

at some point during their life (Depolo, 2018). While screening for these genes can help lots of

people, why wait for cancer to pop up when science has the technology to remove these genes

that cause the tumors? While “designer babies” may still be a highly controversial topic, cancer

is certainly not. As of 2013, The National Cancer Institute has spent ninety billion dollars on

cancer research. Now early treatment and awareness is all well and good, but why would

someone continue to deal with more trouble than they have to? CRISPR has revolutionized

genetic engineering, and it is entirely possible to pull problematic genes from the genome. Why

not get ahead of disease and not make it likely in the first place? Why give a future family the

burden of likely having cancer of some form when one could just deactivate the root of the

problem? John F. Kennedy once said, “there are risks and costs to action. But they are far less

than the long range risks of comfortable inaction.”

Regulatory Body

In 2015, The United Nations International Bioethics Committee stressed the need for the

scientific community to tread carefully when editing the human genome, as any misstep would

“renew eugenics” (United Nations, 2015). This is one of the few official bodies that influences

the FDA, as the United States regulates genes as it would regulate a drug. Other countries are far

more decisive in their restriction of gene therapy (Charo, 2016). China has restricted gene

therapy on human embryos to two weeks at most, something blatantly violated by a Chinese

doctor. Dr. Jiankui He, a biophysics researcher in Shenzhen, has allegedly produced the world's

first genetically modified humans by way of CRISPR. The twins are said to have been modified
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to be resistant to HIV, a move that has shaken the bioethics community (Wee, 2018). Scientists

have been genetically modifying organisms for decades, and while human modification in vitro

was possible in theory, He’s experiments will serve as a proof of concept when the peer

reviewed results are published.

American Legislation

New avenues have been paved for the future of medicine, so that genetic disabilities can

be screened for and removed. This proves the need for The United States to develop legislation

or a regulatory body solely for editing the human genome. While genetic engineering is possible

and a useful tool, an ethically driven group needs to decide when these edits are appropriate.

Unfortunately, The FDA is incapable of regulating the technology properly, as it is meant to

investigate and regulate medical products, and is specifically inhibited from evaluating the

ethical and social wake that a product may cause (Reardon, 2015).

The Dickey-Wicker Amendment, passed in nineteen-ninety-five and signed by then

President Bill Clinton, specifically prevents the use of federal funding to research genetically

modified human embryos, a move that effectively blocks any consideration of an evaluation

involving modifying the human genome (Kiessling, 2010). This law holds back medicine and

prevents the federal government from creating safe practicing terms for the technology which

could ultimately save thousands of lives. Congress needs to repeal this law as it holds back the

scientific community and the United States as a whole. It is an amalgamation of elder’s fears and

a general distrust in science that damages quality of life and medicine. Even though

experimentation with genetic engineering is not banned outright, nothing can be done if the FDA

cannot allocate funds to review the research.

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International Views on Genome Editing

Japan

According to The Journal Nature, Japan has recently drafted guidelines for the promotion

of research into the effects of genome editing techniques on early development. It has stated that

editing should be done for medical purposes only, not socially, as that would create “designer

babies” (Cyranoski, 2018). The goal is to prevent inheritable genetic disorders by way of

CRISPR. The embryos will not be taken to term, which would be incredibly controversial. Japan

is very forward thinking, as most countries are conservative with genetically engineered crops,

not to mention people. Encouraging research helps to push the envelope in medicine and societal

norms, which will ultimately lead to a brighter future for mankind.

China

Ethical guidelines have prevented experimentation unless given special permission by the

Chinese government, such as in the aforementioned trials in esophageal cancer. In hereditary

edits, the Chinese government enforced the fact that none of the embryos should be viable to

come to term, as they predicted it would raise controversy. As the world has now seen, even

small edits to the inheritable human genome cause great controversy, regardless of their medical

viability (Wee, 2018). China swiftly reprimanded Dr. He, who is said to have been on house

arrest. His results were never published. It should be noted that China has invested heavily in

genetic engineering, which it seeks to lead the world in (Stein, 2018). China has a far less intense

clinical trial regulatory process than America, which has lead to more free reign for scientists in

the far east.

England
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England recently took a stand on the issue of an edited human genome, with the Nuffield

Council of Bioethics stating that hereditary modification of the human embryo is “morally

permissible if it is in the child's best interest” (Sample, 2018). The Board maintained that all

modifications should be non-controversial and strictly for the health of the child, and while bans

are still in place on the production of genetically modified children, England has assumed a new

ethical stance on the issue which could lead to legislative change in the near future. George

Church, a geneticist at Harvard University, commented on the ruling by stating (that the edits)

“should not be expected to increase disadvantage, discrimination, or division in society”

(Sample, 2018). This is the closest a country has come to permitting genome editing outright,

akin to a Gattaca-like society. It is important to note that many people who already have genetic

disorders will not have a chance to get the same treatment or cure as future patients, which could

cause them to feel “marginalised” or left out. While it is unfortunate that these patients likely

would not be able to be cured, fewer and fewer people over time will suffer as they did. It is only

a matter of time till Parliament explicitly states that strictly medical modifications to embryonic

DNA are legal in England.

Australia

Australia has explicit regulations against all genetic engineering in human cells, viable or

not (Alexander, 2017). This effectively bans experimentation and research, holding back an

otherwise westernized and advanced society. The fear of “designer babies” is, while possible, an

overblown threat that neuters the ability to advance medicine. Conservative laws like this

promote the use of outdated technologies and slow progress towards an alternative cancer

treatment, and while the reasoning behind the legislation is entirely viable, there is a more
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aggressive approach towards biological advancements. Newer legislation has been proposed to

allow for restricted experimentation with CRISPR, but it has yet to pass (Alexander, 2017).

Australia likely has the strictest legislation of the countries examined; don’t expect for this

legislation to pass.

Canada

Canada’s Assisted Human Reproduction Act bans inheritable modifications to human

cells; violation of the act runs the risk of a five-hundred-thousand dollar fine and/or incarceration

of ten years (Knoppers, 2017). Research is not allowed due to fears of clones and the

aforementioned “designer babies,” though it should be noted that regulation on stem cell research

is not nearly as aggressive. Scientists from all provinces support a partial reevaluation of the

current legislation, as it could push Canada’s healthcare system towards an even brighter future.

Public healthcare is one of Canada’s biggest attributes; it would be a shame to squander the

ability of the state run system.

Summative Assessment

CRISPR is leaps and bounds ahead of the countries that could use it to cure cancer and

other monogenic disorders. The technology has practically limitless capabilities that can and will

save thousands of lives, depending largely on if ethical and legal guidelines grow to lend to the

Broad Institutes technological peak. Prenatal screening and editing is the future of cancer

prevention, and in the meantime, immune system therapies using CRISPR will be at the forefront

of cancer treatment. If the FDA does not update its policies towards genetic engineering,

American medicine will be left in the past. Views are changing internationally, so America

should be at the forefront of technology.

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