Rewriting the Blueprint
Gene editing for improved agriculture, healthcare, and beyond.
Blissful ignorance or worthwhile awareness?
Healthcare and Animals:
Side effects resulting from “off-target” gene manipulations as well as genetic mosaicism--where not all cells carry the alteration, which can lead to further disease and potential immune responses--are some of the major safety concerns that come with genome editing. These technologies are still in the young refinery stages, which can, of course, lead to public hesitance when accepting gene therapies or drugs. The risks of these increase even further for animals such as rodents since they are used to test these treatments and medicines, especially when you consider that therapies have been designed for human bodies. Many fear that these poor animals are being subjected to cruel treatment. To some, it simply is not fair for innocent creatures to be put through all this suffering for research that could possibly yield no results--or worse: counterproductive ones. Indeed, the risks for animal safety to be jeopardized is daunting, but one must not be so keen to ignore the fact that lab animals are taken care of by trained veterinarians and are even given special treatment to offset the sometimes unpleasant experiences that come from tests. These special treatments can include tickling to alleviate discomfort prior to injections.
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Social
Watch the video to understand the potential risks of CRISPR
Potential Health Risks of Gene Therapy
Immune Rejection
Mistargeting Cells
Reversion of Viruses to Infectious State
Tumor
Development
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Food & Agriculture: Many consumers have debated over the safety of consuming GMO food products, especially with paranoia over side effects and possible toxicity. Much of this stems from the lack of information from GMO companies and law regulators like the FDA. For one, foreign material is inserted into crops via viral or bacterial vectors, which can be alarming for many health-conscious consumers. Below are some of the many health safety concerns customers have over GMO foods.
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Toxins:
FDA regulators and consumers have expressed their concerns with genomic edits causing once healthy foods to become harmful and toxic for humans. Many argue that genetic modification of crops is a game of roulette with such “‘genetic instability’” that can arise from unpredictable modification effects (Is.C.3).
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Allergenicity:
Especially after the Hi-Bred International soybean scare, in which some suffered allergic reactions to soybeans GM with Brazil nut genes, consumers have been concerned with the possibilities of allergenic-genes being transferred to previously “safe” foods, and triggering a possibly fatal response in unsuspecting individuals. Their concerns also lie in the lack of thorough labeling.
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Antibiotic Resistance:
Since many foods have been genetically engineered to have antibiotic-resistance markers to show scientists if DNA has been successfully transferred into the host or not, consumers and scientists alike have feared the chances of these resistance genes being transferred to bacteria, rendering antibiotic drugs for humans useless against infections.
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Cancer:
Some consumers anticipate cancer formation/development since the introduction of recombinant Bovine Growth Hormone (rBGH) in cows. Scientists have found significantly higher levels of insulin-like growth factor-1 (IGF-1) in rBGH dairy products which has brought about many concerns: IGF-1 has been linked to breast, prostate, and colon cancer formations.
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Loss of Nutrition:
Through the genomic alterations of these crops, the FDA has investigated and found the potential loss of many key nutrients.
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Are these procedures and foods worth the risk to you?
Ethical
Nature of competition or cheating scandal?
Boosting to the finish line with gene doping
Capitalist ploy or modern beauty solution?
Selecting physical traits with gene editing
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Besides financial gaps, many are also concerned with the possibility of social injustices that can arise from selective germline alterations. Bioethicist, Walter Glannon, has argued that gene therapies can quickly bleed into a greater concept of inequitable genetic enhancement--or alterations for purposes beyond medical reasons. This includes cosmetic procedures, selecting ideal physical or mental traits for offspring, and what’s known as gene doping to boost athletic performance. The World Anti-Doping Agency (WADA) has long declared gene doping procedures as those that “threaten the integrity of sports” (Is.C.4).
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“[Gene therapy is defined as] maintaining or restoring mental and physical functions at or to normal levels, which [is] necessary to ensure fair equality of opportunity for all citizens. Insofar as this aim defines the goal of medicine, genetic enhancement falls outside this goal. Furthermore, insofar as this type of intervention is not part of the goal of medicine and has no place in a just health care system, there are no medical or moral reasons for genetically enhancing normal human functions and capacities”
-Walter Glannon, Bioethicist (Is.C.5)
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To some, this is a greater violation than cheating Mother Nature, since it provides some--specifically, the wealthy--unfair advantages in physicality (fitness and appearance) and mental capabilities.
Genome editing technologies are very new and costly, raising concerns over whether or not they should be offered as commercial procedures/products. Especially for gene therapies and medication, they often come at prices significantly higher than traditional treatments. Until production can be made more efficient, many fear that social disparities can form since only certain individuals will be able to afford them.
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Many bioethicists have stressed the problematic possibility of "designer babies". Since some genome editing tools allow scientists to sort gametes for disease-free genes, what's to say that physical or mental traits can't also be chosen as well? Keeping children healthy should, of course, be the number one priority of any parent or healthcare provider, but do we as a society draw the line at choosing which, say, eye color babies have? Or does that role belong solely to Mother Nature?
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Companies such as MicroSort offer sorting and preimplantation genetic diagnosis (PGD) in which sperm are screened for the most viable ones. This can help predict whether a couple will have a son or a daughter, as well as whether or not they will carry a certain X-linked (male inherited) disease. They make it very clear, however, that these tools are only allowed for families who are in immediate need of it--not for personal preference.
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Curious for more? Watch the videos below for more on designer babies and CRISPR!
The novelty of genome editing brings about many concerns over safety for test subjects and whether or not humans can morally allow this natural tampering. However, there are many laws to regulate production and testing and protect test subjects.
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Legal
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Gene Therapy:
The Food and Drug Administration (FDA) sets strict laws permitting and protecting individuals who participate in human clinical trials. The National Institutes of Health also sets requirements for how companies and labs conduct these trials. The
NIH’s Recombinant DNA Advisory Committee (RAC) reviews all protocols for ethical and safety issues before giving permission for the tests to begin. Additionally, the World Health Organization is working on ways to establish a genome editing registry of sorts so as to protect human safety and integrity in gene editing trials.
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GMO:
When it comes to growing crops, there are many federal divisions in the U.S. that focus their efforts on ensuring environmental safety. The Environmental Protection Agency (EPA) approves and monitors biopesticides in GM foods with the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The Food and Drug Administration: GM crops that can be classified as “generally recognized as safe”-- in which inserted genes do not significantly alter the original crop’s “structure, function, or quality”--are not required to be reviewed (Is.C.11). However, if crops do not pass the Federal Food, Drug, and Cosmetic Act (FFDCA), the FDA reserves the right to require “pre-market approval” (Is.C.11). Additionally, recent laws have been finalized, mandating that foods containing a minimum of 5% GM products must be labeled by companies to ensure integrity and transparency.
However, some are still discontent with the laws:
“The USDA has betrayed the public trust by denying Americans the right to know how their food is produced [...] Instead of providing clarity and transparency, they have created large scale confusion and uncertainty for consumers, food producers, and retailers.” -Andrew Kimbrell, executive director at the U.S. Center for Food Safety.
(Is.C.10)
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GMOs:
Today, it is extremely expensive for companies to design and produce new GMO goods, specifically, an average of $136 million. These patents last for approximately 20 years, and after this time, inventions become "public knowledge" for other companies to use for their own production (Is.C.13).
The U.S. Plant Patent Act of 1930 was passed to make crossbred crops, and now, biotechnologically modified (i.e. foreign DNA integration) patentable for companies. An example of a patent on GMO crops is Monsanto's Roundup Ready soybeans--issued in 1996, which has since expired.
(Is.C.13)
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Due to the high costs of design and production, many companies today have been vying for patents on their technologies, products, and services. Patents serve as a way "to give inventors a period of exclusivity for commercial development of products, thereby encouraging innovation" (Is.C.13).
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Intellectual Property:
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Gene Therapy:
While many companies have had their own contributions to gene therapy success and the likes, there have been many disputes over who the patents truly belong to. For instance, CRISPR's popularity has spurred much excitement and eagerness for intellectual property rights. Of the hundreds of patents that have been issued for CRISPR, the biggest ones have been granted to Emmanuelle Charpentier and her business partner, Jennifer Doudna, as well as Feng Zhang of the biomedical Broad Institute of MIT and Harvard. Being much more cost-efficient than CRISPR and other genome editing tools, TALENS is much easier for companies of all sizes to use and develop. Cellectis and Life Technologies and the Two Blades Foundation are the main investors of TALENs after having licensed "the rights from patent holders at Martin Luther University, the University of Minnesota, and Iowa State University" (Is.C.12).
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Intellectual Property