Ethics of Biotechnology
Biotechnology is broadly defined as any kind of technology that makes use of living systems to create products and solve problems. As technology in the biological science realm has taken off at an increasingly fast rate over the past few decades, countless ethical questions surrounding the use of these technologies have been raised and debated. Ethics is defined by the Markkula Center for Applied Ethics as standards of right and wrong that underlie what people "should" do in different scenarios. In the context of biotechnology, points of ethical concern have been raised in six main realms: safety, liberty, justice, environmental nature, human nature, and religious beliefs. The lines dividing what is right and wrong have been blurred by modern technological advancements involving topics such as gene editing, customer-facing genetic testing, and stem cell research. This article will focus on some of the ethical concerns at the forefront of debate within the modern biotechnology industry.
While the concept of modern biotechnology is largely associated with relatively recent developments in science and technology in the past few decades, humans have been using biological systems to develop products and assist processes for thousands of years. The first examples of biotechnology in civilization include early food science and bread-making, alcohol fermentation, and food preservation. The development of a redefined meaning of biotechnology in the modern era is a product of 20th century advancements in recombinant DNA technology, also known as genetic engineering.
Developments in modern biotechnology began taking off in the early 1950s with the discovery of the double-helix DNA structure by James Watson and Francis Crick. In 1966, another major development took place when researchers uncovered the genetic code. The "dawn of biotech" began in the 1970s when companies began to apply the new knowledge of genes and DNA experimentation.
The company Genentech, established in 1976 by Robert A. Swanson and Herbert W. Boyer, is largely credited as the frontrunner pharmaceutical company to commercialize DNA editing technology. In 1980, the US Supreme Court determined that genetically altered life forms could be patented, allowing companies to exploit and profit off of biotechnology advances. In the few decades that followed, new discoveries in biotechnology became increasingly fast-paced as the field rapidly grew and evolved. Some of the most groundbreaking developments from this time period included the ability to treat diseases through new biotech-derived drugs, the identification of genes that allowed for new treatments for cystic fibrosis and multiple sclerosis, and the completion of the human genome sequence which allowed for new treatments for genetic-based diseased such as cancer, heart disease, and Alzheimer's. Today, numerous biotechnology companies are at the forefront of modern genetic engineering technology, including Gilead Sciences, Amgen, Celgene, and Biogen Idec.
The first concerns for an ethical framework in biotechnology research and production began to take place in 1990, after the first instance of gene therapy was used to treat ADA deficiency (an immunological disorder) in a four-year-old girl. As gene therapy involves editing the basic instructions of DNA creation in the human body, people began to pose ethical questions involving where we draw the line between helping sick people and using the new technology for "enhancement". Additionally, concerns about whether this technology would only be available to the wealthy were raised. In 2012, the revolutionary technology CRISPR was discovered and published, introducing a new tool for editing DNA. This new tool for genetic alteration raised a new system for disease treatment and DNA manipulation with MIT Technology Review calling CRISPR 'the major biotech discovery of the century'. CRISPR technology has remained one of the most controversial developments in biotech of the past few decades. In 2015, a group of scientists began advocating for limited use of CRISPR technology until after ethical and moral considerations had been taken. Other scientists disagreed with this viewpoint, arguing for moving forward completely to continue life-changing research that could cure diseases and save millions of lives.
Customer-Facing Genetic Testing
The genetic testing company 23andMe was founded in 2006 by Anne Wojcicki as one of the first direct-to-customer (DTC) genetic testing kits on the market. 23andMe was advertised to consumers as providing revolutionary health information with a simple DNA swab, giving customers intel into 14 diseases for an upfront cost of $999. Over the next few years, 23andMe increased the number of disease information each test kit revealed, ultimately providing information on 244 conditions by 2011 while progressively lowering the cost of each kit. This version also provided customers with information on drug sensitivity to 18 different medications. In 2008, Time Magazine declared 23andMe to be the "innovation of the year" 
Shortly after its creation, the company also attracted various criticisms and concerns by overseeing agencies and scientists in the biotech community. Critics contemplated whether or not the information given by DTC companies was doing more harm than good to consumers. Some of the concerns raised questioned the statistical and scientific validity of the test results, the accuracy of medical advice given alongside results, and the links 23andMe created between certain genetic markers and diseases. Critics also addressed the dangers associated with results taken out of context without proper guidance from a medical professional; the vast majority of consumers did not consult their doctors with their test results. In 2007, the American Society of Human Genetics issued a statement regarding the dangers and risks associated with companies like 23andMe. In this statement, they said: "consumers are at risk of harm from DTC testing if testing is performed by laboratories that are not of high quality, if tests lack adequate analytic or clinical validity, if claims made about tests are false or misleading, and if inadequate information and counseling are provided to permit the consumer to make an informed decision about whether testing is appropriate and about what actions to take on the basis of test results."
In November 2013, the FDA issued a public letter to 23andMe banning the continuation of test kit sales after failing to follow FDA rules on providing data to support marketing claims. According to FDA rules, 23andMe is required to provide proof on detection accuracy, in addition to error rates on testing. After repeated requests by the FDA to supply this information, 23andMe did not comply while continuing to expand their advertising and reach. The company continued to conduct their own research with data collected prior to the ban until FDA granted authorization to the company in February 2015. In the wake of this authorization, 23andMe transitioned to providing customers with “carrier status” information on 35 genes that can cause diseases, instead of their old results that provided specific genetic linkages to disease risk based on real-time research.
19-year-old Stanford drop out Elizabeth Holmes founded the Theranos corporation in 2003, claiming to make use of innovative new technology to provide easier, less expensive, and faster blood test results to consumers with just a finger pick and without the need to consult a doctor. At first, the technology touted by Theranos seemed revolutionary in the healthcare industry and would transform the way consumers can assess and receive data about their health. However, without solid evidence to back up these claims, critics became suspicious and wondered if her claims were too good to be true. In 2015, the Wall Street Journal published a widespread investigation into the company, revealing that Theranos actually functioned almost identically to a mainstream blood testing lab and using traditional blood testing procedures on almost all of their tests. The report also exposed Theranos' trademark Edison machines' as unreliable and providing inaccurate results to customers. In January 2022, after being put on trial, Holmes was found guilty on three counts of fraud and one count of conspiring to defraud private investors.
The rise and fall of the multi-billion dollar biotechnology company highlights some of the deeply-rooted concerns that many share with the rapidly developing biotechnology field. Critics in the bioethics community have exemplified this scandal as a cautionary tale of what can happen when ethics are not placed at the foreground of biotechnology research and development, and when innovation-hungry bioengineers prioritize rapid revolutionary advancement over "good" scientific practice Political scientist Langdon Winner summarized this concern in a statement in 2003: “the ﬁeld of bioethics... has a great deal to say about many fascinating things, but people in this profession rarely say no.”  The Theranos scandal continues to be cited as one of the most infamous failures in the biotechnology industry and serves as a lesson in ethics to bioengineers around the world.
Stem Cell Research
Stem cells are necessary cells in the body that have the ability to develop into different types of cells and are essential for cell regeneration. Scientists discovered the ability to isolate and grow human stem cells in a lab in 1998, opening the door for the harnessing of stem cells for the treatment of diseases where cells or tissue is damaged. Stem cell research involves looking into how to use these stem cells to treat conditions in the human body such as Alzheimer's and diabetes. Stem cell therapy works to repair damaged tissue by transplanting lab-grown stem cells to promote cell regrowth in the human body. In 2016, there were 570 stem cell clinics operating around the country.
The controversy surrounding stem cell research are largely centered around the use of embryonic stem cells, as opposed to adult stem cells. Embryonic stem cells are considered undifferentiated, meaning they are not yet fully developed and are totipotent: they have the ability to transform into any type of cell. Adult stem cells, by contrast, are only able to develop into similar cell types  The NIH has stated that "human embryonic stem cells are thought to have much greater developmental potential than adult stem cells".  As such, the use of embryonic stem cells has the largest potential for the development life-saving disease treatment, as embryonic stem cells have the ability to reproduce in any kind of tissue.
However, this type of stem cell research has raised a number of ethical concerns because harvesting this type of cell requires the destruction of an embryo. Many individuals believe that life begins at conception and an embryo is a living person with the same moral status as adults, and therefore the use of a fertilized egg to derive stem cells is unethical. In this sense, the concerns surrounding embryonic stem cells have close ties to the abortion debate, with the central question being "when does human life begin?"  US president George W. Bush shared the view that life begins as an embryo; in 2001, he banned federal funding of embryonic stem cell research because embryos are destroyed in the process. However, eight years later during his presidency, president Barack Obama revoked this order. Many proponents of the use of embryonic stem cells argue that a blastocyst does not become a traditional "human life" until much later in development, and therefore does not constitute as a human life in the same way a born child or grown adult is. Many individuals also hold a more middle ground approach, believing that an embryo does deserve a certain level of respect as a potential human being, however it is justifiable to utilize it on the grounds of scientific research for the potential treatment of diseases. Robin Cook holds this view, stating that "as a physician... you don't get a chance very often to cure anybody... the potential of stem cell [research] is that it would be an opportunity to actually cure people." 
Embryonic stem cell research remains one of the most controversial debates in biotechnology, resting at the pivot point between two moral principles: the duty to protect human life versus the duty to alleviate pain and suffering. Today, stem cell research is legal in the United States, with limitations and restrictions on its funding and use, while laws surrounding the use of embryonic stem cells vary by state.
Germline editing is the process of genetically modifying early-stage embryos in-vitro, resulting in a child born with a genetically modified embryo. This process became increasingly debated with the development of CRISPR-Cas9 technology in 2012. CRISPR works by acting as a cutting tool to slice DNA and create gene changes in the genome. This can be done in an effort to "tweak" or adjust the genetic code to fix problems that could cause disease, or it could be used to remove or disable certain genes. CRISPR can also be used to insert new genes into the genome. In 2015, controversy increased when CRISPR technology was used for the first time to genetically modify nonviable human embryos.
He Jiankui Controversy
In 2018, germline editing and CRISPR technology rose to the foreground of debate when Dr. Jiankui He of China announced that the first genetically modified babies had been born, twins Lulu and Nina. Dr. He used CRISPR technology to genetically modify their embryos, specifically targeting the CCR5 gene that is largely responsible for causing human immunodeficiency virus (HIV). The girls' father had HIV, increasing the likelihood for his offspring to contract it  About a year later in 2019, He and two others were found guilty of violating criminal law in China for practicing medical activities without a license.
Dr. He's use of CRISPR technology has sparked a breadth of ethical questions surrounding genetic engineering in the scientific community. Because genetic modifications alter the genome of a human life, these changes are thus heritable for generations to come and have the potential to rewrite the gene pool of human germ lines. A major concern with the use of CRISPR technology is the risks involved with changing genes; cutting or disabling genes in an organism may result in unintended negative effects, because many genes code for multiple proteins or have unexpected interactions with other genes and proteins. This could create for an expression of the genome in ways that are unpredicted and potentially harmful. 
Dr. He has been criticized largely due to his lack of safety considerations surrounding his experiments. Many are concerned that the adjustments that were made to the twins' genomes could actually leave them with more negative effects. While CCR5 is linked to HIV, the gene is also thought to help people fend off the effects of various other diseases, such as West Nile virus. Thus, many worry that the girls might actually be more vulnerable to disease and increased suffering.
The use of CRISPR technology to modify early-stage embryos opens the door for what many call "designer babies". The concept of designer babies satirically addresses the ethical issues that many are increasingly concerned about, if embryo gene editing is the future of medicine. Designer babies refer to the dystopian concept of genetically modifying embryos in the interest of designing desirable traits like hair color or intelligence; genetic choices beyond simply preventing disease.
Many scientists hold the stance that parental input for genetic embryo modification for offspring is ethical, as parents have the right to prenatal autonomy. Additionally, proponents argue that parents already hold a large degree of control in the lives of their children because of environmental choices, and thus genetic modifications to their offspring can be viewed in a similar light
Most scientists agree that it would be decades before the concept designer babies would be able to come to fruition. Modern technological advancements in gene editing technology ensure that the ethical considerations surrounding germline modification will continue to be raised and debated.
Regulation in the US
As modern biotechnology took off in the latter half of the 20th century, the United States government began to take notice of ethical considerations and moral regulations that need to be considered in the context of this research. The federal government has implemented numerous laws and regulatory committees to oversee biotech companies in their research, creation, and uses of new technologies to ensure a standardized system that takes ethical considerations into account.
In 1976, the National Institutes of Health (NIH) published a set of guidelines that govern any agency funded by the NIH or receiving funding by organizations associated with the NIH. These guidelines apply to all research having to do with recombinant DNA technology, and protect biosafety implications of this research. Over the years, these guidelines have been maintained and updated by the NIH.  The White House Cabinet Council on Natural Resources and the Environment formed a Working Group on Biotechnology in 1984. This committee created a Coordinated Framework, assigning different responsibilities to various federal agencies to govern and oversee biotechnology research. Federal agencies included in the Coordinated Framework include the NIH, the Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), the US Department of Agriculture (USDA), and the Occupational Safety and Health Administration (OSHA). In 2001, congress passed the Human Reproductive Cloning Act, which prohibited implantation of cloned embryos in the womb. In 2002, after numerous advances in stem cell research and cloning, President Bush introduced the Council on Bioethics to oversee and advise him on issues in the biotechnology ethics realm. A year later in 2003, Kentucky introduced a law that banned cloning for reproductive purposes while permitting it for research purposes only.
Today, human germline genome editing is prohibited in the United States with the use of federal funding, but is permitted through private funding. Biotechnology research remains overseen by the agencies associated with the Coordinated Framework, with numerous updates having taken place over the years since its original publication.
- The Editors of Encyclopaedia Britannica . Britannica. 23 Jul. 2021 https://www.britannica.com/technology/biotechnology
- Manuel Velasquez, Claire Andre, Thomas Shanks, S.J., and Michael J. Meyer. "What is Ethics?" Markkula Center for Applied Ethics. Santa Clara University. 1 Jan. 2010 https://www.scu.edu/ethics/ethics-resources/ethical-decision-making/what-is-ethics/
- "Biotech Ethics ." Encyclopedia of Science, Technology, and Ethics. . Encyclopedia.com. 24 Jan. 2022. https://www.encyclopedia.com/science/encyclopedias-almanacs-transcripts-and-maps/biotech-ethics
- Bhatia, Saurabh. History, scope and development of biotechnology. Introduction to Pharmaceutical Biotechnology, Volume 1. May 2018. https://iopscience.iop.org/book/978-0-7503-1299-8/chapter/bk978-0-7503-1299-8ch1
- Misachi, John. Top 10 Biotechnology Companies in the United States by Market Value. Worldatlas.com. 25 April 2017. https://www.worldatlas.com/articles/top-10-biotechnology-companies-in-the-united-states-by-market-value.html
- Bergman, Mary Todd. “Perspectives on gene editing”. The Harvard Gazette. 9 Jan. 2019. https://news.harvard.edu/gazette/story/2019/01/perspectives-on-gene-editing/
- Daemmrich, Arthur A., 23andMe: The Business and Ethics of Personal Genetics Testing. Electronic Hallway, University of Washington, Evans School of Public Affairs, Version: 31 March 2015 ,https://ssrn.com/abstract=2587944
- Hudson, Kathy et al. “ASHG Statement on Direct-to-Consumer Genetic Testing in the United States.” American Journal of Human Genetics vol. 81,3 (2007): 635–637. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1950839/
- “FDA bans 23andme personal genetic tests”. 26 Nov. 2013. BBC. https://www.bbc.com/news/technology-25100878
- Stoeklé, HC., Mamzer-Bruneel, MF., Vogt, G. et al. 23andMe: a new two-sided data-banking market model. BMC Med Ethics 17, 19 (2016). https://doi.org/10.1186/s12910-016-0101-9
- Herper, Matthew. “23andMe's Triumph -- And The Long Road Ahead”. 21, Oct., 2015. Forbes. https://www.forbes.com/sites/matthewherper/2015/10/21/23andmes-triumph-and-the-long-road-ahead/?sh=6d12307d5e9f
- Belluz, Julia. “The Theranos controversy, explained”. 20 Oct., 2015. https://www.vox.com/2015/10/20/9576501/theranos-elizabeth-holmes
- Thomas, Daniel. “Theranos scandal: Who is Elizabeth Holmes and why was she on trial?” BBC. 4 Jan. 2022. https://www.bbc.com/news/business-58336998
- Paul, Kari. “Elizabeth Holmes to be sentenced nine months after guilty verdict”. The Guardian. 13 Jan., 2022. https://www.theguardian.com/technology/2022/jan/13/elizabeth-holmes-sentence-september-fraud
- Jeske, Melanie. Lessons from Theranos: Changing Narratives of Individual Ethics in Science and Engineering. Engaging Science, Technology, and Society. 6. 306. 10.17351/ests2020.411. https://www.researchgate.net/publication/342498959_Lessons_from_Theranos_Changing_Narratives_of_Individual_Ethics_in_Science_and_Engineering
- Winner, Langdon. "Under the magnifying glass: nanotechnology needs open deliberation not boosterism if it is to serve the public good." Alternatives Journal, vol. 30, no. 1, winter 2004, pp. 34+. Gale Academic OneFile, link.gale.com/apps/doc/A117180009/AONE?u=umuser&sid=googleScholar&xid=cf274442. Accessed 9 Feb. 2022.
- David Railton, Alina Sharon. “What are stem cells, and why are they important?” Medical News Today. 6 Jul. 2021. https://www.medicalnewstoday.com/articles/200904
- Coghlan, Andy. “Stem cell timeline: The history of a medical sensation”. NewScientist. 30 Jan 2014. https://www.newscientist.com/article/dn24970-stem-cell-timeline-the-history-of-a-medical-sensation/
- Doherty, Julie. “The Stem Cell Controversy”. Wilson Center. 18 Jan 2006. https://www.wilsoncenter.org/event/the-stem-cell-controversy
- Congressional Record (Bound Edition), Volume 151 (2005), Part 8. Pages 11000-11044. U.S. Government Publishing Office. https://www.govinfo.gov/content/pkg/CRECB-2005-pt8/html/CRECB-2005-pt8-Pg11000.htm
- Dr. Ananya Mandal. “Stem Cell Controversy”. AZO Life Sciences. 1 Oct. 2020. https://www.azolifesciences.com/article/Stem-Cell-Controversy.aspx
- Lo, Bernard, and Lindsay Parham. “Ethical issues in stem cell research.” Endocrine reviews vol. 30,3 (2009): 204-13. doi:10.1210/er.2008-0031 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2726839/
- Cunha, John P. “Is Stem Cell Research Illegal in The United States?” EMedicine Health. 2 Dec. 2020. https://www.emedicinehealth.com/is_stem_cell_research_illegal_in_the_united_states/article_em.htm
- Françoise Baylis, Marcy Darnovsky, Katie Hasson, and Timothy M. Krahn. The CRISPR Journal. Oct 2020.365-377. http://doi.org/10.1089/crispr.2020.0082
- Saey, Tina Hesman. “Explainer: How CRISPR works”. ScienceNewsforStudents. 31 Jul. 2017. https://www.sciencenewsforstudents.org/article/explainer-how-crispr-works
- Rose, Bruce I. MD, PhD; Brown, Samuel MD Genetically Modified Babies and a First Application of Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR-Cas9), Obstetrics & Gynecology: July 2019 - Volume 134 - Issue 1 - p 157-162 https://journals.lww.com/greenjournal/Fulltext/2019/07000/Genetically_Modified_Babies_and_a_First.23.aspx
- Cyranoski, David. “The CRISPR-baby scandal: what’s next for human gene-editing”. Nature. 26 Feb. 2019. https://www.nature.com/articles/d41586-019-00673-1
- Ball, Philip. “Designer babies: an ethical horror waiting to happen?” The Guardian. 8 Jan. 2017. https://www.theguardian.com/science/2017/jan/08/designer-babies-ethical-horror-waiting-to-happen
- Ly, Sarah. “Ethics of Designer Babies”. The Embryo Project Encyclopedia. 31 Mar. 2011. https://embryo.asu.edu/pages/ethics-designer-babies
- National Academies of Sciences, Engineering, and Medicine; Division on Earth and Life Studies; Board on Chemical Sciences and Technology; Board on Agriculture and Natural Resources; Board on Life Sciences; Committee on Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System. Preparing for Future Products of Biotechnology. Washington (DC): National Academies Press (US); 2017 Jun 28. 3, The Current Biotechnology Regulatory System. https://www.ncbi.nlm.nih.gov/books/NBK442204/