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.

Background

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.

Ethical Controversies

Customer-Facing Genetic Testing

23andMe

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.

Theranos Scandal

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.

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.