Which example represents a modern biotechnology technique that raises potential ethical issues?

Introduction

Genetic engineering comprises multiple techniques for the intentional manipulation of genetic material (primarily deoxyribonucleic acid, or DNA) to alter, repair, or enhance form or function. Recombinant DNA technologies, developed in the latter half of the twentieth century, include the chemical splicing (recombination) of different strands of DNA generally using either bacteria (such as Escherichia coli) or bacteriophages (viruses that infect bacteria, such as λ phage), or by direct microinjection. In recent years, these traditional tools have been supplemented by new techniques to design and build – literally, to engineer – novel life forms, generally referred to as synthetic biology.

Genetic engineering, writ large, raises a number of significant ethical issues. In agriculture, for instance, ethicists have highlighted potential human health hazards associated with genetically modified crops and livestock, as well as normative concerns about the treatment of animals and the ecological consequences of genetic engineering. In medicine, there has been significant ethical controversy about the putative distinction between protocols meant to restore function and those meant to enhance function beyond species-typical norms. Additionally, ethicists have attended to the potential human health risks associated with germ-line genetic engineering, as distinct from somatic genetic engineering. Finally, in the context of reproduction, ethicists have argued that genetic engineering raises ethical issues involving the screening and manipulation of embryos to eliminate or introduce various medical and/or cosmetic characteristics.

In relation to public health specifically, genetic engineering raises additional ethical issues concerning not only the potential societal consequences of genetic engineering, but also the wisdom of genetic manipulation of plants, animals, and humans. In pursuit of the goals of health promotion and illness prevention, public health initiatives have traditionally sought to improve sanitation, ensure the availability of clean water, and identify the source of, and develop vaccines for, infectious disease. But with the development of genetic engineering techniques and the sequencing of the genomes of plants and animals (including humans), the scope of possible public health interventions has increased dramatically – but so too have the threats to public health.

Ethical Issues: Failures

Biotechnology has sparked a great deal of ethical criticism. This often frustrates proponents of biotechnology because the goals outlined previously seem so obviously good and so obviously advanced by biotechnology. One way to begin thinking through the variety of critical positions that have been staked out is to make distinctions with respect to these goals. First, some are concerned that biotechnologies have not or will not succeed in achieving the goals. Second, some are concerned that biotechnologies may achieve the goals but they will do so only in conjunction with unacceptable trade-offs or unintended consequences that will ultimately undermine the goals. Third, some are concerned that biotechnologies will secure the goals for some but not for others or at the expense of others. Fourth, some argue that biotechnologies have and may continue to succeed in achieving the goals, and that this success itself constitutes cause for concern.

The first three concerns can be treated together because ultimately they all contend that biotechnology is objectionable because of its failures. It fails outright, fails to realize the goals within tolerable levels of risk, or fails to realize the goals in ways that are equitable and respectful of individual liberties. The fourth concern is unique because it contends that biotechnology is objectionable because of its successes. Thus, it is treated in the following section.

The best example of the first objection relates to the claim that agricultural biotechnologies can help alleviate world hunger. Critics respond by arguing that starvation and malnutrition are most often the result of political and social circumstances, rather than food shortages, and thus are not amenable to technological fixes. The Green Revolution (the mid-twentieth century worldwide expansion of modern agricultural technology), from this perspective, did not lift people out of poverty but only subjected them to new forms of corporate and technological control, new environmental problems from mechanization, and new vulnerabilities to world markets. Another example is the argument that creation of transgenic animals to study human diseases is bound to fail because of remaining differences that make extrapolation to human cases unreliable. Biotech proponents, however, have challenged both positions. For example, the argument that food production is not related to famine has several faults, and many positive outcomes of the Green Revolution can be cited.

The second critique, centered on safety, is more common and essentially amounts to the claim that the power of biotechnology disrupts the complex balance of living nature in ways that are likely to be harmful. Critics argue, for example, that GMOs may lead to gene flows that cause wild relatives to mutate into ‘superweeds.’ GMO genes can also contaminate non-GMO crops and threaten biological diversity. Some believed that Bt crops harmed non-pest insects such as the Monarch butterfly. The rule of unintended consequences was also evident in the way that mass production of biofuels contributed to increases in food prices. Critics also raise human health concerns about GM plants and animals, especially their potential for causing allergies and exacerbating antibiotic resistance. They further challenge biomedical techniques that may alter human physiology in unpredictable ways.

Another area of concern within the second critique is the dual-use dilemma, which arises when the same research project has the potential to be used for harm as well as for good. For example, in 2005, the complete genetic sequence of the 1918 influenza A (H1N1) virus was published in Science. This knowledge could help scientists identify and combat the next pandemic. However, it could also be used by bioterrorists to cause the next pandemic. In light of such concerns, critics often espouse some version of the precautionary principle, arguing that biotechnologies should be considered risky until definitively proven otherwise.

It is difficult to say what constitutes definitive proof, but there is no evidence that anyone has become sick from eating genetically modified foods, and no obvious environmental disaster has occurred. Indeed, U.S. federal agencies have relaxed some regulatory measures and concurred with the biotech industry that genetically engineered plants are not substantially different from those derived from traditional breeding techniques. Furthermore, in scenarios in which threats exist, proponents of biotechnology can argue that oversight and regulatory regimes will prevent harms. Nonetheless, successfully averting past disasters is no guarantee that future problems will not emerge.

The third critique has two related facets. Liberty and rights are ethical issues for those concerned that biotechnology will give some people power over others. Justice is an ethical concern for those who argue that biotechnology gives the rich and unjust advantage over the poor or that the benefits and burdens of biotechnology will be unfairly distributed.

Critics have claimed that biotechnology raises a host of individual rights and liberties issues: Government-sponsored eugenics programs threaten procreative liberties, genetic screening and biobanking threaten rights to privacy and raise fears about discrimination by employers or insurers, life support systems pose new challenges to the ‘right to die,’ the nonlabeling of GM foods undermines one’s right to know, and the use of DNA evidence in the courtroom must occur in the context of a defendant’s right to an independent expert. It could also be said that restrictions on biotechnologies would undermine the new personal liberties or rights that they make possible. For example, one could argue that PGS gives one the right to choose the sex or other genetic aspects of one’s children. As long as one’s own personal use of PGS or other biotechnologies does not harm others, the argument goes, then it should not be restricted.

Intellectual property and the patenting of biotechnologies is a central issue for both liberty and justice. Patents encourage and reward inventiveness by giving an inventor the exclusive rights to an invention’s use and sale. They are morally justifiable, proponents claim, because they are fair. In the absence of patents, a competitor can quickly and cheaply reverse engineer the inventor’s product and sell it at a low cost. This competition would make it impossible for inventors to recoup costs and be compensated for their original work. Furthermore, without patents, the argument runs, innovation would dry up because there would be no incentives and protections for innovators.

Critics may grant this argument in the abstract, but they argue that in reality biotech corporations utilize intellectual property as a mechanism for domination. Some argue that patents reduce supplies, increase prices, and limit choices for small farmers. Others claim that patents on living creatures (altered or not) found in the developing world constitute ‘biocolonialism’ or ‘biopiracy,’ the pilfering of genetic resources and traditional knowledge. This undermines a people’s right to self-determination or their rights to profit from their own resources. Supporters of the commercialization of traditional medicines use the term ‘bioprospecting,’ noting that intellectual piracy only refers to acts where the knowledge in question was already protected by domestic patent law, which is not the case in most developing countries. Bioprospecting can also refer to the search for previously unknown compounds not used in traditional medicines.

Publisher Summary

Biotechnology-derived therapeutic products represent a diverse class of agents that are categorized by their method of manufacture, typically based on recombinant DNA technology. These products include recombinant proteins and nucleotides as gene therapies, anti-sense therapies, cytokines, monoclonal antibodies, growth factors, soluble receptors, fusion proteins, vaccines, and coagulation factors. Therapeutic targets of these products include genetic deficiency; neurological, cardiovascular, autoimmune and inflammatory disorders; cancer; metabolic disorders; and other conditions. Given that these molecules are typically derived and produced to mimic endogenous nucleotides and proteins, their toxicity tends to be related to that associated with over-stimulation or suppression of the targeted biological pathways. In addition, unlike potentially active metabolites associated with small molecule therapies, the metabolic by-products of biotechnology-derived therapeutics are generally inactive amino acid and nucleotide fragments.

The Term ‘Biotechnology’

Defining biotechnology poses challenges, for the word is less a tightly defined, technical term than a loose umbrella category, or even a slogan, that conveys – sometimes simultaneously – visions of unbounded progress and unregulated tampering with nature. Many authors have tried to capture biotechnology within their own well-crafted definitions, but these attempts cannot neatly contain this expanding network of activities and increasingly dense connections to diverse social worlds. Although the word has a long history (Bud, 1993), in most contemporary contexts biotechnology refers to a novel and growing collection of techniques, grounded in molecular and cell biology, for analyzing and manipulating the molecular building blocks of life. The term also designates products, such as pharmaceuticals or genetically modified (GM) foods, created using these techniques. At times, it refers not to products or techniques but to an economic sector or area of research. Biotechnology acquired these intertwined meanings toward the end of the 1970s, coming into widespread use in the early 1980s, as molecular biology was increasingly understood not only as a ‘science’ for learning about nature but also as a ‘technology’ for altering it.

The Role of Large Companies

Biotechnology is relatively new in weed science and although HRCs have been rapidly adopted much is still to be learned about their effects on weed science and weed management techniques (Duke, 1998). The science has been market driven toward development of transgenic crops that allow use of patented broad spectrum herbicides that contribute to corporate profit (Gressel, 2000) and crop production. To date, not much has been done to use the potential of biotechnology to develop weed management systems that are not dependent on chemicals. These could include enhancing crop competitiveness for nutrients, light, or water or by exploiting natural allelopathy (Gressel). Gressel also suggests that biotechnology could be used to modify weed populations to make them less competitive and to make hypervirulent biocontrol agents that are safe but not able to spread (they are self-limiting). These innovative ideas show biotechnology’s potential but such achievements may only occur when research is publicly funded rather than profit driven. Profit is not evil, but the quest for profit inevitably leads research in directions that may not be environmentally, socially or politically desirable. The primary GE weed management technology (incorporation of herbicide resistance) has changed the herbicide used but has not reduced inclusion of herbicides as the essential element of weed management programs. Similarly, no GE crops have reduced the need for petroleum-based fertilizer to achieve (perhaps assure is a better word) yield goals. GE technology is best adapted to large scale, industrial, monocultural agriculture, which, depending on the facts one accepts and the view they represent, may or may not be the best way to feed the world, protect human health and the environment and achieve long-term sustainability. There are notable exceptions to this view (see Arguments in favor of biotech, above, and Borlaug, 2001; Sahai, 1997; Tonniessen et al., 2003; and Wambugu, 1999, 2000). Acceptance by big-farms has led editorial writers of the Economist, a magazine that traditionally supports capitalist, industrial entrepreneurs, to worry that GE crops will inevitably destroy small farms and lead to control of a significant portion of the natural world (Anonymous, 2010). They go on to say that the fact (no source is given) that “90% of the farmers growing GE crops are comparatively poor and in developing countries is sinister not salutary. Monsanto’s dominance in America’s soyabean market, seems to suggest a goal of world domination.”

At this point it is worthy of note that in some quarters, it is fashionable to excoriate the pesticide chemical industry as one that takes advantage of farmers and the environment. My experience has been that people in the pesticide chemical industry are capitalists and idealists. They are driven by the quest for profit but are optimistic that their work may benefit the world. It has made and will continue to make significant contributions to agriculture’s moral obligation to feed the world. Modern agriculture would not have achieved what it has without the aid of the research and discoveries of the pesticide chemical industry.

The agricultural view is that genetically modified crops are essential to the moral obligation to feed to world and they will be lost without technological advancements that solve the problem of weed resistance, provide clear benefits, and are part of a sustainable system. Improved technology will solve the problems technology created. An ethical foundation that guides consideration of potential health, environmental, sustainability, and social effects is absent.

Publisher Summary

This chapter explores debates about biotechnology. Science is objective and value-free, as it should be. It is not the scientist's task to create or change social, economic, or political policy. Objective science is driven by curiosity about the natural world, mission of the employing institution, and demands of the funding that enable the research. Scientists attempt to understand and explain the natural world, and technology applies scientific findings to the world. Public and scientific debates about biotechnology often appear to be dominated by polar opposite views. Will biotechnology create a monster and will its creators then be unable to accept responsibility for the bad behavior of their creation or is biotechnology the next great scientific step that will benefit all? Surely, the new technology shows vast promise of crops that are more pest-resistant and nutritious. Proponents of biotechnology and genetic engineering of crop plants or animals see the techniques as a continuation of rather than a radical departure from what scientists have been doing for decades—manipulating the genome of plants and animals by selective breeding. Proponents of biotechnology say they are just continuing to do the same things with techniques that allow changes to be achieved faster and more efficiently with better, more predictable results.

Abstract

The advent of genetic engineering has allowed for an unprecedented level of modification of biological systems, including microorganisms. The impact on food microbiology has been significant, including in the area of diagnostics, ingredient production, and the creation of improved starter cultures. There are two major areas of interest: first, the production of ingredients or enzymes for food products or their production using recombinant microbial hosts; and, second, the modification of organisms that are used to produce the foods themselves. In either case, the core set of tools includes a means to propagate the gene to be expressed and a means to introduce that recombinant gene in the host. Issues related to the development of ‘foodgrade’ organisms are also discussed.

Cloning Genes

All manipulations of genetic engineering require multiple copies of the DNA sequence or gene of interest. The original methods of getting multiple copies relied on bacteriophage or plasmid vectors to introduce the foreign DNA into bacteria to produce these copies, as each modified cell produces multiple copies, and the bacterial culture itself increases. This is done by first physically isolating the vector, opening its DNA with a restriction enzyme, and binding in DNA from the organism being studied that has also been cleaved with a restriction endonuclease. A new population of bacteria is then infected with the altered vector. Given an appropriate way of selecting the population of bacteria so that it uniformly has the DNA of interest multiplying within, one can isolate a large population of vector molecules with the desired sequence, which is then freed by enzymatic cleavage once again.

Fragments of DNA are identified by physically separating them by electrical charge and molecular weight through gels. The DNA of the vectors and bacteria are generally in the range of 1–10 000 bp, and there are a sufficiently small number so that the fragments can be identified with a simple staining technique, usually a compound that binds to DNA and fluoresces under ultraviolet light. The larger quantity of fragments that would be isolated from more complex organisms produces a smear with such dyes, so the base-pairing property of DNA, the obligate pairing of adenine with cytosine and guanine with cytosine that allows for both recognition and synthesis of the linear sequence, is used to identify the same sequence on the gel by labeling a known fragment with an isotope or fluorescent dye. The labeled molecules are called probes. This is also the basis for identifying genetic variation in organisms, either for basic studies or identification of mutations associated with disease.

Isolation of fragments produced by digestion with several enzymes, used both singly and in combination, allows for the construction of a physical, restriction fragment map. Smaller fragments may be replicated, followed by the chemical analysis of the base sequence within fragments, which are then assembled into the final base sequence of the gene. Once the sequence is known, production of useful amounts of a region of DNA may now be done enzymatically in vitro with the polymerase chain reaction. In this technique, the region between two primers, one from each strand of the final DNA molecule is copied in a logarithmic fashion by a heat-resistant DNA polymerase from a small amount of genomic DNA (it has been done with single cells), using multiple heating and cooling cycles. This technique is also used extensively in diagnostic work (Strachan and Read, 2010).

2 Cloning Genes

All of the manipulations of genetic engineering require muliple copies of the DNA sequence or gene of interest. The original methods of getting multiple copies relied on bacteriophage or plasmid vectors to introduce the foreign DNA into bacteria to produce these copies, as each modified cell produces multiple copies, and the bacterial culture itself increases. This is done by first physically isolating the vector, opening its DNA with a restriction enzyme and binding in DNA from the organism being studied that has also been cleaved with a restriction endonuclease. A new population of bacteria is then infected with the altered vector. Given an appropriate way of selecting the population of bacteria so that it uniformly has the DNA of interest multiplying within, one can isolate a large population of vector molecules with the desired sequence, which is then freed by enzymatic cleavage once again.

Fragments of DNA are identified by physically separating them by electrical charge and molecular weight through gels. The DNA of the vectors and bacteria are generally in the range of one to ten thousand base pairs, and there are a sufficiently small number so that the fragments can be identified with a simple staining technique, usually a compound that binds to DNA and fluoresces under ultraviolet light. The larger quantity of fragments that would be isolated from more complex organisms produces a smear with such dyes, so the base-pairing property of DNA, the obligate pairing of adenine with cytosine and guanine with cytosine that allows for both recognition and synthesis of the linear sequence, is used to identify the same sequence on the gel by labeling a known fragment with an isotope or fluorescent dye. The labeled molecules are called probes. This is also the basis for identifying genetic variation in organisms, either for basic studies or identification of mutations associated with disease.

Isolation of fragments produced by digestion with several enzymes, used both singly and in combination, allows for the construction of a physical, restriction-fragment map. Smaller fragments may be replicated, followed by the chemical analysis of the base sequence within fragments which are then assembled into the final base sequence of the gene. Once the sequence is known, production of useful amounts of a region of DNA may now be done enzymatically in vitro with the polymerase chain reaction (PCR). In this technique, the region between two primers, one from each strand of the final DNA molecule is copied in a logarithmic fashion by a heat-resistant DNA polymerase from a small amount of genomic DNA (it has been done with single cells), using multiple heating and cooling cycles. This technique is also used in diagnostic work (Strachan and Read 1996).

3.3 Proliferating monsters?

Biotechnology can be seen as culturally ‘unsettling’, or ‘disruptive’. It is characteristic of this ‘technoscience’, that it continually places into the world new entities which from a cultural point of view may be described as ‘monsters’, that is to say, hybrids of nature and culture that have not yet found a recognized place within existing frames of reference and systems of classification.5 It is precisely because of its “zeal for hybridity”, according to Jasanoff, that biotechnology inevitably requires “ontological ordering” [Jasanoff, 2005b, p. 151]. Categories and classifications that are called into question by biotechnology “include the fundamental divisions between nature and culture, moral and immoral, safe and risky, god-given and human-made” [Jasanoff, 2005a, p. 26].6 Jasanoff uses the following set of examples to illustrate the idea:

We can import genes from spinach into pigs, from jellyfish into rabbits, and from fish into tomatoes; the technique of xenotransplantation allows cells from genetically altered pigs or chimpanzees to be inserted into biologically compatible humans. We can contemplate altering the human genome so as to produce enhanced human beings, with characteristic that today would be regarded as out of the ordinary, even superhuman. What, then, is nature and what is being human? [Jasanoff, 2005a, p. 26]

It must be emphasized that the term ‘monster’, does not necessarily convey a negative connotation. Many postmodernist writers are so excited by crossing borders and blurring distinctions that they almost seem to fall in love with any ‘hybrid’, ‘monster’, or ‘cyborg’, that comes along. Within STS, Latour [1993; 2004] and Haraway [1992] are obvious examples. Other authors use the notion of ‘monsters’, in a more detached way as a conceptual instrument to study public responses to newly discovered or created phenomena. The locus classicus for this approach is Mary Douglas’, anthropological study on Purity and Danger (1966). The Dutch philosopher of technology, Martijntje Smits, adopted and elaborated her approach to illuminate public controversies on plastics and on the release of genetically modified organisms [Smits, 2002]. Jasanoff also treads in Douglas's footsteps.

There is a problem with the ‘monster creation’, thesis if it is taken as a specific claim about the culturally disruptive impact of modern biotechnology and the life sciences. After all, according to Latour's Actor Network Theory (ANT), all new facts and artifacts produced by whatever ‘technoscience’, are to be considered as nature-culture hybrids or ‘monsters’. So then what, if anything, is so special about biotechnology? Interestingly, a similar criticism has been made by Noortje Marres with regard to Latour's recent thesis that scientific and political institutions nowadays are faced predominantly with “hairy objects” (“the partly unknown entities that risk disturbing social life, from ‘BSE’, to ‘GM food”’) as against the relatively simple “smooth objects” of earlier days [Latour, 2004, p. 24]. This fact is thought to induce a major institutional crisis. Marres notes that Latour's newly invented “hairy objects” take on many of the properties he earlier ascribed to all new entities leaving the laboratories of technoscience. So he too suggests a historical discontinuity that cannot be justified by the ANT approach [Marres, 2005, pp. 102–104]. On her part, Jasanoff acknowledges that questions about the ontological and moral status of new entities have arisen “in connection with other technological developments”, but “perhaps never with quite the urgency generated at the fast-moving frontiers of biotechnology” [Jasanoff, 2005b, p. 151]. In other words, what may be valid to some extent for the hybrids created by other forms of technoscience, is even more strongly applicable to the products of modern biotechnology.

Another and related criticism might be that the STS analyst, by subscribing to the monster creation thesis, illegitimately prejudges the outcomes of the very process of framing he sets out to explore. Robin Williams has expressed similar reservations about how “the activist wing of the STS community” takes up the study of the impacts of genomics and nanotechnology, new technologies which in his view are “conceived from the outset as being challenging in terms of risks and social values” [Williams, 2006, p. 327]. This goes against old constructivist tenets of agnosticism and impartiality:

These commitments seem to conflict with the emphasis in most STS academic analysis on the need to deconstruct the objects of study, and in particular to be sceptical about claims regarding the character and implications of technology. [ibid.]

By endorsing the monster creation thesis, Jasanoff effectively abandons her impartiality as an STS analyst and implicitly opposes the framing of biotechnology as product, or what could also be called the ‘business-as-usual’, frame. This frame transpires in the review of Jasanoff's book in Nature, written by the European top-level civil servant, Mark Cantley:

The perception — widespread in Europe — that biotechnology is something fundamentally new, like the discovery of electricity, or akin to black magic, is unfortunate. It has led to the assumption that there are technology-specific risks requiring ad hoc regulations and associated bureaucracies, and to consequent conflicts with sectoral regulations, as well as to international trade disputes. But not for the first time, perceptions, laws and the course of development may be driven by delusion. [Cantley, 2005]

Back in the 1980s, Cantley attempted in vain to align European biotech policy with the ‘product’, frame adopted in the U.S. [Jasanoff, 2005a, p. 79 ff]. It is, of course, ironic that he does not recognize his own view as reflecting a particular framing but sees it as simply based on objective science; the other frames, by contrast, are dismissed as “delusion”. Here, however, we are concerned with the possible shortcomings of Jasanoff's approach. What is problematic from a larger STS viewpoint is that she precludes the legitimacy of the ‘product’, or ‘business-as-usual’, frame by attributing a priori a particular character to biotechnology. This technology is seen as inherently disruptive because it inevitably challenges culturally entrenched categories and classifications, so anybody who merely sees it as business as usual must surely misjudge the issues.7

A possible remedy might be to change the monster-creation thesis from an a-priori into an a-posteriori judgment. In other words, it is not by any ‘inherent’, properties that biotechnology challenges existing categories and classifications. However, as a (contingent) matter of fact it turns out that many applications of biotechnology have indeed called into question many deep-rooted views and distinctions. The latter claim can hardly be disputed.

This reformulation of the monster-creation thesis has an additional advantage. It makes clear that it depends not only on the properties of a particular technology whether or not that technology has a culturally disruptive or unsettling effect, but just as much on the prevailing categories and classifications that may be challenged or ‘offended’, by it. There are two variables in the equation.