Ethical Issues in Biotechnology
Curtis R. Naser, Department of Philosophy and Program in Applied Ethics
Lisa H. Newton, Department of Philosophy and Program in Applied Ethics
Randy Chambers, Department of Biology
As the world population increases and suitable
land for food production decreases or is converted to other uses, there is a
need for more efficient food production. Ocean and fresh water fisheries have
been depleted by overfishing and the effects of pollution. Aquacultural techniques
have been developed to raise native fish species more efficiently, speed up
their development cycles, and confer resistance to a variety of diseases and
pathogens. Some of the most promising techniques have stepped beyond sophisticated
breeding and culturing techniques to employ the very machinery of life itself
to enhance production. Genetic engineering techniques have allowed researchers
to insert genes from wholly unrelated species to alter life cycles and enhance
disease resistance for a variety of aquatic species. Other techniques involve
the development of DNA vaccines and genetically altered bacteria to assist aquacultural
These and other transformations of life through biotechnology have been pursued for the sake of the social benefits they promise. Cheaper and more effective medicines are possible when produced through biological rather than chemical means. Farm production can be made more efficient and the use of biological pesticides, for instance, can reduce the need for chemical pesticides. Some genetic engineering of plants aims to reduce the need for fertilizers, thereby minimizing the pollution effects of runoff to rivers and coastal waters. One of the first applications of a genetically engineered organism was the modification of bacteria that could digest oil spilled in the oceans. Bioremediation and, in general, the improvement of the environment have been the primary aims of a great deal of biotechnological research. In the marine context, much of the scientific work being done is aimed at ameliorating the effects on food species and marine ecosystems of overdevelopment, pollution, and loss of breeding habitats.
While biotechnological methods promise a variety of important social and environmental benefits, public response, especially to the release of genetically modified species into the environment, has been mixed. Though not always based on a sound understanding of the science and technologies involved, the public is wary of genetically altered foods and concerned about the inability to control biological agents once they are released into the environment.
The ethical evaluation of biotechnological interventions rests first upon a good understanding of the science behind these interventions, and second upon balancing the risks and benefits such interventions pose. In addition, the power of new molecular techniques to manipulate life, insert the genes of one species into the genes of another species, and otherwise redirect living organisms both in captivity and in the wild to specific human purposes, raises questions about the proper role of humans in their environment and in the alteration of living organisms.
What are some of the risks associated with biotechnology and how are they balanced against the benefits they promise? What are some of the fundamental objections to genetic engineering and the role of biotechnology in general environmental ethics? This essay will review the types of objections and questions that have been raised about biotechnology in general but will not necessarily provide answers. As biologists explore the increasing power of science to manipulate life, it is important that they are aware of the kinds of arguments that question their practice. How those arguments are addressed requires both a good scientific understanding of the particular details of an intervention, and public moral and political deliberation. Part of that deliberation is to answer these questions and to understand the objections and the different types and models of moral reasoning.
Risks and Benefits
An essential element in the ethical evaluation of biotechnology is the analysis of the possible harms and their likelihood of occurring, weighing these risks against the probable benefits. Since biotechnology encompasses a wide variety of biological methods and techniques in a wide variety of circumstances, the analysis of the risks and benefits will be highly contextual, depending upon the peculiarities of each specific application. For instance, the use of genetically engineered bacteria to produce insulin in a commercial laboratory is quite different from the release of genetically engineered bacteria into the natural environment. Conditions can be controlled in the laboratory and, with appropriate safety measures, the modified bacteria can be prevented from escaping. But the release of a genetically engineered species into the environment poses additional risks depending on the viability of the organism, the nature of its genetic modification, and the purpose for which it is introduced. This discussion will be confined to the principles that may apply to the ethical evaluation of biotechnology in general, recognizing that the ethical evaluation of each particular intervention will depend upon its specific circumstances.
Adequate assessment of the risks of releasing a genetically modified species into the environment entails a thorough knowledge of the ecology of the environment and how the modified species will interact with other species. Proposals for the introduction of genetically modified species into the environment have been criticized on the grounds that there is insufficient ecological knowledge and that, in general, the science of predictive ecology is underfunded and poorly understood.
Even in individual species, it is difficult to predict the health effects of inserting foreign DNA into an organism or otherwise modifying the expression of genes it already contains. A number of deleterious pleiotropic effects (where one gene can effect several traits) have been shown to occur in genetically modified species. In fact, the only way to determine these effects is through experiments upon individual organisms, a fact not lost upon animal welfare advocates. Evaluation of the effects of genetic engineering on individual organisms can be conducted in the safety of the lab, but the impacts of releasing genetically modified organisms into the environment may be very difficult to measure or model experimentally. Ultimately, the safety of transgenic organisms can only be evaluated through careful study of their release into the environment, with the consequent risk that we will discover a cascade of harmful effects on the environment only after it is too late to stop the spread of the organism.
The ecology of environments is highly complex and relational. Individual species can play a variety of roles within an environment and the effects of a change in a species can be highly unpredictable. The problem is not simply inadequate knowledge but rather the complexity of ecological systems. Complex systems, in general, may be highly nonlinear, meaning that there may be little or no correlation between incremental changes in a system and how it behaves. In mathematical models of complex systems, the effects of changes in a system are, in principle, unpredictable. The only way to discover these effects is to observe how the system behaves upon the introduction of a specific change. Modifications to a system can have no effect, an incremental effect, or revolutionary effects.
To the extent that ecological, and more generally, organic systems are complex and nonlinear, modifications of them will, in principle, be unpredictable. Since adequate risk assessment depends upon prediction and quantification of risk, the effects of the introduction of new or modified species into an ecosystem may not be adequately quantifiable or manageable, making each such introduction truly experimental. The lessons learned from the endangered species program are valuable in this context. Biologists have learned that in order to save a species, it is necessary to save its habitat. We might postulate a biotechnology corollary to this principle: Altering a species may alter its habitat, even if you do not know exactly how.
The complexity of ecological systems makes it very difficult to identify specific causes of environmental change, and since one may not be able to anticipate specific changes, it is possible that scientific observation will fail to detect them. Without the development of a much richer general science of ecology, and specific ecological studies of the environments into which biotechnology is introduced, adequate risk assessment may be impossible. It follows, then, that in the absence of adequate ecological study before biotechnological interventions take place, and in the absence of a commitment to long-term study after they have been introduced, the ethical evaluation of risks and benefits is incomplete. Proceeding on the basis of inadequate study may be unethical.
One especially troubling risk of the introduction of genetically engineered species into the environment is the possibility that the modified genes will cross to other species. This problem is most characteristic of plants and microbes, especially bacteria. It is also possible that genetically modified viruses may target unexpected species, spreading either deleterious or beneficial genes in unexpected ways. A related risk is the short generation time and potentially rapid evolution of microbes. If a genetically altered microbe persists in the environment, it is possible that it may evolve in unforeseen ways, producing unforeseen effects. Controlling the spread of genetically engineered species in the environment is also difficult, especially in the marine context where individual organisms can be quickly spread to vast areas by ocean currents.
In addition to the unpredictability associated with introducing new or modified species into the environment, harmful effects may be irremediable. Once a genetic modification has hopped to another species, there is little that biologists can do to effectively contain the spread of the gene. Once disrupted in this fashion, the ecological balance may be irrevocably altered, to the detriment of the ecosystem and its associated benefits to humans. One promising method for protecting marine environments against the adverse consequences of introducing genetically modified species of fish has been to limit the reproductive capabilities of the fish. In this way, adverse ecological impacts may be reversed by discontinuing the release of the modified species.
There are two ways in which risks can be managed. They are reflected in the differing approaches to biotechnology taken by Americans and Europeans. Faced with an entirely new entity in our lives, Americans may ask, "What is the likelihood that this will do me more good than harm?" We can then make our decision about using the item in accordance with the results. This is a risk-benefit approach, and it comes naturally for Americans. On the other hand, Europeans might ask, "Has this item been shown to be safe, so we don't have to worry about serious unforeseen problems down the line?" This precautionary perspective, favored by Europeans, dictates that no product be admitted until it has been scientifically shown to be safe. A risk-benefit approach thus requires that a product or practice is shown to be unsafe before it is ruled out, whereas a precautionary approach requires that safety be demonstrated before the product or practice is admitted.
The United States has consistently favored commercial interests over environmental concerns until it can be demonstrated that a particular practice is unsafe for humans. A notable exception to the risk-benefit approach is the Food and Drug Administration's (FDA) process for granting approval for medical drugs and devices. The FDA takes a precautionary approach, requiring that a sponsor demonstrate safety and efficacy prior to marketing a product. So far, the FDA has refused to assert jurisdiction over genetically engineered foods. The U.S. Department of Agriculture (USDA) regulates genetically engineered plants under the Plant Pest Act. The Enironmental Protection Agency (EPA) regulates the release of genetically engineered microbes into the environment under Section 5 of the Toxic Substances Control Act, Microbial Products of Biotechnology. These regulations apply only to commercial research and development of transgenic microbial species. Under this act, the EPA must operate under the risk-benefit approach and is required to meet a substantial burden of proof before it can even request data on a particular organism or before it can regulate or prohibit the production and release of microorganisms. This patchwork of Federal regulatory authorities covering biotechnology is confusing and inefficient. The public interest would be better served by a single office or agency responsible for evaluating the variety of biotechnological interventions and their impact on the environment.
While the appropriate balance of environmental and health concerns against economic benefits is fundamentally a political and ethical question, there is a serious flaw in the risk-benefit approach favored in the U.S. The benefits of a particular biotechnological intervention in the environment typically accrue directly to the sponsor, often a commercial interest. However, the harms that may result from such interventions typically do not remain confined to those interests or the individuals responsible for introducing them, but instead may propagate throughout the environment and affect the general public. A gene that protects a food crop from certain pests benefits the farmer and the seed company directly, but should that gene cross into a noxious species, it may well create problems for the general public. Thus, an important issue in weighing risks and benefits is not simply whether the benefits justify the risks, but who reaps the benefits and who bears the risks. If the risks and benefits are disproportionately distributed to different groups, the practice may be unjust.
One of the problems with assessing the risks of biotechnological interventions is that it may be very difficult to establish the exact cause of a particular harmful effect in the environment. Several solutions have been offered for this problem, including the use of unique genetic markers to label genetic modifications of organisms. Should the release of such organisms into the environment cause problems, the modified genes can be traced back to the specific project responsible for their release. The Institute of Virology at Cambridge University has demonstrated that such genetic markers can indeed be used to track modified genes. The use of these markers for genetically engineered organisms would promote accountability and provide an added incentive to ensure the safety of genetically modified organisms prior to release.
An additional inducement to minimize risks can be created by amending the legal liability incurred by the release of genetically modified organisms. For instance, the European Parliament's Committee on the Environment, Public Health and Consumer Protection recommended that the release of genetically modified organisms into the natural environment should be conducted under Œstrict' liability, "whereby any individual or organization claiming for damages caused by another party does not have to prove that the other party acted negligently in order to claim damages, but merely to show that the damage was caused by the actions, activities or products of the other party.² Commercial interests involved in the release of genetically engineered organisms into the natural environment would, thereby, have a strong financial incentive to minimize the risks of their intervention. The Committee also recommended that the release of genetically engineered species be conducted only if appropriate insurance coverage has been provided by the sponsor prior to the release.
Ethical deliberation requires impartiality, that is, disinterestedness on the part of those who judge. Thus, scientific grants are awarded through blind peer review so as not to be biased by personal relationships. But the use of biotechnology may affect us all. One of the problems with the peer review mechanism is that the practice of science itself predisposes practitioners to particular values. If the question is strictly scientific, then peer review can provide impartial assessment, but if the question concerns the place of scientific values in public policy or ethical deliberation, then scientific peer review is inherently biased. Because of the uncertainties of the risks of many biotechnological applications and the impacts of these risks to both human and ecological interests, the ethical evaluation of biotechnological applications requires a very different kind of process than our present regulatory system provides. Our system relies heavily upon scientific expertise and a general predisposition to minimize regulation and promote trade. Questions regarding the application of biotechnology in the environment require far greater public participation and, in general, greater impartiality.
Cultural and Social Context
Biotechnology is a tool with which we are able to manipulate our environment according to predetermined and mostly human ends. Biotechnology is offered as a solution to human problems, and often, to problems caused by humans. Yet biotechnology, if history is a guide, may create as many problems as it solves. Some environmentalists and other critics have pointed out that perhaps we would be better off learning to live in harmony with nature, rather than attempting to make nature conform to our specific needs. Biotechnology promises to play an increasingly powerful role in the further taming and manipulation of our natural and unnatural worlds. In part due to the technological imperative, our destruction of the environment is a result of the very impetus which drives the biotechnological interventions to ameliorate it. Biologists and biotechnologists must take a broader view of their practice than the immediate goals they seek to address. The ethics of biotechnology entails both a reflection on the immediate consequences of its use, and on the underlying social and cultural conditions of which it is a part.
From the Luddites of industrializing England to environmental protest groups such as Earth First!, Greenpeace, and the Rural Advancement Foundation International, Western culture has expressed a deep-seated ambivalence toward technology. We embrace its benefits, but recoil at its often insidious effects in transforming our world, our way of life, and ourselves. Biotechnology, in particular, captured the popular imagination well before it became a practical reality. Mary Shelley's Frankenstein bears witness to the fascination and horror engendered by the application of science to life. The reality of biotechnology is quite different from the literary and science fiction fantasies of popular culture. The eugenics movement that occupied serious and well-respected scientists and politicians in Europe and America earlier in this century testifies to the ways in which the application of science can go morally wrong. It is, therefore, not surprising that as the biological sciences and biotechnology have enjoyed remarkable success during the past 30 years, public awareness and discomfort, particularly with genetic engineering, have increased.
All technology modifies our relationship to our environment, to our work, and to ourselves, but biotechnology strikes much closer to home, enabling us to modify life itself. It is one thing to employ a machine to milk a cow, but a quite different thing to employ technology to recreate the cow itself. While breeding techniques for all kinds of life have been employed for centuries, they have only manipulated natural reproductive processes to achieve their ends. The newly developed molecular techniques of gene identification, genetic engineering, and artificial reproductive procedures represent a quantum leap in our ability to manipulate life itself, a domain long held by culture and religion to be the province of a divine agency. As did the physics and cosmology of Galileo and Newton more than 300 years ago, contemporary biotechnology treads upon thin cultural and theological ice. What makes biotechnology quite different from the scientific revolution of the Enlightenment, however, is that science not simply displaces our understanding of the natural world, it allows us to transform nature‹to recreate life itself‹whether it be man, animal, plant or microbe.
This is the fundamental philosophical, theological and ethical issue of biotechnology. Here the question is not what are the consequences and will they be good or bad. The question is whether our intervention in and transformation of life is right or wrong, regardless of the consequences. Such judgments are based on underlying values, whether they be informed by religion, theology, consideration for the welfare of animals, or a simple reverence for nature itself. We cannot analyze the many positions on this question. Rather, we simply hope to clarify that some of the objections to biotechnology rest on cultural values and mores that go well beyond the specific issues of science and its applications.
One objection, however, can be addressed here. It is often argued that biotechnological interventions are not natural, or that they go against some divine or natural order of things. But human beings are also natural---natural products of evolution. Our technological development is no less natural than the mud wasp's construction of a nest. Thus, it might be concluded that genetic engineering is a natural phenomenon, akin to the "genetic engineering" that takes place in nature every time a gene crosses over on chromosomes, a gene mutates, or a bacterial plasmid migrates from one species to another. There is an important difference between "natural evolutionary processes" and "natural genetic engineering." Natural evolutionary processes do not make a choice, they do not deliberate with the intention of achieving an end. What distinguishes natural evolutionary processes is that they are not goal directed, whereas human actions are always goal directed. Human beings have the freedom to choose their goals and the means by which to pursue them. With this freedom comes the moral responsibility to distinguish what is right from what is wrong. To argue that genetic engineering is simply an extension of natural evolutionary processes does not morally justify the practice. With this line of reasoning, any biotechnological intervention could be justified as simply a natural process. But clearly not every intervention is good. It can only be determined to be good based upon a moral deliberation that takes into account its risks and benefits and the appropriateness of intervening in the first place.
These considerations raise the question of the scientists' responsibility in the application of the knowledge and techniques they have produced. Historically, biotechnology has grown out of the simple search for biological knowledge. As biologists sought to penetrate to the molecular core of living processes, they invented tools to assist them in that process. As in the case of PCR---a method for making many copies of specific DNA sequences for analysis---and many other biotechnologies, biologists have put to use the very processes of life itself in their study of life, borrowing the molecular machinery of life to analyze living processes. But as with all scientific endeavors, the tools by which science investigates the world often yield tools by which we may transform the world. While science is often pursued for its own sake and the simple pleasure of understanding the world, the combination of the tools of knowledge with practical ends cannot be ignored when considering the moral value of the enterprise. Investigation of the structure of the atom led inexorably to the application of this knowledge in the building of atomic weapons. It is a legitimate and by no means resolved moral question to ask what the moral responsibility of the scientific community is in guiding the use of the fruits of its intellectual labors.
The ethical evaluation of biotechnology cuts across two distinct ethical domains: the evaluation of risks and benefits, and the evaluation of biotechnology in light of broader cultural, religious, and ethical principles. An enduring problem, and one for which no definitive solution has been found, is how to handle conflicts between these two competing modes of ethical analysis. It is important when evaluating competing moral claims, however, to recognize that just as it is difficult to measure some risks and benefits according to a common scale of value, conflicting moral principles cannot simply be balanced against one another. Social benefits cannot be a basis for argument if the underlying moral question concerns the validity of pitting human benefits against the welfare of other species or natural ecosystems in the first place. Recognizing the differing nature of these competing ethical principles will go a long way towards determining where the moral dispute actually lies. How we resolve these dilemmas, however, should remain a matter of moral and political deliberation based on sound scientific understanding that includes substantial public participation.
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