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
Fairfield University
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
development.
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.
Managing Risks
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.