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SHAPING GENES:
Ethics, Law and Science of Using New Genetic Technology in Medicine and Agriculture

Darryl R. J. Macer, Ph.D. Eubios Ethics Institute 1990

Copyright1990, Darryl R. J. Macer. All commercial rights reserved. This publication may be reproduced for limited educational or academic use, however please enquire with the author.

1. Is There A Problem?


pp.1-9 in Shaping Genes: Ethics, Law and Science of Using New Genetic Technology in Medicine and Agriculture, D.R.J. Macer (Eubios Ethics Institute, 1990).

New Technology

There have recently been major advances taking place in medical science and genetic technology. The growing and widespread availability of such advances has greatly increased the real and potential impact of genetics on the world. We are living in a revolution, in biotechnology and biomedicine. This raises urgent ethical questions. I attempt to examine some of these questions in this work, and examine the types of questions which need to be asked.

There have been several books written recently which claim that we need very new ideas and approaches in ethics to deal with the novelty of the new genetic techniques. Some advocate a radical shift in the basis of our ethics to deal with these problems, such as a move to Eastern religions (Suzuki & Knudtson 1989). Others appear to be so afraid of the possibilities that they want us to avoid using these technologies (Rifkin 1983). There has been a wide spectrum of objections to the new technology, claiming that it poses new and much greater problems for humanity and the world than previous technologies. The new genetic technologies are portrayed as likely to lead to a catastrophe if they are not severely restricted or stopped. However, what I intend to show is that although this new technology has a few novel features, other technologies are also associated with similar ethical problems, and the uses of the new genetic technologies can be assessed by similar principles of ethics. In fact, I regard genetic engineering as a catalyst for our thinking about life itself.

We will examine the details of the new technologies, with an up-to-date account of the progress in each area. Genetic technology consists of the theoretical basic research in genetics aimed at acquiring scientific knowledge, and the applied research. Many possibilities that were classed as speculative several years ago are now grounded on experimental results, and have been applied. We can genetically analyse DNA from a single cell, and babies have been born from the preimplantation diagnosis of early embryos. We can make faster growing fish and pigs, crops resistant to insect attack, or tomatoes that stay firm. We have begun to insert genes into human beings. The progress should continue to accelerate. We should consider what special characteristics of the new technologies is considered to be so awe-inspiring and what features they challenge. We need to examine the validity of claims made and what ethical principles we need.

It is a common belief that scientists do not have any interest in ethical standards, and are uncaring about the social implications of their work. However, some of the major ethical debates over the uses of technology have been begun by scientists themselves, such as that among physicists about the development of nuclear weapons, or among geneticists on the perils of transforming DNA. Some scientists do care about the social, moral and legal aspects of their fields of study. A basis for our ethical stance in areas concerning the use of genetic technology should be firmly grounded in biological knowledge, as a clear knowledge of the scientific facts is essential to any discussion of moral issues. This means the education of society on the likely uses of genetic technology in the immediate future, and the possible uses in the long term.

Molecular biology has moved so fast in the last few years that even those in the field find it difficult to keep up. In some small way, I hope that this book can aid those who cannot spend their days in the library to watch for news outside of their immediate research interest. Science, as viewed by the public, may have ended being the never-ending search for truth, and begun to be the craft of the manipulation, modification, substitution and deflection of the forces of nature. Pure science does still exists, but much emphasis is given to "engineering".

Biology itself is not competent to adjudicate on matters which are philosophical and ethical, such as the status of the human fetus, the use of genetic screening or engineering. The good things we can do are only made complete by the things we refuse to do. People may voice concern, but in the application of scientific techniques, if the line of refusal is not drawn before any violations, it is no longer civilised technology. Our ethics must be more than a rationalisation for things that we are bound to do because of interventions science has now made possible. The onus is on the scientists and technologists to prove beyond reasonable doubt that any real risks can be managed. The increasing understanding of recombinant DNA technology is revealing areas in which caution must be applied, and it is also showing areas where there are few risks. We must also consider the way society has handled similar issues in the past.

Just values of society should be used to assess the medical-technical possibilities that are occurring. We should not change our basic morals because of the possibilities offered by new technology: what we may have to do is to extend their application. We do need however to be open to change our attitudes and realise that technological changes are not necessarily changing our standards, but are accepting new solutions to biomedical problems. There is a major challenge to our medical ethical system from these new techniques, as they could lead to the management and control of parts of human life from conception to death.

The interventions planned in the sphere of genetic technology will affect not just ourselves, in medical uses, but our agriculture, microorganisms, plants, animals and possibly entire ecosystems. Such an increase in our ability to change lifeforms in biology, and especially medicine, and the moral issues attendant upon them, is reflected in the concentration of attention which has given birth to the newly-described science of "bioethics". Bioethics is a composite term derived from the Greek words for life, bios and ethics, ethike. It can be defined as the systematic study of human conduct in the area of the life sciences and health care, in so far as this conduct is examined in the light of moral values and principles. The subject of bioethics has been highlighted by questions in the area of health care. Health policies should be directed to applications of medical knowledge that relieve and prevent human suffering or protect and promote human life.

Ethics has been described as the science of morals, and the rules of conduct recognised in human life. The rules of conduct must be essentially social: they apply to individuals living together in a society. The view of "society" includes many people's outlook, and there are deep political and ideological rifts which exist within humankind,which continue to result in antagonisms and rivalries between nations. The views of religious people are very important because 90% of the world's population are at least nominally religious. Within religions there is also division on many issues on how to act, especially in unforseen or unprecedented issues. Academic philosophers and scientists need to remember that their world view is not the predominant view of life, and it may not even be understood by a lot of people. We need to work towards a few general ethical principles that can be applied by the majority of peoples of the world in a fair, just and useful way..i.Religion;

We need to look at the existing ethical traditions and attitudes that affect the use of new genetics. Since many of the concerns involve medical matters, medical ethics is a key issue. Standards governing the practice of medicine have arisen as a result of continual interactions at the level of the perception and propagation of world-views by groups in society intending to maintain or establish social order and the interactions between individuals physicians and their clients. We can define "morals" as judgements on individual activity, "values" as stated expressions of the cultural framework within which these judgements are made,and "ethics" as socially derived generalizations induced from individual morality. Medical ethics continues to develop, and has important features to learn from challenges discussed later


The Gene Scare

There have been diverse public concerns expressed over the use of new biological technologies. While those technologies include a wide range of techniques, and may be called biotechnology, the expression "genetic engineering" is probably better understood but causes the most emotional response. Many people can not distinguish genetic engineering from other techniques, and in fact may not be sure what the term means. A simple definition would be that genetic engineeringg encompasses those techniques that manipulate genes, especially those using recombinant DNA techniques. The purpose of genetic engineering is to introduce, delete or enhance a particular trait in an organism. This is achieved by either inserting foreign genes, or by altering the existing genetic make-up of the organism. It may involve replacing a single DNA nucleotide, or multiple genes which are thousands of nucleotides in length. Genetic engineering is only part of biotechnology. .i.Biotechnology:definition; could be called the use or development of techniques using organisms (or parts of organisms) to provide or improve goods or services. Biotechnology itself is part of an expanding technology based on a long foundation of human use of living organisms.

This book seeks to examine public concerns about genetic engineering, and responses to them. To gain understanding of what people want, and to understand their fears, we need to look at public opinion. Some of the concerns have little factual basis, but may require public education to dismiss. Responses to these concerns involve both philosophical argument and understanding of current scientific knowledge. Concerns which are genuinely important are highlighted.

There are arguments that are commonly used in support or against genetic engineering. It is important to briefly survey these arguments, and then to examine them to see what are the key factors. In favour of genetic engineering is utilitarian thinking. There will be risks for individuals, but the goal of the application of these techniques includes benefits to human beings and the environment. We are rational beings and we should take advantage of the chances used to apply our rationality to improve agriculture. Against genetic engineering are arguments such as it is unnatural. The most dramatic of these concerns are that we will replace natural procreation of human beings with extensive genetic selection of fetuses. We will always be unsure of the long-term affects of our manipulations, and will have doubts as to their safety. We are still ignorant of the mechanism of gene action, and living systems are very complex. The misuses of genetics in the past, illustrated how bad values may be propagated, and these techniques could be abused in the future. There may be more important uses to put our resources into than into genetic engineering. Although much work in genetic engineering has involved microorganisms and recently plants and animals, much of the anxiety concerns extrapolations to humans. All of nature is important, especially with an ecological awareness, but because of the fears relating to humans they are highlighted.

We need to question what is the goal of society. For several decades after World War II there was a feeling that science and technology could provide everything, and they should be promoted. A majority saw that only science based technology could change our society for the better. However, during the last two decades there has been a growing feeling that technology has actually led to many problems as well as benefits. There has been a growing and strong anti-technology feeling (not so much a anti-science feeling) (Cavalieri 1985). There is still a majority public support for science in most countries, but it is mixed with concerns.

Scientists assume that science is naturally good for society, but this is not an unconditional assumption. We could remember the parallel made between biotechnology and computers, both are thought to give rise to major changes in society, and they are both having some impact. In the early days of the computer revolution the computer was going to change radically every aspect of human life, if some people were listened too. However, today we do not hear so much about this, though I doubt it is because it has lost its potential power for change, but rather that society has accepted the changes so far, which for most people have been for the better. However, with biotechnology we are dealing with the complexity of life itself, which may have greater potential. It has also begun, and society is accepting it and society will continue to change. There is a need for more consideration of the way in which society changes, what effects there are on family life and whether they are for the better or not.

We are often uncertain of the precise outcome of interventions in nature or medicine. Fortunately we are more ready to admit that uncertainty today than in the past. While being the norm in medicine for millenia, has taken recent major ecological disasters, some that have been growing for over a century, to convince people that industry or agriculture may have bad consequences. We will never be certain to have complete control over the effects of introducing new gene sequences. Much further experimentation will be required before we will be able to ethically use genetic therapy, except for otherwise untreatable diseases. Ignorance of the consequences necessitates caution in using new techniques, and this is an approach seen in the regulations governing the introduction of genetically engineered organisms into the environment, and in the use of human gene therapy. Researchers need to consider adverse public reaction to the production of genetically-modified organisms (GMOs). Public opposition to field testing of GMOs is a concern as there have been incidents in the USA and in Europe of both legal prohibitions such as court-orders to prevent trials, and of illegal destruction of trials and property involved.

The uncertainty is all the more important because of the major consequences of any disaster. If we introduce very different gene combinations into the environment they could have major consequences, which may be irreversible. The new genes may enter other organisms, or the new organisms themselves may replace existing organisms in the ecosystem. The ecological system is very complex, minor alterations in one organism have effects throughout the ecosystem. We can not yet predict these affects, therefore we must be careful, and move cautiously. We have had bad experiences in the past to make us realise our limitations. There is only one earth and we are dependent upon it, we must walk carefully. There have been many examples of technology that have exploited nature and natural resources. We are still in a crisis regarding the environment and what we have done, and it is finally becoming a major issue now that such major signs have become apparent to people. Even if the motivation is to save our own skin at least something may be done when people become aware of the dangers.

From an ethical point of view it is also essential to respect nature. We are causing the extinction of numerous species, and causing large imbalances in food chains of organisms that we use for food, such as animals. There are a mixture of concerns, from the level of protecting species diversity itself, another is farming methods we use for animals. Genetic engineering could have varying affects on this problem. It is often claimed that it will revitalise agriculture and increase food production. Some see it as a new way to generate large quantities of renewable resources, using the energy of the sun, to generate biomass. Maybe it will, but we must be careful that we do not disturb the balances of nature so much as to cause more damage than good.

It has been claimed that genetic engineering is like nuclear science, as both confer a power on humans for which they are psychologically and morally unprepared (Cavalieri 1985). Certainly biologists claim that they can outdo evolution, and use genetic engineering widely; but the question is whether we are ready for this new power. In the 1940's we learnt how to use nuclear fission, and physicists initially motivated by the aim of developing a weapon to use on fascist Germany, became so wound up in their work that they did not slow down when they knew it would not be needed. After our experience with atomic power we should face the biological revolution with our eye's open, another question is whether we do?

Another question is, in whose hands will the power be, with the scientists or under commercial control. While scientists might be able to retain control initially, it is very likely that similar to all developments involving much commercial interest, the commercial interest will dominate. Much of the research in these areas is paid for by commercial companies, even human gene therapy has commercial backers. Medicine is very big business, as we already know from the huge number of duplicate drugs and the pharmaceutical companies. Genetic screening tests are being commercially sold, though there is actually little profit in genetic screening. In agriculture also, with many seed companies and the major herbicide and pesticide companies have developed new GMOs. There is much government involvement at this early stage in controlling the trials, but governments are also keen on developing new money earners. On the positive side, because of the lack of biological knowledge, some commercial companies have been forced to conduct much basic research, before the technology can be fully exploited the details of gene regulation need to be known.

In a lot of countries there has been considerable investment in genetic engineering, reflecting world-wide interest in the technology. The level of investment world-wide is unusual, given that large amounts of research are needed before any product is produced. The potential of .i.biotechnology; is very wide. In 1987 there were 400 biotechnology companies in the USA, and another 70 established corporations with significant investments in it. The combined U.S. industry is spending over US$ 2 billion dollars annually in biotechnology, with a similar amount being invested in public money. There are hundreds of international companies, especially in Japan and Europe. Biotechnology is a tool for a wide variety of industries, and it is difficult to imagine all the fields which it will touch. Genetic engineering is also used in many industries, agriculture and medicine, and scientific research.


Outline

This book considers a variety of specific areas of concern, and suggests approaches for dealing with them. Throughout the book ethical questions which are associated with different techniques are discussed. The book is divided into four sections, and sixteen chapters, including the first one you are reading. The introductory section of the book considers a background, to the problems, and a background discussion of the techniques of genetic manipulation. The second section considers some key ethical concerns, and discusses them in four chapters. The third section considers nonhuman genetic intervention, the applications of genetic engineering to make GMOs, and the environmental safety of their release. The regulations to deal with these issues are assessed, and the influence of commercialisation is addressed. The fourth section considers human reproduction, the new reproductive techniques and the use of human genetics. I will give a deeper outline in the following pages.

The second chapter describes some of the techniques involved in genetic manipulation with examples illustrating the reasons why this technology is being used. There have been other books providing more detailed descriptions of the workings of the cell and genes, the purpose of this chapter is to provide the reader with the basics that are needed to consider the applications described in following chapters.

The third chapter considers general ethical concerns, such as our use/misuse of nature. The broad range of genetic engineering has been associated with what has been called the "Frankenstein Factor". Others accuse genetic engineers of "Playing God", or "Interfering with Nature". People are also concerned about moving genes between species, or the integrity of species. Part of this concern is a reaction against the rapidity of technological change, with a perceived harm to society values, and part a reaction to damage caused by other technology in the past.

Other concerns are those of the "slippery slope" type. There is a lack of trust about whether scientists can draw the line between the types of genes that are transferred. Most important is the possible extension of techniques to humans for eugenics. The difference between serious genetic disease and nondisease characters. There is concern over how far we pursue efficiency and the limits of developing a "perfect" animal. Biological warfare is another concern. Public attitudes depend on education, however, even among educated people there is a distrust of scientists. This distrust is heightened if there is seen to be a lack of public review, or of adequate public safeguards and regulations.

The fourth chapter provides a historical and cross cultural account of medical ethics. The healing situation requires special morals as it involves a sick, vulnerable person with a healer who is required to help without exploiting the vulnerability of the patient. One method of controlling behaviour was the following of ethical codes and the taking of Oaths. There are various ancient oaths that have been discovered in different cultures, the most universally honoured is the Oath of Hippocrates. This chapter looks at the Hippocratic tradition, and why it was adopted instead of other alternatives. It provides a background for the concluding chapter, and is aimed at those with an interest in medical issues. The new genetic techniques made the patient-health care provider relationship become even more important, and we must examine how to ensure patient's autonomy is respected.

In the fifth chapter the status of the human embryo is discussed. It is a key question in several important issues of reproductive technology, both old and new. There are questions of abortion and fetal tissue transplants. After discussing the ethical status of the embryo at different stages in development, we can then consider the question of embryo research. This is a very contentious area and different countries have divergent legislation. Legislation needs to include new techniques such as developmental studies on human embryonic carcinoma cell lines.

In the sixth chapter the contentious issue of animal rights is discussed. Religious and philosophical views are contrasted. We can ask in what way will genetic engineering challenge our thinking, and challenge our standards for animal care. The creation of very diseased animals as models of human disease is addressed. There are concerns for animal welfare in the production of new strains of diseased or unusual animals, such as "oncomouse" which is used as a probe for cancer. There are attempts to make faster growing animals, which will go beyond the use of hormones, and battery farming as methods of making more efficient (judged in terms of profit) meat and milk. There are ethical limits to using animals in our pursuit of more profitable farming, though it does not mean we should not use genetic engineering in some way. Animals used as bioreactors can be seen as a new idea, if we forget the use of animals to produce milk, eggs or wool.

Before considering these risks and responses to public concerns, some applications using genetic engineering will be summarised in the seventh chapter. The chapter presents an overview of recent advances in different areas. No doubt there will be future additions, but there are already many applications. Like other fields of technology, potential benefits are associated with potential risks. Standards that are appropriate for use in a developed country may be unenforceable in developing countries, who may more urgently require the benefits of biotechnology.

The safety standards of genetic engineering laboratories developed over the past 15 years have been based on containment of GMOs. However, during the past decade there have been a growing numbers of cases of deliberate free release of GMOs. As there is a lack of a predictive ecology, people are concerned about unpredictable disruption to the ecosystem. This is complicated by the possible transfer of novel genes to other species, such as acquisition of herbicide resistance by weeds. The use of monocrop systems, whether or not they are GMOs, can result in a loss of biological diversity. There is also the question of liability for harm to the environment. In chapter eight the environmental safety of genetic engineering is discussed.

The ninth chapter considers the types of regulations that are being used, and how we should regulate the release of GMOs. Comparison of international regulations is made, including guidelines developed during 1990 in Britain, Germany and Japan. This chapter also considers the pressing issue of food safety. How do we ensure that new foodstuffs made using these techniques are safe to eat?

The commercial interests in biotechnology are the subject of the tenth chapter, they concern both nonhuman and medical uses of biotechnology. Public distrust is also heightened by the commercialisation of biotechnology which may mean financial interests come first. It follows that there is a fear of large corporate control. There have also been losses to the Third World of germplasm which is the new currency of the biotechnology business. Many people object to further control by megacompanies. At a practical level this is perceived to make farmers more dependent on corporations who produce new varieties of enhanced organisms. This cannot be blamed on the science, but rather on the way it is applied, with much research being sold to corporations by the scientists who developed it, or through the way that research is funded. The patenting of living organisms is a sensitive public issue, particularly when applied to animals.

The next section of the book is the largest, and it considers the medical issues, beginning in the eleventh chapter with general interventions in human reproduction. There are issues such as the use of birth control to control the quantity of children, and also the new approaches to aiding infertility. There is often moral objection seen in the trends in emphasis from procreation to the manufacture of our progeny, and the moves away from the integrity of marriage and the family and respect for individual human life. We may need to limit the use of these technologies to people who actually require them, and to those which retain the ideal of the family.

In the twelfth chapter eugenics is addressed considering the history and current trends. We need to learn the lessons from the misuse of genetics in the past, and contrast that to the current genetic programs. In the thirteenth chapter genetic screening, from sex selection to serious diseases, and the question of the use of genetic information is addressed. The protection of patient confidentiality is highlighted in the question of the privacy of genetic information.

In the fourteenth chapter the new medical therapy called gene therapy is discussed, for the cases involving somatic cell therapy - that is where only the individual is affected. There have been approved trials of somatic cell gene insertion in the USA, and we are on the verge of a new therapy being introduced.

In the fifteenth chapter questions of positive genetic manipulation are considered. This includes embryo splitting or cloning, germline gene therapy, and the future developments with the human genome project. We need to talk about the positive genetic selection, it is already possible using artificial insemination from selected donors, and the techniques for genetic manipulation will become safe in the future. The question is so major that widespread international public discussion is required.

The final chapter considers how the problems raised by the use of new genetic technology can be dealt with using principles developed in bioethics..i.Bioethics; There are ethical problems in the practice of human genetics, which are encountered in the everyday operation of medicine. There are social-ethical issues of genetics when applied to medicine or agriculture. There are new social alternatives and policy choices arising from the impacts of genetics on society. We must discuss how we may best move to sustainable living. A way of living with the rest of humanity and nature, that will be sustainable for the future. Clarification of research goals are needed, to allay public concerns about benefits to society and the environment. Researchers need to know whether the use of herbicide tolerant plants will reduce pollution by reducing or shifting the pattern of herbicide use. Similar questions apply to insecticide and fertiliser use.

After the consideration of technological advances and dilemmas we will be in a better position to answer these questions. During the course of the discussion in the rest of the book, ethical principles have been mentioned, it is in the concluding chapter that they come together. Principles that can be applied to new situations that arise with the use of future technology are summarised. Our approach to ethics should be to learn and develop ethical principles that can cope with our dilemmas we face. It is good to ask what we can learn from the situations using genetic technology that helps us develop our medical ethics in general. The relationship between problems and solutions is interactive. There is a short summary of important conclusions that have come from the discussions in the rest of the book.

I have tried to limit the use of technical terms,while explaining as each issue is discussed, the necessary biology required to understand the issues involved. The science referred to is based only on that already experimentally performed, and the likely practical extensions. There have been exaggerations used by many writers. In fact, the science already performed is mind-boggling in its capability: there is no need to become fanciful. I include recent references which I hope may aid others to review the new genetics and offer their approach. I have included authors names in brackets in the text, in preference to a numbering system. This will be familiar to scientists, and it may alleviate some of the need to constantly refer to footnotes.

Everyone should form an educated opinion on these moral problems, not just the scientists. All people, creators of technology and users of it, are responsible for their actions. Science is one of the most powerful agents of change in society, and society should learn how to handle it. There will need to be more public education of science, and the issues raised, to make this possible. Bioethics is not concerned with a philosophical justification for a secular pluralist morality, but with where we must draw the line between doing an experiment, or not; between applying technology or not. The proper limits for science should be governed by morality.

This revolution has more consequences for human life than the Copernican or Darwinian or Technological revolutions. We can control a lot of diseases, and we can reflect on deficiencies in our own genetic make-up in the fields of genetic manipulation, gene therapy and quality control. There are questions about the status of marriage and family life, the degree of freedom human beings should have to procreate and chose a mate, and/or child, the status of human embryos and the selection of embryos to be aborted. I will now begin to consider a few of these.


Please send comments to Email < Macer@sakura.cc.tsukuba.ac.jp >.
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