| Biotechnology Law and Related Issues
1999 Genetics, Law and Society Conference, Saint Paul, Minnesota
Talking with the Genetic Genie: What is the Future?
by Earl C. Joseph
Professor, Walden University
Abstract
In this paper, designed to supplement my presentation, a number of emerging trends, change forces, breakthroughs, and futures for the biotechnology field are noted for its technology, associated ethical considerations, possible societal impacts, law challenges, and genetic advances in general. The genetics field is on a steep j-curve for creating a growing number of emerging opportunities, most, will pose enormous economic, life saving, and other advantages. And many will generate crucial ethical, legal and societal issues and challenges for the future.
Introduction
We are in the midst of continuous revolution in biotechnology, agriculture, computers, software and medical science. One wonders where such advances will take us next. Biotechnological advance, like most any advanced technology introduction into society, is both a strong enabler of positive progress and posees possible negative threats. Will the continual technology turbulence put society also into an era of continuous ethical chaos?
The gene in popular culture, has allowed DNA to become a powerful, deterministic factor, the essence of life, and the secular equivalent of the soul. Society is currently fascinated with the gene and the possibilities that biotechnology portends. But society is perhaps equally concerned about the threats these possibilities could also herald. DNA in our popular culture has assumed extraordinary endowments, as an explanation of life, personality, criminal acts, cause of academic failure, and the basis of financial success. It's fast becoming a scientific guide to social policy, a way to locate responsibility, and to delegate blame.
It's easy to use it to place blame by assuming it's all in the genes. In many stories and metaphors from film, TV, news reports, comic books, ads, and even cartoons, writers reveal how science and culture intersect to shape the social meaning of the gene. The gene is engaged to define and predict future behavior, and advance common stereotypes. Social problems and opportunities in a growing number of instances have disappeared behind the image of the double helix in the popular imagination.
Liberal laws, like technological progress, usually and most often, create mostly winners with a few losers but not without negative impacts on some aspects of a way of life for some sectors of society. Unilaterally opening the usage of new technology, especially biotechnology advances, requires overcoming entrenched beliefs and interests that spend considerable money and time defending their position and privileges often in the disguise of ethics.
The rapids of change created from advanced telecommunications because of the microchips, the Internet, satellites, and fiber optics have changed many of the ethical ground rules. In the run-up to the double impact and supposed consequences of the revolution in globalization and computers/Internet, biotechnology is under intense scrutiny due, in a great part, by the speed at which its potential, as well as its unintended consequences, can sweep to fruition throughout the world.
What does the use of biotechnology in medicine and agriculture have to with ethics? One side of this question is best summarized as follows:
Once the initial frenzy over the cloning of Dolly the sheep had abated, a large number of people began to express skepticism or even outright hostility to the idea that ethics had anything of value to say about human cloning. Biologist Lee Silver spoke for many when he wrote, "[I]n a society that values individual freedom above all else, it is hard to find any legitimate basisfor restricting the use of reprogenetics." (Caplan, 1998, p. 83).
Another side of the question:
To create a human clone based on the experience of cloning one sheep from adult cell DNA would blatantly immoral. ... Safety alone in the earliest stages of human cloning justifies moral concern in the form of clarifying the ethics of human experimentation. ... People of good will can and do disagree about the answers to these questiobs , but the very fact that disagreement exists shows the centality of ethics ... (Caplan, 1998, pp. 90-91).
Future Genetics and Biotechnology
The impact of what University of Minnesota's Dr. Vernon Ruttan (Ruttan, 1991) prophetic forecast of farming and society of "moving from a resource limited future to a science expanding one" has now not only been proven true for agriculture but also for the medical and many other fields. But what other tantalizing futures does the future hold for us?
The advent of the Internet facilitates the rapid spread globally of advances and to foster their speedy evolution. Thus the time gap between the haves and have nots could be greatly shortened, stressing the ethical, political, and legal systems. As the results (positive and negative impacts and consequences) of the advances are spread almost over night around the globe, there is too little time to react to prevent the negative impacts and consequences. Therefore, it becomes more and more necessary to become proactive to prevent them.
Total synthesis, another new biotechnology direction, provides means for reproducing a complex molecule (and possibly later, complex systems like organs) from simple ingredients. Already experiments are going on to create with this technology antibodies, antitumors, etc.
The new technology and tools now being created allow the biotechnological laboratory development of new drugs without the need to rape foreign rain forests and reefs to plumb for nature's secrets to obtain sources of new drugs.
The intellectual property rights resulting in patenting some of these advances present new ethical, social, and legal considerations. Who should own a patent on human life? - or on an altered human?
Some Old and New Possible Futures
Medical Genetics
It should be noted that genetic abnormalities that produce disease can be both inherited or acquired during an individual's life time. Many cases of cancer can be acquired during one's lifetime. Rather than just treating disease, genetic technology can also be used in the future to enhance an individual.
Genetic enhancement may offer the most tantilizing possibilities for shaping our genetic landscape. Once relegated to the province of science fiction, and although not yet part of the present, genetic enhancement will likely be applied to human embryos within the next twenty to thirty years. What is genetic enhancement? ... Genetic enhancement involves no abnormal gene and no disease condition. Instead, its goal is to amplify "normal" genes in order to make them "better." (Mehlmam and Botkin, 1998, pp. 34-35).
Repairs - Genetically reengineering living humans via: 1) cutting and splicing DNA/RNA to implement the repair, 2) injecting newly developed drugs to repair genetic defects, 3) transplanting factory grown organs to replace defective ones, ...
Cures - In the 20th century, medical science made great strides in the diagnoses and easing the symptoms of diseases. Its forecasted for the 21st century that great strides will be in implementing cures. Many new tools are emerging to facilitate cures such as biotechnology and information technology.
Human Enhancements - A new direction offered in the future from biotechnological advances will be the ability to add properties and functionality's to humans.
Smart Life - One way to add "smarts" to living systems is to genetically engineer bio-transistor assemblages that can be transplanted to sense their environment and signal results. In this fashion Communicating Organs and other body parts can inform on their condition.
Individualized Drugs - By data warehousing healthy gene codes, an individual's genetic code could be compared and a drug assembled/tailored (manufactured) to meet that individuals specific condition.
Targeted Drugs - Another new direction for pharmaceuticals is the development of drugs that can be targeted to the specific site before releasing their curative toxins. For example, when one takes an aspirin to get rid of a headache, its toxins go to all areas throughout the body. With targeted drugs, stronger dosages can be used since there are no side effects like today's chemotherapy.
New Humans - Imagine a future wherein enhanced super-humans are patented.
Automation - Embedded bio-sensors could automate much of diagnoses. With nanotechnology, bloodletting operations could be eliminated simply through the use of biotechnology for repairing or growing new organs or body parts. By comparing an individuals genetic make-up and the current internal environment, prescribing treatment could also be automated.
Biological knowledge affects health once it is translated into practical tools. The knowledge obtained from the Human Genome Project will have tremendous implications for the future of medicine as we develop genetic technologies that enable us to prevent and treat a wide range of clinical conditions. (Mehlmam and Botkin, 1998, p. 20).
These futures pose enormous short-term ethical, political, social and legal challenges. For example, what is the future role of doctors in an era when diagnoses and prescribing is automated?
Food and Agriculture Futures
Traditionally, the agriculture arena has been eager to be an early adopter of new technology, and continues to do so with biotechnology. Since the agriculture arena has moved fast to practically apply and use biotechnology, it is illustrative to view the technological, economic, social, ethical, political, and legal opportunities and threats encountered in this arena as a foreteller of what other fields of endeavor may come up against. But the culture in Europe is to distrust science and technology and thus they ban genetically altered crops and foods. Partly due to this cultural leaning and increased international competition, the USA is thus forced to make more food direct investment in the foreign scene than is currently currently gained from agriculture exports (Boehlye, 1999).
Biotechnology advances and precision agriculture are tending to make farming more like true assembly lines. They also make it economic to move away from traditional massive single cropping to more diversified specific crops (Boehlye, 1999). In other words, agriculture is becoming industrialized as the economic gravity flow forces a science based biotechnology future. Of course this trend alters the traditional life and work styles of farmers that have been ingrained for centuries. Since farming is becoming more diverse, there no longer exists a "typical farm." But the trend is not only more environmentally and crop yield more rewarding it also provides for a more sustainable future for U. S. agriculture. Thus biomanufacturing agriculture tends to look more like any other industry.
The problem with these trends in agriculture is that over a short period of time there is more change socially and work wise than experienced over the last century when farming was mechanized (Boehlye, 1999).
Recent biotechnology coupled with information technology, precision agriculture advances and globalization have created a paradigm shift in farming, namely:
Biotechnology has created a growing list of genetically altered plants and animals which give much higher yields, are less impactive on the environment and which produce higher quality and safer foods. However, these assertions are not universally shared. There are many legal, social and ethical concerns associated with them. For example, the EEC does not allow their use due to such considerations, even though it has been proven by one of their scientific agencies that they are safe to use.
Information technology (IT) is the major tool for analyzing massive amounts of data in the development of genetically modified plants. IT makes biotechnological developments practical and to speed them to the marketplace.
Precision farming makes use of satellite data on a specific field which is coupled with three to five years of historical yield data to do predictive mapping of crop yields. This allows the farmer's machines, on a grid or zone basis, to determine how much fertilizer, herbicide, and pesticide to spray to maximize yield and minimize environmental impact over the total field. It reduces the run-off problem making such a process also a little more environmentally attractive while, at the same time, increasing the economic value of the crop. Challenge: intellectual property rights of data collected.
Globalization of farming tends move cropping of the land around the world where it most feasible from a number of viewpoints. This changes from time-to-time causing large localized social problems for farmers.
We now know how to feed the world according to Ambassador and Of Counsel Clayton Yeutter (Yeutter, 1999), even with a population growth, for the next 50 to 100 years. But this observation, trend, and belief is not universally recognized.
These paradigm shifts in agriculture results in the following:
Farmers find that, from their own economic viewpoint, they must become contract farmers (hiring out their expertise) rather than farming their own land.
Higher yields per acre, higher quality and safer food.
There are many other futures resulting from the biotechnology breakthrough. For example, consider the development of pets that make total use of the nutrients they ingest and thus never dirty-up the rugs. Pets that are always loving and that converse with people, calling their owners by name.
But who will grow the food to feed the future in such futures? The predominant agriculture advantaged nation is expected to change often and be different for different foods/crops (Yeutter, 1999).
The U. S. model of farming is moving rapidly into the biogenetic mold. For farmers and ag-business to make a profit in this new era they must change radically from there former ways of managing. It requires that they become more data and knowledge intense. More educated talent and knowledge will be required. Visions of emerging change will also be a necessity. Biotech companies will need more intellectual property rights protection in order to recoup there high R&D costs (Morrison, 1999). Innovation and early adoption of new technology replaces much of an individual's experience as a primary controller of profitability.
Future Ethical Issues in Genetics
Today's newspapers and journals highlight mostly the dark side of possible advances in technology and little on the positive possibilities unlike and the opposite of the 1950s. This is both good and bad from a societal viewpoint. Good, because it prepares society for possible threats that can me ameliorated in a proactive format ahead of their actual occurrence. Bad, from the stance that society is ill prepared for the benefits of the actual futures that could occur. Thus, popular culture, programmed by the media, tends to be somewhat illiterate relative to modern technology.
Conclusion
Cultural interpretations of the gene are influencing individual expectations, institutional practices, and social policies. What does this current fascination with genetics mean for the future? Does the DNA mystique portend solutions to social problems using biological controls? Science, technology, and culture intersect to shape the social meaning of the gene. The gene has been engaged to define the proper food, predict behavior, medical treatment and to advance common stereotypes and strategies for the future. Cultural interpretations of the gene influence institutional practices and social policies. As a result, popular gene culture and science are interacting to create some dangerous ideologies, which reveals how the gene's cultural meaning has gone beyond its biological meanings.
Professionals will quickly, and quite rightly so, point out that today's technology, once they have the best, latest and most advantageous available, misses the mark in some ways so that it is barely up to the need that our expectations were programmed to expect. Thus, an outside observer could justly state that we are our own worst enemies. And now we have some notions of what to expect for the future, and ideas that it won't be enough, thus triggering the next round of advances and new ethical, social, legal and policy considerations.
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