CIAO DATE: 3/00

The Moral Boundaries of Genetic Technology

Daniel Callahan, Eric T. Juengst, Leon R. Kass, Robert F. Murray, David H. Smith, Nelson A. Wivel

Conference Series
August 1998

The American Enterprise Institute for Public Policy Research

Significant challenges lie ahead in the proper application of the powerful revelations concerning human genetics. What boundaries should we place on genetic research and the use of genetic technology? The third seminar in AEI’s series Genetic Research and Society explored the complex interrelationships among freedom of inquiry, reasonable scientific caution, social assimilation, use of new knowledge, and deep moral beliefs. Clarisa Long, an Abramson Fellow at AEI, moderated and organized the seminar. A summary of the presentations follows.

 

Daniel Callahan, The Hastings Center

I see three different ways to set standards to deal with the question of limits on genetic research and its application. One is use of religious traditions, combined with a particular view of nature, that would push one in a direction of seeing fundamental limits to the benefits of trying to manipulate nature. Second is an attempt to balance risks and benefits. We can determine by scientific evidence what the risks and benefits might be and then try to determine what the political and social consensus is concerning our response to those risks and benefits. Third is a belief that scientific progress is good, that it is worth taking a risk for that progress, and that the main point of scientific and technological progress is the expansion of choice and the relief of individual suffering. The presumption here would be that the technologies ought to go forward unless we can find very decisive reasons to stop them.

My own convictions run in the direction of some combination of the first and second approaches. That is a view of human nature that would lead us to develop standards for setting limits with some way of assessing risks and benefits while also taking the religious perspective into account.

There are several obstacles to setting standards. First is the difficulty of proving harm with technologies that are only under development. Second is what I call the pluralistic proposition. It argues that when people have fundamental differences about ultimate human goods and values, people should be free to make their own choices. A third powerful factor is simply the profit motive. I do not believe that we would be having a debate on much of the genetic technology were it not likely that a lot of money is to be made with it if it works. The last obstacle I would mention is the relief of suffering. Some people believe that the relief of suffering is the principal aim of the good society. No matter how much our health increases, it is never good enough. An enormous bias exists in favor of progress and innovation as the only real and serious means of relieving the human condition.

 

Eric T. Juengst, Case Western Reserve University

One of the features of the early debates on in vitro fertilization, besides the focus on physical safety, was an expression of moral unease. If we go back to 1972 and look at the moral boundaries of reproductive genetics, we see that they are clinical risks and moral revulsion. The discussion has shifted because we have so many more things to talk about. We now worry about enhancement, pre–implantation diagnoses, fetal–cell sampling, prenatal diagnostic techniques, germ–line gene therapy, and cloning.

The risk boundary and the public revulsion boundary are expandable as our future shock wears off and we become socialized to the next new intervention. For the purposes of making public policy, no one of those arguments persuades. Even collectively those arguments are not enough to persuade. The wheels have been spinning the past twenty years because one can rebut all those arguments in a free society.

We are still heirs of the Enlightenment. That is, we are still committed to a particular vision of individuals as moral equals and free agents. We are committed to our constitutional respect for moral equality and autonomy. One classic way in which we can violate that commitment is to treat others as if all we needed to know about them was their genes. Our reaction against the ways in which lineage and genetic prejudice had oppressed people led us to our current notion of individuals as free and equal moral agents.

Any intervention simply based on knowledge of people’s genes violates the boundary of genetic prejudice. On the other hand, maybe for interventions that act to increase genetic diversity, we have enough trust in each other to accept the gift of real novelty. That might permit the use of technologies to change individuals to allow them to break free from their genetic heritage through various kinds of enhancement technologies.

 

Leon R. Kass, University of Chicago

Occupying the moral ground of compassionate healing, biomedical technology usually receives a royal welcome in our society, even when it raises challenges to other traditional moral norms. To a large extent, the same will be true of much of what genetic technology has to offer in the future, especially insofar as it actually leads to improved diagnosis and treatment of disease. Who would not welcome genetic surgery that corrected the genetic defects that lead to sickle cell anemia, Huntington’s disease, and breast cancer, or that protected against the immune deficiency caused by the AIDS virus?

But genetic technology strikes most people as different from other biomedical technologies. Many people are concerned, anxious, afraid of “tampering with human genes.” Even knowledgeable people duly impressed by the truly astonishing genetic achievements of the past decade and eager for the benefits are nonetheless ambivalent. They sense – I think rightly–that genetic technology, while in some respects continuous with the traditional medical project, is also in decisive respects radically new and, therefore, disquieting. Often hard–pressed to articulate the precise basis of their disquiet, they talk rather in general terms about the dangers of eugenics or the fear of “man playing God.”

Genetic engineering, when fully developed, will wield two powers not shared by medical practice. Medicine treats existing individuals, and it seeks to correct deviations from a more or less stable norm of health. Genetic engineering, in contrast, will be able deliberately to make changes that are transmissible into succeeding generations (especially with direct germ–line or embryo modifications); and it may be able to create new capacities (through so–called genetic enhancement) and, hence, new norms of health and fitness. For the present, genetic technology is being hailed primarily for its ability to better diagnose and treat disease in existing individuals. To the extent that genetic engineering would and could be confined to such practices, it would raise few questions beyond the usual ones of safety and efficacy.

Even people who might welcome the growth of genetic knowledge and technology are worried about the power of geneticists, genetic engineers, and any other governmental or other authority armed with genetic technology. Precisely because we have been taught by these very scientists that genes hold the secret of life and that our genotype is our essence if not quite our destiny, we are made nervous by those whose expert knowledge and technique touch our very being.

The new biologists and their technological minions do not know all they think they know, and they never will. For all their ingenuity, they do not even seek the wisdom that just might yield the kind of knowledge that keeps human life human. And if the rest of us become clearly aware of the dangers–not just to privacy or insurability, but to our very humanity–we might be better equipped to defend those increasingly beleaguered pockets and principles of human dignity, even as we continue to reap the considerable benefits genetic technology will inevitably provide.

 

Robert F. Murray, Howard University

We need to set limits for the applications of genetic technology. In genetic testing and screening we have the problems of the danger of genetic determinism. We are deficient in the knowledge of gene structure and function relative to the ability to cure disease successfully.

Twice in twenty years we have reviewed the reasons for genetic screening and have suggested that if we can treat or manage disease, if we can provide information for making reproductive decisions, and if we can prevent the onset or manifestation of disease, screening is justified. In many ways, genetic screening is not any different from screening for other conditions, except that my having a disease or carrying a certain gene has implications for anybody who is genetically related to me.

The best–known and described disease in medical literature is sickle cell anemia. If there is any disease where testing and screening applications should work, that ought to be the one. By 1988, many states instituted newborn screening for sickle cell anemia. But we still grapple with problems of the sickle cell trait. A presidential commission reviewed the practices for conducting genetic screening programs and came up with five recommended guidelines. First, the community should have prior education and be involved in setting up the program. Second, informed consent is critical to the proper conduct of genetic screening. Third, accurate diagnosis should be used and the results should be unambiguous. Fourth, results should be kept confidential. Fifth, voluntary programs are preferred, and mandatory programs should be justified.

Even with a simple genetic trait that is easily tested for, readily identified, and unambiguous, problems will arise. Add the complexity of DNA testing and the multiplicity of the gene mutations that we are dealing with, and one can see the kinds of problems that might possibly arise.

Enhancement will clearly raise the specter of discrimination of classification of human beings, perhaps even more rigidly than we are currently being classified. I think that we already have evidence that technological applications driven by the profit motive will cause harm. In the long run, if we do not guide or set limits for the applications of technology, we shall surely do more harm than good.

 

David H. Smith, Indiana University

Genetic research aims fully to understand the workings of life; the ability to understand leads to the possibility of prediction, the power to control–indeed, the power to create. Taken to its logical conclusion, genetic research entails the power to understand life in terms of chemical interactions and physics. We have already gone a long way down that road, and we are certain to go farther. Obviously, we can use the new knowledge for good or ill; everyone agrees that we want the good uses but not the bad ones. The question is exactly what knowledge we should have, which uses are tolerable, and which are not.

We can abuse virtually any knowledge–knowledge of psychology, of marketing techniques, of nuclear physics. We have rightly continued to study in those areas, despite the misuse of power that results, because we think that the benefits exceed the losses. No one disputes the potential for enormous benefits associated with genetic research. Risks are not a good enough reason to curb the research.

Knowledge can also be off limits, however, if one can acquire it only by doing something immoral. In this case, it is not exactly that the knowledge itself is taboo; the problem is that we cannot get it without betraying a moral trust. For example, experimentation on competent adult human subjects without their consent produces immoral knowledge. Human rights, and perhaps the interests of some nonhuman animals, restrict the right of free inquiry so that it cannot be absolute. We should not obtain genetic knowledge through the use of immoral research protocols. Exactly how much genetic research that rules out is unclear; probably at least some.

Genetic knowledge has affected the world in many ways, but many of those relate to having children, or having children free from predictable problems, or having children who will be clearly identifiable as our own. Genetic research suggests the possibility of controlling, filtering, and designing the kinds of children we shall have, that is, children with or without certain characteristics.

Insofar as genetic knowledge helps children to overcome their handicaps, it is to be celebrated. Insofar as it becomes yet another mechanism through which we strive for the perfect child, or raise the bar for any children, it is a curse. Because we and those we love have needs that genetic research might alleviate, we celebrate the possibilities it creates. We should support the research. But we should support it in a distinctive moral context that informs policy.

Given the vision of knowledge, children, and our relations to each other that I have tried to sketch, we must greet genetic advance with ambivalence. We need to find ways of specifying or translating our general moral convictions into policy for particular cases and situations. We need neither laissez faire nor national prohibitions but a system that forces many different people in many different places to work through regulations.

 

Nelson A. Wivel, University of Pennsylvania School of Medicine

I think that we can agree that genetic technology and genetic engineering are essentially generic terms and apply to a range of enabling techniques. In terms of human genetics, there are such elements as molecular testing for genetic disease, the use of molecular genetics in human embryo research, and the cloning of humans and animals. One of the principal problems for the scientifically unsophisticated is to lump all those disparate elements into one common burial ground while missing the fact that significant differences exist among the various applications of recombinant DNA technology.

I have chosen to focus on human gene transfer or human gene therapy. Gene transfer itself does not pose any new ethical problems. Most of the ethical problems concerning gene therapy were first addressed when gene transplantation arrived on the scene twenty–five years ago. Because of the long public oversight of gene therapy, the majority of the public approves of gene therapy as long as it is used to study and treat human disease.

So what is the ethical conundrum surrounding that particular type of applied biotechnology? A substantive problem awaits us, and that is the use of human gene transfer techniques for conditions other than disease. That type of gene transfer has been dubbed enhancement.

Two gene therapy trials are currently underway: one in Boston under Dr. Jeffrey Eisner at Tufts University, the other in New York at Cornell University with Dr. Ronald Kristal as the principal investigator. Both trials have been able to isolate the gene that encodes for vascular endothelial growth factor (VEG–F). VEG–F works well in model systems to produce a growth network of small systems. Dr. Eisner is attempting to treat patients by using a balloon catheter to transfer genes to a major artery in the patient’s leg. Dr. Kristal’s proposal is to inject VEG–F into the myocardium. In both cases, the hope is to increase the amount of collateral circulation.

We can all agree that those are noble gestures. But suppose that we could move over slightly and see what could be done in the way of enhancement. What is to keep the use of that technology away from athletes who would like to have an extra supply of blood vessels to their muscles to oxygenate them better and perhaps increase muscular strength? How does one decide which enhancements are ethical and which are not? How does one reach any common standard by which to make that judgment?

Banning genetic enhancements is impossible under our current regulatory paradigms; it is possible to move from the use of gene transfer for the treatment of disease to the use of gene transfer for enhancement in practically a seamless fashion. The FDA generally approves a drug for an initial type of disease, but nothing in the law prevents physicians from using that drug for another disease. That is called off–label use, and the FDA currently treats a gene as it does a drug.

Another dimension to that problem is even more compelling–the international one. Standards in the United States are not universally applied. If some other nation should decide to engage in those technologies for the purpose of enhancement, one can be sure that those with sufficient financial resources would not hesitate to go to those countries where those technologies are available.

As those technologies develop, public venues for discussion will be indispensable. The public deserves a forum, and public discussion should help to ameliorate some of the potentially negative developments in this area.