Santa Clara University

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Toward a More Communitarian Future?

The Governance of Biotechnology

by June Carbone
Introduction

DNAThe revolution in information technology in Silicon Valley has flourished because of opportunities for public-private partnerships and for private investment. Its success has fueled, in turn, reconsideration of the right formula for technology governance globally. If full recognition of the political consequences of the revolution in information technology has come only as the resolution succeeded, what of the coming changes in biotechnology? Will they, too, be implemented through a decentralized, privatized, globalized marketplace in which consumer demand is the largest factor determining development? Or is biotechnology fundamentally different?

The short answer is that biotechnology is different in at least one critical way: its full implications touch on our deepest hopes and fears. Biotechnology, after all, involves foods, drugs, and medicine. It offers the possibility of saving a dying child or contaminating the food supply. Most far reaching, however, it raises the spectre of transforming us. Until this time, human evolution has been beyond our control. As we unlock the secrets of the genome, we may become able to curtail aging, select the most perfect of our potential offspring, breed athletic superstars, or alter moods to create continual harmony.

How do we begin to make decisions about these possibilities? And perhaps more critically, who gets to decide? We may be willing to leave decisions about the next generation of silicon chips to corporate executives and market transactions, but we may not be so willing to entrust cloning children or allotting life saving vaccines so entirely to the market.

To date, this debate is largely divided into two opposing camps. Scientist Gregory Stock’s new book, Redesigning Humans, is subtitled: Our Inevitable Genetic Future.2  Stock argues that biotechnology is already here, and if we try to control its implementation too tightly, its more radical applications will be marketed to desperate patients or parents in off-shore islands beyond anyone’s control. Leon Kass, who heads the President’s Council on Bioethics, would have tried to stop the revolution by starting with a ban on in vitro fertilization before legions of test tube babies and their parents created too strong a lobby to oppose. And Kass would have done so not because he finds in vitro techniques intrinsically objectionable (though he sympathizes with those who do), but because they constituted the first step toward modification of the species.

Between these two positions are the more prosaic concerns of regulation and access. Even those who embrace genetically modified foods, for example, want some assurance of human safety and some review of potential environmental concerns. Con- versely, the most regulated area of existing biotechnology—pharmaceutical developments—raises serious questions of access exacerbated by the costs associated with oversight of safety and efficacy. If, instead of treating biotechnology as a science fiction fantasy, we think of it as food, drugs, and medicine, then it already resides within the framework of one of the more heavily regulated aspects of our economy.

So what of the future? The answer to which advances in biotechnology will be the most certain to develop depends on the infrastructure we put in place that determines funding and distribution. While the most public discussions have focused on issues like cloning and stem cell research, the more significant long-term development has been a shift from public to private funding of the bulk of biomedical research. Public visibility, debate, and professional oversight provide mechanisms that tie biotech decision-making to shared needs and norms. Entirely privatized development, framed only by decisions to ban or permit, may short-circuit discussion of the best uses of new technology that may, in fact, be independent of the technology itself. Reconnecting public participation with scientific innovation may be biotechnology’s greatest challenge.

Biotechnology: The Political Challenge

Biotechnology touches on our most basic hopes and fears. At its core, biotechnology involves the exploration of the building blocks of life. With mastery of the human genome and the mysteries of the cell, we acquire the means to redesign plants, animals, and ourselves. Francis Fukuyama, in Our Posthuman Future: Consequences of the Biotechnology Revolution, has raised concerns about the future unregulated science may bring.3

Fukuyama’s concern about a "posthuman future" grows less from his understanding of biotechnology than his understanding of politics. He sprang to international fame with a book entitled The End of History, which argued that information technology had helped spur the collapse of communism and a convergence toward liberal democracy and free markets around the globe.4 Asked to write a retrospective a decade later, Fukuyama identified biotechnology, and its potential transformation of human nature, as the single greatest threat to the triumph of liberal democracy. His definition of the dangers of biotechnology is a political rather than a scientific or ethical one.

Fukuyama’s political focus allows him to unite several seemingly disparate developments. Underlying all of them is our increasing understanding of how the human body works and how it can be changed to produce not only better health, but different behavior. Fukuyama picks four areas to illustrate the process. First, he considers the "sciences of the brain." He examines the greater understanding between genetics and behavior, and speculates about the coming ability to identify, for example, those with a "gay gene" and techniques designed to counter or eliminate its expression. Fukuyama explores research on the importance of hormones in utero, and considers the possibility that introduction of testosterone at a critical point in male fetal development might counter the expression of a gene associated with same-sex sexual attraction.5

Complementing the genetic studies is magnetic resonance imaging (MRI) and other brain scans, which allow scientists to observe the brain in operation. The new generation of brain techniques may allow the detection of preferences for boys over girls, preadolescents over more mature sexual partners, and the effectiveness of efforts to "reprogram" those with the "wrong" sexual tendencies.6 Fukuyama emphasizes that the challenge is just as great if the decision to implement these technologies comes from parents choosing a particular future for children as it does when the decision comes from the state. Nonetheless, neuroscience may allow parents, employers, and detectives to discern our deepest thoughts, predict our behavioral tendencies, and reprogram our development.7

Second, and perhaps most prominently, Fukuyama analyzes neuropharmacology. Prozac and Ritalin provide his most cited exhibits. Over 10% of Americans are already on Prozac, an antidepressant colloquially described as a "happiness pill,"8 and 12% of Medicaid recipients between the ages of two and four were on stimulants such as Ritalin in one midwestern study.9 Dietary supplements may be more benign, but over half of American adults (and one suspects nearly 100% of competitive athletes) are now taking them. No science fiction, no new discoveries are necessary; we are already remaking our bodies and our psyches.

Third, Fukuyama highlights the science of aging and the demographic revolution underway on the basis of existing medical advances. Life expectancy in the United States rose from 48.3 years for men and 46.3 years for women in 1900 to 74.2 and 79.9 years for men and women, respectively, in the year 2000.10 Existing trends suggest that the median age in the U.S. will rise to 40 years by the middle of this century, and to 54 years in Germany, 56 years in Japan, and 58 years in Italy.11 The race is on to further prolong life, and research already provides important insights into cellular aging. If these investigations hit pay dirt, life expectancy could double or more, and together with decreases in fertility, they are already creating more rigid, more conservative, and more female societies.

Finally, Fukuyama addresses the implications of genetic engineering. Parents can now select which fertilized eggs to implant based on characteristics such as the absence of a disease-causing gene or the presence of a match for a sibling in need of a donor. With greater understanding of the relationship between genes and intelligence, violence, and sprinting speed, parents may be able to select the children of their choice.

In Our Posthuman Future, Fukuyama emphasizes that the result of these changes is cumulative. With better understanding of genetics, we can more effectively choose among characteristics of offspring. With wholesale changes—for example, the elimination or biochemical suppression of the "gay gene," the organic causes of depression, the physiological sources of aging—we will have fundamentally changed what it means to be human, and we may do so in incremental steps that we barely notice.

Biotechnology: the Scientific Challenge

Fukuyama’s portrayal of our "posthuman future" touches on only the most probable of the changes biotechnology is likely to bring. The problem is that even granting Fukuyama the most chilling of the developments he envisions, no automatic connection exists between any particular avenue of research and the harm Fukuyama foresees. Genetic engineering, for example, is probably the potential development with the broadest consensus against its implementation. Science-fiction writers as long ago as H.G. Wells could envision the breeding of human strains so distinct they become different species.12 Fukuyama fears almost as much discoveries that may identify a genetic basis for intelligence or criminality. Even if, as a matter of statistical probability, the offspring of elite parents are more likely to share their elite characteristics than the general population, the parents cannot be sure their genetic gifts will be passed on, and they cannot be certain that advantageous results are the product of inheritance as opposed to environment. If parents could guarantee offspring with the right gene combinations, or if they could determine in advance that it is futile to train a child who lacks the gene for concert pianist performances, existing societal divisions might be exacerbated. The research thought likely to contribute to such a result, however, might also produce the opposite effect.

Consider the rapidly growing body of information about the genetic basis of disease. Scientists trace families with hereditary forms of illnesses such as breast cancer. By comparing relatives with the disease to those without it, they attempt to isolate the relevant genes or chromosomes. Sometimes, identification of the genetic culprit leads to abortion-based genetic screening or preventive measures such as mastectomies for the healthy. In other cases, however, identifying a particular disease-causing chromosome may lead to the discovery of the underlying mechanism causing the illness. If, for example, the relevant gene produces (or fails to produce) a particular protein, identification of that protein may be critical in fighting the disease, and it may lead to more effective treatments for both the genetic and non-genetic forms of the cancer.13

The same thing may ultimately be true for more complex traits such as intelligence. Scientists may discover that a particular gene combination is associated with superior mathematical reasoning because of its contribution to the biochemical development of the brain. This could lead to the deliberate breeding of the mathematicians of the twenty-third century. It might also lead to early childhood interventions that enhance the mathematical functioning of the average child. Identification of the genetic sources of intelligence is the development that most causes thoughtful observers to be wary. Yet, the result of such discoveries could conceivably increase equality in a manner similar to vaccinations (which compensate for the unequal genetic distribution of disease resistance), universal public education (which in some cases mitigates and in other cases exacerbates natural differences in ability), or the rapidly increasing understanding of the physiology of dyslexia (facilitating more accurate identification of dyslexics and new teaching strategies that increase dyslexics’ success in learning to read).

All biological advances potentially have differential effects for society. Discoveries about the links between nutrition, sanitation, and human flourishing, for example, first brought advantages to the elites, and continue to be a major source of inequality between the developed and the developing world. If the most critical human political value is equal dignity and respect, and if selective breeding is the potential scientific advance that most threatens it, there may still be no necessary connection between any particular line of research and the feared outcome.

Biotechnology: The Governance Challenge

If much of the public debate about biotechnology concerns the advances to be permitted or prohibited, more of the ongoing private and professional discussion concerns the infrastructure necessary to encourage or deter investment.

Let us take, for example, use of the technology associated with genetic transfer. Scientists cloned Dolly the sheep by taking an egg from the womb of a sheep, destroying its nucleus, and replacing the egg nucleus with one from an adult sheep cell. The new egg was transplanted into the womb of a sheep who gave birth to an animal with the same nuclear DNA as the adult. Now compare two other forms of genetic transfer.

In the first form, scientists extract the nucleus from the egg of a fertility patient, insert it into a donor egg whose nucleus has been removed, and add sperm from the patient’s partner. The result is a fertilized egg, implanted in the patient’s womb, that produces a child genetically related to three parents: it has nuclear DNA from the intended mother and father, and mitochondrial DNA (mtDNA)14 from the woman who donated the egg. The result permits a fertility patient with deteriorating cytoplasm or defective mtDNA to bear a healthy child. It also involves a germline genetic alteration.15 The child will pass on mitochondrial DNA from the donor to her offspring.

In the second form, scientists take a cell from a diabetic child. They obtain an egg from a fertility clinic donor. They destroy the egg nucleus, and insert the child’s cell nucleus.16 The scientists then permit the egg, which contains the child’s DNA, to develop in a petri dish long enough to harvest stem cells that can be coaxed into becoming pancreatic cells that the child needs to regulate his production of insulin. The stem cells, a genetic match, cure the child’s diabetes without the risk of rejection. They do not, however, alter the DNA he will transfer to his offspring.

The first example involves genetic alteration of a kind that many ethicists and legislators strongly oppose. The second involves a less controversial technique contentious more because of its destruction of the developing egg from which the stem cells are taken than because of its effect on the patient. Yet, the first has already been done in humans while the second has not.

It is tempting to conclude that differences in regulation provide the primary part of the explanation. Fertility clinics are the frontier of the medical profession, with virtually no federal funding or oversight, and relatively little insurance coverage. Universities, in contrast, rely on federal funding with all kinds of strings attached, and pharmaceutical companies need to convince the shareholder and venture capitalists who fund them that they can produce a marketable product worth the investment.17 Marketability, in turn, requires FDA approval or a measure of public acceptance that would be jeopardized by insensitivity to research protocols.

The regulatory structure, however, is itself a product of the structure and financing of the underlying industry. How expensive is the basic research? Who does it? How far removed is implementation in humans from the initial discoveries? How willing are doctors and patients to try untested techniques? Stem cell researchers working on diabetes could also escape existing regulatory scrutiny if they were willing to operate in decentralized, privately funded clinics. They do not because of the different financing and motivation at play in the two examples. The first scenario, involving mtDNA donation, depended on the development of nuclear transfer techniques financed by potentially large scale agricultural interests and then implemented in humans by small clinics with a determined clientele. The British government, for example, through its Ministry of Agriculture, provided 65% of the funding that made Dolly, the first cloned mammal, possible. PPL Therapeutics, a Scottish biotechnology company, provided the rest.18 The goal was not to clone humans or even to cure disease. Instead, the institute involved in the research hoped to create precisely copied animals carrying proteins valuable in drug-making or replicating high quality beef.

Once the basic science has been developed, however, its application to human patients may be relatively straightforward and inexpensive. Little scientific innovation was involved in the fertility treatments treating the mitochondrial defects. Imple- mentation required only willing doctors and consenting patients. The patients often have an intense relationship with fertility specialists, with both committed to one overriding goal––the production of a child. Maureen Ott, the first woman to bear a child using a donor’s cytoplasm, told reporters that: "When we were told by doctors that it was unlikely we would ever have children, we were not ready to believe that. We wanted a baby so badly that we felt it was important to pursue every option available."19 After four failed efforts at in vitro fertilization, the Otts may well have felt that use of the experimental technique was their last chance to have a child to whom they would be genetically related. In such circumstances, it is easy to discount the risks. Mrs. Ott, when interviewed after her child’s birth, insisted that: "I was never concerned about the risk of abnormality, based on what we were told. To me it seemed that the risk was no greater than it would have been in any birth for someone of my age."20

The doctors, however, may be less sanguine. Dr. Jamie Grifo, the New York fertility specialist who used nuclear transfer techniques, was asked why he had not done safety testing first in monkeys. "Animal colonies cost a fortune to maintain," he said. And because there is a ban on federal research money being spent on embryo research, "we have no research dollars."21 In the four years since the birth of the first child using these techniques, at least one has developed a serious developmental disorder, and some researchers speculate that the conflict between the donor and the patient mtDNA might have caused the problem.22 There may be no way to know without carefully controlled trials that the clinics lack the money to fund.

In contrast, stem cell research involves high caliber university researchers, using proven clinical techniques, including animal experimentation and human trials. The basic research, like that performed to clone Dolly, can be enormously expensive, and lack an immediate commercial application. Dr. Elias Zerhouni, Director of the National Institutes of Health, testified before Congress that:

We are at a very early stage of embryonic stem cell research, and we have a great deal of basic research to conduct before we can unlock the potential of these cells and fulfill their promise. ... As is the case at the beginning of any new field of discovery, there is a shortage of researchers with expertise in stem cell research. This dearth is currently a rate-limiting step in advancing the progress of embryonic stem cell research. Simply growing embryonic stem cells to the state where they can be used for experimentation requires substantial knowledge, training and expertise. NIH will strive to make stem cell research as attractive as possible to our most talented research scientists, whose creativity in developing investigator initiated research will move the research agenda forward.23

In addition, Dr. Zerhouni emphasized that there are many steps required to develop stem cells from when they are first removed from an embryo to the point where they become part of a well-characterized cell line ready for distribution to the research community. As a first step in that process, NIH has awarded $4.3 million in grants to fund the expansion, testing, quality assurance, and distribution of cells. Once the basic research is completed, pre-clinical studies, including animal experimentation, will need to be done, and only then will human trials on small, carefully selected populations be attempted. Under ideal circumstances, it could easily take decades and millions of dollars to realize the beneficial results of such research. And without demonstrated evidence of the safety and efficacy of such treatments, it would be difficult to justify experimentation on diabetic children. The Otts may have been willing to try an untested technique as their only way to produce a genetically related child; they should be far less willing to try such a technique to cure that child of a chronic, but not life threatening, ailment.

The contrast between these two examples illustrates the challenges facing any system designed to govern the future of biotechnology. A particular line of research, at a critical preliminary stage, may be relatively easy to derail or simply to starve from lack of funding. The results of that research, however, are unknowable. They may unlock secrets of the cell that hold the key to curing diabetes or paralysis, or they may facilitate genetic engineering of athletes with faster metabolisms.

Once the research is developed, however, controlling its use, limiting, for example, "pre-implantation diagnosis and screening for therapeutic rather than en-hancement purposes," becomes a far more difficult matter. 24 Egg, sperm, and embryo selection, genetic therapy and drug use (steroids, Ritalin) can be done in a friendly jurisdiction or in carefully concealed labs.25 In an example of "fertility tourism," for example, Swedes now routinely travel to Denmark for artificial insemination with donor sperm in order to circumvent a Swedish law that requires identification of the donors.26If the life of a dying child or the ability to conceive were at stake, prospective patients and their families would be willing to go to even greater lengths to secure treatment. And if an underground practice developed with respect, for example, to enhancing athletic performance or permitting gay and lesbian couples to bear offspring genetically related to two same-sex parents, a whole community might arise committed to funding, promoting, and concealing such activities.

Conclusion

Formal regulation, whether of tax compliance or genetic engineering, is far more effective when popular acceptance fits hand in glove with official sanctions. The Swedes, for example, unable to command respect for their policy of sperm donor identification, cannot prevent their citizens from going to Denmark. Making the norm of identification stick will require either greater voluntary acceptance or more draconian efforts at policing. Driving the practice underground, however, may shortcircuit the discussions that may help forge more broadly held moral principles.

Fukuyama observes that until the early nineties virtually all biomedical research in the United States was federally funded.27 That meant that the best researchers only undertook federally approved projects, overseen by professional boards that developed standards for acceptable practices. The biotech industry has since doubled in size, with private funding upstaging federal efforts such as the Humane Genome Project, and more decentralized programs, like fertility clinics, flourishing in areas too politically hot to fund with public money. Infusion of large amounts of state or foundation grants to underwrite research is likely to produce greater public participation in the decisions about implementation.

In the absence of a new dark age that shuts down research on a wholesale basis, however, we are more likely to muddle our way through than to distinguish in advance the most promising developments from the most troubling. As we can already see from the underground market for organs and the international pressure to insure access to lifesaving pharmaceuticals, a simple discussion of permission or prohibition is unlikely to be enough. We need to think about ways to encourage dialogue about practices the public has yet to fully grasp.

End Notes

1 This article has been adapted from June Carbone, “Toward a More Communitarian Future: Fukuyama as the Fundamentalist Secular Humanist,” 101 Mich. L.Rev. 1906 (2003).

2 Gregory Stock, Redesigning Humans: Our Inevitable Genetic Future (Boston: Houghton Mifflin, 2002).

3 Francis Fukuyama, Our Posthuman Future: Consequences of the Biotechnology Revolution (New York: Farrar Straus and Giroux, 2002).

4 Francis Fukuyama, The End of History and the Last Man (New York: Free Press, 1992), xii-xiii.

5 Fukuyama, Posthuman, 39-40.

6 Fukuyama devotes greater attention to the link between heredity and IQ and gender and behavior than he does to neuroscience. Studies of brain imaging may contribute as much as studies of genetics to predicting human behavior. See, e.g., Wendy Kaminer, "Gender Bender," in The American Prospect (September 9, 2002); Erica Goode, Brain Imaging May Detect Schizophrenia in Early Stages, The New York Times, December 11, 2002, http://www.nytimes.com/2002/12/11/health/11BRAI.html

7 A chilling example of the potential use of this technology comes from a recent Supreme Court decision in which the Court split 5-4 on the question of whether an inmate convicted of sexual abuse had to reveal all prior episodes of sexual assault, including those unknown to the police, as a condition of probation. Why not use brain scans to test an inmate’s suitability for release by seeing whether the government’s efforts at therapy have succeeded in reprogramming his preferences or self-control?

8 Fukuyama, Posthuman, 46.

9 Fukuyama, Posthuman, 51.

10 Fukuyama, Posthuman, 57.

11 Fukuyama, Posthuman, 61.

12 H.G. Wells, The Time Machine (1895); see also Aldous Huxley, Brave New World (New York: Harper and Brothers,1946).


13
For a recent example of this, see "Brain Defect Study Finds Mutation," Associated Press, New York Times (October 1, 2002), http://www.nytimes.com/aponline/health/AP-Amish-Gene-Disorder.html (A newly discovered fatal gene mutation, found only in Amish newborns, could be a major first step toward helping scientists prevent brain defects in babies worldwide).

14 DNA occurs in two places, the cell nucleus and the cytoplasm surrounding the nucleus. The nuclear DNA creates a person’s inheritable traits. The cytoplasm contains mitochondrial DNA, which directs the cell’s energy production. See John Jain, M.D., "The Future of Assisted Reproductive Technologies," 21 Whittier L. Rev. 435, 435-36 (1999).

15 Switching mitochondria would make a permanent and inheritable change in future descendants. Jain, 440.

16 For a description of this process, see "Stanford Announces Stem Cell Project," Associated Press, The New York Times (December 11, 2002), http://www.nytimes.com/aponline/national/AP-Stanford-Cloning.html. See also Testimony of Dr. Roger Arnold Pedersen, Senate Committee on Appropriations, September 25, 2002, http://appropriations.senate.gov/releases/record.cfm??id=187388.

17 See articles cited in note 15 for description of Stanford’s use of private funding and Pedersen’s description of the importance of the research climate.

18 "Poll: Americans Oppose Human and Animal Cloning," Associated Press, March 4, 1997, http://www.gene.ch/gentech/1997/8.96-5.97/msg00187.html.

19 "Healthy Baby Born After World’s First Successful Cytoplasmic Transfer," Business Wire (July 18, 1997).

20 Lois Rogers, "Fertility doctors create babies with two mothers," in Sunday Times (London) (May 16,1999).

21 Nigel Hawkes, "Baby race that may be too fast for safety," in The Times (London) (October 10, 1998).

22 Shannon Brownlee, "Designer babies: human cloning is a long way off, but bioengineered kids are already here," 34 Washington Monthly 25 (March 1, 2002).

23 Testimony of Elias Zerhouni, M..D., Senate Committee on Appropriations, September 25, 2002, http://appropriations.senate.gov/releases/record.cfm??id=187388.

24 Fukuyama, Posthuman, 211.

25 Indeed, after the FDA tried to stop use of the fertility technique in the U.S., Dr. Grifo helped Chinese fertility specialists attempt a newer version of the procedure, producing a pregnancy. The Chinese responded to the international publicity the announcement generated by banning the procedure.

26 Matthew Hill, "Sperm donors ‘want to keep anonymity’," BBC News: World Edition, October 15, 2002.

27 Fukuyama, Posthuman, 214.

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