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The Threshold Challenge of the New Human Genetic Technologies

March 1st, 2003

Introduction

The Basic Science

A New Ideology

What Is to be Done?

The Current Policy Landscape

Towards an International Policy Regime

Conclusion


Introduction

We are fast approaching arguably the most consequential technological threshold in all of human history: the ability to alter the genes we pass to our children.

Crossing this threshold would irrevocably change the nature of human life and human society. It would destabilize human biology. It would put into play wholly unprecedented social, psychological and political forces that would feed back upon themselves with impacts quite beyond our ability to foresee, much less control.

Advocates of this new techno-eugenics look forward to the day when parents quite literally assemble their children from genes listed in a catalogue. They celebrate a future in which our common humanity is lost as genetically enhanced elites increasingly acquire the attributes of separate species.

The implications for individual integrity and autonomy, for family and community life, for social and economic justice and indeed for world peace are chilling. Once humans begin cloning and genetically engineering their children for desired traits we will have crossed a threshold of no return.

The world community is only just beginning to understand the full implications of the new human genetic technologies. There are few civil society institutions, and there is no social or political movement, critically addressing the immense challenges these technologies pose.

We need to move with all deliberate speed to bring the new human genetic technologies within the ambit of responsible societal governance. National and international leaders and civil society constituencies need to inform themselves about critical aspects of the new human genetic technologies and join together to build nothing less than a new civilizational commitment to fully engage this threshold challenge.

The Basic Science

Many applications of human genetic technology are benign and hold great potential for preventing disease and alleviating suffering. Other applications open the door to a human future more horrific than our worst nightmares. We need to distinguish between these, and support the former and oppose the latter.

The two technologies of most concern are human cloning and inheritable genetic modification.

Cloning is the creation of a genetic duplicate of an existing organism. Human cloning starts by creating a human embryo that carries the same set of genes as an existing person. If this embryo is used for research purposes—say, for generating some types of stem cells—the process is called research cloning. If instead the embryo is implanted in a woman's uterus and brought to term to produce a child, the process is called reproductive cloning.

Genetic modification means changing the genes in a living cell. There are two types of genetic modification: non-inheritable genetic modification and inheritable genetic modification. Non-inheritable genetic modification changes the genes in cells other than egg or sperm cells. If a lung disease is caused by defective lung cell genes, it might be possible to treat the disease by modifying the genes in those lung cells. Such changes are not passed to future children. Applications of this sort are currently in clinical trials, and are generally considered to be socially acceptable.

Inheritable genetic modification (IGM) changes genes in eggs, sperm, or very early embryos. These changes not only affect the child immediately born but are passed down to that child's descendants as well, in perpetuity. This application is by far the more consequential, for it opens the door to the reconfiguration of the human species. (The technical terms for non-inheritable and inheritable genetic modification are somatic and germline genetic modification, respectively.)

Many people assume that inheritable genetic modification is needed to allow couples to avoid passing on genetic diseases such as Tay Sachs or sickle cell anemia. This is not so. More acceptable and straightforward means already exist to accomplish this same goal, in all but a very few cases. In the technique known as pre-implantation screening, couples at risk of passing on a gene-related disease use in-vitro fertilization to conceive several zygotes, after which those found to be free of the harmful gene are implanted and brought to term. No modification of genes is required. Options such as adoption and egg, sperm and embryo donation are also available. Inheritable genetic modification is necessary only if a couple wish to "enhance" a child with genes neither of them carry.

A New Ideology

Advocacy of cloning, inheritable genetic modification and the new eugenics is an integral element of a newly emerging socio-political ideology. This ideology differs from conservative ideologies in its antipathy towards religion and traditional social values, from left-progressive ideologies in its rejection of egalitarian values and social welfare as a public purpose, and from Green ideologies in its enthusiastic advocacy of a technologically reconfigured and transformed natural world. It embraces commitments to science and technology as autonomous endeavors properly exempt from social control, to the priority of market outcomes, and to a political philosophy grounded in social Darwinist views of human nature and society.

This ideology is gaining acceptance among scientific, high-tech, media and policy elites. A key foundational text is Remaking Eden: Cloning and Beyond in a Brave New World by molecular biologist Lee Silver of Princeton University. Silver looks forward to a future in which the health, appearance, personality, cognitive ability, sensory capacity and life span of our children all become artifacts of genetic modification. Silver acknowledges that the costs of these technologies will limit their widespread adoption, so that over time society will segregate into the "GenRich" and the "Naturals." In Silver's vision of the future:


"The GenRich—who account for 10 percent of the American population—all carry synthetic genes. All aspects of the economy, the media, the entertainment industry, and the knowledge industry are controlled by members of the GenRich class…. Naturals work as low-paid service providers or as laborers…. [Eventually] the GenRich class and the Natural class will become entirely separate species with no ability to cross-breed, and with as much romantic interest in each other as a current human would have for a chimpanzee."

Silver continues:


"Many think that it is inherently unfair for some people to have access to technologies that can provide advantages while others, less well-off, are forced to depend on chance alone…. [But] American society adheres to the principle that personal liberty and personal fortune are the primary determinants of what individuals are allowed and able to do. Indeed, in a society that values individual freedom above all else, it is hard to find any legitimate basis for restricting the use of repro-genetics…. I will argue [that] the use of reprogenetic technologies is inevitable… [W]hether we like it or not, the global marketplace will reign supreme." (from Remaking Eden: Cloning and Beyond in a Brave New World (New York: Avon Books, 1997), pages 4-7, 11)

Silver is hardly alone. Here's James Watson, co-discoverer of the structure of DNA, Nobel laureate and founding director of the Human Genome Project:


"And the other thing, because no one has the guts to say it, if we could make better human beings by knowing how to add genes, why shouldn't we? What's wrong with it?… Evolution can be just damn cruel, and to say that we've got a perfect genome and there's some sanctity to it? I'd just like to know where that idea comes from. It's utter silliness." (quoted in Engineering the Human Germline: An Exploration of the Science and Ethics of Altering the Genes We Pass to Our Children, Gregory Stock and John Campbell, eds. (New York: Oxford University Press, 2000), pages 79, 85)

And here's Dr. Gregory Pence, professor of philosophy in the Schools of Medicine and Arts/Humanities at the University of Alabama:


"[M]any people love their retrievers and their sunny dispositions around children and adults. Could people be chosen in the same way? Would it be so terrible to allow parents to at least aim for a certain type, in the same way that great breeders…try to match a breed of dog to the needs of a family?" (from Who's Afraid of Human Cloning? (Lanham, MD: Rowman & Littlefield, 1998), page 168)

Or consider this excerpt from an interview with University of Pennsylvania bioethicist Arthur Caplan:


"'[M]aking babies sexually will be rare,' Caplan speculates…[M]any parents will leap at the chance to make their children smarter, fitter and prettier. Ethical concerns will be overtaken, says Caplan, by the realization that technology simply makes for better children. 'In a competitive market society, people are going to want to give their kids an edge,' says the bioethicist. 'They'll slowly get used to the idea that a genetic edge is not greatly different from an environmental edge.'" (from ABCNEWS.com: Babies of the Future)

Here's noted economist Lester Thurow of MIT:


"Some will hate it, some will love it, but biotechnology is inevitably leading to a world in which plants, animals and human beings are going to be partly man made…. Suppose parents could add 30 points to their children's IQ. Wouldn't you want to do it? And if you don't, your child will be the stupidest child in the neighborhood." (from Creating Wealth: The New Rules for Individuals, Companies and Nations in a Knowledge-Based Economy (New York: Harper Collins, 1999), page 33)

Can it get worse than this? Yes. In Germany recently an uproar ensued following statements by philosopher Peter Sloterdijk that the failure of social democracy now leaves human genetic engineering (which he referred to as "Selektion," a word associated with Nazi genocide) as the only means for humanity to improve its lot. 

In the last few years advocates of the new techno-eugenics have become increasingly vocal and confident. They are taking lead roles in organizing major conferences, establishing policy institutes and membership-based advocacy groups, sitting on government panels and corporate ethical advisory boards, publishing a steady stream of serious books and articles, and more. These are the sorts of activities that mark the emergence of a new ideological and political movement.

What Is to be Done?

Recent discussions among concerned scientists, health law experts, human rights leaders, environmentalists, social and economic justice advocates, women's health experts, indigenous peoples organizations and others suggest three policies as the minimal necessary core of a regime addressing the most dangerous applications of the new human genetic technologies:

National and global bans on reproductive human cloning

National and global bans on inheritable genetic modification

Effective, accountable regulation of all other human genetic technologies

If we are to prevent an escalating and potentially catastrophic spiral of human genetic modification, we will need global bans on both reproductive human cloning and inheritable genetic modification. The bans need to be global to prevent the establishment of eugenic tourism. Further, the bans need to be intended to be permanent. Of course, we can't bind the actions of our descendants, and if they someday decide to repeal these bans they can. But we have the responsibility to make a clear statement, as the human community at this point in history, that we consider human cloning and inheritable genetic modification to be profoundly unacceptable. The proposed global bans are an affirmation among the several generations alive today that we will work to build a human future in which reproductive human cloning and inheritable genetic modification are not done.

Pre-natal and pre-implantation testing, sex selection, embryo research and other practices have or may have potentially acceptable applications. However, if these are not brought under effective and accountable societal control the danger exists that they could be used in ways that are unacceptable in themselves and that could erode the commitment to forgo reproductive cloning and inheritable genetic modification. A framework needs to be established to allow humanity as a whole to assess the need for regulation and control of such technologies. Further, individual countries need to be able to proscribe applications of these technologies that they find unacceptable.

We believe that this set of policies is practicable and can attract support from the great majority of the world's countries. All three policies are already in force in one country or another, as described below. The challenge before humanity is to agree that these policies are important enough to require universal adoption.

The Current Policy Landscape

Human Cloning

In 1997 scientists at the Roslin Institute in Scotland announced that they had successfully cloned a sheep. This event triggered a worldwide outcry concerning the potential application of this technique to humans. Many countries banned human cloning, and several international bodies—including UNESCO, the Council of Europe, the European Parliament, the G8, and the World Health Assembly—all took a strong stands against the cloning of human beings. 

In 1997 UNESCO adopted a non-binding Declaration on the Human Genome and Human Rights, signed by 186 nations and endorsed by the United Nations General Assembly. Article 8 of the Declaration prohibits "practices which are contrary to human dignity, such as reproductive cloning of human beings." This initiative helped establish legitimacy for the policy of a global ban, but its non-binding nature renders it advisory rather than authoritative.

The most authoritative multilateral initiative taken to date to ban human cloning was the Council of Europe's 1998 protocol to its Convention on Human Rights and Dignity with Regard to Biomedicine. The protocol prohibits "any intervention seeking to create a human being genetically identical to another human being, whether living or dead." The protocol was opened for signatures on January 12, 1998 in Paris. As of March 2003 it had been signed by 29 of the Council's 41 member states and had been ratified by thirteen of these. 

Other countries that have passed national legislation banning human cloning include Australia, Austria, Argentina, Brazil, Costa Rica, Finland, France, Germany, India, Israel, Italy, Japan, Mexico, Norway, Peru, South Africa, Sweden, Switzerland, Trinidad y Tobago, and the United Kingdom. Some of these laws pertain to human reproductive cloning only, while others also place restrictions on the creation of clonal embryos. As of March 2003 about 34 countries had banned human reproductive cloning. While encouraging, this represents a minority of the world's population. (See http://www.glphr.org/genetic/genetic.htm for national policies throughout the world.) The unsubstantiated claims in December 2003 by a Canadian-based sect of a successful cloning attempt caused leaders in several countries to ramp up efforts to ban human cloning.

Although support in the US Congress for a ban on reproductive cloning is strong there are sharp disagreements regarding research cloning, and the legislative prospects are uncertain. During the 2001-2002 sessions, the House of Representatives passed a bill banning both reproductive and research cloning, but neither proposed bill in the Senate was able to secure enough support. The Food and Drug Administration (FDA) has stated that it has jurisdiction over human cloning, and has signaled that it will work to prevent it. Yet the FDA is required by law to restrict its criteria for approval of a process to those of safety and efficacy. The FDA is expressly prohibited from considering ethical or social concerns when evaluating a proposal.

Advocates of human reproductive cloning hope to make it happen before a global ban is in place, in the expectation that opposition will weaken in the face of a fait accompli. Estimates as to when we could expect the birth of a human clone, if no action is taken to prevent this, range from immediately to five or ten years. If the birth of a clonal child is announced before bans are in place, opponents of human cloning will need to respond in ways that will build support for policies that will keep such an event from ever happening again.

Inheritable Genetic Modification

Some countries have sought to ban inheritable genetic modification, but not as many as have taken action against cloning. As with cloning, the Council of Europe's Convention on Human Rights and Dignity with Regard to Biomedicine stands as the most encouraging international initiative to date. Article 13 of the Convention states: "An intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants." The Convention has been signed by 31 of the 41 member states of the Council of Europe and has been ratified directly by fifteen of them. 

Other countries that have passed laws or regulations that explicitly or implicitly proscribe inheritable genetic modification include: Australia, Austria, Costa Rica, Denmark, France, Germany, Hungary, India, Israel, Japan, Norway, Peru, Spain, Sweden, Trinidad and Tobago, and the United Kingdom. See http://www.glphr.org/genetic/genetic.htm for national policies throughout the world.

In the United States the Food and Drug Administration (FDA) claims authority to approve proposals involving gene transfer. As with cloning, its criteria are restricted to safety and efficacy.

The World Health Organization and World Health Assembly occupy key positions concerning human genetic technology policy. These bodies are global rather than regional and their mandates are operational, not merely advisory. In 1999 a Consultation on Ethical Issues in Genetics, Cloning and Biotechnology was held to help assess future directions for the WHO. The major report prepared as part of this Consultation, Medical Genetics and Biotechnology: Implications for Public Health, was notable in calling explicitly for a global ban on inheritable human modification. The WHO has since then established an advisory committee on human genetic technologies.

The most secure way to ban inheritable genetic modification in any country is to enact national legislation. Treaties, codifications or other multilateral instruments will be needed to secure agreement among all countries to pass such legislation and in that manner institute a global ban.

Regulation of Other Human Reproductive and Genetic Technologies

Countries differ widely concerning the types of reproductive and genetic technologies they regulate, the procedural rules and the jurisdiction of authority. For regulation to be effective there must be a national authority responsible for licensing all research and commercial facilities involving human embryos and gametes and empowered to revoke licenses when necessary. A frequently cited model for an effective structure of regulation is the Human Fertilization and Embryology Authority (HFEA) in the United Kingdom.

The Council of Europe's Convention seeks to regulate genetic testing, embryology, sex selection and other applications. Article 11 provides that "Any form of discrimination against a person on grounds of his or her genetic heritage is prohibited." Article 12 provides that predictive genetic tests shall only be carried out for health or scientific research purposes, and requires that any person undergoing such testing must be subject to non-directive counseling. Article 13 states that human embryos shall not be created for research purposes. Article 14 states that techniques may not be used to choose a future child's sex, except where serious hereditary sex-related disease is to be avoided.

Towards an International Policy Regime

In 2001 the United Nations initiated a process intended to lead to a binding international convention banning human cloning. This historic effort should be seen as the first step towards a more comprehensive set of policies. Great skill and sensitivity will be needed to craft a convention and a process that allows the world's nations to agree to ban those technologies about which a quick consensus should be possible, such as reproductive cloning and inheritable genetic modification, while allowing for subsequent consideration of those technologies about which consensus will be more difficult to achieve, such as gene patenting and embryo research.

The "Civil Society Deficit"

Given the enormity of what is at stake and the fact that advocates of the new techno-eugenics are hardly coy about their intentions, it is remarkable that global civil society has not given these developments more attention. Every important issue complex on the world stage—war and peace, economic growth and equity, social inclusion and exclusion, race and gender equality and the rest—is today accompanied by a dense infrastructure of civil society institutions, academic centers, philanthropic programs, NGO coalitions and more. But none of these exist, to any considerable extent, regarding the social and political issues raised by the new human genetic technologies. Why is this?

One reason is that the most consequential technologies have been developed only within the last few years—there simply hasn't been time enough for people to become aware of what is happening or of the stakes involved. Further, the prospect of "re-designing the human species" is unlike anything that humanity has ever before had to confront. People have trouble taking this notion seriously—it seems fantastical and beyond the limits of what anyone would actually do or that society would allow. In addition, attitudes concerning the prospect of human genetic modification don't fit neatly along the conventional ideological axes of right/left or conservative/liberal—they track more neatly along a less institutionally expressed libertarian/communitarian axis. All these factors work to impede a prompt response from world leaders and institutions. Initiatives intended to redress this civil society deficit are of the highest importance.

Conclusion

Although the work needed to achieve global conventions banning human reproductive cloning and inheritable genetic modification, and establishing adequate regulation of other human genetic technologies, may seem daunting, it is imperative that world leaders affirm the need for such policies now and set the procedures in motion that will make them possible. There is no more important task and there is not much time available. The future of our common humanity is at stake.


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