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A Majoritarian Proposal for Governing Human Biotechnology

The stem cell wars of the past five years have been a divisive and unpleasant affair. At the root of this sorry situation lies the fact that the most politically influential constituencies addressing these issues occupy opposite ends of an ideological spectrum and have generally been unmotivated to seek workable compromises. On the one end are religious conservatives opposed as a matter of faith and principle to any procedures that destroy human embryos. On the other end are many scientists and patient groups, and the biotechnology industry, opposed to constraints on what they believe to be fundamental rights to research, treatments, and profits.

This polarized politics has given us the worst of all possible worlds: a policy stalemate at the federal level accompanied by a plethora of state-level stem cell funding programs lacking the sort of planning, ethical oversight, and regulation that biomedical research of such consequence requires. California’s $3 billion stem cell program is the poster child of this predicament. Since its inception in 2004 it has been under fire for conflicts of interest, inadequate concern for the health and safety of women who provide eggs for stem cell research, unrepresentative policy-making bodies, and misplaced research priorities.

These flawed state programs are setting the stage for even greater problems to come. Technologies now under development, including pre-implantation genetic diagnosis for both medical conditions and cosmetic traits, somatic genetic enhancement, and inheritable genetic modification, promise to make the stem cell wars look like the proverbial church picnic.

If these technologies are embraced by the largely unaccountable infrastructure now being established to support stem cell research, they will be difficult to constrain. Once developed and made commercially available, they would be used disproportionately by the most privileged, and become new and powerful drivers of inequality and exclusion.

The tragedy of this situation is that public opinion surveys consistently show that a strong majority of Americans support a morally serious middle ground regarding the new human genetic technologies. Americans are not irrevocably opposed to research involving the destruction of human embryos, but they want to make sure it is done only after alternatives have been exhausted, and with effective structures of public oversight in place. Americans want cures for diseases, but few are willing to turn the genetic future of the human species over to dismissively arrogant scientists and profit-hungry biotech boosters. Unfortunately, no organized constituencies with influence comparable to that of the religious conservatives or the research/patient/bioindustrial community exist to represent this majoritarian position in the political arena.

But this could change. Beyond Bioethics: A Proposal for Modernizing the Regulation of Human Biotechnologies, by Francis Fukuyama and Franco Furger, could serve as a rallying point for those desiring an end to the current counterproductive policy stalemate.

Since the publication of his book The End of History in 1992, Fukuyama has been widely regarded as a member of the neoconservative brain trust, notably as a participant in the early years of the neocon Project for the New American Century. But Fukuyama’s social and political allegiance has in fact always been more nuanced. In 1990 he joined such left-liberals as Betty Friedan, Harvey Cox and Stuart Eisenstadt in signing Amitai Etzioni’s Responsive Community Platform calling for a revival of communitarian values and practice. In 2004 he publicly broke with President Bush over the wisdom and conduct of the war in Iraq. And last year he repudiated the neoconservative movement itself, calling for a “realistic Wilsonianism” that supports promotion of democratic values but is cautious about the use of military force.

Fukuyama’s centrist communitarianism strongly informed his 2002 book on bioethics and society, Our Posthuman Future. In it he endorsed using biotechnology to address medical needs but argued against its use to modify the human species in ways that would undermine the common human nature that supports human values, behaviors, and institutions. If misused, he said, these technologies could lessen the regard we have for one another as members of a single human community, and irrevocably and increasingly deepen the divide between the world’s haves and have-nots. His line of argument was thus closer to that of center-left critics of unrestrained genetic technology (such as Daniel Callahan of the Hastings Center, Lori Andrews of Chicago Kent School of Law, and environmentalist author Bill McKibben), than it was to that of most religious conservatives, who ground their positions largely on a belief in the personhood of the human embryo (or more precisely, in the ontological continuity of the zygote and the human person).

Fukuyama’s colleague Franco Furger is a political scientist based in Lucerne, Switzerland, with a background in environmental policy, economic sociology and public administration. Much of his work reflects the sorts of social democratic values common among Europeans.

In Beyond Bioethics, Fukuyama and Furger go beyond social critique and focus on the details of human biotech governance. The study broadly follows the approach used by two previous landmark documents: the 1984 Warnock Report that motivated the establishment of the United Kingdom’s Human Fertility and Embryological Authority in 1991, and the 1993 Baird Report that informed Canada’s 2004 Assisted Human Reproduction Act.

Fukuyama and Furger begin with a review of the many controversial technologies now in use or in the pipeline: stem cell research and applications, sex-selection, trait selection, somatic gene therapy, inheritable genetic modification, human-animal chimeras, ooplasm transfer and more. They continue with an analysis of the inadequacy of current state and federal regulatory policies, a comparative survey of policies in other countries, a review of public opinion, and an in-depth discussion of alternative approaches to ensuring stakeholder representation and accountability in federal regulatory decisions.

They include an explicit statement of the ethical values that inform their inquiry and recommendations: the well-being and health of women and children, equal access to assisted reproductive technologies on the part of infertile couples, informed consent, limits to commercialization, and the priority of therapeutic over “enhancement” technologies. These principles lead them to propose that certain technologies be taken off the table at the outset: reproductive cloning, germline modification, the creation of certain kinds of live-born human-animal chimeras, and technologies that significantly alter the genetic relation of parents and children, such as parthenogenesis. They also propose that patenting of human embryos be banned.

Almost everything else would be permitted, including embryonic stem cell research, but made subject to comprehensive regulatory oversight and ongoing review. The key regulatory provision in their proposal follows the British and Canadian systems in calling for all private and public laboratories or clinics working with human gametes or embryos to be licensed and brought under uniform national rules. An independent federal agency, headed by a newly established appointive commission, would oversee these new functions. A separate advisory board would facilitate communication between the commission and directly affected constituencies. Finally, they suggest that mechanisms for public consultation be institutionalized.

The intent of all this is to allow and encourage a wide set of opinions to be heard before decisions are made regarding controversial new forms of human genetic research and applications, and to ensure accountability and transparency in the decisions themselves. At present no regulatory structures in the United States do this in an effective manner. Decisions about the human genetic future are being made by small groups of scientists and investors accountable only to themselves.

Fukuyama and Furger are candid about the hurdles that any proposal to establish a new federal agency would face, and about the unique hurdles facing an agency intended to regulate genetic technology. In the past, both religious conservatives and biotech advocates have given such proposals a wide berth. The former have been afraid that a new federal agency might be too permissive, the latter that it might be too strict. Abortion rights groups would rightly want assurances that such an agency could not adopt measures restricting access to abortion services. Leading figures on both sides of the culture wars would be wary of any structure that might give their perceived adversaries a new, institutionalized site of influence.

Fukuyama and Furger argue that while these difficulties are hardly trivial, the alternatives to the creation of a new federal agency pose even greater ones.  Maintaining the status quo is unconscionable, given the magnitude of what is at stake. Proposals that scientists and the biotech industry regulate themselves through professional and industry-wide standards and codes are unlikely to be effective, given growing competitive pressures. Federal laws passed to address particular technologies on a case-by-case basis are inflexible and often incongruous.

The default alternative is to assign regulatory responsibility for the new human biotechnologies to the Food and Drug Administration, National Institutes of Health, and similar exiting agencies. But this too is unlikely to work. The professional cultures of these institutions have evolved to explicitly exclude regulatory judgments based on criteria other than patient safety and efficacy. This impedes precisely what is most needed now: judgments that take into account the deeper and broader implications of genetic technology for society as a whole.

Fukuyama and Furger appear to have missed a beat on just a few topics. The advisory board they propose is seen as a conduit between the appointed regulatory commission and the most directly affected stakeholders – the biotech and fertility industries, researchers, and patients – regarding mandated regulatory functions. But there is likely a need for an additional advisory body charged with anticipating new challenges and working to build understanding and consensus about how these might be met. An advisory body of this sort should include representatives of the widest possible set of social constituencies.

Fukuyama and Furger propose that the new regulatory commission be required to take into account the views of the general public before making important decisions, through the use of web-based citizen panels, consultative colleges, large-sample surveys, and other innovative techniques. The intent is to offset the influence wielded by organized economic and political interests. The proposal is a useful one but is unlikely to be sufficient. There is no substitute for organized citizen advocacy.  In the same way that environmental organizations, for example, arose to articulate the concerns of those disturbed by new threats to the environment, new organizations now need to be created to articulate the concerns of those disturbed by new threats posed by human genetic technology.

All in all, Fukuyama and Furger have produced the most comprehensive analysis of human biotech regulatory policy yet published in the United States. With the 2008 congressional and presidential campaigns now moving into high gear, the report comes at an opportune time. Beyond Bioethics should be studied carefully by everyone interested in working towards human biotech policies that can be supported by the great majority of Americans.

– Richard Hayes

Published on: January 3, 2007
Published in: Emerging Biotechnology, Science and Society

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