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.
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