[Paleopsych] TLS: Test tube suits

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Test tube suits
Weekly book reviews and literary analysis from the Times Literary Supplement
http://the-tls.co.uk/archive/story.aspx?story_id=2109742&window_type=print

    Michele Pridmore-Brown
    17 December 2004
    REPRODUCTION AND RESPONSIBILITY. The regulation of new
    biotechnologies. By Leon Kass, editor. 254pp. Washington, DC:
    President's Council on Bioethics. $45. - 0 7567 4166 1

    In the United States, the assisted fertility industry is largely
    market driven; the robust confluence of supply, demand and very rapid
    innovation makes for a thriving $4 billion-a-year business. The
    invisible hand of the market has rendered the embryo so fruitful that
    most in vitro babies have been born in the past four to five years,
    and at least 400,000 embryos are currently on ice. The proportion of
    deliveries per embryo transferred is around 25 per cent, which
    suggests that in vitro fertilization is more efficient than natural
    conception. One could argue, however, that the scientists whose
    innovations power the freewheeling American fertility market are a bit
    like the German rocket scientist Wernher von Braun, who explained to
    the Americans from whom he was trying to get a job after the Second
    World War: "I send (the rockets) up, where they come down is not my
    business". Up to now, it has not been clear who is in charge of the
    long-term landing in the American fertility industry.

    The public does ask questions - but only when an embryo gets implanted
    in the wrong womb; or an inordinate number of triplets are born in a
    given region; or a sixty-year-old gives birth to cartoon fanfare; or
    contractual parents and gamete donors go to war in the courts; or
    other culturally jarring practices occur. After all, there is nothing
    like an ostensibly healthy baby to normalize a procedure and lull
    nay-sayers - and nothing like a live miracle gone awry to temporarily
    remind the public of the error rates, and of the moral values at
    stake.

    The fact is that, in America, no federal regulation of assisted
    reproductive practices and services exists - in contrast to the United
    Kingdom, Australia, Canada and most nations in the European Union.
    There is, for instance, nothing even remotely close to the UK's Human
    Fertilization and Embryology Authority. In part, this is because
    health care is itself privatized, geared to customer privacy and
    autonomy. But other reasons also account for why America has a harder
    time with regulation. For one thing, Americans are averse to
    government regulation in general; and they are committed to free
    enterprise and consumer sovereignty. Add to this mix the typical
    consumer in the infertility industry: a hard-working thirty-or
    forty-something professional who desperately wants her own child,
    preferably with her own rapidly senescent eggs, and who feels entitled
    to make reproductive decisions free of government intrusion. And then
    consider that creating viable embryos via IVF necessarily also entails
    creating a slew of spare embryos, "potential lives", that will never
    see the light of day - a boon for embryo researchers hoping to cure
    diseases but criminal from the point of view of pro-lifers. In short,
    regulation is hardly a winning cause for any American politician to
    take on.

    The bipartisan members of the President's Council on Bioethics,
    however, have rolled up their sleeves and done just that. In many
    ways, Reproduction and Responsibility is a watershed document. The
    Council has taken an issue that has so far been too hot to touch in
    the American context, and treated it not ideologically but
    pragmatically. The report examines in straightforward prose the
    abstruse details of biotechnology and public policy, and it makes the
    subject seem terribly urgent. According to the report, we have reached
    a dangerous intersection between three areas of scientific study and
    medical practice: reproductive technologies, embryo research and
    genetic testing. While each contributes tremendously to health,
    happiness and knowledge,certain cherished universal values, such as
    the health and safety of children, might be "imperiled" by the
    rapidity of progress. The report is not about legislating morality or
    deciding who should or should not receive IVF treatment. Rather, it is
    about managing the potential crises with eyes open. The report should
    be useful to policy makers and eventually to historians of technology
    and policy; but its greatest importance lies in the fact that it sets
    a precedent in the US for sustained scrutiny. It may also be useful
    beyond US borders because it so clearheadedly sets out the dilemmas -
    and competing interests at stake - in a field that, more than any
    other, is likely to have seismic consequences on twenty-first-century
    mores, and on how we think about kinship and the "making" of children.

    Throughout history, children have been born for reasons other than
    their own. The report implies, however, that precisely the
    intentionality of IVF-mediated procreation (and notably its proximity
    to manufacture) thrusts their interests on the table, so to speak.
    Indeed, just by virtue of an aspiring parent selecting certain gametes
    over others on the open market, or of a scientist selecting certain
    embryos (for gender, for "quality", for the absence or presence of
    certain genetic markers, to save a sibling), the intentionality of the
    procreative act is undeniably exacerbated. In other words, we can no
    longer ascribe the outcome of sperm-meets-egg, at least the
    lab-mediated variety, solely to fate or nature, or to divine
    providence. Responsibility therefore accrues to parents as well as to
    scientists and clinicians. The problem is that the science of IVF is
    often a process of trial and error. Thus far, success is marked by one
    thing:

    a live birth, presumably a win-win-win situation for fertility
    specialists, parents and embryo. Yet we now know that the children
    created may be harmed by the treatment used to conceive or preserve
    them, as suggested by recent studies showing a link, for instance,
    between freezing and abnormal gene expression. The laissez-faire
    approach has left this long-term perspective out of the picture - or
    arguably has assumed that the interests of future children are the
    same as those of the women (and scientists) who create them. While
    staying clear of any kind of pro-life argument, the report intrepidly
    argues that we have come to a historical juncture in which the
    interests of all partiesshould be separated. In particular, the
    interests of future children should be theorized as distinct from
    those of the women who bear them or contract for their coming into
    being.

    This is a politically loaded argument that could anger some feminists,
    though certainly not all. The report is very careful here. It does not
    call so much for constraining women's reproductive choices, but rather
    for systematic knowledge - regarding rates and risks, previous
    failures and successes, cross-clinic comparisons, etc - that would
    presumably lead to more informed decision making.

    The writers dwell on the irony of the fact that in an age of
    information, little data is available about such an important
    industry; indeed, the phrase "we lack knowledge" operates as a refrain
    throughout the text. Data, such as it exists, comes mostly from other
    countries, such as the UK and Australia. Perhaps no one has cared to
    know too much about, say, embryo disposal, or the commerce in gametes,
    or the details about possible risks. Regardless of the reasons, the
    committee's first policy prescription is a forceful commitment to
    remedying the situation - by way of federal funding for data
    collection, for long-term studies of IVF babies and of the women
    undergoing treatment; it also calls for "transparency" and
    availability of information to all parties; and it urges that
    penalties be imposed at the federal level for those doctors, clinics
    and labs that do not provide data.

    The second broad recommendation seems fairly obvious. The report urges
    further self- regulation on the part of professional organizations
    such as the American Society for Reproductive Medicine (ASRM), the
    oversight board of the infertility industry.

    To its credit, the ASRM has already succeeded in getting its members
    to reduce the number of embryos transferred into a womb - though
    certainly not to UK levels.

    Despite this modest, albeit important success, the report notes a
    glaring failure.

    The history of IVF practices suggests a repeated failure to oversee
    progress "adequately". The rapid pace of innovation means that new
    techniques are constantly coming up the research pipeline. Older
    prospective mothers hardly have time to wait patiently for novel
    procedures or drugs to be tested on animals for safety; and clinics
    intent on improving their success rates do not have incentives to wait
    either - quite the contrary. It follows that new techniques move all
    too quickly from the research lab to clinical practice.
    Intracytoplasmic Sperm Injection (ICSI) is one case in point. Two
    years after having been discovered by accident in 1992, ICSI was in
    widespread use; yet it was only in 1995 that the first ICSI procedure
    on mice was reported on. ICSI trumps nature by injecting a sperm
    directly into an egg and so removing its barrier against sperm; in
    short, sperm otherwise incapable of penetrating an egg are creating
    babies, and lots of them. Since the oldest ICSI baby is only twelve
    years old (the oldest IVF baby, Louise Brown, is twenty-six), we have
    no idea what the long-term effects are - though, as with other in
    vitro practices, recent evidence does point to an increased risk of
    certain rare disorders. Again, the report does not call for
    constraining "progress" per se, but rather for safety controls at the
    professional and federal level, and for systematic oversight.

    No one is likely to argue with either of the first two
    recommendations. It is the third and last set of recommendations that
    may be the most contentious from the point of view of researchers,
    though welcome for the public at large. The report advocates targeted
    legislative measures against what it calls certain "boundary-crossing"
    practices: namely reproductive cloning, the creation of chimeras
    (human/animal hybrids) and the creation of a child "by means other
    than the fusion of egg and sperm". These proposed bans are in line
    with those of several other countries; we do well to remember,
    however, that IVF babies were themselves once considered
    boundary-crossing. The term is hardly absolute - especially in an era
    of rapid change. It may well be that some of the practices now
    condemned, such as the fusion of two eggs, will be normalized with the
    appearance of a baby that looks healthy, especially as definitions of
    the family become more flexible in the US. We can only hope that, if
    this occurs, oversights will be in place so that any such
    ground-breaking baby is more than a shot in the dark.

    The report dismisses outright the threat of "designer babies", a
    concern of critics of genetic testing, who think it will lead to a
    race among the affluent to create superbabies with fast-twitch muscles
    and Einsteinian IQs. This particular threat, according to the report,
    is not worth addressing because it is so highly improbable given the
    complexity of gene interactions. This sounds reasonable enough, and
    one hopes it will calm, at least temporarily, a public worried about a
    runaway genetics technology.

    As for research and those 400,000 embryos suspended on ice in the US,
    the report is circumspect. Scientists are unlikely to be either
    dismayed or delighted. The report prohibits research on human embryos
    beyond ten to fourteen days. Notably, it does not condemn research
    before that time - though it does lapse into poetic language about the
    "never-before- enacted life" an embryo might lead. The report's
    refusal to pronounce on the moral status of the early embryo is its
    greatest strength. This silence allows it to attend to what can be
    pragmatically managed via policy - and it provides a template for
    future discussion across party lines. In short, the report adamantly
    refuses to be shipwrecked by the Roe vs Wade debate (ie, women's right
    to an abortion) that has, for decades now, troubled American politics.
    This is heartening, given that the views of the committee members -
    lawyers, doctors, scientists and various brands of ethicists - span
    the pro-life to pro-choice gamut. The leader of the committee, Leon
    Kass, is known for conservative, even occasionally Luddite thinking.
    Yet he has helped produce a document that does not tidily fit into any
    ideological camp, certainly not his own. It is he who best sums up the
    committee's accomplishment: "the report's major contribution is to
    show how a heterogeneous group of individuals, whose opinions range
    almost as widely as those of the American people, has agreed on the
    need to set some limits on some uses of some bio-technologies, in
    order to protect common values".

    One could also argue that their consensus demonstrates that creating
    life via technology is not just the flip-side of terminating life via
    technology: that in the difference lies the stuff of policy. In other
    words, creating life is about the future - and about a society that
    may have to bear the costs if IVF-mediated children in the long run
    require higher than average health care, or if certain stabilizing
    values are disconcertingly compromised by, say, unfettered innovation
    or the excessive commercialization of procreation. We might also do
    well to consider that, unlike rockets or other manufactured goods,
    children spawned in the American lab may well grow up to sue their
    makers.



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