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--- In [email protected], [EMAIL PROTECTED] wrote:
>
>  
>  
>  
> Medievalizing Biotech Regulation
> Francis Fukuyama wants to control your reproductive  decisions. 
> _Ronald  Bailey_ (http://www.reason.com/staff/show/133.html)  | 
March 9, 2007 
> "We are proposing a new regulatory institution in Washington,  DC," 
said 
> Francis Fukuyama, professor of political economy at the Johns 
Hopkins  University 
> School of Advanced International Studies and author of Our 
Posthuman  Future. 
> "It's been a long time since anyone has done that." 
> 
> What needs  regulating? Human biotechnology. Fukuyama unveiled his 
plan for a 
> new agency at  a conference held at the Rayburn House Office 
building on 
> Capitol Hill. The  blueprint for the new biotech regulatory agency 
being proposed 
> by Fukuyama and  Swiss technology consultant Franco Furger is laid 
out in a 
> 400 page book, _Beyond Bioethics: A Proposal for Modernizing  the 
Regulation of 
> Human Biotechnologies_ (http://www.biotechgov.org/) .
> 
> Why do we need a new  biotech regulatory agency? Because bad things 
have 
> happened? Not at all. In  fact, Fukuyama wants to put his proposal 
in play now so 
> that the denizens of  Capitol Hill can simply pull it off the shelf 
and enact 
> it into law when some  sort of biotech scandal erupts. The proposed 
agency is 
> explicitly modeled after  the British Human Fertilisation and 
Embryology 
> Authority (HEFA). Fukuyama's new  agency would not just regulate 
the safety and 
> efficacy of new biotechnologies,  but also rule on their ethical 
propriety. 
> According to Fukuyama, biotechnology  is "galloping ahead" and it's 
time to move 
> from ethical discussions to  regulation and "social control."
> 
> Furger discussed some recent  developments to illustrate how 
biotech is 
> galloping ahead. For example, a Texas  fertility clinic is now 
offering _embryos 
> for sale_ (http://www.reason.com/news/show/36844.html) ;  
researchers have 
> manufactured _mouse  sperm_ 
> (http://www.newscientist.com/channel/sex/stem-cells/mg19125604.200-
stem-cells-turned-into-sperm.html)  from stem cells; and others 
> have inserted human cell nuclei into _rabbit  eggs_ 
> (http://www.timesonline.co.uk/tol/news/uk/article787775.ece)  to 
try to produce stem cells. Furger said 
> that he was listing these  activities, "not to say that they are 
reproachable. 
> Some may be acceptable and  some not." He asked, "But how do we 
make that 
> determination?"
> 
> Fukuyama  explained that the new agency would regulate anything 
having to do 
> with assisted  reproduction techniques (ART). This would include 
IVF, _ooplasm 
> transfer_ (http://www.sbivf.com/ivf_cyto.htm) , sex selection  
either by 
> pre-implantation genetic diagnosis (PGD) or _sperm sorting_ 
> (http://www.reason.com/news/show/34895.html) . The agency  would 
also regulate research involving 
> human reproductive tissues including all  embryonic stem cell 
research and 
> anything dealing with human developmental  biology.
> 
> "Biotech has reached point where existing regulators, the Food  and 
Drug 
> Administration and the National Institutes of Health, can't handle 
it,"  declared 
> Fukuyama.The agency would be guided by a set of ranked ethical  
principles. 
> Its first concern would be the well-being and health of children.  
Second, 
> ensuring equal access to ART for infertile couples. Third, 
protecting  the 
> well-being of and health of women. Fourth, promoting therapeutic 
uses of ART  over 
> enhancement uses. Fifth, making sure that patients and research 
subjects  give 
> their free informed consent to procedures. And finally, advocating 
for  
> regulations to limit the commercialization of human eggs, sperm and 
embryos.  
> 
> Fukuyama would completely ban human reproductive cloning, the 
creation  of 
> human animal chimeras for the purpose of reproduction, germline 
genetic  
> modifications, any procedure that would alter the genetic 
relationship of  parents to 
> children, and the patenting of human embryos.
> 
> The new agency  would regulate research cloning, PGD, sex selection 
of 
> embryos, and the  commercialization of certain elements of human 
reproduction such 
> as the sale of  eggs, sperm and embryos. It would consist of a set 
of 
> commissioners, appointed  by the president and advised by a board 
consisting of various 
> stakeholder groups  such as patients, ART practitioners, scientific 
community 
> and the biotech  industry. Fukuyama also introduced a novel set of 
mechanisms 
> for consulting with  the wider public including deliberative panels 
and a 
> consultative college of  consisting of randomly selected members of 
the public 
> who convene to consider  regulatory issues over the internet.
> 
> Instead of inhibiting research and  the development of new 
treatments, the 
> new agency could spur them on, suggested  Fukuyama. For example, he 
asserted 
> that Britain is ahead of the United States in  human embryonic stem 
cell research 
> because of the HFEA's regulations. Fukuyama  is just plain wrong 
about that. 
> The Guardian _reported_ 
> (http://www.scenta.co.uk/scenta/features.cfm?
cit_id=1568805&FAArea1=widgets.content_view_1)   last 
week, "Excessive bureaucracy 
> imposed by the Human Fertilisation and  Embryology Authority [is] 
prohibiting 
> development in stem cell research and  threatening Britain's 
position as a world 
> leader in the field." The  Guardian quoted stem cell researcher 
Alison Murdoch, 
> director of the  Newcastle Centre for Life fertility clinic, as 
saying, "The 
> way the government  has handled the work we do is to regulate it to 
the point 
> that it looks like  it's got barbed wire around it."
> 
> But what about the larger question: Do we really want a federal 
agency  
> making and imposing ethical decisions about human reproduction? 
Consider the  
> wretched history of federal and state regulation in this area. In 
1873, Congress  
> passed the Comstock Laws that _outlawed_ 
> 
(http://advocatesforpregnantwomen.org/main/publications/articles_and_r
eports/the_war_on_drugs_and_the_war_on_abortion
> 
_some_initial_thoughts_on_the_connections_intersections_and_the_effect
s.php)  
>  "every obscene, lewd, or lascivious, and every filthy book, 
pamphlet, 
> picture,  paper, letter, writing, print, or other publication of an 
indecent 
> character,  and every article or thing designed, adapted, or 
intended for preventing  
> conception or producing abortion." The Comstock Laws authorized the 
U.S. Post 
>  Office to confiscate any publications providing advice on 
contraception and  
> condoms shipped through the mail. The first eugenics law was passed 
in 
> Indiana  in 1907 and eventually laws allowing the forced 
sterilization of "unfit" 
> people  were _adopted by 30  states_ 
> (http://www.commondreams.org/headlines/021500-02.htm) . Infamously, 
the U.S. Supreme Court upheld forced sterilization in 
>  the case of _Buck v. Bell_ 
> (http://www.law.du.edu/russell/lh/alh/docs/buckvbell.html)   in 
1927. By the 1960s, some 66,000 Americans had been forcibly  
> neutered.
> 
> In the last half of the 20th century, the U.S.  Supreme Court 
finally stepped 
> in to overrule state interference in the  reproductive decisions of 
> Americans. In 1965, the Court found unconstitutional  the 
Connecticut law prohibiting 
> use of birth control by married couples in _Griswold  v. 
Connecticut_ 
> 
(http://www.law.umkc.edu/faculty/projects/ftrials/conlaw/griswold.html
) . In 1967, the 
> Court ruled in _Loving v. Virginia_ 
(http://www.ameasite.org/loving.asp)  that 
> the laws  in 16 states banning interracial marriage were 
unconstitutional. In 
> 1972, the  Court struck down in the case of _Eisenstadt  v. Baird_ 
> (http://caselaw.lp.findlaw.com/scripts/getcase.pl?
navby=CASE&court=US&vol=405&page=438)  
> a Massachusetts law prohibiting the sale of contraceptives to  
unmarried 
> people. And of course, the Supreme Court found prohibitions on  
abortion 
> unconstitutional in 1973 in _Roe v. Wade_ 
(http://www.tourolaw.edu/patch/Roe/) .
> 
> The HFEA, the  model for Fukuyama's new biotech regulatory agency, 
has 
> similarly interfered  with the reproductive decisions of British 
people. The HFEA 
> has told couples  that they could _not select the  sex_ 
> (http://www.wired.com/wired/archive/10.02/biotech.html)  of embryos 
to be implanted. Even now the 
> parents wanting to use PGD to  insure that their children will not 
be burdened 
> with an inherited genetic  disease must _apply  for permission_ 
> 
(http://www.cambridgenetwork.co.uk/POOLED/ARTICLES/BF_NEWSART/VIEW.ASP
?Q=BF_NEWSART_185290)  
> from the HFEA. And the HFEA has _banned_ 
> (http://www.hfea.gov.uk/cps/rde/xchg/SID-3F57D79B-
F047022A/hfea/hs.xsl/1491.html)   paying women for providing eggs 
> to be used in research.
> 
> Fukuyama's agency  would rule not only on safety and efficacy but 
on moral 
> questions surrounding  human reproduction. Some possible techniques 
are 
> objectionable and should be  banned, e.g., any attempt to create a 
half-human 
> half-chimp baby. On the other  hand, Fukuyama wants to ban ever 
allowing parents to 
> safely choose genes that  would tend to give their children 
healthier immune 
> systems, stronger bodies and  cleverer brains.
> 
> It turns out that the proposed agency is largely just a  vehicle 
for Fukuyama 
> to impose his moral choices on other people. What Fukuyama  is 
proposing is a 
> step backward to the bad old days in which strangers get to  vote 
on what 
> kind of children their fellow citizens will be allowed to bring  
into the world. 
> A government bureaucracy, rather than parents, would get to make  
eugenic 
> decisions. As the sorry history of attempts to regulate human  
reproduction shows, 
> the truly moral thing to do is fiercely resist this  proposal.
> 
> _Ronald Bailey_ (mailto:[EMAIL PROTECTED])  is  Reason's science 
> correspondent. His book _Liberation Biology: The Scientific and 
Moral  Case for the 
> Biotech Revolution_ (http://www.reason.com/lb/)  is now available 
from Prometheus  
> Books.
> Send this article to:  
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>  
>  
>  
>  
> More Articles by _Ronald  Bailey_ 
(http://www.reason.com/staff/show/133.html) 
>     *   _Welcome to  Biotech Park_ 
> (http://www.reason.com/news/show/119013.html) 
> Michael Crichton's latest novel is readable, daring,  and flawed. 
(3/7)  
>     *   _Whose Life Is It  Anyway?_ 
> (http://www.reason.com/news/show/118930.html) 
> The FDA versus dying cancer patients. (3/2)  
>     *   _Benign  Cells?_ 
(http://www.reason.com/news/show/118454.html) 
> Cancer and Mobile Phones (3/1) 
> 
>  
>  
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Ronald 
> Bailey (3/7)  
>     *   _Their Bodies, Our  Selves_ 
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> Who owns your body? Hint: It's not you. Kerry  Howley (12/5)  
>     *   _Can We Ever Spend  Too Much on Biomedical Research?_ 
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> The answer depends on whom you're  asking. Ronald Bailey (10/6) 
> 
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> 
> 
> 
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