[-empyre-] FDA to hold first public hearing on GM babies

[Adam Zaretsky]

In one month is the public hearing on ³oocyte modification², often referred
to as three parent babies, carrying a genetic modification through nuclear
transfer of an ovum nucleus into a surrogate egg, to replace defective
mitochondria with healthy egg white of another¹s enucleated donated
egg/ovum. This is both human cloning and a limited form of IGM (Inheritable
Genetic Modification of the human genome.)

It is a test to see how the FDA will ok future coordinated or wild west
farming of rare post-humans. It could be thought of as mitochondrial
transplant... But it shows how to mass produce designer babies and it is up
for review. Pitting raw research against consumer rights and industrial
interests, the heath of the unborn, read as curing infertility, may be the
key to open the door to regulatory approval:

³In re-opening the allowance for GM babies, whose genetic changes will be
passed on to future generations, the FDA is taking the next steps toward
toeing the line on genetic human enhancement.²
--http://www.activistpost.com/2013/09/fda-to-hold-first-public-hearing-on-gm
.html

One question is, since our genome is regulated by the FDA, instead of the
EPA (even though this is a global ecological diaspora)
So our transhumans a food or a drug?

Office of Cellular Tissue and Gene Therapies Center for Biologics Evaluation
and Research (CBER) FDA.
October 22-23, 2013 -
http://www.fda.gov/AdvisoryCommittees/Calendar/ucm361972.htm

This is where the biopolitical debate inserts itself, on the liminal edge of
the Œactual¹. We are talking about Deleuze¹s Spinoza while actually
redesigning what a body can do, how to harness being, othering the isness of
the ofness. And, if we want an affirmative overcoming without the work of
the negative that Foucault implies, how is health, consumerism, industry and
federal rubber-stamp oversight going to bring us overmenching into the lines
of flight that free range ideation can provide?

Can I actually ask how our flora of philosophy will do anything beyond offer
an extra esoteric foil for new eugenics? Elimination of the flawed, erasure
of the differences, Œenhancing¹ away disability (differently abled), is
affirmation a cure in this context? Getting rid of those invented mad, the
dis-eased, those without social etiquette (spectrum disorder, schizophrenia,
etc.)... We wouldn¹t have our Nietzsches, our Kafkas, our Mansons, our
Edisons. I work to make a clinic of GenMod defect accentuation.
Biopolitically this does not fit the regulatory structure being developed.
Society is still the hole we dig.

Options:
http://hplusmagazine.com/2011/02/06/mutate-or-die-a-w-s-burroughs-biotechnol
ogical-bestiary/

For Comment:

Cellular & Gene Therapy Guidance Documents

http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInform
ation/Guidances/CellularandGeneTherapy/default.htm

Draft Guidance for Industry: Considerations for the Design of Early-Phase
Clinical Trials of Cellular and Gene Therapy Products (PDF - 124KB)
http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegula
toryInformation/Guidances/CellularandGeneTherapy/UCM359073.pdf

7/2013. (This guidance document is for comment purposes only.)

Public Participation Information

Interested persons may present data information or views orally or in
writing on issues pending before the committee.
Written submissions may be made to the contact person on or before October
15 2013. Oral presentations from the public can be applied for.

The link for the webcast is available at:
https://collaboration.fda.gov/ctgtac1013/

The team to be aware of now is Shoukhrat Mitalipov  and his research team at
Oregon Health and Science University (OHSU) as well as the Boston-based
company called Ovascience, but this has been going on since the early 1990s
particularly in hospitals that did not receive any federal funding (i.e.
Masonic Hospitals and corporate human trials), in Korea, in Sweden and in
New York City (Cornell Extension).

³If the FDA gives the OHSU researchers a green light to move towards human
clinical trials, it will be the first instance of regulatory approval for
human germline modification ever, anywhere in the world.² -
http://www.biopoliticaltimes.org/article.php?id=7150

Can I ask our small group for a concerted response to the actual technology
of the body being amassed on the border of our genomic commons?


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