On May 9, an FDA Advisory Committee held a public meeting to
discuss ooplasmic transfer, the fertility technique used by
researchers to produce what they provocatively - and in part
misleadingly -- announced in March 2001 was "the first
case of human germline genetic modification." The following
month, FDA told fertility clinics to stop offering the experimental
While seemingly concerned about the social as well as the medical
risks of ooplasmic transfer, FDA is legally forbidden to address
issues other than safety and efficacy, and is largely limited
to procedural matters. The agency asserted its jurisdiction
over the ooplasmic transfer procedure, said it would not permit
it until more pre-clinical work is done, and called for further
In a statement issued at the meeting, FDA expressed concerns
about this "de facto germ line gene transfer" technique,
including its potential to alter the germline, the serious medical
risks associated with it, the high incidence of Turner's syndrome
in fetuses reported in one study (2 of 13 reported pregnancies),
and the paucity of animal studies and other pre-clinical data.
Supporters of the new eugenics believe that approval of ooplasmic
transfer and other fertility techniques involving "inadvertent"
germline alteration will help condition people to accept explicit
germline and other eugenic engineering applications.
More on ooplasmic transfer, including analysis of the St. Barnabas
FDA's statement: http://www.fda.gov/ohrms/dockets/ac/cber02.htm#Biological%20Response%20Modifiers