In 1990 W. French
Anderson became the first person to attempt authorized somatic
gene transfer experiments on humans. In 1998 he proposed to begin
in utero somatic gene transfer experiments and in the process,
in his words, "push the envelope" on inheritable genetic
Specifically, Anderson asked the NIH's Recombinant DNA Advisory
Committee (RAC) to review a draft proposal asking for permission
to begin somatic gene transfer experiments on fetuses in
utero that had been shown by prenatal tests to be afflicted
with a fatal childhood genetic disease, adenosine deaminase
(ADA) deficiency. The proposed gene transfer procedure was intended
to get corrective genes into a fetus' system at a stage early
enough to prevent the defective genes from inflicting developmental
harm on the fetus. However, gene transfer at early developmental
stages poses a "high risk" that some of the transferred
genes would locate in precursor egg and sperm cells, and thus
alter inheritable genes.
Anderson has been a vocal advocate of inheritable genetic modification
for therapeutic purposes. In his draft proposal he freely acknowledged
the possibility of "inadvertent" germline modification,
and said that this "might be considered a benefit."
It was widely acknowledged that Anderson's proposal was a strategic
move to help set the stage for eventual official approval and
public acceptance of intentional inheritable germline modification.
If the RAC ruled that Anderson's proposal was acceptable, it
would put the US government on record as saying that germline
modification was not so objectionable an event that it should
stand in the way of at least some other beneficial interventions.
If the RAC ruled that the proposal was unacceptable, it would
have to state why.
Anderson knew that the RAC was unlikely to invoke ethical,
moral or social concerns as a basis for rejecting a medical
research proposal, other than as might pertain to patient safety.
So disapproval would also work towards eventual approval
of germline modification, by giving official US government sanction
to the notion that its eventual acceptability rests on questions
of patient safety rather than on overarching ethical, moral
or social values.
Reactions to Anderson's Proposal
Press accounts of Anderson's proposal treated it as a particularly
dramatic but otherwise acceptable instance of innovative medical
research, rather than as an effort to "force the debate"
on germline engineering.
The RAC received over 70 letters protesting Anderson's proposals,
most noting that the procedures would come very close to a widely
recognized critical threshold that should not be crossed.
On March 11, 1999, the RAC issued a unanimous agreement stating
that "it is premature to undertake any human in utero
gene transfer experiment." However, its ruling left the
door open to eventual approval by specifying the experiments
in animals, and other tests, that would need to be conducted
to demonstrate sufficient safety and efficacy to allow such
a proposal to be approved.
Anderson had earlier stated his intent to be ready to submit
an official proposal to begin in utero gene transfer
experiments by 2001. However, the death of Jesse Gelsinger in
2000 and subsequent widespread criticism of the practice of
gene therapy research delayed this project, which appears to
be in abeyance.