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In Utero Somatic Gene Transfer Proposals

March 15th, 2002

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 modification.

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.


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