Biomedical Engineering Reference
In-Depth Information
13
Human Genetic Intervention: Past, Present,
and Future
LeRoy Walters
This chapter discusses human gene transfer research, primarily in the
United States but also in Europe. It examines the most successful gene
transfer study to date, considers in depth the issue of public oversight
for human gene transfer research, and looks at issues for the future, par-
ticularly the brain, enhancement, and the germ line.
I will begin with a proposal about terminology. The phrase “human
gene therapy” was always in danger of seeming to overpromise benefits
to the participants in the early clinical trials of human gene transfer.
Especially in light of the meager results of human gene transfer studies
from 1990 to the present, it seems more accurate and honest to use a
neutral phrase that simply describes the procedure that is undertaken.
In English, this more neutral phrase is “human gene transfer.” The
phrase parallels a term like transplantation , which also describes the
movement of cells or tissues from one individual to another but does not
run the risk of unduly raising the expectations of recipients. In this
chapter, then, I will employ the wording human gene transfer research
except in cases where the alternative language appears in the original
document.
Human Gene Transfer Research in the United States, 1988-2003
Between 1988 and June 2003, approximately 569 human gene transfer
protocols had been submitted to the Office of Recombinant DNA
Activities at the U.S. National Institutes of Health (NIH) (I say “appro-
ximately” because a few protocols were withdrawn and a few
consolidated.) Table 13.1 shows the number of protocols submitted by
year. 1
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