Biomedical Engineering Reference
In-Depth Information
an oncogene (LMO2) in some of the cells that were transferred into the
children after genetic modification.
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Public Oversight for Human Gene Transfer Research
Three stages can be distinguished in the history of public oversight for
this field in the United States. The first stage began in the 1980s and con-
tinued through the first half of the 1990s. From 1983 through 1995, the
public oversight system for human gene transfer research was estab-
lished. The second stage began in 1996 and continued through 1999;
during this time, the existing public oversight system was substantially
weakened. A third stage was triggered by the death of a research subject
in a gene transfer trial in September 1999. From the time of Jesse
Gelsinger's death forward, and especially from the years 2000 to 2002,
an effective oversight system for gene transfer research was restored.
In the United States, there was an effective, though somewhat unsta-
ble, national oversight system in place for human gene transfer research
between 1990 and 1995. During the early 1990s, every interested citizen
and policy maker in this country and the world as a whole knew exactly
what was happening in the field of human gene transfer research in
the United States. In fact, several other countries established advisory
committees that paralleled the NIH's Recombinant DNA Advisory
Committee (RAC) in its public review of human gene transfer clinical
research protocols.
The public oversight system established in the United States was an
important precedent. Although it followed by several years the prema-
ture attempts by Martin Cline of the University of California at Los
Angeles to perform human gene transfer, it was nonetheless an antici-
patory system.
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In fact, those of us who helped to develop the guidelines
for research in this field in late 1984 and early 1985 were concerned that
we might not conclude our work before the first research protocol was
submitted. The first gene-marking study was proposed to RAC in 1988,
however, and the first gene transfer study aimed at the treatment of sub-
jects came forward only in early 1990.
There were weaknesses and ambiguities in the public oversight system,
to be sure. The most critical weakness, in retrospect, was the failure of
the NIH and the Food and Drug Administration (FDA) to establish
