Three Legal Frameworks for Regulating Genetic Technology
![handle is hein.journals/jchlp19 and id is 15 raw text is: ARTICLES
THREE LEGAL FRAMEWORKS FOR
REGULATING GENETIC TECHNOLOGY
Wilson Huhn*
INTRODUCGTION
Intellectual and technological revolutions of the past have
fundamentally changed the way we live and vastly expanded the amount
of knowledge we can master. The Renaissance, the Industrial Revolution
and the Information Age each represent a great leap forward in human
potential. The Genetic Age promises another exponential increase in
human knowledge and potential.
With this new age there is also vast potential for harm. We must not
forget Jesse Gelsinger, an eighteen-year-old who volunteered as a subject
in a study at the University of Pennsylvania Institute for Gene Therapy
(the Institute), which at that time was considered the leading program in
the nation.' The most common method for delivering DNA for gene
therapy is by weakened adenoviruses. On September 13, 1999,
researchers at the Institute inoculated Jesse with a massive dose of
adenovirus.3 Jesse slipped into a coma and died four days later.4 Jesse's
mother said, I have read that my son's death has been called by one of
* B.A., 1972, Yale University, J.D., 1977, Cornell Law School. McDowell Professor of
Law and Research Fellow, Constitutional Law Center, University of Akron School of
Law. This paper was presented at the 2001 Human Genome Odyssey Conference,
sponsored by The University of Akron and the Northeastern Ohio Universities College
of Medicine.
1. See Judith A. Cregan, Light, Fast, and Flexible: A New Approach to
Regulation of Human Gene Therapy, 32 McGEORGE L. REV. 261, 267 (2000);
Michael Baram, Making Clinical Trials Safer for Human Subjects, 27 AM. J.L. &
MED. 253,255-256 (2001).
2. Success [of gene therapy], according to researchers, depends upon
effective delivery of the new genetic material into the target cells of the patient
using a vector, usually a disabled virus . Id. at 255. See also Gene Therapy
Touted as Cancer Fighter, NEWSDAY, February 27, 2001, at A42.
3. See Cregan, supra note 1, at 267. See also Joseph M. Rainsbury,
Biotechnology on the RAC - FDA/NIH Regulation of Human Gene Therapy, 55
FOOD & DRUG L.J. 575, 592-594 (2000).
4. See Cregan, supra note 1, at 267.](ViewImageLocal?handle=hein.journals/jchlp19&div=8&collection=&method=preview&ext=.png&size=3)
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