Human Genetic Intervention: Past, Present, and Future - Is Human Nature Obsolete? - page 383

4. See Larry Thompson, Correcting the Code: Inventing the Genetic Cure for
the Human Body (New York: Simon and Schuster, 1994), 230-267.
5. For a fascinating study of this process, see Donald S. Fredrickson, The Recom-
binant DNA Controversy: A Memoir (Washington, DC: American Society for
Microbiology, 2001).
6. The audit was published as “Gene Therapy in the United States: A Five-Year
Status Report,” Human Gene Therapy 7, no. 14 (September 10, 1996):
1781-1790.
7. Eliot Marshall, “Varmus Proposes to Scrap the RAC,” Science 272, no. 5264
(May 17, 1996): 945.
8. On the opposition by members of Congress, see David Pryor, Mark Hatfield,
Ron Wyden, and Henry A. Waxman, “A Word to Varmus,” letter to the editor,
Hastings Center Report 26, no. 4 (July-August 1996): 46-47.
9. See Scott Hensley, “Targeted Genetics Agrees to Buy Genovo,” Wall Street
Journal , August 9, 2000, B2; Scott Hensley, “Targeted Genetics' Genovo Deal
Leads to Windfall for Researcher,” Wall Street Journal , August 10, 2000, B12;
and Andrea Knox and Huntley Collins, “Rival to Buy Local Biotech Pioneer
Genovo,” Philadelphia Inquirer , August 10, 2000, A1.
10. The communications are warning letters to James M. Wilson, March 3,
2000, http://www.fda.gov/foi/warning letters/m3435n.pdf (January 26, 2004)
and July 3, 2000 http://www.fda.gov/foi/warning letters/m3897n.pdf (January
26, 2004), one warning letter each to Mark L. Batshaw and Steven E. Raper,
November 30, 2000, http://www.fda.gov/foi/warning letters/m4911n.pdf
(January 26, 2004) and http://www.fda.gov/foi/warning letters/m4912n.pdf
(January 26, 2004) and a notice of initiation of disqualification proceeding and
opportunity to explain letter to James M. Wilson, November 30, 2002
http://www.fda.gov/foi/nidpoe/n121.pdf (January 26, 2004). Unfortunately the
replies of the University of Pennsylvania researchers are not part of the public
record.
11. Letter from Harold Varmus to Henry Waxman, December 21, 1999
http://www.house.gov/waxman/issues/health/issues health gene therapy.htm/
(January 26, 2004).
12. For the information in this paragraph, see Deborah Nelson and Rick Weiss,
“Penn Ends Gene Trials on Humans,” Washington Post , May 25, 2000, A1.
13. Hensley, “Targeted Genetics”; Hensley, “Genovo Deal”; and Knox and
Collins, “Rival.”
14. See Deborah Nelson and Rick Weiss, “Penn Researchers Sued in Gene
Therapy Death,” Washington Post , September 19, 2000, A3; and Rick Weiss
and Deborah Nelson, “Penn Settles Gene Therapy Suit,” Washington Post ,
November 4, 2000, A4.
15. Office of Biotechnology Activities, “Recombinant DNA Research: Action
under the NIH Guidelines; Notice,” Federal Register 10, no. 65 (October 10,
2000): 60327-60332.