DEPARTMENT OF HEALTH & HUMAN SERVICES 
Public Health Service 
National Institutes of Health 
Bethesda, Maryland 20892 
Building : 
Room : 
(301)496-* 2 4 33 
November 25, 1988 
Mr. Brian F. Mannix 
Resident Fellow 
Economic Policy Studies 
American Enterprise Institute 
for Public Policy Research 
1150 Seventeenth Street, N.W. 
Washington, D.C. 20036 
Dear Mr. Mannix: 
Thank you for your letter of October 28 commenting on the 
Recombinant DNA Advisory Committee's (RAC) review and approval of 
the proposal for human gene transfer. The level of detail in 
your remarks reflects your commitment to the mission of the RAC 
and you must be commended for this. Many of your points are well 
taken and deserve mention, particularly the need to preserve the 
momentum of this important research. I have asked that all 
elements of the review of this proposal proceed as rapidly as 
possible. You may be interested to learn that November 4, the 
National Institutes of Health (NIH) Institutional Biosafety 
Committee, whose formal approval is required for this work to be 
conducted, voted in favor of such approval. This is only one 
stage in the process before the proposal reaches my desk for a 
final decision. In addition, the Institutional Review Boards of 
both sponsoring institutes must give their consent. 
It is important to note that the Human Gene Therapy Subcommittee 
was established and duly constituted with appropriate experts for 
the sole purpose of reviewing proposals to insert genetic 
material into human subjects to ensure their safety to those 
patients as well as to the general public. This subcommittee has 
been engaged in such discussions for over two years as 
preparation for providing a focused, technical critique of such a 
protocol. While the Anderson-Blaese-Rosenberg project does not 
involve gene therapy per se, the techniques to be employed are 
similar to those we expect to see in the first gene therapy 
experiment. With this in mind, the subcommittee felt that their 
review would be appropriate, and I concur in this decision. 
Although the RAC voted to approve the proposal submitted by 
Dr. Anderson, et al., their vote was based in part on information 
that had not been provided to the subcommittee for its meeting 
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Recombinant DNA Research, Volume 13 
