DEPARTMENT OF HEALTH &. HUMAN SERVICES 
Public Health Service 
National Institutes of Health 
Bethesda, Maryland 20892 
8uilding : 
Room 
(301) 496- 
OCT 1 8 1988 
Gerard J. McGarrity, Ph.D. 
President 
Coriell Institute for Medical Research 
Camden, New Jersey 08103 
Dear Dr. McGarrity: 
After reviewing the material provided to the Human Gene Therapy Subccnmittee 
and the Recombinant ENA Advisory Committee (RAC) and discussing with staff the 
events leading up the October 3 RAC vote, I have decided to defer a decision 
on the Anderson, Blaese, and Rosenberg Proposal for human gene transfer, 
pending further review by the Hunan Gene Therapy Subcommittee. Based on still 
unresolved questions raised by the Subccnmittee and the NIH Institutional 
Biosafety Canmittee, I suggest that the entire protocol, including data 
presented at the October 3 meeting and any additional data obtained since that 
date, be reviewed by the Human Gene Therapy Subcommittee prior to resubnission 
of the proposal to the full RAC. 
The proposal represents a very significant advance in both scientific and 
clinical terms and should be pursued as rapidly as an orderly process permits. 
There are compelling reasons to ensure that this first attempt at insertion 
and expression of a foreign gene in human patients is reviewed carefully 
through the channels established for this purpose. Although this does not 
constitute gene therapy per se , gene transfer must be regarded as a prelude to 
such experiments and thus subject to the identical review process. The 
Anderson et al proposal will certainly be regarded as precedent-setting. 
I am hopeful that the availability of additional data will address the 
concerns of the Subcommittee. Clearly, access to this material and time to 
evaluate it thoroughly are necessary to insure proper assessment. An 
expeditious review by the Subcommittee is desirable in order to attain the 
enormous potential benefits of this procedure. Moreover, a timely response 
will also convey a positive message to the applicants who should be encouraged 
to continue their efforts. In order to avoid delay, I suggest that the Human 
Gene Therapy Subcommittee meet soon, and if they approve, obtain RAC 
concurrence by telephone. 
[ 442 ] 
Recombinant DNA Research, Volume 13 
