Dr. Walters 
Dr. LeRoy Walters, chairman, Human Gene Therapy Subcommittee 
( HGTS ) , opened the meeting at 9 a.m. by welcoming Dr. Gerard 
McGarrity, chairman of the Recombinant DNA Advisory Committee. 
Dr. McGarrity was present to observe and to participate in 
discussion of the first agenda item, a proposal for human gene 
transfer, submitted by Drs. Anderson, Blaese, and Rosenberg. 
Dr. Walters noted that a Subcommittee member, Mr. Alexander Capron, 
had been elected chairman of the Congressional Biomedical Ethics 
Advisory Committee. In addition to the gene transfer experiment, 
there were two items on the agenda: a public information brochure 
regarding human gene therapy, and a petition to establish a Human 
Eugenics Advisory Committee submitted on behalf of the Foundation 
on Economic Trends . 
I. Human Gene Transfer Proposal 
Dr. Walters provided a brief chronology of events leading to this 
meeting. Dr. Rosenberg is currently conducting a clinical study 
on the use of adoptive immunotherapy to treat cancer patients. In 
the proposal under review, Drs. Anderson, Blaese, and Rosenberg 
intend to insert a gene coding for neomycin resistance (NeoR) into 
tumor infiltrating lymphocytes (TIL) isolated from cancer patients. 
The Human Gene Therapy Subcommittee first received the human gene 
transfer proposal for review on July 29, 1988. At that time, the 
Subcommittee adopted a motion presented by Dr. Paul Neiman to defer 
approval of the experiment pending receipt and review of additional 
data. The motion included a list of 5 questions that the 
Subcommittee members agreed must be addressed in a future 
submission. 
A telephone conference was conducted on September 29 in order to 
discuss supplemental information provided by the investigators, 
with the goal of reporting a decision at the October 3 meeting of 
the RAC. At the conclusion of the September 29 meeting, there was 
unanimous support for a decision to defer approval of the proposal 
on the basis of significant technical questions remaining 
unresolved. 
At the October 3 meeting of the RAC, Drs. Anderson, Blaese, and 
Rosenberg presented a summary of new data that had not been 
provided to the Human Gene Therapy Subcommittee previously. 
Members of the RAC approved the human gene transfer proposal by a 
vote of 16 in favor, 5 opposed and no abstentions. After reviewing 
the proceedings of both the RAC and the Subcommittee meetings , 
Dr. Wyngaarden, National Institutes of Health (NIH) Director, 
requested that the Subcommittee reconsider the proposal, including 
in their deliberations all the material that had been provided to 
the RAC on October 3 , and any additional data obtained by the 
investigators since that time. 
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Recombinant DNA Research, Volume 13 
