concern to both the Subcommittee and the RAC. Many people did 
not feel this protocol should have come to the Subcommittee and 
that concern should not be over risk but over the future of gene 
therapy. He said he was comfortable with recommending that the 
study go forward but was uncomfortable that the process had 
become truncated which could set the tone for future protocol 
submissions to both the Human Gene Therapy Subcommittee and the 
RAC. 
Dr. Childress added that he was interested in whether there was a 
way to speed the process up without having to wait for another 
formal meeting of the Subcommittee or the RAC. 
Mr. earner moved that the procedure be approved as presented with 
the provision that it be limited to 10 patients, each of whom has 
a life expectancy not to exceed 90 days, and each of whom 
consents to participation after having a full understanding of 
what he or she is accepting. 
The motion was seconded, and Dr. McGarrity offered the motion to 
the floor for discussion. Dr. Davis said there was a gap between 
the assay sensitivity issue and the risk issue but that he didn't 
feel it justified holding the protocol up. He said he was not 
comfortable with Dr. Anderson's emotional appeal but that it 
could not be disregarded. Further, he said this protocol should 
not be viewed as precedent-setting, and future cases will be 
judged on their own merits. 
Dr. Murray said because of the close call and difference of 
opinion as to whether this proposal should even come before the 
Subcommittee and the RAC, it should be deemed a "special case," 
since it is not gene therapy in the classical sense and agreed 
that it would not constitute precedent for future protocol 
consideration. 
Mr. McCreery called the question. Dr. McGarrity put the motion 
to call the question to a vote. The motion passed by a vote of 
11 in favor, 9 opposed, and no abstentions. 
Dr. McGarrity then put Mr. earner's motion to a vote. The motion 
passed by a vote of 16 in favor, 5 opposed, and no abstentions. 
Dr. McGarrity thanked all presenters. Subcommittee members, and 
RAC members for the tremendous amount of time they had expended 
on this item. He then called on Dr. Murray who asked the 
investigators to provide the Subcommittee with the data and to 
keep them informed as to the progress of the protocol. 
Dr. Anderson responded that he would be happy to supply the data 
and the IND provided it was done in a manner that did not make it 
available to the press. 
Recombinant DNA Research, Volume 13 
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