Recombinant DNA Advisory Committee - 7/31/90 
of TNF toxicity would have on the underlying TIL therapy. Dr. 
Rosenberg said any premature withdrawal of IL-2 will lead to 
decreased efficacy of the TIL, therefore, the efficacy of the 
treatment will be decreased. Mr. Brewer asked if there was any 
additional risk to the patient from withdrawal of the 
experimental therapy. Dr. Rosenberg said he knew of none except 
the potential progression of their underlying cancer. Dr. 
Schaechter reminded the group that although there are three 
potentially effective modalities for decreasing toxicity, they 
cannot be used without a price. 
Dr. Epstein moved that: 
"We approve this protocol with the final consent form 
to be reviewed administratively to see that it is 
consistent with the discussion, and pending local IBC 
approval . " 
Mr. Brewer seconded the motion. 
There being no further discussion on the motion. Dr. McGarrity 
put it to a vote. The motion passed by a vote of 17 in favor, 0 
opposed, and no abstentions. 
Dr. McGarrity thanked the committee and said he felt it 
worthwhile to reflect on the significance of the two motions 
passed during the morning session. They are the first approvals 
for true gene therapy rather than simple gene insertion. He 
noted that this is a historic occasion in that now gene therapy 
can be added to the repertoire of vaccines, antibiotics, drugs, 
surgery, and radiation to fight disease. 
Dr. McGarrity thanked the members of the RAC, the members of the 
HGTS, and the HGTS Chair — Dr. Walters. In his opinion, the 
public and national purpose had been well served by the debate 
and discussion. He thanked the investigators for their help and 
cooperation and wished them luck in the execution of these 
protocols. He especially thanked Dr. W. French Anderson who he 
said had "pioneered and taken this from a very embryonic stage 
four or five years ago." 
Dr. Anderson noted the rigor of the review but said it had been 
very fair and very thorough. The public should be comfortable 
with the intense review process that had taken place. He 
expressed the investigators' appreciation for the timeliness of 
the review and the effort that had been put into it. 
Dr. Parkman noted that at the meeting of the HGTS, Dr. Claudio 
Bordignon, who presented the data on his experiments in Milan, 
had made the observation that, in Italy, none of the processes 
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