Recombinant DNA Advisory Committee - 12/3-4/92 
Dr. Carmen asked Dr. Royston if this compassionate plea request would be for 
submission to the protocol that was deferred by the HGTS in November 1991. Dr. 
Royston said that he could not give an exact answer to the question because the 1991 
protocol proposed the administration of transduced autologous fibroblasts in combination 
with irradiated tumor cells. The compassionate use IND submitted to the FDA proposes 
the administration of transduced autologous fibroblasts and/or transduced autologous 
tumor cells. 
Dr. Anderson stated that the Federal Advisory Committee Act, as interpreted in part by 
the NIH Guidelines , states that the NIH Director gives approval and is required to seek 
the advice of the advisory committee (RAC). Does the discussion of this issue at this 
meeting satisfy this criterion? If the current discussion can be interpreted as seeking the 
advice of the RAC , then the final decision could be made by the NIH Director. 
Mr. Barton said that he had a problem with Dr. Anderson's interpretation of the NIH 
Guidelines. The NIH Guidelines clearly state that the RAC cannot approve any formal 
action without giving the appropriate Federal Register notice. If there is an individual 
who has reason to argue that the proposed experiment is particularly dangerous, he/she 
would have been deprived of the opportunity to try to bring that issue to the attention of 
the RAC. One of the major reasons that the RAC exists is to ensure that those 
arguments can be presented before any final actions are taken. The NIH Guidelines 
state that the NIH Director will not make a decision until she has a recommendation 
from the RAC. The public is entitled to rely upon that fact. Technically, any 
recommendation made at this meeting would not fulfill the requirement to seek the 
advice of the RAC because a recommendation made by the RAC without Federal Register 
notice is arguably no recommendation at all. 
Ms. Meyers stated that society is still very afraid that gene therapy and recombinant 
DNA will cause the escape of viruses that will create two-headed monsters. Therefore, 
there is still a great need to review all proposals in a public forum. She noted that Dr. 
Royston has acknowledged that there is no expectation that this protocol will provide any 
therapeutic benefit to the patient. Ms. Meyers explained that there is nothing worse 
than raising false hope in a dying patient. Ms. Meyers asked Dr. Royston why he had 
not submitted his request before the required 15 day Federal Register notice. Dr. 
Royston said that he was not aware that this procedure was an option. As a point of 
clarification. Dr. Wivel stated that the RAC has approved the adoption of a protocol 
submission plan that allows for adequate review by the RAC members and investigator 
responses. The RAC requires that protocols must be submitted 8 weeks in advance of a 
regularly scheduled meeting. Dr. Post noted that the letter to the NIH Director from 
Senator Harkin was dated October 8, 1992. There was obviously sufficient time for the 
investigators to submit this request according the RAC's submission criteria. Dr. 
Recombinant DNA Research, Volume 16 
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