Recombinant DNA Advisory Committee - 01/14/93 
important to review. He does not want the RAC to accuse him of being evasive. Dr. 
Post said that he would like to take Dr. Royston up on his offer to provide the material 
that was submitted to the FDA which was never submitted to the RAC. Dr. Royston 
agreed to provide the FDA material for the March 1-2, 1993, RAC meeting. 
Dr. Post stated that the RAC will make an exception to the January 4 submission 
deadline because the protocol is not under formal review. Submission of this additional 
information will suggest the mechanism that was used to approve this protocol. The 
record can be set straight, rather than continue the guesswork about what information 
was submitted to the FDA Perhaps review of this additional information at the March 
1993 meeting will evolve into a constructive process. 
Dr. Geiduschek asked about the specific protocol that was reviewed by the San Diego 
Regional Cancer Center's IRB on December 18, 1992. Was it the transduced fibroblast 
protocol or the transduced glioblastoma tumor cell protocol? Dr. Royston responded 
that the IRB primarily reviewed the transduced glioblastoma protocol; however, it was 
requested that if the number of glioblastoma cells was insufficient, then fibroblasts could 
be used instead. Dr. Geiduschek asked if the material that was provided as part of the 
RAC mailing was the same material that was supplied to the IRB. Dr. Royston said that 
he could not recall if the same material was presented to the IRB. The protocol 
underwent several modifications. 
Dr. Royston explained that the final protocol was never sent to the NIH. Dr. 
Geiduschek asked if the final protocol was substantially different from the original 
protocol. Dr. Royston said that it depends on whom you ask. The only significant 
difference is that the dose of radiation was lowered from 20,000 rads to 7,000 rads. 
Dr. Royston said that the protocol that was submitted to NIH was written after returning 
from the December 1992 RAC meeting. At that meeting, the RAC said that they would 
entertain a single patient protocol. He stated that Dr. Wivel had requested that 
additional data should be submitted, including the Points to Consider , but was informed 
that the application could be withdrawn following Dr. Healy's approval. Dr. Royston 
said that he would supply this information for the March 1-2, 1993, RAC meeting. 
Ms. Buc suggested that Dr. Royston should present the material that was submitted to 
the FDA at the March 1993 RAC meeting, not for formal review, but as a special 
presentation. Ms. Buc stated that she is extending a formal invitation to Dr. Royston to 
present this information at the March 1993 meeting. Ms. Buc stated that since Dr. 
Royston has accepted the invitation to return in March 1993, the RAC should turn to the 
question to how these compassionate plea requests will be handled in the future. Should 
these requests come to the RAC or a subset of the RAC? Should the NIH Guidelines be 
amended? These questions must be answered within the context of the Federal Advisory 
[24] 
Recombinant DNA Research, Volume 17 
