Recombinant DNA Advisory Committee - 09/14-15/92 
the safety testing standards. The amendment was seconded by Dr. Post. 
Dr. Carmen asked what the impact of this amendment would be on the RAC review 
process with regard to safety testing requirements. Mr. Barton stated that the RAC 
would be sending the message to FDA that they will bear the ultimate responsibility for 
establishing these standards. Dr. Carmen said that the RAC should not be in the 
business of sending messages to the FDA and that the RAC should establish and 
conduct its own agenda as it deems necessary. Mr. Barton agreed that the issue of 
vector safety is certainly within the purview of the RAC. The RAC should not relinquish 
its responsibility to discuss this issue; however, the RAC should not try to second guess 
the final FDA standards. 
Dr. Parkman suggested that the RAC should vote on Dr. Schuening's protocols based on 
the standards that were used earlier in this meeting. In addition, Drs. D. Miller and 
Geiduschek should proposed a recommendation as the vector safety experts on the RAC 
to develop a set of standards that investigators should meet prior to RAC review. 
Dr. Secundy asked if there is a reason to believe that the vector safety standards 
previously established by FDA are currently inadequate. Dr. Parkman responded that 
there is no evidence of inadequacy. The purpose of this discussion is that assays are 
evolving that provide a greater level of sensitivity than existed previously. These tests 
are not better, just more sensitive. Dr. Secundy asked if the current standards are 
quantitatively and statistically inadequate as opposed to inadequate for detecting health 
risks. Dr. Secundy said that if the current standards are in any way inadequate, she 
would not support the approval of this protocol based on ethical standards. 
Dr. Parkman said that there is no clinical evidence that current standards are inadequate 
and provided background information regarding the vector safety concerns. There is 
data from one investigator demonstrating that monkeys developed lymphomas as a result 
of helper virus contamination of the retroviral vector preparation used for gene transfer. 
No patients developed lymphomas. Dr. Walters said that he supports Mr. Barton's 
amendment. 
Dr. Murray called on Mr. Barton to restate the proposed amendment. Mr. Barton stated 
that the amendment will revise Dr. Geiduschek's motion to read approval of the 
protocols as submitted with the expectation that the FDA will report back to the RAC 
about the helper virus safety tests and the approval of the protocol. Dr. Murray called 
for a vote. The amendment to revise Dr. Geiduschek's motion passed by a vote of 12 in 
favor, 4 opposed, and 2 abstentions 3 . 
3 Dr. D. Miller abstained. 
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