demonstrated in the lymph nodes for 2-3 weeks but retroviremia 
disappeared after two days. Further tests were done on stool, 
urine, and saliva; and all were negative. At 84 days, all 
specimens were negative, but there was a persistent antibody 
response . 
Dr. McGarrity said the word "infected" was not a good choice to 
use when discussing insertion of the gene coding for neomycin 
resistance. Dr. Anderson said the word "transduced" was used in 
the IND and is a better word. 
Dr. McGarrity then called on Dr. Walters for his comments. 
Dr. Walters underscored the point that comments (tab 1341) 
received by Dr. Albert Owens (of the Johns Hopkins Oncology 
Center and consultant to the Human Gene Therapy Subcommittee) 
were based on his receipt of the new materials only. Dr. Owens 
did not have available all the materials the Subcommittee had 
received. However, it was made clear to all members of the 
Subcommittee that Dr. Owens was satisfied with the materials and 
was able to base his judgment on them. 
Dr. Erickson said he was not working in this field and further 
was not at the July 29 meeting of the Subcommittee but was party 
to the conference call. He was sympathetic to the Subcommittee's 
desire for quantitative data which had not been presented until 
today's meeting. He pointed out that he did not feel it was the 
purview of the RAC to assess the scientific quality of the 
experiment but to be more concerned with the safety issues, and 
much of this hinged on whether the S+/L- assay was the best way 
to detect the retrovirus. He said he was not sure where he stood 
on this issue, because he had just been presented with the data. 
Dr. Kelley said his feeling was the experiment had no benefit to 
the individual patient in which it was to be carried out and 
therefore this exacerbated the risk issue. He said the long-term 
goals were very important and had the potential to be extremely 
important therapeutic modalities. Because of these reasons, the 
animal model data was important. He expressed concern that the 
only data presented on animal models were obtained from one 
mouse. Dr. Kelley was concerned that these were not enough data 
on which to judge the experiment and that additional studies in 
mice needed to be performed before the technique could be used in 
man. 
Dr. Mulligan said he did not believe enough data had been 
presented on the issue of infectivity and he did not think it 
fair to ask the Committee to make a decision without having had 
time to look at the data and to discuss the assay sensitivity. 
He said tremendous progress had been made on data collection and 
that it could be approved shortly. 
Recombinant DNA Research, Volume 13 
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