Dr. Anderson said they repeated the experiments in 
immunosuppressed monkeys with essentially the same results and 
even went a step further in infecting fibroblasts and reinserting 
them into monkeys. At 84 days there is no evidence anywhere of 
any clinical symptom and no evidence of virus. 
Dr. Cohen asked whether the sensitivity of the assay to detect 
helper virus was significantly below what is a potentially 
infectious dose of the virus. Dr. Anderson replied it was 8 
orders of magnitude better than needed to assure detection. 
Dr. Davis said he was uncomfortable with the situation and 
perhaps some philosophy needed to be discussed. He said there 
has always been a principle in medicine that the sicker the 
patient, the higher the risk you are entitled to take in 
experimenting on the patient. He said Dr. Kelley's statements 
regarding subjecting patients to substantial risk were contrary 
to this principle in that they have only a 2-3 month life 
expectancy. Dr. Davis thought this seemed to be nitpicking over 
inconsequential levels of sensitivity in assaying for the virus. 
He could understand delaying this protocol if there were indeed 
threats to safety of medical personnel or the general public or a 
really substantial risk to the patient. However, he felt the RAC 
were acting as a study section by evaluating the quality of the 
proposal. He did not see this as the purview of the RAC. He was 
quite convinced that there were no risks that would justify 
withholding permission to carry out an experiment which everyone 
agreed would provide valuable information if successful. 
Dr. Davis said he understood Dr. Mclvor's questions on the animal 
experimentation but success in an animal model would not make 
human experimentation unnecessary. Moreover, there was not going 
to be any animal experiment that could be a replacement for human 
experiments on the basis of the data presented in support of this 
protocol . 
Dr. Walters outlined the procedural aspects of the situation 
noting the Subcommittee was to have had the entire protocol 12-14 
weeks before a regularly scheduled meeting, but they had received 
the materials less than 4 weeks prior to the July 29, 1988 
meeting. Despite the late arrival of information, the meeting 
went forward and a conference call was scheduled for September 
29, 1988, to take care of remaining questions before the October 
meeting of the RAC. He noted that the Subcommittee had 
telescoped an anticipated longer process into a much shorter 
timeframe in an effort to be responsive to the investigators. 
Dr. Childress said he found the risk-benefit ratio acceptable and 
felt that the problem was really the issue of the use of gene 
markers versus a therapeutic gene transfer protocol which is of 
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