Recombinant: DNA Advisory Committee - 10/16/90 
approval. She urged that the RAC not withdraw from oversight of 
planned release experiments until the regulatory agencies can 
devise a more focused and explicit plan of how to regulate them. 
Dr. Krogstad commented on a letter received from Dr. Milton 
Schlesinger of Washington University. He said the thrust of the 
letter was "We're doing fine and we can probably do better if you 
leave us alone." He said this resulted from the huge impact of 
Monsanto's efforts in genetic engineering which have focused 
attention on agricultural release and resulted in increased 
community pressure on Washington University. Further, he said he 
was not sure that Dr. Schlesinger would be prepared or 
comfortable to confront a protocol for human gene therapy. 
Dr. Krogstad asked if he could comment at this time on the letter 
from Dr. Robertson Parkman. Dr. McGarrity replied that comments 
of that nature would be in order. Dr. Krogstad said that he 
felt it was an intriguing suggestion that the RAC was going 
through an identity crisis, as well as his suggestion that the 
RAC and Human Gene Therapy Subcommittee begin to discuss germ 
line human gene therapy, which does not imply the committee is 
either in favor or against it, but merely that this is one forum 
where enough expertise and credibility exists to begin this 
discussion. 
Dr. Mclvor said that the Chicago hearing pointed out to him that 
the NIH Guidelines and the RAC were needed to provide expertise 
in evaluating new techniques and experiments that are arising in 
the field. He agreed with Dr. Krogstad that Dr. Parkman 's 
comments relative to the RAC* being the forum to begin a 
discussion of germ line human gene therapy was intriguing. He 
said that he felt this committee was well prepared for dealing 
with somatic cell human gene therapy because it discussed these 
issues early on when it was only an abstract concept. To prepare 
for potential germ line human gene therapy proposals in the 
future, the committee should begin to consider the issue well 
before the first protocol arrives. 
Dr. McGarrity said that it took 5 years from the time of the 
development of the "Points to Consider" for Human Gene Therapy 
until a protocol was actually approved. It is difficult to 
foresee what strides will be made in technology and science in 
the next 5 years and it is probably time to begin to think about 
these issues in a systematic manner. 
Dr. Post reiterated the points made by Dr. Hirano about the 
confusion that investigators and local review groups have 
relative to planned release experiments involving both plants and 
humans. He stressed that there needs to be some type of very 
clear guidance so that people know what procedures need to be 
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