7 
Dr. Gottesman said the working group might have to request a modification in 
the NTH Guidelines to explicitly cover retroviruses. The interpretation of the 
working group, however, is that recombinant RNA is covered by the NIH Guidelines. 
The working group agreed the second sentence of the footnote should read: 
"Section III-A-4 applies to recombinant DNA, as well as to RNA and DNA derived 
from recombinant DNA." 
Dr. Walters said the language in the introduction indicating the working group 
would prefer the initial proposals submitted for RAC review contain no proprie- 
tary information had been modified. 
Dr. Motulsky said the points to consider document should indicate that while 
the working group prefers to review proposals in open session, submission of 
confidential information is not precluded. 
Mr. Capron volunteered to draft language to that effect for this section. 
Dr. Grobstein said the suggestion in the points to consider document that the 
working group will "educate" the public is arrogant; he suggested the word 
"inform" be substituted for the word "educate." 
Dr. Walters called the attention of the working group to new language indicating 
that when gene therapy becomes widely applied FDA publications should be consulted 
Drs. Grobstein, Rich, and Motulsky suggested the term "gene therapy" should be 
modified by the words "somatic-cell." 
Dr. Walters called the attention of the working group to language explaining 
that the working group has concluded somatic-cell gene therapy does not differ 
fundamentally from other accepted practices in medicine. 
Dr. Grobstein said he had written alternative language (Attachment V) for this 
section of the introduction since he was concerned with the term "fundamentally." 
Dr. Gorovitz asked whether any of the concerns mentioned in the letter (Attach- 
ment VI) from Dr. Leon Kass of the National Humanities Center in Research Triangle 
North Carolina, wore valid. Dr. Motulsky said the argument advanced concerning 
inflammatory processes of the gonads and high concentrations of genetically 
modified lymphocytes is not credible. 
Dr. Gottesman suggested Dr. Kass was thinking of possible gametic cell transfor- 
mation through products of s erratic cell breakdown in vivo . Dr. Grobstein said 
this cell transformation argument is very highly speculative; no evidence exists 
at this time to suggest such transformation occurs in the body. Dr. Temin 
said if this type of event were occurring in the mammalian body, genes would 
be constantly inserting at random points in the genome. This does not occur. 
Dr. Motulsky said patients receiving this therapy will be very seriously 
ill individuals. Such highly speculative arguments cannot be seriously 
considered when weighing the benefits of treating such individuals. 
[ 92 ] 
