6 
the intent and base "adequacy" on vector insertion frequency in bone marrow 
cells. 
Dr. Walters said Dr. Miller's next comment suggests language be added to Section 
I-B-2-c ; the new language would request a description of previously-reported 
similar human studies and results (including foreign studies). 
Dr. Andersen said to date no similar human studies have been performed. 
Dr. Gottesman agreed but suggested that if it takes the working group another 
year to get organized, this type of informational requirement might become 
pertinent. She thought Or . Miller's suggested language might be added to the 
working group document but should not be highlighted . 
Dr. Murray felt investigators would include information on similar studies 
in their proposals regardless of whether or not the working group requests it. 
Such information would support the proposals. Ms. Areen felt requesting this 
information would not detract from the points to consider document and suggested 
it be added even if it does not appear pertinent at this time. 
Dr. Walters suggested such language might be added to Section I-B-3 of the 
points to consider document and volunteered to draft the language. 
Dr. Walters called the attention of the subworking group to Dr. Miller's comment 
on Section I-B-2-c-(l)-(c) ; Dr. Miller suggested the word "tumor" be s instituted 
for the word "malignancy." Dr. Miller also suggested the language of this sec- 
tion be relocated to Section I-B-2-c-(l) as it is relevant to gene therapy 
whether or not a retroviral vector is employed. 
Dr. Murrey said substituting the word "tumor" for "malignancy" will narrow the 
scope of the question. He said the word "malignancy" includes leukemias as well 
as tumors. The sitoworking group agreed the section as written is adequate, and 
its position in the document is correct. 
Dr. Walters called the attention of the sitoworking group to the conment by 
Ms. Terri Goldberg, the Executive Director of the Ccmnittee for Responsible 
Genetics, on Section I-B-2-c-(l)-(c) of the points to consider document. 
Ms. Goldberg said the failure of retroviruses to exhibit oncogenicity or 
other pathogenicity in laboratory tests is no guarantee they wall not becane 
novel human pathogens. 
Dr. Anderson said the points to consider document requests test data to address 
this issue. Dr. Walters said for any therapy risk must be balanced against 
benefits; for genetic diseases in treatable by any other therapy the projected 
benefit must be weighed against the risk. 
Dr. Walters then called the attention of the sitoworking group to Dr. Miller's 
cartnent on Section I-B-2-c-(l)-(d) of the points to consider document. 
Dr. Miller had suggested the phrase "specifically germ line ceils" be deleted 
because concern about effects on gametes would be no greater than concern for 
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