Attachment VT - Page 2 
PDA’S COMMENTS ON Nlll’S PROPOSED "POINTS TO CONSIDER 
IN THK DESIGN AND SUBMISSION OP HUMAN SOMAT IC-CELL GENE 
THERAPY PROTOCOLS” 
1. In the discussion of proprietary Information In gene 
therapy proposals, it should be noted that where 
proprietary Information Is Included, those portions of 
proposals would be discussed during closed sessions. While 
this may not occur frequently, the option for closed 
sessions should be available. 
2. Paragraph (10) focuses very narrowly on "undesirable 
consequences of somatic-cell gene therapy," and is 
misleading. First, It Ignores that the appropriateness of 
medical therapies Is the result of complex rlsk/beneflt 
judgements, and Implies that any risk, of teratogenesls 
("vertical transmission of genetic changes from an 
Individual to his or her offspring") Is unacceptable. As 
evidenced by the use In fertile patients of radiotherapy, 
chemotherapy, and many drugs believed to have some 
teratogenic potential, anticipated benefits may outweigh 
possible risks. 
3. In section I.B.l.b., the wording in the first sentence 
would be more clear If It were changed to, “What Is the 
composition of the material . . .” 
4. In section I.B.l.b., we suggest the addition of two new 
subsections : 
a. One would request the investigator to, "Describe 
In detail the methods for harvesting, extraction, 
and purification, and for the removal of any 
toxic chemicals Introduced by these procedures." 
b. The second would contain a warning that 
penicillin and other beta-lactam-contalnlng 
antibiotics should not be used In the production 
of materials administered to patients. 
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