10 
Dr. Gottesman thought mention of inadvertent transmission in this context would 
raise a red flag. She thought clinicians and scientists implicitly recognize 
inadvertent transmission might occur. 
Dr. Murray agreed; he said the working group document does net take a position 
on whether "inadvertent changes" in the patient's germ line are permissible. 
Dr. Murray said the treatment of children with leukemia offers a precedent. 
The effect of chemotherapy on these patients' off spiring will not be known 
intil these patients have children. Most clinicians conclude, however, a fair 
possibility exists that the germ line cells of these patients will be affected. 
Nonetheless, in childhood leukemia therapy, the risk of damaged offspring is 
balanced against the benefit of prolonging the life of the patient. The Working 
Group on Human Gene Therapy is asking for the data to make the same type of 
risk/benefit analysis. He felt the working group was on firm ground as long 
as it evaluated potential inadvertent effects and not intended changes in the 
germ line. Dr . Walters agreed. 
Dr. Anderson said the initial protocols will involve use of modified bene 
marrow cells. Added DM\ does not appear to be transferred from these cells to 
germ line cells, and effects on germ line cells are not likely. 
Ms. Areen suggested the working group might carmunicate to Dr. Miller that it 
has taken no position on whether inadvertent modification of the germ line 
is good or bad. 
Dr. Anderson suggested the word "the" should be deleted from the tenth paragraph 
of the Introduction of the points to consider. The subworking group agreed. 
Dr. Walters said Dr. Miller's third comment suggested the first sentence in 
Section I-B-l-b would be more clear if it referred to the "composition" of 
the material . 
Dr. Gottesman said the working group had considered this comment at an earlier 
meeting. The term "composition" is inappropriate in the context cf human gene 
therapy protocols because composition refers to the diem cal composition of 
a substance. The sufcvorking group agreed. 
Dr. Walters then said Dr. Miller's fourth comment suggested two new subsections 
be added. Che of the new subsections would ask 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." The second new 
subsection would contain a warning that penicillin and other beta- lactam 
antibiotics should not be used in the production of materials administered to 
patients . 
Dr. Gottesman said the working group had considered these two proposed sub- 
sections at the April 1985 meeting. The terms "harvesting, extraction, and 
purification" do not apply to the initial hunan gene therapy procedures; the 
points to consider document contains the appropriate analogous language. 
[339] 
