22 
teratogenic. Teratogenesis per se should not rule out a proposed medical 
intervention. 
Dr. Miller said the document’s request in Section I-B-3-e for information 
on the major anticipated potential beneficial and adverse effects of the 
treatment and on measures taken to control or reverse adverse effects "are 
really causes for speculation that's so complex as to be unreasonable." 
Dr. Miller said the question in Section I-B— 4-a of the document asking on 
vhat basis the potential public health benefits or hazards are postulated 
"is so ambiguous that it would be very difficult to answer and adds very 
little to the document." 
Dr. Miller suggested a point H be added to Part III of the document. That 
point would ask: 
"What admdnistrative official in the hospital, clinic or other institu- 
tion has approved of this procedure?" 
Dr. Miller said: 
"...we strongly believe. . .that since somatic cell gene therapy is an. 
extension of present methods of therapy and is wholly analogous to con- 
ventional medical intervention, that decisions on individual protocols 
should be made in a way that is consistent with other conventional 
therapies; that is, primarily by physicians and scientists with expertise 
in the area. An NTH study section or an FDA advisory cormittee in a 
given discipline would not be conposed largely of public policy 
specialists and bioethicists and attorneys. It would be comprised of 
clinicians and scientists with expertise in the area; and we feel strongly 
that the working group that evaluates such proposals should be comprised 
of persons largely with expertise in that area and not in these other 
areas as is presently the case." 
Dr. Walters said the working group would like to obtain RAC's opinion on 
the April 15, 1985, version of the points to consider document. The 
working group will over the course of the next year be fine-tuning the 
document, and any major changes the working group might propose would be 
submitted to RAC for its consideration. 
Dr. Walters felt the document should be circulated as soon as possible as 
representing RAC's best judgment on appropriate ground rules for this area 
of research and potential therapy. 
Dr. Lardy moved that RAC accept the points to consider document with 
appreciation. Minor changes can be made in the document without resubmitting 
the points to consider for RAC review. Significant changes would, however, 
be discussed by the RAC. This motion was seconded by Dr. Jcklik. 
Dr. Davis said he did not knew if it is necessary to vote on this points 
to consider document. 
[142] 
