Attachment IV - Page 16 
Comments on the Document "Points to Consider in the Design and 
Submission of Human Somatic-Cell Gene Therapy Protocols" 
published in the Federal Register of Tuesday, January 22, 1985, 
Part III 
TO: Director 
Office of Recombinant DNA Activities 
FROM: L.F. Cavalieri, Ph.D. V f '■ 
Member, Sloan-Kettering Institute 
Professor of Biochemistry, Cornell University 
Graduate School of Medical Sciences 
Member, Executive Board, Committee for Responsible 
Genetics 
1. A case-by-case review of proposals for human gene therapy 
is not appropriate for considering the social issues mentioned 
in section II-C-3 of the document. These issues apply to all 
human somatic-cell therapy and therefore require resolution 
by public consensus before any human gene therapy is under- 
taken. But as yet, no attempt to reach a conclusion on these 
issues has been published for public comment. 
2. The social concerns listed in sections I-C and II of the 
document by no means exhaust the issues raised in the "Report 
on the Social and Ethical Issues of Genetic Engineering with 
Human Beings" of the President's Commission, to which the 
RAC Working Group on Social and Ethical Issues was formed to 
respond . 
3. Since the RAC Working Group on Social and Ethical Issues has 
not yet formulated a position with respect to the positive 
and negative aspects of human somatic-cell gene therapy raised 
in the Report of the President's Commission and elsewhere, it 
is premature to consider a review process for individual 
proposed human gene therapy protocols. 
Dr. L. F. Cavalieri 
Memorial Sloan-Kettering Cancer Center 
Walker Laboratory 
145 Boston Post Road 
Rye, NY 10580 
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