The University of Michigan 
Medical Center 
A>m Aihn. Michip* UIOS-OM4 
Department of Internal Medicine 
Offxct of llit Chairman 
JlOOA Tauhwan Ctnltr 
(313) 9J6-M0 
March 3, 1986 
James B. Wyngaarden, M.O. 
Director, National Institutes of Health 
Building I, Room 124 
9000 Rockville Pike 
Bethesda, Maryland 20205 
Dear Jim: 
Thank you for your letter of January 2nd in response to my earlier concern with 
regard to the clinical application of gene transfer technology. Clearly, the working 
group on human gene therapy represents a distinguished group of individuals covering a 
broad spectrum of interest. I think the group would be enhanced if one or two individuals 
were included who had considerable experience with patient related clinical research. I 
would, of course, be happy to serve but as you know there are many other individuals who 
would be at least as competent. 
In general, the guidelines appear highly appropriate. There are several specific 
suggestions, however, which you may find helpful. 
1. With somatic cell gene transfer experiments, there does not appear to 
be any attempt to demonstrate the absence of contamination of germ 
cells in the human subjects. There are several reasons to suspect that 
the use of retroviruses might contaminate germ cells. Obviously, this 
type of contamination should be excluded with a high degree of 
certainty. 
2. There should be additional emphasis on the utilization of objective 
measures of disease activity. For example on page 8, I - A - 2, I would 
add "What objective measures of disease activity are available?" On 
page 14, I r B- 3 - c, I would add "What objective measures of disease 
activity are available? Will all be utilized? If not, explain?" 
I appreciate your attention to this important area of research development. 
Best regards. 
Sincerely, 
William N. Kelley, M.D. 
John G. Searle Professor and Chairman 
Recombinant DNA Research, Volume 1 1 
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