5 Doane St., 4th floor 
Boston, MA 02109 
(6 i 7) 227-8035 
Attachment IV - Page 7 
COMMITTEE FOR RESPONSIBLE GENETICS 
Advisory Board 
Nicholas Ashford, Ph.D. 
Heather Baird-Barney, M.S. 
Roy L. Barnes 
Jonathan Beckwith, Ph.D. 
Philip Bereano, J.D.* 
Eula Bingham, Ph.D. 
David Brower 
Liebe Cavalieri, Ph.D.* 
Joseph Collins, Ph.D. 
Donald Comb, Ph.D. 
Barry Commoner, Ph D. 
Molly Coye, M.D. 
David Ehrenfeld, Ph.D., M.D. 
Ernest Englander, Ph.D. 
Rick Engler 
Sam Epstein, Ph D. 
Richard Falk, J.D. 
Ross Feldberg, Ph.D. 
Marcus Feldman, Ph.D. 
Cary Fowler 
Lois Gibbs 
Richard Goldstein, Ph.D. 
Stephen Jay Gould, Ph.D. 
Colin Gracey* 
Eric Holtzman, Ph.D. 
Ruth Hubbard, Ph.D." 
Vernon Jensen 
Jonathan King, Ph.D.* 
Sheldon Krimsky, Ph.D.* 
Marc Lappe, Ph.D.* 
Marvin Legator, Ph.D. 
Richard Lewontin, Ph.D. 
Bruce Levin, Ph.D. 
Richard Levins, Ph.D. 
Manning Marable, Ph.D. 
Anthony Mazzocchi* 
Everett Mendelsohn, Ph.D. 
Albert Meyerhoff, J.D. 
Claire Nader, Ph.D.* 
Stuart Newman, Ph.D.* 
David Noble, Ph.D. 
Judy Norsigian 
Richard Novick, Ph.D. 
Christine Oliver, M.D. 
David Ozonoff, M.D. 
Scott Paradise 
David Pimentel, Ph.D. 
Bernard Rapoport 
Barbara Rosenberg, Ph.D.* 
Barbara Katz Rothman, Ph.D. 
Roger Shinn 
Victor Sidel, M.D. 
Helen Rodriguez-Trias, M.D. 
John Vandermeer, Ph.D. 
George Wald, Ph.D., Nobel Laureate 
William Winpisinger 
Steve Wodka 
Sidney Wolfe, M.D. 
Susan Wright, Ph.D.* 
'Executive Council 
Terri Goldberg 
Executive Director 
103 
February 19, 1985 
Dr. William Gartland 
Office of Recombinant DNA Activities 
Building 31, Room 3B10 
National Institutes of Health 
Bethesda, MD 20205 
Dear Dr. Gartland: 
I am writing on behalf of the Executive Council of the 
Committee for Responsible Genetics to comment on the 
"Points to Consider in the Design and Submission of 
Human Somatic-Cell Gene Therapy Protocols" published 
in the Federal Register on January 22, 1985. We 
believe that the points listed in the document 
should be expanded in the following areas: potential 
public health impacts of gene delivery systems using 
currently available technology; public participation 
in debates concerning the safety and desirability 
of proposed somatic-cell gene therapy experiments; 
and oversight of private institutions, which do not 
receive NIH funds, that may be interested in or 
planning to undertake somatic-cell gene therapy 
experiments . 
I 
Risk assessment for recombinant DNA activities has 
proceeded up to now under the assumption that 
recombinant organisms would be no more hazardous than 
any of their constituent parts. However, it is now 
recognized that placing a normal gene into a relatively 
innocuous virus can create a tumor virus. We, 
, i 
therefore, urge the Recombinant DNA Advisory Committee 
to reconsider whether the existing technology is 
appropriate for the design of somatic-cell gene 
therapeutic agents, since it is not difficult to 
devise scenarios whereby such agents may prove 
hazardous to the public health. 
Although human somatic-cell therapy is in some sense 
analogous to other experimental treatments of individual 
consenting patients, it differs from such treatment in 
at least one important way. As discussed in the "Points 
to Consider," gene therapy necessitates the development 
of gene delivery systems capable of introducing human 
genes into human cells. This system may be an infective 
agent, such as a modified retrovirus. If such an 
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