5 Doane St., 4th floor 
Boston, MA 02109 
(617) 227-8035 
COMMITTEE 
K 
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 Ehrenteld, 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 HoKzman, 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 Lewontm, Ph D. 
Bruce Levin, Ph D. 
Richard Levins, Ph D. 
Manning Marable, Ph D. 
Anthony Mazzocchi* 
Everett Mendelsohn, Ph D. 
Albert Meyerhoft, 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 
FOR RESPONSIBLE GENETICS 
March 20, 1985 
Secretary Margaret Heckler 
U.S. Department of Health 
and Human Services 
Washington, DC 20201 
Dear Secretary Heckler: 
I am writing on behalf of the Executive Council of the 
Committee for Responsible Genetics (CRG) to express 
our concern about the proposed "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 do not believe 
that the Department of Health and Human Services 
should issue such a document before there has been 
public discussion about the desirability and appro- 
priateness of human gene therapy and before hearings 
have been held on the subject. At present there- is 
no mandate or public policy which defines the 
differences between conventional therapy and gene 
therapy, between the various purposes for which 
gene therapy is intended, and between possible 
forms of gene therapy. 
The Presidential Commission for the Study of Ethical 
Problems in Medicine and Biomedical and Behavioral 
Research 1982 report. Splicing Life , called for 
the establishment of an oversight body outside of 
the National Institutes of Health. This proposed 
group was to examine the social impacts of human 
gene therapy through dialogue and debate among 
scientists, lawyers, clergy, representatives of the 
public, and federal government officials. According 
to the report, "The need for an appropriate 
oversight body is based upon the profound nature of 
the implications of gene splicing as applied to human 
beings, not upon an immediate threat of harm. Just 
as it is necessary to run risks and to accept change 
in order to reap the benefits of scientific progress, 
it is also desirable that society have means of 
providing its 'informed consent,' based upon reasonable 
assurances that risks have been minimized and that 
changes will occur within an acceptable range" (p. 5) . 
Our society does not have a means to give "informed 
consent" to human somatic-cell gene therapy. The 
[593] 
