Attactcezzt IV - Page 15 
FOUNDATION ON ECONOMIC TRENDS 
1346 Connecticut Av«ruc. VW, Suite 1010 Washington DC 20036 202 466-2823 
February 20, 1985 
Director 
Office of Recombinant DNA Activities 
Building 31, Room 3-B10 
NIH 
Bethesda, Md. 20205 
Dear Director, 
The following comments are In response to the NTH g_.dei.nes for ".uman 
somatic gene therapy that was published In the Federal Register - on Jan- 
uary 22, 1985. 
While the NTH guidelines mention the possible germline im pact of sc~ atic 
therapy, too little detail is provided on the profound ethical and physiolog- 
ical issues raised by this potential relationship. 
The National Institutes of Health nas not devoted enough time and atten- 
tion to this important consideration. It is our position that the NTH needs 
to develop more elaborate guidelines that would tai<e Into account the 
possible impact of somatic therapy or. get— line cells. The NTH regulations 
contained in the January 22.od Federal Register are woefully Inadequate 
in this regard. 
Somatic and germline therapy of unr. beings represents a qualitative 
departure in our medical practices as both therapies Involve changing basic 
instructions In the genetic code. The questlo' of engineering changes in 
the somatic cells or germline cells raises a nost of new ethical and public 
policy considerations that require broade' discussion a~c broader represe - - 
tation than are evidenced in the proceedings of the RAC subcommittee 
responsible for drawing up these guidelines. 
The working group on human gene therapy of the Recombinant DNA Ad- 
visory Committee of the National Institutes of Health is not b roar -baser 
enough in its professional composition to adequately represent the spe c tr u m 
of opinion and views that need to oe included tn any discussion of human 
gene therapy. For example, the committee has no representation from 
the major religious denominations. In addition, the academic disciplines 
represented o~ the committee are very limited and i.nc._de only one phil- 
osopher and one ethic is t T-.ere are no anthropologists, sociologists, psy- 
chologists, or theologians, ail of whom could make important contributions 
by bringing to this issue a range of different perspectives which would 
be important In understanding the full .—pact of the genetic engineering 
of somatic cells. 
: 45 : 
