(b) relief of a life-threatening or severely disabling condition 
would not be permitted if germ line alteration as a result of therapy would 
be investigated, since the latter would be a reasonable aim of gene therapy 
research which is not permissible because of the word " solely ". Thus, even 
non-reproduct i ve individuals would be denied potentially life-saving 
therapy if follow-up research into germ line effects resulting from therapy 
is anticipated. 
It is not difficult to envision scenarios in which recombinant DMA 
technology could provide the potential for therapeutic use in human 
medicine. In addition to severe disorders arising from genetic conditions 
such as lay Sach’s syndrome and "inborn errors of metabolism", potential 
therapeutic use for treatment of infectious conditions (such as retroviral 
infection including AIDS-related conditions, some cancers, and other 
disease states), or onset of disfunction with genetic cause or treatment 
(diabetes) can easily be anticipated. 
It seems clear from the text of the announcement in the Federal Register 
that it is not the intent of the ammendment to categorically prohibit 
review and approval of proposals which may strongly serve the public 
interest through development of recombinant DMA therapies for 
life-threatening conditions. However, the warding of the ammendment as 
written may, in fact, have the effect of such prohibition if interpreted 
literally. Therefore, I suggest that the committee consider alteration of 
the ammendment to reads 
"The RAC reserves the authority to refuse to review any proposed human 
genetic therapy: 
1. the principle aim of which is other than the relief of a 
life-threatening or severely disabling condition; or 
2. that could reasonably be expected to affect future generations 
through alteration of human germ line cells. 
The NIH will not approve any human genetic therapy without the review 
and approval of the RAC. 
Furthermore, the RAC wl 1 not review and the NIH will not approve any 
in vitro recombinant DNA experiments that alter human germ line cells 
or early human embryos. " 
I believe that this wording would preserve the di scret i onary authority of 
the RAC to consider research topics which are appropriate for the time, 
with minimal legal interference. It is my firm conviction that timely 
consideration of such topics is in the public interest, and preserves the 
e t h i c a .1 a u t h o r i t y a n d r e s p o n s i b i 1 i t y w h i c h has be e n v e s t e d i n t h e 
committee. Failure to preserve the ethical responsibility and authority of 
the the RAC to consider research topics in a timely fashion would violate 
the public trust. 
T h a n k you f a r y o u r c o n s i d e r a t i o n o f t h i s m a 1 1 e r . 
Si ncerel y , 
* 
Mi crob i ol agist 
[ 218 ] 
Recombinant DNA Research, Volume 1 1 
