Iv'. I : rench Anderson 
by somatic cell therapy are Helped, the next ones may not be, or may 
even be harmed. Therefore, extensive experience with many patients 
over a number of years will be necessary before somatic cell therapy 
can properly be judged to be safe and effective. If somatic cell ther- 
apy has not become highly efficient with very minimal risks, germ 
line gene therapy should not be considered. 
Second, there should be adequate animal studies that establish the 
reproducibility, reliability, and safety of germ line therapy, using the 
same vectors and procedures that would be used in humans. Of 
greatest importance would be the demonstration that the new DNA 
could be inserted exactly as predicted and that it would be expressed 
in the appropriate tissues and at the appropriate times. It should 
be remembered that gene therapy does not remove or correct the 
defective genes in the recipient: it only adds a normal gene into the 
genome. It is not now known what the influence of this combination 
of defective and normal genes may be on the developing embryo. 
Might the regulatory signals still associated with the non-functional 
genes adversely affect the regulation of the exogenous gene during 
development? 
Third, there should be public awareness and approval of the 
procedure. New drugs, medical regimens, and surgical techniques 
certainly do not require individual public approval prior to their 
initiation. There arc already regulatory processes in place that insure 
the protection of human subjects (this issue has been addressed in a 
previous publication (Anderson and Fletcher, 1980)). Somatic cell 
gene therapy is receiving widespread public attention, but prior 
public approval is not being specifically sought. Germ line gene 
therapy, however, is a different and unique form of treatment. It 
will affect unborn generations and has, therefore, a greater impact 
on society as a whole than treatment confined to a single individual. 
The gene pool is a joint possession of all members of society. Since 
germ line therapy will affect the gene pool, the public should have a 
thorough understanding of the implications of this form of treat- 
ment. Only when an informed public has indicated its support, by 
the various avenues open for society to express its views, should 
clinical trials begin. In vitro fertilization, surrogate motherhood, 
animal organ transplants into humans, holistic treatment of cancer, 
and other controversial medical procedures can take place based 
on the decision of the patient (with his/her doctor and/or family) 
whether society as a whole approves or not. But the decision to 
initiate germ line gene therapy demands assent from more than the 
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