somatic -cell gene therapy proposals; to move beyond the current mechanism at this time is unnecessary. 
Dr. Epstein asked for clarification from the GIG as to its proposal, "that the RAC will not review and the NIH will 
not approve any in vitro recombinant DNA experiments that alter human germ line cells or early human embryos." He 
stated that in discussion at the RAC meeting this was referred to in terms of gene therapy with the implication that 
these cells would be used with fertilization techniques and reimplanted. Dr. Epstein stated there was a difference 
between such procedures and experimentation on germ cells themselves which are never intended to be reimplanted. He 
asked for clarification of this point by the CRG. 
Dr. Newman responded by stating that if the interest is in studying basic mechanisms then there are many animal 
models available for study with plenty of research to still be done. Dr. Newman stated, in contrast to work with 
animals, "that if the realm of research moves into working with human material then the agenda, either explicit or 
hidden, will be that the ultimate purpose is to modify human germ cells for the purpose of constructing better human 
beings.... It seems to us that there arc many good reasons to draw the line before doing modifications of human 
germline cells because by incremental steps it will eventually lead to enhancement therapies in the germ line with 
unknown consequences to future generations." 
Dr. Epstein then asked Dr. Newman if he felt that the only conceivable use for germ line therapy would be for 
enhancement therapies rather than treatment of otherwise untrcatable genetic disorders. Dr. Newman responded that in 
his opinion, genetic disorders are validly treated in people who already exist and have genetic disease. If you are making 
genetic modifications to zygotes, you are "constructing an individual who doesn't yet exist." If the purpose was to 
ensure that families that have certain genetic defects would have normal children, "ordinary genetics would ensure that if 
appropriate selection were available." If that’s not the goal, "then the goal must be something on the order of growth 
enhancement.... If it is easier to enhance growth by genetic therapy on the zygote, people will demand it. If not 
prohibited by statute or by recommendation, there will be a market for it and it will be done." Dr. Epstein pointed to 
the fact that at present there are quite vocal people who believe that current methods of prenatal diagnosis and selective 
abortion are reprehensible. 
Dr. Walters added that the Human Gene Therapy Subcommittee has attempted to keep abreast of laboratory science 
results that may be pertinent to human gene therapy or other kinds of human genetic alterations with state-of-the-art 
lectures from experts in the field. Although transgenic laboratory studies are taking place in animals, there is no 
indication that any investigator is considering applying this technique to human beings. 
Mr. Mitchell pointed out that at the January 1986 meeting, the RAC devoted the entire afternoon to three noted experts, 
Drs. Martin, Miller, and Parkman. who set forth the general science pertaining to this area of activity and that it was all 
directed towards severe genetic diseases. Further, as relates to the public education concerning such experimentation, the 
NIH Recombinant DNA Technical Bulletin published a substantial portion of those remarks in the current issue in an 
effort to stimulate discussion and knowledge in this area. 
Dr. Walters moved "That the RAC approve the recommendations of the Human Gene Therapy Subcommittee as set 
forth in tab 1271 with the amendment given in tab 1278." The motion was seconded by E>r. Johnson . 
Dr. Davis commended Ms. Wilker for what he perceived to be a major shift in position between the original CRG 
submission and Ms. Wilker's statement before the RAC. Dr. Davis said Ms. Wilker’s use of the term "at this time" is 
a significant change from the original CRG position which he said he had found to be "ultra-conservative, somewhat 
resembling perhaps that of the more extreme fundamentalist kinds of religions which are so certain that they're right 
that there's no room for the kind of democratic process of pragmatic adjustment and shifts from time to time that we're 
acustomed to in our society." He said the issue now seemed to boil down to whether these issues should be dealt with 
in the NIH Guidelines or simply as it is at present in the "Points to Consider" document. 
Dr. Davis stated he agreed with Dr. Newman that it is now possible to instill genes into animal germ cells. However, 
since a very high percentage of the cells so treated fail and among those that are viable a certain percentage have grave 
defects introduced in them, no responsible medical researcher would want to undertake such experiments in humans at 
this time. 
Ms. Wilker said that CRG has brought the issue up so that public discussion can take place well in advance of the 
RAC receiving any such proposals, as opposed to discussing the matter while a proposal is on the table. Mr. Mitchell 
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