embryologist and a member of the advisory board of the CRG. He said that somatic gene therapy seemed likely to 
present insurmountable technical problems in the shortnm, both with respect to achieving appropriate gene expression 
in differentiated cells and with respect to the very small number of diseases that can be cured by transplantation of 
somatic tissues, genetically engineered or otherwise. 
However, he stated, genetic modification of early embryos at present is technically feasible. He cited modifications 
which extend to the germ line which have been accomplished in mice to produce double-sized mice and mice with an 
inherited defect of the Type I collagen gene. He said that if RAC rejects the CRG's proposal, it is likely in the near 
future to receive proposals for human applications of germline techniques which is both proven in animals and has 
much wider potential medical and commercial applicability than somatic techniques. 
He said since even two parents with a dominant deleterious genetic defect such as Huntington's disease can still give rise 
to homozygous normal offspring, germline therapy is not necesssary to ensure normal offspring of the genetically 
diseased parents. However, the more likely rationale, in Dr. Newman's opinion, for therapy on early embryos would be 
the introduction of traits not characteristic of either parent's genotype, for instance enhanced height 
Dr. Newman stated that, "Our experience is that any technique that is proven feasible, not specifically prohibited by 
regulation, and for which there is a commerical market will eventually be applied and sold." He further questioned how 
it is possible to judge whether human germline therapy is safe when the consequences may not show up until 
subsequent generations. He further stated that, "Disapproval of the CRG's motion will situate future deliberations on 
germline therapy within the realm of the state of the technique and represent dubious progress toward turning the human 
species into an experimental system." 
Mr. Mitchell called on Dr. Colin Gracey. Dr. Gracey state he is a university chaplain and convenor of the Biogenetics 
Working Group of the Forum for Faith in the Future of the Episcopal Diocese of Massachusetts and a member of the 
executive council of the Committee for Responsible Genetics. He stated that in submitting its proposed addition to the 
NIH Guidelines, the CRG was seeking a clearer and more definitive statement as to how research and clinical uses of 
this important technology shall proceed. 
Dr. Gracey said that, "there is widespread concern in our society that what can be done directs and determines what will 
be done. It is a concern that technical feasibility, rather than the counsel of human wisdom, becomes the measure for 
proceeding. The potential and promise of human gene therapy awakens this concern once again and public confidence 
on this matter will be influenced by the framing of public policy." 
Dr. Gracey stated that the CRG proposal would provide substantive counsel on appropriate uses for proceeding with 
human gene therapy to ensure that as it comes into practice it does so with due caution and with sensitivity toward 
existing social consensus. He added that an initial restriction to use in life-threatening or seriously disabling conditions 
would delineate the uses of gene therapy for which there appears a consensus to proceed. And if the CRG's proposal 
were accepted, it would necessitate changes in the NIH Guidelines at some future time before extended use could be 
granted. But such future proposed changes would have the benefit of the experience with gene therapy experiments to 
date as well as provide adequate opportunity for public debate on any issues at hand. 
Dr. Gracey stated that the CRG agreed with the position taken in the "Points to Consider” as regard to proposals for 
germline alterations but believes that the "Points to Consider" is not as strong a policy statement as would be made by 
amending the NIH Guidelines as proposed. He said that the CRG proposal uses the term "review” in the sense that the 
word "entertain" is used in the "Points to Consider." The intent of the proposal is not "to circumscribe the RAC's 
responsibility to remain open to developments in genetic technology and to review any and all material that comes to 
its attention." 
Dr. Walters stated that the Human Gene Therapy Subcommittee agreed with many of the concerns raised by the CRG. 
He believed that the first diseases anticipated to be proposed for human gene therapy will be precisely the types the 
CRG has described. The subcommittee is trying to anticipate an area of biomedical innovation. He gave the credit for 
this forward thinking to Mr. Mitchell, who asked the RAC and the subcommittee to respond to the Presidential 
Commission Report Splicing Life which resulted in the RAC having a "Points to Consider" ready and waiting for the 
first proposals to perform somatic-cell gene therapy in human beings. The scientific community has been cooperating 
well, and there are no indications that any researchers in the United States are attempting to do anything other than the 
types of research envisioned in the "Points to Consider." Thus, there is a good public mechanism in place for review of 
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