said that the Human Gene Therapy Subcommittee meetings are announced well ahead of time and are always open to the 
public; hopefully CRG members could attend the meetings. Ms. Wilker stated that she appreciates that the process is 
an open one, but the meetings are still somewhat limited because of their taking place in the Washington, D.C. area; 
there may be persons who desire to comment who are in other parts of the country. She said, "it's not a comment, 
necessarily, that the process as it is right now is a problem, but that the process needs to be expanded, and I’m not 
necessarily putting that in the purview of the RAC itself." 
Dr. Newman said "Dr. Davis said that the techniques would have to be very much better established in mice before it 
would be contemplated to do germline genetic engineering on humans, and that seems very much to miss the point that 
we put forward, which is that no matter how well established in mice these techniques became, to do it on human 
beings would be to make human beings and the human species as a whole into an experimental system because, of 
course, we'd have the progeny of genetically engineered individuals and this is precisely what we oppose." 
Dr. Miller stated that he believed several assertions made by the CRG were ill-chosen or inaccurate. He stated that 
even if the technology were available to attempt germline gene therapy, that the first attempts would very unlikely be 
aimed at enhancement or at attempted insertion in dominant genetic diseases, but rather would more likely be an 
attempt to intervene in recessive genetic diseases where there were two affected parents, homozygous recessives, and 
where the probability of producing affected off- spring would be 100 percent. 
Secondly, he believed it disingenuous to suggest there should be widespread consensus before the first human trials of a 
new technique. He pointed to the first clinical trials of the Jarvik artificial heart and oral contraceptives where the safety 
and efficacy were really unknown. He said the reason one does clinical trials is that the nuances of these techniques in 
man are not known, and cannot be known before they are done. This is the reason for stringent regulation by local 
Institutional Review Boards and central oversight by agencies such as the FDA. 
Ms. Wilker responded that the reason the CRG is raising these issues at this point in time is that they see the science 
on the threshhold of new development. They believe it is time for slow progress and for raising questions before 
moving ahead. She stated that there are certain technologies we use, such as low-dose radiation, in which we are still 
learning the risks and benefits. We should learn from our experience with these technologies and look closely at 
emerging technologies. 
Dr. Korwek stated he was generally opposed to proposals which set out prohibitory language such as, "the RAC will 
not... and the NIH will not.." If the aim of the CRG is to encourage open discussion, it would be rather better to leave 
the status quo. Further, he felt ambiguity contained in some of the CRG proposed language further clouds the issues of 
what is to be prohibited. Therefore, he was opposed to the proposal. 
Hearing no further comment, Mr. Mitchell called for a vote on the motion to accept the recommendations of the Human 
Gene Therapy Subcommittee as set forth in tab 1271 and as amended by tab 1278. With a vote of 18 in favor, none 
opposed, and one abstention, the motion was carried. 
Mr. Mitchell thanked the members of the CRG and hoped that they will attend future meetings of the Subcommittee on 
Human Gene Therapy. 
VH. PROPOSED AMENDED POINTS TO CONSIDER IN THE DESIGN AND SUBMISSION OF HUMAN 
SOMATIC-CELL GENE THERAPY PROTOCOLS 
Mr. Mitchell called on Dr. Walters to discuss the proposed amended "Points to Consider in the Design and Submission 
of Human Somatic-Cell Gene Therapy Protocols" (tabs 1262, 1272, 1273, 1276). 
Dr. Walters reminded the RAC that there had been a commitment made to review the "Points to Consider" at least 
annually for possible revision. He stated that tab 1272 specifies four changes which were proposed by the 
subcommittee at its August 8, 1986, meeting and is followed by a draft of the document incorporating these changes. 
Dr. Walters went through each of the changes with the RAC. He stated that there had been distributed to the RAC 
additional technical amendments which are, in part, a response to comments of one of the subcommittee members who 
could not be at the August 8, 1986, meeting. These amendments are: 
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