24 
Dr. Landy said he could net agree with Dr. Davis' suggestion to return the 
points to consider document to the working group without RAC endorsement. 
He preferred a "working” document to a "perfect" document. 
Mr. Mitchell said RAC could approve this points to consider document as a 
working document at this time with the understanding that modification is 
an ongoing process. 
Dr. Miller said: 
"The only remaining problem we would have with that is that we feel that 
seme of the nuances of wording and meaning that I described were not 
appreciated fully by the working group and by going back to them I 
think wouldn't be of much avail. 
"I think part of the problem of the working group takes me back to the 
last of FCA's points, that it's a group constituted largely of public 
policy people, lawyers and bioethicists with real ly a minority of 
clinicians and molecular biologists who don't understand completely 
some of these issues." 
Dr. Landy asked whether. Dr. Miller was .requesting, that RAC act as a board 
of appeal on the language of the document. 
Dr. Miller said he was arid said that: "we would prefer, of course, that 
this document is not promulgated in the interim with some of these errors 
still in them. " 
Dr. Saainor suggested the language on teratogenicity might be reconsidered 
since many drugs currently in use have teratogenic or other side effects. 
He suggested the document be approved as a working document, and the modi- 
fications suggested by Dr. Miller be evaluated carefully before the next 
RAC meeting. 
Mr. Mitchell suggested the document could be approved as a working document 
which could be reviewed by the RAC at its next meeting. Dr. Saginor said 
this would be a reasonable approach. 
Dr. Miller said he could not agree with this approach because of the 
"misconceptions" that result. He said: "I think again we haven't broached 
the issue of the carposition of the group that will actually decide on 
these proposals which, as we all agree, are largely scientific and medical 
issues of prime importance." 
Dr. Davis asked why RAC could not sinply wait until the next RAC meeting 
to take action. He did not think investigators would be delayed if the 
document was not approved by RAC as a working document. 
Dr. Gottesman disagreed with Dr. Davis’ approach. She said the alleged 
"misconceptions" are not quite as dranatic as Dr. Miller paints them. 
Several of these comments were not made previously by Dr. Miller to the 
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