25 
working group in the form made at the May 3, 19B5, RAC meeting, thus, it 
is not accurate to suggest the working group rejected these suggestions 
without careful consideration. 
Dr. Got tes rran thought not adopting the document would create problems. 
She said the guestion before RAC is whether this document is so drastically 
flawed it should not be adopted. 
Dr. Walters said the differences of opinion existing between Dr. Miller and 
the working group cannot simply be attributed to differences between the 
scientific and nonscientific connunities . Dr. Walters said distinguished 
scientists such as Drs. Howard Temin, W. French Anderson, and Amo Motulsky 
are members of the working group. These individuals have given a great 
deal of time and effort to developing the precise scientific language in 
the document. The document represents the best judgment of the working 
group on what is required to protect the first recipients of human gene 
therapy. 
Mr. Mitchell said Dr. Miller had questioned the qualifications of the 
working group. He said RAC should satisfy itself that the working group 
possesses the requisite expertise. Mr. Mitchell said an effort had been 
made in constituting the working group to obtain expertise in a broad spec- 
trum of disciplines. The intent was to obtain expert clinicians, scientists, 
ethicists, lawyers, and public policy people. The working group was con- 
stituted in this manner to address concerns raised by the President's 
Ccmission for the Study of Fthical Problems in Medicine and Biomedical 
and Behavioral Research. 
Dr. Friedman said he did not see why Dr. Miller was so concerned with what 
"Science" publishes. He supported the suggestion that the points to consider 
document be used as a working document cpen to further revision. 
Dr. Landy said he wished to modify his motion to emphasize that the points 
to consider would be a working document, and to acknowledge the FDA comments 
which will be considered at the next RAC meeting or by the working group. 
Dr. Martin said the two modifications suggested by Dr. Gottesman could be 
introduced in the points to consider document and the document republished 
for comment. The RAC at the next meeting could respond to any comments 
received including Dr. Miller's comments. 
Dr. Rapp supported this suggestion. He did not think RAC should override 
the working group but should ask them to reconsider these issues. 
Dr. Rapp suggested RAC accept the current points to consider as a working 
document. He said there is seme urgency in developing a document which 
can be sent to investigators; he thought it would be a mistake to hold up 
the document for several more months when the current points to consider 
form a perfectly reasonable document. He called the question. 
Dr. Landy restated his motion that the RAC accept with thanks the points 
to consider with the two modifications suggested by Dr. Gottesman (i.e., in 
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