Statement of Ltc. Robert R. Redfield

issues; however, no one raised any objection to or requested
clarification of the data. I did agree to put natural history
cohort data and Phase I data on separate slides and to provide an
updated report of the assays performed on protocol specimens. The
draft minutes of this meeting were received 22 October.
That same evening (15 September) I was scheduled to present
our data to the NIH ACTG/AVE and I asked Dr. Vahey to present the
data on viral burden but she declined. I also asked Dr. McCarthy
to present his analysis of the data and he did so, concluding that
there was no correlation between viral burden increases and
immunization other than random which supported our claim of safety.
On 16 September I provided COL Burke a copy of the data I
presented to the AVE/ACTG group at NIH the preceding evening. I
also was called by Major Hendrix, for the first time ever; he told
me he respected me because I had earned it. I presented the same
data to the Cold Spring Harbor meeting 17 September.
On 24 September, the Research operations Committee of the
MMCARR met and there were no issues regarding analysis of the RV21
data raised.
on 5 October, I forwarded to COL Burke A p iminary
analysis of the RV21 Phase I viral isolation data and noted that,
although negative in terms of in vivo HIV expression, they
reinforced the safety of rgp 36o vaccination. I requested his
thoughts and comments before forwarding a summary to NIAID as they
had requested. COL Burke replayed 11 September aneknoted he agreed
with an earlier comment of mine th....was time to get these
issues behind us.
On 7 October I presented the same data at the OSD S & T
Review, that had been presented at and since Chantilly. Again I
presented the same data a week later at the ICAAC meeting. The
only question I was asked after my presentation was by an AIDs
activist who wondered why Congress had given us $20M; I -'ponded
that he should ask his Congressman. Dr. Michael's presentation
followed mine and I was asked a question by Major Hendrix. I
presented the same material as at all previous meeting and showed
a slide titled "Limitations of Phase I Trial Design" which stated
"Phase I Trial results support immunogenicity and safety. Meaningfull conclusions related to clinical efficacy must await the
completion of ongoing and future controlled clinical trials."
I presented the RV21 Phase I data to the NIH technology
transfer meeting on 30 october and to the Georgetown grand rounds
on 5 November. On 12 November, the next meeting of the Research
Operations of the MMCARR was held and there were no issues related
to the RV21 Phase I study and analysis raised.
Unt 1 today, I had not seen a copy of the letter from the Air
Force. EI believe there is no basis for any of the allegations and
I resent them. I do not understand why no-one ever asked me how I
analyzed the data if they had questions. I &h '@kept any of
the data from anyone who has asked. I deny that I have
misrepresented the data and that I have oversold the data. The
heroes of the gp 160 trials are the patients themselves and I would
never be less than honest with them. I have made it clear in every