Statement of Ltc. Deborah Birx

professional judgement."

I am unaware of any instances wherein statisticians have been
pressured to use analytic tests to achieve desired conclusions. As
an investigator who needs analyses from this statistical group, I
hope that, if there are questions about the hypothesis that I am
testing, the concerned individual would contact me rather than less
appropriate channels. The more significant problem has been
getting the statistics group to perform any timely data analyses.
"There are many examples of presentation of the data that have
been couched in terms of safety, but delivered in a manner that
communicates a message almost universally received as data
supportive of efficacy, when the facts do not support this. This
message can be subtle with words chosen so carefully that they are
not technically false, but give the observer a misleading
impression. As recently as the 15 SEP 92 meeting and on several
previous occasions, it has been made clear to Dr. Redfield that the
nature of the "efficacy" message received is significantly
different that(sic) the 'afety" message purportedly intended.
Such potentially deceptive presentations persist, however, as
evidence(sic) by the ICAAC presentation last week."
Tapes and hard copies of presentations are available to
evaluate for "efficacy" messages. Every presentation I have made
or heard Dr. Redfield make of Phase I data has stressed
immunogenicity and safety of the rgpl60 vaccine and has stated that
any information regarding efficacy must await completion of the
Phase II trial. LTC Redfield and I have repetitively argued to
maintain the integrity of the Phase II data to this very purpose.
"Additional facts create at least the perception that the
integrity of the gpl60 phase II trial may also have been
diminished. An unblinded laboratory investigator has been seeing
gpl60 patients for research visits and has, at least on one
occasion, altered previous Walter Reed staging designations
(telephone conversation with COL Oster 4 SEP 92."
I was ordered to report to the HMJF HQ at 1600 27 October
1992; COL Burke refused to comment on the topic. I was 10 minutes
late because of an obligation to participate in an HIV symposium
received two months earlier. From the discussion I heard there was
going to be an investigation but it was not clear what the issues
were that had precipitated it. Following the meeting, I discussed
the investigation with Captain Doug Mayers, USN. He said he had
seen a letter from the Air Force signed by Craig Hendrix and Neal
Boswell and that everyone had seen it last week (I had not seen the
letter.) and that it had been distributed throughout the Navy and
Air Force HIV programs, sent to the Navy and Air Force Surgeons
General and through the Army chain of command. On 28 October, I
called COL Boswell to ask what knowledge he had of this letter and
he read it to me. I told him I was incredulous and that he surely