Statement of Capt. Douglas L. Mayers, MC USN

The current investigation was caused by a fundamental level
of distrust between the clinicians caring for patients in the
vaccine therapy trials and the Department of Retroviral Research.
The clinicians do not trust LTC Redfield because they have been
denied access to the raw data and have not participated in the
data analyses for the ongoing vaccine trials. They only seen
summary data which they felt had been presented in a selective
and incomplete fashion. There were real concerns about
significant investigator bias in the presentation of data from
the vaccine therapy trials.
Since my tranisfer, LTC Redfield and I have been able to work
together and I have stayed out of the activities inside his
department until April 1992. At that time there was a gpl60
investigators meeting in San Antonio. After the meeting, I
talked with Dr. Ken Wagner who informed me that Dr. Vahey was in
disffyor in the Department. I asked Dr. Vahey about this and she
p tea that she was being forc&i out because of intellectual
disagr**ments with LTC Redfield. I feel strongly that o~r
program has to tolerate differences of opinion among individual
investigators and I informed COL Burke of my concerns. This
resulted in a 15-6 investigation of LTC Redfield' s department
which was subsequently postponed. After COL Burke initiated the
15-6 investigation, I again withdrew from the activities inside
the Department of Retroviral Research.
On 10 July and 13 July 1992 I sat on a Source Selection
Board with Dr. Vahey. She indicated that she had some data that
she wished to have reviewed outside the Department of Retroviral
Research and that she had forwarded the data set to LTC Redfield
with a request for release outside the Department but that she
had not received a response. She would not release the data
without LTC Redfield' s approvl. She was visibly tense and
anxious when discussing the dat.
On 24 July 1992, when I returned from the Amsterdam meeting,
SI found a memo dated 24 July 1992 on my desk from Dr. Vahey with
copies furnished to COL Burke, Dr Lucey and LTC Chet Roberts.
The memo contained her analysis of the viral burden data for the
patients in the Phase 1 gpl60 study. I reviewed the data over
the weekend and became concerned since it was very different from
the presentations that I had heard of the gpl60 data. The data
analysis showed that there was no change in viral burden for the
group of patients as a whole during the study and that CD4 cells
were dec ining for patients in the second year of the phase 1
study. (I had heard that CD4 counts were dropping in the cohort
and a colleague at Walter Reed had previously told me that he had
4 asked LTC Redfield on several occasions ihy he had not updated
his slides of the CD4 data since the New England. urna ~0f
Medicine article.) I went to COL Burke and expressed concerns
regarding the data. Later that week, Col Burke told me that he

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