Statement of Nelson L. Michael, M.D., Ph.D.

Dr. Vahey began earnestly collating the RV21 Phase I data in
June 92. Although I was a co-author on the manuscript, she spoke
to me of the data only in general terms while other members of the
department, especially MAJ Lucey, were frequently apprised in
greater detail of the progress on the viral burden data. LTCs
Redfield and Birx, co-principal investigators of the RV21 protocol,
were not accorded this access. I began to hear of MAJ Lucey's
concerns with the select irn of a natural history control group from
other members of the department and, ultimately, Dr. Vahey. I did
not and do not understand why this issue was adjudicated with
individuals who were not directly responsible for the clinical
trial nor the technical details of the assay. For the presentation
in Amsterdam, LTC Redfield used the viral burden data that was
available from Dr. Vahey to compare with a natural history cohort.
Subsequent to the Amsterdam meeting, Dr. Vahey completed viral
burden studies on an additional 11 patients for a total of 26.
Interpretation of this data set remained in flux for some time as
various statistical treatments and data groupings were considered
by multiple individuals.
A memo dated 27 July 92 was distributed to all members of LTC
Redfield's department which included the data set from the patients
of the Phase I study and which called for a meeting to discuss
them. I had observed MAJ Lucey with a draft of this memo prior to
its general release. At the meeting 31 July 92, Dr. Vahey seemed
genuinely surprised at what had been intended to be a department
meeting had become a meeting of Rockville MMCARR investigators.
Before Dr. Vahey could complete discussion of the viral burden
data, MAJ Lucey launched an acrimonious attack on LTC Redfield's
Amsterdam presentation based solely on press accounts of the
conference; he raised three major issues: 1.) mentioning the viral
burden studies based on the first 15 patients and a control group
that he thought was selected in a biased manner was a misleading
attempt to derive efficacy data from a Phase I trial; 2.) Stressing
CD4 cell count data from these patients was misleading for the same
reason and 3.) LTC Redfield misrepresented the Phase I trial to the
press. Each of the three times MAJ Lucey made these accusations,
LTC Redfield defended his interpretation of the viral burden data,
denied mentioning CD4 cell counts in the context of efficacy and
denied misleading the press. MAJ Lucey then questioned LTCvy
edfield's conduct with protocol patients stating his belief thatI