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

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Finally, the use of the viral burden data to support safety
was discussed at the meeting. It was deemed acceptable to do so by
the group if appropriate caveats were placed op~.this conclusion in
the context of ~anon-placebo controlled trial.
She argued that presentation of the extensive,
longitudinal viral burden data that we had collected on certain
patients, especially patient 001, was misleading because some of
the data sets showed a fall in viral burden. I pointed out that,
while this was true of patients 001 and 002, it was not true for
patients 003 and 004 and that I thought, therefore, that this data
set was reflective of our conclusions. I told him that "the data
were the data" and that there was no cogent rationale to suppress
it. The discussion then turned to the technical and biologic
variation inherent in viral burden assays. All, including
agreed that studies were lacking in this field and that
they, being of high relevance, merited top priority.
On 15 September 92, LTC Redfield had been invited to attend a
working group of the AIDS Vaccine Evaluation Group (AVEG) by Dr.
Patricia Fast, NIAID, to specifically address the qu sion of viral
replication enhancement with aol60 vaccination.
LTC Redfield and I presented sequential addresses at the ICAAC
meeting on 13 October 92; he co-chaired the session. He presented
an abbreviated version of his Chantilly talk with the same amount
of qualifications and caveat slides as I discussed above. The only
question following his presentation was from an AIDS activist who
asked why Congress appropritd $20 M for gpl60 vaccine therapy
based on the data presented.L
I followed his talk with a 10
minute presentation of my data on DNA sequencing, transcriptional
activity and viral burden analysis from two Phase I patients. The
longitudinal viral burden data on patient 001 was diminished and
that for patient 004 was unchanged. My talk was punctuated by
qualifying remarks and slides.