[Minutes, Advisory Committee to the Director GP-160 Meeting (1992: Bethesda, Maryland)]

155

1 I also want to caution us that it's sort
2 of an if question. Can we go from here to there? The
3 if question is if the information that we have thus
4 far in Phase I trials truly represents what we expect
5 in Phase III trials or large-scale trials.
6 If it does not, for example, if there is
7 a major difference in the safety profile, even though
8 we've heard a lot of issues around the fact that what
9 we've been able to find from the period of observation
10 that we've been able to observe these patient
11 populations, given the CD4 status that they happen to
12 be in, that there are no safety problems. In a large,
13 simple trial, you're now moving from a population of
14 that type.
15 The other issue that, in fact, is really
16 a public policy issue is that once we provide the
17 vaccine, what do we provide with it? I've heard the
18 issue about primary care, but there are also other
19 aspects of that in public health terms or preventing
20 the spread of HIV transmission from those who are
21 already infected who are in the trial.
22 I think to me it seems to me it's not such
NEAL R. GROSS
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