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

109

1 into a large-scale clinical trial as being a
2 therapeutic agent.
3 CO-CHAIRMAN FAUCI: Mark?
4 MR. HARRINGTON: I just think it's quite
5 clear from how little we've actually been shown of the
6 work that's actually already been done that we need
7 more information before we can answer that first
8 question. Therefore, I think we need to have a second
9 meeting to discuss in detail the findings.
10 I think, however, here we can talk about
11 the broad framework and some of the public policy
12 issues. I think it's important to remember there's a
13 public health issue here, too. It's not just a
14 scientific issue looked at in isolation.
15 Is it ideal that we should mount a
16 large-scale Phase III efficacy trial at this time?
17 There are waiting lists for different vaccine trials,
18 hundreds or thousands of people long around the
19 country.
20 Whether or not their expectations have
21 been raised cruelly by a pharmaceutical industry that
22 wasn't really presenting both sides of the story or
NEAL R. GROSS
COURT REPORTERS AND TRANSCRIBERS
1323 RHODE ISLAND AVENUE, NW.
[phone] WASHINGTON, D.C. 20005 [phone]