AIDS Vaccine Panel Discussion [Minutes]

7-APR-97 PACHA AIDS VACCINE PANEL DISCUSSION - p. 62

antitrust. You just can't get four vaccine manufacturers in the same room. It's
impossible.
We have on our group Clark McFadden, the attorney who set up Sematech and
ran it; we have the former Secretary of the Treasury, Bill Miller; we have Ken Shine,
and we've had a preliminary meeting. So that's going forward.
I think it's very important to set a time line, and it's very important to have
leadership. Maybe you don't want to call them a chief executive, but you have to be --
everyone has to be accountable on this thing, and you can't just let it drift.
I think what you've done is great. We're going to pass out a paper which gives
our position. You already heard some of it from Dr. Russell. Thank you very much.
Keep up the good work.
DR. LEVINE: Thank you, Dr. Shepherd. Phyllis Greenberger, and then we'll stop.
MS. GREENBERGER: Bear with me for a moment. I just want to go back to a past issue
that came up, the liability issue. Mr. Gold, we received a copy of, I guess, the
recommendations or the survey that you worked on, the "Industry Investment in HIV
Vaccine Research," which clearly stated that liability was in the top three, if not the top
two, impediments to the development of a vaccine. And it seemed to me, I thought I
heard Dr. Sadoff say that we don't necessarily have to address that issue until we get to
a point where the science is there and we are up against it.
Many of you may know that liability issues have been debated on the Hill now
for a number of years, and there's some feeling that something may actually happen in
the near future. I've been involved in that issue. There's been a tremendous amount of
controversy, needless to say -- I'm sure you're aware of it -- and a lot of hearings, and I
have not heard or seen anyone from the AIDS community talk about this issue relevant
to the vaccine, liability reforms in relevance to vaccine.
It seems to me if it's true that it's an impediment or that the companies feel it's
an impediment, then it seems to me that it should be addressed before we get to that
point, not after. Could you address that, please? Either one of you.
DR. SADOFF: It's a very important issue, and it needs to be addressed, either as becoming
part of the [National Vaccine Injury] Compensation Act that's currently in place, or a
separate act that would make-it occur. And I think that unless something like that does
occur, that would be a strong impediment. Don't get me wrong.
A little bit about it, though, has to do with the kind of vaccine that's made, in
the sense that if you don't know exactly what the form of the vaccine is, you don't
know what the risk is that you might harm somebody with the vaccine, and, therefore,