70
Many, but not all, have had some research experience. They will
bring to the committee-▬
Ms. OAKAR. With this drug?
Dr. CROUT. No.
Ms. OAKAR. Not with this drug.
Dr. CROUT. Not necessarily with this drug, no.
MS. OAKAR. Why wouldn't you have somebody who has worked
with the drug?
Dr. CROUT. Well, it is a matter of maintaining the independence
of the reviewer as compared to the advocate. I think there are
certain general principles about clinical research that are well
understood by research people.
MS. OAKAR. Tell me a little more about it.
Dr. CROUT. The questions are whether the trials are controlled
correctly, whether or not they really showed the effects.
MS. OAKAR. Are they all M.D.'s?
Dr. CROUT. They are not all M.D.'s. We generally have a statisti-
cian on each committee. Sometimes we have a toxicologist.
Ms. OAKAR. With respect to the people going to do the research
on this-the National Institutes of Health-who is on this commit-
tee that you are going to ask to research this that has any creden-
tial related to this drug?
Dr. CROUT. The chairman of that group, Dr. John Ward, at the
University of Utah School of Medicine. I am quite certain he would
be accepted as a peer by any of the previous panel that you
mentioned.
The other people who will study this will be academic rheumatol-
ogists around the country.
Ms. OAKAR. So he is a teacher of medicine?
Dr. CROUT. Yes. You may ask the panel, but I would be very
surprised if Dr. Scherbel and Dr. Jacob did not accept the panel as
peers.
Dr. JACOB. I don't think I would accept that at all.
Ms. OAKAR. Mr. Chairman, you don't mind if I recognize Dr.
Jacob?
Dr. JACOB. I think it is an insult to talk about Dr. Ward. I would
like Dr. Scherbel to get up and answer some of the questions. I am
not at all satisfied that the FDA is giving DMSO a fair shake.
We have proved safety and effectiveness in scleroderma. People
are having their fingers amputated, and these people are sitting
here and twisting the facts.
Ms. OAKAR. If you don't mind-what you are saying is the person
who is going to chair this panel to again review the effectiveness
you feel is personally biased?
Dr. JACOB. I have talked to him and he is anti-DMSO.
MS. OAKAR. That is what I am getting at, Mr. Chairman. People
who have done the research, who are working on a case-by-case
basis-at least some individuals-feel that the people who are neg-
atively disposed are the people you are appointing to do the re-
search now.
You can tell me all you want about research. But you appoint at
a minimum people who are objective and, second, knowledgeable,
and it appears that this individual, whoever he is, doesn't have
those two criteria.
