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Dr. CROUT. Let me draw a distinction between two roles. One is
our review committees, and the other is a committee that is set up
to do clinical trials.
Now, that group has offered to conduct studies on scleroderma. I
don't personally know what the individual biases of those people
are.
Ms. OAKAR. Why did they offer to do it? Do they have a lot of
free time?
Dr. CROUT. That group is established to evaluate remedies in the
field of arthritis.
Ms. OAKAR. Could it possibly be they are negatively disposed and
they want to kill this drug?
Dr. FINKEL. When our Arthritis Advisory Committee reviewed
the data――
MS. OAKAR. Can you tell me who is on your advisory committee?
Dr. FINKEL. At that time there was Dr. Evelyn Hess, Dr. Paul
Plotz from the NIH, Dr. Daniel Furst, and Dr. Fernandez-Herlihy.
Ms. OAKAR. All these people are objective and knowledgeable?
Dr. FINKEL. Yes.
MS. OAKAR. Can I ask Dr. Jacob, do you agree?
Dr. JACOB. Dr. Evelyn Hess was the chairman of the committee.
She showed so little knowledge of the disease that she denied that
patients who had ulcers came to amputations.
I was appalled that they would bring in an expert who didn't
recognize patients with nonhealing ulcers, with scleroderma come
to amputation. That to me is an insult.
Ms. OAKAR. Mr. Chairman, I am not trying to cast aspersions
against anybody's reputation for the record. However, I think I
have asked enough questions in this respect to get at least a
negative reaction on the part of the people who are working on this
on a day-to-day basis.
I think in view of that, you ought to start appointing some
people who are mutually acceptable. It doesn't mean they have to
be predisposed favorably. But, when you get negative reactions
from individuals who have dedicated their lives and have seen
results, then you can understand why the average person out there
wonders what is going or..
Dr. FINKEL. May I make my point? After the advisory committee
reviewed the data they felt that there may be some evidence of
effectiveness. They recognized it is a very serious disease that they
are dealing with, that there is no other adequate alternative
therapy.
So, the advisory committee itself said let's try to set up a con-
trolled clinical trial which will show once and for all whether this
drug is effective. They were very interested in having an effective
agent.
Dr. Evelyn Hess was the one who suggested that the cooperative
clinics group be contacted, the one that Dr. Ward happens to be
chairing right now, to see whether it would be interested in design-
ing a protocol and in doing a study.
Ms. OAKAR. On that note-because I had that marked in your
testimony, Dr. Crout, where you conclude on page 6 that DMSO
may be effective. Do you mean that drugs that are approved by the
FDA must be effective in every instance?
