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The CHAIRMAN. Thank you very much. Dr. Scherbel, we have
some more work for you. I think they are going to have you busy
preparing this new application. So you better start collecting data.
Ms. OAKAR. Mr. Chairman, before Dr. Scherbel leaves, I do think
that Dr. Crout ought to answer the one specific point that he
makes with respect to this particular disease, and that is I think he
is saying you cannot possibly evaluate it if you have not worked
with it over a period of time. Is that not correct? Isn't that pretty
much what you said?
Dr. SCHERBEL. Say it again, please.
Ms. OAKAR. That you cannot possibly evaluate the effects of
DMSO accurately on scleroderma if you have not been working on
a day-to-day basis with these people, because it is such a rare type
of disease.
Dr. SCHERBEL. The rarity was to get the type of patient where I
think we could prove simply effectiveness of treatment. The plan
was to find patients with bilateral fingertip ulcers persistently
present. The ulcers were not intermittent. These patients had
ulcers that were present for over a year.
As they were treated, one hand that was treated improved very
nicely. Within 3 months there was a marked change. Within 6
months the other hand began to improve, which we expected. We
said it was a cross-over effect of the drug. But our advisory commit-
tee said no, this is spontaneous improvement, these ulcers are
beginning to heal.
Well, after 6 months we treated both hands, which was the
protocol. And at the end of 1 year these patients had no ulcers.
Some patients will not stop DMSO treatment. They believe
ulcers stay better healed with persistent DMSO treatment.
This part of the study may be considered a historical control. To
me the explanation is simple enough. Something happened during
treatment which is very unlikely to be spontaneous improvement.
Ms. OAKAR. Dr. Crout, can you guarantee this committee that
none of the people who viewed DMSO negatively in the past will be
on the evaluation committee in the future so that we assure objec-
tivity?
Dr. CROUT. No; I won't guarantee that. I don't think that is the
way you guarantee objectivity. You cannot load the committee.
People on this committee did not, as far as I know-and I would be
pleased if Dr. Scherbel could tell us if he feels differently-have
any personal biases. There were only scientific reasons for a differ-
ent point of view.
Ms. OAKAR. All I am asking you is yes or no. Will you guarantee
to this committee that no one who was on the previous panel that
evaluated DMSO, whether they were pro or con, will be on the
committee again.
Dr. CROUT. No, I won't guarantee that.
Ms. OAKAR. Then, Mr. Chairman, I don't see how we can arrive
at any other conclusion, if you, Dr. Crout, are not willing to have a
clean slate to consider this issue. Because if you put the same
predisposed people on the panel they are going to come to the same
result. You don't have to be a sophisticated research technician to
know that.
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