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sented, then you keep a copy of that record. And we will all have a
chance to look at it later on if necessary to see whether it looks
like a fair record or presentation, and others can judge as to
whether the Food and Drug Administration fairly appraised and
evaluated the data that was presented in that record.
Dr. JACOB. There will be a lot of fingers amputated in the next
couple of years while we play this ridiculous game.
The CHAIRMAN. Dr. Crout and I have agreed on 1 year at the
outside. He is going to try to do that even quicker, if possible.
Dr. CROUT. Those are estimates of how long it would take to
conduct the trial. We are not conducting the trial. How it works
out in the end is going to be dependent on the energy and the
discipline brought by those conducting the trials.
The CHAIRMAN. Well, of course it depends on how soon the case
might be presented to you. You would obviously have to have a
reasonable time after it is presented to you for consideration of it.
Would you think within a year at the outside that the conditions
could be met if they were capable of being met: that is to say time
enough would elapse to where these controlled studies could have
been made?
Dr. CROUT. For sprains and bruises, because that is a common
problem, it is easy to recruit patients and should go very quickly.
As I pointed out, a scleroderma trial is likely to take longer for the
reasons that Dr. Scherbel mentioned. That is an uncommon disease
and there simply are not-
The CHAIRMAN. Well, what if they are incapable of discovering
within a year?
Dr. CROUT. The problem is to get it organized and get the people
on a protocol and to recruit patients. Remember that patients with
scleroderma, many of the patients, can participate in that trial and
will get DMSO by virtue of their participation. So at least some of
the population in the country gets treated as a result of participat-
ing in the trial.
That is a recruitment incentive to them.
The CHAIRMAN. Doctor, I have found when we want to do some-
thing very badly, we can do it a lot quicker than we can if we don't
want to push it too fast. We are dealing with something here that
may mean a great deal to the public interest, to a lot of people,
millions of people. And let's not delay 1 day.
I know when my dear wife was diagnosed as having cancer, when
they wanted to give her chemotherapy, the doctor said "We will
start in the morning." I said, "No, let's start this evening."
You have heard the old story about the tree that took 500 years
to grow. The question was when were they going to plant it. One
fellow said, "It takes 500 years to grow." And the other fellow said,
"Well, then let's plant it this afternoon, by all means."
So let's try to see if we cannot make a record, scientifically sound
and reasonable at the same time that there won't be any inference
whatsoever that it will be properly derived, so there would not be
unusual delay with respect to it.
I want to ask you if I may that you cooperate, Dr. Crout, in any
way you can toward that end.
Dr. CROUT. Yes, sir.
