78
That is why I don't think this drug will ever be approved. A
strict protocol with double blind studies, are demanded.
The CHAIRMAN. Dr. Crout, would you regard the testimony of Dr.
Scherbel as relevant to the decision of this question as to whether
this drug should be approved or not for limited use?
Dr. CROUT. As relevant, yes, sir. He has said that before our
advisory committee and before our agency before. I regard Dr.
Scherbel personally and professionally as an outstanding person.
The CHAIRMAN. So that would be relevant to you, his experience
would be relevant to be included in this.
Would you regard Dr. Paul-he spoke of his experience this
morning with a certain use of the drug, of the substance, in Toron-
to, in the hospital.
Dr. CROUT. I am not familiar with his work. I don't believe that
bore on our decision on scleroderma. Dr. Scherbel conducted a trial
on scleroderma which was the subject of a careful review for a
whole day before our advisory committee.
The CHAIRMAN. What about Dr. Reedy? He was the physician for
a professional football team. He used it over a period of years. And
then Mr. Jones was the quarterback on a professional football
team, and he spoke about his own experience with it. Would testi-
mony like that be relevant?
Dr. CROUT. Not helpful, no, sir; not unless it is put into a scientif-
ic study and controlled and there is some comparative look at other
drugs, or at different concentrations, or under other conditions to
let you know that the effects observed are drug related.
The CHAIRMAN. Well, the tribunal that makes the first recom-
mendation, is it the existing tribunal or a new one to be appointed
by you?
Dr. CROUT. We give problems like this to standing advisory com-
mittees. The members of that turn over in part each year, because
people serve 3- or 4-year terms. So any problem with DMSO would
come back to the arthritis advisory committee. By the time it did
we assume there would be some new members, but also some of the
former members would still be there.
The CHAIRMAN. I would think, Dr. Scherbel, when I see the high
regard Dr. Crout has for you, when you find out this application is
prepared or being presented, and you know who the advisory com-
mittee is, or who the other committee is, if you find you don't think
there is anybody on there really qualified to make this decision, I
would think you would be permitted to go to Dr. Crout and tell him
so, and let him consider your comments.
Dr. SCHERBEL. I don't think it is Dr. Crout or the advisory com-
mittee. I don't think this is the problem. I think the problem is we
are dealing with an unusual type of drug and an unusual condi-
tion. And there is nobody, unless he has worked with this drug this
period of time, who could speak with any authority about DMSO
drug action.
Here is our problem.
I don't think-
The CHAIRMAN. If you follow my suggestion and my earnest plea
for you, according to the sort of understanding we arrived at here
this afternoon, that you are going to get fair if not sympathetic
understanding and consideration when this new application is pre-
