74
Tell us how the decision is actually made and by whom. I in-
ferred you had advisory committees and the like. Do you make the
final decision on all these drugs?
Dr. CROUT. Every drug has assigned to it a team that includes a
physician, pharmacologist, a chemist, a biopharmaceutics expert,
and a statistician. That team will review the application and will
consult with an advisory committee, and then write a recommenda-
tion for approval or disapproval of the drug.
That will be reviewed by the division director, Dr. Gyarfas. That
recommendation will in turn be made to Dr. Finkel, and Dr. Finkel
has the authority to approve or disapprove new drug applications.
I engage in oversight over the whole process. So it is a collective
group of people who would participate in any drug decision.
The CHAIRMAN. Well, now, Doctor, let's say Dr. Jacob and the
group working with him-I am hopeful that Dr. Jacob will put
together a group of knowledgeable and competent people to join
him in the preparation of a new application to be presented to your
agency.
Now, if they don't know enough right now as to how you think it
would be best presented, with whom could they confer? Would it be
with Dr. Finkel or somebody to tell them, now, this is the way we
propose to set it up-does that seem to be generally all right in
structure?
Dr. CROUT. Yes, sir. Research Industries has met with us on
many occasions in the past. We assume they will continue to in the
future. They have met with both Dr. Gyarfas and his staff and with
Dr. Finkel. I am sure I can guarantee their personal attention to
this.
The CHAIRMAN. Very good.
Then you will set up the proper machinery for the preparation of
your material.
Dr. Jacob, I think we have made quite a lot of progress today.
Dr. JACOB. I am amazed Dr. Crout would say there is no disease
altered by DMSO. It shows a complete lack of knowledge. I respect
Dr. Crout and like him. He is from Oregon. But it shows a com-
plete lack of knowledge of the literature on DMSO.
It can be stated with certainty that there are many diseases the
course of which is altered by DMSO. I would like to ask a question
which will be embarrassing, but I would like to ask it.
Dr. Gyarfas is in charge of the DMSO evaluations. He is on
record as saying, “I am going to bury that drug once and for all.” I
would like Dr. Gyarfas to either deny or accept that statement
before this committee under oath.
The CHAIRMAN. Very good. If you will, will you please answer
the question, Doctor.
Dr. GYARFAS. I, too, have heard this accusation many times from
the proponents of DMSO. I was responsible for calling an ad hoc
committee to review the data on DMSO in approximately 1970 or
1971, before we established the 13 advisory committees that Dr.
Crout referred to, before the mechanism of advisory committees
was a well-known fact in the Bureau.
This committee we selected what we thought were the prominent
men in the field of arthritis, especially in surgery. It was, as a
matter of fact, a surgery advisory committee because we had no
