72
Dr. CROUT. No. That means that they must have an effect which
is demonstrably better than chance.
If for example there is a placebo effect in which there may be a
response rate, let's say, of 20 percent, an active drug would have an
effectiveness rate demonstrably greater than 20 percent.
One figures that out by comparing the active drug to a placebo,
in the simplest form of trial. In certain other instances the new
drug is compared with an already known active agent to see that
they produce comparable remission rates.
But there are very few drugs that are 100 percent effective.
Ms. OAKAR. Well, that is the point. Some of the doctors testified
that they would like the opportunity to deal with patients individ-
ually so that they could suit them to the proper drug to relieve the
problems with arthritis.
Dr. CROUT. That is a well-established principle in therapeutics,
and we accept that.
Ms. OAKAR. Because we are hearing more and more negative
things about aspirin with respect to elderly people, as was testified
to today-not in every instance, but in some instances.
So, I am wondering if your panel arrived at that conclusion that
it may be effective, why the holdup? I just want to ask one more
question. Have any drug firms intervened in FDA proceedings to
oppose approval of DMSO?
Dr. JACOB. I would like Dr. Crout to comment on why indocin
was approved with no control studies and DMSO was turned down
from three drug companies at that same moment in time. And Dr.
Finkel also.
Ms. OAKAR. Let me ask the question for you. Why don't you
assume that I asked it.
Dr. CROUT. To my knowledge, indomethacin was not approved
without adequate and well-controlled clinical trials.
MS. OAKAR. Let me just conclude by saying I certainly respect
the position you are in. You have the burden of defending the
position of the sixties that appears to be questionable at best.
You were not around during the sixties, but I am wondering if I
could ask you a personal question. Are you representing your own
point of view or the view of the FDA on this?
Dr. CROUT. Both.
Ms. OAKAR. So you agree that it is not necessarily an effective
drug, is that what you are saying?
Dr. CROUT. I am saying it is not proven to be so by the standards,
by the scientific methods that are appropriate for drugs.
Ms. OAKAR. Thank you, Mr. Chairman. I just want to say that
the American people have a hard time understanding how Premier
Tito can get all kinds of drugs that our people cannot get on their
deathbeds.
Really and truly, there are a lot of people out there who would
like the option of at least trying something which by your admis-
sion is not toxic. Obviously the studies of the seventies contradict
the studies of the sixties.
The CHAIRMAN. Thank you Ms. Oakar. Father Drinan.
Mr. DRINAN. Doctor, I commend you and your associates for
carrying out the law. I fully understand what you are seeking to
