63
Now, we accepted the trials done by Dr. Scherbel as designed
properly at the start. The problem with those trials is they came
out with the equivocal result which I mentioned to you. But
sprains, bruises, and soft tissue injury have really not been subject-
ed to the disciplined kind of clinical research that is really stand-
ard for drugs in this country.
The CHAIRMAN. Well, now, do you set up the procedures? Do you
advise the applicant as to what it must show to get approval?
Dr. CROUT. We will if asked, yes.
The CHAIRMAN. Well, I am curious as to what your role is and
how you regard your role. If you regard your role as that of a
gatekeeper to keep anything dangerous to the public interest from
passing, then you just wait until the dangerous thing comes along
and you stop it.
On the other hand, it would seem to me that from all that has
been said here this morning, there are a lot of people who believe
that this drug has a remarkable efficacy in certain areas at least.
Dr. Jacob thinks the areas may expand with knowledge and use
into an extraordinary scope.
Your curiosity wasn't aroused that the 30 million people in this
country that suffer pain from arthritis and maybe some fellow
comes along the highway saying he has something, that might
really be something that would reduce the pain of those people and
say "Look here, now you have submitted evidence that has a cer-
tain amount of persuasiveness."
But, on the other hand, under the statute and our rules and
regulations, we have to require that the evidence comes within a
certain category and have a certain amount of probity to it. We
would like you to go back and reorganize your presentation.
It is one thing for a judge to be sympathetic to a meritorious case
being presented. It is another thing for a judge just to sit there and
if the fellow can come up with something, all right, and if he
cannot, all right. The judge assumes no responsibility.
Dr. CROUT. I understand what you are saying. Our view is exact-
ly as you have described. I cannot speak personally for what hap-
pened during the 1960's. My suspicion is that back in the mid-
sixties the atmosphere was a confrontational one.
But I do know that in the past decade it has not been. As Dr.
Jacob mentioned, there has been cooperation with the FDA staff. I
keep track of what is happening in DMSO and a number of other
drugs, personally, as does Dr. Finkel and Dr. Gyarfas.
We don't want to give you any impression of disinterest in
DMSO, of bureaucratic obstinacy or of being uncooperative. But
there is a reasonable standard, a scientific burden of evidence, that
drugs properly should meet if we are going to have any drug
regulatory system at all. And we are asking that of DMSO, no
more, no less than any other drug.
The CHAIRMAN. Well, Doctor, we understand you have a great
responsibility. You might, if you acted hastily or unwisely, author-
ize some fellow trying to make a lot of money to put something on
this great market in America, make a lot of money and maybe
injure a lot of people.
And you, of course, feel a moral responsibility for permitting this
to happen. I would assume that those cases would be largely limit-
