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Between 1964 and 1966 and 1971-72 many of the concepts relat-
ing to controlled studies were altered so that they were in effect
evaluating studies done in a period of time prior to newer tech-
niques of controlled studies. That was one of the reasons they felt
that the studies were not all that well controlled.
On the other hand, as I mentioned this morning, given indocin,
had they evaluated indocin the same way, they would have come to
the same conclusion because the conclusion of the house and Dr.
O'Brien was that none of the studies were valid. So that there was
that time frame when one worked with different criteria for con-
trol.
But if you really study the Academy report, they say that DMSO
is at least as good as anything else that we have for acute shoulder,
for chronic shoulder, and for acute injury. They say no better, but
at least as good.
They also say that it has potential and they say in their conclu-
sion that there is no toxicity so great as to preclude its use in any
condition in which efficacy has been demonstrated.
The other point about the National Academy is that there was
no one on that committee who had ever used DMSO. I had the
opportunity of speaking to them. They read the literature, but they
did not have experience with DMSO. I don't know if that answers
your question or not.
In terms of Dr. Crout's feeling relating to DMSO not being a
miracle drug, I don't like to use the words "miracle drug" myself.
But as I mentioned before, there is no chemical substance with a
wider range of primary pharmacological activity or a broader
range of efficacy as one can find in the literature for DMSO.
Mr. BONKER. There just seems to be an institutional bias at FDA
against this substance.
Dr. JACOB. I think there is, no question. I think the FDA is
biased against it.
Now, the only time the FDA was not biased against it was when
it was in Dr. Gibson's division. DMSO got a fair shake from Dr.
Gibson and George James and John Richmond and K. C. Pani.
When the situation was changed to a different division, I no
longer see that fair shake. I don't see how DMSO can receive a fair
shake from the FDA the way it is now being handled.
I am discouraged, regardless of what Dr. Crout or Dr. Finkel or
Dr. Gyarfas say.
is.
Mr. BONKER. And it apparently doesn't matter who the Director
Dr. JACOB. That is right.
Mr. BONKER. It just remains regardless of who the Director is. He
comes in and listens to his technical personnel and just more or
less carries on that policy statement from administration to admin-
istration.
Dr. JACOB. Yes. I think that is what happens.
The CHAIRMAN. Ms. Oakar?
MS. OAKAR. Thank you, Mr. Chairman.
I want to thank Dr. Paul for coming from Canada to be with us.
Dr. Jacob, for the record, we have never gotten the components
of DMSO, so maybe you would like to explain very briefly.
