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Most recently, Research Industries Corp. submitted to the FDA a
NDA stating that DMSO was ready to be prescriptive for sclero-
derma. This was turned down.
I do not believe there is another substance which has been
turned down five separate times, five NDA's by the FDA. One of
the major points brought up by the FDA is that DMSO, that the
studies are not well controlled.
I have in front of me the Washington Post, April 24, 1968. It is
entitled "FDA Approval of Drug Hit." This talks about a drug
called Indocin which the FDA approved at the same time they not
only stopped testing on DMSO in 1965 but actually turned down
three NDA's.
The approval of Indocin was investigated by a congressional
committee. The conclusion was that there were 137 studies submit-
ted on Indocin to the FDA. Only three of these studies were consid-
ered to be well controlled and those three were subsequently shown
to have been biased.
So what we have here is a situation where the FDA approved an
agent which happens to be expensive which is used for the treat-
ment of arthritis with, in essence, no controlled studies, at the
same time they turned down DMSO.
Now at that time when Merck, Syntex, and Gibb submitted
NDA's to the FDA, there were between 1,300 and 1,500 studies
committed on 100,000 patients. These were all tossed aside. These
were all turned down. The FDA approved Indocin and a congres-
sional investigation subsequently showed that the studies on which
Indocin approval was based were certainly not controlled.
It is difficult not to become emotionally involved with DMSO.
The reason it is difficult not to become emotionally involved is that
over the last 18 years we have literally treated thousands of people.
We have visited every country in the world where DMSO is pre-
scriptive. We have read every publication in the literature relating
to DMSO that we could find. We have written several books on
DMSO. I brought them here.
Interestingly enough, this book which is entitled, "Dimethyl Sul-
foxide," doesn't come from the University of Oregon Medical
School. It comes from behind the Iron Curtain. It contains 3,500
references. Not all of them are on the medical uses of DMSO.
But we are not talking here about a substance that is not well
steeped with scientific background. We are talking about an agent
which has been studied in just about every medical school in the
world. There are literally thousands of scientific articles. I think it
can be stated without qualification that this is safe and effective
for many diseases for which we do not have other treatments and
for many diseases for which we do have other treatments.
Before coming here, I picked up a book in the newsstand entitled
"Montgomery Clift." On page 392 there is a paragraph which
starts: "Bachrach began by giving him injections of aristocort, that
is, cortisone in his shoulder. This worked well, gave him relief, but
it was too strong. It ultimately would have disintegrated the shoul-
der bone.
"Later he suggested Monty try DMSO which was a great new
painkiller. You just rub it into your skin like a lotion. It comes out
of your lungs and skin and smells like horse, you know what. But
