5
accurately than I could. There was no other relief for scleroderma
in extremities except, on occasion, amputation of the fingers.
It seems to me that in the absence of any evidence of seriously
adverse side effects, and in view of the obvious therapeutic value it
had in that instance, that it ought to be used. Here we are some 16
years later after that first meeting with scleroderma still not ap-
proved as a disease for which DMSO can be used.
There has been some progress made. I want this committee to
know that I am sympathetic with the problems that FDA has in
operating under a law which we ourselves passed which requires
them to find this drug not only efficacious but safe, and I am
concerned about the standards of proof that are set up by FDA in
order to permit a drug like this to go on the market.
I know they have a narrow line to tread between letting a
thalidomide on the market, for instance, and keeping something
like DMSO off. I am sympathetic to them.
I thought as I drove in here this morning that we will have
serious impact on men's fortunes by a standard of proof which we
call a preponderance of the evidence. We will even deprive people
of their liberty by a standard called "beyond a reasonable doubt.'
But it seems to me that for drugs, and particularly for DMSO, we
are demanding a standard of proof that is almost unattainable. In
all of these years of use, can we say there are no side effects? No,
there is no free lunch in this country. But the side effects are so
minimal that one could almost say there are none.
With respect to my own use of it, the most serious side effect is a
threatened divorce by my wife because she doesn't like the odor.
Dr. Jacob has removed some of the odor and he has masked it in
another preparation by a wintergreen flavor.
I asked my wife if she didn't like the wintergreen flavor, and if
that wouldn't remove her objections. She said, no. Instead of smell-
ing like the tidal flats at Bayonne, N.J., when the tide is out, she
said you now smell like the locker room of the Green Bay Packers.
But that odor is infinitesimal compared with the relief.
But the drug has been shown to have good results in so many
instances and the people who have used it are so enthusiastic that
the scientists downtown naturally, I think, get suspicious about it.
Somebody asked me what it was good for the other day and I
said, did your mother give you medicine when you were a kid and
you asked what is this for, and she said, take it, it is good for what
ails you.
I think I first got a hold of it for my horses. It was good for my
horses. It is approved for use in most of Western Europe, the Soviet
Union, a lot of countries in South and Central America and in
Japan. I obtained some of it from sailor friends of mine from
Japan.
I have observed its beneficial effects for arthritis, bursitis, the
reduction of swelling and inflammation. I have seen it almost make
shingles disappear like a miracle. I have watched it in serious
burns on myself and I watched the pain go away in a matter of
minutes. I saw that the serious burn barely got pink and never
swelled blisters. The doctor will tell you about these things.
With your permission, I will ask you to put my prepared state-
ment in the record.
