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the stuff was miraculous. For the first time in years Monty was
completely without pain. He stopped taking Demerol.
"I invited Bachrach out to the house for dinner. Monty was able
to use DMSO for several months before the FDA took the drug off
the market labeling it unsafe. DMSO had been tested on rats eyes
and the female rats got pregnant. The males developed cataracts.
Monty was furious.
"Bachrach told him, look, they are not sure what the side effects
of this drug are on humans, to which Monty retorted, 'I have had
cataracts and I can't get pregnant, so what the heck.'
"Monty wanted the DMSO so much that he managed to get it
through a vet. When he was unable to attain it any more he went
back on Demerol." As many of you know, he eventually died from
an overdose of narcotics.
I know this committee is most interested in DMSO in arthritis.
Based on 18 years of experience, based on treating arthritic pa-
tients resistant to no other modality of treatment, I am willing to
go on the record that there is no question that this agent is safe
and effective for arthritis, at least in relieving pain.
Now this can be shown by article after article in the scientific
literature. The Germans have studied 10,000 patients using historic
controls with 70 to 80 percent rate in degenerative arthritis, rheu-
matoid and gouty arthritis. Gibb has an article in this particular
book on 2,000 patients, many of whom have arthritis, most of
whom were resistant to other modalities of treatment, again with.
People say to me, why did I finally decide to speak out on this
issue after remaining quiet for 6 years? There were two reasons.
One was that we submitted data on a disease called scleroderma. It
is a horrible disease that affects maybe 50,000 to 75,000 people in
the United States. The skin becomes taut, the blood vessels have
diminished blood supply to the extremities. Patients develop pain-
ful ulcers. If these ulcers do not heal, amputation of the fingers is
necessary.
We went to the FDA in 1974. We designed a protocol to study
DMSO in scleroderma. We followed that protocol. We submitted
data in 1979, an NDA which was heard by the FDA, and it was
turned down. Now, scleroderma is an orphan disease which affects
a few thousand people in this country. The DMSO was used in
patients who had ulcers which were resistant to all other modali-
ties of treatment. Dr. Arthur Scherbel, who is one of the world's
leading experts on scleroderma, will speak to this point today.
The alternative to DMSO for these patients is amputation. Yet
the FDA turned down this application. This to me is unconsciona-
ble.
The second reason I decided to speak and to bring this case to
the American people is that we now have solid animal data from
the University of Chicago, and Dr. Jack de la Torre who did the
work is here. Jack is currently chairman, or in charge, of neurosur-
gical research at the University of Miami.
At the University of Chicago they have done extraordinarily
precise evaluations in monkeys, dogs, and other animals showing
that DMSO is clearly the treatment of choice when it is given
intravenously to animals with what ordinarily would be lethal
stroke, lethal head injury, and lethal spinal cord injury.
