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paired hearing may notice aggravation, or if they have ringing in
their ears, it may increase. Aggravation of these symptoms may be
permanent.
We don't want elderly persons to become deaf while taking pain-
relieving medication. Therefore, we try and find various ways of
using a combination of drugs that we have in our therapeutic
armamentarium. Certain patients will notice a greater effect from
one drug, while other patients will have more effect from another
drug. So these are some of the therapeutic problems that we en-
counter. There is nothing simple in the treatment of the diseases
that we are discussing today.
The disease that I would like to talk to you about very briefly is
scleroderma. Scleroderma is a very serious disease. It involves
many organs of the body. There is an abundance of collagen in
many organs of the body. Blood vessels tend to thicken. The inner
lining of small blood vessels thickens and the lumen may close. In
many of these patients ulcers will occur at the fingertips.
All patients with scleroderma do not have serious disease, but in
most people there is slow progression over a period of 10, 15, or 20
years. If fingertip ulcers occur, they are painful, and finger motion
is restricted.
The problem that exists when a double blind, controlled study is
carried out is the odor that occurs as well as the characteristic
effect observed on the skin.
We treated patients with the most severe types of ulcers, ulcers
that did not heal, ulcers which lasted a year or longer. One hand
was treated and compared with the untreated hand.
The study was planned with doctors at FDA and consultants
from the National Academy of Sciences. We carried out these
studies and indeed we saw changes in the treated hand, as com-
pared with the untreated hand. In 3 months there was a marked
difference which was statistically significant.
But at 6 months the untreated hand was beginning to show
improvement. We believe this resulted from DMSO traveling
through the blood stream to the untreated hand. We also noticed
the same effect with pain relief. If we treated one hand, lo and
behold, in 3 weeks there was less pain in the other hand. We
believe this is systematic effect of the drug which results from
rapid absorption into the tissues.
When we came to FDA with this explanation, this was not statis-
tically significant in their view and therefore they could not accept
the study. We showed objectively that there was an increase in grip
strength in the treated hand compared to the untreated hand. We
noted that ulcers healed more rapidly in the treated hand as
compared with the untreated hand. We also noted that there was
less frequency of recurrence of ulcers in the treated hand as com-
pared with the untreated hand.
One of the investigators at the New York University found that
his pathologist could interpret from histologic sections which pa-
tients were treated with DMSO. He did not know if the patient had
received treatment or not, but in 8 out of 11 cases he was able to
show histologically which patients received treatment.
We believe we have good evidence to show this drug is effective
for this condition, but we have not been able to convince FDA that
