59
I would like to submit a copy of the academy's report for the
record.
[The above-mentioned report is retained in committee files.]
Dr. CROUT. Since the Academy's report, drug developmental in-
terest in DMSO has been focused primarily on two uses-sclero-
derma and interstitial cystitis. I should add at this point there are
no new data since that time on the use of DMSO in sprains, bruises
or soft tissue injury.
So, new data gathered by modern standards since the 1960's on
these common disorders are not available even to this day.
Well-controlled studies have been conducted in patients with
interstitial cystitis, a painful chronic bladder disorder for which no
really satisfactory treatment exists. These studies have shown that
DMSO provides symptomatic relief of bladder pain for this condi-
tion.
A new drug application for use of 50-percent DMSO in intersti-
tial cystitis was granted to Research Industries Corporation of Salt
Lake City, Utah, in 1978.
Research Industries Corporation also submitted in 1978 a new
drug application to market DMSO for the symptomatic relief of
pain and ulceration in the fingers of patients with scleroderma, a
crippling disorder involving the hands and sometimes other tissues
in the body.
After detailed review by the Bureau of Drugs staff and by our
Arthritis Advisory Committee, this application was turned down on
the grounds that the available clinical trials do not yet demon-
strate that DMSO is effective for this use.
I want to point out that our evaluation process is not simply a
narrow, one-person review by the Food and Drug Administration
staff. This decision was taken only after careful review by an
advisory committee of experts, all of which was open, and a careful
review by our staff and by the management of the bureau.
So, our process involves a great deal of scientific consultation.
It is not a matter of one or two persons exercising arbitrary
authority.
This was not an easy decision to make, and I would like to
elaborate briefly on the reason we reached this conclusion so that
you may see some of the ambivalence that faces an advisory com-
mittee of scientists who have that sort of a decision to make.
The most important clinical trial on which the company relied
for demonstration of effectiveness was a study in which only one
hand in each patient-and by the way, the patients get ulcers on
both hands-but one hand was treated with DMSO. The other
hand was followed as a control.
There was a general improvement trend in the healing of ulcers
of the fingers in many patients, and in a few this was quite strik-
ing. Interestingly, however, this improvement occurred in both
hands in these patients with scleroderma; that is, both the treated
and untreated hands tended to heal.
The company argued that the overall improvement trend sup-
ported the point of view that DMSO is effective. The firm suggested
that the beneficial effect in the nontreated hand could probably be
attributed to absorption into the body of DMSO from the treated
hand. Thus, both hands were treated with DMSO.
