57
STATEMENT OF DR. J. RICHARD CROUT, DIRECTOR, BUREAU
OF DRUGS, FOOD AND DRUG ADMINISTRATION, ACCOMPA-
NIED BY DR. MARION J. FINKEL, ASSOCIATE DIRECTOR, NEW
DRUG EVALUATIONS, FOOD AND DRUG ADMINISTRATION;
AND DR. WILLIAM J. GYARFAS, DIRECTOR, DIVISION OF ON-
COLOGY AND RADIOPHARMACEUTICAL DRUG PRODUCTS,
FOOD AND DRUG ADMINISTRATION
Dr. CROUT. Thank you very much, Mr. Chairman.
We are pleased to be here to represent the Food and Drug
Administration at this hearing on DMSO. I will review the regula-
tory history of DMSO and then comment on the current status of
the drug in this country, with particular reference to its potential
value in the treatment of arthritis.
Let me say right at the beginning, however, that the fundamen-
tal problem with DMSO from our perspective is not bureaucratic
opposition. I assure you of that personally and on behalf of our
institution.
The fundamental problem from our point of view is the quality
of the scientific information that is available to support the various
claims that are made for DMSO, and that is a point I would like to
emphasize in my testimony.
I want to make it clear that the Food and Drug Administration
has approved DMSO for the indication for which there is evidence
that meets the statutory standard. We are prepared to approve it
for any other indications when the evidence comes along that it
does meet that statutory standard.
The first investigational new drug application for the study of
DMSO in humans was approved by the FDA in 1963. Enormous
interest in the drug developed rapidly, and it began to be used
widely, especially for the treatment of sprains, bruises, and minor
burns.
By 1965 an estimated 100,000 patients had received the drug. No
well-controlled studies were conducted, however, to document clear-
ly that the observed effects were actually due to the drug.
This widespread, uncontrolled use of DMSO was curtailed sharp-
ly on November 25, 1965, when FDA published a statement in the
Federal Register terminating all clinical use of DMSO because of
toxicological studies showing that high doses of the drug changed
the refractive index of the lens of the eyes in experimental ani-
mals. The agency's concern at the time was that visual damage
might occur in humans exposed to the drug.
A year later this policy was relaxed to permit clinical evaluation
of DMSO in serious conditions, such as scleroderma, persistent
herpes zoster and severe rheumatoid arthritis, for which no satis-
factory therapy is now available."
In September 1968 the FDA published a further revision, a relax-
ation of its DMSO policy permitting topical application to the skin
for not more than 14 days for less serious disabilities such as acute
musculo-skeletal conditions; for example, sprains, bursitis, and ten-
donitis.
This was based on a toxicological study in humans that provided
a reassuring result; that is, no evidence of eye toxicity due to
DMSO was found in humans.
