58
In light of continued lack of evidence of eye damage in humans
since that time, FDA has concluded that the regulation establish-
ing specific requirements for clinical testing on humans is no
longer necessary and, thus, on September 21, 1979, the agency
published a Federal Register proposal to revoke the regulation.
A final order on this proposal is now being prepared for publica-
tion. Mr. Chairman, I would like to submit for the record copies of
the various Federal Register notices on DMSO that I have just
discussed.
During the 1960's at least three major drug firms considered the
possibility of marketing DMSO commercially under approved new
drug applications but all later lost interest, presumably because of
low profit potential due to the fact that DMSO cannot be patented
as an original molecule.
The CHAIRMAN. Excuse me just a minute. Did I understand you
to say that these three companies simply desisted in the presenta-
tion of their application? I thought some of these witnesses testified
that they were turned down by Food and Drug.
Dr. CROUT. They were. But we turn down, I might say, most new
drug applications the first time around, because there are usually
deficiencies in applications. So that is not an uncommon thing to
have happen. In this case, the firms did not come back to us.
Because of continuing controversy over the FDA's position on
DMSO, Dr. Charles C. Edwards, then Commissioner of Food and
Drugs, asked the National Academy of Sciences in 1972 to review
all available information on the effectiveness and toxicity of DMSO
and provide FDA with an independent judgment on these matters.
The academy appointed a committee of experts with six subcom-
mittees to conduct this review. To this day, the National Academy
of Sciences' review stands as the most comprehensive independent
evaluation of DMSO by the medical and scientific community.
The academy basically agreed with the position of FDA on
DMSO. Specifically, the report stated that there was inadequate
scientific evidence of effectiveness of DMSO for the treatment of
any disease, that the toxicity potential was sufficiently great that
the drug should remain an investigational drug, and that con-
trolled clinical investigations were necessary to demonstrate the
effectiveness of DMSO.
Mr. Chairman, because of your committee's particular interest in
arthritis, I would like to quote the conclusions in the academy's
report of the Subcommittee on Connective Tissue Diseases. The
subcommittee concluded:
(1) That most of the studies reviewed were of such poor quality as to be useless for
its purposes.
(2) That there is no convincing evidence that DMSO has any effect in the treat-
ment of osteoarthritis.
(3) That there is some indication that DMSO decreases pain in rheumatoid arthri-
tis, but no evidence of an anti-inflammatory effect on that condition.
(4) That DMSO has no effect on the systemic manifestations or the progression of
scleroderma.
(5) That there is insufficient evidence of the efficacy of DMSO in the treatment of
gout, polymyositis, polyarteritis nodosa, Dupuytren's contracture, or ankylosing
spondylitis. These are a variety of arthritic type diseases.
(6) That the varied effects of DMSO on immunologic mechanisms as studied in
human and animal models seem to have little application in the treatment of
human diseases.
