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my of Sciences-National Research Council. Some might not consider those positions
to be neutral.
There are people who think the Arthritis Foundation is "against" DMSO. That's
not so at all. We would be delighted if it proved through a full course of controlled
clinical testing to be a truly effective remedy for arthritis.
But we are against promotion of DMSO or any other remedy that makes claims
for which there is not yet acceptable scientific proof. We are against promotion that
dangles what may be false or unrealistic hope before arthritis sufferers, who are
already deluded and bilked and led down the garden path in so many other ways.
The crux of the DMSO impasse seems to be time. Why has it taken so very long to
resolve the doubts about it?
This repeated question has been accompanied by fault finding and a search for
scapegoats. This atmosphere only inhibits reasonable approaches to solutions.
If some way could be found to wipe the slate clean of the disputes of the past,
then perhaps the new question can be posed: What would it take-starting now, and
without sacrifice of proper scientific standards, and without bias-to determine
DMSO's value as an arthritis remedy, good, bad or indifferent, and lay the matter to
rest?
I do not have an answer. But I believe, oversimplified as it is, that this is the
critical question that should be addressed.
SUPPLEMENTARY STATEMENT BY CHARLES C. BENNETT
I respectfully submit this statement, with the request that it be made part of the
record, to supplement both the prepared statement and oral testimony which I
presented on March 24, 1980 at the hearings on DMSO held by the Committee.
My purpose is: (1) to propose a possible solution to the immediate DMSO approval
impasse; and (2) to bear witness in defense of the scientific integrity of certain
rheumatologists which was impugned at the hearing on March 24.
PROPOSAL
Speaking for the Arthritis Foundation, I propose that appropriate sponsors (Re-
search Industries Corp., or other interested party) be encouraged to submit to the
FDA a New Drug Application for release of DMSO as a prescriptive topical analge-
sic for such condition as: pain in joints, muscles, ligaments, tendons and other
tissues due to strains, sprains, certain types of traumatic injuries incurred in sports
and/or accidents, etc.; osteoarthritis (degenerative joint disease); bursitis, tendinitis,
and other poorly defined disorders of the musculoskeletal system in which diagnosis
has eliminated serious systemic disease.
It appears that with such limited use clearly defined, it might be possible to have
DMSO approved and available as a palliative remedy within a short time; while
clinical studies, which predictably will take much longer, are continued to establish
the efficacy of the drug for major and critical chronic conditions such as rheumatoid
arthritis, scleroderma, and some of the other rheumatic diseases for which it has
been proposed.
The FDA's positive reaction to this proposal is noted below.
I submit the following as the Foundation's argument for such a course.
(1) It seems clear that the side effects of DMSO are so mild and so few in the vast
majority of cases that its short-term safety is not of significant concern and is not
involved in withholding of approval. Furthermore, it may be that sufficient scientif-
ic testing has already been carried out providing adequate evidence of safety which
would not have to be repeated and which could be cited in an NDA.
(2) There seems to be virtual 100 percent agreement among the experts that
DMSO appears to be effective in providing short-term relief of pain. If valid tests
acceptable by stringent standards have not yet provided conclusive evidence of this,
it might not take an inordinate amount of time or money to produce such evidence.
What I am suggesting would, if accepted, make the drug widely available for a
multitude of ailments of considerable consequence to the public; though not yet for
major inflammatory arthritis and other rheumatic diseases. It seems to me that the
proponents of DMSO have not done their cause any favors by making a vituperative
issue of its rejection for an uncommon and highly unusual disease, scleroderma,
while not even applying for its approval in treating a variety of lesser conditions
about which there is less scientific doubt and little controversy.
The Arthritis Foundation has solicited unofficial reaction to this proposal by
authorities at the FDA. They have responded by saying they consider it reasonable,
and already intended to solicit such an NDA. But of course until a specific applica-
tion is received and the clinical trials that are used to support it have been
reviewed, no promise can be made.
