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mental drug. The Food and Drug Administration itself has data on over one hun-
dred thousand patients. Despite the prescriptive use of DMSO worldwide, there is,
to my knowledge, not a single case of well-documented serious toxicity.
Dimethyl sulfoxide is currently a prescriptive agent in the United States for
interstitial cystitis. It is prescriptive in Canada for scleroderma. It is prescriptive in
Great Britain and Ireland for shingles when mixed with IDU. It is prescriptive for a
whole range of disorders for topical administration in Germany, Austria, and Swit-
zerland. It is widely prescriptive in many parts of South America. It is prescriptive
in the Soviet Union and has been since 1971.
When Dr. Chauncy Leake, one of the world's most eminent pharmacologists,
reviewed the New York Academy of Sciences Symposium on DMSO in 1966, he
stated that the well known legal phrase "res ipsa loquitur" applied to the DMSO
situation. In summarizing the conference, Dr. Leake said,
"Rarely has a new drug come to the attention of the scientific community with so
much verifiable information, from so many parts of the world, both as to safety and
effectiveness."
There is little doubt but that DMSO should be prescriptive in the United States
today for a whole host of disorders, including its potential for pain relief in arthritis.
It is prescriptive only for one numerically insignificant entity, interstitial cystitis.
I am willing to make the statement to this Committee that there is no question
concerning the effectiveness of DMSO. It is one of the few agents in which effective-
ness can be demonstrated before the eyes of the observers. For instance, if we have
patients appear before the Committee with edematous sprained ankles, the applica-
tion of DMSO would be followed by objective diminution of swelling within an hour.
No other therapeutic modality will do this!
If we have patients appear with acute bursitis unable to move a shoulder in any
direction, the topical application of DMSO would be followed by a dramatic increase
in the range of motion at the end of a half hour. If we had patients appear with
chronic bursitis, the topical application of DMSO would be followed by a notable
increase in the range of motion within a half hour.
If we had patients appear with fresh ecchymoses such as an early black eye, a
topical application of DMSO would be followed by a reduction in this discoloration
within one hour.
An NDA on DMSO for scleroderma was submitted almost three years ago. During
this time we have revised the submission several times to meet decision delaying
tactics. FDA is currently considering whether to require additional months, or most
probably years, before they approve this indication. These delays cause unnecessary
suffering for thousands of Americans and possibly the loss by otherwise unnecessary
amputation of fingers, toes, and limbs. This is an intolerable situation.
Dimethyl sulfoxide (DMSO) is a particularly promising treatment with injuries of
the central nervous system (brain and spinal cord). Data from lower animals and
man indicate that DMSO may be more important than any other pharmacologic
agent in treating injuries to the brain and spinal cord.
With such a promising new medical application for DMSO, one might presume
that we are satisfied and optimistic about the project's future. This is far from the
truth. Results with CNS accidents, to date, though dramatic and life-saving, are not
even fractionally different from multiple clinical findings with DMSO for other
disorders.
Heretofore, every time we have concluded a clinical study demonstrating and
safety with DMSO, we have been rewarded with a new stabilized, FDA position of
confoundment. An obdurant barrier of bureaucrats housed in the office of the FDA
has shredded the data with their own, unique methodology. In their house, support-
ed by public funds, they play dangerous games-harmful games with truth, statis-
tics, objectivity, ethics and the health and welfare of citizens of the U.S. If their
policies with DMSO are an accurate barometer of their general procedures with
food and drug policies, the Bureau, itself, may be a great hazard to the health of the
people of this country.
Let me make a grim prediction concerning the fate of our CNS-DMSO projects.
Unless responsibility for DMSO decisions are removed from the FDA or the FDA is
subject to a radical change in management, despite the potential saving of tens of
thousands of lives per year or prevention of permanent paralysis, post-CNS accident,
FDA will continue to block public access to the drug for at least several years.
Recall the so-called "historical" control to this matter-FDA has blocked other
important medical usage of DMSO in man for more than a decade.
The major question continues to be, has the public benefited, or has the public
been harmed by the FDA blockade on approving DMSO. If DMSO had been truly a
nostrum, or even worse, a drug associated with serious clinical toxicity, the public
would have benefited by FDA actions. If, as overwhelming scientific evidence indi-
