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these patients have benefited from treatment. I believe, as do these
patients, that pain relief and improved ulcer healing occurs with
treatment. We have been unable to perform a true double blind
study because of the unique characteristics of the drug.
Many of the FDA officials are very good friends of mine. I know
them well and I agree that an unbiased study is desirable in the
study of any drug. But one cannot take this drug with its charac-
teristic odor and permeability and carry out a true double blind
study.
Moreover, many patients in the study were sent to us with
severe ulcers. The referring doctors requested DMSO treatment
before resorting to amputation of fingers. We could not take these
patients and place them in a randomized study.
Ten years ago, we reported on the effect of DMSO on cutaneous
ulcers while using the patient as a historical control. We did a
second study which was planned with members of FDA. When the
study was completed another group of FDA officials was assigned
to evaluate the results. The second group turned down the study. I
am critical of the double standards imposed on us as a result of a
change in FDA monitors while this study was in progress.
If one looks at the objective criteria submitted, it is statistically
valid material.
For those patients who could indeed profit from the use of a very
simple drug, we cannot use it unless we carry out a very strict
protocol. If I wanted to give this drug to a patient today, I must
obtain sophisticated eye examinations every 6 months. This patient
must have blood studies every 3 months. If this patient lives 150
miles from Cleveland, he or she must come back at a determined
time and the studies must be carried out according to FDA regula-
tions.
Long ago we realized that toxicity was not a problem but we do
not dare to give this drug without carrying out a battery of very
sophisticated laboratory studies. Who pays for this? The patient
might not have funds to pay. Will the Cleveland Clinic? They will
if I ask them to, but it is not fair to the Cleveland Clinic to do this
because it is the FDA request.
If we obtain funds from a pharmaceutical firm and eventually
they sense this drug is not going to be approved, where do the
funds come from to continue treatment for this group of patients?
Now, in summary I would like to state that we have made no
claims for cure with this drug. It affords purely symptomatic relief.
It is a palliative drug. It has minimal or no toxicity when used as
recommended. It does have an odor. If patients use this drug before
going to church, their friends will not sit with them in the same
pew, but the odor is a problem that we have to contend with. I
don't think this drug will ever be abused. I think people will use it
only when they need it and they won't use it when they don't have
to.
My recommendation would be that this drug should indeed be
made available for the treatment of various forms of arthritis,
rheumatism, ulcers in patients with scleroderma. It should also be
used in shingles. I have never seen a patient, and we have treated
many, who has developed postherpectic neuralgia. It is a very
