54
If they are not sure, they are not going to take a stand. But I
really don't understand, now that it has been acknowledged that it
is safe, why they are so hesitant about releasing this drug.
Now, I went all through the safety precautions in my DMSO
studies with scleroderma and rheumatoid arthritis. It was a pain in
the neck. There is no question about it. Doing monthly blood scans,
3 monthly eye exams was a pain in the neck. The paperwork was
awesome. That was a definite deterrent to any type of testing for
me.
I really don't understand why they don't open it up. They may
not be able to get the physicians to achieve sufficient numbers to
justify release because of the amount of paperwork entailed.
I don't know. But there is a reluctance there, there is no question
about it-in both countries, obviously.
The CHAIRMAN. Well, Doctor, I would appreciate it if you and all
of you who have been on this panel could wait in the room until
after you hear the Food and Drug Administration's testimony.
Can you stay that long until you have heard them? All right. If
you have to go, of course we will understand that.
Mr. Bonker?
Mr. BONKER. Mr. Chairman, I just want to anticipate the FDA
Director's testimony and ask Dr. Jacob if he could return to the
table just a minute.
Everyone is interested in FDA's response to the overwhelming
testimony that has been presented here today, particularly the
eloquent statement that you presented. Just reading through Dr.
Crout's testimony, it places a lot of emphasis on the National
Academy of Science study in 1972.
I want you to comment on that just briefly, so we have the
benefit of that when his statement is presented. Then on his last
page he says there is no evidence that DMSO alters the course of
any disease or is in any sense a miracle drug.
To suggest on the basis of the evidence available to date, controlled or uncon-
trolled, that DMSO is a major medical advance for any serious disease let alone a
variety of such diseases is misleading.
Then he concludes and says that the FDA is willing, indeed
anxious-it is kind of ironic after 16 years-to approve DMSO for
such uses whenever, and I am going to quote,
***** controlled
trials meeting the statutory standards are available."
Then he goes on to say that they would be happy to work with
any party in developing protocols for such trials and in expediting
their review.
Question No. 1, your response to the NSA study; No. 2, if the
FDA is so willing and anxious to help, what is the problem with
these so-called control trials meeting the statutory standards that
seems to be a major roadblock in their estimates?
Dr. JACOB. Well, in terms of the National Academy of Science's
report, I had the opportunity of speaking before the Academy prior
to their writing their report. We furnished a good share of the
bibliographic references on which they based their report.
Now, the National Academy of Sciences began their evaluation
of the published literature on DMSO in the late 1971-72 era based
on studies which were done in 1964-65.
