10
This drug, for instance, is on the market in most of the western
world. There are other drugs where that is so. I am not saying that
our standards ought to be identical with the standards in Western
Europe or the Soviet Union. But I am saying that I think that we
have, both by our writing of the law and the FDA's interpretation
of it, detoured the drug companies in making applications, the
terribly expensive protocols that they must go through.
If I am not mistaken, there is another problem. By the time they
go through this multiyear process, and here it has taken 16 years,
by the time you get a patent, after 17 years your patent time is
almost gone. So with all this expense and effort the drug company
might find itself with a product in the public domain within a year
or two and not even be able to recover its expenses.
Mr. HOPKINS. Thank you.
The CHAIRMAN. Mr. Ford?
Mr. FORD. Thank you, Mr. Chairman.
Again, Mr. Duncan, thank you for appearing before the commit-
tee. Fifteen years is a long time. And now to say for the Food and
Drug Administration to lift their standards to allow the DMSO to
go on the market, what has happened in that 15-year period, Mr.
Duncan? Five years ago, what were they saying then? What is new
that we can say to the Food and Drug Administration that would
change their mind? Have they really absolutely made up their
mind, you know, they are concrete on a decision that they are not
ready to complete any future studies to see whether the drug
would be acceptable on the market or not?
Mr. DUNCAN. No. They keep saying that it needs more testing.
Let me correct the record at this point because FDA has approved
the use of this drug for interstitial cystitis which is a bladder
problem that affects females for the most part. So they have said it
is safe for that use.
Now the question, I guess, is its efficacy in this broad range of
other illnesses for which it ostensibly has some utility. There they
keep saying, well, we don't have tests. Well, you can't have a
double blind test. The odor to which I referred is so distinctive that
it is impossible to disguise a placebo. One knows instantly whether
one is getting the DMSO or the placebo. The doctor has said, figure
out a protocol and we will do it.
One foundation, I don't remember the name but it is pretty
impressive, laid out a discipline, followed it, and the FDA doesn't
like that one now. So it is the difficulty of getting a protocol that
will satisfy people who because, as I say, I suspect the broad range
of applications, its relative inexpensiveness, I guess, that they just
feel suspicious of anything.
Mr. FORD. What happens when they reject one of the applica-
tions or will not go along with it? How do they respond, by cutting
you completely off?
Mr. DUNCAN. This was done at one time. They did cutoff further
experimentation in it. That was back in the sixties. Then they
subsequently reinstated it on an experimental basis. If I am not
mistaken, experimental protocols can be laid out and would prob-
ably be approved by the FDA on an experimental basis. Then
gathering the data from all these experiments, hopefully some day
the FDA will say, the scales tilt in your favor.
