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Mr. BONKER. I know the trials, but we are talking about efficacy.
Since you have not authorized the use of DMSO, of course it is not
going to have that same base of scientific evidence.
But nonetheless, where it has been applied, and the veterinar-
ians who have shared their experience, fully 70 percent had used
this chemical and 95 percent claimed that the drug was effective.
Again these are reputable professional witnesses. Eighty percent
went on to say that it should be legalized for human use. It seems
to me wherever we have had experience with DMSO, it has met
that efficacy test.
I assume that it probably is competitive with other drugs that
you have approved over the years. I know when I take an aspirin,
60 percent of the time it will work, maybe. It has got to be that
way with most drugs because of the peculiar nature-how they
apply to various people.
It just seems to me that unless there were a serious health
problem involved, where it would endanger public safety, that it
certainly must meet that efficacy test that has been so demonstra-
bly presented here today.
Dr. CROUT. If I could comment. Between 1938 and 1962 there was
no effectiveness standard in this country. The 1962 amendments
required the Food and Drug Administration to go back and look at
all the drugs approved for safety alone between 1938 and 1962.
Hardly a drug, at least for all of its claims, survived that review,
in fact. About 20 percent were removed from the market because
they were not effective. Almost all of the remainder had at least
some ineffective claims so that the labeling had to be revised.
So, the history of the marketplace is that absent an effectiveness
standard, there are a lot of drugs in the marketplace which are not
effective.
I am not saying DMSO is one of those. What I am saying is that
one sets up properly, the Congress set up properly-a standard, an
evidentiary standard, that a drug should properly meet.
Now, there isn't any reason to lower that evidentiary standard
for DMSO. It is not necessary. I think your concern should be
directed in at least two ways. One may be toward us. But the other
ought to be at why it has taken its advocates so much time to take
their testimonial evidence and turn it into genuine science.
That is why DMSO is not on the same pathway as other drugs. It
is why DMSO has become a cause celebre.
Mr. BONKER. Well, if you are referring to statutory standards-
and I have looked briefly at section 505, and we seem to hinge your
decision on substantial evidence-
Dr. CROUT. On controlled trials. The definition of controlled trials
is actually in our regulations, not in the statute.
Mr. BONKER. OK. It must be controlled trials and not substantial
evidence because I think that you can take care of any reservations
you may have in the labeling that goes on the product, as it is
provided for under the definition of substantial evidence.
Well, I just have to conclude that there is either an institutional
bias or some kind of bureaucratic intransigence. That is not uncom-
mon in the Federal bureaucracy, as we are beginning to discover
on the Hill.
