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At our medical school in October of this year we presented data
on 11 patients with severe head injuries. These were people who
had markedly elevated pressure in the brain, secondary to head
injury. Six of the eleven patients were resistant to other modalities
of treatment, of great historic control.
Despite the fact that they are resistant to barbiturates and man-
nitol which are the treatments currently used, they were all given
DMSO and within 3 to 5 minutes the pressure came down to
normal. We have another five patients in whom we started DMSO
as the initial treatment of choice in which the results in terms of
survival were much better than when we waited until the end.
But I came here today and I agreed to go on "60 Minutes" and I
want to bring this case to the American people because we have to
select between a bureaucratic way of life and people losing their
fingers or losing their lives. This is a serious question. It is not a
game. Yet a game is being played. I would like to try to answer
any questions that anyone would care to ask of me.
The CHAIRMAN. I would suggest to the committee that we hear
the other doctors and then we can question all of them.
Dr. JACOB. Thank you very much.
[The prepared statement of Dr. Stanley W. Jacob follows:]
PREPARED STATEMENT OF DR. STANLEY W. JACOB
The passage of the Kefauver-Harris amendments in 1962 has been followed by an
obvious drug lag in the United States. By "drug lag" I mean:
1. Reduced rate of discovery and development of new therapeutic entities.
2. Increased period of time to move new drug discoveries from the laboratory to
prescriptive use.
3. Restricted release of new drug entities in the United States compared with
other technically advanced countries.
Since 1962, the United States Food and Drug Administration has grown in both
power and population-in many ways like a malignant tumor. There are at least
four serious side effects secondary to the way the FDA has functioned:
1. FDA regulations have increased the cost for therapeutic substances.
2. FDA regulations have brought about a termination of research on many thera-
peutants which might be useful in so-called "orphan" diseases, that is, diseases
affecting fewer than 100,000 Americans.
3. FDA regulations have brought about a de-emphasis of research and develop-
ment of the so-called "soft" (less toxic) drugs which are difficult or impossible to
clear through the present methodology of required by the FDA. If aspirin were to be
introduced today, it would fall into the category of a "soft" agent of low toxicity.
4. The FDA has brought about a de-emphasis of research and development on
drug combinations.
I would like to discuss dimethyl sulfoxide (DMSO).
My major research interest since 1962 has been the pharmacology and clinical
usefulness of DMSO.
Dimethyl sulfoxide in the United States is derived from lignin, the cement sub-
stance of trees. It can, however, be made from a number of organic chemicals and
may be inexpensively produced.
DMSO was first chemically prepared in 1866 but remained a laboratory curiosity
for more than three quarters of a century. In 1948, a number of papers began to
appear in the chemical literature showing it was a solvent for many other sub-
stances. In 1959, a group in Great Britain demonstrated that dimethyl sulfoxide
would protect red blood cells and other tissues against freezing damage.
The use of DMSO as a drug was not shown until a collaborate effort between
scientists at the University of Oregon Medical School and the Crown Zellerbach
Corp. demonstrated in laboratory tests that DMSO would not only pass through the
skin and mucous membranes, but during passage would carry with it a certain
number of other substances. For instance, Penicillin can be dissolved in DMSO and
be carried through the skin without a needle.
In these early studies, dimethyl sulfoxide was shown to relieve pain, reduce
swelling, slow the growth of bacteria, improve blood supply, soften scar tissue,
