6
I would like to urge you to do what you can. If it is necessary to
make some modifications in our law, I would urge you to do that. I
don't think it is. The FDA has prescribed protocol after protocol for
the testing of this drug. There have been no serious adverse im-
pacts noted on human life or health. It has so many good effects
that in my judgment the welfare of the country demands that we
either go ahead and approve it for many more uses than it is now
approved for or that we lay out once and for all a protocol and
commence the testing and get it done so that we know once and for
all what the effects of this are and we can get it into the hands of
the American people.
I thank you, Senator.
The CHAIRMAN. Without objection, the statement offered by Rep-
resentative Duncan will be admitted into the record.
[The prepared statement follows:]
PREPARED STATEMENT OF REPRESENTATIVE ROBERT B. DUNCAN
Thank you Senator Pepper for the opportunity to testify this morning before the
Select Committee on Aging in consideration of the use of Dimethyl Sulfoxide,
DMSO, to treat arthritis. I also appreciate the chance to introduce my good friend
from Portland, Oregon, Dr. Stanley Jacob, a pioneer in the development and use of
DMSO.
My involvement in the DMSO controversy stretches back many years. When I
first came to Congress in the 1960's from Oregon's fourth district, I communicated
frequently with the Food and Drug Administration about the then recently discov-
ered medicinal properties of DMSO. In my present reincarnation from the third
district, I find myself doing the same thing some 16 years later. Progrss has been
made during that period, but it is barely perceptible. DMSO is now, as you know,
prescriptive for a troublesome bladder disease, interstitial cystitis. It cannot be
prescribed for any other uses on human beings.
DMSO helps alleviate symptoms in many, many ailments. Sophisticated experi-
mental protocols designed by the National Academy of Sciences offer substantial
evidence that it is helpful in easing the pain and preventing digital amputation in
scleroderma patients. There is evidence that it is effective in reducing intracranial
swelling, heretofore virtually untreatable. DMSO exhibits evidence of effectiveness
in treating burns and bruises. Studies indicate improvement in retarded and Down's
Syndrome children when given DMSO orally. I have used it enthusiastically for
several years for troublesome bursitis and am satisfied, beyond any reasonable
doubt, that it works, quickly, effectively. The only serious side effect is that Mrs.
Duncan can't stand the smell, and even that is being solved.
Today we gather to explore the uses of DMSO in treating arthritis, a disease
particularly bothersome and disabling to the elderly. I am no scientist and do not
pretend to evaluate its medicinal and therapeutic effects. What I do know, as a
lawyer and a legislator, is that the FDA should make it possible for DMSO to reach
those suffering the relentless pain of arthritis as soon as possible. I fully understand
the cloud hanging over the FDA these many years after the Thalidomide tragedy.
We should continue to do everything in our power to keep all Americans safe from
such dire consequences.
But try as we might we cannot create, either legislatively or through regulation, a
riskless world. Every human endeavor carries with it some probability of injury or
death. The probability in most actions is very slight, but it exists. We all know
stories of bathtub drownings and choking to death on food. Life is rife with exam-
ples of illness, injury, and even death that no amount of regulation or study would
have foretold or circumvented.
The FDA requires high standards of proof, nearly impossible to attain, before it
allows a drug to be prescriptive. In a court of law, civil cases must be proven by a
preponderance of the evidence; in a criminal case, the standard is beyond a reason-
able doubt. The FDA requires something beyond the criminal standard. In many
instances it seems they require absolute proof, not only of efficacy, but of no
negative effects. This requirement is analogous to attempting to prove in court that
something did not happen. A good example is trying to prove that a police siren was
not turned on. One can call a witness to the stand and have him testify that he did
not hear a siren. But that leaves the jury free to draw inferences of a range of other
possibilities—the witness could have been asleep, he could have had a radio turned
