"DMSO - NATURE'S HEALER" by
Morton Walker, M.D.
The American Medical Association (AMA)
held a leadership conference the weekend of February 14, 1981, and one of
its speakers was Otis R. Bowen, M.D. Dr. Brown is former governor of
Indiana, a leader in medicine, management, and politics. In his presentation
to the AMA, he shocked the assembly by admitting that he took the law into
his own hands and used an illegal drug to ease his wife’s pain when she was
dying. Beth Bowen died January 1, 1981, after months of agony from multiple
myeloma, a type of bone cancer.
Dr. Bowen, who was preparing to step
down from the governorship at the time, turned to dimethyl sulfoxide, or
DMSO, to ease his wife’s intense pain. He had obtained the liquid solvent
from a veterinarian and found that it relieved his wife’s suffering “in
minutes,” he said.
The Food and Drug administration (FDA) forbids the
use of DMSO in humans except in treating a rare urinary bladder
condition. Even in the face of the government ban, Dr.; Brown did what he
knew was right for his wife by administering intravenous DMSO. “Why can’t
dying persons, with severe pain, have easy prescription access to it?” He
asked in his speech. “The only excuse I could find was that, after prolonged
use and heavy dosage, it caused an occasional cataract in dogs only.”
Before you’ve read very far into this book, you’ll probably be asking
questions similar to Dr. Bowen’s. It won’t be difficult to identify with the
patients involved here, some of whom have been forced to take treatment into
their own hands by turning to DMSO.
In fact, DMSO has not been found
unsafe for humans. Any side effects are merely minor irritations. DMSO stops
bacterial growth. It relieves pain. As a vasodilator, the drug enlarges
small blood vessels, increasing the circulation to an area. It softens scar
tissue and soothes burns. DMSO’s anti-inflammatory activity relieves the
swelling and inflammation of arthritis, bursitis, tendinitis, and other
musculoskeletal injuries. And it does many more good things of a therapeutic
nature for anyone who is injured or ill.
I recommend that you use
DMSO strictly under the supervision of a doctor who is skilled in its
application. Only the pure pharmaceutical grade should be employed, not the
crude industrial grade.
DMSO is both a drug and a good
solvent. Industry values it for removing paints and varnishes, and
dissolving certain plastics such as rayon, polyvinyl chloride, polyurethane,
methacrylate, and acrylic. It doesn’t affect cotton, wool, nylon, leather,
or polyesters.
Most important, it benefits human body cells, tissues,
and organs in unique ways. DMSO is the twenty-first century’s newest healing
principle with a very wide range of usefulness. It represents an entirely
different means of treating diseases – not as an ordinary drug works for a
given disease, but as a holistic ingredient that brings whole-body cellular
function back to normal.
Dimethyl sulfoxide has had a bettered
thirty-year history. But because of the general public outcry about its ban,
DMSO has become a household word and a medical-political cause
célèbre. Those of us who have been using the drug for twenty-six to
twenty-eight years never dreamed that it would become a focal point in the
continuing battle between individual freedom and the power of government
My colleagues and I have been criticized, ridiculed, and even persecuted
in some medical circ les for promoting and using DMSO. But I, and others
like me, came to the conclusion, having observed establishment medical
thinking for forty years that the only way a truly revolutionary treatment
principle can be brought to the patient is by appealing to the general
population through the information media. That is the purpose of this book.
Much of my material will appear anecdotal to the scientist, but such
language is what the public understands best. And sometimes a hundred
patient stories, heard by a sensitive and intelligent physician, are as good
as or better than a double-blind research project. Double-blind studies are
often just that – everyone involved is blind and stays that way until, many
years later and thousands of patients later, it is discovered that the
particular drug doesn’t work or is too toxic to warrant its use.
Good
examples of toxic drugs are the arthritis agents Motrin, Tolectin Nalfon and
Naprosyn. They all underwent extensive double-blind testing. All are weak
organic acids and prostaglandin inhibitors – like aspirin. About as
effective as aspirin, these four drugs have two distinct differences: they
are more toxic than aspirin and cost ten to thirty times more money. So much
for double-blind studies.
Whether you agree or disagree with current
claims, it’s likely you’ll affirm that if a drug has been proven safe,
doctors should be free to use this agent when they believe it will help
their patients. With all the extremely potent and dangerous drugs on the
market, it is absurd to keep such an effective product as DMSO from pharmacy
shelves.
Certainly not all of the claims for DMSO will prove to be
valid, but in my opinion, many of them have already shown themselves to be
true. And the most dramatic use of the medication is likely yet to be
discovered.
Another purpose for my book is to point out the myriad
applications of this unique substance. Once DMSO is legalized for use in all
states and ethically produced for topical, parenteral, and oral
administration, people won’t have to smuggle the feed-store grade and the
crude industrial grade into their homes to paint on their arthritic joints.
DMSO will eventually find its place in the armamentarium of American
medicine. We who believe in the substance want to see it happen sooner than
later. The clinical evaluation of DMSO began in the United States in 1963
and now, in 1992, the FDA still has not approved the drug for more than one
use. This situation gives rise to some underlying questions you may find
running throughout this book. How do we get the FDA to see beyond its blind
spot? How can we either bring DMSO to the people or declare the substance
useless once and for all?
You will find lots of answers in these
pages. DMSO needs even more public pressure than has been leveled at the
regulatory process already. We want doctors to be able to prescribe DMSO
without fear of censure from the medical world or the hospitals that employ
them. If this doesn’t happen, it appears that little will be done to ensure
that a pure, medical grade of DMSO will be made available for patients.
In writing this book, I have found a distinct reticence by doctors to
have their names mentioned in connection with DMSO. Often they provided me
with glowing case reports of successes with the drug treatment, but their
fear of colleague criticism prevented my revealing their identities. I had
to discard such reports, and there were hundreds of them.
DMSO has
the largest potential number of uses ever documented for a single
chemical. My wish is that this book will bring more of them into the public
domain than has been allowed to this point. It should be well understood by
everyone at the outset that I don’t say the substance is some kind of
miracle cure. More properly, DMSO is a very effective and versatile compound
that has been successfully adapted for a number of health problems. I want
to get it into the hands of more people so that they may be relieved of
discomforts and diseases for which DMSO is appropriate. I hope you will
agree that mine is a worthy goal.
Morton Walker, D.P.M.
Stamford, Connecticut
CHAPTER 1 - The Painkiller with a
Problem
In the late spring of 1980, Eva Lee Snead, M.D., then a
family practice specialist in San Antonio, Texas, learned that her friend,
thirty-two-year-old psychologist Marjorie Saloman, was supposed to undergo a
hysterectomy, the removal of her uterus. Mrs. Saloman’s genital system
problem arose from a stenosis of the cervical os. This condition is a
narrowing or stricture at the mouth of the neck-like opening to the uterus
where it extends into the vagina.
The psychologist described to Dr.
Snead how several unsuccessful attempts at cervical dilatation had been
attempted by her gynecologist. He tried to relax the cervix by injecting
local anesthesia at its lower quadrant. Such an anesthetic technique usually
is simple and effective, but this particular block had been no help to the
woman even after many tries. Mrs. Saloman’s gynecologist admitted that for
her the attempted cervical dilatation was a complete failure.
The
pain had been so great for this patient that when the dilatation instrument
was inserted she had fainted. Her gynecologist quickly removed the
instrument because4 the anesthetic was not allaying the pain. None of his
attempts to relieve the problem worked; surgical removal of the uterus was
the next procedure of choice.
Dr. Snead asked her friend to wait a
week before having the hysterectomy, if delay was agreeable to the
gynecologist. Complying with this request, Marjorie Salomon had her
physician telephone Dr. Snead to learn the medical reasoning behind it.
Having some prior experiences with DMSO (dimethyl sulfoxide) treatment,
Dr. Snead persuaded him to combine the substance with vitamin E and apply it
topically to the patient’s cervical area. Dr. Snead wanted to try to reduce
the woman’s scar tissue and adhesions, which DMSO is able to do.
“I
was lucky enough to run into the gynecologist on the day that we were going
to apply the DMSO,” Dr. Snead wrote me, “and he inserted the substance
himself with the vitamin E. Before five minutes were over, his instrument
slipped into the cervix without any sensation felt by the patient.”
A
month later, the gynecologist rechecked the woman’s constricted cervix and
found it was still overly narrow. He repeated the application of DMSO and
vitamin E and after a few minutes was able to insert eh instrument to
stretch the opening without any problem. This time it was a highly
successful procedure, and the hospital appointment for surgery was
cancelled.
The patient wore a device that was inserted to keep the
cervical canal’s wall stretched. In the meantime, Dr. Snead placed her
friend on megavitamin therapy using high doses of nutrient substances to
restore health to surrounding tissues.
One month after the device had
been inserted; the woman was again checked by her gynecologist who found the
cervical ok perfectly expanded. He was able to insert probes without first
applying DMSO or anesthesia and without the patient feeling any
discomfort. Marjorie Saloman had definitely been saved from having a
hysterectomy.
Yet Dr. Eva Lee Snead had her medical license revoked
for repeatedly employing DMSO and other forms of complementary medicine –
what some have labeled “quackery” but that rightly may be considered
alternative methods of healing. The state of Texas is not predisposed to
allowing deviations form the medical mainstream. And, as you will see, use
of dimethyl sulfoxide by forward-looking physicians is out of the medical
mainstream.
***
Lorae Avery, Ph.D., director of The
Health Center, Inc., an acupuncture and nutrition clinic in Auburndale,
Florida, expressed her amazement to me at the effectiveness of DMSO in
eliminating pain. She saw excellent results when physicians working for The
Health Center applied the substance externally to patient. One of them was
sixty-five-year-old Anna Goldeman, who had been suffering for years with
bursitis of the right shoulder. She went to The Health Center for relief of
the bursitis in November, 1980, and was gratified by the results of DMSO
treatment.
More dramatic than the patient’s alleviation of her
shoulder pain was the easing of a discomfort that had begun four years
previously. Mrs. Goldeman had undergone amputation of the left hip high in
the groin, which resulted in “phantom limb pain.” After amputation of a
limb, or a portion of it, the amputee may experience strange sensations as
though the part were still there. This feeling of phantom pain is generally
considered to be a stump hallucination. It arises from various types of
nerve stimuli, resulting in burning, tingling, pricking, tickling, or really
severe pain. Such sensations are not uncommon for an amputee and are not
readily treatable.
With application of DMSO to her right shoulder,
phantom limb pain with its constant twitching went out of Mrs. Goldeman’s
left groin. She no longer sensed that she still had an extremity. Now she
could feel more at peace with her situation.
Dr. Avery said, “We did
not attempt to treat the phantom limb pain; our physicians were concerned
with the bursitis. Yet, the phantom pain disappeared coincidentally from
application of DMSO to the woman’s shoulder. Thus, what happened is, DMSO
applied to one part of the body caused phantom pain to go away in another
part of the body. And it’s permanently stayed away.”
Checking back
with Dr. Avery over ten years later, I learned that Mrs. Goldeman continues
in comfort knowing that DMSO is available to cease her pain whenever needed.
***
Murray Franklin, M.D., of Chicago, is a Clinical Associate
Professor of Medicine at the University of Illinois College of Medicine, as
well as the medical director of the Union Health Service, the largest
pre=paid medical plan in the state of Illinois. He received a supply of DMSO
in the fall of 1980 and decided to try it for the benefit of some patients
for whom nothing else had worked. One of the people receiving topical
therapeutic applications was Lucas Sheinholtz, fifty-two, who had been
troubled with rheumatoid-osteoarthritis of both knees for more than a
decade. Mr. Scheinholtz, hobbling with the assistance of two canes, arrived
at Dr. Franklin’s office complex to visit another physician. The patient had
previously received many injections of cortisone, which his regular
physician administered routinely. But no appreciable improvement in his
arthritis had been observed by either the patient or his doctor.
“I
suggested to the man’s physician that we might paint some DMSO on both of
his painful knees,” Dr. Frankin said. “His right knee was swollen; the left
knee was not. The right knee was warm to the touch. The patient’s doctor
agreed to a therapeutic trial, and I applied DMSO in three
applications. Since I was not fully acquainted with how to use the solution,
I allowed an application to dry and then put in on again and again. Within
fifteen to twenty minutes the patient said he felt no pain and was able to
walk practically without the use of a cane.
“He returned in one week
and described his pain the left knee as having disappeared completely,” said
Dr. Franklin. “There just wasn’t any. The pain in the swollen right knee had
returned just a little. I applied the DMSO again and the man got a similar
result within a quarter of an hour. No more pain! I haven’t seen him since
and presume he is feeling fine.”
THE NEW MEDICAL BREAKTHOUGH FOR PAIN
The people have a new medical breakthrough for pain: dimethyl sulfoxide,
called DMSO. By itself or in combination with other medical ingredients,
dimethyl sulfoxide should be useful in treating almost every disease known
to mankind. The substance, a byproduct of pulp and paper manufacturing, has
been employed safely and successfully by millions of people around the world
to control swelling; reduce discomfort; take away inflammation; slow the
growth of, and in many instances kill, bacteria, viruses, and fungi. It
heals burns and relieves sprains, strains, and arthritic joints. It has
worked effectively against cataracts, sports injuries, scleroderma,
myasthenia gravis, tuberculosis, and even lessened mental retardation in
people with Down’s syndrome.
Cancer seems to respond well to DMSO. At
Mount Sinai Hospital in New York City, Charlotte Friend, M.D. has turned
cancerous cells into harmless normal ones in the test tube by putting them
in touch with the DMSO solutions. Thus, DMSO cancer research is in progress.
Reported in the Journal of Clinical Oncology, in November 1988, twenty
cancer patients with extravasations of anthracycline (destructive secretions
from tissues of the toxic chemotherapeutic agent anthracycline onto the
recipient’s skin with the potential to form cancerous ulcers) were treated
on a single-arm pilot study with topical-applied 99 percent dimethyl
sulfoxide and observed for three months with regular examinations and
photographs. DMSO was applied to approximately twice the area affected by
the extravasations and allowed to air dry. This was repeated every six hours
for fourteen days. The initial signs of extravasations included swelling,
redness, and pain. The median area of damage on the skin of these patients
was 8.25 square centimeters (cm2) and a median of twenty-five minutes
elapsed between extravasations and application of DMSO.
In no patient
did extravasation progress to ulceration or require surgical intervention,
as is usual with this toxic chemotherapeutic agent for cancer. The authors
of this report suggest with 95 percent confidence that ulceration was likely
to have occurred in at least 17 percent of these patients. They go on to say
that at three months there was no sign of residual damage in half the
patients, while a pigmented indurate area remained in ten. The only side
effects of DMSO included a burning feeling on supplications, subsequently
associated with itch, redness, and mild scaling. Slight blisters occurred in
four patients, and six reported a characteristic breath odor associated with
oysters. The oncologists stated that topical DMSO appears to be a safe and
effective treatment for the cancer-related condition, anthracycline
extravasation.
DMSO tends to prevent the formation of scar tissue, or
to dissolve it once present. The contracture (drawing together) of scar
tissue ordinarily left after a burn doesn’t take place.
Chilean
physicians have published their results of using the substance, which
indicate that it reduces the incidence of heart attacks or angina pain. It
has been credited with preventing damage to heart muscle when tested in
animal experiments. As with its use in stroke, DMSO may be lifesaving if
employed early in heart attacks. Investigation is continuing.
Studies
in Chile also show DMSO to be a penetrate across the blood-brain barrier. It
carries drugs effective against certain forms of mental illness directly
into the brain.
Placed into the nostrils, DMSO can open blocked
sinuses with a few minutes.
It transports antibiotics right into the
middle war to lessen infections. It does the same against viruses and
reduces the symptoms of herpes zoster (shingles) and herpes simplex (fever
blisters). The viruses are hit with antiviral drugs by the DMSO
transport. Furthermore, the herpes II venereal disease is greatly relieved
by application of DMSO directly to the genitalia.
Periodontitis in
Poland have cleared up gum disease and reduced tooth decay and their
associated pain by painting DMSO on the involved areas. Some pioneering
dentists are dropping it into empty tooth sockets after extractions,
especially those for wisdom teeth. It stops post-extraction swelling.
A 1987 paper coming out of Russia described the treatment of patients
having generalized Periodontitis with indomethacin in a suspension of
dimethyl sulfoxide. Periodontitis is disease of the structures su7pporting
the teeth such as the gums, periodontal membrane and alveolar bone. The
action of bacteria on food debris accumulated around the margins of the gums
causes the formation of plaque, which eventually forms a hard deposit,
tarter (or calculus). This accumulates in the gingival crevices (the spaces
between the gums and the surface of the teeth), which become abnormally
enlarged to form gingival pockets. It’s an early stage of periodontal
disease.
In chronic gingivitis, the gums are marked by chronic
inflammation, and they become swollen and bleed easily. Calculus accumulates
in the gingival pockets, causing bleeding and ulceration. Untreated, the
plaque spreads to the underlying periodontal membrane and alveolar bone,
which are destroyed. In this stage of chronic Periodontitis, the teeth
become loosened and eventually fall out.
Periodontal disease is the
major cause of tooth loss in middle-aged and elderly people. It is brought
on by poor oral hygiene and also by ill-fitting dentures and badly made
artificial crowns and fillings. The early stages of Periodontitis are
treated by scaling to remove the calculus and polishing to remove the
plaque, combined with careful oral hygiene. In advanced disease the gingival
pockets are surgically removed by gingivectomy (gum excision).
Now
periodontal disease is being treated with indomethacin and DMSO, in
combination. Indomethacin is a drug with anti-inflammatory, anti-fever, and
pain-killing properties, but containing no corticosteroids. Its mode of
action, like that of certain other anti-inflammatory drugs, is not known.[1]
Before this Russian publication, clinical results from the treatment of
a hemorrhagic form of Periodontitis were reported from Bulgaria. The
clinicians used a complex herb extract and 15 percent DMSO to rid their
patients of periodontal disease.[2]
American podiatrists have found
DMSO effective for the treatment of painful corns, calluses, ingrown
toenails, bunions, hammertoes, heel spurs, and even the inflammation of
gouty big toes. DMSO appears to control gout pain after just seven days of
application.
All this happens in a way that medical scientists have
yet to fully understand. They don’t know how DMSO actually works. For this
reason primarily, DMSO is not approved by the United States Food and Drug
Administration (FDA) for any other human medicinal use except as a treatment
for interstitial cystitis, a condition that causes scarring and gradual
shrinkage of the bladder.
Bruce H. Stewart, M.D., of the University
of Alabama, administered DMSO to 213 patients and found it quickly healed
the bladder condition despite the fact that the patients had not responded
to traditional treatment. Before the success of DMSO, people suffering with
interstitial cystitis faced either major surgery of the bladder, or even its
complete removal. They suffered from the urge to urinate as frequently as
every ten minutes.
Unlike criteria laid down for studying the use of
DMSO for other conditions, the study on interstitial cystitis was done
following an elementary protocol. The patients were ill, didn’t improve
spontaneously, and all forms of treatment were ineffective. They then
received DMSO and improved markedly. DMSO had eliminated the patients’
health problems and won approval by the FDA for use in bladder treatment –
but only for interstitial cystitis.
THE FDA OBJECTION TO OTHER DMSO
USES
“The fundamental problem from the point of view of the FDA is
the quality of the scientific information that is available to support the
various claims that are made for DMSO,” said J. Richard Crout, M.D.,
Director of the Bureau of Drugs with the Food and Drug Administration. Dr.
Crout made his statement at a hearing before the House Select Committee on
Aging, 96th Congress, held March 24, 1980.
Dr. Crout continued, “I
want to make it clear that the Food and Drug Administration has approved
DMSO for the indication for which there is evidence that meets the statutory
standard. We are prepared to approve it for any other indications when the
evidence comes along that it does meet that statutory standard.”
In
brief, the drug can be approved if clinical researchers show substantial
evidence of its effectiveness by providing the FDA with well-controlled
trials. The “possibility” that DMSO is effective, according to the present
statute, is simply not enough. For this reason, the only thing holding up
FDA approval of DMSO for any of the substance’s indications is the
availability of well-controlled trials that meet statutory standards, said
Dr. Crout. There is a basic conflict between the quality of the scientific
evidence available and the statutory standard for approval.
This
fundamental confrontation is best illustrated by a new drug application
(NDA) submitted in 1978 by Research Industries Corporation of Salt Lake
City, Utah, the major producer of a human medicinal grade of DMSO in 50
percent concentration Rimso-50. Research Industries Corporation wanted to
extend the use of its product and market it for the symptomatic relief of
pain and ulceration in the finders of patients with scleroderma. Scleroderma
is a rare collagen disorder that results in thickening of the skin from the
swelling of fibrous tissue. It most often involves the hands, especially
causing ulcers on the fingers, and less frequently on other tissues in the
body. After detailed review by the FDA’s Bureau of Drugs staff and its
Arthritis Advisory Committee, the NDA was refused on the grounds that the
available clinical trials did not yet demonstrate that DMSO was effective
for scleroderma. Medical science’s current investigative techniques using
double- or single-blind studies seemed inadequate for evaluating the
effectiveness of DMSO in this instance.
Research Industries
Corporation relied principally on one particular study to demonstrate DSMO’s
effectiveness against scleroderma. This study had each patient dip only one
hand into a solution of DMSO. The untreated hand was observed as a
control. Both hands had ulcerations of the skin of the fingers, and
investigators thought that DMSO’s effectiveness in healing sclerodermatous
ulcers would clearly be shown by what happened to the two hands.
Dr.
Crout described what happened. “There was a general improvement trend in the
healing of ulcers of the fingers in many patients, and in a few this was
quite striking. Interestingly, however, this improvement occurred in both
hands in these patients with scleroderma; that is, both the treated and
untreated hands tended to heal.”
Now, DMSO is different from any
other known medical substance in that it is easily absorbed into the
body. Paint an amount the size of a silver dollar anywhere on your upper
body and in thirty seconds you’ll taste it on the tip of your tongue. It
penetrates the skin and travels through the blood stream that fast.
The officials of the Research Industries Corporation argued that both hands
of the affected patients healed because DMSO worked equally well on the hand
in touch with the liquid and on the control hand. Simply, DMSO healed the
control hand by traveling through the blood stream to the ulcer
site. Absorption of the substance into the body from the treated hand was
inevitable because of its unique power of penetrability. Current techniques
utilizing the scientific method as it is understood today cannot be applied
to the study of DMSO.
Dr. Crout said, “Our staff and advisory
committee felt, to the contrary, that improvement of the untreated hand
raised the strong possibility that the general improvement trend in the
whole trial was attributable to a nonspecific effect of DMSO. Everyone
agreed that the trial showed that DMSO may be effective, but few felt that
the trial proved the point.
“Because the statutory standard for
approval of a drug is substantial evidence of effectiveness as shown by
well-controlled trials, not simply the possibility of effectiveness,”
continued the FDA chief, “we are unable to approve DMSO for this indication
at this time.”
In order for a new drug to be recognized by the FDA it
must conform to section 505 of the Food, Drug, and Cosmetic Act, which holds
that the standard for effectiveness is “substantial evidence” of
effectiveness. This means evidence must come from controlled clinical
investigations conducted by experts qualified by scientific training and
experience to evaluate the effectiveness of drugs.
Dr. Crout declared
that applications for an investigational new drug (IND) submitted for DMSO
during the previous eighteen years were faulty. They had not been assembled
into scientifically designed studies. They had not followed that certain
discipline required by research. All INDs must go through a standard FDA
procedure to win approval. The prior investigational new drug applications
submitted by three pharmaceutical companies of national repute were poorly
prepared, said Dr. Crout, and the companies did not know how to present an
IND application to the FDA to show proper evidence of value in the use of
DMSO. He made this statement despite the fact that these same pharmaceutical
firms had previously won approval for other drugs.
FLAWS IN FDA
PROCEDURE
Of course, the pharmaceutical companies disagreed. The co
discoverer of the therapeutic properties of DMSO, Stanley W. Jacob, M.D.,
Associate Professor of Surgery at the University of Oregon Medical School,
certainly disagreed. He believed the advisory committee that made
recommendations against FDA approval of DMSO was biased against DMSO. Dr.
Jacob told the House Committee of Aging: “I am not at all satisfied that the
FDA is giving DMSO a fair shake.”
The DMSO researchers who worked
with patients on a case-by-case basis pointed out that the FDA advisory
committee was negatively disposed. The committee members had never
themselves used DMSO as a therapeutic tool. And this was admitted by Dr.
Crout.
The Honorable Claude Pepper, former Chairman of the House
Select Committee on Aging, was inclined to agree with the analysis made by
Dr. Jacob. Congressman Pepper told Dr. Crout, “If there is a drug that was
being pressed upon you by three drug companies who apparently thought the
drug had enormous potential, in a case like that, I would think that you
would be eager to see if the claims that were made could be justified. You
would be looking for a satisfactory proof that would square with your
conscience and your judgment that that product might give relief to a lot of
people and could be put on the market.
“Now, the public – and I must
say up to now I share the opinion – has the impression that your agency in
its desire to be careful and its desire not to let anybody be hurt, has
denied perhaps a lot of people relief in fear that if they allowed the thing
to be approved as it was being presented, that they might be hurt by it;
that yours is a negative attitude, that you don’t tell them what is wrong
with the application in an informal way so they can attempt to correct it
and the like; that you are not eager to see the users of the country that
might profit from it get the advantage of it,” said the Congressman.
“You say, ‘It is no skin off my back,’ as the old saying goes, ‘if these
folks cannot comply with the technicalities. That is the law; it is none of
our responsibility. Let them get a better lawyer or somebody else. We are
not running it. We are just sitting up here trying to protect the public
interest.’
“Are you sure that there is no justification for the
public or even members of Congress having that impression of our regard of
your duties?” asked Congressman Pepper. “Are you sure there is no foundation
for that fear?”
Dr. Crout discounted such a possibility and implied
that DMSO was having difficulties because it was so unorthodox. He said it
would be far easier for a new drug to have its application approved if it
was closer to something already in the marketplace, such as a new antibiotic
or tranquilizer that duplicates an existing one.
DMSO is a substance
totally strange to medical science. It has a novel mode of action not
understood within the context of our current healing concepts. It is an
altogether new principle that will possible revolutionize therapeutics once
it is studies in a more exacting way. For now, however, DMSO is not being
studied in accordance with the standard double- or single-blind procedures
commonly used in the scientific method. This is the present problem. And it
is one that has perplexed the medical community ever since DMSO was first
discovered to have therapeutic value to counter human injury and heal human
disease.
The existence of this new anti-inflammatory painkiller
raises the questions: How can it be established with certainty the degree to
which DMSO does or does not work for the numerous and varied conditions
reported in the medical literature by clinicians using it successfully? Are
we able to break the logjam that enables a federal agency to keep this drug
from general use because its research studies don’t conform to the
regulations laid down by that same federal government for its citizen’s
protection? Does DMSO have a history of controversy among pioneering health
professionals and bureaucratic medical conservatives alike, because neither
group truly comprehends how radically this substance departs from know
principles of healing? Must DMSO remain controversial?
CHAPTER 2 - DMSO’s Controversial History
On November 10, 1980, United
Sates Food and Drug Administration officials entered the office of Dr.
Stanley Jacob at the University of Oregon Health Sciences Center. They were
looking for research reports on possible damage to human eyes from the use
of DMSO. They had an administrative search warrant issued by a federal judge
and were prepared to rifle through and seize the files kept by Dr. Jacob.
William Zuber and Dr. Alan B. Lisook of the FDA were refused access to
any documents by Jacob even in the face of the federal warrant. Instead,
Jacob’s attorney, Jay Geller, answered the warrant point-by-point in federal
court. Mr. Geller said such reports or documents didn’t exist or, if they
did, were not in Jacob’s possession .
Geller added that certain
documents requested were privileged patient information and not available
even under court order except in cases where patients give permission. Zuber
and Lisook walked away with only one paper that Jacob provided a two-page
memo on DMSO and its legal use in treating interstitial cystitis. Otherwise,
they got no response to questions they asked. Zuber admitted he did not have
any authority to question the physician, since the Food, Drug, and Cosmetic
Act does not give the FDA “access to people, just things.”
When
Lisook asked Geller whether the reports had ever been in Jacob’s possession
in the past, Geller assured the investigators that they had not and that no
documents had been removed from the doctor’s office since the warrant was
issued. Zuber and Lisook then terminated the meeting, saying they didn’t
believe they could obtain any information “central to this warrant.”
Geller accused the FDA of harassing Jacob. He said much of the information
requested in this federal warrant was on record from previous hearings.
Jacob said there was no evidence of damage to the human eye caused by
DMSO. “Allegations of hidden toxicity are false,” he stated.[3]
Such
controversy, with legal actions and reactions, has commonly surrounded the
puzzling painkiller dimethyl sulfoxide. Its exciting biological and medical
uses have made the substance one of the stormiest and most disputed drugs of
our day. It lay dormant for nearly one hundred years after its discovery;
now it had burst on the medical scene amidst contention, discord, charges
and countercharges – literally a war intended to convince others of the
truth.
The loser in all this intraprofessional argument is the
medical consumer. Patient advocacy doesn’t seem to exist when it relates to
DMSO. Welfare for the people has been abandoned. The facts remain
undetermined with certainty; guidance to help victims of illness made the
wisest health decisions for themselves has been ignored. Health
professionals and medical bureaucrats apparently are failing to fulfill
their responsibilities to the public.
THE SOURCE AND ORIGIN OF
DIMETHYL SULFOXIDE
DMSO was first synthesized in 1866 by Russian
scientist Alexander Saytzeff in Kazan, on the Volga River in Central
Russia. He saw that the substance was colorless, had a garlic-like odor,
felt oily to the touch, looked like mineral oil when poured from the test
tube, and left an aftertaste similar to clams oysters. It had laboratory
curiosity value for Dr. Saytzeff and his fellow chemists because dimethyl
sulfoxide combined with almost any chemical he dropped into the liquid. It
was an excellent solvent, useful as a degreaser, paint thinner, and
antifreeze. For about eighty years, the only publication advising scientists
about the stuff was a paper Dr. Saytzeff had submitted to an obscure German
chemistry journal that printed his article in 1867.
After World War
II, chemists started to show active interest in the substance. A number of
papers appeared in chemical literature in 1948, showing DMSO to be an
excellent solvent. In 1959, a group in Great Britain demonstrated that the
solvent would protect red blood cells and other tissues against freezing
conditions.
Dr. H. Harry Sczmant, Chairman of the University of
Detroit’s chemistry department, explained that the liquid has a tremendous
capacity to dissolve substances. It is a reagent that can speed up some
chemical reactions a “billion fold.”
“The unique capability of DMSO
to penetrate living tissues without causing significant damage is most
probably related to its relatively polar nature, its capacity to accept
hydrogen bonds, and its relatively small and compact structure,” he
said. “This combination of properties results in the ability of DMSO to
associate with water, proteins, carbohydrates, nucleic acid, ionic
substances, and other constituents of living systems. Of foremost importance
to our understanding of the possible functions of DMSO in biological systems
is its ability to replace some of the water molecules associated with the
cellular constituents, or to affect the structure of the omnipresent
water.”[4]
Controversy began to surround DMSO in 1962 when Dr. Jacob
first became interested in how to safely freeze human kidneys and considered
the solvent for this purpose. He asked Robert Herschler, a chemical
applications supervisor at the Crown Zellerbach Paper Company, for some of
the chemical. Crown Zellerbach had plenty to spare, since DMSO is a
byproduct of its paper-making process. For five dollars a quart it can be
produced commercially in crude form for refining into human medicinal
application.
At their first meeting, Robert Herschler mentioned that
he had difficulty washing the stain off his hands when both DMSO and dye got
on them. Dr. Jacob recalls: “We painted DMSO on our skin and within fifteen
minutes noticed an oyster and garlic taste. The skin where the chemical had
been was dry.”
The drying effect of dimethyl sulfoxide set off the
DMSO explosion. Dryness of a therapeutic agent makes it valuable in the
treatment of burns, since moisture tends to promote infection. Jacob and
Herschler tried it on burned rates and found those treated were quieter in
behavior than the untreated. The drug relieved burn pain. “From that point
on, DMSO usage just spread like wildfire,” Dr. Jacob said in an interview.
In the United States DMSO is derived from lignin, the cement substance
from trees. In Europe and other places it is synthesized from coal,
petroleum, of other organic substances.
Collaborative efforts between
Jacob’s staff representing the University of Oregon Medical School and
Herschler representing Crown Zellerbach Corporation 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 he skin without a needle. Local anesthetic can be carried the same
way.
In these early studies, DMSO was shown to relieve pain, reduce
swelling, slow the growth of bacteria, improve blood supply, soften scar
tissue, enhance the effectiveness of other pharmacologic agents, act as a
diuretic, and function as a muscle relaxant. It eliminated the pain of
sprains, strains, and arthritis, and even the pain of broken bones.
Veterinarians used the substance, by prescription, for arthritic conditions
or injuries in animals. In arthritic greyhounds, k an injection of either
DMSO or corticoid (a substance that has an action like a hormone of the
adrenal cortex) will enable the animal to race again. In six months 60
percent of the corticoid-treated dogs will have a recurrence, but less that
20 percent of the dogs treated with DMSO show such recurrence.
THE
FDA ENTERS THE PICTURE AND CONTROVERSY STARTS
The first report on the
use of DMSO as a pharmacologic agent was written by Jacob in 1963 and
published February 1, 1964. It caused a flood of trials and wild enthusiasm
over the new “miracle” drug that carried other substances through the skin
and into all organs of the body. It was soon obvious that the chemical could
relieve inflammation and pain in many conditions, some heretofore
untreatable any other way.
The first investigational new drug (IND)
application for the clinical study of DMSO in humans was submitted to the
FDA on October 25, 1963, and subsequently approved. Enormous interest in the
drug developed rapidly, to the point where it began to be used very
extensively, especially for the treatment of sprains, bruises, and minor
burns. The drug was supplied at no charge to great numbers of investigators
in general medicine, specialty medicine, and to paramedical professionals,
including physiotherapists, a few dentists, nurses, and the author of this
book, a former practicing podiatrist.
By 1965 an estimated 100,000
patients had received the medication. Studies were being conducted but the
FDA did not consider them to be well enough controlled to document clearly
that the observed benefits were actually due to the drug. The New York
Times, in a lead editorial on April 3, 1965, called DMSO “the closest thing
to a wonder drug produced in the 1960s.” An international symposium of
medical scientists in Berlin, West Germany, in July 1965, was held to
exchange information on the effects of DMSO.
Still, when three new
drug applications (NDAs) on DMSO were submitted to the FDA in 1965, all
three were turned down. The pharmaceutical companies Merck, Syntex, and Gibb
submitted their NDAs with the statement that DMSO was ready to be a
prescriptive agent. The FDA denied their statement and applications, and in
fact published its own statement in the Federal Register terminating all
clinical use of DMSO. The agency cited toxicological studies showing that
high doses of the drug changed the refractive index of the eye lens in
experimental animals. That is, a change occurred in their focusing power and
a certain cloudiness came over the lenses.
The agency’s concern was
that visual damage might occur in humans exposed to DMSO. Researchers and
bureaucrats didn’t know at that time that the eye changes were limited to
particular species. Nothing happens to monkeys or, most important, to human
beings.
A year later this prohibitive policy was relaxed
somewhat. The FDA permitted new investigations for the clinical evaluation
of DMSO in serious conditions, such as scleroderma, persistent herpes
zoster, and serious conditions, such as scleroderma, persistent herpes
zoster, and severe rheumatoid arthritis, for which no satisfactory therapy
is available.
In September 1968 the FDA published a further revision,
a relaxation of its DMSO policy that allowed topical application to the skin
for not more than fourteen days for less serious disabilities such as acute
musculoskeletal conditions – for example, sprains, bursitis, and
tendinitis. This relaxation of rules was based on a toxicological study of
people that provided a reassuring result: no evidence of human eye toxicity
due to DMSO was present.
[1] Babenko, V.N.
“Treatment of patients with generalized periodontits with a suspension of
indomethacin in a dimexide solution.” Stomatologiia (Mar./Apr. 1987);
66(2):26-28.
[2] Goranov, K.; V. Zarankova; M. Velceva; and
S. Dermend: zieva. “Clinical results from the treatment of a hemorrhagic
form of periodontosis with a complex herb extract and 15 percent
DMSO.” Stomatologiia (Nov./Dec/ 1982); 65(6):25-30.
[3] “DMSO
Documents Sought,” NHF Public Scrutiny. Vol. XXVII, No. 27, January, 1981,
p. 29.
[4] Szmant, H. Harry. “Physical properties of
dimethyl sulfoxide and tis function in biological systems,” Biological
Actions of Dimethyl Sulfoxide, Stanley W. Jacob and Robert Herschler (eds.),
New York: Annals of the New York Academy of Science, Vol. 243, January 27,
1975, pp. 20-23.
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