I. FDA STATUS
A. Dimercapto-propane sulfonate
(DMPS) is NOT approved by the FDA.
B. FDAMA and the List of
Bulk Drug Substances That May Be Compounded by Pharmacists.
B. DETOX OR RETOX?
C. Dr. Thomas Levy
D. Informed Consent
E. Risk Factors
2. ALLERGY TO SULFA DRUGS OR SULFITES
3. ELEVATED CADMIUM, IRON OR SELENIUM LEVELS
4. ELEVATED COPPER LEVELS
F. CALL FOR HONEST CLINICAL
I. FDA STATUS
Dimercapto-propane sulfonate (DMPS) is NOT approved by the FDA.
FDA approval occurs when a new drug has gone
through monitored clinical trials which assess the drug's metabolic effects on
the various physiological systems. From such trials, protocols for safe and
effective use are developed, and side effects and contraindications are made
known. This has not been done for DMPS. (Even FDA approved drugs are not
totally safe. I believe patients should always read the drug inserts carefully
before taking a prescription or nonprescription drug.) (top)
B. FDAMA and the
List of Bulk Drug Substances That May Be Compounded by Pharmacists.
Physicians may use unapproved drugs with
special permission from the FDA, and with the informed consent of the patient.
In 1997, Congress passed the Food and Drug Modernization Act, which permitted
the FDA to create what was called the “Bulk Drug List”. This was a list of
UNAPPROVED drugs which physicians would be permitted to use without special
permission from the FDA. It was thought that physicians should be freed from
the permission requirement when such drugs were needed for the unique needs of
unique patients. DMPS was being considered for placement on this list.
In February of 2001, the Ninth Circuit Court
of Appeals invalidated the section of FDAMA which permitted the creation of
the Bulk Drug List (for reasons related to free speech and severability
issues). The United States Supreme Court has recently affirmed this decision. The bottom line is that the Bulk Drug List, which was never actually
created, will probably not be. DMPS remains an unapproved drug. Don’t be fooled by
DMPS advocates who say that DMPS is 'allowed' by the FDA. It is not. Unless
special permission is given by the FDA, it is not lawful for physicians to use
it, nor is it lawful for pharmacies to compound it. (top)
I've spoken to physicians, patients,
researchers, biochemists, toxicologists and others about this drug. The
picture I get is that the majority of patients who try DMPS will not have a
serious adverse reaction. (Nor will this majority experience any significant
improvement in their conditions as a result of using DMPS.) Most patients will
have only mild side effects.
A minority of patients will experience some
benefit. (My researchers say that this benefit would also have occurred by
using oral DMSA.) Another minority of patients will experience a serious
adverse reaction. (I consider a "serious adverse reaction" to be a
disabling reaction which lasts for weeks, months or more.)
Because neither physicians nor patients are
reporting these adverse reactions, it is impossible to know just how high this
percentage is. As stated elsewhere, estimates by those who have taken an
interest in this drug indicate that the incidence of serious adverse reactions
is anywhere from 5% (a victim/researcher) to 20% (a physician and a
pharmacist). But no one really knows. I have reason to suspect, from the
reports of Ray and "M" that the most serious adverse effects are not
being reported by those who claim to have done clinical trials.
The term "backfire" means "to
have the reverse of the desired or expected effect". DMPS is used to
remove heavy metals from the body. However, sometimes DMPS can have the
reverse effect. It can actually induce metal poisoning.
I believe that the fact that many patients
will not experience serious adverse reactions, is due more to luck than the
skill or knowledge of most practitioners. There is still too much left to be
learned about this drug for there to be truly knowledgeable practitioners. To
the best of my knowledge, there have been no honest clinical studies which
address safety issues, and which will guide practitioners in distinguishing
patients who will fare well from those who will suffer serious side effects.
Without this knowledge, taking DMPS is the equivalent of playing Russian
To convince you that DMPS is safe, some
practitioners may tell you "It has been used safely in Europe for
years." I don't believe it. I've now communicated with enough people in
Canada and Europe (as well as the United States) to know better. It HAS been
used in Europe for years, and there are many patients there who have suffered
very serious side effects.
Most physicians learn about DMPS at seminars
where anecdotal evidence is provided, and then they run back to their offices
and start "practicing" on patients. Some patients will experience no
serious side effects. The first backfire comes as a surprise. I've talked to
physicians who have stopped using DMPS precisely because they have no way of
foretelling who will have a serious adverse reaction. Other doctors cause a
backfire, and keep on shooting. One physician told me quite nonchalantly that
a female patient collapsed in his office after an injection of DMPS. She had
to be taken out on a stretcher.
Another DMPS advocate cavalierly dismisses
reports of serious adverse reactions by saying that proper protocols were not
followed. Of course, the "protocols" are very complex, and in a
constant state of flux. It is a convenient, if disingenuous, way to
rationalize these adverse reactions.
Watch for these self-serving platitudes:
"you're a sensitive patient"; "mercury detox is more of an art
than a science"; "you have to feel worse to feel better";
"in Europe, patients feel they haven't gotten their money's worth if they
don't leave the doctor's office feeling worse"; "when you're on the
cutting edge, there are bumps in the road, you're a bump in the road".
All of these are insulting to the patient, and the hallmark of a clinician who
doesn't know what he's doing. Run. (top)
B. DETOX OR
There are various theories about why DMPS can
be devastating to some people. One I find compelling is that DMPS frees up
stored mercury, but is unable to maintain its bond to all that it has shaken
loose. That permits the now loose mercury to enter the bloodstream and be
redistributed to other places in the body, doing new damage. Remember that
these chelators merely mobilize mercury. It takes properly functioning
excretory systems to remove the now DMPS-bound metals from the body.
Galen Knight, Ph.D., is a chemist
knowledgeable about metal poisoning. This is what he told me:
"Much of my time is besieged by people
who have tried systemic chelators as a way of detoxing, finding out only too
late that edta, DMPS or DMSA draws the metal toxins out of the cells and bones
(where the body sequesters them as conjugates with glutathione,
metallothionine and phosphates, respectively) and then dumps them into the
bloodstream where they poison the immune and nervous systems, and vital
organs. Consequently these poor individuals can remain extremely toxic and
incapacitated for years after their `detoxing', or perhaps one should say `retoxing'.
C. Dr. Thomas
Since launching this website I have received
a number of messages from physicians. Each of them thanked me for providing
information which was new to them, or for publicizing what they knew to be
Dr. Thomas Levy is a cardiologist who
co-authored Uninformed Consent with Hal Huggins. In the book, Drs. Levy and
Huggins discourage the use of synthetic chelators in general, and DMPS in
particular. At page 252 they state:
"Heavy metal chelators almost
always overaccelerate the detoxification of the post-TDR (total dental
revision) patient. DMSA, DMPS, and EDTA can all do this. DMPS is consistently
the greatest offender here. Immune declines and clinical illness can result
for weeks and sometimes even months after only one injection of DMPS".
Dr. Levy has given me permission to repeat
what he has told me directly. In his words, "DMPS is an unqualified
sledge hammer to the immune system". He referred to the administration of
DMPS as an "assault". Dr. Levy believes that synthetic
chelators should just plain be avoided most of the time. Most patients simply
don't need them.
However, on those occasions where it is TRULY
necessary for the patient, Dr. Levy states that contemporaneous administration
of intravenous vitamin C can reduce the clinical toxicity.
I have great respect for Dr. Levy, so I told
him about how the intravenous vitamin C induced a nasty bout of kidney stones
(I have no known risk factors for stone
formation.) Dr. Levy found my experience to be unusual, and suggested I try to
determine what else my physician may have included in the IV. So far, I have
been unable to do so. However, my urologist routinely advises his kidney stone
patients to reduce or eliminate vitamin C intake. Unfortunately, there are no
scientific studies regarding the administration of vitamin C contemporaneously
with DMPS. Such studies would be welcome.
I've heard of a relatively new protocol which
calls for the administration of glutathione along with the intravenous vitamin
C. That's an intriguing notion to me, and I believe that it deserves further
However, let me reiterate. Synthetic
chelators are powerful drugs with potentially serious side effects. I have
found no consensus among experts that serious adverse reactions can be avoided
under any of the currently used protocols. Honest clinical trials are
desperately needed. (top)
What concerns me most is that patients are
being told that DMPS is a harmless drug. It is not. There are very serious
A group which advocates the use of parenteral
DMPS makes the following statements on their website: "Side effects of
the medication are minimal. In some people, mild reactions have been noted.
The symptoms include nausea, itching, elevated body temperature and fever.
These symptoms are rare and believed to be attributed to the actual
detoxification process." I find those claims to be both misleading and
irresponsible, given the patient reports I have received.
I was not told that DMPS is an experimental
drug. I was not told that there could be very serious side effects. Instead,
my physician led me to believe that the drug was "harmless". I was
not given the opportunity to give an informed consent, because I wasn't
informed of anything.
As I learned more about the physicians,
dentists and clinics using DMPS, I couldn't find a single incident where
patients were being properly informed. These patients could not make an
educated decision about their treatment, because the practitioners were not
being forthright. I encourage all patients to conduct their own investigations
(for themselves and their loved ones) before beginning a mercury
detoxification program, especially one involving synthetic chelators. (top)
E. Risk Factors
While there is much to be learned about this
drug, we do have some knowledge which should be employed before using DMPS on
any patient. I have accumulated this information from a variety of sources,
and hope it will help guide patients and physicians.
When you buy a bottle of Advil, you will
receive a lengthy insert describing its indications and side effects. When you
obtain a prescription for an approved drug from your doctor, your pharmacist
will provide you with a patient insert, informing you of all of the relevant
information you need to know to use the drug safely. No doctor or pharmacist I
have spoken to has that kind of information, and my guess is that it doesn't
exist for DMPS.
The closest I've come to an informative
patient document is a paragraph in the scientific monograph on DMPS from
Heyltex. ("DMPS-Heyl" refers to the parenteral form of DMPS; "Dimaval"
refers to the oral form.) The relevant paragraph reads as follows (the
emphasis is mine):
"Contraindications: DMPS should not be
used in the presence of hypersensitivity to DMPS or its salts. Especial care
is required on injection of DMPS-Heyl in patients with allergic asthma
symptoms. Side effects: Occasionally shivering, fever or skin reactions,
presumably of an allergic nature, such as itching and exanthema or rash may
occur, which are generally reversible on withdrawing treatment. In isolated
cases severe allergic skin reactions (e.g. erythema exsudativa multiforme,
Stevens-Johnson syndrome) have been reported. Long term use of DMPS can
influence the mineral balance, especially for elements zinc and copper.
Administration of DMPS causes mobilization of mercury taken up in the body. In
isolated cases therefore, CLINICAL SYMPTOMS OF MERCURY POISONING MAY BE
PRODUCED. In individual cases there may be raised levels of certain enzymes (transaminases).
After ingestion of Dimaval (DMPS) nausea may rarely occur. Cardiovascular
reactions may occur, especially on too rapid injection of DMPS-Heyl and is
apparent as a fall in blood pressure, nausea, dizziness and weakness generally
a short time after injection."
(Note that Heyltex acknowledges that
"clinical symptoms of mercury poisoning may be produced." In other
words, DMPS can INDUCE mercury poisoning! Trust me, you don't want to
experience this. Mercury poisoning affects you physically, mentally and
psychologically. In has driven victims insane - thus its reference as
"Mad Hatter's disease".)
A reader sent me the Informed Consent form
which was to be used in a proposed clinical trial of DMPS. (I was told by a
physician who was to participate in this trial that it never got off the
ground) The Informed Consent form lists the following adverse effects:
Pancreatitis (inflammation of the pancreas),
nausea, headache, muscle pain or weakness, gastrointestinal symptoms (nausea,
diarrhea, stomach pain), rashes, sensomotor neuropathy, decreased urination,
cardiac arrhythmias and allergic reactions.
The following additional risk factors have
been identified for me by researchers and practitioners.
I believe that there is now almost
universal agreement that DMPS should not be given to any patient who has
metal in his/her mouth. It seems the drug can quickly enter the saliva, and
begin to dissolve the metals in the mouth, pulling them into the body, and
resulting in "acute poisoning of the mucosa of the gut". More
researchers are recommending that synthetic chelators be avoided for six
months to a year after amalgam replacement. (Amalgam replacement will cause
an elevation in mercury levels in the body for a period of time afterwards.
It only makes sense to avoid increasing the blood burden of metal during
this time.) (top)
2. ALLERGY TO SULFA DRUGS OR
One researcher told me that a patient is
more likely to have an adverse reaction to DMPS if s/he is allergic to sulfa
drugs, or sulfites. I couldn't ever drink wine, and wine has sulfites. So
perhaps my adverse reaction had something to do with this.
3. ELEVATED CADMIUM, IRON OR
Because DMPS is not an approved drug, you
can't find it in the Physician's Desk Reference. You can, however, find its
predecessor, Dimercaprol. (I believe it is also known as BAL or Unithiol.)
Because of its similarities to DMPS, the cautions for its use should
probably be observed when using DMPS.
The PDR states that Dimercaprol is
indicated for poisoning by arsenic, lead gold and mercury. It further
indicates that it is appropriately used for ACUTE mercury poisoning, but not
for chronic mercury poisoning. It is contraindicated in patients with high
levels of selenium, iron, or cadmium because the resulting complexes are
more toxic than the metal itself, especially to the kidneys. Other adverse
reactions listed are:
a rise in blood pressure accompanied by
tachycardia; nausea and sometimes vomiting; headache; burning sensation of
the lips, mouth and throat; a feeling of constriction, even pain, in the
throat, chest or hands; conjunctivitis; lacrimation; blepharal spasm;
rhinorrhea; salivation; tingling of the hands; a burning sensation in the
penis; sweating of the forehead, hands and other areas; abdominal pain; and
occasional appearance of painful sterile abscesses. It further stated that
these symptoms may be accompanied by a feeling of anxiety, weakness, and
unrest, which could be relieved by administration of an antihistamine. (top)
4. ELEVATED COPPER LEVELS
A medline search has revealed a study which
demonstrated that DMPS can combine with copper to form more toxic complexes.
I had elevated copper levels (from copper pipes in my house) prior to my
injection with DMPS, so it's possible I suffered from acute copper poisoning
as a result. See:
Aaseth, J, Ribarov,S, Bacher,P; "The
Interaction of copper (Cu++) with the erythrocyte membrane and
2,3-dimercaptopropane-sulfonate in vitro: a source of activated oxygen
species." Pharmacol Toxicol 1987 Oct.; 61(4): 250-3. (top)
F. CALL FOR
HONEST CLINICAL TRIALS
Because serious adverse reactions are not
being reported, it has become that much more difficult to identify risk
factors for DMPS. Honest clinical trials with patient VOLUNTEERS (fully
informed and consenting adults) are desperately needed to identify the risk
factors, and to develop safe protocols for the use of DMPS.