Definition
of Chelation: Chelation,
from the Greek word “chele” meaning claw, implies that an organic
molecule binds a cation (charged mineral) in a pincer-like fashion,
forming a heterocyclic ring structure. The most widely accepted use of
chelation therapy is for the removal of toxic minerals such as lead from
the body. A more controversial indication, discovered serendipitously
during treatment of patients suffering with lead toxicity, involving the
use of the chelating agent disodium ethylene diamine tetraacetic acid (EDTA),
is in the treatment of all forms of atherosclerotic cardiovascular
disease.
1893
Alfred Werner proposed the theory of metal-ligand binding (“the
pincer-like fashion”), which provided the foundation for modern
chelation therapy.
1930’s
The textile industry required a chelating agent to remove calcium
during textile processing and this led to the synthesis of polyamino-carboxylic
acids, one of which was EDTA. A patent was filed for EDTA in Germany in
1935.
1940’s
Martin Rubin, PhD, professor at Georgetown University, who was
involved in getting a patent for EDTA (along with chemist Frederick
Bersworth), discovered its biological effects on calcium homeostasis.
This led to its laboratory use as an anticoagulant, for which it is
still used today (“purple-top tubes”).
Dr. Rubin collected the world literature on chelation and helped
to achieve approval by the FDA for
the treatment of lead poisoning (CaEDTA) and hypercalcemia (disodiumEDTA),
1950’s
Norman E. Clarke, Sr. and Albert Boyle separately published
several articles showing improvement in patients with heart disease who
were being treated for lead poisoning.
Foreman reported that high doses of disodium EDTA over a short period of
time can cause kidney damage.
1960’s
In 1960, Dr. Marvin Seven and other authors edited a book
entitled “Metal Binding in
Medicine”, which contained papers on chelation that had been
presented at two major symposia. Dr. Seven, who was associated with the
National Institutes of Health, was killed in auto accident in 1961. This
was considered by many to be a major blow to the development of EDTA
chelation therapy.
Kitchell and Meltzer
wrote several articles reporting on positive effects of EDTA treatment
for heart disease but their last article had a negative conclusion(not
supported by their reported data), which discouraged further research by
conventional doctors. A later re-examination and critique of this
negative article, by Cranton and Frackelton, was ignored by mainstream
medicine.
Ray Evers and Carlos
Lamar each collected huge volumes of anecdotal data showing vascular
improvements with chelation therapy.
Lamar published his experiences in a series of articles,
particularly documenting the salvage of legs with diabetic peripheral
vascular disease. Evers won
a precedent-setting court case establishing that once a drug is approved
for any purpose, it can be used for other indications at the discretion
of a physician, which allowed the use of EDTA for vascular disease.
In 1969, Abbott’s patent for EDTA expired, which resulted in
decreased motivation to promote EDTA as a treatment for cardiovascular
disease.
1970’s
The American Institute of Medical Preventics, later called the
American College for the Advancement in Medicine (ACAM), was formed in
1973 by Harold Harper, Ross and Garry Gordon and others to promote and
teach chelation therapy. Since that time, ACAM has sponsored conferences
and workshops on cutting edge subjects involving nutritional medicine
and chelation therapy twice a year. Many physicians were trained in the
safe administration of EDTA chelation therapy.
Garry Gordon and Robert Vance wrote an article about the
mechanisms of action of EDTA chelation therapy.
Bruce Halstead wrote the book Scientific
Basis of Chelation Therapy, This book was later updated by Ted
Rozema.
1980’s
Richard Casdorph, a practicing cardiologist, showed improvements
in ejection fractions of the heart and in cerebral blood flow with
chelation therapy in several articles.
McDonagh, Rudolph, and Cheraskin published about 30 articles
documenting various positive effects with chelation therapy, including
improvement in lipids, carotid blood flow, and lung function and no
adverse effect on bone density. This
group and Cranton each wrote articles showing no problems with kidney
function in patients treated with EDTA according to the published
protocol.
The American Medical Association called for studies to see if
chelation worked. At the
same time, conventional cardiologists wrote several editorials against
the therapy.
The American Board of Chelation Therapy was formed to certify
doctors who give the therapy. It was later called the American Board of
Clinical Metal Toxicology. ACAM also certified doctors who took its
workshop on chelation therapy and passed its written and oral
examinations.
The Great Lakes College of Clinical Medicine, later called the
International College of Integrative Medicine (ICIM) was formed in 1983
to teach and do research on chelation and other integrative therapies.
After complex negotiations, in the late 1980’sWalter Reed Army
Hospital agreed to do a randomized clinical trial on EDTA chelation
therapy, but part way through the study it was discontinued, allegedly
because the investigators were called to serve in the Gulf war and did
not return to complete the study.
Frackelton and Cranton published a landmark study about free
radical control as the primary mechanism for chelation therapy in 1984.
Olszewer and Carter published a study in in 1988 in Medical
Hypothesis documenting 87% of vascular patients showing improvement with
chelation therapy. They
later published a small cross-over clinical trial in 1990, documenting
significant results in peripheral vascular disease, in the Journal
of the National Medical Association.
Arlene Brecher lectured throughout the country and wrote a
popular book (Forty Something Forever) promoting chelation therapy from the
patient’s point of view.
Blumer and Cranton raised the possibility that EDTA therapy might
prevent cancer in a population exposed to environmental lead exposure.
1990’s
Three groups of cardiovascular surgeons published small clinical
trials on chelation therapy. None
had enough subjects to come close to clinical significance.
All were severely criticized in letters to the editor because of
procedural errors. All came
to negative conclusions. One
even admitted that their purpose was to disprove the therapy.
At the initiative of Claus Hancke, the Guldager study was
criticized for its shortcomings by the Danish supreme court.
Hancke and Flytlie published an article showing that 58/65
patients on the waiting list for cardiac bypass and 24/27 peripheral
vascular patients also on a surgical waiting list were able to cancel
their surgeries after receiving EDTA chelation therapy.
Peter van der Schaar, a Dutch cardiovascular surgeon, published
several favorable studies and wrote a massive textbook on the therapy,
recently in its 10th edition.
Michael Schachter had an article published titled: “Overview,
Historical Background and Current Status of EDTA Chelation Therapy for
Atherosclerosis” in 1996.
Elmer Cranton published a Textbook
on Chelation Therapy, into its 2nd edition in 2001.
Terry Chappell published two meta-analyses summarizing the
literature to date and coming to the conclusion that treatment with EDTA
chelation therapy was very closely correlated to measurable improvement
in vascular function
Opponents of chelation therapy, as well as almost all alternative
therapies, call themselves “quackbusters”.
This small group of doctors has infiltrated the Federation of
State Medical Boards and travels around the country making formal
complaints about doctors who provide the therapy.
They tried to outlaw the
therapy in California. ACAM
testified in defense of chelation and the California Medical Board voted
down the proposal.
The Federal Trade
Commission filed a complaint against ACAM for making a claim in a
brochure that chelation was effective for vascular disease.
ACAM submitted almost 100 articles in support of the claim, but
the FTC insisted that a large randomized trial was required to make that
claim. ACAM finally gave up
after spending a million dollars in legal fees and signed a consent
order saying they would not make such a claim any more, based on the
evidence at that time.
Articles began appearing in the conventional medical literature
that too much heart surgery was being done in the United States.
The outcomes from medical therapy were just as good for many
patients, if not better.
Steve Olmstead, a research cardiologist from the University of
Washington Medical School, wrote a 100 page monograph discussing in
detail the mechanisms, chemistry, and scientific evidence on chelation
therapy. One of his
conclusions was that the preponderance of the evidence was in favor of
the therapy for peripheral vascular disease.
This document was distributed to every medical school library in
the United States.
2000’s
Representative Daniel Burton, chairman of the Congressional
Oversight Committee held a hearing with testimony from the NIH and from
experienced chelation physicians. The
conclusion was that a large study was clearly indicated.
Subsequently, the NIH sent out a call for proposals.
A review panel turned down the first proposal, but approved the
second one, called the Trial to Assess Chelation Therapy (TACT).
The chief investigator is Gervasio A. Lamas, who is a
world-renowned researcher. Several
prominent medical schools (Miami, Duke, Harvard) and experienced
chelation physicians agreed to participate.
Several articles appeared in major journals showing that even
small amounts of lead can increase the risk for hypertension and
vascular disease.
Lin and Lin Tan published a leading article in the New England
Journal of Medicine that chelation can improve moderate non-diabetic
kidney failure, presumably by improving circulation to the kidneys.
Terry Chappell and seven colleagues published a study showing
that patients with known vascular disease treated with chelation therapy
had a much lower incidence of subsequent cardiac events, such as heart
attacks and the need for surgery, than a comparable group of patients
treated with conventional cardiac care.
These were the same end points as TACT, but the study was much
smaller and was not a randomized, double-blind study.
2010’s
It was reported by the Center for Disease Control (CDC) that a
child died after receiving disodium EDTA in a short intravenous push.
It is very important to know that calcium EDTA, which is approved
to treat lead toxicity can be given as a short IV push, but that
disodium EDTA, which has been described in this timeline as a potential
treatment for vascular disease, must always be given by a slow
intravenous drip, at a rate no more than 1 gram per hour.
Otherwise, the calcium blood level drops dangerously fast.
The unfortunate child was given the wrong preparation, and that
is the reason for the death.
Because many
cardiologists discouraged patients from participating in TACT,
enrollment proceeded slowly. For
several months, the study was delayed because a complaint by the “quackbusters”
saying that it should be stopped immediately. The
same group convinced a reporter from the Chicago Tribune to write a
negative article about the study, even though no data had yet been
released. However, after
seven years the study was finally completed on October 31, 2011.
The findings of the study are to be presented at the American
Heart Association meeting in Los Angeles on November 4, 2012.
All we know at this point is that over 1700 patients enrolled
nationwide, and the safety committee, which was active throughout the
study, found no concerns for safety, using the study protocol.
All of the studies noted
in the timeline used intravenous disodium EDTA with various vitamins and
minerals. The protocol for
the safe administration of intravenous EDTA chelation therapy has been
published by ACAM and ICIM in their training courses, and is used in
certifications by ACAM and ABCMT. Despite
numerous claims, that oral EDTA might be similarly effective, there is
no published evidence that oral EDTA might be helpful for treating
vascular disease. Oral EDTA is only about 5% absorbed, which might make
it useful for prevention for those exposed to high levels of lead on an
ongoing basis, but most doctors who utilize intravenous disodium EDTA
for vascular disease do not recommend oral EDTA for primary treatment.
The references for the
articles cited in this timeline are available in Schachter’s
historical article, in Chappell’s meta-analysis, and from L. Terry
Chappell at P.O. Box 248, Bluffton, Ohio 45817 or at lterryc@wcoil.com.
A good number of additional articles and
events were not included in the timeline for lack of space.
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