[back] Chelation
BUSTING THE QUACKBUSTERS
REBUTTAL TO "QUACKWATCH" WEBSITE OPPOSING CHELATION THERAPY:
http://www.drcranton.com/chelation/rebuttal.htm
A small number of self-styled medical thought-police call themselves
"quack busters." They attack chelation and other alternative, innovative
and leading-edge medical therapies in favor of the existing medical
monopoly. They have their own
Quackwatch Internet website. Who are these so-called Quackbusters,
who funds them? It would be interesting uncover the financial backing
for this group. Who pays for this type of attack on competing therapies?
It has been alleged that funding comes indirectly, through a number of
cutouts, from a consortium of pharmaceutical manufacturers.
In past years the so-called quackbusters have attacked nutritional
supplementation and high potency multi-vitamins as "quackery." As
summarized on this website
(Nutrition In The News), recent scientific studies now prove that
virtually anyone could benefit from nutritional supplementation. With
egg on their faces from recent nutritional research, these
"Quackbusters" continue to attack chelation therapy. The Icon below
links to the Quackwatch website article by Dr. Saul Green entitled "CHELATION
THERAPY: UNPROVEN CLAIMS AND UNSOUND THEORIES." Green attempts to
discredit EDTA chelation using half-truths, speculation, and false
statements. Saul Green is President of ZOL Consultants, a company paid
to investigate alleged health frauds. Now, who do you suppose would pay
Saul Green for that? You might ask him.
Read below for a point by point rebuttal to this misleading article.
ALSO READ "A MEDICAL SCHOOL PROFESSOR BUSTS THE QUACKBUSTERS"
Critics of EDTA chelation rarely state that chelation "does not work"
or that chelation is "proven not to work." Instead they state that it is
"unproven" by large, FDA approved, double-blind placebo controlled
clinical trials. That same statement can be made about most widely
approved treatments in medicine. They deceptively apply a double
standard. Bypass surgery, balloon angioplasty and close to 80% of all
therapies routinely used routinely in medical practice are "unproven" by
the same criteria.
More than 80% of widely-accepted and traditional medical therapies have
never been subjected to double-blind, placebo controlled clinical trials
―as demanded by opponents of chelation therapy. Critics evasively and
deceptively apply a double standard.
Detractors of chelation insist that large, multimillion-dollar studies
must be performed, giving half the patients a placebo, with the placebo
group "blinded"―unknown to the investigators until the study is complete
(called "double-blind and placebo controlled" because neither the
doctors nor the patients know who gets the placebo and who gets the
medication under study). Drug companies are required by the FDA to test
new prescription drugs that way, before they can make marketing claims.
On the other hand, bypass surgery, balloon angioplasty and 80% of widely
accepted medical procedures have never been subjected to that type of
testing. Because patents have expired on EDTA, there is no way to recoup
the cost of such a study.
Saul Green cites an FTC ruling in 1998 banning the interstate
advertising of EDTA chelation therapy by a professional medical
membership association. That ruling does not in any way apply to the
practice of chelation therapy by clinics and health care providers.
Because the FDA has not yet approved EDTA chelation therapy for
treatment of atherosclerosis, the FTC ruled that it is not proper for a
professional membership association to imply otherwise in advertisements
to the lay public. That ruling does not apply to individual health care
providers and clinics.
An informed consent provided to patients by chelation clinics has always
made clear that the FDA does not endorse this off-label use. Politically
powerful opponents of chelation therapy thus generated adverse publicity
using what was essentially a non-issue.
Drug companies patent new to allow them to charge high prices (usually a
dollar or more per dose, sometimes much more) to recapture the millions
of dollars it costs for FDA-required double-blind studies. EDTA is a
generic drug and patent protection expired many years ago.
Many smaller studies have been published documenting the benefits of
EDTA chelation therapy, with data showing objective measurements of
before and after improvement. Statistical analyses of those improvements
are highly significant. Summaries of those studies can be read on the
following webpage:
Chelation
Research. A chapter from the book,
Bypassing Bypass Surgery,
summarizes a large amount of research and clinical studies supporting
EDTA chelation therapy. Every published study of chelation therapy has
been positive, with data that showing benefit (although several studies
have misrepresented that positive data).
The studies that support EDTA chelation are scientifically valid, even
though they are not placebo controlled. Only if it is assumed that
placebo effect could cause long-term, sustained increases in objective
blood flow measurements to the brain, heart and extremities through
diseased arteries can those studies be ignored. Placebo effect has never
been observed to last more than 6 months. Benefit from chelation therapy
comes on slowly, not peaking until 3 or more after treatment is complete
and persisting for years after a course of therapy. Placebo benefit
occurs immediately and has never been reported to last 6 months.
Saul Green's quackbuster attack on chelation therapy states that
published studies are poorly designed and therefore meaningless. Any
educated lay reader will be impressed with the data in those studies. It
is always desirable to have bigger and better studies. There is always
room for improvement. That same statement could be made about any study
ever published. The existing clinical data is all positive and highly
significant on statistical analysis. Independent researchers, at
different research facilities, using different technology, have been
able to duplicate the beneficial findings of increased blood flow
through blocked arteries. Statistical analysis high significance.
According to
"Business Week," doctors are doing about 400,000 bypass surgeries and 1
million angioplasties a year—a
heart-surgery industry worth an
estimated $100 billion a year. The cardiovascular drug industry
takes in upwards of another $100 billion dollars per year. If the
clinical studies of chelation therapy were accepted as valid, those
industries would suffer enormous losses. They have no reason to want to
see chelation therapy accepted.
Opponents of chelation have published several sham studies, in an
attempt to show that EDTA chelation does not work. In every instance the
actual data from those studies showed benefit, but the
authors published deceptive erroneous conclusions.
The so-called PATCH
study performed in Calgary, Canada, is a blatant example of such a
practice and represents a kind of junk science that proves nothing. It
actually contains evidence to support EDTA chelation therapy, despite a
deceptively negative conclusion. Such studies are quickly published in
mainstream medical journals, interspersed with full-page, four-color
advertisements for new and expensive pharmaceutical drugs. The news
media report that EDTA chelation therapy has been proven not to work.
Few readers take the time to carefully analyze the data to arrive at
their own unbiased conclusions.
The informed consumer should review all available sources of information
and then make up his or her own mind about what is best. Study at all
the facts and decide what feels right, without being subjected to the
"time-bomb-in-chest" hard-sell for bypass surgery or angioplasty at a
time when you are frightened and highly vulnerable. Treadmills and
angiograms can bee very effective marketing tools for expensive,
dangerous and often unnecessary therapies.
Mark Twain once wrote, "If the only tool you have is a hammer,
everything looks like a nail." A similar statement could be made about
cardiologists, whose favored tool is a catheter with balloon or stent
attached, or surgeons and their scalpels. The same might also be said of
a chelation therapist. Buyer beware! Be an informed consumer. Every
therapist has their own bias.
Saul Green writes that the Kitchell, Meltzer reappraisal study in 1963
showed no significant benefit. The opposite is true. The data from that
study is carefully presented and analyzed on the following webpage:
Chelation Critics Deceive the Public. Decide for yourself if you
think that study shows significant benefit. For political, economic and
other unknown reasons, researchers often interpret their data to fit
their personal prejudices, either positive or negative. An unbiased and
objective appraisal of that same data may indicate an opposite
conclusion. This has occured repeatedly with chelation therapy. Studies
have been stated by the researchers themselves as having been designed
at the outset to discredit chelation therapy. Results are then
interpreted to support that position.
Saul Green writes that chelation is "not recognized by the scientific
community." That is not true unless it is assumed that the many highly
trained physicians who administer chelation therapy are not a part of
the scientific community. Doctors who disagree with Saul Green are thus
labeled as unscientific.
Various segments of the medical community seem to join together in
professional membership associations with one goal of protecting their
turf and maintaining a monopoly in their field as much as possible. It
is not justified for one such group to state that other medical
scientists who disagree are "unscientific." Instead this merely
represents a disagreement between experts, differing opinions of others
in the medical profession—a common occurrence in any profession.
Innovative, complementary and alternative therapies are commonly
subjected to that type of bias. (It might be mentioned that Saul Green
is not a clinical practitioner with experience in chelation therapy. He
is a PhD and his stated career has been in cancer research.)
Saul Green writes that at least fifteen different reports document that
EDTA did not benefit patients. That is not true! For the most part, he
cites letters to the editor, which report an occasional treatment
failure. No therapy is 100% effective and treatment failures do occur
with EDTA. However, more than
85% of patients
have been helped. Anecdotal case reports of treatment failures are
used by critics of chelation, but anecdotal reports of treatment success
are rejected by critics―more double
standard. Saul Green also
misrepresents those studies previously mentioned as documenting that
EDTA chelation does not work.
Arteriograms before and after treatment are demanded by critics to prove
benefit from chelation therapy.
It is not possible, however, to reliably measure improvements on
arteriogram (also called angiogram) unless the diameter of an artery
is increased by approximately 25%. With turbulent blood flow past a
plaque blockage, it requires a mere 10% increase in arterial diameter
to double the flow of blood (Poiseuille's
Law of hemodynamics as can be found in any textbook of medical
physiology or biophysics). As proven in published clinical studies,
arteriograms and ultrasound are not sensitive enough to consistently
measure changes of less than 25% in the diameter of a blood vessel.
Increases much less than that can greatly relieve or totally eliminate
symptoms, and thus not be detectable on arteriograms. Studies which
measure heart and organ function and total blood flow consistently prove
that EDTA
chelation therapy is highly beneficial.
If patients improve their physical endurance, if exercise tolerance
increases by objective measurement, and if symptoms improve, that in
itself provides good scientific evidence of benefit. If measurements of
walking distance on a treadmill with an uphill incline consistently
increase after treatment and with statistical significance, that is
valid scientific proof of benefit.
Angiograms are not sensitive enough to measure even a doubling in blood
flow. Angiograms are often used as marketing tools to justify bypass
surgery, stents or balloon angioplasty; however, angiograms cannot show
increases in arterial diameter that can increase blood flow by 200% or
more. They do, however, show the surgeons where to cut and are necessary
to place a balloon or stent in angioplasty.
Saul Green is in error when he states that the Curt Diehm study in
Germany did not show benefit. The raw data from that study has been
analyzed by medical school experts in the United States and was found to
be highly positive, as detailed in a
Critique of the Heidelberg Study. Patients who received EDTA
increased their walking distance by an average of 400%, compared to 60%
increase in the control group patients (controls actually received
another type of active drug, not a placebo. The manufacturer of the
control drug funded the study and reserved the right to manipulate and
report the data. The patients who responded best were eliminated from
the final data as "outliers." Final results were reported too soon.
Three months later the improvements were much greater, as expected
following EDTA. Analysis of raw data from that study proves that EDTA
chelation therapy was highly effective in treating arterial blockage in
the legs.
Potential adverse side effects described by Saul Green were reported
many years ago when large overdoses of EDTA were infused in a very short
time. Any medicine given in overdose can cause harm. There are no
documented reports of harm when EDTA has been administered using the
currently approved dose-rate protocol. In recent rare reports of
adverse side-effects, the approved protocol was not followed. Even when
administered improperly, 10 deaths in a million patients indicates that
chelation is infinitely safer than surgery or balloon angioplasty, which
result in death from complications in approximately 2 out of every
hundred patients treated.
Fifty thousand people die in automobile accidents every year and another
200,000 are seriously injured. IThe drive to the clinic in an automobile
to get chelation therapy is statistically far more dangerous that the
chelation they receive after they arrive. More than 8,000 deaths and
200,000 hospitalizations each year result from complications of
ibuprofen, naproxen, aspirin and other widely accepted over-the-counter
pain remedies. EDTA chelation therapy is infinitely safer than even
those treatments.
Critics of chelation therapy rarely put things in proper perspective.
Saul Green goes on to speculate about a number of theoretical reasons
why chelation therapy might possibly be
dangerous. He ignores the amazing safety record of a million patients
who have received the therapy. The dangers of surgery and angioplasty
are well proven, not just theoretical―two percent death rate and twenty
percent or more serious but non-fatal complications. It is not necessary
to merely speculate why invasive procedures might possibly cause harm.
Saul Green's statements about why chelation might be dangerous are
supported after more than 40 years of experience.
The Danish study mentioned by Saul Green was misrepresented and
proved nothing. It was actually a positive study and showed benefit from
chelation therapy.
Saul Green states that the FDA once had EDTA chelation on their list of
"Health Care Frauds." Many years ago the FDA removed chelation therapy
from that list, and for good reason. Why did they do that?
BE SURE TO READ:
If
EDTA Chelation Therapy is so Good, Why Is It Not More Widely Accepted?
A Professor of
Cardiology Critiques Bypass Surgery.
Chelation
Critics Deceive the Public
RELATED ARTICLES:
Survival Rates:
Bypass Surgery vs. No Surgery Bypass
Angioplasty After
Heart Attack show No Change in 1 Year Survival Rates.