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.
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
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 drugs 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. That is not true. 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, angioplasty, or stents, at a time when you are frightened and highly vulnerable. Treadmills and angiograms can be 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. Not incidentally, Dr. Kitchell was a surgeon and at just that time vascular surgery was coming into vogue as the definitive therapy for arterial occlusion. 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 occurred 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. Lack of full agreement among experts is common in all fields of endeavor.
Various segments of the medical community customarily form professional membership associations with a principal goal of protecting their own turf and maintaining a monopoly in their field as much as possible. It is not justified for one such group to use ridicule and ad hominem attacks 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 certainly 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 up to 25%. With turbulent blood flow of a viscous fluid past a plaque blockage, it requires less than a 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 of heart and organ function and total blood flow consistently show that EDTA chelation therapy is highly beneficial.
If patients improve their physical endurance, if exercise tolerance increases by objective measurement, if need for anti-angina medications decrease, 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 with pain on walking (claudication).
Potential adverse side effects described by Saul Green were reported many years ago when large overdoses of EDTA were infused in too short a 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. The drive to a 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 bypass surgery 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 refuted 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
Survival Rates: Bypass Surgery vs. No Surgery Bypass
Angioplasty After Heart Attack show No Change in 1 Year Survival Rates.
Copyright © 2012 Elmer M. Cranton, M.D., all rights reserved