Karl's Expose Of the Fraud Connected With The NIH Study, And Elmer Cranton's Explanation of the FTC Attack
NIH to study chelation therapy for heart disease
It is almost impossible that an honest study would be done on chelation therapy. There is not a single possible doubt that it "works," but there is every reason to doubt if an honest study will be done! The "cost" of an honest study, in damage to the traditional heart disease treatment industry would be measured only in trillions of dollars. Therefore, no matter what you read here, this study cannot be honestly done, because there would be too much harm to the drug and medical industries. It will be interesting, nonetheless, to see how they try to mislead the public with this study.
Read the comments of Dr. Elmer Cranton, on this page, below, by clicking here.
Click here to read of other so-called "scientific studies" that "prove" that chelation doesn't work. The attack on chelation therapy, greatly increased in recent years, means that the traditional heart doctors are truly beginning to worry. They should worry, they should actually look for another profession!]
NIH to study chelation therapy for heart disease
August 10, 2002 Posted: 11:16 AM EDT (1516 GMT)
WASHINGTON (AP) -- The government is beginning a $30 million study to determine once and for all whether chelation therapy offers any benefit for sufferers of heart disease.
Chelation therapy is the main treatment for lead poisoning. A manmade amino acid called EDTA is seeped into patients' blood, through a vein, to sop up the toxic metal so it can be excreted in urine.
Some doctors have argued for decades that chelation therapy also could clear blocked heart arteries, perhaps by sopping up inflammation-causing molecules or calcium in buildups that clog blood vessels.
No one has ever proved chelation truly helps the heart. The first rigorously controlled clinical trial found last year that chelation failed to relieve heart disease.
Federal regulators have cracked down on proponents for falsely promoting chelation as a proven heart remedy -- several years ago the Federal Trade Commission forced a doctor's group to quit such advertising -- and warned that the therapy can cause kidney damage or other side effects, especially if not administered by a properly trained professional.
[Karl Note: I have written many times of the terrible pickle the IV chelation doctors have put themselves into. They make the false claim IV chelation "removes the plaque" in a person's arteries. This is not true. What IV chelation does, as I have repeated said, over more than 10 years, is to remove the toxic metals in the body -- that is the ONLY claim I make. It is an honest and easily proven claim. The IV doctors SHOULD be making the same claim, but they do not. Why? Because they would have to retract what they have claimed previously, and also because they would THEN have to educate their patients about how metals increase the number and activity of free radicals, and how free radicals create damage in the cells of the arteries, and how that damage results in excessive calcium INSIDE the cells -- not where almost all doctors claim it is located. If they would get honest and straight, they would not be in the terrible position of having to prove what cannot be proved.
Doctors may not "believe" that free radicals cause heart disease, but that fight is the important one to be fighting. The study described here can easily come to the conclusion, truthfully, that IV chelation does NOT remove plaque and does NOT help the heart. The study will NOT go into whether or not IV Chelation removes metals. The ACAM doctors are shooting themselves in the foot. Dr. Cranton knows this, but his voice is hardly heard within ACAM.
Last year's clinical trial was small, however, and proponents counter with numerous reports of patients who say chelation relieved their chest pain. Americans spend millions of dollars each year on chelation, either in addition to standard treatments like cholesterol-lowering drugs or as an alternative.
So the National Institutes of Health's alternative medicine center decided to fund a big enough experiment -- involving 2,372 heart-attack survivors -- to possibly settle the debate. Led by Dr. Gervasio Lamas of the Mount Sinai Medical Center-Miami Heart Institute, the five-year study will begin enrolling participants at about 100 different spots around the country in March.
Participants will receive 40 intravenous infusions, each lasting three to four hours, under methods endorsed by the American College for Advancement in Medicine, a doctors group that promotes the treatment.
Half the participants will have chelation drugs dripped into their veins; the other half will get a dummy intravenous solution. Scientists will track whether chelation recipients live longer, suffer fewer heart attacks or strokes, need less hospitalization for chest pain and need fewer angioplasties or bypass surgeries.
Study participants will get standard heart treatments, so the question is whether chelation will provide any added benefit.
Lamas said he decided to design the study when one of his own patients asked about chelation.
"While my answer, as a very conventional cardiologist, was initially, 'No, that's silly,' as I looked into it I realized I didn't really have the evidence base to say that," Lamas said. "Now we'll see what the real truth is."
Indeed, Lamas said, the need for a rigorous chelation study was reinforced last month when the NIH abruptly stopped a study of hormone replacement therapy that found -- to many doctors' shock _ that long-term use harmed instead of helped women's health.
The chelation study is "really important," agreed Dr. Rose Marie Robertson, former president of the American Heart Association. "If it's a positive study, that will be wonderful, and if it's not then we can in a definitive way tell people not to use this."
The heart association has long cautioned patients not to try chelation in place of proven heart treatments. Patients now considering chelation should "wait for the results of this trial," Robertson advised -- or enter the study instead of seeking chelation elsewhere.
[Karl Note: Those who wait will die! Thus does our medical establishment regard their customers -- sources of cash!]
To enroll in the NIH-funded study, patients must be heart-attack survivors age 50 or older who have never undergone chelation therapy, don't smoke and haven't undergone an angioplasty or bypass surgery or have one planned within the next six months.
Copyright 2002
Other similar pages:
NIH to study chelation therapy for heart disease
Dr. Garry F. Gordon, Biochemist and Father Of Chelation Therapy
JAMA: Chelation Therapy for Ischemic Heart Disease A Randomized Controlled Trial
Government Hearings On IV Chelation Therapy
JAMA Attack On Chelation Therapy
Elmer Cranton's Explanation of the FTC Attack
"Cardiovascular Disease: Is the Federal Government Doing More Harm Than Good?" EDTA Chelation
The For-Certain Proof That IV Chelation Does Not Work -- Traitors Set This Study Up
THIS PAGE: Source
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By Elmer M. Cranton, M.D. There exist a number of self-styled medical thought-police types who call themselves "quack busters." They are fond of attacking alternative and emerging medical therapies in favor of the existing medical monopoly. They even have their own Quackwatch Internet website. It is uncertain where the money comes from to fund those efforts, but it might be enlightening to trace that money back to its original source. One investigator alleges that funding comes from pharmaceutical manufacturers. For years these so-called quackbusters have attacked nutritional supplementation with high potency multi-vitamins as "quackery." As summarized elsewhere on this website (Nutrition In The News), recent scientific studies now prove that virtually anyone can benefit from nutritional supplementation. With egg on their faces from this recent vitamin research, those same critics continue to attack chelation therapy. I will now answer, point by point, an article on the Quackwatch website by Dr. Saul Green entitled "CHELATION THERAPY: UNPROVEN CLAIMS AND UNSOUND THEORIES," in which Dr. Green attempts to discredit EDTA chelation using half-truths, speculation, and false statements.
ALSO
Opponents and critics of EDTA chelation, such as Saul Green, rarely state that chelation "does not work" or that chelation is "proven not to work." Instead they merely state that it is "unproven." They are evasive and set a double standard. Bypass surgery, balloon angioplasty and close to 80% of all other therapies routinely used by medical doctors in everyday practice are also "unproven," using those same unreasonable standards. Most widely-accepted and traditional medical therapies have never been subjected to double-blind, placebo controlled clinical trials costing many millions of dollars―as demanded by opponents of chelation therapy. Detractors of chelation therapy insist that large, multimillion-dollar studies 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" because neither the doctors nor the patients know who gets the placebo and who gets the active medication). Drug companies are required by the FDA to test new prescription drugs in this manner before they can make marketing claims. On the other hand, bypass surgery, balloon angioplasty and most other widely accepted medical procedures have never been subjected to that type of testing. Because patent protection has long since expired on EDTA, there is no source of funding for such a study. N.I.H., the government source for research money, has repeatedly refused to fund a research grant to study EDTA chelation. Saul Green makes an issue of an FTC ruling in 1998 relating to advertising for EDTA chelation therapy. Because the FDA has not yet approved EDTA chelation therapy for treatment of atherosclerosis, the FTC ruled that it is not proper to imply otherwise in advertisements to the lay public. The informed consent provided to patients by chelation doctors has always made that fact clear, but once again politically powerful critics of chelation therapy have generated adverse publicity, using what was essentially a non-issue. That FTC ruling was based partly on their opinion that professional physicians associations, such as the American College for Advancement in Medicine (ACAM), should not advertise directly to the lay public. The FTC ruling does not apply to the doctor patient relationship. Training courses on chelation therapy continue to be given to practicing physicians twice yearly by ACAM. Drug companies quickly patent their newly developed remedies, which allows them to charge high prices (usually a dollar or more per capsule, sometimes much more) to recapture their millions of dollars in expenses for the FDA-required double blind studies. EDTA is a generic drug. Patent protection expired many years ago. Double-blind placebo studies of adequate size have therefore never been funded and probably will not be funded in the future unless N.I.H. or a private foundation can be convinced to do so with either public or philanthropic funds. (In 2002 a $30 million research proposal for a multi-center study of EDTA chelation therapy is under consideration by N.I.H. Let's all hope that it gets funded.) Many highly positive smaller studies have been published proving EDTA chelation therapy, reporting objective measurements of before and after improvements. Statistical analyses of those improvements are highly significant. Summaries of those studies can be read on the following webpage: Chelation Research. A chapter from my recent book, Bypassing Bypass Surgery, summarizes the vast amount of research supporting EDTA chelation therapy.
Those studies that support EDTA chelation are good science and are scientifically valid. 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; increasing for 3 to 5 months after treatment is complete and persisting for years after a course of therapy. Placebo benefit has never acted that way. Saul Green's quackbuster attack on chelation therapy states that those published studies are poorly designed and therefore meaningless. I challenge any educated lay reader to review those studies and not be impressed. It 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. All of the existing clinical data is positive and highly significant on statistical analysis. Independent researchers, at different research facilities, using different technology, were able to duplicate the positive findings of increased blood flow through blocked arteries. Statistical analysis continues to show consistent high significance. The bypass surgery and balloon angioplasty industries gross upwards of $6 billion per year. The cardiovascular drug industry takes in upwards of $100 billion dollars per year. If the existing studies of chelation therapy were to be accepted as valid, those industries would suffer enormous losses. They have no reason to want to see chelation therapy accepted. In recent years opponents of chelation have published several a number of small sham studies, falsely alleging that EDTA chelation does not work. In every instance those studies were actually supportive of EDTA chelation therapy, but they contained an erroneous conclusion otherwise. Click here for an analysis of deceptive studies. The recent PATCH study in Calgary, Canada, is a truly blatant example of that practice. That kind of junk science proves nothing, and the studies cited actually contain evidence to support EDTA chelation therapy. Nonetheless, they are quickly published in mainstream medical journals, interspersed with full-page, four-color advertisements for new and expensive pharmaceutical drugs. The news media then prominently print articles stating that EDTA chelation therapy has been proven not to work. A wise consumer will review all existing sources of information and then make up his or her own mind about what is best. A Ford salesman will most likely tell you that a Ford is superior to a Chevrolet and vice versa. Consumers should be allowed to decide what feels right for them, without being subjected to a "time-bomb-in-chest" hard-sell, with a high-pressure, frightening sales pitch at a time when they are highly vulnerable. Treadmills and angiograms are very effective and can be frightening marketing tools leading to expensive, dangerous and often unnecessary therapies. Mark Twain once said that, "If the only tool you have is a hammer, everything looks like a nail." A similar statement could be made about cardiologists, whose only tool is a catheter with balloon attached, or surgeons with 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. I have described their exact data on the following webpage: Chelation Critics Deceive the Public. You decide for yourself if you think it shows significant benefit or not. For political, economic and other unknown reasons, researchers occasionally interpret their data in a way that fits their personal prejudices, either positive or negative. When an unbiased, objective appraisal is made of that same data, the opposite conclusion can sometimes be supported. That has happened repeatedly with chelation therapy. The facts are presented (Chelation Critics Deceive the Public) to enable readers to form their own opinions. Saul Green states 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 scientific. He engages in name-calling. Doctors who disagree with Saul Green are called unscientific. Various segments of the medical community join together in professional associations with the 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." This merely represents a disagreement between experts, between differing factions of the medical profession—a common occurrence in any profession. Emerging, complimentary and alternative therapies often confront that type of bias. 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. These anecdotal reports of treatment failures are used by critics, but anecdotal reports of treatment success are rejected by critics. This represents more evidence of the double standard. Saul Green also misrepresents the the unscientific studies previously mentioned as documenting that EDTA chelation does not work, Chelation Critics Deceive the Public. Arteriograms before and after treatment are demanded by critics to prove benefit from chelation therapy. It is not possible, however, to accurately measure decreases in atherosclerotic plaque unless the diameter of the artery is increased by approximately 25%. In the presence of turbulent blood flow past plaques, it requires only 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 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 are not 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 and if symptoms improve, that 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 marketing tools frequently used to justify bypass surgery and 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. And sometimes those procedures are necessary. 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 professors in the United States and found to be highly positive, as documented in detail on the following webpage: 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, who received an active drug, not a placebo. The manufacturer of the control drug funded the study and reserved the right to manipulate and report the data in their own way. Patients who responded best were eliminated from the final data. Final results were measured immediately, 3 months before full improvement from EDTA could be expected. Analysis of raw data from that study proves that EDTA chelation therapy was highly effective in treating arterial blockage in the legs. The adverse side effects described by Saul Green were reported many years ago when massive doses 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 protocol. In rare reports of adverse side-effects, the current 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 3 out of every hundred patients treated. Fifty thousand people die in automobile accidents every year and another 200,000 are seriously injured. I tell my patients that the 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 pain remedies, many of which are available without prescription. EDTA chelation therapy is infinitely safer than even those treatments. Critics of chelation therapy never 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 completely 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―three 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 have not been supported by 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." The FDA has long since removed chelation therapy from that list, and for good reason. Why did they do that? In my opinion, it is a beneficial and highly cost effective therapy. BE SURE TO READ:
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