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Dragons Medical Bulletin

June, 2013

The TACT Trial and Detoxification with Oral EDTA Chelation Therapy

By Gary Gordon, MD, DO, MD(H)

Finally, the details about the Trial to Assess Chelation Therapy (TACT) have been released. EDTA chelation was thought to reverse vascular disease by removing calcium in arterial plaques. I believe that this now outdated hypothesis should be revised as it is not the best approach to understanding what chelation therapy actually does. It would be more beneficial to look at the adverse effects of lead on health, the benefits of removing lead via EDTA, as well as the effects of EDTA on blood clotting.

Lead and heavy metal toxicity is the real problem. We are polluted from birth. Lead levels in patients are on average a 1,000 times greater than bone lead levels that were present 700 years ago. Higher bone lead levels increase risk of heart attack sixfold.

Lead in bones is also in equilibrium with body tissues including the eyes, which Harvard has reported leads to the formation of cataracts. The American Heart Association Journal 'Circulation' published an article in 2006 entitled 'Low-Level Environmental Exposure to Lead Unmasked as Silent Killer', showing that we all need more de-leading, not less. There is simply NO SAFE LEVEL of lead.

What about mercury amalgams and fluoridated water? Lead makes mercury 100 times more toxic and the ongoing fluoridation of our water supply has increased blood and tissue absorption of lead by six-fold. This makes daily EDTA chelation more important than ever. I have probably read more EDTA literature that anyone alive today, since EDTA changed my life nearly 40 years ago.

My personal health history motivated me to think outside the conventional box. I suffered from ill health from birth through adulthood, culminating in a disabling heart condition that forced me to close my practice before age 30. Therefore, I have always been strongly motivated to study all approaches to health restoration, not just allopathic medicine. I worked with Dr. Lester Morrison, former Director of the Arteriosclerosis Research Institute, to develop a unique oral chelation formula. The formula was based on their documented 91% reduction in fatal heart attacks due to a heparin-like effect.

It was discovered that when we added EDTA to the formula, it significantly enhanced its anticoagulant and blood viscosity lowering effects. That formula is now called Beyond Chelation Improved (BC-I). Although IV EDTA chelation adds a useful "kick start" for faster results in detoxing lead, neither oral nor IV chelation alone predictably removes plaque, so enzymes such as nattokinase and/or lumbrokinase can be very beneficial. Lumbrokinase is extracted from earthworms, while the nattokinase enzyme is derived from fermented soybeans that the Japanese call natto. Both of these natural substances target fibrins in the blood, helping the body naturally break down and digest blood clots safely.

I highly recommend Boluoke® (lumbrokinase) as the best natural alternative to Coumadin®, Plavix® and other standard medications that carry harmful side effects. There have been some highly skeptical editorials published about the reliability of the $33 million dollar, ten year TACT study, which I believe were written to downplay the benefits of chelation in order to save the invasive approaches (e.g. by-pass & stents) to heart disease. It is my hope that we can distill out of the TACT trial results more useful information as further data becomes available. I will be personally digging into this report in considerable detail.

Now that the TACT report has been published in JAMA, the idea that chelation therapy is dangerous and useless can finally be put to rest.  The TACT study did not offer enough ongoing de-leading efforts to reveal the true benefits that I see continually in my patients. I believe lifetime detoxing is the key.

The rich also cry: Killer metals in the blood
December 23, 2012 by TOYOSI OGUNSEYE

In this second part of a three-part series, TOYOSI OGUNSEYE reports that medical tests conducted on 16 residents of Adekunle Fajuyi Estate, off Adeniyi Jones, Ikeja, Lagos, who are exposed to fumes from Universal Steels Limited, revealed heavy metals in their blood, urine and water that could lead to death

On any weekday, the air over Universal Steels is certain to be thick with sooty fumes. These fumes are at the centre of a dispute that has pitted the company against the residents of an upscale estate in the heart of Lagos.

Residents of Adekunle Fajuyi Estate accuse the company of polluting their homes and environment with the heavy gases emanating from its huge machines. These gases, they add, are also responsible for the high incidence of cancer and respiratory ailments in the estate.

When our correspondent visited the company to get its side of the story, a company representative, Mr. David Igwe, was quick to dismiss the allegations.

Igwe said, “There is nothing like that. It is not true. We have an abatement plant that takes care of the gases we emit. We bought the plant two years ago and the Lagos State government was here during the launch.

“Go to the Lagos State Environmental Protection Agency and they will tell you what we have done. We don’t pollute the environment and there is no estate that is affected by our operations.”

The test

In late November, 16 of the residents agreed to SUNDAY PUNCH’s request for a series of blood and urine tests that would either validate their allegations or confirm the company’s innocence.

The tests were to determine the heavy metal concentrations in the residents’ blood systems and ascertain if they were within safe thresholds.
For the tests, researchers from the Department of Biochemistry, College of Medicine, University of Lagos, randomly selected16 residents who had lived in the estate for a minimum of seven years.

The team got 15 blood samples and 14 urine samples — one of the 16 residents did not give blood, while two declined to submit urine samples. Samples were also taken from borehole water, well water and a coconut from a 15-year-old coconut tree. SUNDAY PUNCH paid for the tests.

Killer metals in their blood
At the end of three weeks, the results were ready. The researchers published their findings in a 10-page report. The report showed that the concentrations of chromium, cadmium, zinc and iron in the blood of the residents of Adekunle Fajuyi Estate were much higher than the levels permitted by the World Health Organisation.

The head of the team that conducted the tests, Prof Albert Ebuehi, described the results as “alarming.”

He warned that the residents’ blood had “heavy metal toxicity” which posed serious health risks.

According to him, the test showed that the urine and blood of the residents were contaminated with chromium, cadmium, zinc and iron.

Ebuehi stated that the highest and lowest values of iron in the plasma of the tested residents were 8,067 per cent and 565 per cent respectively and were higher than the WHO permissible levels.

The cadmium level in the most contaminated resident among those tested was 130,000 per cent greater than the WHO acceptable level. The least contaminated individual had cadmium concentration that was 327 per cent, higher than the normal value of 0.0011mg/L.
According to professor, the levels of chromium in the tested residents were also ‘alarming.’
The 16 residents also had high zinc toxicity in their plasma. The highest value of zinc was 146 per cent, greater than the permissible level of 1.1mg/L, while the lowest was 7.3 per cent greater.

The trend was the same with the urine tests. The highest value of iron in urine was 4,963 per cent, greater than the WHO acceptable level while the lowest was 205 per cent.
For cadmium in urine, the highest value was 130,000 per cent, greater than the permissible level of 0.0011mg/L, with the lowest being 46,363 per cent.
The highest value of zinc was 143.6 per cent, higher than the WHO permissible level, while the lowest was 5.5 per cent.

The heavy gas contamination was also extremely high in borehole water, well water and coconut water samples found in Adekunle Fajuyi Estate.

The report stated that, “A final revelation became more glaring when these heavy metals were identified and determined in the coconut grown and harvested within the same vicinity. The metals in the coconut water were abnormally high and unsafe for human consumption.

“Heavy metals could enter coconut water through soil or water contamination. The metals have also affected the quality of the water in the environment. They were detected in heavy quantities.”

Groundbreaking Federal Study Proves Chelation Therapy Helps Cardiac Patients
November 5, 2012
Alliance For Natural Health

Chelation has long been favored by many integrative doctors. Now conventional cardiologists with vested interests in surgery and drugs are trying (and failing) to trash the study. What a surprise.

TACT, the Trial to Assess Chelation Therapy, is a seven-year study funded by the NIH and carried out by university cardiologists and experienced chelation physicians from around the United States. This randomized, double-blind study compared patients who were treated with medication and intravenous chelation therapy to those receiving medication but no chelation.

The results of the study, announced Saturday at the annual meeting of the American Heart Association, shows important improvement in patients who had previous heart attacks and were already under cardiology treatment—especially patients with diabetes. The group treated with chelation had fewer subsequent surgeries than those who received a placebo. The findings were unexpected by the conventional medical establishment which long fought the funding and implementation of the study and which tried to undermine it over the years. Not surprisingly, the study authors noted that additional research will needed to explain the precise mechanisms at work.

How does chelation therapy work? As we reported in February, one method involves injecting into the patient’s bloodstream organic chemicals, which can bind and remove the heavy metals in the bloodstream (metals which are toxic to humans and interfere with various physiological functions). There are also oral or suppository supplements for chelation, and some foods are natural chelators (e.g., cilantro and chlorella). In the TACT trial, patients were given an organic molecule, EDTA (disodium ethylene diaminetetraacetic acid), which binds to (or “chelates”) the toxic minerals. Chelation therapy for heart and vascular disease has long been shown to be safe and statistically effective, and now the TACT trial has validated its promise.

Immediately after the results were presented, five cardiologists were shown the study data on PowerPoint slides, and all agreed that a second clinical trial would be needed before making chelation for heart patients standard practice. Forbes called the study “highly controversial” and said that “most physicians and scientists have dismissed chelation therapy as lacking any evidence or rationale.” The Associated Press, in one of the most slanted, sneering, CAM-bashing pieces of “reporting” we’ve ever seen, called it “fringe medicine” despite the positive results of this government run-study.

The study found that chelation reduced deaths from heart attacks by 18% (by over 39% for diabetics). Despite this, the New York Times stated that the study’s benefits “barely reached statistical significance” and claimed, without evidence, that “there were questions about the reliability of the study.”

So mainstream medicine did all it could to sink this study but couldn’t do it. The study’s results speak for themselves.

Much-Debated Treatment for Heart Disease Shows Slight Benefit in Clinical Trial

LOS ANGELES — To the surprise of many cardiologists, a controversial alternative therapy proved beneficial to people with heart disease, reducing the rate of death and cardiovascular problems in a clinical trial, researchers said on Sunday.

The benefit of the treatment, known as chelation therapy, barely reached statistical significance, and there were questions about the reliability of the study. Even the investigators in the trial said the results were insufficient by themselves to justify recommending use of the treatment.

Still, the unexpected finding should provide some vindication to the National Institutes of Health for sponsoring the $30 million study, which was plagued by delays and problems.

“There may be a biological effect and that biological effect should be taken seriously,” and “pursued with additional research,” Dr. Gervasio A. Lamas of Mount Sinai Medical Center in Miami, the lead investigator, said at a news conference here at the annual scientific meeting of the American Heart Association.

Dr. Elliott Antman, representing the heart association, applauded the National Institutes of Health for sponsoring the study while also expressing caution. “Intriguing as these results are, they are unexpected and should not be interpreted as an indication to adopt chelation therapy into clinical practice,” said Dr. Antman, a cardiologist at Brigham and Women’s Hospital in Boston.

Chelation therapy involves the infusion of agents that remove metals from the bloodstream.

More than 100,000 Americans with heart disease undergo chelation therapy each year, at a cost of about $5,000 per course of treatment, experts here said. The hypothesis is that chelation can remove the calcium that is a contributor to arterial plaques.

But skeptics said there was not enough evidence backing chelation therapy to even begin a clinical trial. Proponents of the study said that since chelation therapy was already widely used, it should be subject to the same rigorous scientific testing used to study conventional pharmaceuticals.

And some skeptics were not persuaded at all. Dr. Steven Nissen, head of cardiovascular medicine at the Cleveland Clinic, said the study was “fatally flawed,” with many of the doctors involved being on the fringes of medicine and many patients dropping out of the trial. He said if people got the mistaken idea from the study that chelation was beneficial “it would be a public health catastrophe.”

The study, which began enrolling patients in 2003, was plagued by problems from the start. It fell way behind its goal of recruiting nearly 2,400 patients in three years. The trial was also suspended in 2008 for investigations by government agencies, one over conduct at trial sites and the other about whether patients were being adequately informed that chelation can cause death. The study was allowed to resume the next year, after some changes were made.

The trial ended up with 1,708 patients at 134 centers in the United States and Canada. The patients all had had previous heart attacks.

Half the patients received the chelation therapy, a synthetic amino acid called disodium ethylene diamine tetra acetic acid, or EDTA, as well as other substances. These were given by infusion every week for 30 weeks, followed by 10 more infusions at intervals of two to eight weeks. The other half received infusions of placebo.

After a follow-up of 55 months, 26 percent of those who received chelation therapy had died, suffered a heart attack or stroke, had a procedure to reopen a coronary artery or had been hospitalized for angina. That was less than the 30 percent for those who received a placebo, a difference that was barely statistically significant.

Doctors said there were reasons for caution.

Virtually all the of difference between the treatment and the placebo groups occurred in the third of patients who had diabetes. The placebo contained some sugar, which conceivably could have harmed the diabetics. Also, at least within the first two years, the chelation therapy did not improve physical functioning or psychological well being, according to surveys of the patients.

Dr. Mark A. Creager, a cardiologist at Brigham and Women’s Hospital who was not involved in the study, said the chelation infusion also contained a high dose of vitamin C and the blood thinner heparin. It could be that one of those ingredients, not the chelation agent, were responsible for any benefit, he said.

Dr. Lamas, the lead investigator, said the chelation treatment was well tolerated. But he said investigators did not yet know why some patients receiving the therapy dropped out of the trial.

Another study presented at the heart meeting on Sunday found coronary bypass surgery superior to the use of stents for patients with diabetes and multiple heart blockages.

The trial involved 1,900 patients followed for five yeas. About 27 percent of those who received stents either died or had a heart attack or stroke, compared with about 19 percent of those undergoing bypass surgery. There was an increase in stroke risk with surgery, but that was outweighed by fewer deaths and heart attacks.

Previous studies had already suggested that surgery was better for diabetic patients with severe coronary disease, and practice guidelines already say it is “reasonable” to choose surgery. But the new study, sponsored by the National Institutes of Health, shows the same result even using modern drug-covered stents.

About 700,000 Americans undergo artery opening procedures for more than one blood vessel each year, and about 25 percent of them have diabetes, according to the investigators.

The study results were also published online by the New England Journal of Medicine. Johnson & Johnson and Boston Scientific provided the stents used in the study.
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