EDTA Chelation Therapy as a Treatment for Vascular Disease

Dr. Gervasio Lamas is the Principal Investigator and Chair of the Trials to Access Chelation Therapy (TACT). After the initial 10-year TACT study, Dr. Lamas found extraordinary results, particularly relating to diabetic patients.

Intravenous Disodium Edetate Therapy

Introduction

At the 2013 Summit on the Future of Chelation Therapy, participants identified the need for suggested clinical practices for physicians conducting intravenous disodium edetate (EDTA) therapy in their offices. This general guideline has been developed by an ad hoc committee with references from trusted sources within ACAM, ICIM, TACT, and IBCMT. It is an evolutionary document, in no way a substitute training or certification in chelation therapy, and should not be used as stand-alone instruction.

History

The word chelation, derived 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. Alfred Werner won a Nobel Prize for recognition of this new type of bond. Chelating agents were used as antidotes in WWII to counter nerve gasses.

The most widely accepted use of EDTA therapy is for the removal of toxic minerals from the body. In the 1950’s, while treating patients suffering from lead toxicity, cardiologist Norman S. Clark, MD serendipitously discovered that EDTA therapy also relieved angina and claudication. Physicians began treating all forms of atherosclerotic cardiovascular disease with EDTA therapy.

FDA Approved Usage

The Food and Drug Administration has approved EDTA therapy for treatment of excess body burdens of lead. The term “disodium edetate” is often used to refer to either calcium EDTA or disodium EDTA. Calcium EDTA is approved by the FDA to lower blood lead levels. Disodium EDTA is approved in emergencies to help lower elevated blood levels of calcium, as well as to treat heart arrhythmias due to digitalis toxicity. See the FDA website for updated information.

Clinical Experience

Disodium EDTA with magnesium has been used “off-label” for most published studies using EDTA to treat vascular disease. Studies have shown EDTA removes metals and is beneficial in treating any form of atherosclerosis. Calcium EDTA is more effective at decreasing an excess body burden of heavy metals, but is less effective in treating atherosclerosis.

Scientific Evidence

In 2012, the Trial to Assess Chelation Therapy (TACT) became the first (and only) large randomized, double blind clinical trial assessing the use of EDTA therapy for cardiovascular indications. Until this point, studies on the effects of EDTA therapy did not have sufficient power to be clinically significant.

All patients in TACT had a previous myocardial infarction and received conventional cardiac care. Those who also received EDTA therapy improved more than those who received an intravenous placebo. Concurrent treatment with high dose vitamins provided further improvement. Both of these results were statistically significant.

Timeline for EDTA Chelation Therapy as a Treatment for Vascular Disease

By Terry Chappell MD, John Trowbridge MD, and Michael Schachter MD

1893

Alfred Werner proposed the theory of metal-ligand binding (“the pincer-like fashion”), which provided the foundation for modern chelation chemistry and development of treatment.

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 helped to achieve approval by the FDA for the treatment of lead poisoning (CaEDTA) and hypercalcemia (disodiumEDTA), and later collected the world literature on chelation.

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, leading to the development of safe treatment protocols.

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, because he was a leading advocate of the 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 1980’s re-examination and critique pointing out glaring errors in 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 as well as for the use of dozens of other drugs by all American specialists.
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 in 1983 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’s Walter 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 in a study with an 18-year follow-up.

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 10^th
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 2^nd 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 removing lead and 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 the wrong medication, 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 can drop dangerously fast. The unfortunate child was given the wrong preparation by IV push, 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.

20teens

After seven years the study was finally completed on October 31, 2011. The findings of the study were presented at the American Heart Association meeting in Los Angeles on November 4, 2012. The conclusions of TACT were 1. EDTA is a safe treatment (only two patients died unexpectedly, one each in the treatment and placebo groups), 2. Chelation therapy showed an unexpected treatment benefit in post-MI patients who are already on evidence-based therapy. The effect was statistically significant. The cardiac event that was best prevented was the future need for cardiac surgery. Diabetics did better than non-diabetics, and 3. More research is needed to confirm the results and explore the mechanism of action.
Virtually 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.
ICIM provided a grant for Dr. Lamas to apply for funding for another major study called TACT II. This study was for chelation to treat diabetic patients who also had documented coronary artery disease. As of October, 2019, 800 patients out of a projected 1100 patients were enrolled. In addition, Dr. Lamas was funded for a critical limb study of 30 patients compared to 20 placebo patients. Thus far Lamas has participated in over a dozen articles in peer-reviewed journals about chelation. He has presented his findings to cardiologists in medical schools across the country. He anticipates that completion of ongoing studies might take more than three years. If these studies are positive, EDTA chelation might take its place as an accepted treatment for vascular disease.

International College of Integrative Medicine:

“Translating science in to clinical practice since 1984”

An Organizational History of ICIM’s activities to promote

and advance the practice of chelation therapy

2004 Integrative/Environmental Medicine Standard of Care Guidelines for Increased Total Body Burden of Toxic Metals was edited by Robban Sica, MD

It was endorsed by the American Board of Clinical Metal Toxicology, the American Academy of Environmental Medicine, and the International College of Integrative Medicine.

2003— 2013 The NIH invested $31 million to fund the TACT Trial

ICIM members testified at Dan Burton’s Congressional hearing that eventually led to NIH funding of the Trial to Assess Chelation Therapy (TACT), and several became investigators in the study.

March, 2012 in Lexington KY Saving a Million Hearts: “Ask the Experts” Forum Anticipating the New Direction in Cardiovascular Medicine

Under the direction of Terry Chappell MD, ICIM gathered leaders in the field with extensive experience to share the stage to discuss and evaluate controversies in this area of medicine. We asked what interventions worked most effectively to quickly reverse symptoms and reduce the risks of cardiovascular disease. This day of conversations was facilitated by Jeannette Soriano MD. It was videotaped and is available at http://chelation.me/saving-a-million-hearts/.

March, 2013 in Washington DC: Summit On Chelation Therapy for Cardiovascular Disease: Where Do We Go from Here?

As chair of the Scientific Committee of ICIM, Terry Chappell MD called for a summit of international experts on chelation therapy and vascular disease, to plan the quickest and most cost-effective way to accumulate the evidence needed to achieve recognition by the FDA. He wrote:

The Trial to Assess Chelation Therapy (TACT) has provided statistically significant evidence that intravenous EDTA chelation therapy is effective for reducing future cardiac events in post-MI patients who are already on “evidence-based” cardiac therapy. In order for disodium magnesium EDTA to be approved by the FDA as a treatment for vascular disease, the authors of TACT suggest that we need a confirmatory study as well as further work to identify the mechanism(s) of action.

April, 2014 Chelation.me

ICIM launched a campaign in response to the Washington Summit, which identified an urgent need for better public education and public relations.

Facebook, Twitter, Linked In, and our weekly e-newsletter “Between Conference Connection” were all utilized to make multiple accounts with regular posts about chelation.

We created a website dedicated to chelation, which listed all the articles, books, research papers and recordings we could find in our own archives and online. In this process, we scanned Ed McDonnah’s book and made that publicly available on the website. To get this wealth of information out into the world, we started #chelationtuesday, and used the hashtag to post every possible link on chelation.me. This weekly hashtag continued for four years.

June, 2014 ICIM Awards $20,000 Research Grant to Dr. Gervasio Lamas: Chelation Therapy for Diabetics

Dedicated to Dr. Carter, this grant was created to inspire innovative thinkers to conduct further clinical research that will aim to confirm the results of the Trial to Assess Chelation Therapy (TACT) for treating vascular disease and diabetes. ICIM received three poposals, but chose Gervasio Lamas MD as the winner of the grant.

Several ICIM doctors suggested that it might be easiest to attempt to replicate a 1990’s Danish study led by Claus Hancke, which showed that 24 of 27 patients on a waiting list for amputation were able to cancel their surgery after chelation treatment. Dr. Lamas reported that researchers from several prominent medical schools stressed the scientific importance of doing a similar study to TACT for confirmation purposes. He will also examine whether the elevation of toxic metals such as lead is a possible mechanism of action. An amputation study could be performed at a later date.

The original clinical trial coordinated by Dr. Lamas, TACT, showed that patients who had suffered heart attacks in the past subsequently treated with intravenous chelation had fewer future cardiac events than those who only received conventional cardiac care. Diabetic patients in TACT who received chelation plus high-dose vitamins and minerals had 51% fewer cardiac events over a five-year period.

The late James P. Carter, M.D.’s contributions to the acceptance of chelation therapy were immeasurable. Dr. Carter played a critical role in helping ICIM define its commitment to educating its members, protecting their ability to practice innovative medicine, and stimulating meaningful research.

February 2015 The American Board of Clinical Metal Toxicology merged with ICIM

ICIM absorbed twenty-one of its members. At this time, ICIM decided to stop using the language of “certification” and to give certificates of completion for its trainings. ICIM utilized a provision in the bylaws to form Chelation and Metal Toxicology ICIM Professional Section. Moneys transferred from ABCMT were to be used only for that cause.

June 2015 Guidelines for Chelation Therapy

At the 2013 Summit on the Future of Chelation Therapy, participants identified the need guidelines for physicians conducting intravenous EDTA chelation therapy in their offices. ICIM started working on a general guideline, developed with input from a large ad hoc committee with references from trusted sources within ACAM, ICIM, TACT, and IBCMT. Past ACAM Presidents Neal Spaight MD, Buddy Green MD, John Trowbridge MD, and Terry Chappell MD participated. Protocols from Conrad Maulfair DO, William Schacter MD, TACT, Ted Rozema MD, Peter VanDerShaar MD, Robban Sica MD, and Wm. “Butch” Shrader were evaluated.

October 2015, We reached out to ACAM and asked if they would collaborate on the writing of chelation guidelines, with the goal of co-publishing the document

After a variety of emails, and a conference call in which ACAM chelation physicians agreed in principal with the guidelines, they determined that any official collaboration with us would be detrimental to them.

2016 Jeanette Tallaj memorial

ICIM received funds from the family of Jeanette Tallaj (mother of Jeannette Soriano MD) who sent a donation in memory of her life, to support the Staff/Affiliate training programs of ICIM. Our detailed and supportive chelation staff trainings have offered value to our members throughout our organizational history.

March, 2016 ICIM hosted an International Chelation Summit in Atlanta, Co-Sponsored by the International Board of Clinical Metal Toxicology

Gervasio Lamas MD lectured on the latest status of the second Trial to Assess Chelation Therapy by the NIH (TACT 2) We also featured stories and updates from chelation research pioneers such as Charlie Rudolph MD and Tammy Born DO, and offered time for international guests to give reports on chelation in their countries.

During the summit, the chelation guidelines document was rigorously discussed and evaluated by attendees. ICIM used funds from the Chelation Professional Section to pay for expenses to bring ACAM president Buddy Green MD to the table, to participate as an ACAM representative. We went through a consensus building process to try to pull various protocols into agreement, creating basic guidelines for chelation practitioners. One of the questions was if the protocol was meant to substitute for a class (no), and if this was meant to be a Standard of Care (no, just guidelines).

Here is a commentary by John Parks Trowbridge MD:

A problem unique to integrative medicine practitioners is that the physicians (MDs and DOs) come from the traditional training and practice background, often bringing their earlier approaches along with them. One example is how some of them approach guidelines, specifically in this case those recently developed with regard to performance of chelation therapy. Sadly, several organizations — including ACAM, which was among the first to propose treatment guidelines — have declined to support the recent ICIM proposal. While “competing” specialty societies in conventional medicine risk little by “being different,” integrative practice groups have much to gain by having a “united front,” especially when officers from the different organizations have contributed to the finished product. To clarify, the recent guideline proposal is not a “final” one by any consideration, and newer ones will evolve in coming years. When we all “agree” upon a set of general protocols, then we continue to raise the bar in terms of providing what our patients need and want.

Participants in refining the Guidelines document at the International Chelation Summet included: Sarah Cole PA-C; Joergen Wantzin MD (Denmark), Charles Adams MD, Eric Born DO, Ellie Campbell DO, Ronald Casselberry MD, Terry Chappell MD, Martin Dayton MD, PhD, Buddy Green MD, Amanda Kaufman MD, Marina Johnson MD, Emir Kisyanto (Phillipines), Jeffrey Kotulski MD, Nelson Kraucak MD, Helen Kwon MD, Conrad Maulfair DO, Norma Migoyo (Cuba), Vintonne Naiden MD, Richard Plumb DO, Nkem Obianagha (Nigeria), Megan Strauchman DO, Melissa Taliaferro MD, Matthew Van Olm MD (Canada), William Wiers MD, and Aage Winther Nielsen MD (Denmark), Robban Sica MD, Paul Jaconello MD, and John Parks Trowbridge MD.

April, 2016 The ICIM board voted to officially endorse ACAM’s statement on Flint.

Our statement to Sister Organizations was if AAEM and AANP and other groups could do the same, that would have significant impact on the conversation Jed Natzke MD is having with colleagues. We urge your boards to endorse the statement as soon as possible: http://icimed.com/blog//blog5.php/acam-address-the-flint-water#item_175

July 2016 Finished editing our document “Intravenous Disodium Edetate Therapy Guidelines for Office Use.”

ICIM continued to collaborate with other organizations by teaching chelation courses at shared meetings.

October 2017 ICIM Research Contest during the conference in Grand Rapids, MI.

Attendees paid $100 for a chance to vote on three research proposals. The winner got the final amount of money taken in. The grant was awarded to a proposal to study chelation and leukemia; however, it was returned to ICIM because the project was not yet ready to get off the ground.

Heavy Metal Toxic Blues (humorous postscript)

At the Grand Rapids meeting, President Chuck Adams MD wrote the new ICIM “Fight Song” about chelation called Heavy Metal Toxic Blues, with help from Steve Edwards. This is available on YouTube and other social media.