IV Chelation Therapy Reduces Cardiovascular Events in Heart Attack Subjects. Especially Diabetics – A Review of the TACT 1 & 2 Trials with Cardiologist Gervasio Lamas MD

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Kirk Hamilton’s podcast with Dr. Gervasio Lamas (30:07 min)
Background To The TACT 1 & TACT 2 Trials of IV Chelation in Patients with Previous Heart Attacks  Dr. Gervacio Lamas has been studying chelation therapy for more than 20 years (TACT 1, [9/2003-8/2012] and TACT 2 [10/2016-4/2021 estimated completion] Trials). He chose to study chelation therapy to challenge his own belief that chelation therapy was not valid after being asked by a patient in August of 1999 if chelation therapy was a legitimate cardiovascular therapy. He later acknowledged that he based his initial skepticism from his professional bias and it was not evidence-based. (JAMA. 2013 Mar 27;309(12):1241-50.) (Full Article; Abstract ; ClinicalTrails.Gov)
Kirk Hamilton’s original interivew (audio) with Dr. Gervasio Lamas in May, 2013      Interview Transcripts

Early Chelation Studies
Initially he looked at studies on chelation and it was split down the middle. There were positive case studies on the one side and on the other there were 3-4 small studies by conventional cardiologists saying chelation therapy didn’t work and had no validity. The negative studies were so small you couldn’t exclude that there was some benefit. EDTA was developed in 1937. One of the first reports was in 1956 “Treatment of Angina Pectoris with Disodium Ethylene Diamine Tetraacetic Acid” Am J. Sci. 1956;6:54 [PubMed] []. EDTA lost its patent in the 1960s. It’s current I&D (FDA license to use in research) is under Dr. Lamas’s name.

The Beginning of TACT 1 (Trial to Access Chelation Therapy)
He contacted colleagues at the National Institutes of Health (NIH) and stated there was the methodology available to put the question of whether chelation therapy was valid or not to the test and he felt that chelation would be found to be non-efficacious and the question of chelation’s value would be put to rest. Three years after that he received a 30 million dollar grant to do the TACT 1 study (Trial to Assess Chelation Therapy). Ten years later in 2012 the study became unblinded (1708 subjects, 55,222 chelation infusions, 40 chelations per participant (infusions including vitamins with the EDTA – vitamin C and B vitamins) all subjects had previous heart attacks, were at least 50 years of age, and had adequate kidney function). The statisticians were from Duke University, the cardiac events were judged to be real or not from Harvard. He made sure he had the best statisticians (Duke University) and clinical event evaluators (Harvard University).

TACT 1 Study Results
When they looked at the data they were surprised to see that the study was positive. They were able to show a reduction of the combined clinical endpoint for death, heart attack, stroke, bypass, angioplasties, hospitalizations for unstable angina in all subjects who previously had a heart attack, which was a “spectacular” result.

A third of the patients had diabetes (633 patients) in TACT 1 and the effect of the EDTA chelation was spectacular, reducing the combined cardiovascular end point by 41%; reducing the risk of death from all causes over 5 years by 43%; reducing the risk of another heart attack in these diabetics by 50%.

Eighty-three percent of these patients were taking statins. There was no reduction of effect with or without statins. So chelation works by a different mechanism than statins. Compared to the old statin studies (statin vs. a placebo) the effect size of the chelation was much greater.

How Does Chelation Work – Toxic Metal Excretion?
EDTA chelates positive divalent ions with great efficacy – like the metals lead and cadmium (++). Measuring metals in the urine before and after the IV EDTA challenge you will find after a challenge individuals will excrete 3000-4000% more of these metals into the urine harmlessly.

Lead runs with calcium and goes initially into the red blood cell, then after one month it goes into bone. Lead has a half-life in bone of 30 years. About 50% of cadmium is stored in your kidneys and the rest is the liver, lungs, neural tissue, the soft organs essentially.

You don’t want any metals in your body. Lead slowly leaches out of bone. In older people lead will have blood levels of 1-2 micrograms/dl. The EPA says this is acceptable. Lead is very “vasculo-toxic.” It poisons the endothelium, the lining of the arteries. It replaces calcium in intracellular reactions and “gums-up” the works.It is an oxidant stressor and increases oxygen free radicals.

All of these toxic metals increase oxidative stress. And then each metal has their own individual metabolic mechanism of cellular poisoning.  Diabetics live in a state of high oxidative stress and may be more susceptible to the toxic effects of heavy metals.

Lead and cadmium effect the acetylation of histones, the proteins that unspool DNA or ‘spool it back up’ your DNA. These metals may “gum up” how your DNA is transcribed (created).

We all have these toxic metals being taken up by our bodies. These metals may be causing or contributing to disease and health professionals are not paying any real attention to this problem and have no real knowledge how this toxic metal burden is contributing to common diseases.

Dr. Lamas equates the current situation with everyone being exposed to toxic metals, and probably having a significant burden of them, to the problem of smoking after World War II and the Korean War. Everyone smoked so initially it was difficult to prove that diseases were caused by smoking. But eventually people started looking at smoking as a cause of many diseases. Like-wise, sooner or later, the medical community will eventually start to ask and study the question of what effects do all these toxic metals have on the body and the burden of chronic disease. Cadmium and lead are just two of 5-10 toxic metals seen frequently in the urine upon EDTA IV provocation.

Dr. Lamas’s focus is to look at the effect of toxic metals and chelation with respect to cardiovascular diseases which he believes is significant and can be potentially treated. To look at the effect of toxic metals as a global health problem is beyond the scope of his investigations, but the environmental and health problems from global toxic metal burden are probably significant. He notes science and medicine moves forward in small parts and pieces by evaluating and testing aspects of one disease. In this case he is focusing on cardiovascular disease and the effect of chelation therapy.

TACT 1 Trial Results, The Acceptance of EDTA for Cardiovascular Disease and the FDA
He went to the FDA and sat down with the experts in cardiovascular disease in 2014 and requested from the results of TACT 1 that EDTA chelation therapy be approved for the treatment of cardiovascular disease.  The FDA said the study was positive, the drug (EDTA) was safe, but it was only one study. None of the other previous studies mattered because they were too small and with questionable outcome. In reality the FDA said when only one study shows a positive outcome a drug is usually not approved. Without a second confirmatory study of cardiovascular benefit EDTA would “fade” off in the public and health professional’s memory as something that failed and was “shot down.” So, the FDA recommended doing the study again (TACT 2) studying the most responsive group in the TACT 1 trial which was diabetic patient who had a previous heart attack. If the outcome was as positive as the first study, as it should be if EDTA chelation really is a valid therapy, then he could come back to the FDA and it would be “smoother sailing” to getting EDTA chelation therapy approved for cardiovascular disease.

TACT 2 Trial
TACT 2 will follow 1200 diabetic patients with a previous heart attack (MI) who will receive 40 infusions. Presently (April, 2019) they have almost 700 patients enrolled in TACT 2. The study is ongoing and proceeding smoothly in multiple centers and there will be an answer in a couple of years.

There is an oral vitamin arm of the TACT 2 trial since in TACT 1 chelation patients also took oral, high dose, antioxidant-rich supplements as part of the IV chelation protocol. Dr. Lamas is a conventional cardiologist and he is not an expert in dietary supplement use and asked a consensus panel of expert chelation doctors on what should a multivitamin and mineral supplement contain to be given along with the intravenous chelation therapy. In the TACT 1 trial there was a vitamin supplement arm and a placebo arm along with the chelation therapy. There was an 11% reduction in cardiovascular events in the vitamin consuming group in TACT 1 which was not clinically significant, but this doesn’t necessarily mean there was no benefit from the oral vitamins. There may not have been enough patients to have statistical power to show an effect. It was also observed that there was a “HUGE” benefit from the vitamins in the 27% of subjects who were NOT taking statins. In the 83% of subjects who took statins there was no appreciable benefit in cardiovascular risk reduction with vitamin supplementation. Dr. Lamas has no idea what the mechanism might be from this possible benefit of the vitamin supplements in the statin non-users in the TACT 1 trial, but this is another reason they are studying an oral vitamin supplemented group in the TACT 2 trial. If this benefit is confirmed in this diabetic population then this will open up a whole new area of study on the role of high dose antioxidant supplements and their use in cardiovascular disease patients.

Side Effects and Conventional Cardiologist’s Attitudes Towards Chelation
Most traditional cardiologists still believe that chelation therapy has no benefit and may have side effects like causing kidney problems, which it doesn’t. Dr. Lamas has recently given lectures to leading cardiologists at Harvard University, Brigham’s and Women’s Hospital, where he worked and is well received. There was no hostility, no disbelief and patronizing. There were friendly questions and the desire for more information. The physicians saw the evidence, along with pictures of case studies of gangrenous limbs being reversed (amputation avoided) with chelation therapy, and they wanted more information.  That said you won’t find these open-minded conventional cardiologists who want more information prescribing chelation therapy or referring their patients to chelation doctors.

Chelation Therapy at Mount Sinai Medical Center, Miami, Florida
Mount Sinai Hospital (Miami, Florida) is the only hospital that he knows of in the U.S. where chelation has been approved through the pharmacy and therapeutics committee and can be prescribed, though it is rarely done so. Dr. Lamas is not out there as a chelation physician but as a scientist trying to develop a new treatment for an unrecognized risk factor for cardiovascular disease. Like cholesterol was before the Framingham study, he is out to prove that chelation therapy is a valid new therapy for cardiovascular disease, possibly my reducing toxic metal burden.  He would have no problem putting patients on a statin and utilizing chelation therapy concurrently. They are both proven and safe therapies with no adverse interactions.

Dr. Lamas’s Diet Recommendations
He has poor compliance with any dietary recommendations he makes and doesn’t recommend a specific diet. The diet pattern he encourages is the one that assists the patient in losing weight. He just wants less weight in his patients because “fat is toxic.” He is open to plant-based diets and Mediterranean diets if people will adhere to them and if they have lost weight.

Infection as A Cause Atherosclerosis?
He has not seen any good evidence of an infectious cause of atherosclerosis. Chronic infections in general may increase overall inflammation and may have an adverse effect on the endothelium and other components of the blood vessels in a secondary kind of way. He has not seen evidence of microorganisms growing in plaque that could be treated with an antibiotic or antimicrobial that would lead to a reduction in cardiovascular events. He still believes that coronary calcification is do to microvascular ruptures of inflamed plaque that is walled off by the body with calcium.

Dr. Lamas’s Closing Comments
He hopes that individuals who hear this recognize that there I s much more than meets the eye in terms of cardiovascular risk factors.

Critical Limb Ischemia Studies With Chelation Therapy
He just started TACT “3A” which is a 50-patient study with critical limb ischemia subjects (impending amputation). Thirty will receive active treatment and 20 will receive placebo. I shared a case study of an 83-year-old diabetic female who was partially blind who was to have her foot amputated because of a non-healing ulcer. After 2-3 weeks of daily chelation the wound started to heal and she didn’t have to have the food amputated.

Dr Lamas stated, “There is something just so sterile about the Kaplan–Meier curve. You can…you know you can just say well blah blah blah, blah blah blah. You can’t ‘blah blah’ a foot that has gangrene, that had gangrene six months ago and it is still attached now without gangrene. YOU CANNOT ‘SCIENCE’ THAT AWAY” after chelation therapy! He shared that’s how he finished his talk at Brigham’s and Women’s Hospital at Harvard speaking to a cardiologist audience about the TACT 1 & 2 trials and there was nothing that the audience could really respond to with regards to in these critical limb ischemia patients who didn’t lose their limbs due to gangrene because of intravenous chelation therapy.

Kirk Hamilton’s original interivew (audio) with Dr. Gervasio Lamas in May, 2013      Interview Transcripts

Gervasio A. Lamas, MD, Chairman of Medicine and Chief of the Columbia University Division of Cardiology at Mount Sinai Medical Center in Miami Florida. He received his B.A. in Biochemical Sciences from Harvard and his M.D. from New York University. He completed his internship, residency and cardiology training at the Brigham and Women’s Hospital at Harvard Medical School. I interviewed Dr. Lamas almost 6 years ago in May of 2013 on the TACT 1 Study – or Trial to Assess Chelation Therapy  published in JAMA. 2013 Mar 27;309(12):1241-50.) 

Gervasio A. Lamas, MD, Columbia University Division of Cardiology at Mount Sinai Medical Center 4300 Alton Road, Suite 2070 Miami Beach, Florida 33140 Telephone: 305-674-2690, 305-674-3936, 305-674-2169 (f), Gervasio.lamas@msmc.com   

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