Posted By Ronald Hoffman, MD & Dana Cohen, MD,
Tuesday, February 21, 2017
If you or a loved one is a diabetic over 50 who has suffered a heart attack, there's an opportunity to obtain a potentially lifesaving therapy AT NO CHARGE. Dr. Dana Cohen describes the TACT2 trial, a multi-million dollar government-sponsored study to evaluate the effectiveness of chelation therapy. What is chelation? What is its history? How did the first TACT study demonstrate its effectiveness? Why was it greeted with skepticism by the medical establishment? Why have only integrative doctors been eager to embrace chelation? CLICK HERE
PART II: Dr. Hoffman continues his conversation with Dr. Dana Cohen about the TACT2 trial to evaluate the effectiveness of chelation therapy. CLICK HERE
Excessive toxic metal exposure from the air, food, water, dental amalgams, and other sources is becoming a recognized and established underlying cause of both acute and chronic disease. With ongoing medical research validating the link between chronic diseases like heart disease and environmental exposure to toxic metals, it is more important than ever for doctors and patients to be well-informed about the detrimental effects of toxic metals and the potential treatments for heavy metal toxicity, including IV chelation therapy.
What is chelation?
The Greek word “chele” means claw. Chelation is the binding of metals (like lead) or minerals (like calcium) to a protein “chelator” in a pincer-like fashion, forming a ring-like structure. Chelation is an important treatment protocol for the removal of toxic metals such as lead and mercury from the body’s bloodstream and tissues. Natural chelation, although weak, regularly occurs from eating certain foods such as onions and garlic. A stronger chelation effect can be induced when certain supplements, such as some amino acids, are taken orally. The strongest chelation effect is achieved with intravenous chelation.
What is chelation used for?
Intravenous chelation therapy is used and accepted within conventional medicine as an FDA-approved treatment for the removal of toxic minerals such as lead from the body in cases of severe poisoning. However, it is also used in a less conventional way: the repeated administration of intravenous chelating agents is used to reduce blood vessel inflammation caused by specific toxic metals and to reduce the body’s total load of those metals, especially lead. It has been shown that the risk of dying from cardiovascular events begins when a person’s blood level of lead is still well within the established normal reference range.
IV chelation therapy often utilizes the chelating agent disodium ethylene diamine tetraacetic acid (EDTA) and is sometimes referred to as EDTA chelation. EDTA chelation is being used in the treatment of all forms of atherosclerotic cardiovascular disease, especially heart disease and peripheral artery disease. Although there is less published research in these areas, chelation therapy is also being used to treat macular degeneration; osteoporosis; mild to moderate Alzheimer’s disease associated with heavy metal toxicity; autoimmune diseases, especially scleroderma; and fibromyalgia or chronic fatigue syndrome with high levels of toxic metals detected with a challenge test.
Does chelation really work?
The most recent study to examine the effects of EDTA chelation therapy showed compelling value for preventing cardiovascular events, especially in people with diabetes who had a history of heart attack. The controversial Trial to Assess Chelation Therapy, or TACT, found an amazing 40% reduction in total mortality, 40% reduction in recurrent heart attacks, and about a 50% reduction in overall mortality in patients with diabetes who had previously suffered from a heart attack. TACT was a large, randomized, placebo-controlled study published in JAMA that randomized patients to a series of IV chelation using EDTA or placebo.
What kinds of doctors offer IV chelation therapy?
Doctors must be well-trained in chelation therapy in order to utilize the correct tests and treatments. Testing for toxic metal exposure is not straightforward since blood tests typically identify only those with severe and acute toxicity but fail to identify those with toxic metals stored in the tissues due to chronic exposure. Applying the appropriate chelating agent to properly treat toxic metal accumulation is also not a straightforward endeavor. Different chelating agents bind with different affinity to different metals. Some chelating agents may be taken orally, while others are administered intravenously.
Chelation therapy is not taught in conventional medical school but rather through various professional medical organizations. The most recognized leader in educating and certifying healthcare professionals, including MDs and NDs, in chelation therapy is the American College for the Advancement of Medicine (ACAM). ACAM’s chelation therapy training teaches doctors how to diagnose and treat patients with heavy metal toxicity as well as how to use diet and nutrients to optimize toxic metal chelation strategies and protocols.
 ACAM website. Detoxification / IV Chelation. Downloaded Jan 7, 2014.
§216.24 Drug products withdrawn or removed from the market for reasons of safety or effectiveness.
The following drug products were withdrawn or removed from the market because such drug products or components of such drug products were found to be unsafe or not effective. The following drug products may not be compounded under the exemptions provided by section 503A(a) of the Federal Food, Drug, and Cosmetic Act:
Adenosine phosphate: All drug products containing adenosine phosphate.
Adrenal cortex: All drug products containing adrenal cortex.
Azaribine: All drug products containing azaribine.
Benoxaprofen: All drug products containing benoxaprofen.
Bithionol: All drug products containing bithionol.
Bromfenac sodium: All drug products containing bromfenac sodium.
Butamben: All parenteral drug products containing butamben.
Camphorated oil: All drug products containing camphorated oil.
Carbetapentane citrate: All oral gel drug products containing carbetapentane citrate.
Casein, iodinated: All drug products containing iodinated casein.
Chlorhexidine gluconate: All tinctures of chlorhexidine gluconate formulated for use as a patient preoperative skin preparation.
Chlormadinone acetate: All drug products containing chlormadinone acetate.
Chloroform: All drug products containing chloroform.
Cobalt: All drug products containing cobalt salts (except radioactive forms of cobalt and its salts and cobalamin and its derivatives).
Dexfenfluramine hydrochloride: All drug products containing dexfenfluramine hydrochloride.
Diamthazole dihydrochloride: All drug products containing diamthazole dihydrochloride.
Dibromsalan: All drug products containing dibromsalan.
Diethylstilbestrol: All oral and parenteral drug products containing 25 milligrams or more of diethylstilbestrol per unit dose.
Dihydrostreptomycin sulfate: All drug products containing dihydrostreptomycin sulfate.
Dipyrone: All drug products containing dipyrone.
Encainide hydrochloride: All drug products containing encainide hydrochloride.
Fenfluramine hydrochloride: All drug products containing fenfluramine hydrochloride.
Flosequinan: All drug products containing flosequinan.
Gelatin: All intravenous drug products containing gelatin.
Glycerol, iodinated: All drug products containing iodinated glycerol.
Gonadotropin, chorionic: All drug products containing chorionic gonadotropins of animal origin.
Mepazine: All drug products containing mepazine hydrochloride or mepazine acetate.
Metabromsalan: All drug products containing metabromsalan.
Methamphetamine hydrochloride: All parenteral drug products containing methamphetamine hydrochloride.
Methapyrilene: All drug products containing methapyrilene.
Methopholine: All drug products containing methopholine.
Mibefradil dihydrochloride: All drug products containing mibefradil dihydrochloride.
Nitrofurazone: All drug products containing nitrofurazone (except topical drug products formulated for dermatalogic application).
Nomifensine maleate: All drug products containing nomifensine maleate.
Oxyphenisatin: All drug products containing oxyphenisatin.
Oxyphenisatin acetate: All drug products containing oxyphenisatin acetate.
Phenacetin: All drug products containing phenacetin.
Phenformin hydrochloride: All drug products containing phenformin hydrochloride.
Pipamazine: All drug products containing pipamazine.
Potassium arsenite: All drug products containing potassium arsenite.
Potassium chloride: All solid oral dosage form drug products containing potassium chloride that supply 100 milligrams or more of potassium per dosage unit (except for controlled-release dosage forms and those products formulated for preparation of solution prior to ingestion).
Povidone: All intravenous drug products containing povidone.
Reserpine: All oral dosage form drug products containing more than 1 milligram of reserpine.
Sparteine sulfate: All drug products containing sparteine sulfate.
Sulfadimethoxine: All drug products containing sulfadimethoxine.
Sulfathiazole: All drug products containing sulfathiazole (except those formulated for vaginal use).
Suprofen: All drug products containing suprofen (except ophthalmic solutions).
Sweet spirits of nitre: All drug products containing sweet spirits of nitre.
Temafloxacin hydrochloride: All drug products containing temafloxacin.
Terfenadine: All drug products containing terfenadine.
3,3′,4′,5-tetrachlorosalicylanilide: All drug products containing 3,3′,4′,5-tetrachlorosalicylanilide.
Tetracycline: All liquid oral drug products formulated for pediatric use containing tetracycline in a concentration greater than 25 milligrams/milliliter.
Ticrynafen: All drug products containing ticrynafen.
Tribromsalan: All drug products containing tribromsalan.
Trichloroethane: All aerosol drug products intended for inhalation containing trichloroethane.
Urethane: All drug products containing urethane.
Vinyl chloride: All aerosol drug products containing vinyl chloride.
Zirconium: All aerosol drug products containing zirconium.
Zomepirac sodium: All drug products containing zomepirac sodium.
Posted By Administration,
Thursday, October 6, 2016
Updated: Friday, October 7, 2016
Today, the U.S. Food and Drug Administration issued a final rule amending FDA’s list of drug products that may not be compounded under certain sections of the Food, Drug, and Cosmetic Act (FD&C Act) that allow the marketing of unapproved compounded drugs.
Posted By ANH: Alliance for Natural Health USA,
Friday, June 3, 2016
Chelation therapy has been receiving a lot of attention lately for the accumulating evidence of its effectiveness in treating patients—but also from regulators whose recent actions threaten to eliminate access to important chelation drugs.
Is chelation safe?
Despite concerns voiced by regulators, recent evidence has shown that intravenous therapy with edetate disodium (EDTA) to treat cardiovascular disease is safe. In a study of the NIH-sponsored Trial to Assess Chelation Therapy (TACT), Dr. Jeanne Drisko and co-authors concluded, “The experience with 55,222 infusions of edetate disodium or placebo in TACT shows that this therapy is safe when used according to the TACT safe infusion protocol.”
What are the threats to future access?
Recent events show a number of reasons to be concerned about continuing access to chelation therapy in your practice.
FDA compounding rules.
In 2013, Congress passed the Drug Quality and Security Act which tightened federal control over compounding pharmacies. This law set guidelines for what can be compounded at “traditional” pharmacies (503A facilities) and outsourcing pharmacies (503B facilities). Among other things, these rules limit the substances that can be compounded by traditional pharmacies to those that either 1) have US Pharmacopoeia monographs, 2) are components of approved drugs, or 3) appear on a pre-approved list by the FDA. 503B facilities will only be able to compound drugs that appear on a separate pre-approved list, which has not yet been finalized.
Recent meetings strongly suggest that many natural substances and substances used by integrative doctors are being rejected for inclusion on the FDA’s pre-approved list for 503A pharmacies, meaning they will be illegal to compound. An FDA advisory committee has already rejected curcumin, aloe vera, boswellia, and acetyl-L-carnitine, to name just a few.
This means it is extremely unlikely that doctors and patients will continue to have access to:
·Compounded chelation drugs such as dimercaptosuccinic acid (DMSA)
·DMPS (sodium 2,3-dimercaptopropane-1-sulfonate)
·Compounded IV nutrients
·Compounded supplements (even though many supplements have monographs, the FDA has said supplements must be pre-approved to be legally compounded)
Recent regulations have also made it illegal for doctors to keep compounded medications from 503A facilities in their offices without a prescription, a practice known as “office use.” This has increased the cost of these medications, not to mention the added hassle for patients. Medications without prescriptions from 503B facilities can continue, but the list of medications that can be legally compounded by 503B facilities will be limited.
EDTA on the chopping block?
In response to patient deaths allegedly linked to chelation therapy, the FDA is reviewing the “benefit/risk profile of [EDTA] to determine if the benefits of its intended use continue to outweigh the serious risks.” Given the agency’s antipathy towards integrative medicine, it is likely to take action against EDTA.
State Medical Board Hostility.
State medical boards have been historically aggressive against doctors using chelation therapy—totaling 194 actions over 40 years. Mostly these actions have been against doctors using chelation without proving heavy metal toxicity with a blood—even though blood tests are not a reliable measure for heavy metal toxicity, since metals circulate in blood for a short time before concentrating in tissue.
Medical boards in Tennessee, New Hampshire, and Oregon have taken official positions on chelation that threaten action against doctors using chelation beyond FDA-approved uses.
What can you do?
·Follow the developments regarding chelation therapy at ANH-USA.org.
·Participate in ANH-USA action alerts that urge lawmakers and regulators to preserve access to chelation therapy.
 Poster: Post-myocardial Infarction Treatment with Edetate Disodium Was Safe in the Trial to Assess Chelation Therapy (TACT)- Jeanne A. Drisko MD, Karen P. Alexander MD, Rhonda S. Roberts MSPH, L. Terry Chappell, MD, Kerry L. Lee PhD, Robin Boineau MD, Daniel B. Mark MD, Richard L. Nahin PhD, Christine Goertz DC PhD, Yves Rosenberg MD, Gervasio A. Lamas MD. TACT chelation infusion: disodium EDTA, 3 grams, adjusted downward baed on eGFRl ascorbic acid, 7 grams; magnesium chloride, 2 grams; potassium chloride, 2 mEq; sodium bicarbonate, 840 mg; pantothenic acid, thiamine, pyridoxine; procaine, 100 mg; unfractionated heparin, 2500 U; sterile water to 500 mL
Dr. Murray Susser is an expert in chelation therapy. He discusses the benefits as well as some of the preferred methods of removing heavy metals from the body. He also mentions some things you need to be aware of before starting a therapy.
Posted By Administration,
Thursday, April 4, 2013
Updated: Wednesday, January 29, 2014
It is with great enthusiasm that ACAM announces that we have the
distinct pleasure to host Gervasio Lamas, MD to our upcoming Spring 2013
conference and tradeshow. Dr. Lamas will be speaking on Saturday, June
1, 2013 as a special lunchtime presentation during ACAM's General
A. (Tony) Lamas, M.D., is chief of Columbia University Division of Cardiology
at Mount Sinai Medical Center in Miami Beach, Fla. and author of the TACT trial
report. Dr. Lamas is the Chairman of Medicine at
Mount Sinai Medical Center and Chief of the Columbia University Division of
Cardiology at Mount Sinai Medical Center. He received his B.A. in Biochemical
Sciences cum laude from Harvard College and his M.D. with honors (AOA) from New
York University. He completed his Internship and Residency at the Brigham and
Women's Hospital of Harvard Medical School, where he later served as Assistant
Professor of Medicine. During the last decade, he
has enrolled thousands of patients in more than a dozen U.S. and international
trials in order to improve cardiac care and prevent death and disability from
heart disease. He served as Chairman of the Mode Selection Trial in Sinus Node
Dysfunction (MOST), a trial that led to profound changes in cardiac pacemakers.
He served as Co-Chairman for the Occluded Artery Trial (OAT), and Study Chair
for the Trial to Assess Chelation Therapy (TACT), a $30 million trial sponsored
by the National Institutes of Health. He has authored over 300 scientific
publications, and maintains an active clinical practice in Miami Beach and Key
About the Conference
ACAM's Spring 2013 Conference and Tradeshow will be hosted at the
Westin Diplomat Resort in sunny Hollywood, FL Wednesday, May 29th -
Sunday, June 2nd.
ACAM will offer pre-conference workshop
learning opportunities in the areas of Lyme Disease & Biotoxin
Illnesses, Basic Chelation Therapy (Heavy Metal Toxicology), Integrative
Psychiatry, and Hyperbaric Oxygen Treatment presented by International
Hyperbarics Association (IHA) on Wednesday, May 29th and Thursday, May
ACAM will also be hosting its Certified Chelation Therapy Examination, is partnering with the Certification Board For Nutrition Specialists to host their examination, and will offer a multitude of bonus learning and networking opportunities.
Posted By Administration,
Monday, September 10, 2012
Updated: Wednesday, January 29, 2014
ACAM's certification exam, developed in conjunction with
Applied Measurement Professionals, is the only certification exam for
chelation therapy. The examination was developed using state-of-the-art
psychometrics, robust questions development and the academic rigor
necessary for a certification program. The CCT Designation Exam allows
physicians to use CCT as a credential and showcases his/her commitment
to applying the highest standard of care when administering Chelation
CCT Designation elevates the practitioner to a higher standard of
reputation and professional development. Our rigorous and sound program
ensures that only those truly qualified to administer chelation therapy
safely and effectively are awarded designation. Patients will look for
CCT designation when selecting a healthcare provider.
ACAM is offering the course: A Clinician's Guide to Chelation Therapy: Integrating Chelation Therapy Into Your Practice,
as well as the CCT exam at our upcoming Fall 2012 Conference and
Tradeshow, Nov. 14 - 15, 2012. If you cannot take the exam at our event
in November, the exam is also offered at over 220 testing centers around
the United States.
Please visit our website (www.acam.org)
for more information regarding this program.
Please note that additional documents are required to sit for the
examination and ACAM must receive all candidate materials by October 1,
2012 if you would like to take the examination on-site in Las Vegas. For
more information on our Las Vegas conference please visit www.acamvegas.com.
Please contact the ACAM Executive Office for more information at 1-800-532-3688 or 949-309-3520 for international callers.
Posted By Administration,
Thursday, November 19, 2009
Updated: Friday, April 18, 2014
by Ronald Hoffman, MD
The most common and toxic heavy metals that can poison our systems and lead to fatigue and illness are iron, lead, cadmium, and mercury. Iron is by far the most common of the heavy metals that predisposes individuals to heart disease. It promotes free radical activity and thereby leads to accelerated arterial damage. Lead and cadmium are common industrial pollutants that also foster free radical activity and poison critical enzymes which repair tissue. Mercury is found in some kinds of seafood and in dental fillings. Its toxicity can depress the immune system and cause an array of symptoms. Even too much iron, such as occurs in the hereditary disease hemochromatosis, can hasten degenerative disease and damage the heart, hastening free radical damage.
One of the most reliable approaches to determining heavy metal toxicity is to test a person with a chelator--a substance that tends to pull metals and minerals out of the body. You simply give the person two urine tests--one before chelation and one after chelation. If, between the two tests, metals in the urine increase dramatically, toxicity is almost certain. Chelation tests can detect lead toxicity in people who have stored high levels of lead in their bone, even though blood levels may be "safe."
Getting the iron, lead, cadmium, and mercury out can be accomplished with chelation therapy, which both prevents and can reverse heart disease, atherosclerosis, and the other problems mentioned above.
How does chelation therapy work? For most of these metals, an intravenous solution of vitamins, minerals, and the chelator EDTA is prepared. EDTA is a substance known for its ability to pull heavy metals out of the body. This is infused into the bloodstream through a vein. EDTA leaves the body in the same form by which it entered, but on its way out, it chelates metals and minerals from the body. Patients usually undergo between 10 and 20 chelation treatments over a period of weeks or months. Each treatment lasts several hours, during which patients can read or watch a movie.
I've seen patients with mysterious, low-level, chronic fatigue feel absolutely rejuvenated after a series of chelation treatments. The spring is back in their walk, the energy back in their lives. Circulation is improved, and the body no longer has to work overtime to carry its load of toxic metals.
Chelation therapy must be performed by an experienced practitioner. Because EDTA is excreted by the kidneys, the possibility of kidney damage is a concern and must be closely monitored. Minerals and nutrients may also bind with EDTA, so their levels must be carefully checked and controlled through supplementation. Chelation must be done slowly over a period of three to four hours. Too much fluid at too rapid a rate might cause an increase in blood volume and a fluid overload, which could be problematic, particularly in patients with serious heart disease. Oddly enough, the magnesium in the chelation bottle might cause the opposite--a drop in blood pressure. That's why all patients must be closely supervised.
To safeguard against possible problems, blood and urine tests are taken before chelation to check kidney function. Cardiac function is evaluated, through a stress test and a noninvasive heart test called an echocardiogram. After every few chelations, blood work is repeated. The patient is advised to eat a good meal before the treatment, and blood pressure is monitored before and after each infusion. To flush the kidneys, at least 16 ounces of water must be drunk during the treatment.
If high levels of mercury have been detected in the body's cells, two other chelating agents called DMSA (also known as succimer) and DMPS can help pull the mercury out. If mercury levels are high, either DMSA or DMPS can be used as chelators. Another chelator, which sometimes causes allergic side effects, is known as D-penicillamine (or Depen.) In addition, the following nutrients are known to chelate mercury in the body: the amino acid L-cysteine, the antioxidant glutathione, the mineral selenium, and vitamin C. Garlic is rich in the sulfhydryl groups that help chelate mercury. Selenium, in particular, competes with mercury for binding sites in the cell. The other nutrients grab on to mercury and help the cells release it.
Beyond its effects on heavy metals, chelation with EDTA also helps to remove inappropriate accumulations of calcium from tissue. Calcium gravitates to atherosclerotic plaque in blood vessels, leading to arterial narrowing and blockage. Chelation gently and gradually mobilizes calcium from plaque, restoring elasticity and flow to blood vessels.
While controversial (chelation for cardiovascular disease reversal has few adherents among orthodox cardiologists), several thousand physicians practice chelation throughout North America and the world.
The American College for Advancement in Medicine (ACAM) is a not-for-profit organization dedicated to educating physicians and other health care professionals on the safe and effective application of integrative medicine.