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PODCAST: Chelation - A Potentially Life-Saving Therapy

Posted By Ronald Hoffman, MD & Dana Cohen, MD, Tuesday, February 21, 2017
PART I:
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

Tags:  chelation  chelation therapy  detoxification  TACT  TACT2 

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IV Chelation Therapy: Finding a Doctor Who Will Test for and Treat Heavy Metal Toxicity

Posted By University Health News, January 17, 2017, Monday, February 20, 2017

VIEW ORIGINAL PUBLICATION by UHN

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.[1]

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.[4]

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.[2] TACT was a large, randomized, placebo-controlled study published in JAMA that randomized patients to a series of IV chelation using EDTA or placebo.[3]

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.

 

[1] ACAM website. Detoxification / IV Chelation. Downloaded Jan 7, 2014.

[2] Medscape Heartwire. 2013, Nov 19. ‘Extraordinary’ Chelation Effects…. Downloaded Jan 7, 2014.

[3] JAMA. 2013;309(12):1241-1250.

[4] Townsend Ltr. 2013 Aug/Sept. Report on the Proceedings of a Summit…. Downloaded Jan 7, 2014.

This article was originally published in 2014 and has been updated.

Tags:  chelation  chelation therapy  detoxification  toxins  university health news 

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What is the FDA's Code of Federal Regulations at Title 21, Section 216.24?

Posted By Administration, Friday, October 7, 2016

§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.

Tags:  chelation  chelation therapy  compounding  FDA 

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FDA: Additions/modifications to the list of drug products that have been withdrawn or removed from the market for reasons of safety or effectiveness

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.

Drug products on the list may not be compounded because the drug products have been withdrawn or removed from the market for safety or effectiveness reasons. The list appears in the Code of Federal Regulations at Title 21, section 216.24.

The final rule:

  • Adds 24 types of drugs to the withdrawn or removed list.
  • Modifies the withdrawn or removed list to allow one type of drug product to be compounded under certain circumstances.
  • Clarifies that the withdrawn or removed list applies to sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.

In addition, FDA published a discussion in the Federal Register that clarifies the procedure FDA intends to use to amend the withdrawn or removed list.

FDA’s website has additional information on compounding.

Tags:  chelation  chelation therapy  Code of Federal Regulations at Title 21  compounding  fda  fda compounding  section 216.24 

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Threats to Compounded Medicine and What You Can Do

Posted By ANH - Alliance for Natural Health USA, Friday, June 3, 2016

In 2013, Congress passed the Drug Quality and Security Act (DQSA), which tightened federal control over compounding pharmacies.
To implement the law, the FDA is setting guidelines for what can be compounded at “traditional” pharmacies (503A facilities) and outsourcing pharmacies (503B facilities).

In general:

·        503B facilities will only be able to compound drugs that appear on a separate pre-approved list, which has not yet been finalized. Current thinking is that this list will be extremely limited in terms of the needs of integrative physicians. 

·        503A pharmacies are also facing harsh restrictions. DQSA 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. The FDA is developing a separate “Demonstrably Difficult to Compound List” that will exclude many other important ingredients from compounding.

What is threatened?
Bioidentical Hormones
—Estriol, progesterone, testosterone, and other hormones have been nominated to the “Demonstrably Difficult to Compound” list, meaning that access to compounded hormones is in grave danger.
Supplements—Although many supplements have USP monographs, the FDA has stated that supplements must be pre-approved to be legally compounded. Many supplements and natural ingredients that have been nominated have been rejected, such as curcumin, aloe vera, boswellia, and acetyl-L-carnitine, to name just a few.
IV Nutrients—It is unclear whether the FDA will allow the compounding of nutrient IV bags—especially due to the threats to compounded supplements.
Office Use— The FDA has 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.
Affordability—Due to the above-mentioned restrictions, and the threat of more to come, it has become extremely difficult for doctors to obtain medications. For example, the price of injectable B-12 has climbed just under 700% from the mid-2000’s.
Interstate Commerce—DQSA limits the amount of interstate shipments that 503A facilities can make to 5% of total sales. This is extremely problematic given that certain pharmacies specialize in specific preparations. A memorandum of understanding released by the FDA increases this amount to 30%, but then states must take over regulatory responsibility over these facilities. Since it is likely that many states will not elect to take on this additional burden, the upshot is 503A facilities will only be able to ship a small portion of their medications out of state, which could create shortages and increase the price of compounded medications further. 

What Can You Do?

·        Follow the developments regarding compounding at ANH-USA.org. 

·        Participate in ANH-USA action alerts that urge lawmakers and regulators to preserve access to compounded medications.

·        Share your story with ANH-USA at http://www.anh-usa.org/contact-anh-usa/

·        Support ANH-USA in its efforts to rein in these excessive, burdensome, and costly regulations at http://www.anh-usa.org/donate/

Tags:  chelation  compounding pharmacy  FDA compounding 

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ACAM Addresses Flint, MI Water Crisis

Posted By Administration, Friday, January 22, 2016
Updated: Monday, February 8, 2016

Flint, Michigan recently declared a "State of Emergency" in the wake of lead contaminated drinking water. As a result, we are once again faced with the age-old discussion regarding the health implications of lead accumulation. We know that protecting all people from lead exposure is extremely important to lifelong good health. Children, however, are particularly vulnerable to the harmful effects of lead because they absorb lead much more readily than adults. The current controversy over treatment revolves around three questions:

  1. Who should be considered at higher risk for harm and offered treatment?
  2. What treatments should be offered to individuals with elevated lead levels?
  3. At what blood lead level burden is it appropriate to start therapy?

Unfortunately, this tragedy goes far beyond Flint, Michigan. People worldwide continue to be exposed to potentially harmful levels of many toxic metals that can profoundly affect their health. They face potentially enduring, serious and complicated health issues.  Perhaps the major question, especially in children, is the level of lead in the blood to cause concern.

The CDC states, “Experts now use a reference level of 5 micrograms per deciliter to identify children with blood lead levels that are much higher than most children’s levels. This new level is based on the U.S. population of children ages 1-5 years who are in the highest 2.5% of children when tested for lead in their blood.  In the past, blood lead level tests below 10 micrograms per deciliter of lead in blood may, or may not, have been reported to parents. The new lower value means that more children will likely be identified as having lead exposure allowing parents, doctors, public health officials, and communities to take action earlier to reduce the child’s future exposure to lead.”

The CDC also states, “What has not changed is the recommendation for when medical treatment is advised for children with high blood lead exposure levels. The new recommendation does not change the guidance that the therapy used to eliminate lead from the body be considered only when a child has been tested with a blood lead test result greater than or equal to 45 mcg/dL.” [http://www.cdc.gov/nceh/lead/ACCLPP/blood_lead_levels.htm]

However, medical science has determined that even very low blood lead levels in children can affect IQ, ability to pay attention and future academic achievement. It is now clear that IQ loss in lead-exposed children can occur at levels below 5.0 mcg/dL. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2212280/, from Neurotoxicology, 2006 Sep; 27(5): 693–701.

The American College for Advancement in Medicine (ACAM), an educational organization and a leading authority in the field of heavy metal toxicity and treatment believes, as the CDC does, that “no safe blood lead level in children has been identified.” The effects of lead exposure on child cognitive development and behavior may be permanent if no intervention occurs. Experts from ACAM believe that certain interventions may be useful in lessening the symptoms and long-term neurocognitive damage that lead causes in children.

ACAM experts also contend that the myriad, harmful effects that lead can cause in other organ systems in people of any age should also be lessened. The original guidelines for intervention in lead poisoning were based on early FDA drug approval studies from the minimal research conducted in pediatric patients with blood lead levels above 45 mcg/dL. ACAM believes that appropriate medical intervention may be beneficial to those suffering from lead levels even at the current CDC cutoff of 5 mcg/dl, the level that places the child in the upper 2.5% of tested individuals.

Due to the lack of current, cohesive, long-term studies in children with elevated blood levels below 45 mcg/dL, the decision when to initiate chelation therapy is a personal choice between a patient and their physician. To better elucidate what is the best treatment strategy for lead poisoning, ACAM is calling for the immediate initiation of a collaborative long-term research project. The project, conducted through appropriate channels, could provide immediate medical attention and intervention to all children and adults in Flint who have high blood lead levels (>5 mcg/dl). This research project should also investigate assessing those common genetic and metabolic defects that could render individuals even more susceptible to the harmful effects of lead.

We can take a more proactive approach to prevent permanent damage and disability not only in the population of Flint, MI but to everyone exposed to the potential devastation caused by lead.

ABOUT ACAM:
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. ACAM's healthcare model focuses on prevention of illness and strives for total wellness. ACAM has been educating physicians in metal removal techniques such as chelation therapies since 1973. A recent NIH sponsored study has demonstrated that the chelation technique using EDTA is safe when it is used by physicians educated in these techniques.


FIND A PHYSICIAN NEAR YOU FOR ASSISTANCE:
ACAM offers Physician+Link – a free service provided to the public for finding integrative practitioners in their area. Call
1.800.532.3688 for personal assistance or visit www.acam.org/ACAMPL

ADDITIONAL RESOURCES:
A rationale for lowering the blood lead action level from 10 to 2 μg/dL

Effect of Chelation Therapy on the Neuropsychological and Behavioral Development of Lead-Exposed Children After School Entry

American Academy of Pediatrics: Lead Exposure in Children: Prevention, Detection, and Management

Safety and Efficacy of DMSA in children with elevated blood level concentrations

Children with moderately elevated blood lead levels: a role for other diagnostic tests?

What level of lead in blood is toxic for a child?

Tags:  chelation  detoxification  Flint Michigan  water 

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The Road to TACT2: Updates from the Second Trial to Assess Chelation Therapy

Posted By Reprinted with permission from CardioSource WorldNews, Thursday, January 22, 2015
Updated: Thursday, March 5, 2015
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Tags:  chelation  Lamas  TACT  TACT2 

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