Is the TACT Trial ‘Lost in Space’? The first NIH-sponsored research trial on intravenous EDTA chelation therapy for the treatment of cardiovascular disease – the Trial to Assess Chelation Therapy (TACT trial) – is under attack by the notorious, so-called ‘quackbusters’ and their unofficial, but official sounding National Council Against Health Fraud (NCAHF). And the attack is being used to threaten our access to EDTA chelation therapy once again. It’s not about science. It’s about politics and medical economics.

‘Quackbusters’ Use Medscape to Publish their Biased, Inaccurate Article Against EDTA Chelation and the TACT Trial. This most recent attack by the so-called quackbusters comes in the form of an article they published on Medscape, an online resource for physicians that is supposed to be unbiased and objective. Title of article: Why the NIH Trial to Assess Chelation Therapy (TACT) Should Be Abandoned.  Link to the original and summary articles. The authors concluded, using their supposed ‘expertise’ that the TACT trial is unethical, dangerous, pointless, and wasteful and that it should be abandoned. This conclusion is unwarranted, unsubstantiated and offensive to many physicians – and undoubtedly to many scientists at the NIH – who have invested significant time and money to make this important research possible.

Is the Medscape Article Evidence that the TACT Trial is Very Important? Some integrative medicine doctors think it is evidence that the pharmaceutical industry and the medical-industrial complex see chelation as a major threat economically. If the safe, inexpensive intravenous EDTA chelation therapy really is effective for treating cardiovascular disease then it is a huge threat to conventional medicine.

Dubious Authors and Referenced ‘Authorities’ of the Medscape Article: The article’s conclusions, and the opinion that the TACT trial should be abandoned, are from what appear to be grossly biased NCAHF doctors who hold themselves out to be ‘experts.’ Some of them have been discredited in court, even branded as being unfit as medical experts. A few of the NCAHF cronies include Wallace Sampson, Robert Baratz, Kimball Atwood (authors); and Stephen Barrett, Victor Herbert (referenced in the article); other ‘quackbusters’ of the NCAHF: William Jarvis, John Renner.

What Do the Federal Reserve and the National Council Against Health Fraud Have in Common? Both are private organizations, but use ‘National’ and ‘Federal’ in their names so they sound like official government entities. The NCAHF is anything but a legitimate council, with governmental oversight. Yet because of misleading names, people are fooled into believing they are official, sanctioned.

Are the NCAHF ‘Experts’ the Real Frauds? Court Discredits NCAHF and Medscape Authors:
1. See the article on attorney Carlos Negrete’s website: ‘Barrett Put in His Place Again.’ In Dr. Barrett’s own hometown the court commented on his de-licensed status. The NCAHF ‘quackbusters’ tried to convince the court that “…existing law should be changed” to allow them to bring lawsuits against doctors and companies, even if they have “little or no evidence against the targeted entity.” Essentially the NCAHF  told the court that the companies they target should be forced to defend themselves on the basis of accusation alone. The court concluded that it “was not persuaded that such a change in law was appropriate or logical.”

2. In a California Superior Court case, Medscape article author Dr. Wallace Sampson and Dr. Stephen Barrett were the so-called ‘experts’ representing the NCAHF in a case in which the NCAHF was accusing a homeopathic company of wrong doing. Judge Haley Fromholz concluded:

A. Dr. Sampson has “thin credentials to opine on the proper standards for…clinical or scientific research…for obtaining valid evidence about…the efficacy of drugs.”
B. Both Dr. Sampson and Dr. Barrett are “biased.” And the weight of their testimony was “slight in any event.” The two doctors “can be described as zealous advocates of the [NCAHF's] position.” They “therefore [cannot be considered] neutral or dispassionate experts.”
C. “In light of their affiliations and their orientation, it can fairly be said [of] Dr. Barrett and Dr. Sampson [that] their testimony should be accorded little, if any, credibility….”

Yet these are some of the so-called experts on Medscape that the medical world is relying on to opine that an NIH drug trial on EDTA chelation is ‘unethical and pointless’ and that it should be abandoned.

ACAM Response: The American College for Advancement in Medicine (ACAM), has publicly reaffirmed its commitment to the TACT trial. ACAM President, Dr. Jeanne Drisko said, “Ultimately, the TACT trial results will assess chelation therapy’s place in health care.” The TACT trial’’s principal investigator, Dr. Tony Lamas, is a Cardiologist who teaches at the University of Miami School of Medicine. He said he believes the allegations made by the ‘quackbusters’ are “without merit” and that “we’ll sufficiently answer their unfounded allegations of impropriety,” and that federal officials “will find that the allegations are of a political nature.”

EDTA Chelation Therapy Would Rock the Medical World. If EDTA chelation therapy is effective, which it appears to be empirically and in many published clinical reports, then something this safe and inexpensive – implemented on a large scale to treat heart and peripheral vascular disease – would rock the medical world as we know it.

To learn more and get involved in protecting your health freedoms:
Visit www.acam.org and find an ACAM doctor in your area. Also visit the Health Freedom Foundation and the foundation Dr. Julian Whitaker started: the Whitaker Health Freedom Foundation.

Good Medicine Word Of The Week: The ‘not-so-good’ NCAHF – stands for the non-official ‘National Council Against Health Fraud’ – a private organization we on TGM think is fraudulent and comprised largely of physician zealots who are on a quixotic global crusade to stamp out what they judge to be medical quackery.

Next Week: Rapid-fire review of recent published research on various other promising integrative medicine approaches that may help you have a Heart of Health.

Heart of Health – installment #3

Is it time to quit viewing EDTA chelation therapy for heart disease as medical heresy, and start using on a more wide spread basis in this new age of medicine?

This is Part 2 of Effective Alternatives for Treating Cardiovascular Disease – EDTA Chelation as Front-Runner.

Trial to Assess Chelation Therapy, TACT trial: We discuss this placebo-controlled trial sponsored by the National Institute of Health. This research is worthwhile, but in our opinion we already have enough empirical and research-based evidence to be offering intravenous EDTA chelation therapy to cardiovascular disease patients now. Regardless, and unfortunately, it appears that the so-called ‘quack busters’ – the phony ‘experts’ from the ‘National Council Against Health Fraud’ – are trying to sabotage the TACT trial in attempt to expunge this safe, simple, effective and inexpensive alternative treatment for cardiovascular diseases. Next week we shine the TGM spotlight on the ‘quack busters.’

EDTA Monograph by Cardiologist Dr. Stephen Olmstead: “The preponderance of clinical reports in the medical literature support a claim of efficacy for symptomatic angina, intermittent claudication and critical leg ischemia.” Note: we are currently trying to get in touch with Dr. Olmstead to find a digital version of the Monograph and link to it from the TGM website.

EDTA Chelation Therapy as ‘Holistic’ Therapy: EDTA is not a ‘natural’ product. It is an artificial, synthetic drug. However, one could argue that it is a ‘holistic’ therapy since it is infused systemically, and reaches and potentially detoxifies heavy metals from most of our tissues and organs.

EDTA Package Insert Altered by Abbott Labs to Remove Cardiovascular Disease as an Indication for the Drug: Even by the 1960s existing evidence for EDTAs efficacy to treat cardiovascular disease was enough for Abbott Labs to include it as one of the ‘indications’ for the drug. Later the language was arbitrarily changed, stating that EDTA is ‘not’ indicated for this purpose. To the best of our knowledge, this mysterious manipulation of medical product information is unprecedented in medical history.

Off-Label Drug Legislation the Result of One Doctor’s Fight Against the FDA to Be Able to Offer EDTA Chelation to His Patients. In 1981, during a ‘David and Goliath’ type battle, Dr. Ray Evers from Alabama fought the US Food and Drug Administration for his right to use EDTA to treat his patients with cardiovascular disease. With EDTA in his ’sling’ he toppled the FDA. The federal court ruling in favor of Dr. Evers stated that the FDA’s arguments against Dr. Evers were “nonsensical.” This was a huge victory for patients and the advancement of good medicine not only because it lessened the FDA’s tyranny against our medical freedoms, but also because it resulted in today’s doctors’ ability to prescribe drugs ‘off-label.’ This means we  can now legally use any medication for any purpose, even though that purpose – that ‘indication’ – is not necessarily approved by the FDA. All this because of Dr. Ever’s fight for EDTA! Kevin asks the logical question: Why was the FDA trying to regulate an Alabama doctor’s medical practice? And Dr. Douglass asks: What political influences – what constituencies/vested interests – may have teamed up with the FDA to start that battle against EDTA and Dr. Evers in the first place? We’ll may never know.

Dr. Rogers vs. the Florida State Board of Medical Examiners: Dr. Robert Rogers, MD fought the Florida Medical Board all the way to the Florida Supreme Court over his right to provide EDTA to his patients with cardiovascular disease, and won. The Florida Supreme Court ruled that the action of the Florida medical board restraining Dr. Rogers from utilization of chelation therapy for his patients was “an arbitrary and unreasonable exercise of the state’s police power.”

Note: To download full report as a pdf file click on the document.

Negative Published Studies On EDTA Chelation Therapy For Treating Cardiovascular Disease: There have been six negative studies. We discuss them, and how they all either have major irregularities from a scientific standpoint, or have negative conclusions even though the results reported in the studies were positive. For an excellent online resource with commentary and analysis of each one of the studies, go to http://www.drcranton.com/chelation.htm And as we’ve mentioned on previous shows, a good resource for finding physicians who are likely to be offering intravenous EDTA is the organization American College for Advancement in Medicine at acam.org.

Good Medicine Word Of The Week: Off-label use – in commemoration of Dr. Ray Evers and his ‘David and Goliath’ fight against the FDA. Now American physicians can use EDTA, and any other drugs, for purposes other than what the FDA approves them for.

Next week: If intravenous EDTA chelation really is a safe, effective and inexpensive alternative to bypass surgery and angioplasty, do you think there might be attempts by conventional medicine to squelch it? We’ll shine the TGM spotlight on the phoney ‘quack busters‘ and the so-called National Councel Against Health Fraud (or is it the ‘National Councel of Health Frauds’?) in their obvious efforts to supress the TACT trial and our access to EDTA chelation therapy for treating heart disease.

Heart of Health – do you have one?

Part I of Effective Alternatives for Treating Cardiovascular Disease – EDTA Chelation as Front-Runner

Dr. Douglass Interview with Dr. Ronald Hoffman on Health Talk, WOR Radio 710, New York City, N.Y., discussing the relative worthlessness of bypass surgery and angioplasty for stable heart disease. Click here to listen.

EDTA chelation therapy could result in profound health care cost savings, which are sorely needed with the current financial crisis the world is in. And with the prospects of massive tax increases and socialized medicine under an Obama administration probably doesn’t make the outlook much better. An example of research showing the potential cost savings from EDTA chelation comes from a study done by Danish physician Dr. Clause Hancke: 90% of his patients who were on the waiting list for getting coronary artery bypass surgery or leg amputation due to poor circulation to their legs, were able to cancel their surgeries after a course of intravenous EDTA chelation treatments. Imagine the potential for financial savings and real health improvements.

Basics of EDTA Chelation: EDTA – Ethylene-diamine-tetra-acetate – is one of many ‘chelating agents’. The ‘chel’ (pronounced keel) in chelation (”kee-LAY-shun”) comes from the Greek for ‘claw.’ Chelating agents, chelation drugs ‘claw’ strongly onto metals and minerals in our blood, cells, tissues and organs and are then ‘flushed’ out of the body, primarily through the kidneys. The attraction between EDTA, and say lead (or other positively charged atoms) is through electromagnetic forces, not ‘covalent’ chemical bonding. EDTA’s has varying attractions for different metals. For example, if an EDTA-calcium complex comes into the presence of lead, the EDTA will have a higher electromagnetic attraction for lead and thereby preferentially bind to the lead, and release the calcium in to the body, allowing for the efficient removal of lead through the kidneys (and a small amount of elimination through the bowels). It is a true ‘detoxification’ therapy.

EDTA chelation therapy is not ‘natural.’ It is a synthetic amino acid approved by the FDA for treating lead toxicity, not cardiovascular disease. Use of EDTA for treating cardiovascular disease is considered ‘off-label’ use of the drug. The controversy of EDTA chelation is primarily around the financial implications it has, as a replacement for bypass surgery and angioplasty. Listeners will recall from last week that entire ‘industries’ have been built around bypass surgery and angioplasty, and that these two procedures do not extend life or even decrease the rate of subsequent heart attacks in people with stable heart disease.

History of EDTA Chelation for Treating Cardiovascular Disease: The benefits were discovered serendipitously in the 1950s. Cardiologist Dr. Norman C. Clarke reported that while treating a patient for lead toxicity who happened to have angina symptoms at the time, that the patient told Dr. Clarke that his chest pains lessened. Dr. Clarke reported his earliest findings – his empirical, experience-based discoveries – in the American Journal of Medical Sciences and the American Journal of Cardiology. Since then, numerous studies and clinical reports have been published supporting EDTA’s efficacy for the treatment of cardiovascular disease. An excellent resource for finding published studies on EDTA chelation for cardiovascular disease: Saunder’s textbook, Cardiovascular Drug Therapy chapter titled “Magnesium EDTA Chelation.” Other resources: www.drcranton.com/chelation.htm and www.acam.org.

Scientific studies on EDTA Chelation for Cardiovascular Disease. We discuss a few of the published studies. It appears, in general, from the research and from clinical experience (when treating patients who are not diabetic and who do not smoke cigarettes), that 75%-90% of patients experience significant improvement in their symptoms, such as chest pain and exercise-induced leg pain, after a course of intravenous EDTA chelation treatments. Some research supports EDTA chelation as being of benefit to cerebrovascular disease too (improving arterial circulation to the brain). The ultimate question becomes, when is the evidence enough?

Good medicine word of the week: EDTA chelation – the intravenous administration of an FDA-approved drug, used ‘off-label,’ for the treatment of cardiovascular diseases, including poor circulation to the heart, legs and brain; to the entire body, in fact.

Next Week: Part II Effective Alternatives for Treating Cardiovascular Disease – EDTA chelation as Front-Runner! Maverick doctors challenged legally by state and federal governments win their cases thereby foiling attempts to take away our freedoms to use EDTA chelation for treating cardiovascular disease.

Heart of Health – do you have one?

What is Cardiovascular Disease? ‘Cardio’ for heart. ‘Vascular’ for vessel. Cardiovascular disease generally means the obstruction of arteries – the vessels that deliver oxygen and other nutrients to all of our cells and tissues. This includes obstruction of the arteries to the heart: the coronary arteries; arteries to the brain: the carotid arteries; arteries to the legs: the peripheral arteries. In fact every single artery in the body can become obstructed as a result of atherosclerosis (‘hardening of the arteries’).

Medical Economics of Cardiology and Cardiovascular Surgery Trumps Evidence-Based Medicine: According to current scientific evidence, surgical intervention with bypass surgery or angioplasty does not improve the health outcomes of patients with stable coronary artery disease.

A. Case Against CABG.
The scientific evidence generally does not support the use of ‘bypass surgery’ (coronary artery bypass grafting, CABG) for the treatment of patients with stable angina: a pattern of recurring chest discomfort, that is not worsening in frequency, duration, quality, location, severity, etc. This is in contrast to unstable angina.

Studies:
1. Eleven Year Survival in the Veterans Administration Randomized Trial of Coronary Bypass Surgery for Stable Angina, The Veterans Administration Coronary Artery Bypass Surgery Cooperative Study Group: Eleven (11) year study done at 13 different veterans hospitals showed that patients who undergo bypass surgery have the same survival rates as patients who have only medical management, without surgery. New England Journal of Medicine 1977; 311:1333-1339.

2. European Coronary Artery Surgery Study Group, Long-Term Results  of a Prospective Randomized Study of Coronary Artery Bypass Surgery in  Stable Angina Pectoris: This study found a slight, statistically insignificant increase in survival rate in bypass surgery patients. Lancet 1982; Nov.27, pp 1173-1180.

3. Ten-Year Follow-up of Survival and Myocardial Infarction in the Randomized Coronary Artery Surgery Study: Results were similar to those of the Veterans study (#1 above). Circulation 1990; 82:1629-1646.

B. Case Against Angioplasty: COURAGE Trial.
This study of 2,300 patients with stable coronary disease (stable angina) shows that angioplasty and stents do not prolong life, or even prevent heart attacks in most of these cases. This was discovered by comparing the outcomes of patients with stable angina who had angioplasty, with the outcomes of the patients who had only medical therapy (no surgical intervention). New England Journal of Medicine 2007, March 26.

Conclusion: despite the widespread belief that angioplasty and stenting cuts down on heart attacks and death, it’s never been shown to do that in patients with stable coronary disease.

Important note of caution: For patients having heart attacks – myocardial infarction – or unstable angina, the angioplasty procedure or bypass surgery may be life saving in those cases. It is thought that about 50% of all deaths from heart attacks occur within 1 hour of the start of symptoms, often before the patient gets to the hospital. If you experience chest pain that is new, worsening or not lessening in severity, call 911 immediately.

To Intervene or Not to Intervene: How do the world’s doctors treat stable angina (stable coronary artery disease)? In this 2007 New England Journal of Medicine survey of over 7600 doctors, essentially 60% (57%) of them recommended surgical intervention: angioplasty or bypass surgery. The other 40% (43%) recommended the more conservative approach: medical management alone, thus ‘bypassing bypass’ and ‘avoiding angioplasty.’ Australia and Oceania win as the most conservative areas globally, with essentially 55% of the surveyed doctors recommending the ‘medicine-only’ approach, compared to the rest of world at around 45% with the same recommendation. Click here to view the excellent Clinical Decisions Interactive by Drs. Susan Cheng and John Jarcho.

Belief System and Mantra Sometimes Necessary in Conventional, Allopathic Medicine: “The benefits outweigh the risks and costs; The benefits outweigh the risks and costs!” – even if the evidence may not support that belief.

Consequences of Ignoring or Regarding Evidence-based Medicine, Evidence-based Cardiology:

A. Ignoring: “…an ‘industry’ is being built around this operation – coronary bypass surgery: the creation of facilities for open heart operations in community hospitals…and proliferation of catheterization and angiography suites…the expansion and development of training opportunities in clinical cardiology, cardiovascular surgery and cardiovascular radiology. This rapidly growing enterprise is developing a momentum and constituency of its own, and as time passes, it will be progressively more difficult and costly to curtail it materially…. The financial implications of CABG are profound…. The enormous funds already being devoted to this procedure divert support available for other, perhaps more necessary, aspects of medical care.” Eugene Braunwald, M.D., Professor Emeritus of Medicine and Cardiology at Harvard Medical School. New England Journal of Medicine 1977; 297(12):661-663.

B. Regarding: The COURAGE trial and the studies on bypass surgery cited above should lead us to improve the way we treat all patients with stable coronary artery disease. Now that would be good medicine. But will we regard and act upon the scientific evidence, or continue to largely ignore it?

Next Week: Intravenous EDTA chelation therapy for the treatment of cardiovascular disease. The conclusion in the New England Journal of Medicine survey above said many of the doctors surveyed from around the world expressed how important it is for doctors to discuss with their patients all treatment options and their possible outcomes. But are all the treatment options being discussed? If not, why not? Let’s look at and regard the scientific evidence for one option some doctors think is part of a good ‘Integrative Medicine’ approach to treating cardiovascular disease: EDTA chelation therapy.

Good Medicine Word Of The Week: Angioplasty – the process of mechanically opening a partially or completely obstructed artery by inflating a balloon to squash the obstructing material (the ‘atherosclerotic plaque’).