Health Research Foundation, Inc

A non-profit public foundation dedicated to research, education and service
Tryon, N.C.

Testimony of Theodore Rozema, M.D. 

Committee on Government Reform
United States House of Representatives

Hearing:
Cardiovascular Disease: Is the Federal Government
Doing More Harm Than Good?

EDTA Chelation


Mr. Chairman, members of the Committee, I thank you very much for the privilege of presenting information about the facts surrounding the administration of EDTA for vascular and degenerative diseases by qualified medical practitioners. I am the Founder of the International Chelation Research Foundation, a co-sponsor of the FDA approved study on EDTA chelation therapy for peripheral vascular disease at Letterman and Walter Reed Army Hospitals. I am the Founder, President and Director of the Health Research Foundation, with the mission of investigating alternatives in medicine and dissemination of that information to the public. I have co-authored the second edition of The Scientific Basis of EDTA Chelation Therapy with Bruce Halstead, M.D. and am the author of The Protocol for the Safe and Effective Administration of EDTA and Other Chelating Agents for Vascular Disease, Degenerative Disease, and Metal Toxicity, published as a special edition in the Journal of Advancement in Medicine in 1997.

I have been actively involved in the care of my patients using EDTA for the past 16 years and can attest to it's clinical effectiveness, having treated over 2000 patients, having administered over 80,000 infusions.

I was asked to give a brief overview of EDTA and it's historical significance.

EDTA was invented in Germany in the mid '30's as a substitute for citric acid, used to demineralize water prior to dyeing cloth. About the same time, EDTA was also developed in the USA, and a US patent was given to Fredrick Bersworth in the mid 40's for using a different manufacturing process. EDTA is a synthetic amino acid. It is a chemical chelator. This means that it has only one main action, it chelates or binds minerals to itself, in this case holding them tightly, then leaving the body with the mineral, primarily through the urine. Due to the structure of the molecule, it seemed appropriate to consider it a biologically active detoxifier Remember the days when the lead industry knew their product could not produce harm to humans? Long before research proved otherwise, studies demonstrated EDTA's effectiveness in the removal of lead from the body. It is used today around the world to remove lead from children burdened with this metal. Currently, even low level lead toxicity is suspected to be an unrecognized cause of many ailments including kidney failure.

Subsequently, researchers postulated that this compound might remove calcium from soft tissue, including arterial walls. It was originally tried for vascular disease by researchers in Detroit in the early '50's. Clinical benefits led many centers to investigate this "new" compound, and results were encouraging. Symptoms of angina and intermittent claudication were relieved, calcium in aortic valves was reduced. Encouraged by these findings, investigators tried it for other conditions such as radioactive element poisoning, cataracts, calcified muscles, scleroderma, sarcoidosis and porphyria, with positive results. Even insulin requirements in diabetics were reduced.

We all know that lifestyle changes are necessary to improve health. You all are aware that bypass surgery may only last for 5 to 7 years before another procedure is needed, and angioplasty may restenose within 4 to 6 months. The literature on EDTA chelation therapy indicates that over 85% of people may avoid bypass and over 88% of people may avoid amputation of limbs due to vascular disease. With an approximate savings of $30,000 per patient (angioplasty or bypass) chelation therapy with EDTA (for the over 500,000 patients undergoing bypass and 600,000 patients undergoing angioplasties), would save the establishment Billions of dollars on a yearly basis. The chelation treatments usually will cost less than $6,000 each, only about 15% of the costs for the invasive alternatives and leave the patient in a far better permanent physical condition.

Dr. Stephen F. Olmstead M.D., a noted research cardiologist, recently published A Critical Review of EDTA Chelation Therapy on the Treatment of Occlusive Atherosclerotic Vascular Disease. He concluded in the epilogue, Page 96: "The preponderance of clinical reports in the medical literature support a claim of efficacy for symptomatic angina pectoris, intermittent claudication, and critical leg ischemia".

The subject of this hearing is, Cardiovascular Disease: is the Federal Government doing more harm than good?? Let me relay to you a personal story that will lead to my conclusions on this question.

In 1983, study of the subject and actual use of EDTA on select patients in my office led to a realization that this therapy was doing something more for my patients than any other therapy I had practiced. However, within a year after beginning to use EDTA, the North Carolina Medical Board charged me with prescribing the use of EDTA for patients: "you treated various patients with EDTA for the alleged treatment and alleviation of vascular ailments, including arteriosclerosis and atherosclerosis and for such prescribing and treating you were paid money. The above allegations, if proven, would constitute grounds for the suspension or revocation of the license to practice medicine issued to you by the undersigned Board".

Prior to this action by the North Carolina Board of Medical Examiners, I had created the International Chelation Research Foundation, Inc., (ICRF), expressly for the purpose of obtaining funds for research in this field of medicine. I had asked Keith Sehnert, M.D. to be the president as he had eight years experience as the medical director of Ciba, and was on the teaching staff of the University of North Carolina Medical School. He was denied a license to practice medicine in North Carolina simply because he had practiced chelation therapy in Minnesota. This led to the selection of Martin Rubin, Ph.D., Professor Emeritus, Georgetown University, as the president of the ICRF and to the subsequent study of EDTA in Peripheral Vascular disease at Letterman and Walter Reed Army Hospitals. Because of the FDA approved scientific study of EDTA, the action against me was put on hold until the study was completed.

For a number of reasons, including the unwillingness of Army vascular surgeons to refer eligible patients into the study and the transfer of personnel active in the study to the Persian Gulf during Desert Storm, the trial was discontinued before any useful data were obtained. Nevertheless, the North Carolina Board of Medical Examiners sent me a letter informing me that I was no longer under investigation. By this time, however, I had moved by complete practice to South Carolina. A month later they brought new charges against the physicians in North Carolina that were doing chelation therapy and proceeded again to remove their licenses. This resulted in a great public outcry; the state legislature created new regulations that specifically protected licenses of physicians involved in alternative medicine and chelation therapy.

Over the years thirteen states have tried -- without success -- to eliminate or reduce the practice of chelation therapy. Now we find that the Federal Trade Commission -- a federal agency with no authority to regulate the practice of medicine -- has been working with the Federation of State Medical Boards to assist the states in their failed regulatory efforts. Who stirred up this FTC action? The FTC hosted a meeting in Dallas, ostensibly for law enforcement officials only, where they deputized for a day a group of private citizens known as "the quackbusters" who are openly opposed to chelation therapy as well as other complementary and alternative medical treatments. Although an anti-chelation group was permitted to participate in this closed meeting of government officials, when chelation advocates requested to attend, they were turned away. This reminds me of the antitrust case brought against the American Medical Association for suppressing the practice of chiropractic medicine. Except this time a government agency is facilitating the anticompetitive behavior.

What is the basis for this aggressive anti-chelation action? From whom did the FTC receive complaints? Where are the unhappy consumers? Where are the patients seeking redress against their chelation doctors? Where are the injured? Where are people saying they wish they'd had surgery instead of chelation? Is this a genuine issue or a trumped-up charge by powerful special interests with a self-rewarding hidden agenda?

It has always amazed me that the negative comments and scathing diatribes leveled at practitioners who utilize this therapy traditionally come from the self-appointed "experts" who have never used the therapy, hiding behind the rubric of "unproved" "unscientific" and of no "statistical significance". The repeated claim by opponents that there is no science supporting EDTA chelation is science fiction. Physicians who have well satisfied patients know that this therapy is working, and the patients know their health has been improved. The complaints about this therapy are not coming from the patients but from the establishment nay-sayers with a built-in bias against a therapy that would help millions of patients and save billions of dollars. The skyrocketing medical costs of treating heart disease primarily with surgery and drugs can be cut dramatically by re-evaluating and changing the established methods of the present health care delivery system.

People are not stupid. It costs money out of pocket to take these treatments. It takes fortitude to continue 30 or more treatments and endure the testing and IV needles on a regular basis. I can solidly attest that people will not continue to pay for something that isn't working. A physician doing chelation therapy would not stay in business if he weren't delivering positive results. Patients talk - to friends, relatives, neighbors, and as a result, referrals come from satisfied patients.

We all have a great deal to gain from ending this ongoing controversy: heart disease is the leading cause of death and disability in this country. Heart attacks, stroke and related ailments take a huge toll in human suffering and medical costs, while chelation therapy is not only life-saving but an economic boon as well. So far there has been not one penny for a therapy which has been documented as life-saving for over forty years by hundreds of thousands of patients. The Center for Alternative Medicine should be working diligently with the NIH to free up dollars for the benefit of our citizens.

If the large number of supportive documents that have already been presented to the FTC are not sufficient to convince them that this therapy is everything millions of patients and thousands of physicians have found it to be, then there is a simple solution.

Let's put tax dollars to work where they'll do a great deal of good - in research to establish the effectiveness of EDTA chelation therapy for both peripheral vascular disease and coronary angina. And let's not wait while many patients who could be alive today with this therapy will never have the opportunity to better health with it.

 

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