Why Is EDTA Therapy Not Widely Accepted By James P. Carter, MD DrPH Reprinted from the Journal of Advancement in Medicine, Volume 2, Numbers 1/2, Spring/Summer 1989, pages 213-226.

ABSTRACT: A summary of medical politics, turf struggles between medical specialties, and the medical economics of EDTA chelation therapy is presented to answer the question, "If EDTA chelation therapy is so good, why is it not more widely accepted?"

Most people, including physicians, are not aware of the medical politics, legal machinations and economic sanctions that covertly control the practice of medicine in the United States. A physician who introduces an innovative and nontraditional type of therapy often becomes the target of those forces.

When a radical new therapy like chelation is first introduced, physicians who do not utilize that therapy feel threatened, both professionally and financially. Their professional integrity is threatened by obsolescence of their scientific knowledge and they lose patients who seek out the new therapy. They forget that if their established treatments were really successful, and without major disadvantages, patients would not look to another type of treatment.

As with EDTA chelation therapy, major pressures are brought to bear on the "deviant" physician to coerce him back into the accepted mold. He is ostracized by his peers; he comes under professional attack for "lack of ethics;" his medical and mental competence are questioned; he is accused of "exploiting" his patients for personal gain; and epithets of "quack" and "charlatan" are hurled his way. Ad hominum attacks are common, in the absence of more cogent and scientific criticisms.

The history of medicine is replete with examples of medical "heretics" who were eventually credited with major advances. They were often not recognized for their achievements until after death. Paracelsus, for example, is exalted as one of the great pioneers in medicine, but he was the original "quack" in his own time. Paracelsus introduced the use of mercury to treat syphilis. There was no other cure for syphilis at the time, although, as with many treatments today, the lethal dose of mercury was close to the therapeutic dose. Paracelsus was viciously attacked by his medical peers and derisively called a "quack" (short for "quacksalber," the old German word for mercury).

Inertia in science and medicine is a powerful force and is reinforced by major economic and legal forces in the United States. Many industries and special interest groups that are politically and economically powerful would be hurt financially if chelation therapy were to become more widely accepted. Those same industries have a major influence in our society at all levels. Grants for university and medical school research often stem from those same sources. They spend heavily to lobby for laws, regulations and government funded medical research to favor their own interests and to suppress competition. It is difficult to obtain NIH research funds in the face of opposition from powerful lobbies that occur when that research goes against those special interests.

Those same special interests have a major influence on lay and professional exposure through the news media. Advertising revenues are essential to the survival of medical journals, newspapers, magazines, television and radio. Even with freedom of the press, the media cannot survive without advertising revenues. There often exists an understandable reluctance to bite the hand that feeds them. It is difficult to educate the public and the medical profession about new developments without media cooperation. Medical schools also cannot afford to offend their corporate sources of research funds.

The welfare of the American public is often pushed aside by the industrial quest for profits and pressures to suppress competition. Every industry wants a monopoly, if that can be achieved. Mainstream medicine has come very close to that goal.

Scientific arrogance is commonplace. Physicians consider themselves to be experts in their own field. If a majority of physicians do not endorse a new therapy, they collectively rely on public recognition of their own "expertise" to discount a new concept that they themselves have not yet embraced. They forget that all great advances in medicine began with a small minority. Their thinking tends to follow along these lines: "If I'm the expert and I don't use this new therapy and if my many colleagues and peers are experts and they don't believe in the new therapy, then we must be right and that small group of physicians who believe differently must be wrong. We're the experts."

The most frequent criticism leveled by critics of non-traditional and alternative medical therapies is that new treatments are "unproven" because randomized, double-blind, controlled studies have not yet been done to prove effectiveness. Those criticisms ignore the fact that most medical procedures routinely performed in the practice of medicine are also unproven using those same criteria.

The Office of Technology Assessment, a branch of the United States Congress, with the help of an advisory board of eminent university faculty, has published a report with the conclusion that, " . . . only 10 to 20 percent of all procedures currently used in medical practice have been shown to be efficacious by controlled trial." Therefore, 80% to 90% of medical procedures routinely performed are unproven.¹ That report further points out that the research which purports to prove effectiveness of the remaining 10% to 20% of medical procedures is largely flawed, and " . . many of the other procedures may not be efficacious." The most frequent reason for not accepting the value of EDTA chelation therapy reflects a flagrant double standard.

A complete program of chelation therapy involves dietary changes, away from highly refined and processed foods. The use of nonprescription nutritional supplements is emphasized more than expensive and highly profitable drugs manufactured by the pharmaceutical industry. Chelation therapy is performed in doctors' offices, without the need for hospitals, surgeons, cardiologists and the large team of health professionals who profit greatly in dollars and reputation from the $6 billion per year bypass surgery and balloon angioplasty industry.

For obvious reasons, double-blind studies have never been done to prove or disprove clinical benefits from bypass surgery or balloon angioplasty. The effectiveness of EDTA chelation therapy has been clinically proven to the same extent as bypass surgery and angioplasty, or more so, as established by the clinical data published in the TEXTBOOK OF EDTA CHELATION THERAPY.

Recent reports conclude that from 44% to 85% of coronary artery bypass surgery is routinely performed on patients who do not meet the criteria for benefit, even using standards derived from non-blinded studies.^2-9 The media consistently makes light of such flagrant abuses of surgery, while widely publicizing any hint of "quackery" associated with chelation. The American Medical Association, in its official journal (JAMA), admits that 44% of all coronary artery bypass surgery is done for inappropriate reasons.⁹

When a therapy is widely accepted by the medical profession, no scientific proof of effectiveness is required, and anecdotal evidence is accepted as valid. If an alternative therapy is contested by those physicians, however, they attack by demanding that the therapy in question be subjected to very expensive and time-consuming double-blind, placebo controlled trials. Medicare regulations also exclude the need for scientific proof for treatments that are utilized by a majority of physicians. The federal government thereby adds support to this double standard.

In the case of EDTA, those demands ignore the fact that it would normally cost millions of dollars for double-blind studies to prove effectiveness, and public funding for medical research cannot be obtained without political support. Without patent protection, pharmaceutical manufacturers will likewise not fund that research. The cost and time required for research of that scope is also beyond the resources of the clinicians in private practice who utilize chelation therapy. EDTA chelation therapy has therefore been an "orphan" without a source of financial support for research.

Despite those drawbacks, even in the face of a severe and unjust double standard imposed by opponents, research money has been successfully obtained from private foundations and from patients and physicians who believe in this treatment. Patients have been accepted into double-blind studies, beginning in mid-1988 [not completed for political reasons].

Deprived of reimbursement by medical insurance, patients have thus far paid for EDTA chelation therapy entirely from their own pockets. If Medicare refuses to pay for a therapy, most other insurance companies follow suit. It costs far more to fight those unjust policies in court than to pay for the treatment.

Historical examples of similar campaigns to control the practice of medicine, in favor of organized medicine and other special interests, against the public interest, are easy to find. As many innovative physicians have discovered, one of the quickest ways to become the target of opposing forces is to utilize nutritional or other nontoxic and noninvasive treatments for cancer.

On August 3, 1953, Charles W. Tobey Jr., son of the late Senator Charles Tobey, Chairman of the Senate Interstate and Foreign Commerce Committee, entered into the Congressional Record a report of an investigation by Benedict F. Fitzgerald Jr., Special Counsel to the Committee on Interstate and Foreign Commerce. Fitzgerald's investigation was directed at an alleged conspiracy to suppress what, in the 1950s, would have been considered alternative methods of treating cancer. His findings could equally have been applied to other innovative and nontraditional methods of treating any disease.

Fitzgerald criticized those who supported the party line of the American Medical Association (AMA), and who applied themselves to efforts to hinder, suppress, and restrict the free use of new therapies. Those therapies included medicines that were supported by evidence of success from clinical records, case histories, pathological reports, and x-ray and other photographic proof, together with living testimony of former cancer victims. Fitzgerald concluded that a conspiracy existed, and that public and private funds had been "thrown round like confetti at a country fair" to shut down clinics, hospitals and research laboratories which did not conform to the AMA's viewpoint.

Investigation tactics used against emerging and nontraditional medical therapies show a consistent pattern of: 1) arrogance; 2) a sense of mission and of knowing what is best and right for other people; 3) depriving citizens of their constitutionally protected rights to freedom of choice; and, 4) acceptance of the concept that the end justifies the means. Opponents of nontraditional therapies have viewed as legitimate activities: disinformation, smear campaigns, harassment, instituting IRS tax audits, encouraging patients to sue physicians, entrapment, illegal wiretaps, and possibly even break-ins. These tactics have been used against physicians for nothing more serious than administering intravenous EDTA chelation therapy.

When evidence, real or fabricated, is uncovered which is unfavorable to the targeted physician, a representative of the opposition will contact the state board of medical examiners, asking for an official investigation and prosecution. Pressures are brought on the physician to cease and desist his aberrant practices or lose his license to practice medicine.

Investigations and proceedings of licensing boards are often confidential and not available, even to the physician under investigation. By definition, it is difficult for an outsider to learn all of the specifics of such covert tactics, although a good approximation of how these things work has gradually emerged over the years.

The power structure of organized medicine may be visualized as a pyramid, with the sides composed of different physician specialty associations, each with its own special interests to protect. The result may be collectively called "organized medicine." The apex of the pyramid represents the governing boards and officers of those groups, while the base represents the broad general membership. Local and state chapters centralize the power and influence from the base upward to the national level. This pyramidal structure in medical politics forms the basis for a conspiracy that operates in coalition with other groups to benefit the individuals who compose the core of the pyramid. Although the composite organizations draw authority to sanction their collective actions from individual members, those members are often unaware of the larger structure within which power brokers and medical politicians operate.

By representing almost every practicing physician and specialty group in the country, this coalition has enormous influence in the affairs of our nation. That is especially true when an alliance is formed between organized medicine, the pharmaceutical industry and food processing corporations. The food industry profits greatly from sales of margarine, unsaturated fats, fake eggs, and other refined and fractionated foods with the endorsement of physicians.

The AMA and other segments of organized medicine are second only to the National Rifle Association in political campaign contributions to senators and congressmen at the national level. They give more than any other special interest groups in the country. Through political influence, bought and paid for, the policies of public institutions and federal and state agencies can be influenced by this group, including medical schools and universities, HHS, PHS, FDA, FTC, NIH, state medical licensing boards, etc. When a physician is selected for censure by organized medicine, the FDA, FBI, IRS, postal inspectors, district attorneys, Antifraud Division of Medicare and other agencies with quasi-police powers are quick to join the fray. This has occurred to physicians who have had the courage to offer EDTA chelation therapy to their patients.

An average of approximately 60% of all state medical licensing boards' time is spent confronting, rehabilitating or defrocking physicians who are impaired or otherwise incompetent. Most of those are chemically dependent on alcohol and drugs. Increasingly, addicted physicians are being successfully rehabilitated, with the help of medical societies and recovered physicians. That function is truly in the best interests of both the medical profession and the consumer.

The remaining 40% of state medical licensing boards' time is, on the average, spent "witch-hunting," in the manner described above, in an effort to control the practice of medicine. The result is to force conformance with majority practices and to protect the medical profession against financial competition from "maverick" physicians who are bold enough to espouse innovative practices ahead of their peers. Restraint of trade and government support of a medical monopoly is the bottom line.

All too often, academic physicians on medical school faculties and research scientists allow themselves to be influenced by propaganda and disinformation, instead of obtaining the true facts and relying on their own analytical abilities and scientific methodology to determine the truth. The overwhelming majority of physicians in clinical practice appear to be totally unaware that a conspiracy exists and that covert activities are routinely taking place to protect their monopoly and to prevent competition.

The AMA Coordinating Conference on Health Information (CCHI) was formed in 1964, as an offshoot of the AMA's Committee on Quackery.¹⁰ All responsible citizens, by definition, must be opposed to quackery. The main difference between the AMA Committee on Quackery and the newly formed CCHI was that the CCHI was a totally secret and covert organization which functioned in coalition in a network with other, similar groups. The CCHI operates in partnership with the National Council on Health Fraud with regional chapters in many states. The director of each regional chapter must swear to an oath of secrecy. National and regional chapters of the Council on Health Fraud stay in communication with individual members of each state's board of medical licensing examiners. The CCHI operates through this secretive network, without access from public scrutiny. There are no checks and balances.

Both the CCHI and the National Council on Health Fraud purport to be scientific and authoritative sources of information. A significant portion of their activities, however, have nothing to do with real quackery, but are rather a means to coerce practitioners of medicine to adhere to practices approved by medical politicians. The end result is to preserve certain monopolistic and economic advantages enjoyed by organized medicine.

An important reason that research into the use of EDTA in the treatment of atherosclerosis and its complications stopped after 1960, until the mid 1980s, was because of an active and vicious campaign of misinformation and unjust harassment of physicians who used EDTA in their practices. Scientific researchers who showed an interest were also discouraged and harassed.

Practicing physicians who used EDTA have been summoned to appear before state boards of medical examiners to answer complaints. Charges were often contrived and rarely documented by careful investigation. The Federation of State Boards of Medical Examiners is associated with the CCHI network. State boards of medical examiners are legally constituted bodies that have ultimate authority to revoke a physician's license to practice medicine. Medical licensing boards in at least six states have attempted to mandate a blanket prohibition against chelation therapy within their states. Fortunately, the courts have been quick to nullify most such arbitrary rulings.

EDTA is already on the market as a legitimate pharmaceutical agent to treat lead toxicity, digitalis toxicity and acute hypercalcemia. EDTA is legally available for physician use, and it is quite legal for any licensed physician to utilize a drug for any purpose which, in that physician's judgment is best for his patient. The only restriction is that pharmaceutical companies that manufacture EDTA cannot make advertising and marketing claims of effectiveness in the treatment of atherosclerosis, in the absence of FDA approval for that indication.

The patent on EDTA expired many years ago. It is now a generic drug. Any drug company can manufacture and sell EDTA. There is no longer any patent protection to allow recovery of research, development and licensing costs. It customarily costs a drug company millions of dollars for research and paperwork to satisfy FDA requirements for the addition of a new therapeutic claim to the package insert of an established drug such as EDTA. No company will spend the money without the ability to recover those costs in the marketplace. This lack of FDA approval for atherosclerosis is commonly used against physicians by opponents of chelation, although it has always been a fully accepted and common practice for doctors to use medicines for diseases not yet approved by the FDA. This is another blatant example of double standard.

A communication from Dr. John Parks Trowbridge, a physician using chelation therapy in Texas, dated August 1986, illustrates very succinctly the difficulties physicians have encountered when they offer chelation therapy to their patients. The following illustrates how the system of repression often works:

In the last 90 days, at least 3 chelating physicians have been hauled before the board—1 lost license, 2 threatened. We've been put 'on notice,' through one who was threatened, that they were going to 'get' each of us, one by one.

Such legal harassment can bankrupt a doctor in order to pay the legal fees to defend himself against ongoing attacks by legally constituted agencies. Due process is a constitutional right but can be very expensive. The state pays its attorneys and legal costs with public funds. An unjustly accused physician must defend himself at his own expense. That is the basis for a tactic used by state licensing boards to keep up the pressure until a targeted doctor can no longer afford to pay for his defense. At that point, more than one highly competent and ethical physician has submitted to injustice and agreed to stop using EDTA chelation therapy in his practice, accepting probation and censure, just to end the mounting legal expenses and other stresses of harassment.

The original motivation to discredit EDTA as a treatment for atherosclerosis may have stemmed from ignorance of its benefit and arrogance in the belief that EDTA was dangerous treatment and that it did not work. The motivation may have once been to weed out fraud and quackery. With the development of enormously profitable coronary artery bypass surgery and angioplasty, however, not to mention peripheral and carotid artery surgery, it is obvious that many influential groups in organized medicine and the hospital industry would suffer greatly if EDTA chelation therapy, administered in physicians' offices at approximately 10% of the cost, became widely accepted. That now seems to be the most significant reason for ongoing attempts to suppress the practice and clinical investigation of EDTA chelation therapy. What other explanation could there be in the face of the large body of clinical and scientific data in support of EDTA chelation therapy?

In recent years, mainstream medical journals have refused to publish the results of research of EDTA chelation therapy for atherosclerosis, while at the same time publishing many frivolous letters to the editor and editorial comments criticizing chelation therapy. This ongoing editorial bias and censorship have largely prevented ready access by interested clinicians and, researchers to favorable clinical data. Most literature searches begin and end with the Index Medicus or its electronic counterpart, the MEDLINE computer database. Recent studies of chelation therapy have been published in less widely circulated journals, many of which are not included in the Index Medicus.

Most physicians and medical students are not aware that only 10% of the world's total biomedical literature can be found in those databases.¹¹ If a physician becomes interested enough to do a computer search of EDTA chelation therapy for treatment of atherosclerosis, he will find a plethora of negative editorial comment and propaganda, but no negative data to support that criticism. Most clinical data to support the effectiveness of EDTA in treatment of atherosclerosis has appeared in journals that are not listed in easily accessible references. [The most pertinent of that data is summarized on this website.]

The first randomized, double-blind, controlled study of EDTA chelation therapy for treatment of atherosclerosis was conducted by Professor Doctor Schettler, et al, in the clinics of the University Hospital in Heidelberg, West Germany, while Dr. Schettler was Chairman of the Department of Internal Medicine and President of the International Atherosclerosis Research Association. That study was funded by Thiemann Pharmaceutical Company, manufacturers of the platelet inhibitor, bencyclan, marketed as Fludilat®. Fludilat® is widely prescribed in Europe to treat atherosclerosis. EDTA chelation therapy was compared with bencyclan.

It is unknown why a pharmaceutical company would fund a study of a generic drug for which the patent had expired. It is possible that Thiemann believed AMA propaganda stating that EDTA was ineffective. Why else would Thiemann put EDTA up against their own Fludilatl®?

Thiemann did take precautions, however. When the grant was awarded, Thiemann reserved the right, in its written contract with Schettler, to edit any published reports of the study. Thiemann reserved the right to interpret the final data for publication and to do the statistical analysis themselves. All recorded data from the study were to be the property of Thiemann. It was agreed that all data would be given to Thiemann at the end of the study. Such a contract seems to eliminate the possibility of an unbiased report, and it eliminates free access to the original data by other investigators.

A total of approximately 48 patients were treated, 24 in the Fludilat® group and 24 in the EDTA group. Disodium EDTA was administered in a dose of 2.5 gms in 500 ml 1/2N Saline. Treatments were given five days each week for a total of four weeks. Each patient received 20 infusions. Only patients with peripheral vascular disease who could not walk 200 meters without pain of claudication were included in the study. Pain-free walking distance was measured before, during and after therapy on a treadmill, at 3.5 km/hr with a 10% uphill gradient.

The measured results showed a 250% increase in distance walked before onset of claudication pain in the EDTA-treated group after four weeks of therapy. By comparison, there was only a 60% increase in the bencyclan group. Bencyclan, however, is a drug proven to be of benefit in this disease and is widely prescribed in Europe for that indication.

There were four patients in the EDTA group who experienced more than a 1,000-meter increase in their pain-free walking distance at the end of only 30 days treatment. Highly favorable data from those four patients mysteriously disappeared when the final results were made public. Thiemann, of course, had a legal right under terms of their contract to edit the final results and to interpret the data in any way that suited them. Their final report contained data that reduced observed benefit from EDTA by 72%, from 250% increase to only 70%. The fact that data from the best EDTA responders were altered would not have been known if scientists from Heidelberg with intimate knowledge of the study had not been shocked by what they considered unethical and dishonest scientific conduct. Raw data from the study were personally delivered to an official of ACAM for an independent interpretation.

The fact that a highly placed representative of American organized medicine went to Heidelberg and met with Dr. Schettler while the study was in progress may or may not be significant.

The study was reported at the Seventh Atherosclerosis Congress in Melbourne, Australia, 1985. An attachment to the abstract of that presentation, available at the meeting, contained a graphic plot of pain-free walking distance extending out to three months after the end of therapy. By that time, even using the modified data made public, the increase in pain-free walking distance in the EDTA-treated patients had increased to 430% of the baseline, while bencyclan-treated patients averaged less than half that much with no significant improvement after therapy was stopped at 30 days. Nothing in the text of the abstract described that graphically depicted observation, despite its great clinical significance in proving the effectiveness of EDTA chelation therapy. The report analyzed data only to the end of 30 days, when the bencyclan and EDTA groups had responded equally. It is well known that full benefit from EDTA is often delayed for up to three months after therapy.

When deleted data from the EDTA subjects with maximum relief of symptoms is considered, average walking distance increased by more than 400% three months following EDTA chelation therapy.

The data reported in Australia show only a 70% average increase in pain-free walking distance in the EDTA-treated group (instead of the 250% increase at 30 days indicated by the raw data) and was compared with a 76% average increase in the group treated with bencyclan. Even that amount of improvement is significant. It is rare for placebo effect alone to exceed 33%.

The only patient death was in the bencyclan group. No serious side effects were observed from EDTA. The reportedly negative results of this study received widespread coverage in the news media, but the data were never published in a peer-reviewed journal. Furthermore, the press release stated that "EDTA was no better than a placebo," without mentioning that the "placebo" in this case was Thiemann Pharmaceutical's very own Fludilat®, a proven effective drug.

By way of comparison, in the study which resulted in U. S. FDA approval of pentoxifylline (Trental®), for the treatment of claudication, walking distance before pain of claudication increased by only an average 25% over baseline with treatment. Nonetheless, that small amount of improvement was considered statistically significant and Trental® was approved for marketing by the FDA. EDTA was more than twice as effective, even using the publicly announced results of the Heidelberg study.

The intensity of the attitudes and the arrogance that has lead to a conspiracy of this enormity will ultimately be responsible for its exposure and eventual downfall. It might be argued by some that such a strategy was justified as a means of eliminating widespread quackery. But who is to decide what is quackery, and who is to give a self appointed group of physicians with vested interests in competing therapies the right to assume that they alone know what constitutes quackery and what is in the public's best interest?

With 800,000 people per year dying in the United States alone from atherosclerosis and its complications, despite the best of high-technology hospital and surgical care that is available, it is imperative that the public be given the option to receive EDTA chelation therapy. It would be senseless and even criminal for medical insurance companies to continue to deny payment for a therapy which has the potential to greatly reduce long-term medical expenditures by reducing the need for far more expensive hospitalization, surgery or angioplasty. Savings to medical insurance companies with resulting reduction in insurance premiums could be great.

A physician signatory to the Constitution of the United States of America, Dr. Benjamin Rush, wrote:

The Constitution of the Republic should make special provisions for medical freedom as well as religious freedom. To restrict the art of healing to one class of men and deny equal privileges to others will constitute the Bastille of medical science. All such laws are un-American and despotic.

The chiropractic profession was the first to feel the sting of the CCHI. On August 28, 1987, Federal District Judge Susan Getzendanner ruled that the AMA led an effort to destroy the chiropractic profession by engaging in "systematic, long-term wrong-doing with the long-term intent to destroy a licensed profession." That was also the ruling in an anti-trust lawsuit filed in 1976.

The "conspiracy" described in this chapter cannot be dismissed and called paranoid or a figment of someone's imagination. Chiropractic physicians were not the only target. With ample funding from membership dues, enormous real estate holdings, and advertising revenues from their many publications, supplemented by contributions to the Council(s) on Health Fraud by the pharmaceutical industry, food processing companies, and others, the AMA and organized medicine has led efforts to discredit EDTA chelation therapy and nearly every other therapy that is less invasive, less toxic, nutritionally oriented or more natural, when such treatments have competed directly with mainstream physicians for patients and health care dollars.