The doctors HERE are proof.
If EDTA Chelation Therapy is so Good, Why Is It Not More
Widely Accepted?
James P. Carter, MD, DrPH
Dr. Carter is Professor and Head, Nutrition Section, Tulane
University School of Public Health and Tropical
Medicine, New Orleans, Louisiana.
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. That is especially
true if a new therapy, like EDTA chelation: 1) involves a
major shift in the scientific paradigm; 2) if acceptance
of the new therapy somehow implies that currently used
medical practices are inappropriate; or 3) if the new
therapy threatens the financial well being of a
politically powerful and well established branch of the
medical profession. Quite the opposite occurred with the
immediate and widespread acceptance of bypass surgery and
balloon angioplasty, which quickly brought wealth and fame
to surgeons, cardiologists, large teams of health care
professionals, and the hospital industry.
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.
Well known historical examples of that phenomenon occurred
with the introduction of the germ theory of disease. That
simple concept took 50 years for complete acceptance by the
medical profession.
Lister was viciously attacked when he proposed that wound
infections were not inevitable after surgery if aseptic
techniques were used. Semmelweis was likewise dealt with
when he urged doctors to wash their hands before delivering
babies to prevent maternal deaths from puerperal sepsis.
Lister's recommendations were not accepted by mainstream
medicine for many decades, and Semmelwels was persecuted to
his death by medical colleagues, who were incensed by the
notion that they themselves transmitted disease from patient
to patient on their unwashed hands. Has human nature changed
since that time?
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 this book.
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 ED