Critique of the Calgary PATCH EDTA Chelation Study
Adapted
from a report by Croft Woodruff in Canada.
Click here for a more detailed critique of this study following subsequent
publication
A doctor from the University of Calgary, Canada,
has announced the results of an allegedly negative clinical trial (Calgary
PATCH Study) that used EDTA chelation to treat heart disease. He claimed
that no benefit was seen using EDTA chelation to treat stable angina
pectoris.
That verbal announcement was made from the
podium at a cardiology meeting in Orlando, Florida, attended largely by
outspoken opponents of chelation therapy. The results have not yet been
written up nor have they been submitted for publication in a scientific
journal. The lay media, however, has widely publicized the undocumented
report.
This event is reminiscent of three similarly
deceptive studies, alleged to disprove EDTA chelation therapy, all of which
actually supported the therapy on careful review. One such study in Denmark
was announced before publication over the public address system at a major
national football game, while another study from Heidelberg Germany was
announced from the podium at a medical meeting in Australia, but was never
published. A third study was done in New Zealand. All three studies
contained positive data, highly supportive of using EDTA chelation to treat
atherosclerosis, but were deceptively interpreted as negative by the
researchers. (click here for detailed analysis of
those studies)
For more on the medical politics of EDTA
chelation therapy, click here to read what a
medical school professor has to say.
The administered dose of EDTA in the Calgary
PATCH study was significantly less than that used by qualified chelating
physicians and was lower than prescribed in the accepted
protocol. Patients selected for the study had the least severe form of
heart disease, which made the final end points difficult to measure.
Why was that study made public when it has yet
to be published in a medical journal and before the data have been subjected
to peer review? Two years ago, Arpad Pusztai, a world-renowned authority on
plant proteins and nutrition, with nearly 300 refereed publications to his
credit, was terminated from his employment and treated disgracefully by his
own colleagues for speaking publicly about his research concerning food
safety, prior to publishing his findings in a refereed journal. Is there a
double standard here? Who controls the media?
An ACAM representative in Calgary objected to
the way the protocol was designed for the control group, but the
cardiologists in charge insisted on using their design. The Calgary study
seems to have been designed from the outset to have a negative outcome.
There are more than 56 medical doctors in Canada
and more than a thousand in the USA now offering EDTA chelation therapy.
This is a consumer driven movement, stemming from the large number of
patients who have been helped, often against the advise of cardiologists.
Patients seek out this therapy after talking with others who have benefited.
For several years in Canada, cardiologists,
various provincial Colleges of Physicians and Surgeons, medical
associations, federal and provincial health ministers and their bureaucrats
have decried the lack of scientific proof demonstrating chelation therapy to
be safe and effective in the treatment of cardiovascular and peripheral
vascular disease. That was their justification for opposing EDTA chelation
therapy, and has resulted in ongoing harassment of physicians and
interference with access to drugs and supplies needed to administer the
therapy.
There have been instances involving hostile
intimidation of patients by cardiologists. The Ontario government of David
Peterson even passed a law making it illegal for medical doctors to practice
EDTA chelation therapy for atherosclerosis and related afflictions. (Since
then it has again been legalized by the Mike Harris government.)
In the middle 1980s a clinical trial on
chelation therapy was set up by Dr. A. R. Matthews at the Roland Watson
Clinic in Victoria, B.C., with the approval of the British Columbia College
of Physicians and Surgeons, and with a proviso that the study was to be
carried out with the cooperation of the University of Victoria (a cynic
might suggest that the College approved the study believing their own
propaganda—they were certain it would fail). That study was funded by the
patients, who paid $3,000 a month to the University of Victoria physiology
laboratory and raised some $60,000, plus the cost of a new Doppler blood
flow measuring machine.
The study started with 300 patients, and 7,236
chelation treatments were given. It was proved unequivocally that EDTA
chelation therapy was safe, even for patients with some degree of kidney
insufficiency. That was the safety study, to be followed by an
"effectiveness" study. The "effectiveness" study began with only 40 patients
allowed to take part. The number of patients was reduced to 17 when it was
found that some of the doctors making referrals had deliberately changed the
patients' medication, thereby compromising study results. Very few patients
were referred to the second study by their doctors. Even then, there were
such remarkable results that, paraphrasing the words of the clinicians, "it
encouraged us to proceed with this trial."
Meanwhile, a Victoria cardiologist persuaded the
Victoria University Senate to cancel the University's support of the study
because it was "unethical" for the patients to be funding their own clinical
trial, no matter that funding was not forthcoming from the government, the
pharmaceutical industry, or fund raising charitable organizations such as
the Heart and Stroke foundation. Without the University's support, the
physicians conducting the trial had no choice but to shut it down. The
College of Physicians and Surgeons claims that the study was ended by Dr.
Matthews. Other correspondence suggests the opposite: "there being
difficulties with other members of the profession."
The University records concerning the study were
shredded and the College of Physicians and Surgeons, when accessed through
Freedom of Information, has refused to release 44 pages "containing research
information of employees of the University of Victoria" from their files.
This is with the full knowledge that the University claims the records have
been destroyed. The College forced Dr. Matthews to personally pay out
$24,000 for laboratory fees, in spite of the fact that the bulk of expenses
had been paid by the patients. Was this to make sure that another chelation
study would not happen in B.C.?
By 1990, in a letter addressed to the late Mr.
Ted Dickson, founder and president of the EDTA Chelation Association of
B.C., over the signature of its registrar, the College of Physicians and
Surgeons stated that although doctors in B.C. could practice chelation
therapy, it was without the approval or endorsement of the College. In the
United States clinical trials on chelation therapy have similarly been
aborted. A trial at Walter Reed Army Hospital was discontinued because
doctors were sent off to the Persian Gulf War. That study not resumed when
the war ended. The doctors were reassigned elsewhere.
In 1992 it was announced that a clinical trial
would be funded by American Home Products (Wyeth Pharmaceutical Company).
That study never got off the ground. It was canceled when the company's
clinical director was replaced by another doctor who was an outspoken critic
of EDTA chelation therapy. Perhaps not coincidentally, Wyeth had a large
vested interest in cholesterol lowering drugs based on the lipid theory of
atherosclerosis.
The U.S. National Institutes of Health funded a
clinical trial at the University of Washington, Seattle. That study was
sabotaged at the eleventh hour because of "political pressure." There is
evidence that politically powerful and vociferous opponents to chelation
therapy are using every means possible to thwart clinical trials from taking
place at any university. Whenever clinical investigators take an interest
and propose a study, they are inevitably taken aside and told, behind closed
doors, that to do so would be "career suicide."
To quote from a medial school professor on this
subject:
Censorship in Science
and Medicine
University Shenanigans Foil
Chelation Study by James P. Carter, MD, DrPH, "Townsend Letter," July 1997
Mainstream medical
journals refuse to publish positive research studies of EDTA chelation
therapy for treatment of atherosclerosis, while at the same time printing
poorly documented letters to the editor and editorials criticizing
chelation. This type of editorial censorship has prevented easy access to
favorable research. Literature searches usually begin and end with the
"Index Medicus," or its electronic counterpart, the MEDLINE computer
database. Positive studies on chelation therapy have been systematically
excluded from those databases.
Physicians are often
unaware that only 10% of the world's total biomedical literature is indexed
in the MEDLINE computer database. Many research studies have been published
that support chelation therapy, but because of editorial censorship, they
are not easy to find. A MEDLINE database search will point to only four
publications, three with unsupported and deceptively negative conclusions in
their abstracts. For that reason the results of a computer search for
studies of EDTA chelation therapy for treatment of atherosclerosis will be
very misleading and largely negative.
More on the medical politics of chelation
therapy by Dr. Carter, describing an unpublished study widely cited in the
lay press:
(Adapted from : Carter JP.
If chelation therapy is so good, why is it not more widely accepted? Chapter
25 in
A TEXTBOOK ON EDTA CHELATION THERAPY, SECOND
EDITION, edited by Elmer M. Cranton, M.D., Hampton Roads Publishing
Company, Charlottesville, Virginia, 2001)
This randomized, double
blind, placebo controlled study of EDTA chelation therapy for treatment of
atherosclerosis was conducted by Professor Doctor Schettler and associates
in the clinics of the University Medical School in Heidelberg, Germany. Dr.
Schettler was Chairman of the Department of Internal Medicine and President
of the International Atherosclerosis Research Association. The study was
funded by Thiemann Pharmaceutical Company, manufacturers of the platelet
inhibitor, bencyclan, marketed as Fludilat(r). Bencyclan is widely
prescribed in Europe to treat atherosclerosis.
EDTA chelation therapy
was compared to bencyclan. It's unknown why a pharmaceutical company would
fund a study of EDTA, a generic drug for which the patent had expired. It's
possible that Thiemann believed mainstream propaganda that EDTA is
ineffective. Why else would Thiemann put EDTA up against their own
Fludilat(r), a proven effective drug? 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. It was also agreed that Thiemann would
retain all data at the end of the study. Such a contract seems to eliminate
the possibility of unbiased research. Approximately 48 patients were
treated, 24 in the bencyclan group and 24 in the EDTA group.
Treatments were given
five days each week for a total of four weeks. Each patient received 20
infusions of EDTA. Only patients with peripheral vascular disease who could
not walk 200 meters without leg pain of claudication (caused by
atherosclerotic blockage of blood flow) were included in the study.
Pain-free walking distance was measured before, during and three months
after therapy on a treadmill set 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 immediately 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.
Four patients in the
EDTA group experienced more than a 1,000 meter increase in pain-free walking
distance. This 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 censor and misrepresent
the final results and to manipulate the data in any way that suited them.
Their final report contained edited data that deceptively reduced the
measured benefit from EDTA immediately after the infusions from 250%
increase to only 70%.
Results of the
Heidelberg study were reported verbally from the podium at the Seventh
Atherosclerosis Congress in Melbourne, Australia, 1985 [very similarly to
the way in which the Calgary PATCH study was announced]. The presentation in
Australia described only a 70% average increase in pain-free walking
distance in the EDTA-treated group (instead of the 250% increase indicated
by the raw data), which was compared to a 76% increase in the group treated
with bencyclan. The only patient death was in the bencyclan group. No
serious side effects were observed from EDTA. 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 and showed a 250% increase. Few took notice of that handout,
however.
The fact that data from
the best EDTA responders were deleted wouldn't have been known if other
scientists from Heidelberg with intimate knowledge of the study had not been
shocked by what they considered unethical and dishonest scientific conduct.
The original raw data from the study, as described here, were personally
delivered to an official of the American College of Advancement in Medicine
in the United States for independent analysis. When the original data from
the all the deleted ETDA-treated subjects was added back (which included
those with maximum relief of symptoms), average walking distance increased
by more than 400% three months following EDTA chelation therapy.
Deceptively negative
interpretations of this study received widespread coverage in the news media
[as with the Calgary PATCH study], but the truly favorable results were
never published in a scientific medical journal. Furthermore, press releases
stated that "EDTA was no better than a placebo," without mentioning that the
so-called "placebo" was a proven effective drug. By way of comparison, in
the study that resulted in FDA approval of pentoxifylline (Trental) for the
treatment of claudication, walking distance increased by only 25% over
baseline. Because the number of patients was sufficiently large, that amount
of improvement was statistically significant and the FDA approved Trental
for marketing.
The American College for Advancement in Medicine
(ACAM) is the parent body that trains medical doctors in the correct
protocol for EDTA chelation therapy in the treatment of atherosclerotic
vascular disease.
_________________________________________________________
COMMENTS ON THE CALGARY PATCH STUDY by Elmer M.
Cranton, M.D., 4/18/2001, written well before subsequent publication of
this study in the Journal of the American Medical Association January 2002.
Click here for Dr. Cranton's critique after publication.
The so-called PATCH study performed in Calgary,
Canada, alleging to disprove EDTA chelation therapy has not yet been
submitted for publication in a medical journal, and, according to one of the
researchers, not yet even been written up. It was briefly described by
outspoken opponents of chelation from the podium at a recent medical meeting
and widely publicized in the lay press. There is no way to comment on or to
critique that study in detail until the complete research data (raw data,
with no manipulation or editing) becomes available (if that ever occurs). It
is known at this time that the dose of EDTA was at least 20% less than
called for in the accepted protocol. My book "Bypassing
Bypass Surgery" has been extensively rewritten, expanded and updated. It
is now in press and about to go to the printer as a new book with a new
name, "Bypassing Bypass Surgery." The following is a last-minute insert
added to the chapter on chelation research when the PATCH study was
publicized in the lay media. Click here for more on
the medical politics of chelation therapy and the dirty tricks chelation
opponents use, you might click on the link below.
Coypright ©2005 Elmer M. Cranton, M.D.
________________________________________________
Inserted into chapter 10 of
Bypassing Bypass Surgery, the chapter on
EDTA chelation research. This book is extensively rewritten, expanded and
updated since Dr. Cranton's earlier book, Bypassing Bypass.
"Just
as this book went to the printer, another small study alleging to
disprove EDTA chelation therapy is being widely reported by the news media.
This recent study was conducted by cardiologists in Calgary, Canada, who
freely admit their bias against chelation. They seem to have set out to
discredit a therapy that they oppose by studying a few patients with heart
disease. Because the study has not yet been published in a scientific
journal, it is not possible to provide a meaningful critique. I feel
certain, however, that when we finally do have an opportunity to conduct a
detailed review of that study's design and data, the final assessment will
be very similar to that of the Danish and New Zealand studies, as described
in detail in this chapter--another hatchet job.
"It's relatively easy to design a study
specifically to discredit an unpopular therapy, and to make that study
superficially appear to be scientific. The United States Congress once
commissioned its Office of Technological Assessment to analyze all published
medical research for scientific merit. After a careful review of research
studies from leading medical journals, they concluded that, "more than 75
percent of all published medical research has invalid or insupportable
conclusions as a result of statistical problems alone." The final report to
Congress stated, "few published clinical trials are well enough designed to
yield valuable results."
"And it's not merely intellectual dishonesty. Many
doctors who oppose chelation therapy firmly believe that it is ineffective.
That is what they have been told. So they attack, with no personal knowledge
about what they are attacking. Perhaps they feel threatened because very few
doctors have the time to thoroughly read and analyze published studies in
medical journals. They usually skim the abstract and jump to the authors'
conclusions, accepting them without question.
"I have also found medical doctors to be naive and
unaware that the peer review process is often used as a form of editorial
censorship--a way to maintain the status quo and protect the professional
reputations and practices of the reviewers. Also, because medical journals
so often depend heavily on advertising by major pharmaceutical companies,
studies that are unpopular with that industry are rarely published; while
brief letters to the editor and unsupported editorial opinion attacking
opposed therapies quickly find their way into print. Journals tend to be
reluctant to bite the hand that feeds them.
"Powerful psychological defense mechanisms also
come into play. If doctors are not taught about EDTA chelation therapy in
medical school (and they are not), and if those doctors therefore do not
routinely use or prescribe chelation therapy for patients, then they believe
one of two things: 1) either their medical educations were deficient and
they are not providing the best of care for patients; or, 2) other doctors
routinely using and prescribing chelation therapy for medical conditions
that are not FDA-approved must be "quacks," exploiting desperate patients.
Which do you think their choice will be? It's apparently difficult for many
medical doctors to shed an attitude of God-like omniscience and admit that
they simply do not know everything there is to know."
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