Calgary PATCH study of chelation

Critique of the Calgary PATCH EDTA Chelation Study

Adapted from a report by Croft Woodruff in Canada.

A doctor from the University of Calgary, Canada prominently 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 by a large number of outspoken critics of chelation therapy. At the time of that announcement, the results had not yet been published, nor had they even been submitted for publication in a scientific journal. The lay media, however, widely publicized the undocumented report.

A more detailed critique of this PATCH study was made following subsequent to formal publication

That 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 an earlier study from Heidelberg, Germany, was announced from the podium at a medical meeting in Australia. The Heidelberg study was never published. A third study was performed in New Zealand. All three studies contained positive data, and were supportive of EDTA chelation to treat atherosclerosis, but they were deceptively interpreted as negative by the researchers. (Those studies are discussed in detail elsewhere on this website)

For more on the medical politics of EDTA chelation therapy, read here 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 [Heidelberg study] 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®. 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®, 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 EDTA-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.
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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. Read more in Dr. Cranton's critique written 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 when announced. 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. (That did eventually become possible.) The dose of EDTA was at least 20% less than called for in the accepted protocol.

Elmer M. Cranton, M.D.

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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."