Chelation Therapy Under a Cloud : Treatment Claims Challenged by Medical Establishment
Imagine, for a moment, that there is a drug a doctor can inject into your body by intravenous tube that can cure the following: hardening of the arteries, angina pain, abnormal heart rhythms, high blood pressure, senility, rheumatoid arthritis, Alzheimer’s disease, diabetes and perhaps even bone loss connected with old age.
And, in the process, it will make the wrinkles disappear from your face and take 10, maybe 20 years, off of your appearance. Not only that, but if you’re young and don’t have any of these diseases or displeasures, the cure can probably prevent your ever being afflicted with them.
From a Greek Word
The subject in question here is something called chelation (pronounced “key-LAY-shun”) therapy. The name comes from the Greek word chele , which means “to claw,” and it graphically illustrates how the treatment is said to work--grabbing evil particles of calcium from the bloodstream and tossing them out of the body.
While even its advocates disagree on whether it can do all of the above, its most expansive backers describe it in language a plumber might use. They call it a sort of Roto-Rooter of the arteries, swirling away the fatty plaques that clog major vessels leading to the heart. And all of this, they note, at a cost that is only a fraction of the price of bypass surgery, whose effects, not even a heart surgeon could argue, are merely temporary.
Unfortunately, there are two problems clouding the chelation picture: Despite the fervor of the treatment’s advocates, the claims made for it--other than as a generally recognized treatment for lead poisoning--have never been confirmed in any scientifically defensible study. (This is a nettlesome and unfortunate problem, its backers say, but one that will soon be rectified.)
Actively Suppressed
More serious, as its supporters see it, is that chelation therapy is being actively suppressed by all but about 2,000 of the nation’s doctors. This is a political problem, not a medical one, say the advocates. It was made so by the mischievous work of the vast majority of the nation’s physicians who, though most of them are not surgeons, have banded together to protect bypass surgery and its concomitant profits.
While chelation therapy is being widely advertised by its practitioners, Dr. Peter Frommer, deputy director of the federal government’s National Heart, Lung and Blood Institute, dismisses it as the “Laetrile of cardiology.” It’s a dispute that has raged between 10 and 20 years. It is nowhere near resolution.
Two to Three Infusions
A patient undergoing chelation receives two or three infusions of a drug called EDTA a week, each administered over a three-hour period, at a cost of as much as $100 each. After several weeks or months of intensive initial therapy, treatments are often reduced to once a month or once every two months, but, with laboratory tests and charges for such adjuncts as megavitamins and books about the therapy that are widely sold in chelation clinics, the cost of the experience easily tops $3,000 and can reach $10,000.
Weight-loss and anti-smoking therapy are usually ordered in addition to chelation. The sense of well-being, critics argue, probably is due to better dietary habits and the absence of tobacco.
It is an emotional and political dispute that threatens to become as disruptive for medicine as the controversy that boiled up over Laetrile before it was ultimately dismissed as a quack drug.
The dispute over chelation is a national one, but one of its focuses is in Albany, next door to Berkeley, across the bay from San Francisco. In a suite of offices in a nondescript building behind a Wells Fargo Bank branch, Dr. Ross Gordon carries on a busy chelation practice and presides as president of the American Academy of Medical Preventics--a name that sounds a great deal like that of a mainstream medical organization. But it is a trade group founded about a dozen years ago by a small group of doctors--including Gordon and his brother, Garry, who also is a veteran of Laetrile advocacy--who wanted to keep chelation alive in the face, Ross Gordon says, of action by health insurance companies to stop paying for it because its claims could not be supported.
But if the chelation movement has the trappings similar to the situation that surrounded Laetrile--and even if the doctors who practice chelation therapy include a disquieting number who are veterans of the malpractice courtroom and license revocation proceedings--it also suggests a question that haunts even its most vociferous foes.
Graphically, Succinctly
The question was put most graphically and succinctly more than halfway across the country, in a hotel dining room in Springfield, Mo.
Springfield is no medical backwater. It boasts six hospitals--including the medical center serving the entire U.S. federal prison system--and 400 physicians. One of them, cardiologist Dr. Duane Hellam, a leader in Springfield’s battle against chelation therapy, is, nonetheless, bothered by the question :
What if chelation’s advocates really do have something?
Hellam is certain enough that the answer is negative that he is unmoved by the rejoinder of many chelation advocates who ask: What would any doctor do if his or her mother or wife or husband had a terminal condition like Alzheimer’s, a stroke or heart failure and all other treatments had been tried without result? Would not the mainstream doctor then try chelation, rationalizing that nothing else offered any hope?
“My answer is no,” Hellam said. “I could not justify using it on my mother because I would have to justify using it on my patients if I did and I can’t do that. It is so illogical to me.”
It’s uncertain how many people have taken chelation, because the doctors who offer it frequently practice without maintaining hospital privileges. Many practitioners claim to have given the therapy to 5,000 people or more. The size of the industry that has sprung up around chelation is likewise unknown, though Gordon’s group claims a membership of about 400 doctors and Gordon’s estimate is that another 1,500 non-members probably offer chelation too.
Chelation has been controversial since the 1960s when it was first introduced as a cure-all for heart disease, having already established itself as the best treatment available for lead poisoning. The fight over chelation has shifted from battlefield to battlefield. As this has occurred, chelation’s proponents have modified their claims for it as mainstream scientists have zeroed in on some of the assertions made on the drug’s behalf, leaving a discernible trail of contradictions. Three of them are these:
--Roto-Rooter. From a brochure distributed by at least one San Fernando Valley chelation clinic: “Chelation therapy removes the calcium from the plaques in hardened blood vessels and has a ‘Roto-Rooter’ action.” Untrue, said Ross Gordon. “We cannot make the assertion that we’re Roto-Rootering plaque out of humans because we don’t have any evidence to that effect.”
--Alzheimer’s. One of California’s most prominent chelationists, Dr. H. Richard Casdorph, operator of a Long Beach clinic and a member of the American Academy of Medical Preventics, is one of many chelationists who claims Alzheimer’s is due to the transmission of aluminum in the bloodstream to brain tissue and that chelation can remove the aluminum and treat the Alzheimer’s. “My results in Alzheimer’s have been very encouraging,” Casdorph said. Gordon disputes that too. “I don’t think anyone in our group suggests that EDTA is valuable in Alzheimer’s,” he said.
--Basic research. Key to the arguments of chelationists, led by Gordon, is the claim that studies in the early 1960s by a research team in Philadelphia led first to rejection of chelation, but then to its acceptance after patients originally dismissed as failures turned into successes. The research, conducted by a team led by Drs. J. Roderick Kitchell and Lawrence E. Meltzer, was published widely between 1961 and 1963. Their studies appear in indexes of literature circulated by the Academy of Medical Preventics.
But a close reading of the work of Kitchell and Meltzer finds that, in 1963, after the group had worked for four years to try to evaluate the effects of chelation on 38 patients, they could find none. The study circulated by chelationists concludes: “We believe that chelation . . . did not benefit patients more than other commonly used therapeutic methods. It is not a useful clinical tool in the treatment of coronary disease.”
Though Kitchell has been retired for several years, Meltzer is still at the University of Pennsylvania School of Medicine, where he has watched the controversy over chelation with interest and puzzlement. In a telephone interview, he said that when he and Kitchell dismissed chelation in that journal article in 1963, “it was essentially the end of it, for all practical purposes.”
Couldn’t Document Changes
What had happened, he said, was the research team had found that techniques for measuring such things as arterial blood pressures were so primitive more than 20 years ago that, while patients reported they felt better after chelation, “we could not document changes commensurate with the feeling of well being.”
Kitchell and Meltzer found something else that bothered them, too: Their chelated patients were dying about at the same rate as those who did not receive treatment. In one review by Kitchell and Meltzer, of 10 patients with severe angina who were treated with EDTA, five died, one patient survived but deteriorated 12 months after chelation and one patient who lived improved only briefly and then returned to his former disability.
“I can’t say I’m pleased” about the uses that have been made of the work,” Meltzer said. “I don’t know if chelation is totally worthless or what.”
The purported main scientific premise of today’s chelationists--that EDTA (for edetate disodium) binds to calcium in hardened arteries and flushes it from the body--strikes most mainstream scientists as not just unlikely, but ridiculous. That is because, said Missouri’s Hellam and heart institute’s Frommer, calcium deposits usually don’t become significant in blocked coronary arteries until quite late in the disease process--long after much of the damage has been done to the heart by decreased blood flow. The problem in such cases, said Frommer, is fat. Sometimes, calcium is never present, even in advanced disease.
Not only that, but EDTA--which has long been recognized as the drug of choice in treatment of lead poisoning and, hence, has a significant if small role in legitimate therapy--is opportunistic in its action. It will grab calcium deposits (it works so well in lead poisoning because calcium drawn from the bloodstream in turn attracts lead and the whole business is excreted in urine) from the easiest spots to reach: the bloodstream itself or bone. EDTA is not known to be terribly adept at pulling calcium from arterial walls.
The lack of what he considers scientific logic to the central premises of chelation has also bothered Dr. Antonio Gotto, an internationally known heart disease expert who is chairman of the department of internal medicine at Baylor College of Medicine and the Methodist Hospital in Houston. Gotto is also a past president of the American Heart Assn.
But illogical though it seems, Gotto said he believes that only when a reputable scientific study is conducted will the chelation controversy be laid to rest. While some doctors believe that even performing such a study would accord chelation a measure of respectability it does not deserve, there is every indication such a study will be done soon.
And while the news may surprise many of Gotto’s mainstream colleagues, he said in a telephone interview he is negotiating with Ross Gordon on a research protocol to be used for just such a study--perhaps to begin within three months. It would take at least two years to complete the research alone, and results probably could not be published before at least three years from now.
Buying Chelation Time
Chelation opponents argue that the lag only buys time for a questionable treatment. Gotto figures there is no other way to resolve an emotionally charged question. He and other doctors note that, only after the National Cancer Institute reluctantly performed a legitimate study on Laetrile (finding it worthless) did that drug’s popularity begin to wane.
This study of chelation would be what doctors call double-blind and prospective. In other words, neither patients receiving either chelation or treatment with an inactive placebo nor the doctors treating them would know which group of subjects was which. Then, perhaps halfway through the two-year research project, the placebo group would start getting chelation drugs and vice versa.
Gordon recognizes that the lack of scientific backing is chelation’s most serious problem as it attempts to establish legitimacy. “There is absolutely no question this is backwards” in terms of the way new therapies are normally introduced, Gordon said, agreeing that the customary way for new medical ideas to gain use is for research to establish that they work before they are brought to the marketplace.
But Gordon contended he remains convinced of chelation’s efficacy, even if the mainstream of science is still skeptical. He said he is not bothered that even its backers have never filed a U.S. Food and Drug Administration application to test EDTA.
Under normal circumstances, Gotto said, the weight of existing scientific evidence that chelation does not--indeed, cannot--make good on the promises made for it would be enough and chelation probably would not be deemed worthy of such a clinical trial. But these are not, he said, normal circumstances. “I believe a study should be done not based on scientific evidence, but by virtue of the fact that this has become such a major health (political) issue,” Gotto said.
Chelation as it has come to be known outside of lead poisoning treatment is a development with its roots in the 1950s and early 1960s, when doctors studying EDTA became intrigued by the possibility it could be of enormous use in treating heart disease. It appeared to be an effective way to treat some abnormal heart rhythms, and it could be used to overcome the effects of too heavy doses of digitalis, one of the oldest and most common drugs used to regulate the action of the heart.
One of the doctors fascinated by the early promise of EDTA was Dr. Alfred Soffer, then a relatively obscure Chicago researcher who eventually became principal author of a book called “Chelation Therapy” in whose introduction Soffer speculated that “it is certain that this form of therapy will prove to be of indispensable aid in diverse circumstances.” But even then, Soffer and others who had high hopes for chelation couldn’t make the promise bear fruit in the laboratory.
Became Disappointed
As the 1960s progressed, Soffer and others who hoped for early promise from EDTA were disappointed. In fact, in a chapter of the same book, Soffer conceded that the benefits he observed in patients treated with chelation were only temporary, and he concluded that “early enthusiasm for chelation in treatment of (diseases of the coronary arteries) has waned.”
It is there that the chelationists and their critics--who now number Soffer among the most vocal--part ways. Chelationists still tender as substantiation and justification for their claims reams of studies conducted in the 1950s and 1960s--in which the fascination with EDTA was still more speculation about its potential than proof of its performance.
The other side, led by Soffer, Frommer and virtually every major medical organization concerned with heart disease, along with a wide cross section of the nation’s most influential medical publications, argues that the chelationists, by the most charitable assessment, have somehow been trapped in time.
Chelation therapy for heart and related diseases has specifically been rejected as unproven by the U.S. Food and Drug Administration, the American Medical Assn., the American Heart Assn., the National Institutes of Health and the American College of Physicians. Two of the three major drug companies that manufacture EDTA have long included warnings in labeling written for doctors that the drug is unsuitable for treating coronary artery disease. Last year, one of the firms, Riker Laboratories, a division of the 3M Corp., stopped making EDTA because the market for it was small to begin with, according to a company spokesman, and was being dominated by what Riker and other drug companies view as inappropriate uses for the chemical.
Chelationists say the drug companies are merely doing the FDA’s bidding and trying to isolate themselves from potential product liability suits. This surrender by drug companies, say the chelationists, came because the patent to EDTA expired in 1960 and no pharmaceutical house can corner the market in it now--making it economically impractical for a drug firm to sponsor research about EDTA. But chelation opponents point out that there is no shortage of valid, probing contemporary research on aspirin and digitalis--two drugs long since past the point of patent protection and manufactured by far more generic drug houses than EDTA.
(Actual deaths from the effects of chelation are rare, largely because the early ‘60s research found that if the treatments are spread out over three hours or more, EDTA is not toxic. If the sessions are too short, however, kidney damage or death may result.)
Condemned Clinics
Today, Soffer is editor of the journal Chest, published for heart specialists, and in an editorial last year condemned today’s chelation clinics as “an abuse of the physician’s freedom of choice.” He makes an argument that has become increasingly common in mainstream medicine as chelation has tried--and in a few states succeeded--in carving a niche for itself despite the best efforts of mainstream doctors to prevent it.
“Every (medical) cultist in the last 3,000 years has said that it is unethical to withhold treatment (with something that might work), but I say it’s more dangerous to give something that is unproven.”
The estrangement between Soffer and Gordon is enormous. Soffer has spent several years arguing that, by offering chelation treatment essentially without any reputable scientific evidence of its effectiveness, chelationists are introducing a serious threat to the freedom of mainstream physicians to practice as they see fit.
“In the face of this evidence, the clinician who recommends chelating drugs for the treatment of vascular disease is abusing a precious freedom,” Soffer wrote in Chest. “This freedom is a privilege that has been granted physicians for uses vastly different from the establishment of chelation clinics!
“Chelation therapy for atherosclerosis does not meet the standards of acceptable medical care for any community in the U.S. or any other country in the world.”
