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“Chelation Therapy”: Another Unethical “CAM” Trial Sponsored by Taxpayers

Please forgive the promotion of our own work and the facile evasion of a full-length blog, but two of your faithful bloggers are co-authors of an article published this week:

Why the NIH Trial to Assess Chelation Therapy (TACT) Should Be Abandoned

Kimball C. Atwood IV, MD; Elizabeth Woeckner, AB, MA; Robert S. Baratz, MD, DDS, PhD; Wallace I. Sampson, MD

Medscape J Med.  2008;10(5):115.  ©2008 Medscape

Posted 05/13/2008

Available here.

You may be asked to “register”; don’t worry, it’s free. The article is very long, but the Introduction, Executive SummaryDiscussion, and Conclusion are reasonably succinct and make the important points. Readers who want to learn more details, who want to see more evidence for our assertions, or who are compelled by an odd fascination with crackpotism (my own weakness) will want to read more. Here is a small sample:

Abstract

The National Institutes of Health (NIH) Trial to Assess Chelation Therapy (TACT) was begun in 2003 and is expected to be completed in 2009. It is a trial of office-based, intravenous disodium ethylene-diamine-tetra-acetic acid (Na2EDTA) as a treatment for coronary artery disease (CAD). A few case series in the 1950s and early 1960s had found Na2EDTA to be ineffective for CAD or peripheral vascular disease (PVD). Nevertheless, a few hundred physicians, almost all of whom advocate other dubious treatments, continued to peddle chelation as an office treatment. They claim that chelation dramatically improves symptoms and prolongs life in 80% to 90% of patients. In response, academics performed 4 controlled trials during the 1990s. None favored chelation, but chelationists repudiated those findings.

We have investigated the method and the trial. We present our findings in 4 parts: history, origin and nature of the TACT, state of the evidence, and risks. We present evidence that chelationists and their organization, the American College for Advancement in Medicine, used political connections to pressure the NIH to fund the TACT. The TACT protocols justified the trial by misrepresenting case series and by ignoring evidence of risks. The trial employs nearly 100 unfit co-investigators. It conflates disodium EDTA and another, somewhat safer drug. It lacks precautions necessary to minimize risks. The consent form reflects those shortcomings and fails to disclose apparent proprietary interests. The trial’s outcome will be unreliable and almost certainly equivocal, thus defeating its stated purpose.

We conclude that the TACT is unethical, dangerous, pointless, and wasteful. It should be abandoned.

Readers of my postings on SBM will find more discussion (and abundant evidence) of familiar material: ethical breaches resulting from political incursions into science; the pitfalls, both scientific and ethical, of ignoring prior probability; a Dirty Secret of the Extraordinary Popular Delusion that is “CAM,” that much of what masquerades as sober research or the practice of “integrative medicine” was spawned by Laetrile; and widespread dishonesty in “academic CAM.”

Medscape Journal of Medicine invites readers to post comments or to send private letters to the editor for potential publication (and replies by yours truly, in this case). If you are so moved, you might consider posting comments in duplicate, both there and here on SBM, for the benefit of our select readership.

Posted in: Clinical Trials, Health Fraud, Medical Ethics, Politics and Regulation

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The Trojan Horses of Education

Last time I described what I could find about the “Quiet Revolution” plan for medicine through the eyes and minds of the Bravewell Collaborative and Christy Mack, wife of the multi-millionaire or billionaire CEO John Mack. The idea seemed two-pronged; “humanize” physicians and medicine generally, and integrate folkway, sectarian and “alternative” methods into the system. What bothered me more, having become inured to patient philandering with quackery, was the brazen attempt to re-educate physicians and indoctrinate students into the political and social views of wealthy idealists. The entry below, one might conclude, has little to do with medical quackery and pseudoscience, but I beg your indulgence for this series as I attempt to connect dots between the stalls of the seemingly unrelated steeds of political indoctrination in universities and the proposed med school re-education camps of Bravewell. For several years a controversy has roiled at the University of Delaware over a program of educational activities for the dorms called Residence Life. The program structures student time with a number of usual activities – games, talks, discussion groups – but the content of the discussion groups and interpersonal counseling upset some students, who complained to an off-campus conservative organization, and got to the attention of faculty, which pressured the administration to stop the program last fall.

To outsiders such as we, the program looked like a feel-good, beneficent guidance tools. To the complaining students and critics the discussions seemed more like indoctrination groups, with political agendas taking on disguised roles as helpful guidance for student angst. Students complained about invasion of their privacy through group and leader pressures, and the faculty saw indoctrination and invasion of their educational duties (turf) by student counselors bearing ideological messages with little qualification.

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Posted in: Medical Academia, Politics and Regulation

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Canada Bill C-51 – Regulating Natural Health Products

In Canada a new bill has been proposed, Bill C-51, that would make changes to the Food and Drug Act – the body of laws by which the Canadian federal government regulates food and health products in Canada. This is the equivalent of the Food and Drug Administration (FDA) in the US. It seems that Canada, like the US, is struggling to deal with a burgeoning industry of “natural health products” that are minimally regulated.

The new bill will increase government oversight of natural health products (NHP) for the purpose of ensuring higher quality standards for products and accuracy in the claims that are made for them. Proponents of the bill claim that it will serve to improve consumer protection. But the NHP industry is not happy with the increased oversight the bill would bring. Their hysterical reaction to the proposed bill is very revealing about the propaganda and deception used by the NHP industry.

This history of NHP regulation in Canada also reveals the two primary strategies by which the promoters of unscientific medicine and health products seek to advance their business. On the one hand they seek licensure, certification, and other formal recognition by the government in order to bolster their legitimacy with the public and also to keep competition at bay. When seeking such things they argue that licensure etc. will give the government the opportunity to regulate the industry and ensure quality control. They therefore take the position of consumer protection.

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Posted in: Herbs & Supplements, Politics and Regulation

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“CAL”: a Medico-Legal Parable

Preamble

From the fall of 2000 to the winter of 2002, the Commonwealth of Massachusetts convened a Special Commission on Complementary and Alternative Medical Practitioners. There were 12 members: 6 legislators, 3 MDs, a naturopath, a lawyer who represented the New England School of Acupuncture, and the chairman, who was also the Director of the Massachusetts Division of Professional Licensure. At the start of deliberations two things became apparent: first, the Commission would concern itself almost exclusively with the petition of “naturopathic physicians” to become licensed health care practitioners in the Commonwealth*; second, there were only two recognizable, medically-sophisticated skeptics among the members. They were Arnold “Bud” Relman, the emeritus editor of the New England Journal of Medicine (appointed by the Massachusetts Board of Registration in Medicine), and I (appointed by the Mass. Medical Society). We expected a third, an MD soon to be appointed by the Commissioner of Public Health, Dr. Howard Koh.

Within a few weeks it became clear that the third MD would not be a skeptic. Dr. Koh, apparently thinking he had found an expert, appointed as his representative David Eisenberg, Director of the Harvard Medical School (HMS) Division for Research and Education in Complementary and Integrative Medical Therapies. Dr. Koh must not have known that in 1997 Dr. Eisenberg had called for

A national listing of licensed alternative medical providers (e.g., chiropractors, acupuncturists, massage therapists, naturopaths, and homeopaths) in each of the 50 states as well as a uniform credentialing process.

Commissioner Koh also must not have known that Dr. Eisenberg had received or was currently receiving funds from several sources committed to furthering the ambitions of ”CAM” practitioners in general or of “naturopathic physicians” in particular: the NCCAM, the Fetzer Institute, the New York Chiropractic College, Cambridge Muscular Therapy Institute, New England School of Acupuncture, American Specialty Health Plan, and the Southwest College of Naturopathic Medicine.

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Posted in: Politics and Regulation, Science and Medicine

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Integrative Medicine – Sectarians’ Trojan Horse

Integrative Medicine – Sectarians’ Trojan Horse leapfrogs science (Or, I can misuse language with the best of them…)

I stumbled across an article from Archives of Internal Medicine, 2002 (Integrative Medicine: Bringing medicine back to its roots. Arch Intern Med. 2002 Feb 25;162(4):395-7). It is one of the first authored by Andrew Weil on “Integrative Medicine “ – another is BMJ in 2001. This one he co-authored with Ralph Snyderman. Dr. Snyderman was dean of the Duke University med school, and is now upstairs as a chancellor of health affairs. He is one of the highest ranking academicians to express fondness for sectarian systems (they prefer “Integrative Medicine.”) Fondness in his case is an understatement. He appears to have fallen up to his frown into the sectarian vat and emerged transformed as the poster-prof for the Bravewell Collaboration, funding organization for the 36 departments and programs in US medical schools. Andrew Weil, of course is one of the prime movers of the “CAM” phenomenon, and may have invented the neo-term, “Integrative” – with the clever occult purpose of diverting attention away from plausibility and toward acceptance according to our suggested motto, “teach it and use it regardless of efficacy.“ He directs this activity from his spread near Tucson, where he also heads the U. of Arizona “integrative” program.

I experienced several problems on reading the article – mainly a cloud of dysphoria and a sense that of disagreement with it, but through a fog of obscure language, I could not identify why. One has to look closely at the language. The abstract alone yields enough for this entry. It displays language distortion by re-definition, as Kim Atwood recently explored, language obscurantism – use of generalizations and words with obscure or multiple meanings, and invented language. It also mis-states, misrepresents, assumes; these are established propaganda techniques and used to construct false labels on sectarianism’s Trojan Horse. After starting this I found a similar article by Edzard Ernst in Mayo Clinic Proceedings in 1993. Nothing new under the sun…

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Posted in: Medical Academia, Politics and Regulation, Science and Medicine

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The North Carolina Board of Medical Examiners, Dr. Rashid Buttar, and protecting the public from practitioners of non-science-based medicine

One of the most contentious and difficult aspects of trying to improve medical care in this country is enforcing a minimal “standard of care.” Optimally, this standard of care should be based on science- and evidence-based medicine and act swiftly when a practitioner practices medicine that doesn’t meet even a minimal requirement for scientific studies and clinical trials to support it. At the same time, going too far in the other direction risks stifling innovation and the ability to individualize treatments to a patient’s unique situation–or even to use treatments that have only scientific plausibility going for them as a last-ditch effort to help a patient. Also, areas of medicine that are still unsettled and controversial could be especially difficult to adjudicate. Unfortunately, with medicine being regulated at the state level, there are 50 state medical boards, each with different laws governing licensure requirements and standards for disciplining wayward physicians, our current system doesn’t even do a very good job of protecting the public from physicians who practice obvious quackery. The reasons are myriad. Most medical boards are overburdened and underfunded. Consequently, until complaints are made and there is actual evidence of patient harm, they are often slow to act. Also, in my experience, they tend to prefer to go after physicians who misbehave in particularly egregious ways: alcoholic physicians or physicians suffering from other forms of substance abuse; physicians who sexually abuse patients; or physicians who are “prescription mills” for narcotics. These sorts of cases are often much more clear-cut, but most importantly they don’t force boards to make value judgments on the competence and practice of physicians to nearly the extent that prosecuting purveyors of unscientific medicine does.

Dr. Rashid Buttar: Autism and cancer

The reason I’ve been thinking about this issue again is because last Friday it was announced that one of the most dubious of dubious physicians of which I have ever become aware, Dr. Rashid Buttar of North Carolina, was, after many years of practice, finally disciplined by the North Carolina Board of Medical Examiners. Basically, the Board restricted his practice so that he could no longer treat children or cancer patients (more on why those two particular restrictions were imposed below). Once hailed as a hero by antivaccinationists and even once having testified to the Subcommittee on Wellness & Human Rights on autism issues, he is now disgraced.

Dr. Buttar runs a clinic called the Center for Advanced Medicine and Clinical Research, which features on its front page this quote:

“All truth passes through 3 phases: First, it is ridiculed. Second, it is violently opposed, and Third, it is accepted as self-evident.”- Arthur Schopenhauer, 1788-1860.

I can’t resist mentioning that any time I see this particular quote, I know that I’m almost certainly dealing with someone who is far on the fringe, because what one first has to realize about the quote is that non-”truth” never makes it past phase one or two–and rightly so. Right off the bat, we can see that Dr. Buttar has a greatly inflated view of his own importance.
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Posted in: Cancer, Health Fraud, Medical Ethics, Neuroscience/Mental Health, Politics and Regulation, Vaccines

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Charlatan: Quackery Then and Now

Charlatan: America’s Most Dangerous Huckster, the Man Who Pursued Him, and the Age of Flimflam, by Pope Brock, is not only a rip-roaring good read, but it brings up serious issues about regulation of medical practice and prosecution of quackery. It tells the story of John R. Brinkley MD, who transplanted goat glands into people, and of Morris Fishbein MD, the editor of the Journal of the American Medical Association, who tried to stop him.

The Charlatan

Brinkley was a colorful character whose very first job was a scam, selling a patent remedy. He went to medical school but never finished, eventually buying a diploma elsewhere for $100. A bigamist, drunkard, liar, and con man of incredible audacity, he built up an empire of quackery that made him filthy rich. Apart from his medical adventures, he practically invented modern political campaigning techniques, revolutionized advertising, and was almost single-handedly responsible for popularizing country music and the blues with his radio station.

An impotent patient supposedly told Brinkley, “Too bad I don’t have goat nuts.” So Brinkley gave him some. A few weeks later he went back for a refresher course in surgery (which he failed because of drunkenness and poor attendance). He began to feel that he was gifted and should not be bound by the “jealous sheep ethics” of the AMA. (more…)

Posted in: Book & movie reviews, Health Fraud, Politics and Regulation

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The Ethics of “CAM” Trials: Gonzo (Part III)

A Reminder (Mainly to Myself): this Blog will Eventually get back to Discussing the NIH Trial of the “Gonzalez Regimen” for Treating Cancer of the Pancreas†

Which, if you’ll recall, is an arduous dietary and “detox” regimen that includes 150 pills per day, many of which contain pancreatic enzymes, two “coffee enemas” per day, ”a complete liver flush and a clean sweep and purge on a rotating basis each month during the 5 days of rest,” and more. In Part II I ventured off on a tangent about Laetrile and government sponsorship of trials of implausible cancer “cures.” That became more involved than I had planned (but also more enlightening, or so I hope), and Part III continues on that tangent.

The Politics of “Alternative Cancer Treatments”: the Lamentable Legacy of Laetrile (cont.)

The whole tide is beginning to turn toward metabolic therapy for degenerative disease and preventive medicine. Laetrile…has been the battering ram that is dragging right along with it…B-15,…acupuncture, kinesiology, …homeopathy and chiropractic…And we’ve done it all by making Laetrile a political issue.”

-Michael Culbert, editor of The Choice, the newsletter of the Committee for Freedom of Choice in Medicine. Quoted in 1979.¹

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Posted in: Health Fraud, Medical Ethics, Politics and Regulation, Science and Medicine

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The Weekly Waluation of the Weasel Words of Woo #3

Last Week’s Entry: Everyone’s a Winner!

The resounding total of 4 “translations” for the second W^5 entry might have been trying to tell me something…nah!

I gotta say that each of the four nailed the central point: the esteemed Institute of Medicine (IOM), a subset of the esteemed National Academy of Sciences, has decided that it’s just fine—no, it is “important” and even “required”—that when it comes to “CAM,” the medical profession dispense with ethics, law, and science. Otherwise we might mistakenly argue, er, against the “integration of CAM therapies with conventional medicine.” That, clearly, would be unacceptable.

Stephen Barrett and others have critiqued some of remainder of the text. Regarding our own group of translators: yeah, you are all winners, but Stu once again rose above the crowd. Whadizzy, some kinda ringer? If he keeps this up I might have to insist that he be tested for performance-enhancing substances.

Hoodathunk that the IOM’s opinions are for sale? They are: the language that you deconstructed was bought and paid for, as we clunky Americans are so fond of saying, by…you and me! Yup, our tax dollars, funneled through the NCCAM and some other government agencies, generated the very Pap that we Smeared.

This Week’s Entry

In order to encourage more participation, I’ll try limiting entries to a single paragraph each, for a while anyway. This week’s entry, which will be the first of several from the same treatise, is found on the website of the American Medical Student Association (AMSA) as part of its “CAM Education Initiative“:

EDCAM – CAM and Medical Education Report

Medicine today is experiencing a paradigm shift that involves the blending of two disparate philosophies of health and disease, the biomedical or scientific reductionist view and the clinical, experiential holistic view. While the biomedical model reduces disease to a disturbance in biochemical processes and relies heavily on the “curative model” of care, holistic medicine derives from a “healing model,” which emphasizes the complex interplay between multiple factors: biochemical, environmental, psychological, and spiritual.

Feel free not only to restate it in the Queen’s English (it’s already in the Prince’s), but to comment upon its assertions. Remember, you gotta week, and I’ll announce the lucky winners in 2 weeks.

Happy waluating!

The Misleading Language and Weekly Waluation of the Weasel Words of Woo series:

  1. Lies, Damned Lies, and ‘Integrative Medicine’
  2. Integrative Medicine: “Patient-Centered Care” is the new Medical Paternalism

Posted in: Humor, Medical Academia, Politics and Regulation

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The Ethics of “CAM” Trials: Gonzo (Part II)

Laetrile and the Politics of NIH-Sponsored trials of “Alternative Cancer Treatments”

Part I of this blog ended by asking how, in light of the implausible and arduous nature of the “Gonzalez regimen” for cancer of the pancreas, and the unconvincing “best case series,” the NIH could ever have decided to fund a trial of it.† This entry will begin to answer that question. In so doing it may seem to veer from the original subject, but hold on to your seats: what you’ll find here is a piece of the treasure map that leads to the Mother Lode of Fool’s Gold that is government-sponsored “CAM” research.

All historical accounts of the encroachment of implausible claims into the research agenda of the NIH must begin with Laetrile. By that is meant all implausible claims, not merely those having to do with cancer. Elsewhere we have traced the history of “chelation therapy” for coronary artery disease, and have shown that its origins as a political movement, eventually leading to an unethical, $30 million, 2000 subject NIH trial, were intimately associated with people and organizations advocating Laetrile—the most lucrative health fraud ever perpetrated in the United States. In that essay we offer evidence that the creation of the NCCAM itself was at least partly attributable to the history of Laetrile and its advocates. Several good histories or partial histories of the Laetrile debacle are available online, including here, here, here, here, here, and here. The best,¹ but one that does not seem to be available online, is by the recently deceased dean of historians of American quackery, James Harvey Young. (more…)

Posted in: Cancer, Clinical Trials, Health Fraud, Medical Academia, Politics and Regulation

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