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Another State Promotes the Pseudoscientific Cult that is “Naturopathic Medicine.” Part 2

The “Safety of Naturopathic Treatment”

In their nationwide effort to convince lawmakers to pronounce them primary care physicians, “educated” naturopaths have repeatedly claimed that their “natural” treatments are “safer and gentler” than those offered by medical doctors. The Alliance Legislative Workbook, a website that for several years provided strategies and “talking points” for ND-activists seeking state licensure, made this assertion in 2001:

Malpractice insurance rates [for licensed NDs] are generally less than $4000.00 per year, indicating the safety of naturopathic treatment as assessed by insurance companies. Master Insurance Trust reports that of the naturopathic physicians for whom MIT provides liability insurance, there have been only four incidents reported to the company for follow-up. However, nothing has been paid in either settlements or judgements on any of these items. “While this pooling of physicians is much too small to base actuarial considerations, this claims experience is clearly superior.” (Jeffrey D. Brunken, Program Manager, MIT, Letter dated May 21, 1990.)

Jury Verdicts Northwest, a legal database which records court cases in Washington and Oregon, the area of the country with the largest number of naturopathic physicians, shows no judgments for malpractice against N.D.s since the database was started in 1983. One in five M.D.s is sued each year in the US (AMA).

Why is malpractice so much lower among naturopathic physicians?

Naturopathic methods are less likely to cause injury than orthodox methods. Prudent dietary and lifestyle changes, for instance, are unlikely to cause harm. Naturopathic physicians by philosophy and training use the least invasive means to treat and prevent disease. This results in less injury to patients. Naturopathic physicians also have excellent diagnostic and referral skills. There is no significant history of complaints against naturopathic physicians resulting from a missed diagnoses, the most common cause for suits in a general practice. From insurance data, it appears that naturopathic physicians as a group know the limits of their methods and refer patients to other practitioners or specialists when appropriate.

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

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The FDA Cracks Down on Fake Cancer Cures

The Food and Drug Administration (FDA), the agency that regulates the drug industry in the US, put out a press release yesterday warning “Individuals and Firms to Stop Selling Fake Cancer ‘Cures’.” The press release reports:

“Although promotions of bogus cancer ‘cures’ have always been a problem, the Internet has provided a mechanism for them to flourish,” said Margaret O’K. Glavin, the FDA’s associate commissioner for regulatory affairs. “These warning letters are an important step to ensure that consumers do not become the victim of false ‘cures’ that may cause greater harm to their health.”

The FDA therefore recognizes that this is a serious problem, and that is good. They also acknowledge that the problem of “bogus cancer cures” is a longstanding one, not a new or recent problem, but the reason they are taking action now is because the internet is significantly increasing the reach of these fake cures.

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Posted in: Cancer, Health Fraud, Politics and Regulation

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Another State Promotes the Pseudoscientific Cult that is “Naturopathic Medicine.” Part 1

Minnesota has recently become the 15th state in the U.S. to formally endorse the claims of a tiny group of naturopaths who portray themselves as physicians.* The bill , like the popular-media “CAM” reports that Steve Novella criticized on Wednesday, merely parrots what these naturopaths claim about themselves. It reveals no attempt to investigate or to judge the tenets of the field. The following excerpts present false assertions as though they were facts. I’ve underlined some of the more obvious examples:

“Naturopathic medicine” means a system of primary health care for the prevention, assessment, and treatment of human health conditions, injuries, and diseases

“Naturopathic physical medicine” includes, but is not limited to, the therapeutic use of the physical agents of air, water, heat, cold, sound, light, and electromagnetic nonionizing radiation and the physical modalities of electrotherapy, diathermy, ultraviolet light, hydrotherapy, massage, stretching, colon hydrotherapy, frequency specific microcurrent, electrical muscle stimulation, transcutaneous electrical nerve stimulation, and therapeutic exercise.

The practice of naturopathic medicine includes, but is not limited to, the following services: (1) ordering, administering, prescribing, or dispensing for preventive and therapeutic purposes: food, extracts of food, nutraceuticals, vitamins, minerals, amino acids, enzymes, botanicals and their extracts, botanical medicines, herbal remedies, homeopathic medicines, dietary supplements and nonprescription drugs as defined by the federal Food, Drug, and Cosmetic Act, glandulars, protomorphogens, lifestyle counseling, hypnotherapy, biofeedback, dietary therapy, electrotherapy, galvanic therapy, oxygen, therapeutic devices, barrier devices for contraception, and minor office procedures, including obtaining specimens to assess and treat disease

Unlike the Minnesota leglislators, I have substantial knowledge of the tenets and practices of “naturopathic physicians,” and I am capable of judging those tenets according to standards of reason, science, and modern, science-based medicine. Beginning with my stint on the Massachusetts Special Commission on Complementary and Alternative Medical Practitioners 6-8 years ago, I have spent years listening to “NDs,” reading their literature, and writing about them. I described a bit of my experience on that Commission in a post on Science-Based Medicine several weeks ago. I have continued to observe NDs’ cult-like behavior since then, and have seen no indication that they have begun to awaken from their collective, pseudoscientific stupor.

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Posted in: Health Fraud, Politics and Regulation, Vaccines

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Mercury Must Be Bad – If Not in Vaccines, In Teeth

Those of us who are baby boomers or older can remember playing with mercury when we were young. The thermometer broke, and you pushed the little globules around. Or you fooled around with the stuff in science class. My husband says he used to get mercury to flow over the surface of a dime and make it look really shiny. Who knew our old playmate would turn out to be such a bugaboo?

The real dangers of mercury have been recognized. Guidelines have been published to limit exposure. Instructions for safe cleanup of mercury spills are available online. This is good. Other developments are not so good. Scaremongers have demonized mercury and blamed it for everything from autism to Alzheimer’s.

Just when you thought the mercury/autism scare was finally subsiding, another mercury scare has resurfaced. The alarm has been raised (again!) about the mercury in amalgam fillings. (more…)

Posted in: Dentistry, Health Fraud, Politics and Regulation, Science and the Media

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Touched by a Touched Healing Toucher

Recent posts by Drs. Sampson and Hansen and some recent comments have got me to thinking for the umpteenth time about this issue: quackery is quackery, even if it seems harmless and even if some people seek it. This is the first of a series that will discuss it. I’m afraid I will ramble a bit; it may be that not every post will support that premise. Nevertheless, in the aggregate I’ll try to do exactly that.

The posts about Healing Touch sent me on a walk down memory lane, to one of my early forays into “CAM” skepticism. It was there that I discovered just how removed from reality some true believers, even those that project a superficial air of sobriety, can be. Here I’ll recount a brief exchange that I had with one such person, who was undoubtedly well-meaning. My attempts to influence her by the use of reason proved futile.

Shortly after the publication of the famous Emily Rosa article in 1998, I read a report about it in Newsday. It wasn’t all that bad, but my annoyance with mainstream publications giving the slightest credence to “alternative medicine” had been growing, and this moved me to act. I wrote a diatribe to Newsday that was not published (I can’t imagine why):

To the Editor:

“Therapeutic touch” is such obvious humbug that it never should have been taken seriously by anyone with the slightest aquaintance with how things work. Nevertheless, academic careers have been based on it, hundreds of useless papers have been written about it, courses in it have been given and even required of nursing students, grant money has been provided for it (but not used to test it!), and scores of ridiculous magazine and newspaper articles have praised it, apparently to a naive and credulous public. All of this constitutes a huge embarrassment to nurses, a fact that would appear to be lost on their largest professional organization (the ANA).

One of the statements in your article about the JAMA study was incorrect: the practitioners were not able to detect the energy field half of the time. They were able to guess the correct hand half the time, as would be predicted by chance alone. Thus there is no evidence that the “energy field” was detected at all. This is no surprise, because this kind of “energy field” exists only in the fantasies of true believers.

Dolores Krieger’s objection to the study, that the right practitioners were not tested, is disingenuous. She has been asked numerous times, by James Randi and others, to submit to testing of the same sort as described in Rosa’s study (Randi’s foundation has even offered a $1 million reward for anyone who can demonstrate the ability to detect the “energy field”!). Neither she nor any of her trainees or colleagues has come forward, nor has any of them published a single study supporting the efficacy of “therapeutic touch.”

Among the shamelessly fawning, uncritical articles on TT referred to above is one in Newsday by Tina Morales, 7/8/96. Really, now. There are very simple, basic skills useful for evaluating questionable claims. If the writer doesn’t have them the editor certainly should!

Before gentle readers admonish me for the scolding, schoolmarmish tone of that letter, let me assure them that I have long since learned to couch my objections to “woo” in more matter-of-fact, less provocative language. As frustrating as it may be, amiable, well-meaning, intelligent people who haven’t the slightest idea how to evaluate questionable claims vastly outnumber their more savvy counterparts, even in surprising fields: journalism and medicine, for example. Ten years ago I had no intention of becoming more than a temporary, annoying gadfly. I imagined that the “CAM” fad would soon blow over, and that I’d go back to spending my free time watching re-runs of Seinfeld and Law and Order. Alas, ’twas not to be. Patience.

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Posted in: Energy Medicine, Faith Healing & Spirituality, Health Fraud

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

Part IV of this blog ended by observing that the NIH-funded trial of the “Gonzalez regimen” for cancer of the pancreas,† to have begun in March, 1999, was in trouble almost as soon as it started. As originally designed, it was to have been a randomized, controlled trial comparing gemcitabine, the standard chemotherapy, to the “Gonzalez regimen” of pancreatic enzymes, “supplements,” twice-daily coffee enemas, and other purported methods of “detoxification.” By June, 1999, according to Dr. John Chabot, the Columbia University surgeon acting as Principal Investigator (PI) of the trial, only 3 of the first 50 potential subjects had agreed to be randomized, and none of the three met the eligibility criteria. By January, 2000 it had become clear that the trial would not accrue a sufficient number of subjects if it remained randomized, because almost all of the potential subjects were intent on being in the “nutritional,” ie, the Gonzalez arm.

Trouble with Randomizing

The investigators at Columbia therefore decided to change the protocol to a “single-armed, non-randomized case-cohort study where patients will only be enrolled in what was the nutritional arm.” Paradoxically, PI John Chabot had recently explained, at the 1999 Comprehensive Cancer Care Conference of James Gordon’s Center for Mind-Body Medicine, why this would not be a scientifically sound design:

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Posted in: Clinical Trials, Health Fraud, Medical Academia, Medical Ethics

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

A Review; then Back to the Gonzalez Regimen†

Part I of this blog introduced the topic of the “Gonzalez regimen” for treating cancer: “Intensive Pancreatic Proteolytic Enzyme Therapy With Ancillary Nutritional Support” and “detoxification” with twice daily coffee enemas, daily “skin brushing,” “a complete liver flush and a clean sweep and purge on a rotating basis each month,” and more. The topic was occasioned by the federal Office for Human Research Protections having recently cited Columbia University, for the second time, for violations of human subject protections in its NIH-funded trial of Gonzalez’s method as a treatment for cancer of the pancreas.

Part I discussed the implausible and bizarre regimen and cited Gonzalez’s troubles with malpractice suits and with the New York medical board during the 1990s. It ended by wondering what could have induced the NIH to give a $1.5 million grant to Columbia University to study the method.

Parts II and III began to answer that question, tracing some of the key events and individuals from the Laetrile wars in the 1970s to the NCI-funded trial of Laetrile reported in 1982, to the ”immuno-augmentative therapy” (IAT) battles of the mid-’80s, to the Report on “Unconventional Cancer Treatments” by the Congressional Office of Technology Assessment (OTA) in 1990, which in turn led to the NCI adopting its “Best Case Series Program” in 1991.

The end of Part III hinted that the conspiracy mongering that had greeted every attempt by the government to explain its positions on implausible cancer treatments, from Laetrile to the OTA report, ultimately led to the creation of the Office of Alternative Medicine (OAM) at the NIH, also in 1991. There is plenty of evidence for that, both from the conspiracy mongers themselves and from more level-headed observers. Each time the government acted—to fund a trial of Laetrile, to solicit the OTA report and propose a study of IAT, to establish the NCI “Best Case Series” program, and to establish the OAM—it was not because of scientific or medical considerations, but because of political pressure. More on that from time to time, but now back to Dr. Gonzalez.

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Posted in: Cancer, Clinical Trials, Health Fraud, Medical Academia, Medical Ethics

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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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