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The regulation of nonsense

 The most meticulous regulation of nonsense must still result in nonsense.

– Edzard Ernst, M.D., PhD., professor, Complementary Medicine, Peninsula Medical School, University of Exeter, UK

One necessity of licensing so-called “complementary and alternative,” or “CAM,” practitioners is to spell out exactly what is encompassed in the CAM scope of practice. This is unfortunate for the practitioners because it forces an exposé of the nonsensical precepts underlying their claims. For example,

‘Acupuncture’ refers to a form of health care, based on a theory of energetic physiology that describes and explains the interrelationship of the body organs or functions with an associated acupuncture point or combination of points located on ‘channels’ or ‘meridians’. . . Acupuncture points are stimulated in order to restore the normal function of the aforementioned organs or sets of functions.

(Delaware acupuncture practice act.)

[Chiropractic is] the science of adjusting the cause of the disease by realigning the spine, releasing pressure on nerves radiating from the spine to all parts of the body, and allowing the nerves to carry their full quota of health current (nerve energy) from the brain to all parts of the body.

(North Carolina chiropractic practice act.)

The practice of naturopathic medicine includes, but is not limited to, the following services:. . . 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 otaining specimens to assess and treat disease. . .

(Minnesota naturopathic practic act.)

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Posted in: Energy Medicine, Legal, Politics and Regulation, Science and Medicine

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The CAM Docket: Texas MDs v. DCs

In April, the Texas District Court of Appeals (Third District) affirmed a lower court ruling that chiropractors are prohibited from performing manipulation under anesthesia and needle electromyography[EMG]. The lower court also ruled that the Texas Board of Chiropractic Examiners exceeded its authority in defining the chiropractic scope of practice to include “diagnosis.” This part of the ruling was overturned by the Court of Appeals, but with some interesting language in the opinion which could turn their one win into a Pyrrhic victory for Texas chiropractors.  In a separate ruling, not on appeal, a lower court held that vestibular testing is outside the scope of chiropractic practice.

First, some background. Back in 1949, the Texas Legislature defined the scope of chiropractic practice as, among other things, “the practice of adjusting the vertebrae to correct any subluxation or misalignment thereof . . .” Over the ensuing years, the legislature amended the chiropractic practice act with an eye toward modernization, resulting in the current scope of practice being “nonsurgical, nonincisive procedures, including, but not limited to, adjustment and manipulation, in order to improve the subluxation complex or the biomechanics of the musculoskeletal system.” Now that’s progress!

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Posted in: Chiropractic, Legal, Politics and Regulation

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The CAM Docket: Boiron II

Five consumer lawsuits are pending in the U.S. against Boiron, the world’s largest manufacturer of homeopathic products. One lawsuit is also pending in Canada. As reported in a previous post, the U.S. plaintiffs claim they purchased homeopathic products, such as Coldcalm, Oscillo, Arnicare and Chestal Cough Syrup, based on Boiron’s misleading and false statements that they are effective for various ailments. Therefore, these plaintiffs allege, Boiron has defrauded consumers, as well as violated various consumer protection laws. Boiron denies these claims.

The plaintiffs’ allegations in each of the five U.S. lawsuits are based in part on the same fallacies underlying homeopathy discussed many times before here at SBM:

we can summarize . . . by saying it has extreme implausibility and the clinical evidence shows lack of efficacy. It should not work, and it does not work. There is no legitimate controversy about this.

Which raises an interesting question: how does one defend a product that appears to be indefensible? Let’s take a look. (more…)

Posted in: Health Fraud, Homeopathy, Legal, Politics and Regulation

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The “CAM” Consumer: Misled and Abused

There is a disturbing lack of protection for the consumer of “complementary and alternative” products and services. I can think of no other area of commerce where misleading, as well as out and out false, information is so regularly employed, without consequence, to entice the consumer into forking over his hard-earned cash. Nor do I know of any other manner of goods or services where giving consumers patently false information is protected by law.

Consider first the fact that nonsensical gibberish is enshrined in state law in the form of “CAM” practice acts, which give practitioners of implausible, if not wholly discredited, diagnostic methods and treatments carte blanche to ply their trades. For example, as has been discussed before on SBM, state law defines chiropractic as the detection and correction of subluxations, which, as many chiropractors themselves admit, do not exist. State practice acts define acupuncture in such pseudoscientific terms as “modulation and restoration of normal function in and between the body’s energetic and organ systems and biomechanical, metabolic and circulation functions using stimulation of selected points.”

As well, naturopathy practice acts allow “mixing and matching treatments including traditional Chinese medicine, homeopathy, herbalism, Ayurvedic medicine, applied kinesiology, anthroposophical medicine, reflexology, craniosacral therapy, Bowen Technique, and pretty much any other form of unscientific or prescientific medicine that you can imagine.” State practice acts also permit the indiscriminate use of the term “doctor” and “physician.” Scope of practice is broadly defined as “primary care.” (more…)

Posted in: Acupuncture, Chiropractic, Energy Medicine, Herbs & Supplements, Homeopathy, Legal, Naturopathy, Politics and Regulation

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The CAM Docket: Boiron I

Author’s note: This will inaugurate a series of occasional posts observing the wheels of justice grind slowly over “CAM.”

In a previous post, I posited that CAM practitioners might well subject themselves to liability for the tort of fraudulent misrepresentation. This misrepresentation could be based on both the lack of scientific evidence of effectiveness and the lack of scientific plausibility for their treatments. One example was homeopathy, which, as Dr. Steven Novella aptly stated,

we can summarize . . . by saying it has extreme implausibility and the clinical evidence shows lack of efficacy. It should not work, and it does not work. There is no legitimate controversy about this.

In the last couple of years five lawsuits have been filed against Boiron, a somewhat prickly company based in France and the world’s largest manufacturer of homeopathic products. In 2011, Boiron had $520,000,000 in sales, although some of this revenue comes from its other products, such as dietary supplements. The plaintiffs are consumers who purchased Boiron’s homeopathic “remedies” and who now allege that they were deceived by Boiron’s false and misleading representations, allegations Boiron denies. Four of the lawsuits are pending in California and one in Illinois.

All of the suits are filed as putative class actions, which generally proceed like this: a plaintiff claims she was injured in a certain manner by the defendant’s conduct and that there are numerous others who were injured in the same, or a similar, way. She asks the court to allow her to proceed with a class action in which she will represent all those other people. In essence, the class members become plaintiffs themselves and are bound by the results of the case. (They can’t, for example, bring their own individual lawsuits.) If the plaintiff is successful, all class members are entitled to relief, including monetary damages. (more…)

Posted in: Homeopathy, Legal, Politics and Regulation

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FDA versus Big Supp: Rep. Burton to the Rescue (Again)

The Dietary Supplement Health and Education Act of 1994 (DSHEA) has been aptly described here at SBM as a travesty of a mockery of a sham. The supplement industry’s slick marketing, herb adulteration due to lack of pre-market controls, Quack Miranda Warning, and the many supplements for which claims of effectiveness failed to hold up under scientific scrutiny (e.g., antioxidants, collagen, glucosamine and hoodia) have been impaled on the sharp pens of SBM posters as well.

And we’re not the only ones. Investigations of the supplement industry (or, Big Supp) by reputable institutions such as the U.S. Government Accountability Office and the Institute of Medicine have resulted in numerous recommendations to improve dietary supplement safety by, in part, strengthening the FDA’s ability to effectively regulate the industry. Many of these have gone unheeded.

A recent federal law tried to ameliorate this situation by directing the FDA to take specific steps designed to increase supplement safety. Yet the ink of President’s Obama’s signature was barely dry when a bill was proposed in Congress to gut its provisions. In fact, there are now several bills pending in Congress which would actually weaken the government’s already puny regulatory authority over supplements. Yes, things could get even worse.

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Posted in: Herbs & Supplements, Legal, Politics and Regulation

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Informed Consent and CAM: Truth Not Optional

In three recent posts, Drs. Novella, Gorski and Atwood took the Bravewell Collaborative to task over a report on its recent survey of U.S. “integrative medicine” centers. As Dr. Novella noted,

So what is integrative medicine? When you strip away the rebranding and co-opting of features and treatments of mainstream medicine, you are left with the usual list of pseudoscientific practices that have been trying to insert themselves into mainstream medicine for decades through a series of marketing and propaganda strategies. Bravewell has positioned itself at the forefront of that effort.

Among these pseudoscientific practices listed in a chart from the report included by Dr. Gorski in his post were acupuncture, TCM, reiki, therapeutic touch, naturopathy, homeopathy and reflexology.
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Posted in: Acupuncture, Chiropractic, Energy Medicine, Homeopathy, Legal, Medical Ethics, Naturopathy, Science and Medicine

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Antipodean CAM

It is one of the pleasures of travel to read the local newspapers of places I visit. I wholly agree with In a Sunburned Country author Bill Bryson, who observed,

It always amazes me how seldom visitors bother with local papers. Personally I can think of nothing more exciting – certainly nothing you could do in a public place with a cup of coffee – than to read newspapers from a part of the world you know almost nothing about. What a comfort it is to find a nation preoccupied by matters of no possible consequence to oneself. I love reading about scandals involving ministers of whom I have never heard, murder hunts in communities whose name sound dusty and remote, features on revered artists and thinkers whose achievements have never reached my ears, whose talents I must take on faith.

In a Sunburned Country chronicles Bryson’s travels in Australia, which I recently visited, along with New Zealand. Lovely places both – friendly people, jaw-dropping scenery, delicious food and wine. And a welcome vacation from American political wars, American economic wars and American war wars.

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Posted in: Humor, Science and the Media

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Legislative Alchemy: The New Year

A new year brings new opportunities for practicing the magic of legislative alchemy, the process by which state legislatures transform implausible and unproven diagnostic methods and treatments into perfectly legal health care practices, such as naturopathy, chiropractic and acupuncture. Different states have different legislative calendars, but many begin a new session soon after the first of the year. This gives “complementary and alternative medicine” providers a fresh opportunity to increase their scope of practice, insurance coverage and influence.

The state house doors have barely opened but CAM-friendly bills are already being docketed and sent on to health care and other committees for analysis. Unfortunately, legislators seem less than adept at critical thinking when it comes to perusing CAM legislation. To this point, I’ll start with an example from 2011: “Vertebral Subluxation Awareness Month” in Pennsylvania.

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Posted in: Chiropractic, Legal, Naturopathy, Politics and Regulation

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Strains, sprains and pains

What do you think would happen if you gave a bunch of “complementary and alternative medicine” practitioners access to a big pot of money — say, up to $10,000 per patient — and let them treat patients virtually without restriction, hampered only by a fee schedule. No utilization review, no refusal based on a treatment being “experimental” — none of the usual foils which trip up CAM practitioners in the health insurance field.

Think they’d run up the bill? Yes, they would.

In fact, that’s exactly the scenario playing out in Florida right now with the state’s no-fault auto insurance.

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Posted in: Acupuncture, Chiropractic, Legal, Politics and Regulation

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