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Dept. of Education to Council on Chiropractic Education: “Straighten Up!”

Our last look at the Council on Chiropractic Education (CCE), about 18 months ago, found the CCE deeply embroiled in a heated dispute among various chiropractic factions over new accreditation standards for chiropractic colleges. Today we offer an update on that situation.

Update: the CCE is deeply embroiled in a heated dispute among various chiropractic factions over new accreditation standards for chiropractic colleges.

As you may recall, the CCE, which accredits chiropractic colleges in the U.S., stood accused of removing the subluxation from its standards for accreditation, so that chiropractic students would no longer be required to learn how to “detect” and “correct” the putative vertebral subluxation. Of course, the chiropractic subluxation doesn’t exist, but we’ll get to that in a minute. This brouhaha was raised by the more traditional wing of the chiropractic community, called “straights,” whose practice (and livelihood) is based on convincing patients that their spines need “adjustments” to remove these subluxations under the threat of ill health should they be left unattended. The straights were also upset at the move by another faction of chiropractic seeking to rebrand chiropractors as primary care physicians who diagnose and treat a wide variety of diseases and conditions.

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Posted in: Chiropractic, Legal, Politics and Regulation

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Legislative Alchemy: 2012.5

Legislative alchemy, as faithful SBM readers know, is the process by which state legislatures and Congress take scientifically implausible and unproven treatments and diagnostic methods and turn them into licensed health care practices and legally sold products. Previous posts have explored this phenomenon in naturopathychiropractic and acupuncture.

Our last report on the legislative efforts of CAM providers appeared almost six months ago, the beginning of the legislative year for many states. Now, most legislatures have shuttered the statehouse doors and gone home. So let’s see how the CAM practitioners are doing this year.

Naturopathy

A goal of the American Association of Naturopathic Physicians (AANP) is “full scope of practice” in all 50 U.S. states. They’ve got a ways to go. Naturopaths are currently licensed to practice in only 17 states and the District of Columbia. Bills to expand licensure failed to make it out of committee again during the 2012 legislative sessions of two states, Iowa and Maryland. In Colorado and Virginia, where licensing bills failed to pass in previous years, no new legislation was introduced to license naturopaths in 2012. Bills to license naturopaths are still pending before legislative committees in Illinois, Massachusetts, Michigan, North Carolina, New York and Pennsylvania. However, in North Carolina and Pennsylvania these bills have been languishing in committee since 2011, making passage appear less likely This is especially true in North Carolina, where the legislative session ends soon.

Another strategy of the AANP is “progressive legislation.” This means that while some compromise in initial licensing legislation may be necessary to get a licensing bill passed, successive attempts can cure any initial disappointments through expansion of scope of practice and insurance coverage, for example. Nowhere was this strategy more successful in 2012 than in Vermont, where “naturopathic physicians” (as the Vermont Legislature calls them) were officially defined as “primary care providers” (PCPs) for the purpose of health insurance coverage. The new law means that naturopathic physician practices can qualify as patient “medical homes” under the state’s Blueprint for Health and that they may practice as such independently and without supervision.

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

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POM: Not So Wonderful

“POM Wonderful” is a brand of pomegranate juice. It is manufactured by a company owned by Linda and Stewart Resnick, California billionaires who pretty much single-handedly created a multi-million dollar market for pomegranate juice where none existed before. Or, as LA Times columnist Michael Hilzik wrote,

It has long been clear that the most wonderful thing about Pom Wonderful pomegranate juice is the spectacular marketing skill that persuades consumers to fork over their hard-earned cash for a liquid that sells for five to six times the price of, oh, cranberry juice.

He’s right about the expense: a daily 8 oz. dose of POM Wonderful juice costs about $780 annually according to a recent Federal Trade Commission case, which we’ll get to soon.

The Resnicks parlayed their success selling pomegranate juice into two additional products, both dietary supplements, in the form of POMx pills and POMx liquid. The Resnicks and their companies have shelled out $35 million in sponsored research to determine what health benefits might arise from ingesting pomegranate juice or its components, research they have not been shy about using in touting their products. The couple apparently has a flair for taking the mundane and making it appear, well, wonderful to the consumer – they also own Fiji Water and the Franklin Mint, among other business interests.

In 2010, the Federal Trade Commission (FTC) filed a complaint against Resnicks, one of their business partners, and two of their companies (which I’ll refer to collectively as “POM”), alleging unfair and deceptive trade practices. POM, according to the FTC complaint, made false and misleading claims that its POM products treat, prevent, and reduce the risk of heart disease, prostate cancer and erectile dysfunction.

An Administrative Law Judge (ALJ) agreed with the FTC and on May 17, 2012, issued a 335-page decision and cease and desist order, ruling POM lacked competent and reliable scientific evidence that drinking 8 ounces of POM Wonderful Juice daily, or taking one POMx pill, or one teaspoon of POMx liquid, treats, prevents or reduces the risk of heart disease, prostate cancer, or erectile dysfunction. In the Matter of POM Wonderful, LLC, et al., F.T.C. No. 9344 (May 17, 2012).

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Posted in: Clinical Trials, Herbs & Supplements, Legal, Nutrition, Politics and Regulation

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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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Consumer Reports and Alternative Therapies

Consumer Reports (CR) and its Health Newsletter provide sound advice about nutrition and medicine, with one exception: their recommendations concerning alternative therapies, especially dietary supplements. With regard to dietary supplements, part of the problem is the failure of CR to make a distinction between authentic dietary supplements, such as multivitamins and minerals, and non-vitamin, non-mineral medicinal products. For example, the September 2010 issue of CR contains a table listing “Eleven supplements to consider”. The list includes calcium and vitamin D supplements, and St. John’s wort and Pygeum herbals.

The nomenclatural confusion was created by the Dietary Supplement Health and Education Act of 1994 (DSHEA), which was termed “The Snake Oil Protection Act” by the New York Times. DSHEA, which was passed after a massive lobbying campaign by industry, arbitrarily designated herbals and other traditional medicinal products as dietary supplements. Herbals are used worldwide as medicines and in Europe some are available by prescription only.

The purpose of the Act was to prevent the Food and Drug Administration (FDA) from effectively regulating those products, and it succeeded brilliantly. Sales of dietary supplements rose from $4 billion annually in 1994 to $28 billion in 2007, and reports of severe adverse events caused by those products rose in parallel (1). Another consequence of DSHEA is that designating herbals as dietary supplements misleads consumers about their medicinal nature and conceals their potential for causing severe adverse effects.

The selling points for herbals are that as “natural” products they are safer and gentler than the powerful “foreign” chemicals in purified medications, and they possess unique qualities not found in conventional medications. Dr. Varro Tyler, an expert in the medicinal use of plants, termed those unfounded claims “paraherbalism”, and described herbals as “crude drugs of vegetable origin” (2). In reality, the active ingredients of plants are chemicals that are similar or identical to conventional medications, and many of the latter were first identified in plant extracts. It is no more “natural” to swallow dozens of chemicals in a plant extract than to ingest a single purified chemical – a drug is a drug. Before discussing CR’s advice about supplements, it is necessary to consider briefly basic differences between herbals and conventional medications.

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Posted in: Herbs & Supplements, Legal, Science and the Media

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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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