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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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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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Legislative alchemy (briefly) revisited: Naturopathy in Vermont and colloidal silver

A couple of weeks ago, Jann Bellamy wrote about “legislative alchemy” in the new year, in which CAM mischief works its way into state legislatures. Specifically, she mentioned the case of legislators in Vermont trying to declare in law that naturopaths are primary care physicians, who can serve as a patient’s medical home without supervision by real doctors.

Rosemary Jacobs, whose life was altered irrevocably when she developed agyria due to colloidal silver noticed another aspect of this new proposed law:

I recently learned that Vermont licenses naturopaths, NDs, as physicians and that they have a state sanctioned formulary, a list of drugs they can prescribe and administer to patients. To my horror, the 2009 formulary includes “colloidal silver preparations” to treat eye infections and “silver” which they can administer intravenously.
http://www.vtprofessionals.org/opr1/naturopaths/info/Naturopathic Physician Formulary 20091211.pdf [pdf download]

I was horrified because of the danger this poses to patients, the incredible ignorance it shows on the part of naturopaths, and because NDs had, without my knowledge, been licensed in Vermont to administer prescription drugs and other strange substances like silver and tin, do physical exams and order the same diagnostic tests that MDs order.

How had this happened without my knowledge? I have been following alternative medicine for 15 years and warning people about the danger of ingesting silver, an alternative “remedy”, because I don’t want anyone else disfigured by it like I was over 50 years ago.

Silver drugs were used by medical doctors before the advent of antibiotics. Although they didn’t work, they permanently turned many people blue and gray. The condition is called argyria. It was formerly common, and is well documented and understood by scientists.

If NDs had known as much about medicine as I, an educated consumer, do, they would have searched the medical literature before including anything in their formulary. If they had done that, they would have seen that: there are no studies showing that ingesting silver in any form or amount offers benefits; colloidal silver does not treat eye infections; taking silver internally or putting it in your eye can result in permanent discoloration.

Colloidal silver is nonsense. There’s no evidence that it is good for anything. Rosemary also revealed to me something I didn’t know before, namely that there’s another woo-friendly Senator that I didn’t really know about: Bernie Sanders, who, according to her, helped naturopaths become players in the medical marketplace.

Posted in: Legal, Naturopathy

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