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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’s 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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Vaccination mandate exemptions: gimme that ol’ time philosophy

Each of the 50 states and the District of Columbia require vaccination against certain diseases as a prerequisite to public and private school attendance, most commonly polio, mumps, measles, diphtheria, rubella, chicken pox, Heamophilus influenza type b, pertussis, tetanus, pneumococcal disease and hepatitis B. Unfortunately, mandatory vaccination for home-schooled children is rare. (1)

All states provide medical exemptions to vaccination mandates for those for whom vaccination poses a health threat. Indeed, it is doubtful that a state could constitutionally deny such medical exemptions.

Forty-eight states also allow exemptions based on religious beliefs. While it might be assumed that religious exemptions are required by the protection afforded religion under the First Amendment to the U.S. Constitution that is not the case. The opposite is true. Religious exemptions themselves are constitutionally suspect. In fact, to pass First Amendment muster, a state’s religious exemption statute may have to be so broad as to become, in essence, a “philosophical” exemption.

Vaccination mandates survive early challenges

Compulsory vaccination laws have enjoyed strong support in the state and federal courts for over a century. Early in the 20th century, the U.S. Supreme Court considered the constitutionality of a statute authorizing a municipal board of health to require and enforce vaccination, in this case during a smallpox epidemic. The Court found the legislation represented a valid exercise of the state’s police power. In a statement that proved prescient about the failed constitutional challenges to vaccination mandates which followed, the Court said that “we do not perceive that this legislation has invaded any right secured by the Federal Constitution.” Jacobson v. Massachusetts, 197 U.S. 11, 38 (1905).

In 1922, the Court specifically addressed the subject of school vaccination, holding that it is a valid exercise of the state’s police power to make vaccination a condition of attending public or private school. Zucht v. King, 260 U.S. 174 (1922).
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Posted in: Chiropractic, Legal, Politics and Regulation, Public Health, Religion, Vaccines

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Pediatrics & “CAM” II: just wrong

In November, the journal Pediatrics published an entire supplement devoted to Pediatric Use of Complementary and Alternative Medicine: Legal, Ethical and Clinical Issues in Decision-Making. The authors purport to have “examined current legal, ethical, and clinical issues that arise when considering CAM use for children and identified where gaps remain in law and policy.” (S150) Their aim is to “illustrate the relevance and impact of identified [ethical, legal and clinical] guidelines and principles,” to recommend responses, identify issues needing further consideration, and thus “assist decision makers and act as a catalyst for policy development.” (S153)

Unfortunately, as we saw in Pediatrics & “CAM” I: the wrong solution, the authors’ solution for the “issues that arise when considering CAM use for children” consist, in the main, of placing a huge burden on the practicing physician to be knowledgeable about CAM, keep up with CAM research, educate patients about CAM, warn patients about CAM dangers, refer to CAM practitioners, ensure that CAM practitioners are properly educated, trained and credentialed, and so on.

Limit CAM? Not happening

Curiously absent are recommendations placing responsibility on those who profit from the sale of CAM products and services — the dietary supplement manufacturers, homeopaths, acupuncturists, and the like — whose actions are directly responsible for the deleterious effects on patients’ health detailed in the supplement articles and described in the earlier post.

Apparently the authors’ view is that there is no accommodation to CAM too onerous to ask the practicing physician or the patient to bear. Even though they plainly locate the problems they describe — a missed diagnosis, ineffective treatments, drug therapy interactions, poor advice — in the CAM services and products themselves, suggesting that these services and products be limited or eliminated never seems to cross their minds.

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Posted in: Acupuncture, Chiropractic, Herbs & Supplements, Homeopathy, Legal, Medical Ethics, Politics and Regulation, Vaccines

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Pediatrics & “CAM” I: the wrong solution

Oh no!  Not again! The venerable medical journal Pediatrics devotes an entire supplement this month to Pediatric Use of Complementary and Alternative Medicine: Legal, Ethical, and Clinical Issues in Decision-Making.

We sense from the very first sentence that we are in familiar territory:

Rapid increases the use of complementary and alternative medicine (CAM) raise important legal, ethical, clinical, and policy issues. (S150)

“Rapid increases”? And evidence of these “rapid increases?” None cited.

We do, however, see the same shopworn reference to popularity deconstructed elsewhere on SBM. What we learned by actually examining “the large 2007 US survey” which purportedly “revealed that ~4 in 10 adults and 1 in 9 children and youth used CAM products or therapies within the previous year”(S150) is that

…most hard-core CAM modalities are used by a very small percentage of the population. Most are less than five percent. Only massage and manipulation are greater than 10 percent. These numbers are also not significantly different from 10 or 20 years ago — belying the claim that CAM use is increasing.

We also find this definition of “CAM”:

a broad domain of healing resources …other than those intrinsic to the politically dominant health system of a particular society or culture in a given historical period. (S150)

I’m not sure what it takes to become “intrinsic” to the “politically dominant” healthcare system. If it includes being legal, licensed or covered by public and/or private insurance, that would appear to disqualify dietary supplements, chiropractic, acupuncture, homeopathy, homeopathic products and naturopathy as “CAM” in some, or in some cases all, of the American states.

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Posted in: Acupuncture, Chiropractic, Herbs & Supplements, Homeopathy, Legal, Medical Ethics, Naturopathy, Politics and Regulation, Science and Medicine, Vaccines

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Spinal Fusion: Chiropractic and Subluxation

A spirited exchange about chiropractic arose in response to a recent post proposing “The Cure” for the legalization of implausible and unproven diagnostic methods and treatments. Some comments pointed to the implausibility of the chiropractic “subluxation” and the lack of robust evidence of efficacy/effectiveness for spinal manipulation, as well as the difficulty of understanding what exactly “chiropractic” is, or does, that distinguishes it from other manual therapists.  In response, other comments were posted positing that the Science-Based Medicine blog “is not informed  on contemporary chiropractic practice,” that “the profession does not support [the chiropractic] subluxation as a cause of disease,” that chiropractors who treat the chiropractic subluxation are “on the fringe,”  and that the chiropractic “subluxation” is no longer taught in chiropractic colleges as a clinically relevant concept, but merely as an artifact of chiropractic history.

However, a review of recent chiropractic literature does not appear to support the latter opinions.  The same concerns as raised on SBM are shared by chiropractors themselves and are discussed in articles appearing in peer-reviewed chiropractic journals. Nor is the chiropractic literature as sanguine on the demise of the chiropractic “subluxation” as a clinically relevant condition which is both diagnosable and treatable.

Despite the concerns expressed by chiropractors themselves, the chiropractic literature continues to discuss the chiropractic “subulxation” as if it were a clinically relevant condition subject to diagnosis and amenable to treatment for both non-musculoskeletal and musculoskeletal conditions.  This same view of the “subluxation” is taught in chiropractic colleges in North America and Australia. (more…)

Posted in: Chiropractic

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