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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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The New England Journal of Medicine Sinks a Bit Lower

I suppose it was bound to happen, but it still rankles. Here is the back cover of last week’s issue of the decreasingly prestigious New England Journal of Medicine:

 


Here’s the front cover:

It’s the 200th Anniversary issue, no less. Some might protest that ‘probiotics’—live bacteria of ‘good’ varieties, as far as the gut is concerned—aren’t all that implausible, and that there is some trial evidence that they help for some conditions. That’s true, but as is typically the case even for the somewhat plausible end of the “CAM” spectrum, the hype greatly surpasses the evidence. The abstract of the most recent systematic review that I could find for probiotic treatment of irritable bowel syndrome (IBS: symptoms and signs that best match the claims in the advertisement above) concluded:

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Posted in: Clinical Trials, Herbs & Supplements, History, Legal, Medical Ethics, Pharmaceuticals, Politics and Regulation, Science and Medicine, 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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Dr. Stanislaw Burzynski, antineoplastons, and the selling of an orphan drug as a cancer cure

Over the last couple of weeks, I’ve been spending a lot of time (and, characteristically, verbiage) analyzing the phenomenon known as Dr. Stanislaw Burzynski and his “cancer cure” known as antineoplastons. In part I of this series, Stanislaw Burzynski: Bad medicine, a bad movie, and bad P.R., I used the legal threats against bloggers criticizing the credulous promotion by the British press of fundraising campaigns to send children with terminal cancer to the Burzynski Clinic and the promotion of the medical propaganda movie Burzynski The Movie: Cancer Is Serious Business to review the movie’s claims and look into Burzynski’s claims for antineoplastons. Not surprisingly, I found the evidence for extravagant claims for their anticancer effects unconvincing. In part II, Dr. Stanislaw Burzynski’s “personalized gene-targeted cancer therapy”: Can he do what he claims for cancer?, I looked into Dr. Burzynski’s recent efforts to “diversify his portfolio, in which he has apparently decided to ride the new wave of genomic medicine to claim he can do “personalized, gene-targeted cancer therapy.” I concluded that he does appear to do that, only very badly, in essence “making it up as he goes along.”

In this third and final part, I want to come back to antineoplastons, because it has been pointed out to me that there is an aspect of this story that has received little attention. One reader in particular has helped enormously in my education about this aspect of the Burzynski saga. I wish I could credit this person by name, but, for reasons I fully understand, I can’t. However, this person’s input was essential, and I’ve even appropriated (with permission, of course) a little bit of text here and there from our e-mail exchanges to “integrate” into this post. Putting this together with information in my previous posts, I think we can come to some conclusions about what it is that Dr. Burzynski is really doing.

Burzynski and an orphan drug

In the first part of this series, I pointed out that back in the 1970s Dr. Burzynski claimed to have discovered cancer-fighting substances in human urine, which he dubbed “antineoplastons,” claiming that patients with cancer had lower levels of these substances in their blood and urine. However, I was pretty vague about just what these substances were, other than to point out that they were modified amino acids and that since 1980 Dr. Burzynski has been synthesizing them in a chemistry lab rather than isolating them from urine as he had done up until then. This vagueness came simply from my interest in moving straight to looking at Burzynski’s claims rather than what these substances were. In retrospect, that might have been a mistake. The reason is that understanding what two of Burzynski’s antineoplastons are is critical to understanding what he is doing with them and why he might occasionally appear to be observing an antitumor response.
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Posted in: Basic Science, Cancer, Legal, Medical Ethics, Pharmaceuticals, Politics and Regulation

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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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