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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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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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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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Dummy Medicine, Dummy Doctors, and a Dummy Degree, Part 2.3: Harvard Medical School and the Curious Case of Ted Kaptchuk, OMD (concluded)

Dummy Medicine, Dummy Doctors, and a Dummy Degree, Part 2.3: Harvard Medical School and the Curious Case of Ted Kaptchuk, OMD (concluded)

A Loose End

In the last post I wondered if Ted Kaptchuk, when he wrote the article titled “Effect of interpretive bias on clinical research,” had understood this implication of Bayes’s Theorem: that interpretations of most scientific investigations are exercises in inverse probability, and thus cannot logically be done without consideration of knowledge external to the investigation in question. I argued that if Kaptchuk had

…understood the point when he wrote his treatise, he was dishonest in not explaining it and in not citing at least one pertinent article, such as Steven Goodman’s (which I’m willing to bet he had read). If he didn’t understand the point he should have withheld his paper.

In researching more of Kaptchuk’s opinions I’ve discovered that he had certainly read Goodman’s article, but that he either didn’t understand it or preferred to obscure its implications in deference to his ongoing project in belittling scientific knowledge. In a letter to the editor of the Annals of Internal Medicine in 2001, Kaptchuk opined that even if “more trials of distant healing with increased methodologic rigor” were positive, it still would not “be persuasive for the medical community”:

The situation resembles the predicament with homeopathy trials, another seemingly implausible intervention, where the evidence of multiple positive randomized, controlled trials will not convince the medical community of its validity. Additional positive trials of distant healing are only likely to further expose the fact that the underpinning of modern medicine is an unstable balance between British empiricism (in the tradition of Hume) and continental rationalism (in the tradition of Kant).

…It seems that the decision concerning acceptance of evidence (either in medicine or religion) ultimately reflects the beliefs of the person that exist before all arguments and observation. [Kaptchuk cites the second of the two Goodman articles that I referred to above, discussed here]

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The Cure

Legislative Alchemy

In Legislative Alchemy I: Naturopathy, II: Chiropractic and III: Acupuncture, we learned how state legislatures transform scientifically implausible and unproven diagnostic methods and treatments into legal health care practices. Examples typical of the sheer nonsense found in both proposed and actual legislation include:

Naturopathic health care [is] a system of health care practices for the prevention, diagnosis, evaluation and treatment of illnesses, injuries and conditions of the human body through the use of education, nutrition, natural medicines and therapies and other modalities which are designed to support, stimulate or supplement the human body’s own natural self-healing processes.

[Chiropractic is] the science of adjustment, manipulation and treatment of the human body in which vertebral subluxations and other malpositioned articulations and structures that may interfere with the normal generation, transmission and expression of nerve impulse between the brain, organs and tissue cells of the body, which may be a cause of the disease, are adjusted, manipulated or treated.

[Acupuncture is] a form of health care that is based on a theory of energetic physiology that describes and explains the interrelationship of bodily organs or functions with an associated acupuncture point or combination of points that are stimulated in order to restore the normal function of the bodily organ or function.

This is gobbledygook, tarted up with a few scientific-sounding terms — “physiology,” “tissue cells,” “diagnosis.”

 

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Legislative Alchemy III: Acupuncture

Acupuncture is typically depicted as sticking needles at various points on the body prescribed (inconsistently, it turns out) by charts indicating purported “meridians” through which “qi” flows in the human, or animal , body. However, from one of the many SBM posts on acupuncture , this one by Dr. Novella , we in fact know that:

the consensus of the best clinical studies on acupuncture show that there is no specific effect of sticking needles into acupuncture points. Choosing random points works just as well, as does poking the skin with toothpicks rather than penetrating the skin with a needle to elicit the alleged “de qi”. The most parsimonious interpretation of the evidence is that the needles (i.e. acupuncture itself) are superfluous — any perceived benefit comes from the therapeutic interaction. This has been directly studied, and the evidence suggests that the way to maximize the subjective effects from the ritual of acupuncture is to enhance the interaction with the practitioner, and has nothing to do with the acupuncture itself. Acupuncture is a clear example of selling a specific procedure based entirely on non-specific effects from the therapeutic interaction — a good bedside manner and some hopeful encouragement.”

Unfortunately, those who draft state legislation do not read SBM. They should. If they did, they wouldn’t be enacting acupuncture practice acts. But they do.

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Legislative Alchemy II: Chiropractic

As we learned in Legislative Alchemy I: Naturopathy, legislative alchemy is the process used by state legislatures to transform implausible and unproven diagnostic methods and treatments into legal health care practices.

Today, we review how chiropractors are faring in the 2011 state legislative sessions.

Chiropractic 101

In 1895, a self-described “magnetic healer,” Daniel David Palmer, claimed to have discovered that every person possessed an “Innate Intelligence,” defined as the body’s capacity to heal itself, which flowed from the brain out through the nerves in the spinal cord. Misaligned vertebrae impinged on nerves and interfered with the flow of Innate Intelligence, causing “95 percent of all disease.”

Palmer named these putative misalignments “subluxations,” and began teaching students how to detect and correct them based on his notion that removing this interference would return the free flow of Innate Intelligence and the body would heal itself. In other words, chiropractic was — and, as we shall see, still is — simply another form of vitalism, a long-discredited notion that illnesses are caused by a disturbance or imbalance of the body’s “vital force,” which is distinct from the body’s biochemical processes.

Palmer and his disciples were arrested for practicing medicine without a license, which led to a strategy of chiropractors lobbying state legislatures for their own chiropractic practice acts. This effort stretched from 1913, when Kansas became the first state to license chiropractors, to 1974, when Louisiana became the last.

Subluxation: it’s the law

The non-existent chiropractic subluxation remains the central tenet of the 50 state chiropractic practice acts to this day.[1]

Twenty-one state chiropractic acts mention it specifically as the basis for chiropractic practice. For example, Connecticut defines chiropractic practice as:

the science of adjustment, manipulation and treatment of the human body in which vertebral subluxations and other malpositioned articulations and structures that may interfere with the normal generation, transmission and expression of nerve impulse between the brain, organs and tissue cells of the body, which may be a cause of the disease, are adjusted, manipulated or treated.

Twenty-three states refer to its purported attributes — without actually using the “s” word. In North Carolina, chiropractic practice is defined as:

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.

Did they say “science”? Here’s how much science is involved in chiropractic’s core concept — there’s not even a plausible hypothesis of what a subluxation is or how it might affect human functioning.

Six states simply incorporate by reference practices and procedures taught in chiropractic schools, which remain loyal to the subluxation although some have tried to distance themselves from the word, if not the concept.

This doesn’t mean, of course, that chiropractors are permitted by law to treat any disease or condition by detecting and correcting subluxations, just most any disease or condition, as long as the problem is defined in terms of the patient’s having one or more subluxations stopping up the “flow” of “nerve energy.” Asthma, allergies, ADHD, painful periods and earaches are a few of the many conditions widely advertised as treatable by chiropractic adjustment.

You might think it would cause the chiropractic industry some alarm that legislators might wake up to the fact that subluxations don’t exist. And apparently that is the case. In a few states chiropractors are attempting to expand the chiropractic scope of practice by including authority to prescribe that former anathema to chiropractic: drugs. For years chiropractors branded themselves as doctors who treat patients “without drugs or surgery.”
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Legislative Alchemy I: Naturopathy

Via the magic of “legislative alchemy,” state legislatures transform implausible and unproven diagnostic methods and treatments into perfectly legal health care practices.[1] Without the benefit of legislative alchemy, chiropractors, naturopaths, homeopaths, acupuncturists and other assorted putative healers would be vulnerable to charges of practicing medicine without a license and consumer fraud. Thus, they must seek either their own licensing system or exemption from licensing altogether.

Licensing bestows an undeserved air of legitimacy on “alternative” practitioners. Because a state’s authority to regulate health care lies in its inherent power to protect the public health, safety and welfare, the public understandably assumes licensing actually accomplishes this purpose. In fact, the opposite occurs. Any attempt to impose a science-based standard of health care becomes impossible when vitalism and similarly debunked notions of human functioning are enshrined into law.

Initial licensing is just a beginning. Once the beach head is established other benefits can follow, such as expansion of the scope of practice. If not granted in the initial legislation, “alternative” practitioners can return, seeking more goodies like self-regulation and mandatory insurance coverage.

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