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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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Posted in: Acupuncture, Book & movie reviews, Health Fraud, Legal, Medical Academia, Medical Ethics, Politics and Regulation, Science and Medicine, Science and the Media

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

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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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Posted in: Acupuncture, Herbs & Supplements, Legal, Politics and Regulation

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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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Posted in: Chiropractic, Legal, Politics and Regulation

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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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Posted in: Legal, Naturopathy, Politics and Regulation, Science and Medicine

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New Dietary Ingredient (NDI) rules planned for the supplement industry

A rumble of discontent is being heard across the dietary supplement industry since a draft guidance document was published last month by the US Food and Drug Administration. In response to the FDA Food Safety Modernization Act signed into law in January by President Obama, the FDA was required to produce a documents requiring dietary supplement and foods companies to submit safety information on any new dietary ingredient (NDI) placed into products after 1994.

The guidance document is open for comments from industry but, when issued, a final rule will require dietary supplement products to file a claim of a New Dietary Ingredient (NDI) for any supplement component that was not part of the diet before 1994. What seems to be riling up the industry is that any change in supplement composition after 1994 will require filing of a NDI disclosure. That is, if you as a manufacturer add more DHA to your fish oil supplement, you have to file a NDI notification.

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Posted in: Herbs & Supplements, Legal

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Electrodermal Testing Part II: Legal and Regulatory Aspects

Last week I described electrodermal testing. I’m sure many readers thought, “There oughta be a law against that.” Well, there are laws. Unfortunately, having laws and enforcing them are two different things.

Some of these devices are not approved at all. Most have received 501(k) approval from the FDA as biofeedback devices so similar to previous devices that they do not require new approval — for biofeedback. It is illegal to use the devices for anything other than biofeedback. The FDA has prohibited their sale or importation for unapproved purposes like electrodermal testing; it has sent warnings to companies, raided clinics, and confiscated machines. States have prosecuted users for practicing medicine without a license. Medical boards have chastised licensed providers. The Quackwatch website lists these regulatory actions but points out that there has been no systematic effort to drive these devices from the marketplace.

Excuses, Excuses

One electrodermal testing website admits that what it is doing is illegal and tries to fight back with this specious disclaimer:

It is important to understand that the laws in the USA forbid me from being able to treat, diagnose, cure or prevent disease. The AMA has a patent on those words and only a licensed medical doctor can do that.  And although it is legal for a licensed medical doctor to violate the Hippocratic oath and prescribe toxic drugs that cause harm and sometimes even kill patients, it is illegal for me to claim you can be cured using natural, nontoxic remedies, even though thousands of people can testify how they have been healed using natural remedies.

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Posted in: Diagnostic tests & procedures, Energy Medicine, Legal

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The Dow of Accutane

At home the kids current TV show of choice is How I Met Your Mother, supplanting Scrubs as the veg out show in the evening. Both shows are always on a cable channel somewhere and are often broadcast late at night. Late night commercials can be curious, and as I work on projects, I watch the shows and commercials out of the corner of my eye.

Law firms trolling for business seem common. If you or a family member has had a serious stroke, heart attack or death from Avandia, call now. The non-serious deaths? I suppose do not bother. One ad in particular caught my eye: anyone who developed ulcerative colitis or Crohn’s disease (collectively referred to inflammatory bowel disease, or IBD) after using Accutane, call now. Millions have been awarded.

My eye may have been caught because of my new progressive lenses, but I will admit to an interest in inflammatory bowel disease, having had ulcerative colitis for years until I took the steel cure. It also piqued my interest as these were three conditions among which I could not seen any connections. Accutane, ulcerative colitis, and Crohn’s. One of these is not like the other.

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Posted in: Legal, Politics and Regulation, Science and Medicine

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Supreme Court Saves Nation’s Immunization Program

The Supreme Court of the United States made a ruling the other day that has profound implications for the health of millions of children. Since October 12, 2010, The Court has been quietly deliberating the case of Bruesewitz v. Wyeth, inc. The case centers on Russell and Robalee Bruesewitz’s allegation that their 18 year old daughter, Hannah, was irreversibly injured by a DTP vaccine she received when she was 6 months old. What is important about this case is not the allegation itself (I will discuss its merits, or lack thereof, in a moment), but the ramifications the ruling has for the future of childhood immunization in this country. The Supreme Court’s ruling against the Bruesewitz’s and in favor of the U.S. vaccination program was the right one, and safeguards our children from the irrationality of the anti-vaccine movement. Some important background is necessary here to understand why this is so.

Prior to the development of effective vaccines, diphtheria, tetanus, and pertussis were common diseases, terrifyingly familiar to all parents. Death records from Massachusetts during the latter half of the 1800’s indicate that diphtheria caused 3-10% of all deaths. In the first part of the 20th century, these dreaded organisms still caused illness in hundreds of thousands of people each year in the United States. These are devastating diseases which, if not resulting in death, often produced severe and permanent damage to those afflicted. In the 1920’s, vaccines against each of these scourges were finally developed, and in the mid 1940’s the combined DTP vaccine was introduced. The vaccines were so effective that cases of these deadly infections were practically eliminated. Today, few parents know the terror once routinely wrought by these pathogens.

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Posted in: Legal, Science and Medicine, Vaccines

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CAM and the Law Part 4: Regulation of Supplements and Homeopathic Remedies

Another major set of legal standards that apply to alternative medicine are the laws and regulations that govern the manufacturing and availability of homeopathic and herbal remedies and dietary supplements. Although there is less ambiguity in these standards than in some of the areas I’ve covered previously, there are certainly loopholes aplenty available to avoid the need for any truly scientific standards of evaluating safety and efficacy. This is perhaps the area in which the triumph of politics over science is most vivid.

Regulation of Homeopathic Remedies

The Food and Drug Administration was constituted as the agency responsible for regulating medicines and most foods by the Food, Drug, and Cosmetic Act (FDCA) of 1938. The FDCA has been updated and amended in various ways since then, but it is still the primary law governing the regulation of prescription and non-prescription substances used to treat illness. The law identifies substances acceptable for sale as medicines as those listed in its official compendia, the United States Pharmacopeia-National Formulary (USP-NF) and the Homeopathic Pharmacopeia of the United States (HPUS). The HPUS was a list of homeopathic remedies first published by the American Institute of Homeopathy, a professional body for homeopaths, in 1897 and now published and maintained by the Homeopathic Pharmacopoeia Convention of the United States (HPCUS), an independent organization of homeopathic “experts.” The inclusion of homeopathic remedies as accepted drugs in the original legislation was primarily due to the efforts of Senator Royal Copeland, a physician trained in homeopathy and one of the principle authors of the FDCA.1
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Posted in: Homeopathy, Legal, Science and Medicine

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