Regulating CAM Aussie Style

 

CAM proponents view National Health Interview Surveys recording the supposed popularity of CAM, an amorphous conflation of anything from “conventional” to mythical methods, as an invitation to unleash even more unproven remedies on the public.  My interpretation is quite different. I see the same figures as proof that we are doing too little to protect the public from pseudoscience.

In fact, state and federal governments are acting as handmaidens to the CAM industry by legalizing practices and products that have insufficient proof of safety and efficacy and, in some cases, are so scientifically implausible that they can never meet that standard.  The federal government keeps “integrative” medicine centers at major academic institutions and private foundations afloat with taxpayer money by funding research that has failed to improve public health or the treatment of disease, despite seemingly endless trials, because “more research is needed.”

As we shall see, Australia has a more effective regulatory system for dealing with CAM. And the advocacy group Friends of Science in Medicine (FSM), an organization with goals similar to our own Society for Science-Based Medicine, is keeping the government on its toes, investigating violations of the law on its own and reporting them.  We in the US could learn something from their two recent successful campaigns attacking misleading health claims.

Diagnostic testing: gateway to quackery

Diagnostic testing is the CAM practitioner’s gateway to bogus diagnoses and treatments.  There are tests for “chronic” Lyme disease, dubious food sensitivities, various “toxicities,” supposed nutritional deficiencies, genetic tests for alleged susceptibility to disease and so forth.  In the US, regulation of diagnostic testing is multi-jurisdictional. First, the state where the practitioner works must have granted him or her the authority to diagnose and to use various means of diagnostic testing. (This rule seems to be honored mostly in the breach by naturopaths.)  For example, some states specifically permit chiropractors to perform “hair analysis.” More typically, a practice act will contain the authority to order (and perhaps perform) lab analyses and do physical exams, without being specific. (See., e.g., Massachusetts Senate Bill 2148, which would register naturopaths.)  If the practitioner uses a diagnostic method improperly, he is subject to discipline by his state regulatory board if he has fallen below the standard of care for his profession.

The actual diagnostic testing process and testing devices are regulated by both the states and the federal government. Clinical laboratories must be certified by their states as well as the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing. In addition to CMS, two other federal agencies, the FDA and the CDC, are involved in regulating testing devices, whether used in laboratories or clinical settings.

To date, the FDA has taken a hand-off approach to regulating one type of testing: laboratory-developed tests (LDTs), that is, tests developed and performed at a single laboratory. This lack of regulation has been a boon to dubious lab tests, but the FDA’s final regulatory framework for LDTs, scheduled for 2016, may spell doom for at least some of these.

You can how this system fails the consumer when a health care profession embraces pseudoscience, their state practice act permits it, they are self-governed, and the FDA has decided to ignore bogus lab tests.  Obviously, we need a more effective system.

Australia does it better

Australia’s Therapeutic Goods Administration (TGA) regulates prescription and over-the-counter medicines, dietary supplements, blood products, biologics, medical devices and in vitro diagnostic devices – their supply, import, export, manufacturing and advertising.  No product can be sold unless it is registered with the TGA.

According to the Australian Health Practitioner Regulation Agency (AHPRA), all registered health professions are regulated by nationally consistent legislation under the National Registration and Accreditation Scheme, although each profession is governed by its own national board. (Registration appears to be the equivalent of state licensing here.) Australia has rejected the registration of naturopaths, although they do have a voluntary professional organization.

AHPRA works with the Boards as an umbrella organization supporting the Boards and their regulatory functions, including registration and investigating complaints. Together with the AHPRA, the Boards jointly developed advertising guidelines to assist health care practitioners, whether registered or not, in complying with the advertising laws, which prohibit (as is true in the U.S.)  false and misleading advertising, among other things. Interestingly, testimonials (an ubiquitous feature of practitioner and product advertising here) are prohibited, as is direct-to-consumer drug advertising.

In 2013, Friends of Science in Medicine, supported by The Royal College of Pathologists of Australasia, issued a paper on pathology tests offered in Australia. The paper has a simple explanation of the three characteristics that determine the validity of a lab test, that I, as a layman, found useful:

• Does the test result reflect the reality in the patient’s body? In other words, does the measurement in the test tube accurately reflect the measurement in the patient’s blood (or whatever tissue is being analysed)? This characteristic of the test is called its “analytical validity”.
• Does the test result have a significant relationship with the disease in question? In other words, is the measurement typically abnormal in patients with a particular disease? Can the test result be used to predict that a person is likely to develop a particular disease? This characteristic of the test is called its “clinical validity”.
• Does the test result provide additional information that is not already available? In other words, does the test result enable the patient to make a health care decision that would not have been otherwise possible? If the test result simply confirms something that the patient already knows, then the test has not provided useful information. This characteristic of the test is called its “clinical utility”.

The paper identified many tests with no proven validity being offered in Australia. Among them:  live blood analysis, salivary hormone tests, iridology and kinesiology testing, vega tests, “functional” pathology tests (e.g., liver detoxification profile) and pseudo-diagnostic machines (e.g., “Electro-dermal screening“).  (If you click on the links in this list, you’ll see that all of these are available in the US as well.)

More recently,

FSM documented over 700 websites links, mostly offered by naturopaths as part of their initial patient consultations, to a range of pseudo-diagnostic interventions . . .  A series of reports documenting images from practitioners, sponsors and training institutions were sent to the TGA with a request for an investigation of the following . . .

Documented tests included hemaview/live blood analysis, electrodermal screening, body scanning devices, taste test for zinc deficiency, hair analysis, urinary indican test and Thyroflex websites.  You can see screen shots of the websites by clicking on each of the tests in the list in FSM’s newsletter,  which is most illuminating. One marvels at the credulity of naturopaths and other “alternative” practitioners, as revealed on their websites. A sampling of what FSM uncovered:

The ESTek [body scanning] systems is a combination of non-invasive biosensors, with fast measurement (5 minutes) and results immediately available, to provide an overview of the homeostasis (internal environment and the main regulatory mechanisms of the human body processes and response.

And is a handy tool for selling patients nutritional supplements based on the “results.”

The Thyroflex test is performed by measuring the reaction time, or reflex, of the brachioradialis muscle of the forearm. A small reflex hammer is used to strike the reflex region of the brachioradialis muscle. Then using a specially developed software program the Thyroflex measures the response rate of the muscle within milliseconds. There is a strong correlation between your reflexes and your metabolic rate.

I imagine, there is a “strong correlation” between the results and the patient’s being prescribed glandulars, made from dessicated animal organs and touted as a “natural” alternative to prescription drugs like Synthroid. Websites claim the Thyroflex is 98.5% accurate.  The Thyroflex is actually approved by the FDA, as pointed out by one website. However, it is listed as a neurological diagnostic device. Perhaps the FDA should have been tipped off by the name that it wasn’t going to be used that way.

The complaints were investigated by the TGA, which resulted in nearly 100 website links for Hemaview being deleted or amended, including links on the websites of the naturopaths’ national organization and other CAM organization websites. The TGA continues to investigate the other complaints.

Compare this to the way state regulatory boards protect naturopathic doctors, as opposed to the public. Britt Hermes has detailed the failings of Arizona’s naturopathic board.  The California Naturopathic Doctors Association recently warned its members to be careful about advertising biotherapeutic drainage and electrodermal screening, not because they are quackery, but because it might not look good to legislators considering naturopathic practice expansion.

In 2014, the the Washington State Office of Laboratory Quality Assurance (LQA) cited a Spokane naturopathic clinic for conducting “live blood cell analysis,” for which it was not licensed. The clinic director then asked the Washington State Board of Naturopathy to resolve a jurisdictional issue regarding who had say-so over whether the tests in question could be performed because, in the clinic’s view, this type of “live blood cell analysis” was one within the “statutorily designated naturopathic scope of practice.”

First under consideration was the “Bolen Blood Procedure,” described by the Board as follows:

 The Bolen Blood Procedure uses a finger lancet and five to six drops of bloods are placed on a clean slide to dry (no reagents ar used in the slide preparation). When dry, the slide is then observed under a microscope to detect blood vitality.

Next under consideration was the “Carroll Food Intolerance Evaluation,” which, as described by the Board,

 uses a finger lance to collect a dime-size circle of blood on a piece of absorbent paper, which is put into a small envelope and placed upon the patient’s forehead.  A glass rod is used to locate acupuncture point “Stomach 25” on the abdomen, which then interacts with skin current to produce a “tug” (an electro-magnetic response, a normal “positive”). Food samples in glass containers are then placed on top of the envelope and if the food is incompatible to the patient, a negative skin response occurs (no “tug” effect).

It hardly bears mentioning that both of these tests are pseudoscience. Yet, the State Board of Naturopathy decided that the Board

 governs what naturopathic physicians can do (to include performing laboratory tests) and, as an [federally] approved program, LQA governs how those laboratory tests are done based on federal . . . laws.

 What is significant here is not who controls what aspect of testing. It is that the that the Board was perfectly comfortable with these tests being used at all, even in the face of the fact that, as the Board itself states in its policy statement, rather grandly,

 The Washington State Legislature has granted the Board of Naturopathy . . . the authority to protect public health and safety by regulating the competency and quality of licensed naturopathic physicians.

Australian Chiropractic Board clamps down on advertising

The Chiropractic Board of Australia recently issued a reminder that chiropractic advertisements need to conform to required standards, developed in cooperation with the AHPRA, prohibiting any statement or claim that is “false, misleading or deceptive or create[s] and unreasonable expectation of beneficial treatment.”  Advertising claims in Australia, according to the Board, must meet a high level of evidence, usually “meta-analysis, systematic reviews or one or more high quality and well respected and acknowledged studies.”  The Board warned that chiropractors who make deceptive claims risk prosecution and disciplinary action. It even went so far as putting out a media release, publicly reinforcing its warning to chiropractors.

The warning was issued in response to urging from FSM. The organization had documented images from hundreds of chiropractic websites which didn’t meet the required standards, despite repeated guidance from the Board.

The Board’s Statement on Advertising specifically mentions

claims in advertising that there is a relationship between manual therapy (e.g. manipulation) for spinal problems and achieving general wellness or treating various organic diseases and infections; or that spinal problems may have a direct role in various organic diseases and infections. There is insufficient scientific evidence to support these claims.

Of particular concern, the Board says, are

claims in advertising relating to infants and children. Claims suggesting that manual therapy for spinal problems can assist with general wellness and/or benefit a variety of paediatric syndromes and organic conditions are not supported by satisfactory evidence. This includes claims relating to developmental and behavioural disorders, ADHD, autistic spectrum disorders, asthma, infantile colic, bedwetting, ear infections and digestive problems.

The Board also warned chiropractors not to make statements that are anti-vaccination or discourage vaccination in any way.  In fact, they shouldn’t be giving vaccination advice at all. Patients are to be referred to an “appropriately qualified health care professional for advice.”

Finally, the Board reminded chiropractors that they are not trained to apply any direct treatment to an unborn child. They should not provide “an obstetric breech correction technique” to the fetus. (The latter is known to chiropractors as the “Webster technique.”)

Compare this to the rampant pseudoscience that characterizes American chiropractic practice.  In fact, in the U.S., chiropractic professional organizations like the American Chiropractic Association and the International Chiropractors’ Association openly encourage chiropractic practices that would subject chiropractors to discipline if they practiced in Australia.

For example, the International Chiropractic Pediatrics Association is openly anti-vaccination, while the ACA takes a more “dog whistle” approach.  The ICPA promotes the Webster Technique, based on the absurd notion that chiropractors can somehow effect the equivalent of an external cephalic version of a breech baby.

Many chiropractors claim they can treat the very pediatric conditions the Australian Chiropractic Board warns about: developmental and behavioral disorders, ADHD, autistic spectrum disorders, asthma, infantile colic, bedwetting, ear infections and digestive problems.  Both the ACA and the Council on Chiropractic Education encourage the notion that chiropractors are capable of acting as primary care physicians. (They are not.) An ACA “specialty council” offers a “board certification” for “chiropractic internists.”

American chiropractic schools and organizations could greatly improve the reputation of chiropractic in this country by adhering to the same requirements as those imposed in Australia. But they won’t. They are far too entrenched in promoting pseudoscience and hustling for an expanded scope of practice.

Can the US emulate Australia?

There are many impediments to implementing a more sensible system of controlling the rampant advertising and practice of pseudoscience in the U.S.  The imprimatur of legitimacy bestowed on practitioners, by licensing, and on products, by the illusion of regulation, means many (perhaps most) Americans are wholly unaware that there is nothing more than the effective equivalent of magic behind many of these practices and lack of evidence of efficacy and safety supporting those that at least have scientific plausibility. (An effort aided by “integrative” medical practitioners who supply the surgical tape holding the wool firmly in place over consumers’ eyes.) Without public recognition of the extent to which they are being fleeced, there won’t be any public will to change the system.  And you can bet that state and federal legislators aren’t going to mess with a system that makes billions for the CAM industry, especially when it fills their campaign coffers.

from Science-Based Medicine http://ift.tt/1SzLzgL