The Hangover Cure

Budweiser Fields
Big Pharma meets Big Beer meets Big Farma.

Success in the vast marketplace of natural health products is no easy feat. Where does one begin? Well, you could find a unique ingredient in the wild with some as of yet unknown medicinal properties. However, you would need to identify the valuable ingredient, demonstrate a potential medical use, ensure safety in effective doses, run clinical trials, register with Health Canada, and finally figure out bulk production. I’ll be honest with you, I’m not about to go to the trouble.

So why not take a few shortcuts? Why not identify an existing ingredient that already has Health Canada approval and then simply re-appropriate the ingredient for a similar, but distinct medicinal use? Give it fancy branding and position it as a unique product within the marketplace, permitting significant mark up. Without the serious science, the product will need something to lend legitimacy; maybe association with a major research institution or university? Bingo.

Entirely unrelated to the above hypothetical, I recently came across an article by Global News published earlier this month promoting a new “Hangover Pill” created in Manitoba. I immediately rejoiced; as documented by the World Health Organization, hangovers are the leading cause of death in the developed world and the second leading cause of getting up late on Sundays. What’s worse, there is no known preventative measure; it could happen to anyone at any moment. Just kidding, that’s bullshit. So, too, is the article.

The article describes a hangover remedy called Clear Head. If you’ve been drinking and that’s too difficult a name to remember, don’t worry; the article names the product a whopping 7 times. Read on and you will get it eventually. What you won’t get is any serious science or skepticism.

The article claims that “Clear Head works to counteract the action of [brain receptors]” and also “helps the liver clear the toxins.” Ah, of course! It’s those pesky toxins again. The product’s origin story is even more dubious.

Alex began researching vitamins and ingredients he thought might help with his dreaded hangovers.

“I compiled a list of products I thought would help me,” he said. “I started to divide and conquer these ingredients by experimenting on myself and friends to better understand what is the actual ‘magic’ ingredient.”

Source 

Well, that sounds both scientific and ethical. Luckily, Alex realized that experiments on his buddies might not be the most valuable in developing a health product, so he passed the torch to his father Ron Marquardt – a professor at the University of Manitoba. The team also enlisted the help of marketing specialist and distributor Ray Takacs, who is careful to only make reasonable scientific claims when promoting the product.

If you use it properly, it will work.

Ray Takacs, T.H.E Food Source Owner and Clear Head distributor

Oh, never mind. Well with that confidence, there must be some high-quality evidence supporting this product. Let’s start with what we know from the original promoter – ah hem I mean reporter. What evidence is reported?

“Clear Head was developed at the University of Manitoba and has a Health Canada stamp of approval.”

Brittany Greenslade, Global News

None, of course, but why bother with science when we can invoke scientific authorities? But wait; are these legitimate scientific authorities?

Let’s start with Health Canada. As I’ve noted in the past, Health Canada – despite their claim otherwise – does not require a product to demonstrate efficacy prior to registration as a natural health product. In place of legitimate evidence, Health Canada permits “traditional use claims,” meaning if someone has used some natural product in the past for anything and sufficiently documented it, the text – scientific or not – can be used in place of sound evidence (with minor restrictions). If anyone from Health Canada is reading, I want you to know that you are doing a bad job and should feel bad.

I’m sure you know where this is going: Clear Head’s registration with Health Canada relies not on well-designed clinical research, but on traditional use claims referencing monographs that existed long before the product. Although the main ingredient – silybum marianum (milk thistle extract) – has been examined as a potential “liver protectant,” it has failed to pass the rigor demanded of clinical trials.

A 2007 Cochrane review noted that there is no reliable evidence supporting its use. Higher quality evidence tended towards negative results, which is expected in the absence of a real effect. A 2012 randomized controlled trial (RCT) did not show any liver benefits for subjects with hepatitis C. Oh, and a 2017 systematic review of biochemical indicators of silymarin effects in patients with liver disease concluded results were “without clinical relevance.” Worse still, not a single RCT has been published on silybum for hangovers. Even Health Canada’s monograph does not mention hangovers once. Oops!

Clear Head and Science
Maybe it will evolve into a morning Caeser or something?

Perhaps the reporter should have looked this information up before publishing a suggested dose:

Each packet comes with four capsules.  People take two before consuming alcohol and then one more before they go to bed. The fourth is a spare, to take the next morning if you need it.

Brittany Greenslade, Global News

Then again, can we blame her when a CBC reporter failed the same critical thinking step before reporting nearly identically two years earlier (2016):

Each packet comes with four capsules and you’ll need to take two before consuming alcohol and then one more at the end of the evening. The fourth is a spare, in case you need it the next morning.

Darren Bernhardt, CBC

A simple perusal of the product’s website should be enough to sense that straws are being grasped at to legitimize the product; the site offers a single testimonial and a “Why It Works” page that provides no evidence supporting the claim that this hangover cure “actually works.” Can you spot the appeals to nature and tradition?

All natural ingredients

Clear Head is prepared from an extract of Silybummarianum [sic] (Milk Thistle). The active compound in the extract is silymarin. This extract has been used for over 2000 years to treat a range of liver diseases. More recently, it has been shown to be effective in the relief of symptoms of hangovers.

Source

A look at the ANNP’s website also reveals that the ingredient is not novel. While you can pick up 12 pills of ANNP’s Clear Head for $10, they also offer a silybum product without the Clear Head branding at $21.16 for 90 pills. If you’re not convinced the products are identical, Health Canada includes both under the same registration initially licensed in 2010.

Clear Head Health Canada
Oh, you sneaky marketing folk.

 

Clear Head Branding
Wait a minute . . .

Of course, you can also find silymarin much cheaper on Amazon, but perhaps lacking the backing of a research institution.

Product Price Comparison
To be fair, bulk pricing does come into play, and ingredient sourcing and concentrations may differ slightly, but there is no strong evidence either way to support one product over any others.

If we were to base our purchase on the product making the most grandiose and unsubstantiated health claims, however, ANNP’s Liver Health steals the show:

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While none of these claims are supported by high-quality evidence, there is something more troubling here: these are unambiguous schedule A disease prevention claims in the context of product marketing. While Health Canada permits direct-to-consumer prevention claims for natural health products, the claims must first be authorized. As none of these claims are supported by the product’s registration, why exactly would Health Canada permit them?

When it comes to the product’s relationship with the University of Manitoba (UM), the story gets more complicated. You would think the connection is straight forward considering Clear Head’s Facebook page proclaims that Clear Head was “Created at the University of Manitoba!” ANNP has even deemed the relationship important enough to place on marketing material.

Clear Head Marketing
I’m sure this isn’t an important feature of their marketing campaign. Source.

What’s up with that? Well, UM is home to the Richardson Centre for Functional Foods and Nutraceuticals (RCFFN) – a “bioprocessing and product development facility” whose mission is to “lead functional food and nutraceutical research for the improvement of health and nutrition” and “support the development of an economically viable functional food industry.” The RCFFN hosts the aforementioned ANNP, who developed the Clear Head product. Just as in their ad, the Clear Head website prominently brandishes this connection:

Developed at the Richardson Centre for Functional Foods and Nutraceuticals at the University of Manitoba.

Source

Yet the RCFFN merely leases space and equipment, prominently indicating on their website that ANNP is a tenant. To say the product is developed at the University of Manitoba is true geographically, but the product is not developed or endorsed by the University of Manitoba. In fact, there is no indication that any clinical research on the product has been performed at the university. It is, however, developed by professors at the university.

Heading up the ANNP is the aforementioned professor, Ronald Marquardt – ANNP president, UM professor, and Clear Head “developer.”  Dr. Peter Jones – a scientific and business adviser with ANNP – is the Director of the RCFFN at UM. I was unable to find publications by either professor on hangovers or silymarin. I reached out to the RCFFN, ANNP, and the professors. Vice President and R&D Director of ANNP, Dr. Suzhen Li, got back to me.

Regarding the evidence for Clear Head, Dr. Li directed me to Google Scholar, noting that there is “a very large number of scientific publications on silymarin dealing with the safety, efficacy, mode of action, etc.” She went on to list the number of publications containing relevant keywords in the title: “milk thistle” (944) and “silymarin” (2880). There are no publications that include both “silymarin” and “hangover” in the title, but Dr. Li noted that 568 publications contain both keywords in the text.

The large number of results indicates that there has been interest in the area, but it has no bearing on whether these compounds are valuable for anything. For example, the same search for “homeopathy” returns 5,280 results, yet we know that homeopathy is an implausible concept. In addition to quantity, we must consider the precise question that each study addresses and how rigorously the question is addressed.

In addition to highlighting the quantity of results from various search queries, Dr. Li provided the results from some, claiming that they “demonstrate that silymarin has many different beneficial effects in humans and animals.” Still, none of the studies are clinical trials examining silymarin and hangovers. I address each study in the Appendix.

While milk thistle and silymarin do appear to possess some interesting properties and biochemical interactions, the failure of the literature is in making the transition from the basic sciences to the clinical sciences. The distinction is quite important, but too often ignored in the pursuit of promising therapies. In essence, basic science involves research looking at the low-level mechanisms, often in a laboratory setting. For example, if we were looking for a novel compound to eradicate cancer cells, we might first test the compound in vitro on cells in a petri dish. Unfortunately, the success of such an experiment tells us very little about clinical applications.

Let’s suppose – for example – that we were examining bleach as a potential chemotherapy. While bleach would undoubtedly kill cancer cells in our petri dish, there remain unanswered questions required to make the leap to clinical applications. What is the toxicity of the compound and what are the side effects? How is it best administered? What is the optimal dose? What is the bioavailability? Does it make a meaningful clinical impact? Does it work generally at a population level or only under specific conditions?

In the case of bleach, we know that it does not satisfy these criteria as a cancer treatment. With novel compounds, there is an additional risk: there is a good chance that our knowledge of the basic science is incomplete. A popular example reader’s should be familiar with is the hype behind anti-oxidant supplementation. While our initial conceptualization of cellular metabolism demonized reactive oxygen species, contemporary research indicates that excessive anti-oxidant supplementation is not necessarily a good thing. As with most biological processes, the human body is often capable of maintaining a balance from a healthy diet alone.

For these reasons, I find the confidence of marketing claims for silymarin troubling. As in the Global News article, Dr. Li noted that “milk thistle’s ability to mitigate hangover was discovered by Alex Marquardt” and has been “confirmed by positive feedback response from many different users and by researchers,” yet this is not actual confirmation from RCTs.

Triggered Newton
First the apple, now this?

If you are not yet scientifically triggered, look at how ANNP represents Health Canada licensing on their website:

In Canada all nutraceutical products must be licensed and issued a Natural Product Number (NPN). Products that are licensed have been shown to be safe (minimum of two clinical trials with humans) and effective (minimum of two clinical trials). Some companies market nutraceutical products that are not approved by Health Canada and often do not have the recommended concentration of active compound. Products that do not have a Health Canada NPN should not be purchased.

ANNP

Based on this claim, would you not expect that products you buy from ANNP have been validated by two clinical trials demonstrating efficacy? At very least, should there not be a single, high-quality, double-blinded, and randomized study showing that individuals taking silymarin reported less severe hangover symptoms compared to those taking a placebo? Dr. Li responded to my concerns regarding their representation of Health Canada licensing:

This is a stated requirement by Health Canada and repeated by ANNP. Please consult the Health Canada milk thistle monograph to see if this is correct and, if not, please contact Health Canada to determine why they have issued an NPN for milk thistle to many companies containing 80% silymarin. We believe that some traditional medicine such as milk thistle can be issued NPN’s without safety and efficacy trials if they have been successfully used as a traditional medicine. You need to discuss this with Health Canada.

Dr. Suzhen Li, ANNP Vice President

Indeed, Health Canada’s registration notes traditional use claims. Again, this is a failure of Health Canada to properly require evidence of efficacy, but that’s no excuse to represent the product as proven effective. Regarding ANNP’s claims marketing their Liver Health product (such as “Cancer Prevention“), these claims were authorized by Nelson Pereira of Health Canada’s Inspectorate Program. I reached out to Health Canada and Nelson Pereira for comment, but have not yet heard back. I’m very interested to hear about the evidence Health Canada relies on to authorize these claims. After all, if milk thistle really could prevent cancer, wouldn’t we all want to be taking it?

In addition to the citations provided in the Appendix, Dr. Li provided me with a brief document outlining the basic research behind hangovers and the potential role of silymarin. While some of the research was interesting, there was still no clinical research in humans examining the benefits of silymarin for clinical endpoints related to hangovers.

Despite the lack of evidence demonstrating the product to be effective, ANNP has pushed forward, partnering with distributor T.H.E Food Source, and marketing the product to credulous reporters, radio shows, and “natural healthstores. They have even begun looking for Chinese distributors.

In all this marketing madness and curative certainty, only one limitation of Clear Head is offered:

If you go out and challenge it . . . you’re going to hurt.

Ray Takacs, T.H.E Food Source Owner and Clear Head distributor

So just don’t drink too much or it won’t work. This isn’t the first “hangover cure” that isn’t supported by clinical evidence and I doubt it will be the last. Bad journalism, bad marketing, bad regulation, and bad science are the status quo. As always, don’t buy the hype.

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Acknowledgments

Thanks to Dr. Terry Polevoy for bringing this issue to my attention.

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Appendix: Selection of Milk Thistle and Silymarin Studies

The following studies were sent to me by ANNP. I provide a brief summary below each. None of them examined clinical efficacy of silymarin for hangovers. Overall, my impression was that the totality of the evidence simply does not support the hypothesis that milk thistle supplementation provides any meaningful benefits. A number of sources note that oral supplementation results in poor bioavailability. Additionally, although milk thistle is well tolerated at typical doses, side effects do occur, often in the form of gastrointestinal distress. Allergies may also be somewhat common.

Perhaps most telling is that US-based NCCIH (National Center for Complementary and Integrative Health) – the NIH’s most infamous center – admits that “we know little about whether milk thistle is effective in people, as only a few well-designed clinical studies have been conducted.”

(Note: papers that appeared in multiple search results were only included in the first seen query section).

Search query: “allintitle: milk thistle saftey”

  1. Review of clinical trials evaluating safety and efficacy of milk thistle (Silybum marianum [L.] Gaertn.). (2007)
    • This was published in a low-quality journal “Integrative Cancer Therapies” and even they concluded: “The future of milk thistle research is promising, and high-quality randomized clinical trials on milk thistle versus placebo may be needed to further demonstrate the safety and efficacy of this herb.
  2. The Many Faces of Silybum marianum (Milk Thistle): Part 2 – Clinical Uses, Safety, and Types of Preparations. (2004)
    • Another low-quality journal “Alternative and Complementary Therapies,” this is simply a narrative review written by an herbalist and naturopath. In their conclusion they reveal both their scientific ignorance and the lack of evidence:  “Second, given the safety profile of the herb, clinicians would be well-advised to expand their use of this plant although clinical studies are lacking.” Just because something is relatively safe, does not mean it should be used clinically. Then again, that’s an apt summary of the naturopathic profession.
  3. Milk thistle in Wilson’s disease: what is the pledge of safety? (2015)
    • This paper simply noted that products prepared with milk thistle could include significant amounts of copper, which should be avoided by patients with Wilson’s disease.

Search query: “allintitle: milk thistle review”

  1. A review of the bioavailability and clinical efficacy of milk thistle phytosome: a silybin-phosphatidylcholine complex (Siliphos). (2005)
    • This review noted that the flavonoids in milk thistle (the compounds generally considered to be ‘active’) have poor bioavailability. Instead, they examined a related compound and noted that it “provides significant liver protection and enhanced bioavailability over conventional silymarin.” This doesn’t exactly make a great case for Clear Head . . .
  2. Milk thistle for the treatment of liver disease: a systematic review and meta-analysis. (2002)
    • This review concluded: “We found no reduction in mortality, in improvements in histology at liver biopsy, or in biochemical markers of liver function among patients with chronic liver disease.” They noted the data were too limited to “support recommending this herbal compound for the treatment of liver disease.
  3. Milk thistle for alcoholic and/or hepatitis B or C virus liver diseases. (2007)
    • This Cochrane review concluded: “Our results question the beneficial effects of milk thistle for patients with alcoholic and/or hepatitis B or C virus liver diseases and highlight the lack of high-quality evidence to support this intervention.”
  4. Milk thistle and its derivative compounds: a review of opportunities for treatment of liver disease. (2013)
    • This was a review for veterinary applications in a veterinary journal that concluded: “Future study is justified to evaluate dose, kinetics, and treatment effects in domestic animals.”
  5. A review of Silybum marianum (milk thistle) as a treatment for alcoholic liver disease. (2005)
    • This review’s conclusion is similar to my own conclusions: “while Silybum marianum and its derivatives appear to be safe and the available evidence on the mechanisms of action appears promising, there are currently insufficient data from well-conducted clinical trials to recommend their use in patients with alcoholic liver disease.”
  6. Milk Thistle (Silybum Marianum) : A Review. (2011).
    • This is another narrative review published in a low-quality journal. Even so, it concludes: “available evidence is not sufficient to suggest whether milk thistle may be more effective for some liver diseases than others or if effectiveness might be related to duration of therapy or chonicity and severity of liver disease.” In other words, there is no high-quality evidence on the topic.

Search query: “allintitle: milk thistle clinical”

  1. Clinical assessment of CYP2D6‐mediated herb–drug interactions in humans: Effects of milk thistle, black cohosh, goldenseal, kava kava, St. John’s wort, and Echinacea. (2008)
    • This study examined in vivo effects of milk thistle supplementation and found that – contrary to in vitro studies – it is not a potent modulator of CYP2D6 activity. On the one hand, this means that concomitant supplementation milk thistle with CYP2D6 substrate drugs is unlikely to result in interactions, but, on the other hand, this demonstrated the failure of milk thistle to impact a biochemical pathway that may have been expected from basic science research and animal studies.
  2. Milk Thistle for Alcoholic and/or Hepatitis B or C Liver Diseases—A Systematic Cochrane Hepato-Biliary Group Review with Meta-Analyses of Randomized Clinical Trials. (2005)
    • This Cochrane review concluded that milk thistle “does not seem to significantly influence the course of patients with alcoholic and/or hepatitis B or C liver diseases.
  3. Assessing the Clinical Significance of Botanical Supplementation on Human Cytochrome P450 3A Activity: Comparison of a Milk Thistle and Black Cohosh Product to Rifampin and Clarithromycin. (2013)
    • Conclusion: “Milk thistle and black cohosh appear to have no clinically relevant effect on CYP3A activity in vivo.”
  4. Milk Thistle: Effects on Liver Disease and Cirrhosis and Clinical Adverse Effects: Summary. (2000)
    • This review concluded: “clinical efficacy of milk thistle is not clearly established. Interpretation of the evidence is hampered by poor study methods and/or poor quality of reporting in publications.” In terms of side-effects, “available evidence does suggest that milk thistle is associated with few, and generally minor, adverse effects.”
  5. The Clinical Utility of Milk Thistle (Silybum marianum) in Cirrhosis of the Liver. (2002)
    • The review concluded: “major flaws in many of the studies make it difficult to draw solid conclusions.

Search query: “allintitle: silymarin clinical”

  1. Hepatoprotective Herbal Drug, Silymarin From Experimental Pharmacology to Clinical Medicine. (2007)
    • Though the article is referenced as being published in the Indian Journal of Medical Research (a rather low-quality journal), this narrative review is hosted on the site RedOrbit, which appears to be news, but is merely a promotional outlet. This article is simply not even worth addressing.
  2. Silymarin: A Review of its Clinical Properties in the Management of Hepatic Disorders. (2001)
    • Regarding the properties of silymarin, the study concludes: “studies evaluating relevant health outcomes associated with these properties are lacking.”
  3. The efficacy of Silybum marianum (L.) Gaertn. (silymarin) in the treatment of type II diabetes: a randomized, double‐blind, placebo‐controlled, clinical trial. (2006)
    • It’s nice to see an RCT, but the paper was published in a low quality journal and suffers from methodological issues. I won’t perform a full analysis as the paper concerns diabetes.
  4. An Updated Systematic Review with Meta-Analysis for the Clinical Evidence of Silymarin. (2008)
    • This is another low quality journal and review. How shoddy is this journal? Well when I opened the link there was a fucking animated skeleton telling me to participate in a survey to win a prize. Alternative medicine journals: always good for a laugh. The earlier referenced Cochrane review performed a review on the same subject only a year earlier and with greater rigor. Refer to it.
  5. Combined therapy of silymarin and desferrioxamine in patients with β‐thalassemia major: a randomized double‐blind clinical trial. (2009)
    • This was a low quality RCT examining silymarin supplementation among β‐thalassemia patients. The study isn’t relevant to this article, but for curious readers, I recommend taking a look at Tables II and III for some glaring issues in this study.
  6. Silymarin in treatment of non-alcoholic steatohepatitis: A randomized clinical trial. (2014).
    • Another RCT published in a very low quality journal. Again, glaring issues and not relevant to hangovers.
  7. Combined effects of silymarin and methylsulfonylmethane in the management of rosacea: clinical and instrumental evaluation. (2008)
    • This paper concerns a topical treatment of a skin condition . . .
  8. The Efficacy of Silymarin in Decreasing Transaminase Activities in Non-Alcoholic Fatty Liver Disease: A Randomized Controlled Clinical Trial. (2008)
    • Another low quality journal, however, they do report some promising initial results for NAFLD markers, although clinical outcomes were not evaluated. Again, this is not a study on hangovers.
  9. Effects of Silybum marianum (L.) Gaertn. (silymarin) extract supplementation on antioxidant status and hs-CRP in patients with type 2 diabetes mellitus: A randomized, triple-blind, placebo-controlled clinical trial. (2015)
    • Low quality journal, some methodological issues, and concerning diabetes again. As an aside, the Editor in Chief of the journal (Phytomedicine) is the head of research & development at Swedish Herbal Institute, a company which essentially uses bad science to market dubious products. Sound familiar?
  10. The Safety and Efficacy of a Silymarin and Selenium Combination in Men After Radical Prostatectomy – A Six Month Placebo-Controlled Double-Blind Clinical Trial. (2010)
    • Why? Why does this exist? Regardless, the study is not relevant and I haven’t the time to describe every methodological issue. Refer to Table 3 to see where the authors went fishing for significance with dynamite. 

Search query: “allintitle: silymarin safety”

  1. A randomized controlled trial to assess the safety and efficacy of silymarin on symptoms, signs and biomarkers of acute hepatitis. (2009)
    • Another masterpiece published in Phytomedicine. I’ll just leave this portion of the conclusion here: “our results suggest that standard recommended doses of silymarin are safe and may be potentially effective in improving symptoms of acute clinical hepatitis despite lack of a detectable effect on biomarkers of the underlying hepatocellular inflammatory process.” The authors also concluded that “patients receiving silymarin had earlier improvement in subjective and clinical markers of biliary excretion,” which can be decoded from science-speak to “we didn’t find the result we were looking for, so here’s an artefact of our poor methodology to help get this published.
  2. Maca (Lepidium meyenii) and yacon (Smallanthus sonchifolius) in combination with silymarin as food supplements: In vivo safety assessment. (2008)
    • The study was not specific to silymarin and – quite frankly – does not tell us much of anything.
  3. Evaluating the Safety and Efficacy of Silymarin in β-Thalassemia Patients: A Review. (2015)
    • This is not a systematic review, not related to the topic at hand, and calls for more research on the topic.
  4. The effect and safety of combination of silymarin and leuprorelin for the treatment of endometriosis. (2011)
    • I’m not even going to address this . . . click the link if you dare.
  5. Potentiality and safety assessment of combination therapy with silymarin and celecoxib in osteoarthritis of rat model. (2013).
    • What aspect of rats with osteoarthritis is relevant to humans experiencing a hangover?
  6. Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of Silymarin (SM) Following Chronic Dosing in Patients with Chronic Hepatitis C (HCV). (2008)
    • As in the title, the study does not address efficacy of the treatment. 

Search query: “allintitle: silymarin review”

  1. Silymarin treatment of viral hepatitis: a systematic review. (2005)
    • Conclusion: “There is no evidence that silymarin affects viral load or improves liver histology in hepatitis B or C. No studies were found that investigated the use of silymarin concomitantly with interferon, nucleoside analogues, or other conventional treatments for hepatitis B or C. In conclusion, silymarin compounds likely decrease serum transaminases in patients with chronic viral hepatitis, but do not appear to affect viral load or liver histology.”
  2. Silymarin: A review of pharmacological aspects and bioavailability enhancement approaches. (2007)
    • The review noted that silymarin: “is orally absorbed but has very poor bioavailability due to its poor water solubility.”
  3. An Updated Systematic Review of the Pharmacology of Silymarin. (2007)
    • Conclusions: Data presented here do not solve the question about the complex mechanism(s) of action of the medicinal herbal drug silymarin.
  4. Silymarin- A review on the Pharmacodynamics and Bioavailability Enhancement Approaches. (2010)
    • Again:  “the main drawback of silymarin is its poor solubility therefore different approaches are been taken to enhance the solubility in turn the bioavailability of the drug.”
  5. Potential Renoprotective Effects of Silymarin Against Nephrotoxic Drugs: A Review of Literature. (2012)
    • Whether the protective administration of silymarin could be an effective clinical pharmacological strategy to prevent DIN is a question that remains to be answered in clinical trials.
  6. Silymarin and hepatocellular carcinoma: a systematic, comprehensive, and critical review. (2015)
    • This is a poorly done review that even fails in some areas of basic science, and relies heavily on studies in rats to draw conclusions. They conclude, as they should: “well-designed clinical studies are urgently needed to evaluate the full potential of these natural agents to effectively treat or reduce the risk for liver cancer.”
  7. A Review on Hepatoprotective Activity of Silymarin. (2011)
    • Perhaps the lowest quality journal yet. The ‘study’ is worth a read if you’re looking for an example of how to avoid thinking critically and how not to perform a literature review.
  8. Silymarin: a comprehensive review. (2009)
    • Basically the same as above. 

How To: Complaints Against Canadian Health Professionals

Unlike other articles on my blog, this is a living document and will be updated as needed to be relevant and accessible. The intent is to provide a comprehensive and accurate guide to pursuing regulatory action against unethical health practitioners. This is not legal advice. This article is constructed from my own research and experience and – while every attempt has been made to ensure accuracy – errors may be present. Please contact me for any corrections. Comments are permitted, but – unlike my other posts – I will not permit trolling or unsubstantiated criticism. Last updated September 15, 2018.

A Brief Introduction to Health Profession Regulation in Canada

Canadian health professionals operate in a privileged marketplace; under various regulatory laws and frameworks, they are granted the ability to offer and advertise services within a prescribed scope of practice. This prevents anyone without the appropriate training or education from offering services as a medical doctor, dentist, nurse, massage therapist, and more. It is a reasonable expectation – for example – that a surgeon has actually attended medical school and has been trained in surgery.

These privileges come with a set of responsibilities that members of health professions must adhere to. The responsibilities are set out by provincial legislation and refined by regulatory authorities that draft and enforce standards of practice using the legal framework as a scaffold to build additional ethical and professional obligations. This includes addressing aspects such as informed patient consent, advertising, medical record keeping, dispensing of drugs, and more. Naturally, the extent and focus of standards vary from profession to profession.

The colleges that maintain these standards are not government agencies. Rather, Canadian provinces have granted the various health professions the right to regulate themselves. There are a number of advantages to this regulatory structure. First, it unburdens the government from the job. Second, it gives the job to those who possess the precise domain knowledge required to ensure that professionals are practicing in a way that is in the best interest of the public. After all, how is a bureaucrat to know what constitutes valid and invalid medical practices? This is the expertise of physicians, not government officials. That’s part of the reasoning, anyway.

While the intent of the self-regulating colleges is to facilitate professional regulation in the interest of the public, this regulatory structure presents a number of challenges. First, professionals who contravene their obligations are not judged by an independent group of arbitrators, but by their own peers. While legislation has attempted to mitigate this concern by permitting the requirement for members of the public to hold positions within regulatory authorities, this certainly does not eliminate the risk of bias.

An additional challenge is posed when it comes to scientific issues. While professionals may possess extensive domain knowledge relevant to their specialization, what happens when this knowledge is antithetical to the scientific and medical literature at large? For example, consider Ontario’s College of Homeopaths. The practice of homeopathy is not only scientifically implausible but remains entirely unsubstantiated by clinical trials. How then, can the College appropriately regulate complaints concerning misleading advertising and ineffective treatments? To address these issues appropriately, the college would have to admit that the entire profession is not distinguishable from health fraud. Of course, the obvious solution is to dissolve the profession via provincial legislature, but the solution is not as clear cut when it comes to professions that offer both legitimate and borderline fraudulent practices.

A further limitation of the regulatory system concerns the balance between proactive and reactive efforts to regulate the industry. The colleges employ a number of proactive measures towards protecting the public; members of the profession must be appropriately educated, registered, and cleared from basic criminal record checks. In many cases, they must submit to ongoing evaluations and engage in continuing education. Unfortunately, for many professions, there is little direct oversight of professional practices once the barriers to entry are overcome. A specific consequence of this includes the spread of misinformation and promotion of phony procedures by fringe practitioners and professions, ultimately endangering the health of Canadians.

This is where you come in.

Though you may not have realized it, public participation is a crucial component of our regulatory system. Whether you have stumbled upon unethical practices through marketing material or have been personally wronged by a health professional, you have the power to initiate a cascade of regulatory events that could help to protect the public at large. Unfortunately, this is no easy task. How is a layperson to know what is a valid and invalid practice? How is a patient to know when they have been a victim of malpractice? Further, how does one make the case to the regulatory authority and go head-to-head against a practitioner and their legal team?

The best approach is undoubtedly to seek legal counsel. If you can afford it, this is the route for you. Unfortunately, legal advice and representation is prohibitively expensive for many of us. If this your limitation, you’re in the right place. While I cannot provide legal or medical advice, the intent of this post is to empower you – the patient, the consumer, the public – to best access and navigate the regulatory mechanisms available to you. This guide covers accessing professional standards, drafting and submitting complaints, performing investigative work and documentation, and proceeding through the complaint process. In addition, if you want to chat or need direct assistance, you can always contact me.

Terminology

The terminology used in the complaints process is not extensive, but worth including for clarity. Ontario-centric terminology is used for simplicity and due to my own familiarity.

College – A self-regulating, provincial regulatory authority for a given health profession.

Complainant – The member of the public or patient who is submitting a complaint to a regulatory college.

HPARB (Ontario) – Health Professions Appeal and Review Board. This is an independent tribunal that addresses appeals from complaints to the colleges. Other provinces have similar appeal boards.

ICRC (Ontario) – Inquiries, Complaints, and Reports Committee. This is the college-designated committee mandated to investigate complaints submitted to the college and determine their merit. Other provinces have similar committees.

Member – A health practitioner who is registered with a college.

SoP – Standards of Practice. These standards are drafted by a self-regulating health college based on provincial legislation.

Assessing Professional Standards

If you are unclear on what constitutes appropriate practices, you should begin with the SoP of the health professional’s college. All colleges are required to maintain and make available their SoP. A web search of the following form will likely bring you to the right page: <province> college of <profession> standards of practice.

As an example, take a look at the College of Massage Therapists of Ontario’s SoP. Here, they reference the legislation that governs the profession and make available the standards that members (massage therapists, in this case) must adhere to. If you cannot find a standard concerning your particular issue, you may need to consult the legislative framework, which could include profession-specific legislation, or province-wide legislation such as the RHPA in Ontario. Of course, you can always contact the college itself, though I have found some to be less than helpful.

Regardless of a profession’s standards, it is worth noting that there are many issues that are universally enforced. For example, if you are assaulted in any way, this is a serious offence and you should immediately contact the police. Non-criminal issues are less clear-cut, but there are still many prohibited practices that apply to all professions, such as false or misleading advertising.

Additionally, informed consent is universal and patients cannot be deceived in their care. This presents an issue when confronting pseudoscience; is it deceptive when practitioners seem to believe that their pseudoscientific practices are appropriate and present these beliefs as “information“? Ignorance is not an appropriate defense, but situations like these present additional challenges in establishing a practitioner’s duty to facilitate informed consent.

Other issues vary significantly from profession to profession and may require a nuanced examination of the SoPs. Conflicts of interest arise in many forms and what constitutes a conflict of interest in one profession may be acceptable in another. A common issue you may come across is direct sale of products or pharmaceuticals to patients.

The Complaint Process

Provincial legislation ensures that the complaint process is relatively consistent across health professions. The details presented in this section are largely sourced from Ontario’s Registered Health Practitioners Act, but other provinces follow similar complaint processes. Often, legislation and the colleges will stipulate time constraints both for the conclusion of complaints as well as numerous milestones along the way (such as how long a member is granted to submit a response to a complaint). Specific times are excluded here as they vary between jurisdiction.

The process is as follows:

  1. A complainant submits a complaint to the college.
  2. The college sends a letter to the complainant acknowledging receipt of the complaint.
  3. The college will summarize the complaint and send a letter to the complainant requesting a confirmation of the accuracy and an authorization to forward the complaint to the member (practitioner) in question.
  4. The college will forward their letter detailing the complaint to the member.
  5. The member has a limited timeline to submit a response to the complaint. The member can respond personally or utilize legal services to respond on their behalf.
  6. Some colleges will forward the details of the member’s response to the complainant.
  7. The complainant may now comment on the response from the member to their complaint. Typically, a comment is not required for the complaint to proceed, but this provides an opportunity for the complainant to address the member’s defensive arguments and provide additional evidence if necessary.
  8. If an additional comment is submitted, the college acknowledges receipt and forwards details to the member. The member now has an opportunity to respond to additional details provided in the comment.
  9. If the member responds to the comment, the college will forward the details to the complainant. Unless additional information is required from the complainant, the complaint will proceed at this point.
  10. The complaint is now in the hands of the ICRC (terminology applies in Ontario) who will designate a panel to perform an investigation and determine the merit of the complaint. There are a number of actions that the ICRC may take, which range from dropping the complaint to referring the complaint to a disciplinary panel. You will be notified of the result. The panel will consist of professional members as well as members of the public depending on the province (example).
  11. Following the conclusion of the complaint process, the results may be appealed by either the complainant or the member. The appeals process involves a submission to a health professions appeal board (HPARB in Ontario).

At any point during the complaint process, the complainant can request that a complaint be withdrawn. However, if the complaint has reached the investigatory stage, the investigation will often proceed.

For an alternative resource on this process, check out the guide published by the College of Physicians and Surgeons of British Columbia for filing complaints; while many aspects are college- and province-specific, they provide a detailed overview of this process in a user-friendly format.

Drafting a Complaint

Before you begin drafting your complaint, you should familiarize yourself with the specifics of the college you are submitting to. Some colleges require a specific format/template that they provide (example), while some will accept a complaint in any form. If any form is accepted, you may want to follow the formatting of a business letter for your complaint.

Different colleges permit complaint submission through different channels. While most colleges now permit submission by email, there may be some that require you to print your complaint and mail it or fax it. My preferred approach is to submit a PDF via email. I keep a complaint template that includes an image of my signature so there is no need to print, sign, and scan every complaint that I submit (many colleges request signed documents). If you have supporting media/files to submit, I have found that some colleges allow submission by file transfer platforms such as WeTransfer. When submitting electronically, ensure that you adhere to a consistent and logical file naming convention for your sake and theirs.

Like many others before you, you may feel that the complaint process and regulatory system is working against you. In order to improve the odds of regulatory action, you will need to submit a comprehensive and credible complaint. This will include submission of all relevant information as well as a compelling argument for your case. Unfortunately, unless you seek legal counsel, no one will do this for you. Even if the member you are submitting a complaint against is clearly engaged in unethical practices, good arguments can be made for bad practices, so you will want to put your best effort forward. Especially when it comes to issues of science and evidence, do not consider any claims or information to be self-evident. Indeed, I have submitted complaints against practitioners who deny the germ theory of disease.

Your first step is information gathering. At very least, you need to identify the practitioner you are submitting a complaint against and their practice. If the complaint concerns you personally, you will want to submit all relevant details. You may have to divulge personal information and authorize the college to collect this information if it is pertinent to the complaint. Generally, the college will not release your personal contact information to the member.

If the complaint concerns advertising/marketing material, you will want to submit information regarding the origin (where/when/how it was obtained) of the material as well as a replica of the material itself (such as a scan of a pamphlet). If the material is online, I recommend the following procedure:

  1. Record the URL from your browser’s Address Bar. Include this in the complaint.
  2. Obtain a replica of the material. You can either take a screenshot, print to PDF, or use a browser-based plugin such as FireShot. I often include screenshots of pertinent materials within my written complaint or submit files as supporting documents.
  3. In the event that the validity of the material is disputed, you will want a reliable record that the practitioner has actually published the offending material. For this, I recommend saving the page to an Internet Archive. This will preserve the content as it is and time stamp it as well. This tool has been used in legal proceedings. Mileage may vary when attempting to archive social media pages such as Facebook.
  4. Ideally, submit both the date the resource was retrieved (by you) as well as when it was published (if available).

If your aim is to perform a comprehensive investigation of a practitioner, you may want to make use of tools beyond simply browsing a practitioner’s website and social media. As the Toronto Star revealed in early 2018, such in-depth investigations can reveal troubling information about practitioners that colleges may or may not be aware of. This is particularly prevalent when practitioners have moved between regulatory jurisdictions. Unfortunately, this is not a guide on how to perform such investigations. I may address this in the future, but you can always contact me for assistance.

If you have concerns regarding a specific profession and their policies, processes, standards, and bylaws, you can always try reaching out to the college itself for assistance or information. Some colleges are more transparent and helpful than others. An interesting example that deserves recognition is the College of Veterinarians of Ontario, who run a podcast addressing important issues primarily for members, but of interest to the public as well.

The Response to Your Complaint

You will most likely receive a response to your complaint from the member (although not in all cases and not for all colleges). This may be written by them personally or by their legal representation. Ideally, the response will either admit to wrongdoing and address remediation taken by the member, or provide substantive evidence that supports the actions that prompted the complaint. If this is the case, you may want to consider dropping the complaint. In my experience, the best responses I have received have admitted to some wrongdoing, but defended other practices addressed in the complaint. As a result, I have yet to drop a complaint in entirety (although I welcome the opportunity).

Most likely, the member will put forward their best effort to defend their practices. While you have no obligation to comment on their response, it very well may help your case to deconstruct and rebut their arguments. The response may deny the allegations outright, provide evidence supporting the conduct, or may cite previous regulatory rulings that support (or contend to support) the member’s position. You may even be personally attacked and have your credibility challenged. You should be prepared for all of these possibilities. Cordiality cannot be expected, but its absence certainly reflects poorly on the practitioner.

In composing a response, ensure that you reference the initial complaint. Have all aspects of your complaint been addressed? Did the practitioner comprehend the nature of your complaint? How have they supported their practices? Did they provide citations to back up their claims? Make sure to focus on the nature of their response as well as the specifics of the content.

The member may employ semantic arguments to defend their practices. I find this particularly pervasive among practitioners practicing pseudoscience. Rebuttal can seem tedious, but you should do it. You cannot assume that the regulatory authority will see through the member’s semantic arguments. This process can also help you better form your complaints. As an example, I have typically claimed that there is “no evidence” supporting certain pseudoscientific practices. Practitioners have been quick to respond that this is incorrect. I find this pedantic, but – indeed – they are correct; even the weakest and most invalid evidence is still evidence. There is plenty of evidence, for example, that aliens have made contact with humans. If your standard of evidence is so low that you accept these propositions, however, I contend that you should probably not be a health practitioner. Perhaps instead use the qualifier “no reliable evidence.” It can be helpful to provide scientific literature with your initial complaint, but you also have the chance within your rebuttal.

The nature of the response precludes in-depth cookie-cutter guidelines, so I will not go into additional depth on this issue. I will note that you may be tempted to publish the response, especially if it is particularly absurd. I would caution against this as this process is typically private and you may face legal or other actions that could put your complaint and you personally at risk. If you think there is information worthy of public disclosure, contact legal experts or the media to go forward.

Appealing a Decision

If you are not satisfied with the outcome of a complaint and feel that the college did not satisfactorily address your concerns or perform an effective investigation, you can appeal to a higher authority. Health appeal boards (HPARB in Ontario) exist independent to both the government and the health professions.

Generally, an appeal must be initiated within a strict timeline following the conclusion of the college’s complaints process. Likely, an attempt will be made to resolve the issue without assembling the Board. Should a review proceed, the Board will review whether the investigation and action of the college’s committee was appropriate. The Board typically cannot discipline members directly, but they can deem the investigation insufficient and send the complaint back to the college for additional review and potential discipline.

One advantage of pursuing appeals is that they will end up documented in CanLII regardless of the decision. This can aid in setting precedent as well as bringing exposure to issues through publicly accessible documentation. When you draft your appeal, make sure to offer background, so that someone reading it later on the public record will understand the earlier complaint process and result from the college.

While appeals are worth pursuing, appeal boards are not free from issues. In the case of HPARB, decisions have been made that demonstrate a lack of regard for public safety and complete ignorance of scientific issues. As a result, this mechanism can provide protection of blatant health fraud and set illogical standards that can be referenced as a pseudo-legal precedent in defense of complaints. Indeed, members of HPARB (and other boards) are not domain experts in health nor are they scientifically trained.

Alternative Regulatory Mechanisms

While any unethical or incompetent practices performed by regulated health professionals should first be addressed by their regulating colleges, jurisdictional overlap exists with some issues that open additional avenues for protecting the public.

As mentioned previously, health professionals are not immune from criminal law. Unlawful conduct and abuse should immediately be reported to law enforcement authorities. Some issues may arise when distinguishing between assault and controlled acts performed by health professionals. Involving both law enforcement and the professional authorities (college) is likely always the best approach.

When it comes to advertising and marketing, health professionals are not only bound by their college’s SoP. False and misleading advertising of various forms is not permitted in Canada. Issues regarding improper advertising to consumers are addressed by both Ad Standards – Canada’s advertising self-regulatory body – and the Competition Bureau – an independent law enforcement agency to ensure a prosperous and innovative marketplace. The value of complaints against health professionals is unclear, but may be worth pursuing.

Health Canada is an additional regulatory avenue concerning medical devices and health products. When examining the use and advertising of devices and products, first examine whether a valid registration exists with Health Canada. For example, drugs will have a Drug Identification Number (DIN) and natural health products will have a Natural Product Number (NPN) identifying the respective registrations with Health Canada. If a registration exists, it will outline the authorized uses and advertising, including references product monographs that provide technical and (ideally) scientific information. Complaints can be submitted both for unauthorized uses/advertising and for unregistered products.

As with the colleges, reaching out to these organizations with specific questions or concerns may help you to formulate a complaint or determine whether the issue falls within their purview.

Conclusion

As with all regulatory frameworks, those that govern the health professions are far from perfect. It is virtually effortless for me to identify numerous health practitioners in my province who are either advertising illegally or promoting and practicing blatant pseudoscience that is not only ineffective, but potentially harmful. Further, I expect that complaints against many of these practitioners may fail to bring about regulatory action. Does this demonstrate that our regulatory structure is a failure? Maybe, but our system is designed to rely on public participation and I contend that we should truly exercise our rights in this domain to put the system to the test.

I encourage readers who encounter unethical practices from health practitioners to confront them. If you are not comfortable putting your own name on a complaint, I am happy to submit any complaint on your behalf that I feel is reasonable. Even if you have lost faith in the regulatory colleges to act in the interest of the public, the submission of complaints at very least establishes a paper trail of misconduct. We have the power to demand better. We should use it.

The Architect of Fear

Fraud Andrew Wakefield
Supervillians walk among us

If you’re not familiar with former doctor Andrew Wakefield, here is a quick primer: Mr. Wakefield was (and continues to be) primarily responsible for the widespread misconception that there is a possible link between autism spectrum disorders and vaccination. In 1998, Wakefield published a case series of 12 children where he suggested a link between gastrointestinal disease, autism, and the measles, mumps, and rubella (MMR) vaccine. In addition to the study entirely lacking scientific merit and rigor, investigative journalist and pharmaceutical critic Brian Deer uncovered fraudulent reporting and serious conflicts of interest. Despite all appearances, Wakefield was not an objective researcher, but was funded by a legal team launching a class action lawsuit against MMR manufacturers. In addition, Wakefield had previously applied for a single-jab measles vaccine patent. Wakefield possessed not one, but two serious conflicts of interest where he stood to benefit financially by slanting his research.

Google Vaccines and Autism
The legacy of Wakefield’s misinformation campaign.

In addition to retraction of his original paper from The Lancet, the UK’s General Medical Council revoked his medical license and barred him from practicing medicine. Beyond the fraud and dishonesty, they found that Wakefield acted with “callous disregard for any distress or pain the children [in the study] might suffer.” Despite being one of the worst medical and scientific debacles in modern history, Wakefield used it to his advantage by becoming the ‘expert’ voice of the anti-vaccine movement, enriching himself while deceiving the public at large.

Today, Wakefield has started life anew in Texas where he produces anti-vax conspiracy documentaries and influences gullible celebrities and politicians ranging from Jenny McCarthy – who helped popularized the anti-vax movement in North America – to Donald Trump, who – despite not possessing basic critical reasoning skills – is the current president of the USA.

Trump and Wakefield
How could he be a stable genius if he was vaccinated?

But that’s not all Mr. Wakefield occupies his time with; he also is quite engaged in speaking tours and evidently takes any platform that will host (and presumably pay for) his propaganda. Of course, this has all been written about quite extensively. So what’s left?

What’s left is the big picture. What’s left is Andy Wakefield’s evolution from a medical doctor and researcher to full-time charlatan who profits from fear and paranoia. The progression of Wakefield’s career and scaremongering is worth examining because it illustrates how a lack of moral regard (a callous disregard, if you will) can be used to fuel a movement built on conspiracy and distrust of expertise.

These points are important to emphasize because of how Wakefield is viewed and idolized by his supporters; they see him as a public defender who has been demonized by a vast conspiracy. The foundations of this belief, however, rely on Wakefield’s integrity as a fervent pursuer of truth. Such a characterization of Wakefield couldn’t be further from reality.

Since the initial scare and fallout from Wakefield’s fraudulent paper, a substantial effort has been put into examining the safety of vaccinations and their ingredients, including multi-dose vaccines like the MMR that Wakefield initially raised concerns over. These studies have continued to affirm the safety of existing vaccination schedules and have dismissed links between autism and vaccination. An honest scientist would admit the failure of their pet hypothesis, but Wakefield’s approach has been profoundly different.

Wakefield was recently invited to give a speech on vaccination at the less-than-reputable chiropractic college Life University. Did he give a balanced and comprehensive talk on current state of immunization science? Of course not.

Andy delivered an hour of anti-vax propaganda going as far as claiming that measles might have offered benefits if it continued to infect us. He claimed that vaccination has “destroyed herd immunity.” He claimed that we will experience a “plague” of neurodevelopmental disorders and allergies in children as a result of vaccination. He claimed that vaccines will increasingly fail at protecting us from the contagious diseases they prevent. He even suggested that vaccination may cause the next great extinction.

Andrew Wakefield Extinction
Crazy ol’ Andy “vaccines are causing a mass extinction of humans” Wakefield

It’s important to note how this speech should continue to undermine what little credibility Wakefield has left. In addition to diverging from scientific and medical evidence, Wakefield has evidently changed his stance from “vaccine safety advocate” to “vaccines are bringing the apocalypse.” This is important because Wakefield’s proponents often portray him as someone who is supportive of vaccination generally, but critical of vaccination schedules. This is obviously no longer the case.

Watching his speech, it’s clear where Wakefield’s talents lie; he is a persuasive and captivating speaker who knows precisely how to engage his target audience.

Andrew Wakefield and Chiropractic
😂😂😂😂 Oh, please.

Ironically, the only impending apocalypse from infectious diseases will be a result of anti-vax efforts as measles outbreaks once again plague developed nations and polio reemerges in areas of low vaccination. Wakefield’s advocates need to recognize that his approach has evolved in exactly the way one would expect to capitalize on the anti-vaccine movement. His game isn’t science; it’s fear.

 

 

Chiropractic Pediatrics Vs. Reality (Part I)

No Adjustment Necessary

On May 8th, Sharon Kirkey published an article in the National Post on the dubious offerings of chiropractors who manipulate children and infants. The article was respectful of responsible chiropractors and instead focused on bogus pediatric claims outside the domain of musculoskeletal conditions. In the worst cases, I have encountered chiropractors who believe that they can use spinal manipulation to treat mental illness, infectious diseases, and even cancer in children. Despite being a regulated health profession, these claims continue nearly unabated on websites, social media, and other advertising mediums, putting the health of Canadians at great risk. I have taken it upon myself to report these practices in my spare time, but I simply do not have enough time to take on every unethical practice.

Following the publication of Kirkey’s piece, the National Post published a response from the Canadian Chiropractic Association’s (CCA) Chair, chiropractor David Peeace. The CCA is generally considered to be among the voices for progressive and evidence-based chiropractic in Canada. How progressive are they? Well, they have accepted vaccination as an effective public health measure outside the scope of chiropractic practice. You might think that is a pretty low bar for a national organization representing health professionals, but it’s a standard that even some chiropractic regulators have failed to meet.

This is why the response from the CCA was so troubling; their letter ignored the issues at hand and instead defended pediatric practices broadly. Of course, it’s worth remembering that the CCA is not a public health organization and not a regulatory body. Rather, they are an advocacy organization for chiropractors whose mission is for chiropractors to be “an integral part of every Canadian’s healthcare team by 2023.” All I will say in response to that is: won’t somebody please think of the children?

While pediatrician Dr. Clay Jones wrote a response to the CCA’s letter at Science-Based Medicine, I wrote my own response which I forwarded to the National Post editors. Since it seems evident at this point that they will not be publishing my response, I will post it here. Enjoy.

Chiropractic Pediatrics Not All It’s Cracked Up to Be

In response to criticism of pediatric practices that “border on the fraudulent,” Canada’s largest chiropractic advocacy organization responded in a fashion that one would expect from politicians rather than registered health professionals; the response ignored the pseudoscientific elephant in the room and mounted a defense of indefensible practices.

While there may be a role for chiropractors to manage musculoskeletal (MSK) conditions in adolescents and children (although not well established in the literature), this was not the issue addressed in Sharon Kirkley’s original piece, which narrowed in on “outlandish” claims that mislead the public on serious medical conditions outside of the scope and expertise of chiropractors. The piece also addressed erroneous claims that “birth trauma” to the spine is a common concern that parents should address with chiropractic care.

Despite claims of “successful outcomes,” there is no credible evidence suggesting that spinal manipulation is indicated for any infantile condition. Though the risk of serious adverse events may be low, unnecessary procedures with no demonstrated benefits and documented risks have no place in our healthcare ecosystem. An additional risk exists with young children who may present with MSK complaints that arise from serious underlying causes, requiring appropriate medical evaluation beyond the scope of chiropractic care.

Unfortunately, unsubstantiated pediatric practices and the deceptive advertising that comes with them are commonplace in Canada. Although the precise prevalence is unknown (neither chiropractic advocacy organizations nor regulators seem to keep track), their existence is no secret to anyone with a web browser.

A small proportion of these chiropractors belong to the International Chiropractic Pediatric Association (ICPA), which boasts almost 600 Canadian members. The ICPA’s mission includes the claim to “improve the health of children,” yet they have propelled anti-vaccination ideas and act as a publication venue for papers of questionable quality, highlighting additional affronts to both public health and science.

These are not just my opinions. Earlier this year, the Canadian Paediatric Society reaffirmed their position on chiropractic, raising concerns regarding lack of evidence, lack of training, misleading vaccination advice, overuse of x-rays, and potential side effects. While I have observed many members of the chiropractic profession lambast the medical profession, at least the Canadian Medical Association is forthcoming about the skeletons in their closet and is actively engaged in public health efforts, including confrontation of the opioid crisis.

To avoid instigating a #notallchiropractors movement, it’s worth acknowledging that the profession has made progress in recent years. Indeed, public health experts are increasingly willing to extend an olive branch to the chiropractic community in recognition of the responsible and knowledgeable practitioners who look after the musculoskeletal health of Canadians. The terms, however, are non-negotiable: it is time to drop the pseudoscience.

Social Media is More Harmful Than Fluoride

Driven by alternative health practitioners and people who share articles without reading them (do I repeat myself?), a recent article has been making its rounds on social media. Just like anything that would make Alex Jones say he told us so, the boldly titled article, “Fluoride Officially Classified As A Neutotoxin In World’s Top Medical Journals,” should give us pause.

Firstly, who is the source? The website is branded with the “Awareness Act” moniker, but there is no indication that this is a legitimate organization or that it is affiliated with anything other than its own pseudo-brand. There is no about page, no mission statement, no contact information other than a Gmail address offered on the DMCA page, and no single person brave enough to take personal responsibility for this monstrosity. They do, however, have some pretty dank conspiracies:

ConspiracyMan
You’re better off not knowing what this video is about. Source: https://www.facebook.com/awarenessact

If you still are not convinced that there might be more reputable sources to inform public health policy, perhaps you should check out the Awareness Act misinformation featured on Snopes, or their rating on mediabiasfactcheck.com. Still want to hear what they have to say? Alright, let’s dive in.

As we know from the title, the article claims The Lancet (a medical journal) classified fluoride as a neurotoxin. That would be a strange thing for a journal to do. Why the article was written recently when they reference an issue of The Lancet Neurology from 4 years ago is another oddity, but it is clear that they were biased from the onset: “people are hoping that by bringing awareness to this that somehow we can get sodium fluoride removed from the world’s water supply.” It’s almost as if they already found their conclusion and are merely victims of confirmation bias.

Of course, it is no mystery that fluoride can be harmful in high enough doses. This is true of anything. If there is one thing alternative health and conspiracy theory communities continuously fail to grasp, it’s that the dose makes the poison. I doubt anti-fluoride activists are as careful to avoid equally harmless natural toxins found in produce.

As with all things, the benefits must be weighed against the harms. When it comes to public health, this requires careful cost-benefit analysis drawing on years of complex scientific evidence. In the case of fluoride, the evidence tells us that there are public health and financial benefits to maintaining an optimal level of fluoride. I say optimal because there are consequences from a high dose, but – despite what you might hear from dubious internet sources – overly high fluoride intake is more likely to occur from natural fluoride sources than from carefully controlled municipal systems.

Regarding the paper cited in The Lancet, it’s worth pointing out that – despite the Awareness Act article being published less than a month ago – the link in article is a dead end.

The Lancet
Must be a conspiracy, naturally. Source: http://www.thelancet.com/400.jsp

When searching for the original study, I came across this article on Snopes, which debunks the very article I set out to address in this post. Since they were so thorough, I will only conclude by pointing to a recent study examining fluoride neurotoxicity in mice. What did they find? Absolutely no evidence of neurotoxicity, strengthening the growing body of evidence indicating that fluoridated water is both safe and effective.

So what should concern you? Certainly the increasing risk of being misinformed on social media. Unfortunately – despite their best intentions – it’s likely that we all have friends and family who pose a risk by sharing misinformed health information. While it would be nice if everyone took a bit more personal responsibility ensuring they aren’t putting anyone at risk, it’s hard to blame them when even health professional endanger public health with falsehoods.

Argumentum ad Chiropractum: A Case Study

Want to make a fool of yourself? Commit a logical fallacy. Want to make a bigger fool of yourself? Incorrectly employ a logical fallacy. Indeed, if there is anything more detested on the internet than the incorrect answer to a question (see Cunningham’s Law), it’s incorrectly qualifying a statement as fallacious. While there is a term for grammar mistakes that are made in the correction of grammar, no such equivalent exists for fallacies generally (as far as I can tell).

Some time ago, I wrote an article criticizing a chiropractor for not understanding basic science and using a diagnostic technique that would constitute health fraud if he wasn’t just ignorant. In essence, the tool (an ear thermometer) has legitimate uses, but it was used in an invalid capacity to infer the existence of a biological construct that is – as far as modern science can tell – purely mythical. This is the chiropractic subluxation.

In my first draft, I had the gall to compare the practice to ghost hunting. For reference, ghost hunters employ a range of legitimate measurement tools in the pursuit and quantification of the paranormal. Just like with the chiropractor, they use legitimate tools inappropriately to infer the existence of something that probably doesn’t exist. Just like the chiropractor, they evidently believe that their tools infer the existence of unproven entities. Quite apropos, non?

I ended up removing the ghost analogy in an early draft (I largely felt that it was unnecessary filler, as I often do with my attempts at comedy). Nonetheless, was it a fair comparison? Not according to your friendly twitter chiropractor (a different chiropractor than from the article):

ChiroTweet
Why even bother? Retrieved Jan, 2018 from Twitter.

Because the response was to my article, I first thought this must mean that the friendly twitter chiropractor was served some form of internet cache of an old version of my draft. I surmised that his internet provider must provide a robust caching service to save all that sweet bandwidth that would otherwise be lost to logical fallacy cheat-sheet queries. As with Cunningham’s law, it’s worth remembering the old adage: the internet never forgets.

Then again – in this case – the internet did forget and it turned out that I’m just not that original; another contributor made the same connection I first did:

Ghosts
The theatrical version of ghost hunting. Retrieved Jan. 2018 from: Twitter.com

Did we commit a logical fallacy in this analogy? Let’s unpack.

A reductio ad absurdum is actually not a fallacy. In fact, it’s a valid and essential logical tool for either proving or disproving a statement based on the inevitable conclusions that must be made by following the statement to logical extremes. If I say – for example – that the more I roll a ball of snow, the bigger it will get, one can dismiss the truth of the statement on the grounds that a ball of snow cannot get bigger than all of the snow on the planet. This extreme example proves that at some point, I will no longer be able to make the ball bigger with more rolling.

Snowball
Cold, hard logic. Source images retrieved Jan. 2018 from boygeniusreport.files.wordpress.com and img-aws.ehowcdn.com.

While a reductio ad absurdum is not a fallacy itself, the argument can be used fallaciously. If – for example – I claimed in my article that the scientifically-confused chiropractor must believe that only an ear thermometer is required to diagnose any disease because he used it in this one case, that would be a fallacious argument. It is not, however, a reductio ad absurdum fallacy – such a thing does not exist. Rather, this would be a straw man fallacy, which involves the misrepresentation of the initial premise. Indeed, incorrect use of reductio ad absurdum arguments often result in straw man or slippery slope fallacies. Instead, when illustrating why spinal thermography with an ear thermometer is an invalid practice, comparison to ghost hunting is employed as a comedic device to illustrate the palpable silliness of grown adults hunting for things that likely do not exist.

This would be an opportune time for a deprecating remark about the quality of chiropractic education, but I would hate to provoke twitter warriors with logical fallacy keyboard macros to wrongfully conflate my assertion with an ad hominem. Then again, I love a good rant.

Stay logical.

Heads it’s a Boy, Tails it’s a Girl

The CBC recently published a story promoting a urine-based test to determine the sex of a fetus during pregnancy. Although the article claims the kit has an 80-92% accuracy based on three studies, no citation was provided and there was clearly no assessment of the quality of these studies (if they exist). While this should have been the focus of controversy surrounding the article, a controversy was instead manufactured surrounding the name of the product: GenderSense.

Remy Warren GenderSense
Founder Remy Warren and her GenderSense. Retrieved Jan. 2018 from: https://www.therecord.com/news-story/8035054-kitchener-woman-counting-on-curiosity-of-expecting-parents/

Rather than relying on a qualified OB-GYN to discuss the nature of this sort of testing, the author interviewed a sociology professor from Wilfred Laurier. While the professor pointed out the issues in conflating gender as a social construct and sex as a biological trait (and I mean – come on – it’s not 2012, people), there was no discussion contextualizing the product medically. When is sex normally determined via ultrasound? How does this time frame and accuracy compare with the proposed product? How will this knowledge empower the consumer to make decisions going forward? Perhaps the company could have avoided this distraction by naming the product SexSense. Then again, that name sounds more like something you’d see in your spam folder rather than a pharmacy.

SexSense
The sixth sense?

Like most journalists, I don’t know a damn thing about reproductive health. Unlike many journalists, however, I am concerned with the accuracy of scientific and medical claims. So, time to learn a thing or two.

First, we should establish why sex determination is important. The most obvious answers are for social reasons: preparing psychologically, shopping, religious reasons, and even just plain curiosity. While we can debate the validity of these reasons and their potential consequences, there are also good medical indications. There are numerous sex-linked disorders that a fetus could be predisposed to, either necessitating prompt medical intervention, or potentially forming part of an informed decision in the choice to terminate a pregnancy. The ethical considerations are vast and there is no way I’m touching those. So, how do we determine sex?

As it turns out, prenatal biological sex is not trivial to determine. Although there are many exceptions – especially in cases of genetic anomalies and divergence between genotype and phenotype – sex is generally best determined by identification of the sex chromosomes (XX vs. XY). The gold standard test is a sampling of the chorionic villi, however, this procedure does not come without risk, including a very small increased risk of miscarriage. Amniocentesis is an alternative test that comes with similar low, but quantifiable risks. As a result, secondary measures are preferred, such as the examination of physical traits or testing of cell-free fetal DNA, which are both rather accurate and safe.

How accurate are these measures? The answer is: it depends on how far along the pregnancy is. Obviously it would be great to know at the time of conception, but the unfortunate reality is that we don’t live in a world where techniques like Chinese Astrology are anything more than chain email content or Reader’s Digest filler. Instead, we have to wait for the expression of traits that our science-based tools actually measure.

In the case of ultrasound – while generally inaccurate in the first trimester – the accuracy of sex determination greatly improves between weeks 11 and 13 (nearing 100% if anomalous cases are excluded). While the procedure is evolving with newer, higher resolution imaging technologies, it has historically relied on a simple premise: is there a penis? Obviously, the modality is very dependent on physical characteristics, which do tend to vary.

Trump
A 217th Trimester Fetus. Retrieved Jan. from: http://i0.kym-cdn.com/photos/images/original/001/187/563/38d.jpg

Cell-free fetal DNA testing is a bit more interesting. This is fetal DNA circulating in maternal blood that is sampled with a blood test. The obvious limitation is the requirement for enough fetal DNA to be in circulation, which most certainly is not the case at the moment of conception. A recent review indicated that the test was unreliable if performed before 7 weeks of gestation. Interestingly, the authors also concluded that urine testing for cell-free fetal DNA was unreliable. Is any urine testing reliable?

Scouring the literature, there were no conclusive studies that supported any form of urine testing for sex determination. Despite this, many products south of the border have made bold claims regarding the efficacy of their urine tests. Experts appear to conclude that these test are entirely bogus.

One particular product bears a remarkable resemblance to GenderSense; IntelliGender claims to be the “first in-home Gender Prediction Test.” Let’s compare the products:

A Comparison of GenderSense and IntelliGender Claims 
 GenderSense Claim IntelliGender Claim
Type of Test Urine-based prenatal sex determination Urine-based prenatal sex determination
 Alleged Accuracy  80-92%  80-90%
Alleged Evidence Three Studies Internal lab trials plus two independent trials
 Colour Indicator Orange or yellow for a girl, green for a boy Orange or yellow for a girl, green for a boy
 Earliest Claim of Efficacy  10 weeks 10 weeks
 Wait Period After Mixing  About 5 minutes  5 minutes
 Retail Price  45 USD  Around 40 USD

While these are some pretty striking similarities, it’s worth noting that there is one big difference between the two products; new to the market, GenderSense has yet to be on the receiving end of legal action for selling a misleading and dangerous product. That’s right; IntelliGender was found to rely on lye, aka Drano, aka sodium hydroxide – a caustic chemical that was likely the cause of multiple explosions. Ultimately, IntelliGender was ordered to pay penalties in the amount of $250,000 for marketing a product attorneys for the city of San Diego called “nothing more than Drano in a pretty box.” While there appears to be no published evidence of efficacy, experts concluded that the test results were “about the same accuracy as a coin toss or random guess.”

Does GenderSense have anything better to offer? The purported studies might have the answer, but I won’t hold my breath for their release. After all – as with IntelliGender – GenderSense’s founder Remy Warren does not possess any formal scientific or medical training. Business as usual.

Because the product does not claim to treat a medical condition or make a diagnosis, Health Canada has announced that it will not pursue regulating the device. They make a fair point, but who is to regulate the science of this pseudo-medical product? What happens if parents rely on this information to make medical decisions? Regardless of the implications of knowing the sex of a fetus, the implications of making the wrong assumption could be dire.

It would have been nice if these issues were raised by the CBC. Then again, if it weren’t for bad science reporting, I wouldn’t be learning so much about fetuses.

Thanks to Dr. Terry Polevoy for his investigative work and commitment to Canadian health issues. Remy Warren was contacted prior to the release of this article, but I have not yet received a response.

 

Chiropractors and the Fetus

While chiropractic care for infants has generated substantial controversy (and rightly so), there has been little criticism regarding chiropractic prenatal care. Back pain is, of course, common during pregnancy, but – although it is reasonably safe – there isn’t good evidence that chiropractic care can be effective during pregnancy. Chiropractic care for back pain, however, isn’t the most egregious service chiropractors offer pregnant women. What is? Chiropractic care for breech presentation of the fetus.

Breech positioning occurs when a fetus is positioned bottom-first, rather than the common presentation of head-first. It’s not particularly common and the best course of action is generally to perform a caesarean section. As caesareans are not without side-effects, it’s understandable that expectant mothers would like to pursue alternatives. Enter, chiropractic.

Breech Baby Position
Breech Position. Retrieved Dec. 2017 from: https://en.wikipedia.org/wiki/File:Breechpre.jpg

In a 2009 article published in Canadian Chiropractor, CMCC graduate John Minardi promotes what is known as The Webster Technique – a technique “specifically designed to detect and correct for pelvic subluxations that occur in a pregnant patient.” Of course, we know that’s bullshit because subluxations don’t exist, but what does he claim is the purpose of this approach? To “improve birth outcome,” naturally.

Luckily, CMCC graduates are often more scientific than their US-educated counterparts. They may not all understand science, but they at least understand the importance of science. In his article, Minardi (who teaches the technique) cites a single paper supporting the approach: “The Webster Technique in a 28 Year Old Woman with Breech Presentation & Subluxation“.

The paper is exactly what it sounds like; it’s a case study that followed an individual woman with breech presentation who received chiropractic care in the form of Webster’s technique. Her follow-up indicated that the fetus re-positioned to the vertex (head-down) position. The study concluded – based on this alone – that Webster’s technique should be offered to all patients instead of a caesarian section. This is an interesting conclusion considering that spontaneous correction occurs in the majority of cases regardless. This study portrays mastery only of regression to the mean and should be cast adrift with the multitude of chiropractic case studies making unsubstantiated claims.

So exactly how pervasive is this unsubstantiated technique in the business of chiropractic? Every word in this sentence links to a London, Ontario Chiropractor advertising Webster’s Technique. Good job, none of you. Of course, there is no firm data because there is no oversight of unscientific chiropractors in Ontario, but – based on 29 chiropractors identified online in London offering the technique and using data from the CCO – at least 21% of chiropractors in London sell this bit of pseudoscience.

One of the most prolific chiropractors offering the technique is London’s own B.J. Hardick (recently suspended for illegal blood tests). His YouTube video describes a 32-week pregnancy adjustment that he seems rather confident in:

B.J. Hardick Webster
Retrieved Dec. 2017, from: https://www.youtube.com/watch?v=XP4VceZsZgI

If this is a claim of 100% efficacy, disclosure of the supporting data would certainly be interesting. Regardless, practitioners who claim Webster’s technique is effective at turning breech fetuses have put themselves in a precarious position; a well-defined clinical trial with objective measures of outcome would be easy to run at a low cost and possibly low risk. Yet – after decades of promotion – all we have are useless case studies and useless surveys.

As it stands, the promotion and practice of Webster’s technique as a remedy for breech presentation is quite possibly patient abuse, yet offerings like these appear to be endemic to chiropractic in Ontario. A little bit of reservation from chiropractors offering unsubstantiated techniques would be great. Widespread adoption of a culture that respects and understands science would be even better.

Chiropractic: A Modern Threat to Canadian Health

A Brief History of Chiropractic

No more than a year ago, my preconception of chiropractic was probably similar to that of most Canadians; I assumed that chiropractors were doctors who specialized in back pain as it relates to the spine and musculoskeletal system. As I began to research chiropractic – dissecting both modern practice and historical origins – I found that this simplistic understanding did not account for the wide variety of diagnostic and treatment paradigms that practitioners adhere to. While many chiropractors are experts in the domains of pain and function in relation to the musculoskeletal system and spine, there are many chiropractors who purport treatment of nearly all medical ailments. These chiropractors hold on to age-old beliefs that are steeped in a spiritual mysticism and vitalism.

The invention of chiropractic is attributed to D.D. Palmer. Palmer was originally a magnetic healer who appropriated the osteopathic technique of joint manipulation. He further appropriated the medical term “subluxation” to refer to what he thought were misaligned vertebrae. Positing that these misalignments impinge on nervous tissue which control healing forces within the body, Palmer implicated subluxations as the root cause for all manner of disease. In his book The Science, Art and Philosophy of Chiropractic, he claimed:

Image retrieved Jan. 2017 from here

D.D. Palmer’s practice of chiropractic may never have gained the following it has today if it weren’t for the mythologizing of a particular extraordinary deed. In 1895 – examining the back of the hearing impaired Harvey Lillard – Palmer claimed to have discovered a bony protrusion. By performing a manual adjustment of the offending vertebrae, Palmer was credited with restoring Lillard’s hearing.

Harvey Lillard
Retrieved April 2017 from here.

Although the incident is often said to be instrumental to the proliferation of chiropractic, treatment of the deaf is not something found within the scope of modern chiropractic. In fact, no chiropractor has performed the procedure successfully under controlled conditions. The challenge of repeating this chiropractic miracle is likely attributable to the anatomy of hearing (something we now more clearly understand); the auditory nerves reside exclusively within the skull and at no point travel down the spine. To put it bluntly: chiropractic cannot heal the deaf.

As chiropractic first expanded, some practitioners incorporated radical religious and philosophical beliefs. The adoption of religious symbolism and ideology was – in part – a ploy by Palmer to protect chiropractors from prosecution for practicing medicine without a license. Although much of Palmer’s writings were contradictory and far from concise, his philosophy generally describes a Universal Intelligence (God) that manifests as an Innate healing power channeled through the nervous system and spine.

In essence, Palmer’s principles of chiropractic assert that subluxations result in interference between the Innate vitalistic force and the body by compressing the nerves, causing disease. When chiropractors perform adjustments on patients, they claim to be completing the body’s connection with Innate, allowing it to perform its healing ability. It is this practice that led chiropractors to coin the notion of, “connecting man the physical with man the spiritual,” which is often expressed as turning people’s power on.

Of course, no one would believe these things in this modern age would they? Actually, London’s own celebrity chiropractor B.J. Hardick evidently subscribes to a very similar worldview:

BJ Hardick Universal Intelligence
Image retrieved Jan. 2017 from here.

While many current practices today developed from mythologies of the past, chiropractic is unique for retaining much of its philosophical and religious heritage. It’s not uncommon today to hear chiropractors reference Innate or subluxations within their practice. Although the term subluxation does have an appropriate medical use, chiropractors have manipulated it to fit their own design. The lack of substantiation for vertebral subluxation did little to impede the proliferation of chiropractic.

Image retrieved Jan. 2017 from here.

If subluxations are a valid source of concern, we should be able to identify them, illustrate their causal link to disease, and demonstrate that their treatment has a positive effect on specific disease processes and patient symptoms. In 2009, a group of chiropractic researchers examined the evidence relating to subluxations and found “no supportive evidence . . . for the chiropractic subluxation being associated with any disease process or of creating suboptimal health conditions.” Some chiropractors took issue with the findings, but none put forward a substantive critique. Indeed, when suggesting a novel scientific paradigm, the burden of proof rests on those who make extraordinary claims.

While practitioners of unproven techniques often recall the aphorism that an absence of evidence is not evidence of absence, after years of investigation, evidence of absence is precisely what plagues the chiropractic subluxation. The British General Chiropractic Council denounced the subluxation complex in 2010, followed by additional chiropractic institutions in 2015. Despite the fact that there is no evidence or plausible biological mechanism to validate subluxations as the cause of disease, and despite the fact that chiropractors can’t reliably identify subluxations, some chiropractors continue to apply this philosophy in their clinical treatment. Prominent chiropractors in support of evidence-based practice have noted the detriment to public health that is subluxation theory.

In his book Chiropractic Abuse: An Insider’s Lament, chiropractor Preston Long details how the chiropractic profession is plagued by unscientific beliefs that have persisted in spite of their clash with modern scientific and medical knowledge:

“I am a chiropractor. I do not say this with pride. My profession is full of men and women who exaggerate what they can do and provide unnecessary and sometimes dangerous services to their patients. Most chiropractors are not bad people, but far too many embrace cult-like beliefs.”

Source: Chiropractic Abuse: An Insider’s Lament, pg 21

Chiropractic Abuse by Preston Long

Reformation

Today, a contentious rift exists within the chiropractic community. There even exists terminology to demarcate between those clinging to the ideas of the past and those who incorporate novel techniques: straights (often self-described as principled) are those who follow the classical Palmer doctrine whereas mixers are those who incorporate other techniques including modern scientific understanding of disease processes (although mixers sometimes pursue equally suspect health practices). This leaves us with two different chiropractic philosophies. The former (the straights) generally believe that subluxations are the root cause of most disease and that a lifetime of spinal adjustments is essential for maintaining proper health. The latter (the mixers) apply spinal manipulation therapy to relieve musculoskeletal pain and generally work with patients to improve mobility and function.

So if the subluxation is a mythical concept, what benefits do chiropractors offer? A 2011 Cochrane review examined the use of combined chiropractic interventions for what chiropractors are most known for: treatment of lower back pain. While they found evidence that “chiropractic interventions slightly improved pain and disability in the short term and pain in the medium term for acute/subacute” lower back pain, they concluded that “there is currently no evidence that supports or refutes that these interventions provide a clinically meaningful difference for pain or disability in people with [lower-back pain] when compared to other interventions.” Follow up research examining spinal manipulation therapy reached a similar conclusion in 2013.

In addition to lower back pain, there is some evidence indicating that spinal manipulation may aid migraines, as well as neck pain. While the evidence is weak, this may be a result of biomechanical variability among patients, causing some patients to respond well to treatment but not others. After all, many patients swear by chiropractic; while recent Gallup polls illustrated that the American public finds physical therapy generally more effective and safer than chiropractic for neck and back pain, chiropractic care did rank higher than all other interventions. Indeed, many patients are satisfied with their chiropractic care. Despite the mixed evidence, there may be a future for spinal manipulation therapy in treating some pain and disability. If chiropractors can help curtail the opioid crisis as they purport, then their deployment in conservative musculoskeletal care is welcomed.

Unfortunately, a significant impediment to healthcare integration is the division within the chiropractic community. Chiropractic’s historical baggage has led to disparate professional identities, causing criticism from the medical community, particularly among orthopedic surgeons. It’s not hard to see why. Many chiropractors make outlandish and unsubstantiated claims regarding treatment of conditions unrelated to the musculoskeletal system. While evidence-based practitioners generally offer manipulations with the intent of mobilizing joints, those in the straight community claim to precisely adjust misaligned vertebrae and restore them to their proper positions. These claims are dismissed even by chiropractic researchers, yet many practitioners still offer these unscientific services.

A Legacy of Anti-Science

Subluxation-based chiropractic is a treatment in search of a disease. Unlike most medical research which seeks to evaluate novel treatments and diagnostic techniques, chiropractic research is still trying to vindicate an age-old approach to health. This led the American Medical Association to label chiropractic an “Unscientific Cult” as early as 1969. In response, chiropractors sued. Though the AMA lost in an antitrust suit (not by scientific merit), the war continues to this day and chiropractors have still not demonstrated the existence of the subluxation.

In contrast to health practices like physiotherapy or massage, subluxation-based chiropractors are particularly vocal in their opposition to the medical system. A likely explanation – aside from the obvious history – is that physiotherapy, massage, and even modern chiropractic are exclusively complementary to medical practices. Quite distinctly, subluxation-oriented chiropractors often find themselves in competition with the medical system; after all, subluxation-based chiropractors consider their treatment to remedy the cause of most afflictions (despite the lack of evidence). A simple Google search involving the term ‘chiropractic’ and any disease will produce unsavory results. Even chiropractic’s patriarch D.D. Palmer spent time in jail for practicing medicine without a license.

Perhaps the most repugnant philosophical stance that remains pervasive in the chiropractic world is the fervent opposition to vaccination. While scientists and public health experts unanimously recognize vaccination as an effective approach to prevent disease with little risk, the topic remains a contentious issue within the world of chiropractic. D.D. Palmer’s son, B.J. Palmer – the great promoter of chiropractic – is largely responsible.

“The idea of poisoning healthy people with vaccine virus . . . is irrational. People make a great ado if exposed to a contagious disease, but they submit to being inoculated with rotten pus, which, if it takes, is warranted to give them a disease.”

Source: B.J. Palmer’s The Science of Chiropractic: Its Principles & Adjustments

B.J. Palmer

With a long history of opposition to vaccination, chiropractors who cling to the ideas of the past put children at risk and endanger public health. If you think that chiropractic in Canada has outgrown its superstitious and unscientific views, you would be wrong. A recent investigation uncovered significant promotion of anti-vaccination propaganda among Manitoba chiropractors, leading to calls for proactive oversight and regulation. Some chiropractors are even ignorant enough to make media statements against vaccination.

“My parents chose to opt me out of the routine vaccination schedule many years before the world was paying attention to mercury toxicity, Autism, studies, or anything else … My parents wanted me to develop my immune system naturally, without interference.”

Source: Dr. B.J. Hardick [Facebook]

B.J. Hardick

Steven-Salzberg-on-Vaccinations
Image retrieved Jan. 2017 from here.

Anti-vaccination beliefs aren’t the only risk posed to children by chiropractors. One area in particular where chiropractic has received extensive criticism from the medical community is in the domain of pediatrics. Many chiropractors in Ontario and abroad have made outlandish claims with regards to chiropractic treatment for infants and children. While there are documented consequences from chiropractors working on infants, precise rates of complication are unknown – likely a consequence of poor adverse event documentation and reporting.

“There’s nothing that I love more than seeing a kid jumping up on the table . . . make sure they’re subluxation free and whether it ever elicits a symptomatic change in that child or not, just being able to know that we’ve turned on the power.”

Source: Dr. B.J. Hardick: A Maximized Living Co-Author explains “Why he died.”  [The Chiropractic Philanthropist]

“I check a ton of kids the day that they’re born.”

Source: Kids Chiropractic Adjustment [YouTube]

B.J. Hardick

B.J. Hardick is a prominent example of a chiropractor promoting treatments for infants and children. The following images were all scraped from his professional Facebook page:

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The absurdity of chiropractors treating infants is only eclipsed by what they claim they are treating; many chiropractors advocate for treatment of children with ear infections, asthma, colic, and other non-musculoskeletal conditions. It’s important to note that the vast majority of conditions that chiropractors treat in children are self-limiting – they tend to resolve spontaneously. A prominent example is colic, for which there is no evidence supporting chiropractic treatment.

Dr. Harriet Hall Chiro
Retrieved Jan. 2017 from here.

In Canada, the problem is pervasive enough that the Canadian Pediatric Society released a position paper: “Chiropractic care for children: Controversies and issues. The original position was posted in 2002 and reaffirmed in 2016. When examining the scientific evidence, they found that there was no evidence for chiropractic to treat any pediatric disorder. Instead, they found that chiropractors put children at risk by spreading misinformation regarding immunization and by attempting to treat acute pediatric conditions that instead need serious medical treatment. These weren’t the only risks identified. The authors noted that “parents should be made aware that there is a lack of substantiated evidence for the theory of subluxated vertebrae as the causality for illness in children, and x-rays taken for this purpose expose the child to unnecessary radiation.” In fact, chiropractors often overuse x-rays. Even for lower back pain, Choosing Wisely Canada recommends against x-rays partly because it has not been shown to improve management of symptoms. Naturally, misuse of X-ray technology has a long history in chiropractic. B.J. Hardick himself claims that it’s dangerous to adjust without x-rays and has showcased x-rays of children in his YouTube videos.

In a further affront (conscious or otherwise) to public health, many chiropractors attribute risk of subluxation to how the baby is delivered (here is a prime example). Not only are they doing a disservice to public health, but they are unnecessarily shaming mothers about their personal choices regarding the birth process.

“The more natural the delivery, the less interference, the fewer interventions medically that are necessary, the less trauma to the skull . . . I had a baby last week where unfortunately based on the way the baby was presented, they had to turn the baby manually inside the mom and then pull the baby out. So the baby’s neck was definitely subluxated.”

Source: Kids Chiropractic Adjustment [YouTube]

“One fact we do know, however, is that the first subluxation usually happens in the birth canal because of the normal trauma associated with vaginal deliveries. Even babies delivered by C-section are subject to birth trauma and vertebral subluxation. This is why it is absolutely critical for parents to bring their babies to their chiropractor as soon after birth as possible. This will ensure that their child’s nervous system is functioning at full capacity, which will provide the framework for a long life of health and vitality.”

Source: http://drhardick.com/kids-chiropractic

B.J. Hardick

Where are the regulators?

In 1991, chiropractors became authorized to use the title ‘doctor’ under the Chiropractic Act. This privilege has been used irresponsibly by chiropractors nation-wide when making public statements on medical concerns unrelated to musculoskeletal issues. When the public is likely to conflate the use of the title ‘doctor’ with ‘medical doctor’, it is irresponsible to apply the title in the context of non-musculoskeletal medical advice; this is especially true when practitioners are disseminating misleading information.

The College of Chiropractors of Ontario is the self-regulating body for chiropractic in Ontario. As authorized in the Chiropractic Act, the chiropractic scope of practice is as follows:

  • The practice of chiropractic is the assessment of conditions related to the spine, nervous system and joints and the diagnosis, prevention and treatment, primarily by adjustment, of,
    • (a) dysfunctions or disorders arising from the structures or functions of the spine and the effects of those dysfunctions or disorders on the nervous system; and
    •  (b) dysfunctions or disorders arising from the structures or functions of the joints.

The problem is that the application and enforcement of this scope is open to broad interpretation. If you subscribe to the classical subluxation philosophy and believe that spinal adjustments channel the healing power of Innate through the body, what could possibly be considered outside of a chiropractor’s scope of practice?

How pervasive is the belief among practitioners that chiropractic can effectively treat a wide range of medical conditions unrelated to the spine? Unfortunately, it is not known. No regulatory body surveys and disseminates this information and existing literature on the topic is unreliable at best. A recent survey of Canadian chiropractors indicated that large proportions of chiropractors in clinical practice use entirely unsubstantiated diagnostic and treatment techniques (for example, 22% claimed to prescribe homeopathy – a treatment that isn’t only unproven but implausible).

Ultimately, the regulatory body has not enforced evidence-based practices, resulting in a vast number of chiropractors who sell useless, even dangerous treatments. My article regarding the Byron-based chiropractor who uses a cheap ear thermometer to diagnose subluxations is a prime example of a chiropractor running a successful business in spite of either having no idea what he is doing, or consciously conning his patients. It’s worth repeating: where are the regulators?

Unfortunately, patients seeking responsible chiropractic care must be extra diligent in screening their care provider. My advice would be to take time to examine the chiropractor’s website. Do they make absurd claims regarding non-MSK conditions? Do they treat infants? Do they treat subluxations? Do they offer long-term treatment/payment plans? Do they advertise testimonials regarding conditions outside of the scope of chiropractic? Do they perform x-rays on every patient? If the answer is yes to any of these, you’re very likely dealing with a quack.

“Good chiropractors are essentially physical therapists who specialize in the spine. Spinal manipulation is an effective option for mechanical low back pain, but physical therapists and some doctors also use that treatment. Some chiropractors want to be primary care providers and treat a variety of non-MSK diseases, but they are not trained to do that. Many chiropractors subscribe to outright quackery like applied kinesiology; and only half of them support vaccination. A medical subluxation is a partial dislocation of a joint that is readily visible on x-ray; the “chiropractic subluxation” is a myth and does not show on x-ray. And chiropractic can be dangerous: stroke is a rare but devastating complication of neck manipulations.”

Source: Interview with Dr. Harriet Hall

Dr. Harriet Hall