There’s Coronavirus in the air. Can it be detected in real time?

If you’re the Ontario government, you answered yes. In fact, the provincial government was so impressed by a specific application of this technology that they committed $2 million in funding. There’s just one problem. Well, actually, there are many.

CEM Specialties Inc.’s (CEMSI – based in London, ON) Kontrol BioCloud is a device its inventor describes as a “game changer” in the fight against the SARS CoV-2 virus. The device was designed to be installed in a room where it will continuously monitor the air for traces of virus. Upon detection, the system sends alerts to those designated to receive them, empowering them to make decisions based on the presence of the virus within their facility. The device’s promotional material asserts that these decisions will help mitigate outbreaks and speed up contact tracing.

CEM Specialties Inc’s president Gary Saunders has said this technology will further help diminish the spread of the virus. Across a number of press releases and interviews, the company and its representatives have floated potential clients for these devices: schools, hospitals, factories, transit systems, etc. Essentially, every shared space where there is concern of COVID transmission is a business opportunity. According to Kontrol Energy Corp. (parent company) CEO Paul Ghezzi, “BioCloud will not just monitor air quality, it seeks to create the conditions for Canadians to safely and confidently return to their jobs and their schools.”

This all sounds great, of course. Wouldn’t you want to know if you were breathing in the virus? Wouldn’t you feel more comfortable sending your children to school knowing they are monitored by the eager sniffer of a BioCloud? Don’t you want to put anxious people at ease so we can all return to work and “get the economy going”? BioCloud and its possible use cases are very compelling, which is precisely why the device should be examined with a skeptical lens.

If there is one lesson I hope the public has learned from this pandemic, it’s this: public health is not simple. From issues of basic science to questions of how interventions play out in practice, our assumptions and intuitions are contingent on science, which is often complex and even clumsy when it comes to large scale public health interventions. Many factors that might influence outcomes are not trivial to investigate, and even coming up with a model that takes such factors into account is a daunting task, typically refined by iterations of research across the scientific establishment.

With the real life complexities taken into consideration, I will attempt to address how we might answer the question: is the BioCloud product a viable public health intervention? We can decompose this question further into two primary concerns:

  1. Does the BioCloud device function as advertised?
  2. Assuming a working product, is it an effective solution to mitigate the spread of the virus?

Deciphering the hype

At time of writing, there are no publicly available demonstrations of BioCloud units, no peer reviewed publications, no regulatory approvals, no public health endorsements, and no approved patents. The device is not authorized by Health Canada, which means it cannot be used as a medical device to diagnose. With no information available from independent institutions or regulators, info about the device must be derived from publications by the company and the largely uncritical media frenzy that has followed.

Focusing on the detection capabilities, let’s begin at a high level with relevant technical specifications of the device as described throughout media releases and marketing material:

  • The device is to be installed in indoor spaces up to 1,000 square feet or 225 cubic meters (the white paper also provides detection time calculations for rooms up to 2,500 square feet).
  • The device samples the air in “real-time” (5 times an hour) to detect the SARS-CoV-2 virus.
  • The “advanced” sampling technology “optimizes” the air for analysis (whatever that means).
  • The device uses a proprietary detection chamber. Presumably, the undisclosed patent applications relate to this tech. There are apparently 3 USA and 1 Canadian patent applications that have been submitted.
  • The device uses “three independent [virus] capture techniques that allows for intact virus sampling while achieving a high capture ratio.”
  • The device uses “both a viral collider and a chemical process to trap virus particles.”
  • The chemical process involves an unnamed reagent that is currently sourced from the US.
  • The SARS-CoV-2 virus is ultimately identified with a laser sensor.
  • Lower detection is based on detection of the live virus at 0.005ng, though laboratory tests allegedly found a sensitivity to 50 virus particles at the lower end.
  • As far as I can tell, no human interaction/maintenance is intended to be required during operation with the exception of cleaning and detection chamber replacements, which occur 3 times a year, or following a positive detection.
  • Kontrol provides estimates of detection time that range from 6 minutes for a 1,000 square foot space to 15 minutes for a 2,5000 square foot space (based on a number of assumptions).

I have excluded specifications relating to connectivity/alerting as these are technically trivial and uninteresting (though someone may want to follow up with the possible security concerns of a such a high stakes device supporting numerous network protocols).

According to the BioCloud reference white paper, independent lab validation was performed by “leading virology and microbiology experts” at the following labs:

  • Heinrichs Lab (Dr. David Heinrichs)
  • Dikeakos Lab (Dr. Jimmy Dikeakos)
  • ImPaKt Lab

Dr. Heinrichs himself is quoted as saying “There’s no doubt in my mind that this technology can quickly and effectively detect an array of airborne pathogens, including the virus that causes COVID-19. Our results are absolutely conclusive.” It is not entirely clear what Heinrichs is referring to when he says “this technology.” I reached out to both David Heinrichs and Jimmy Dikeakos, but received no response.

While reports indicate that testing has been performed on a fully operating prototype, this does not appear to be the case based on how the results are reported. This may be due to inadequate documentation; overall, the experimental descriptions and supporting images are unclear and insufficiently detailed and labelled. Personally, if I was demonstrating a scientific achievement with an intent to commercialize, I would make sure that I communicated the important details in such a way so as to render the results unquestionable.

If you scroll to page 15 of the white paper, you will find the opening page of the publicly available findings related to testing of the device. The following page documents the detection process: a “viral target” captures SARS-CoV-2, a reagent is introduced that binds to the virus, then a laser is used to detect the presence of the virus. The process makes sense and is well illustrated within the accompanying figure, but the subsequent experimental documentation raises concerns.

In short, the experiments seem to indicate that a nitrocellulose membrane coated with a receptor protein is repeatedly washed with samples from the air as well as the reagent. After the “the reagent detection sequence,” a “measurement sequence” is performed (no details given). Presumably this last step would be the laser’s role, but throughout the experiment, the paper was only ever said to be “inspected”. There was no laser described or shown.

Considering the absent laser component, a fully working prototype did not appear to have been tested. In addition to the laser, the device would presumably need to recycle the requisite testing materials for sustained use. This would include the nitrocellulose, receptor protein, reagent, and the various solutions utilized. To operate as advertised, this process would have to occur over and over again within the machine without human interaction.

Based on the replacement frequency of the detection chamber, and assuming that the machine operates 5 days a week for 8 hours, the BioCloud would have to perform over 3,000 tests without intervention. In my opinion, this is the more remarkable feat than demonstrating a one-time detection event, but there are further challenges still when attempting to align the testing with the claims made for the device.

Even if we assumed that the device was fully functioning and could perform sustained sampling and testing of the air, we have no idea how it will perform in the real world. Whereas the lab presumably provided a controlled environment with limited air particulate, the intended deployment environments are surely not quite as ideal. How does the device remain reliable for extended periods of time when cycling through the air? Are there conditions that may result in false positive detection events? How does the device ensure the extended lifespan and integrity of the compounds/materials it uses? These questions are unanswered.

Even the calculations estimating the detection time (extrapolated from ideal testing conditions) require a number of assumptions unlikely to hold true in deployment scenarios. In particular, the calculations rely on the presence of a model of a COVID-19 “high emitter” who breathes regularly and coughs once per air exchange. We will return to this assumption later, but it is worth noting that this excludes low or even moderate emitters.

The concerns raised up to this point, if left unaddressed, should be enough to preclude the deployment of this device as a public health intervention. Not only can we not be sure the device fully works, but there is no firm evidence that it can function effectively within environments it is intended to safeguard. Nevertheless, let’s go a layer deeper as devil’s advocate and speculate on the value a fully validated (functioning) device of this nature might offer.

(As an aside, it is also worth noting that there are some mistakes in the white paper that would have been caught by a seasoned reviewer. As perhaps the most egregious example, one of their references [9] lists only a title and a school with no indication of the format or how it was retrieved. It does not appear to be available online and does not appear to be an actual scientific publication, which is unfortunate, as it is referenced in support of a strong claim.)

Life in the real world

Public health considerations are often more complex than they might seem at first. In part, this why public health positions on mask use evolved over time. In addition to questions about how the virus spread and how effective masks were when utilized by the general population, there were also initial concerns about shortages for medical personnel, which could have had drastic consequences. There are further concerns about the use of improvised or inappropriately fitting masks, which may give people a sense of security without offering significant protection to themselves or others. Even knowing that respiratory droplets are a potent transmission route for the SARS-CoV-2 virus and that face masks generally mitigate the travel of such droplets, it was difficult to estimate the benefit at a population level because of the complex factors surrounding the use of masks in our everyday lives compounded with uncertainty of viral transmission specifics. The possible benefits the BioCloud might provide are even more of a mystery at this time.

First, we have to contend with the fact that the BioCloud is perhaps least likely to find itself in the idealized situation such as those at the foundation of the white paper’s calculations. Recall that one of these assumptions was the presence of an actively coughing COVID-19 “high emitter.” So-called high emitters would undoubtedly stand out in a COVID-aware world. Even without a cough (which alone would defeat the assumptions behind the model), workplaces, businesses, and many other places where people gather increasingly screen for symptomatic individuals and may have a strict policy for people experiencing even one of a number of symptoms.

In areas where such screening occurs, we might expect to see spread primarily from asymptomatic people or people whose symptoms are not visible. While such individuals can spread the virus, they are likely not quite as efficient as symptomatic carriers. Of course, this presents an additional impediment to the possible performance in the real world.

One term oddly absent from the analysis and assumptions regarding this technology: masks. Masks have become commonplace in indoor settings where people gather to work in close spaces. While this isn’t universally the case, I suspect it represents the majority of locations considered. Since we know various types of masks mitigate the amount of expelled virus, it is safe to assume that mask wearing would further impede the likelihood of a unit from detecting the virus.

With these few realities taken into consideration, the likelihood of the device actually detecting the virus in a short time in practice is looking to be questionable, but there may nonetheless be some situations where it gets just what it needs: a dose of unmitigated virus right into its detection chamber. Such a situation would include indoor spots where people gather without full compliance to public health guidelines and without direct supervision or screening.

Two possible hotspots that came to mind were certain churches and mass transit such as the Toronto subway, but the former is likely to not buy in to detection technology (even if it worked) and the latter is of questionable value when people are either stuck on a train or moving around the terminals. With people constantly on the move, what value is a detection event that lags 6 minutes at best? What are operators to do when the sick individual has moved on and the virus has already been spread?

Let’s once again – for the sake of argument – dive to a deeper layer of hypotheticals and assume that there exist indoor spaces that satisfy all the assumptions behind the product where both uninfected and “high emitter” individuals congregate for long periods of time. What happens when the BioCloud unit detects the virus?

The team behind the device has indicated that the decision making process following a positive result is up to the management at that facility. So what, then, is a facility to do upon detection? Do they evacuate? To what extent? Is everyone in the facility tested? What happens over the subsequent days? What liability might a company take on with respect to their response?

These are just some of the questions that should be addressed not just prior to deploying the device, but in preparation for conducting an actual clinical trial to demonstrate value. After all, the BioCloud is backed by claims that it can help stop the spread of the virus. To prove that, we would need to study a fully working unit in a real setting with well-thought-out procedures. But again, for the sake of argument, let’s assume that all this work had been done and a study was published showing at least modest reduction in positive cases where units were deployed. We would then ask: is it worth the cost?

All health interventions must consider both the benefits and the costs. We could, for example, perform a COVID assessment (nasal swab) of every Canadian, 3-times per day. We would find more cases, allowing us to quickly isolate those infected and mitigate spread. Would it be worth the cost? I’m no health economist, but I am going to suggest that it would not be.

The BioCloud is priced at $15,000 (on the low end) with a maintenance cost likely around $2,000 per year. Is it worth the cost? The answer depends on a great number of factors that we simply do not know. This makes it a rather high stakes bet, especially for potentially high risk settings that are already strapped for cash.

Where are the scientists?

For a novel technology like this that appears to be the first-if-its-kind on the market, there must be scientists behind it, no? Oddly enough, I could not identify an employee of CEMSI with what I would consider a sufficiently relevant scientific title or background. Just take a look at the LinkedIn listing of employees (disclaimer: LinkedIn is never a comprehensive employee list).

While the company does appear to have some experience with technology that makes up components of the BioCloud, the key components that drive the detection process cannot seemingly be traced back to a laboratory or scientific group. This may seem like a strange way to assess the validity of the technology, but tech of this nature often possesses a scientific lineage that consists of basic science research, early prototypes, publications, etc.

It may be that the company has found a very creative way to repurpose existing technologies into a fully automated product. It may even be that the company has developed entirely novel processes that have evaded scientists working in this area. I am open to being proven wrong, but I am skeptical of these possibilities. Don’t get me wrong, I love the idea of people outside the scientific establishment inventing novel and practical science-based tools, but history is not necessarily in their favor.

I do understand that there exists motivation for secrecy. If the company does have a brilliant product, it would not be in their interest to reveal sufficient information to permit reverse engineering, especially as they do not yet hold patents and there is no guarantee that their applications will be granted. That said, I would be much more reassured to see public support for the product beyond that coming from the company and its apparent shareholders. If you search Twitter for BioCloud or $KNR, for example, you will see unrelenting promotion from accounts that appear dedicated to boost the company’s stock. Of course, I am not claiming that these are bots or paid accounts; they might just as well be investors with a stake in the company. The accounts range from clearly dedicated investors to accounts that have been inactive for years before taking a strong stance on the product and company.

As mentioned earlier, David Heinrichs is the only researcher who was quoted in support of the technology, yet I cannot find any statements he has made about the device besides the primary quote repeatedly attributed to him. I find it odd that he wouldn’t simply respond to my email reassuring me that the device works and that he stands behind his claims and testing. He may certainly be bound by some form of non-disclosure agreement, but I still find it odd that he wouldn’t confirm this restriction or even affirm his published comments.

When I reached out to other experts in this field, they were skeptical, noting the device’s white paper did not contain sufficient information to determine whether the BioCloud worked and how. Others on Twitter (an investor and financial crime expert) shared similar concerns about the lack of public scientist support shortly after the device was first announced. The most relevant credentialed public support for the device I could find was a Newfoundland-based former dentist whose apparent sole tweet (at time of writing and assuming that this is not an impersonator) appears to be no different than the hoards of presumed shareholders spamming social media in a likely attempt to bolster their investments.

Just as curious as the development, one manufacturer contracted to actually make the devices (or at least components of them) is OES Manufacturing – another company in London, Ontario that specializes in making sports scoreboards and wire harness quality assurance devices. They appear to work with a variety of industries, presumably in the design and manufacturing of circuit boards, but it is not clear that they possess sufficient capabilities to manufacture what might be required for a functioning BioCloud device. Then again, without sufficient technical information, it is impossible to know just what the manufacturing requirements are and we do know that some components, such as the reagent, are externally sourced.

I reached out to Brad Young – the BioCloud Technical Manager. My first interaction with Brad was on Twitter, where he wouldn’t confirm with me that there existed a fully functioning prototype, instead posting a picture of some units that did not appear finished. In his defense, he is not very active on Twitter, but I find this a strange question to leave unanswered, especially after initially engaging me. I followed-up with an email to Brad, asking if he would be willing to answer some questions or put me in contact with someone who could. I never heard back.

Skepticism, but not absolute

It should be clear from my writing that I am highly skeptical of this product. I am skeptical that it works as intended. I am skeptical that it can perform sufficiently in real world scenarios. I am skeptical that it has value as a public health intervention and I am skeptical that its cost would be justified in many of the target settings.

I am equally skeptical – as everyone should be – of companies that hype novel technologies without providing sufficient supporting evidence or demonstrations. When it comes to publicly-traded companies, shareholders don’t just stand to benefit from revenue, but from speculation on the value of the stock. I don’t possess the expertise to analyze the business elements of this situation, but others have suggested some interesting trends. Then again, a company can hardly be blamed for capitalizing on opportunity.

Nevertheless, I am not so skeptical to conclude this product definitely cannot work. I won’t even claim that it has no possible value as a public health tool. As a science advocate, I simply demand a higher level of evidence. As a taxpayer, I can only hope that the Ontario government was provided with such evidence.

Despite How Some Chiropractors Deceive Patients, “Adjustments” Do Not Benefit The Immune System

Let me preface this article with my position on patients who are mislead by health professionals: these people are victims. I do not believe this makes all patients immune from criticism when they defend abhorrent practices, but it is worth keeping in mind that – between the patient and the caregiver – only one of these two has a professional obligation to disseminate reliable, science-based information and provide informed consent. With that in mind, this post is a rebuttal to a chiropractic patient’s perspective published by a group that advocates for various forms of pseudoscience. From the piece:

A common-sense piece of information – that misalignment equals stress, equals weakened immune response, equals heightened vulnerability to the COVID-19 pandemic – had been conflated into an outlandish accusation that chiropractors were claiming that chiropractic treatment would make one immune to the novel coronavirus and prevent COVID-19. Quite a stretch. But is it really so far-fetched that a healthy spine can improve one’s ability to fight off the coronavirus should one contract it? Or that an individual might suffer milder symptoms should they develop COVID-19? I think not.

Claiming that something is common-sense neither makes it so, nor does it make that belief true. Throughout the relatively brief history of science, there have been numerous cases where common-sense (what we might refer to as conventional wisdom) has be overturned by rigorous experimental science, producing results that differ from what was expected. This has been discussed to such great lengths that I won’t go into further detail here. The internet is your oyster, friends.

What I will dive into are the assumptions in the quote above, which are not-so-subtly glossed over. The first contention is that misalignment equals stress. This can be debunked without understanding it within a chiropractic (vitalistic model, to be clear) framework. There is substantial clinical evidence to inform us that just because something may appear to be misaligned or abnormal, does not mean that there is a real impact to a patient’s well-being. This has been an increasing concern with widespread use of advanced diagnostics that turn up incidental findings. Ironically, the treatment of these findings has – in some cases – lead to unnecessary harm as patients are subjected to therapies that carry risk for something that did not need to be treated.

This type of over-treatment is especially true for chiropractors who claim to diagnose and treat vertebral subluxations, which is the term most commonly used to refer to such misalignments. The major difference between medical over-treatment and over-treatment of subluxations is significant, however: subluxations – as defined by vitalistic chiropractors – do not exist and cannot be identified using any diagnostic technique. Don’t take my word. Refer the opinion of contemporary chiropractors, their associations, or chiropractic research if you must. On the immune issue, why not also check in with Canada’s largest chiropractic association, who are clear that “there is no scientific evidence that supports claims of a meaningful boost in immune function from chiropractic adjustments.” Interesting how this is left out of the article, no?

Regarding the claims that stress leads to a weakened immune system, leading to an increased susceptibility to COVID-19, these claims are plausible, but without clinical evidence, we can’t know if there is a meaningful impact nor if there was an approach to reducing stress that could meaningfully reduce your COVID-19 risk. Remember: common-sense is distinct from truth. Scientific methodologies are the best tools we have to overturn our false, preconceived beliefs. This is an ongoing effort in medicine.

In regards to the so-called “conflation,” I don’t recall identifying a chiropractor who guaranteed patients receiving care would not get COVID-19, not would I make such a claim; however, perhaps this was not directed at me. I will affirm that it is “far-fetched that a healthy spine can improve one’s ability to fight off the coronavirus should one contract it.” This is absolutely far-fetched, as should be clear at this point.

The author went on to cite a video from a chiropractic marketing firm run by the dubious Heidi Haavik, whose “research” assumes vitalistic philosophy a priori. I will be writing a post on Haavik and her bad science soon enough. For now, I will note two things about the video:

  1. This is not scientific evidence, but a video constructed by a chiropractic marketing firm to deceive patients in order to make money.
  2. The video constructs a reasonable narrative about the importance of the spine/brain, but concludes with nonsense that has no basis in science. Go ask Haavik for clinical science demonstrating meaningful benefits that would support her claims. There is nothing; this is smoke and mirrors.

The author goes on to cry fowl on the unimportant distinction between chiropractors offering some immunity benefits compared to chiropractors offering absolute immunity against COVID-19. These claims are different in magnitude, but they are both false. Again, I try to put great care into my own claims and doubt I have made the suggestion that chiropractors guarantee absolute immunity. She continues:

I also noted in my rebuttal that even yoga can improve overall health by reducing stress. And what do yoga and chiropractic have in common? They are all about alignment. They also both promote better breathing habits. Anyone who has taken a yoga class will know that breathing technique is very much incorporated into yoga practice. As for chiropractic, anyone with a bound-up spine and adjoining muscles will know that constricted muscles around the ribcage – which attach to the spine – will inhibit the ability to take a full breath. When one muscle or joint doesn’t move properly, other muscles will compensate, and before you know it, your whole body is in knots, which causes all kinds of stress, which can depress the immune system. More on that later.

Yoga probably can improve some facets of one’s well-being. It is, after all, simply exercise. I am not aware of any clinically demonstrated benefits derived from yoga’s stress reduction, however. The notion that yoga and chiropractic are both about “alignment” is nonsense. Again, contemporary chiropractors do not play make believe with their patients’ spines, pretending to correct non-existent misalignments. We can have a debate about whether spinal manipulation offers truly meaningful benefits for back and neck pain, but that it out of the scope of this discussion.

Further, there is absolutely no reliable evidence that spinal manipulation (or “adjustments” for chiropractors who got their education by applying to a school through a magazine ad) provides any benefits towards taking a “full breath.” In fact, research into chiropractic treatment of asthmatic patients has failed to elucidate any objective benefits for lung function, despite great efforts. To see how some chiropractors still spin negative results to fit their ideology, check out the conclusion of this sad paper. Returning to the article:

The news report makes much of “one Ontario man” who had submitted at least 34 complaints against various chiropractic clinics, citing “misinformation” regarding the health benefits of chiropractic. Ryan Armstrong, with his PhD in biomedical engineering, heads up an organization called “Bad Science Watch,” which according to its website is “an independent non-profit consumer protection watchdog and science advocacy organization dedicated to improving the lives of Canadians by countering bad science.” Armstrong’s conclusions about the efficacy of chiropractic in boosting immune system function are based on a lack of science, or more accurately, on his inability to find any. “There’s very immediate harm from this type of misinformation,” he says. Indeed, making assumptions and publicly dismissing claims of health benefits based on a lack of information, rather than on evidence that the claims are false, is truly harmful and bad science.

I’m not sure why the emphasis is put on “one Ontario man”. Do you disagree? Just to be clear, my personal activism from complaint writing is distinct from our work at Bad Science Watch, though we do have our sights set on this area of activism. Now, with that all cleared up, let’s address the author’s very limited and naive understanding of what science and evidence are.

What is science? What is evidence? These are philosophical questions that are far beyond the scope of both this post and my expertise generally (though I do read all I can on the philosophy of science and recommend so for anyone in science advocacy). Unfortunately, there really are not universally accepted standards that allow us to reliably determine what is science and what is not. This is known as the demarcation problem. I encourage the author to pursue some reading in this area. I think she will find it both enlightening and enjoyable.

The best I can do here is to tell what I mean by these things. Typically, I use science and evidence as short-hands. What I mean by science is close enough to the Wikipedia definition: the “systematic enterprise that builds and organizes knowledge in the form of testable explanations and predictions about the universe.” When one claims to be fitting pieces into our collective knowledge that do not appear to belong based on their incompatibility with existing knowledge and their lack of experimental rigor, I deem this to be bad science. This obviously includes the classic notion of the vertebral subluxation.

When it comes to evidence, I typically mean reliable evidence, leaving the reliable component to be assumed. Evidence – broadly speaking – is anything that is used to used to support a claim, but I find the term to be largely useless when used this way. To offer an example, you might tell me that there is no evidence that all of the vitalistic chiropractors across Canada have formed a death cult intending to bring about the destruction of the planet. After all, that is an absurd assertion. I would simply counter your point by saying I heard it from someone. You might say “well that doesn’t make it true,” and you would be right; however, it still constitutes evidence by definition. Is it reliable evidence that we should accept as truth to make better decisions? No.

When claims such as those made by chiropractors implying immune benefits are made, they should be dismissed for two reasons. The first reason is that they do not fit into our most refined and accepted scientific theories and paradigms (in fact, they contradict much of our understanding of human biology). The second reason is that there is no reliable evidence in the form of clinical trials looking at meaningful clinical outcomes supporting these claims. They fail on all counts.

You might think that it is “exceedingly difficult to either prove or disprove in a measurable scientific study that a chiropractic adjustment has a direct causal effect on improved immune system function” but this is false; you simply lack imagination and presumably a scientific background. I can think of a very simple trial design:

  1. Randomize two large groups of subjects between real manipulation and sham manipulation.
  2. Have subjects come in to clinics on a regular basis to receive their “treatments” over the course of maybe 4-12 months.
  3. Measure a number of meaningful clinical outcomes: number of sick days, duration and incidence respiratory symptoms, hospitalization, other cold/flu symptoms, etc.
  4. Make sure to do better than all other vitalistic chiropractic studies (well, we already are by having n>1) and control for the multiple endpoints when you compare outcomes.

There is a reason such a study has not been performed, and it is not because there is a global conspiracy against the minority of chiropractors who believe this nonsense. The study would not meet the minimal requirements to be deemed ethical nor would it meet the requirements to be funded by a granting agency. The cause for both of these is the same: the foundation for these beliefs is not in sound science, but in an outdated ideology.

Keep in mind, this is not for lack of trying. Vitalistic chiropractors have been trying for decades to (mis)use science to prove themselves correct. Despite significant efforts (largely through dubious special interest journals), they have failed. So although it would not be philosophically accurate to say that chiropractic immune claims are “disproven”, it would very much be pragmatic to do so, as the foundational ideas have so thoroughly failed every test that there is little more we could do. At very least, it would be deceptive for practitioners to suggest that they may benefit immune systems with a spine rub. If you don’t accept this, then you must also believe it acceptable for pharmaceutical companies to make any unproven claim for their products. Naturally, I object to both. Fraud is fraud.

With that said, I am confident to assert that spinal manipulation does not offer a real benefit to one’s immune system just as I am confident in asserting that there is no teapot between Earth and Mars that is orbiting the sun (I am sure it is just a matter of time before Trump’s Space Force inserts one, however, thereby proving God’s existence).

The author continues by grappling with statements made by friend of the blog Tim Caulfield. This next bit is staggering.

Caulfield said that he couldn’t find any evidence to support that 200% increase, in particular, and not that he couldn’t find any evidence of an increase in function at all. Not to mention that his search for this study consisted of a “quick Google search,” which apparently was fruitless, and which the CBC is implying as evidence that the study doesn’t exist. That’s just misleading representation of his words and shoddy reporting. Even if that is exactly what he meant by referring to an “alleged author,” implying that the study is fabricated by the chiropractic community to support their claims, again, it was sloppy journalism on the part of the CBC to blindly accept that and promote that interpretation. There were three journalists on this story – did none of them have the time to bother looking for the study themselves?

By the way, Tim Caulfield and Ryan Armstrong, to your claims that “there is no science behind it,” my own “quick Google search” yielded this “partial list” of 114 citations regarding the effects of spinal adjustment on immune system function, including the one Tim couldn’t find by “alleged author” Dr. Ronald Pero, PhD, chief of cancer prevention research at New York’s Preventive Medicine Institute and professor of medicine at New York University. Fill your boots.

https://healthsourcelombard.com/does-chiropractic-strengthen-immunity/

Let’s address the funny part: the author takes great issue with the suggestion that the chiropractic community has collectively manufactured a fabricated reference purporting that “adjustments” can boost the immune system by 200%. Why is this funny? Because that’s exactly what has happened here; this so-called study is nothing more than a fabrication. This is even recognized and refuted by evidence-based chiropractic groups.

So if the study is a fabrication, what exactly did the author cite to prove its existence? She cited a chiropractic clinic’s website, that simply contained the following reference:

Pero R. “Medical Researcher Excited By CBSRF Project Results.” The Chiropractic Journal, August 1989; 32.

You’re permitted to have a laugh here, reader. Even if we were to assume that the referenced article existed at one point in time, it is obviously not what practitioners purport it to be. At best, it appears to be an opinion piece published in a special interest chiropractic journal probably misquoting or misrepresenting a researcher over 30 years ago. Perhaps the author’s time would have been better spent asking chiropractors citing this why they have no respect for their patients or for science broadly? If her own chiropractor put her up to this, I implore her to ask the practitioner why they have so little respect for her that they would suggest a source without performing high-school level fact checking.

The second contention made by the author in the above segment is this: because a Google search of hers yielded many results “regarding the effects of spinal adjustment on immune system function,” there therefore is ample evidence of such effects. It is worth keeping in mind, dear author, that not everything you read on the internet is true or reliable. This is especially the case for these types of studies which do not contain any reliable evidence. Would you rather hear this from chiropractors? How about the most prominent international chiropractic association, which reviewed the available evidence on this topic and concluded:

No credible, scientific evidence that spinal adjustment / manipulation has any clinically relevant effect on the immune system was found. Available studies have small sample sizes and a lack of symptomatic subjects.

At the time of writing, there exists no credible, scientific evidence that would permit claims of effectiveness for conferring or enhancing immunity through spinal adjustment / manipulation to be made in communications by chiropractors.

I would also like to draw the author’s attention in this report to yet another dismissal of the alleged Pero study contained within the WFC’s report:

Overview: It has been reported that in 1986 Dr Ronald Pero, a Professor of Medicine in Environmental Health at New York State University, collaborated with Dr Joseph Flesia, a basic science researcher and
chiropractor. Reports state that subjects receiving chiropractic care (n=107) had a 200% greater immune competence than those who had not received chiropractic care and a 400% greater immune system competence than those with cancer or other serious disease.
Response: Numerous attempts have failed to retrieve this study. Without the original study to review, no scientific assessment of its claims can be made. Therefore, the “Pero and Flesia” study does not constitute credible, scientific evidence that spinal adjustment / manipulation enhances or confers immunity nor should it be used as a basis to provide care.

The author continues, repeating many of the same ineffectual arguments in, invoking both common-sense as well as her own personal experience. She concludes her tirade against myself and Caulfield with the following:

So can chiropractic care help to ward off COVID-19, just like any other virus? Of course it can. I believe retractions by the CBC, Ryan Armstrong, and Tim Caulfield are in order.

How ironic that the CBC should choose to end the news report with Ryan Armstrong’s statement that this “misinformation” about chiropractic “undermines our democracy.” I fail to see the democracy in the act of making sweeping one-sided statements based on a lack of information and understanding, particularly when, by his own admission, he has never been to see a chiropractor himself. I, for one, suggest that anyone who insists on discrediting an entire health care profession and dismissing the benefits it claims to offer needs to try it first before passing judgment. Far from doing the Canadian public a service through his work, he is dissuading us from availing ourselves of a valuable tool for improving and maintaining good health. This is particularly disadvantageous at this unprecedented time in history with worldwide quarantines, resulting in widespread job loss, leading to high levels of stress across the planet.

Here is my own conclusion, which – not that it matters – is in agreement with contemporary chiropractors and their associations: chiropractic care does not help ward off COVID-19 nor any other viral contagion. Chiropractors who continue to deceive patients otherwise are effectively committing health fraud while continuing to embarrass a profession with a reputation that hangs on a thread. Equally ironic and sad, my predictions have been fulfilled; chiropractors have disseminated misinformation in a way that has made their victims committed warriors of pseudoscience, weaponizing nonsense in another misleading article that orbits the world of health policy and regulation.

Finally, to the author I say this: I hold ill will against you. You have been mislead and deceived for profit. Your chiropractor has failed in their obligation to adequately inform you on serious matters of health and they have failed in their responsibilities to continue learning and remain competent. Just as troubling is to see your piece published by an organization guilty of consistently spreading health misinformation, whose Board of Directors all have direct stakes in the “alternative” health industry.

It is precisely because these forces are pitted against patients and the public that I feel science-based activism is more important than ever. And I will keep fighting for your rights as a patient even if you feel the need to attack me for it.

The Prestige Grift: How Fake Success is Manufactured to Sell Pseudoscience

Let me introduce you to Timmins’ Chiropractor: Timmins Chiropractor. Yes, he really has dubbed himself the chiropractor of Timmins. 

Timmins ChiropractorHenceforth, I’m Canada Blogger.

Dr. Luc Lemire appears to be your typical subluxation-based chiropractor. His philosophy identifies “vertebral subluxations” as misalignments of the vertebrae that are alleged to cause a wide array of illness not at all related to the spine. Of course, it’s a myth that is likely not even accepted by the majority of chiropractors.

That has not stopped Dr. Lemire from operating his clinic under this philosophy and advertising to the public that he can improve the “gut-brain connection” to aid various conditions including acid reflux, colic, and ear infections. This is nonsense, but it isn’t remarkable; there are many similar chiropractors across Canada selling nonsense that regulators fail to regulate. So, why are we talking about Dr. Luc Lemire?

Besides his absurd ASMR videos (sorry, this one seems to have been recently deleted, but I’m sure you can find some gold in there somewhere), Dr. Lemire makes some interesting claims in his marketing material. We will dive in, but first, a warning: we are about to peer into a world without shame.

My first sighting of Dr. Lemire was through his Facebook page. It’s odd, to be sure, but it doesn’t deviate far from like-minded chiropractors; there are unsubstantiated claims, misuses of science, and a handful of videos that feature 80’s themed testimonials. Seriously, go listen. Also, shout-out to Brenda; I’m glad you’re feeling better.

A number of links on his Facebook page direct would-be customers to a promotion on his clinical website, which is… interesting. He really has turned it up a notch. The page features a full color vibrant background of Dr. Lemire in his clinic with a center overlay of his current promotion.

Clinic Website
If we beat climate change and you are reading this in the distant future, check out the archive

That’s not all. Thought you were safe from ads since the entire page itself is an ad? Nope. You get another ad that – while remarkably similar to the underlying page – takes the full screen for itself. Amazing.

Clinic Ad
Free gift will include the entire first season of Luc Lemire: How to Smile in Portraits on DVD

By the way, have you heard of NASA? What’s NASA? Oh nothing, just a little organization that makes Space Technology. Have you heard of space? Well they make the technology for it. You wouldn’t call Space Technology a scam, would you? Because you would be calling NASA a scam, which is absurd.

nerve-scan-chiro
This machine was the first chiropractor in space

Too bad this expensive machine has no clinical validity. Subluxation-based chiropractors have employed all sorts of gimmicky devices to “demonstrate” their findings, but studies have failed to show that these chiropractors can reliably detect anything at all. Just think about that for a moment. There are chiropractors all across Canada who spend hundreds, even thousands of dollars on elaborate machines that do nothing more than turn the patient into the clinical malpractice version of a Rorschach test.

Subluxation?

So what is a Certified Space Technology? Oh, well it’s a label purchased by brands to sell products. Just watch the video: “there are direct competitors with very similar products in Japan, and we outsell them 5 to 10 to 1, which is great.” They even certify a Texas Drinker’s Guide as a “Creative Product,” but I guarantee NASA astronauts do not drink space beer nor do they use gimmicky technology to play pretend medicine in space.

I went searching for more details about our great Timmins Chiropractor. Specifically, I wanted to know more about his “Award-Winning Bestselling Books.” As it turns out, the real winner is you, good reader, because this is where we dive deep into the grift.

Award
Oh yes, the well-known Quilly Award

According to his website (and Linkedin), Dr. Lemire was chosen as one of the “world’s leading experts” to co-author a bestselling book with “success expert” Brian Tracy, winning the “highly coveted Quilly Award” via a “red carpet event” in Hollywood. Wow. Sounds prestigious.

The book in question is “The Winning Way“, which features Brian Tracy on the cover and a list of “Leading Experts from Around the World” that is.. extraordinarily long.Authors

Don’t care to count? That’s 49 authors in total. That would be (on average) just under 10 pages per author. Amazing. 

Obviously, something is going on here. We have an unremarkable self-help book with a ridiculous number of authors and – perhaps most interestingly – the Amazon reviews are relatively negative overall (whether from fake reviews or a credulous audience, these types of books tend to at least have decent reviews).

Reviews
A selection of negative reviews

A this point, you’re probably wondering how a book with a 2.5 rating on Amazon from just 6 reviewers (2 of the 5-star reviews were not verified purchases and did not reference book specifics) that appears to be nothing more than an assortment of short stories from 49 unrelated authors ever landed our Timmins Chiropractor the prestigious Quilly Award. You’re probably also wondering what a Quilly Award even is. Don’t worry; you’re hardly alone. 

The Quilly Award was founded by an organization called the National Academy of Best-Selling Authors. If you can’t tell from the website, both terms are registered trademarks. The award is “exclusively distributed at the Academy’s Annual Golden Gala™ in Hollywood.” If you don’t yet feel the prestige, allow them to remind you: “no award conveys Best-Selling Author® status as recognizably and elegantly as the Quilly® Award.” Well if “Best-Selling Author” is a legitimately registered trademark, surely no other award is even permitted to convey the status. 

The Academy’s Annual Golden Gala™ is nothing short of stunning. Here is our award winning author accepting his award at the event. Pay close attention to the applause. Do you think this audience was able to muster that much applause?

The audience
I modified the colours from the video to help you see just how empty the event is.

I hope you can intuit what is happening here. This entire ecosystem, from the book, to the award, to the gala, appears to be constructed entirely to create prestige for prestige’s sake. This is The Prestige Grift. 

Returning to Amazon, one of the primary authors listed is Nick Nanton, who also appears as an author on a large number of eerily similar self-help books featuring Brian Tracy and a large number of “expert” authors you have never heard of.

Brian Tracy Books
If there is a hell, this is it. I only realized after making this image that two of the books feature Jack Canfield. I am not sure how this happened considering how they look nothing alike.

Who is Brian Tracy, anyways? As a self-described “Speaker, Author, and Success Expert,” I cannot tell whether this is an earnest endeavor, or whether he is merely an actor in an elaborate money making scheme. Even his Wikipedia page carries this uncertainty. 

Brian Tracy Wiki
I have actually never seen this before on Wikipedia

Returning to our beloved Quilly, Nick Nanton and fellow author JW Dicks appear to be pulling the strings. Not only do they appear on a number of these books, but they co-founded the National Academy of Best-Selling Authors itself. Are they effectively handing themselves their own awards?

National Academy Founders

Award Process

You might be surprised to find that an academy created for “the purpose of recognizing and promoting the accomplishments of authors worldwide” has a testimonials page that seems to suggest the award is more a product than an independent recognition of excellent craftsmanship. Then again, you probably aren’t surprised. There are, after all, fees for these “services”.

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Promotional material from the first year of the award (formerly known as the Quill Award) describes in more detail what you can expect to receive by attending a the gala.

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Nanton and Dicks also appear to be involved in a number of similar ventures. In particular, as referenced in the testimonials, they run DNA, also known as Celebrity Branding Agency. It would not be a stretch to suggest that the Quilly Award and its supporting organization are projects of this branding agency, especially when the main page includes a guaranteed best-selling author service, which links to a page promoting – you guessed it – The National Academy of Best-Selling Authors. 

Become a Best-Selling Author

Best-Selling Service

I am certain there are rabbit holes still untraveled here. Even a brief search will reveal numerous related websites, domains, registered businesses entities, etc. If you have some time on your hands, I encourage you to see how deep and twisted these schemes go. 

I will leave you with two things. The first, is a press release featuring our protagonist, Mr. Timmins Chiropractor, promoting his best selling success. The release would be embarrassing under normal circumstances, but with the prestige grift laid bare, it is even harder to stomach (note that CelebrityPress™ is also run by Nick Nanton and the Dicks). The second item is an excerpt from a Glassdoor entry by an alleged former employee of Celebrity Branding Agency:

These people will not become celebrities by being featured in random books and promos by washed up professionals. You are trying to invent the word celebrity or make it mean something other than what it is and no, it is incredibly deceitful.

Well said.

The Failure of Self-Regulation of the Chiropractic Profession is an Urgent Public Health Crisis

Below is a letter I recently sent to Ontario’s Minister of Health and Long-Term Care, Christine Elliott. The letter was written following a number of very disappointing decisions I received from the College of Chiropractors (CCO) of Ontario concerning a number of complaints I have submitted over the past couple of years (details to follow soon). 

The CCO has made it clear that they are either unable or unwilling to hold chiropractors to a reasonable ethical or scientific standard for the protection of the public. I have submit complaints detailing how Ontario chiropractors have used deceptive advertising, how they have disseminated provably false claims, how they have misled the public on scientific and medical issues, how they have cautioned that vaccinations are “toxins”, how they have lectured that medical doctors “kill” their patients, how they have endangered lives by claiming such nonsense as one cannot overdose on vitamin D, how they have made false claims supporting invalid tools and techniques, how they have exposed patients to x-rays unnecessarily, how they have targeted patients with predatory sales tactics, and how they have shown a blatant disregard to their responsibilities as regulated health professionals. No single chiropractor has been disciplined for any of the above issues.

I am at wit’s end. The regulatory college is not effective and not appropriately acting on its mandate to protect the public. I have been reasonable and gone through the proper channels by submitting complaints, but now I realize that chiropractors are not capable of self-regulation. There are many great chiropractors who initially gave me hope that the profession could reform itself, but I no longer see this as a realistic possibility. The profession must either be dismantled or there must be intervention by independent authorities.

We are increasingly aware of the danger that health and science misinformation both pose to public health, democratic decision making, and the public’s understanding of science. The chiropractic profession was given a chance to regulate themselves and improve. They have collectively failed. 

The Letter

Dear Minister Elliott,

Several years ago, while completing my PhD, a colleague of mine handed me a pamphlet advertising an event put on by a local chiropractor. Curiously, the topic of the seminar was cancer, but chiropractors are not medical doctors and certainly not specialists in oncology.

As I learned more about this practice, I found that the chiropractic profession harbored strange beliefs surrounding medicine generally. While some practice akin to physical therapists, there exists a large subset of practitioners who believe that spinal “adjustments” are the core requirement to maintain good health and prevent disease – a provably absurd notion. The philosophy behind this belief is even
more absurd, but I will spare you the details.

At the time, I was most passionate about science education, but I felt that my efforts were undone by regulated practitioners who disseminated misinformation to large audiences, utilizing their authority as health professionals to deceive the public for financial gain. This was the beginning of my adventure in science advocacy in activism.

Learning of the existing regulatory mechanisms in place that are intended to protect the public, I began systematically submitting complaints against practitioners to The College of Chiropractors of Ontario. Most recently (today), I submitted a complaint concerning two chiropractors who claim that vaccinations are the “absolute number 1 chemical stressor” requiring chiropractic treatment. This is merely a sampling of the many absurd and dangerous claims I encounter daily.

Unfortunately, the regulatory college has failed to appropriately act on complaints. Recent stories in various national outlets (some of which have featured my activism) highlight the extent of the issue and shed light on a greater regulatory failure: The College of Chiropractors of Ontario itself is comprised of council members who harbor pseudoscientific beliefs, including a strong opposition to immunization. In the midst of low vaccination rates and increasing outbreaks, this is completely unacceptable.

I have – thus far – played by the regulatory rules and mechanisms available, but they are simply inadequate. For the safety and general good of the public, I ask that you intervene with the College, review complaints, and enact stronger regulation. As with other health professionals, chiropractors
operate within a privileged marketplace. It is time that the profession took on the responsibility that comes with that privilege.

Sincerely,

Ryan Armstrong

The Science Aesthetic

Appearances matter. I do not expect anyone to object to that conclusion in reference to art or in the day-to-day appreciation of beauty in its various forms. But aesthetics in science? Is science not the one domain where we can isolate and mitigate the forces that colour our perception? Can we not harness the powers of logic and rationality to steer us towards conclusions that are true rather than conclusions that please us?

Simply exploring the role of the aesthetic in science can be troubling; it reveals a bias of human cognition where all the pretty hypotheses are developed into full-fledged theories while the less desirable wait at home, hoping a dreamy scientist will one day reach outside the institutional norms and bring them to the prom of ideas. One must look no further than the search for a single theory of everything as a scientific pursuit predicated on the beauty of simplicity and totality.

While the exploration of aesthetic influence within science is certainly fascinating, there exists also an aesthetic of science and the institutions that support and surround it. These are the cues – interpreted both consciously and subconsciously – that confer scientific authority to ideas without granting them any particular merit with regard to their descriptive power of reality.

One needs not look far for popular imagery and stereotypes in science. If you Google “scientist“, the search yields a large number of photos (including many stock photos) depicting lab coated chemists hard at work with their various laboratory apparati, yet most scientists are not chemists and lab coats are not particularly pervasive across other specialties. For better or worse, these aesthetic stereotypes invade the public consciousness, impacting not only how professionals in science and medicine are portrayed, but becoming symbolic of the authority and legitimacy of those professionals. As a result, the aesthetic itself has become a tool for exploiting public trust.

Whether purposefully manipulative or entirely subconscious, various movements have adopted aspects of the established aesthetic within the scientific and mainstream medical domain. Take – for example – a Google search for “naturopathic doctor“. What do you see? White coats, stethoscopes, lab spaces, and – notably absent from our search for scientists – an obvious appeal to the natural aesthetic that has so infected our consumer culture. One could very well argue that the naturopathic profession was built largely to appeal to our aesthetic values. Indeed, many have argued that the profession merely takes advantage of such deficiencies in the medical system. This is perhaps most evident in the narrow conditions most commonly treated and utilized as naturopathic “success stories”; such lists often contain self-limiting conditions which tend to resolve without any intervention at all. Patients do not need treatment, but do they need the comfort of being heard and cared for?

Of course, any profession that is built on such thin facades as borrowed apparel is doomed to fail. I can dress a monkey up as a physician, but at some point you’re going to question if eating the lice he grooms out of your daughter’s hair is really proper clinical etiquette. But what if he didn’t eat the lice? What if he could write and speak? What if that monkey didn’t look like a monkey? Evidently, the aesthetic of scientific legitimacy is not a simple binary, but a continuum of qualities that are context and observer dependent.

For some people, a clean office, lab coat, and stethoscope may be sufficient for putting their faith into a practitioner. For others, they may be sufficiently persuaded by formal credentials. Of course, persuasion of patients alone is not sufficient to create a professional health paradigm; in Canada, provincial jurisdictions have the final say over what types of practices are permitted and whether they receive public funding. This is, after all, why we have elected representatives and regulators. In theory, their job is to evaluate objective criteria against our shared values to create a system that best balances access to healthcare, patient safety, consumer choice, value, and more. Luckily, it seems to take more than a white coat to fool these folks. Unfortunately, this means that deception just gets that much more complicated.

The naturopathic establishment knows it cannot exist without some level of scientific validation, or – at very least – the appearance of scientific validation. This notion launched a movement that is perhaps best typified by the US-based National Center for Complementary and Integrative Health (NCCIH), which despite billions of dollars of funding has not produced particularly impactful research and has failed to report clinical trials. What do they have? An aesthetic that relies on buzzwords to convey a unique patient-centered value and studies that are scientific only in appearance.

A shocking proportion of the scientific literature consists of works that do not simply fail to expand upon human knowledge, but impede such developments by promoting false notions, often the result of vested interests. While these studies typically rely on methodology of such poor rigor that they fail to impact the broad scientific consensus, they can be wielded as devastating weapons against the public consciousness for political and social gains. Indeed, they generally possess all of the aesthetic markers that the lay public rely on to distinguish scientific work from news, opinion, commentary, etc. And when the peer-review process fails, such works can even make their way into prestigious journals that confer an additional veneer of legitimacy.

One need not look beyond the border to find such egregious abuses of science. Recently, I’ve become familiar with a naturopath-driven cancer institute close to home: the Ottawa Integrative Cancer Centre. The clinic claims to provide treatments for “any stage of cancer” as well as “prevention of cancer”. Throughout the website, there are many claims that the clinical practices employed are “evidence-informed” or “evidence-based“, but are they really?

Let’s explore the “Evidence-Based Monographs” page. The page includes various monographs targeting both patients and health professions with rousing titles such as “Flax for Breast Cancer“. Virtually all of the documents make extraordinarily strong suggestions of benefits for compounds that simply are not supported by quality research. Take for example Mistletoe. The author(s?) rely on carefully suggestive language; instead of claiming that mistletoe has definitive benefits, they say that it “is most commonly used in cancer care” for a number of purposes, which include reducing tumour size and slowing disease progression. Elsewhere on the site, you can find claims that “Mistletoe Improves Overall Survival” referencing a single dated study. More recently, the preponderance of evidence indicates that “the literature does not provide any indication to prescribe mistletoe to patients with cancer” yet this review is nowhere to be found on the website of a clinic that just happens to offer intravenous mistletoe therapy for cancer patients.

At what point does this become the abuse of science for its aesthetic? At what point does this become a serious ethical breach of informed consent? Obviously, I don’t have a window into day-to-day clinical practices, but the website really does not instill any confidence that vulnerable cancer patients are receiving accurate information. Is this really the type of clinic we are comfortable permitting patients to be lured into spending their money and last hours in?

This is all – quite frankly – infuriating, but we have barely scratched the surface here. My first run-in with the OICC was through a Twitter exchange with Jean Seely, who just happens to be the sister of the clinic’s Executive Director: Dugald Seely. Jean pointed out that patients were provided “helpful support” without “false expectations.” Well, if the website reflects what goes on in the clinic, I am highly skeptical of both claims. She went on to cite a “goodstudy performed by her brother, which didn’t touch on cancer at all, but on “Naturopathic medicine for the prevention of cardiovascular disease“. The study is a perfect example of science in appearance only; while the authors conclude that the findings “support the hypothesis that the addition of naturopathic care to enhanced usual care may reduce the risk of cardiovascular disease among those at high risk” the study entirely fails to adequately test that hypothesis. Let’s dig in.

The study was designed as a trial to compare enhanced usual care to enhanced usual care with the addition of naturopathic care among middle aged postal workers with an increased risk of cardiovascular disease in a number of major Canadian cities (classic A vs. A+B). Billed as a “pragmatic” approach, the study – if properly designed – should give insight into the practical benefits that naturopaths can offer patients via regular visits. Unfortunately, the study was only pragmatic in the sense that its design effectively guaranteed positive results, but not through the magic of naturopathy.

Let’s take a step back. What do we know about the clinical practice of naturopaths? We know that most of what Canadian naturopaths advertise is an assortment of completely bogus therapies, including homeopathy, chelation, colon cleanses, and various forms of IV therapy. We know that a large proportion of Canadian naturopaths advertise phony treatments and diagnostic techniques related to allergies and asthma. We know that a vast number of naturopathic websites (and presumably practitioners) promote vaccination misinformation, which is undoubtedly related to the high prevalence of vaccination hesitancy among patients who see naturopaths (indeed, I have personally submitted complaints on this issue to various regulatory bodies that have yet to take any action). We know that a large number of naturopaths offer completely pseudoscientific “stem cell” therapies. We also know that patients who receive “complementary medicine” for their cancer are more likely to refuse medical care, and ultimately, are at a greater risk of death.

By these measures, the naturopathic profession in Canada is largely anti-science and a measurable threat to public health. So how did Seely et al. work this reality into their pragmatic study design? Well instead of opening the floodgates to the multitude of dangerous and pseudoscientific practices popular among Canadian naturopaths, the authors cherry-picked the acceptable interventions that could be utilized by the participating naturopaths:

  • Dietary interventions (tailored diet, caloric restriction, etc.)
  • Supplement-based interventions (fish oil, fibre, lutein, etc.)
  • Lifestyle interventions (exercise)

And how did they track what interventions were chosen? They didn’t:

“Because a range of interventions were recommended to participants in the naturopathic group, the frequency and composition of each recommendation as well as participant adherence are not reported. We did not have direct control over the care given to the control group; thus, we did not track or report recommendations made by the participants’ family physicians. “

So what were the results of added diet and lifestyle counselling? The group receiving “naturopathic” counselling improved marginally over the control group on the primary endpoints relating to cardiovascular risk (there are some statistical issues, but those are really trivial compared to the fundamental conceptual flaws of the paper). What is worth noting, is that the “naturopathic group reported significantly more weekly minutes of moderate exercise.

So… wait a minute. The study took a group of naturopaths, restricted them to traditional interventions to promote physical activity and dietary lifestyle changes for cardiovascular risk factor reduction, including exercise, which is known to reduce CVD risk, and – as a result – the naturopathic group exercised more, reducing their risk, and they have the audacity to attribute these benefits to the magic of “naturopathic medicine“? If I was a betting man, I would bet that a Richard Simmons VHS would outperform these amateurs.

So what did the study really tell us? Well, ignoring the other major methodological deficiencies, the most generous interpretation tells us that naturopaths could have a positive effect when they act as glorified diet and fitness motivators, but could this not be accomplished more efficiently with a science-based specialty that practices exclusively in this domain? Did the authors forget about the following more science-based practitioners who can give advice in this domain:

  • Physicians
  • Occupational therapists
  • Physical therapists
  • Dietitians
  • Personal trainers
  • Nurses
  • Nurse practitioners
  • Chiropractors (vitalists excluded, sorry)
  • Kinesiologists
  • Karen from Farm Boy

Or did they simply ignore them in the quest to legitimize their field with the scientific aesthetic? Because once you peel back the assumptions and the misleading language, that’s all this study is: an aesthetic of science.

Studies like these are among the many ways that alternative practitioners misuse the aesthetic legitimacy of existing establishments to bolster their own professional identity. I continue to be shocked that journals do not require authors to report conflicts of interest when their work is primarily intended to promote their own profession rather than to ask legitimate scientific questions relating to novel medical interventions. The evidence shows that these types of practitioners will use any means available to elevate their reputation, from producing and relying on bad science, to claiming that 3 years of arbitrary undergraduate schooling constitutes “university-level pre-medical training.”

Worse still, the Canadian associations that represent naturopaths are nothing short of ignorant and dangerous. The Ontario Association of Naturopathic Doctors – for example – has promoted turmeric as a cancer treatment, homeopathic alternatives to vaccines, and high dose IV vitamin C therapy as a possible cancer cure. In this context, the monkey in the white coat doesn’t look so bad…

David Gorski, in his article looking at funding for dubious research performed out of the OICC, said it best: “In the end, naturopaths like Dugald Seely are cosplaying real doctors and clinical trials are their props.” Whether conscious of not, these practitioners co-opt the scientific aesthetic for personal and professional promotion without adopting firm scientific principles. Look for substance here, and you will be shocked at what you find.

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.

——————————————————————————————————————————————-

Acknowledgments

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

——————————————————————————————————————————————-

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.