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Philosophy | Skepticism in Health and Medical Science - Series

Part 3 Mainstream Skeptics

Contributor Bio

Alex Tarnava is the CEO of Drink HRW, and the primary inventor of the open-cup hydrogen tablets. Alex runs the clinical outreach program for our company, working with over a dozen universities coordinating research. Alex has also published research of his own. You can find it on his ResearchGate. Additionally, he has been interviewed for many prominent publications, such as Entrepreneur and Forbes, and on many popular Podcasts. You can find all of his interviews and articles on his media page.

Part 3 Mainstream Skeptics

Mainstream skeptics groups have risen in popularity over the last decade by debunking magical claims made by both the deluded and intentional fraudsters. This is a noble pursuit, and for much of the fantastic work they’ve done, they need to be applauded. That said, as the dichotomy in the “prevailing wisdom” regarding health strategies has widened, many skeptics, groups, prominent figures, and hobbyists alike have taken to broadening their scope and pursuing targets beyond the most egregious and obvious.

Nothing is above skepticism and criticism. I’ll repeat, nothing is above skepticism and criticism. However, many subjects are murky, with the evidence unclear or not yet fully established. Many criticisms levied at evidence are also not universally accepted or fully logical 100% of the time. Further, many mainstream skeptics will use an arsenal of attacks against their opponents, finding the best suited strategy and narrowing in, determined to not concede any ground. This isn’t the pursuit of truth, but rather, a predetermined goal to discredit a perceived foe.

Let’s take a look at some of the arguments used by mainstream health skeptics, often inappropriately, to “win” their arguments against those not aware of what they’re doing or talking about, and to drive a stalemate with others.

Presumption of a Universally Accepted Standard of Evidence

Many skeptics in the US have fallen to speaking as if it were irrefutable that there is a clear transition between unproven pseudoscience and hard, accepted science – namely, FDA approval of a new drug. Interestingly, many of these very skeptics will, on one hand, criticize the FDA’s low required evidence threshold to “not object” to structure function claims allowed by supplements and the lack of regulation of the supplement industry in general, while simultaneously championing the FDA’s determined threshold for drugs as an accepted fact.

There are some key issues with this position. First, evidence accumulation is a spectrum and is not binary, which should be obvious. Second, the accumulation of evidence does not always exist to drive something down a specific regulatory approval. Case and point: exercise. The accumulated evidence for health benefits, and disease modifying activities, of exercise are so overwhelming that it is one of few things that virtually everyone can agree on. Despite this, there is no condition where exercise would meet the evidence threshold to be declared a new drug, even for type 2 diabetes.¹ For osteoarthritis, a disease where exercise is universally recommended, reviews on the topic have shown no disease modifying capabilities, although it does significantly reduce side effects and discomfort.²

“Few studies have evaluated the effects of exercise on structural disease progression and there is currently no evidence to show that exercise can be disease modifying.” ᶦᶦ

Part of the issue in gathering sufficient evidence is adherence to protocols in participants of large-scale clinical trials and the ability to double blind experiments. At best, we can observe effects in large observational studies or studies that “single” blind a physician, meaning that the study organizers and the participant know the protocol, but the physician does not.³ These are some of the reasons that some researchers have suggested that rodent research on exercise should be used to determine protocols in humans.⁴

Of course, exercise is rarely used as a cure for specific diseases. Neither are many supplements that have significant evidence, although not to the level required for a new drug. Exercise gets a pass from mainstream health skeptics, whereas supplements rarely, if ever, do. An oft used position is that supplements cost money and, as such, they should meet the evidence requirements of drugs for consumer protection, which is again not clear cut. Further, some advice given by alt-med practitioners, such as cold exposure, can be free, but is still ridiculed. Additionally, for most, exercise can be quite expensive, when considering for example, memberships and attire.

Regarding consumer protection, the clear response is consumer freedom. Many products may have slight benefits while having a high safety profile. Such supplements may never pass the threshold of evidence as a standalone drug, which doesn’t mean they are necessarily devoid o benefits. Unfortunately, given the current economic costs needed to get a drug to market (in the billions), most of these products, molecules that are safe and slightly effective, would never
justifiably be pursued. Of course, due to the lack of regulatory enforcement, many products that are neither safe NOR effective are on the market. This is a serious issue in the supplement and natural health industry, and one that skeptics attacking it are justified in.

There is also the issue regarding molecules that may facilitate beneficial outcomes through improving normal structures and functions. Hence, the FDA’s allowance of claims on supplements pertaining to regular structure and function of the body. This is something very relevant to molecular hydrogen and my hydrogen water tablets. Our best evidence, both for our tablets and for hydrogen water in general, is regarding metabolic issues, such as metabolic syndrome. Our recently published trial on metabolic syndrome showed clear and strong benefits over 24 weeks of use in 60 participants⁵. Due to the previously published human evidence, this could be considered a Phase II trial. It is not unreasonable to suspect that high-dose hydrogen water could succeed in Phase III trials at this point, as there is a high percentage of successful transitions from Phase II to Phase III. The argument is moot, as thankfully, despite having serious health consequences and affecting one-third of the US population, metabolic syndrome is not considered a disease by the FDA, and as such, a drug cannot be prescribed for it.

For molecules such as hydrogen, with emerging evidence for important health considerations like metabolic syndrome that are not disease states, from the FDA’s own regulatory positions the supplement route is the way to go. The FDA’s rules are very clear: If something is on the record as a generally recognized as safe (GRAS) food substance, or a new dietary ingredient (NDI), which our hydrogen tablets have, FIRST, investigational new drug applications can be pursued for disease models and it can be sold as a supplement in the meantime. Even if approved as a drug, it can continue to be sold as a supplement for non-disease outcomes, such as metabolic health and exercise performance. Conversely, if something is investigated as a drug first, it can NEVER be sold as a supplement. This means that if a company like mine had first pursued hydrogen tablets as a drug, later found out it was very effective in an adjuvant sense but not as a standalone, it would be dead in the water for that use. In addition, it would not be able to be used for exercise performance and recovery as well as metabolic health. The latter true even if it gained new drug status, unless, of course, physicians started to prescribe it en masse for off label purposes, or it gained over-the-counter (OTC) status. In those cases, education would be the hardest part, as marketing these outcomes would not be legal.

These skeptics groups love utilizing FDA regulations on the subject, while ignoring the larger body of FDA regulations. Basically, they are cherry picking what they want to agree with when it comes to the FDA, using the authority of the FDA to justify their reasoning, while simultaneously ignoring and discrediting the decisions the FDA makes elsewhere. It’s completely fair to agree with some of the things the FDA does, while criticizing other aspects. It is neither logical nor honest to cherry pick where they agree to strengthen their argument, while discrediting FDA regulations in the next. Either the argument is that the FDA is the authority, or it is that they are not. Either is fine, moving the goal posts to satisfy an argument is not.

Pharmacological Understanding

Many skeptics will state that one must first understand how a molecule works, with a clear understanding of the pharmacodynamics and pharmacokinetics, before it can be even considered. While it is always preferred that we fully understand how a molecule works, it is not always the case. Often, many years of research are needed to uncover the mechanism behind specific molecules’ beneficial effects. I’ve previously written about why we know enough about molecular hydrogen, pointing to the fact that we do not fully understand and are still learning more about common drugs, such as lithium, acetaminophen, and even penicillin.

Using exercise as an example again, we are really just starting to learn about how it works to improve various health outcomes. It was only a decade ago we discovered irisin, for example.⁶ Regarding exercise and cancer, it is widely accepted that exercise helps lower cancer risk and improve quality of life during cancer treatment, despite us having no clear recommendations or knowledge regarding its mode, duration or dose.⁷ This is typically a massive red flag to skeptics. In fact, when it comes to exercise, there are likely far more variables in determining the ideal dose, duration and mode than other interventions, making it far more complex to understand. Fortunately, with exercise there is a fairly large window to estimate these parameters.

It is always better to fully understand a molecule, but there are clearly exceptions. Lack of a complete understanding should give pause, but not completely discredit an idea, particularly if evidence suggests that it does, in fact, provide beneficial effects. This is especially true if it repeatedly shows to do the same thing through many trials both in cells, animal models, and humans.

HARKing & the Multiple Comparisons Problems

Many of you have likely never heard the term “HARKing,” short for “hypothesizing after results are known.” Drawing from the belief that we should fully understand a molecule, or at least be able to confidently predict some outcomes, the concept of HARKing has been used to criticize researchers who change their opinions based on the evidence they observe. This may sound ridiculous at first, but the practice is criticized for a good reason, and the argument that many things that work take a while to understand is often used to justify ridiculous propositions and
interventions, using the argument, “We just don’t know how it works yet.”

HARKing becomes even more eyebrow-raising when researchers measure countless outcomes to see what, if anything, is affected by the intervention. Of course, if you measure enough outcomes, some are bound to be significant purely by chance and probability. This is called the multiple comparisons problem, or the look-elsewhere effect. Often, early studies utilizing HARKing and researching multiple outcomes are outright dismissed as bad science and purposefully creating pseudoscience. Often, this is the case, but in many instances, significant exploratory work and HARKing are necessary in understanding the mechanisms of how something that seemingly works, but shouldn’t, works.

Hydrogen water is a great example of this. Early human clinical evidence on metabolic syndrome appeared to be nothing but fishing exercises with multiple outcomes measured,
followed by HARKing. As I recently wrote about in my article regarding our recent publication on metabolic syndrome, the first three studies all had very questionable outcomes, with low percentage success rates in measured outcomes, despite two being unblinded or placebo-controlled open label trials. It truly appeared to be bad science. One thing stuck out to those looking closely: all three initial studies showed improvement in some of the outcomes of cholesterol markers measured.⁸,⁹,¹⁰ This was sufficient for one of the research teams to research cholesterol as the focus, in a much more targeted study. This targeted study was randomized, double-blinded, placebo-controlled, and had the largest group to date, of 68 participants. Despite these additional controls, which would typically lead to far less prevalent or no results, the significance was much higher and clearer.¹¹ This was also seen in the recent study on metabolic syndrome using our hydrogen tablets, again, with a higher dose and longer duration, despite being a randomized double-blind placebo-controlled trial.

Exploratory work is needed, however, and ideally, it should be done in basic research and not in humans. Occasionally an intervention’s popularity can lead to research in humans without the typically prerequisite knowledge from animals. In this instance, it can be both good and bad. It is good if it leads to further understanding, and more focused research that finds clear benefits. It is unquestionably bad if it is used solely to prop up marketing claims.

HARKing is a controversial practice, with some arguing vehemently against it by stating it always offers “concealment of the truth” and that the detriments outweigh the benefits,¹² while others argue that there are different kinds of HARKing which should be evaluated based on each case¹³ and others defend the practice.¹⁴ I fall into the middle category. HARKing has uses, but it also comes at a cost. Research relying on HARKing and a few results based on exploring numerous outcomes should be looked at with a heavy dose of skepticism. If those early practices lead to better controlled and more focused science, the early questionable practices should be forgiven as well-intentioned.

Ad Hominem Attacks & Straw Man Fallacies

Perhaps the most striking hypocritical tendency I see from many skeptics of this camp is the combined practice of dismissing ad hominem attacks against themselves as ridiculous and admission of defeat in the argument (usually amounting to being called shills), all the while heavily relying on ad hominem attacks against those they are criticizing. It is incredibly common for most skeptics to question someone’s credentials or affiliation, without acknowledging their argument, the definition of an ad hominem attack.

Additionally, most of these skeptics tend to attack all positions made by individuals if said individual happens to hold one demonstrably false position. This is a dangerous approach, as virtually everyone holds at least one superstition or false belief, whether provable or not, as true and dear. Each position must be assessed on its own merits. Even for known celebrity doctors/marketers such as Dr. Oz, who is wrong about half the time,¹⁵ that leaves the other half where he is right. Don’t get me wrong, being wrong half the time is an abysmal track record, and anything said by someone who is wrong at that rate should be rightfully questioned.
However, it can’t be dismissed as wrong because that individual said it. That position is illogical. It goes even further when skeptics will discredit one individual just for fraternizing with another individual or group on their radar.

Guilt by association is increasingly a very real and very troubling reaction. There are many people I work with, know on a personal level, and consider friends that I disagree with on many fundamental issues relating to established science. I’ve found that in many cases, them being wrong (based on my position and consensus), on one or even several subjects, often does not at all impact their knowledge and understanding in another area. Suggesting that it does, not
just by default but always, is frightening. This attitude is a large factor in driving the chasm deeper, limiting any common ground or ability to discuss issues.

Additionally, many skeptics groups simultaneously teach against the ridiculousness of straw man fallacies and then, employ it in their own arguments. It can be observed very prominently in the most primitive form when used in mocking memes, headlines, and favoured go to lines in many popular groups. In the more academic groups, straw man fallacies are employed far more tactfully. For instance, I’ve seen many supposed skeptics latch on to usage of the word natural, even outside of marketing and in FAQ sections, to discredit a company for using the natural fallacy. Often, the use of natural is not actually used to denote beneficial outcomes as such, nor does it have any bearing on the rest of the argument. Unfortunately, there are many questions that must be answered to consumers, due to widespread marketing and misinformation, and if they aren’t answered, a company appears to be hiding information. There is a clear difference
between implying something is good because it is natural, front and center in marketing, and acknowledging it is natural on a FAQ page in response to the question being frequently asked. I have personally had this argument leveled against me, despite my repetitive support of an evidence-based approach to molecules, regardless of whether they are synthetic or natural (e.g., our use of sucralose in formulations with sweetening agents).

This is simply one example of the widespread usage of straw man arguments. Skeptics ought to focus on the use of the steel man argument, popularized by Sam Harris. I will provide more information on that later in this series.

Next week, where the alt med skeptics et it right, and where they are painfully wrong.

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