Creator of Herbex products shares his thinking

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Posted 25 April 2018

GroundUp recently published the article “How a journalist took an ethical stand and risked her job” pertaining to the journalist Natasha Bolognesi who “refused to edit a bogus article” on the WAVEEX product for Daleen Totten, owner, publisher and editor of Natural Medicine. 

This resulted in many comments, including one from Dr Frank Muller (“a medical doctor and a pharmacologist”) who writes “as the formulator of most of the Herbex range of products“. His letter drew a response from Annika Larsson, to which he responded.

Dr Muller’s letter is very informative on his thinking about Herbex products. When challenged, his response is interesting, and how he evades an adequate answer. I post these 3 letters as they are reveal how little science or “proof” went into developing these products.

Dr Jacques Rousseau who teaches critical thinking & ethics at the University of Cape Town and a co-author of Critical Thinking, Science & Pseudoscience, has weighed in on this and I post his opinion at the end following these.

Letter 1 from Dr Frank Muller

Leave efficacy to Darwinian economics

Dear Editor

I write as a medical doctor and a pharmacologist. I was an occasional contributor to the SA Journal of Natural Medicine. Since 1997, I left my position as Director of Clinical Research at a prestigious research entity and devoted my time to the study and promotion of (mainly) herbal remedies. Does that make me a quack?

I also write as the formulator of most of the Herbex range of products, now under fire from various quarters. Does that make me a quack? Disclosure: I have not received any income from Herbex for ~11 years.

When I formulated the products, I used the best science AND clinical experience available to me at that time. But I broke some pharmaceutical rules. For example, I realised (based on clinical findings) that the dose-response curve was not a valid paradigm for mixed herbal remedies. Synergy was the correct paradigm. Does that make me a quack?

I am not defending Herbex or WAVEEX or any other -EX, nor their adverts. I have nothing to do with any of them. But I am defending freedom of choice and freedom of speech. If a “snake oil” item is promoted and sold to the so-called “unsuspecting public”, whose job is it to defend the public? I think it is terribly condescending and patronising for anybody to assume that the “unsuspecting” public is a collection of morons who cannot think for themselves.

Every therapeutic product has to cross two hurdles: Safety and Efficacy. Of these, safety is the most important. If a safe, but useless product is sold, surely the public will figure it out sooner rather than later? Why the need for one or more “Councils” to deliberate on this? If I, as a member of the public, choose to spend my R150 on a useless but safe weight loss product month after month, surely that is my choice? I don’t need some super-dooper academic to step in and protect me against my choice?

My cry is this: Allow the public to choose. Safety is important, so set up legal bodies to ensure stringent safety. But leave efficacy to Darwinian economics. Products that don’t work, will die out. Products that do work, will flourish.

Sincerely

Dr Frank Muller

13 Apr 2018

Response letter from Annika Larsson

Dr Muller has fooled himself

Dear Editor

Allow me to respond to Dr Frank Muller who poses a series of pointedly provocative questions.

When Dr Muller asks whether “study and promotion of (mainly) herbal remedies” makes him a quack, the answer is obviously, “No, not in and of itself. But if you promote same as effective without adequate substantiation, the answer quickly changes to, ‘Why, yes, it does!’”

When Dr Muller asks whether writing “as the formulator of most of the Herbex range of products” makes him a quack, the same caveat applies.

When Dr Muller asserts that, “the dose-response curve was not a valid paradigm for mixed herbal remedies. Synergy was the correct paradigm,” he is taking a position contra to that of established science, unless he can first elicit this consensus from the scientific orthodoxy. If he can’t and he nonetheless avers this stance, then clearly he is a quack because he seeks to short-circuit proper scientific protocol. For better or worse, that’s the required discipline and rigour of participating in science.

In his support for “Darwinian economics” regarding the sale of alternative “remedies” where he would like the reader to believe that “Products that don’t work, will die out. Products that do work, will flourish,” Dr Muller conveniently ignores the placebo and nocebo effects. There’s a reason the evidence-based medical fraternity regards the double-blind, placebo-controlled clinical study as the gold standard of evidence about both safety and efficacy for medications. The more recent requirement that researchers disclose their affiliations is a further handbrake on temptations to subvert due process.

In short, Dr Muller seems to take no issue with exploiting people if you can get them to fool themselves—which is not surprising, given that Dr Muller appears to have fooled himself so thoroughly.

Sincerely

Annika Larsson

15 Apr 2018

Response Letter from Dr Frank Muller

The plecebo [sic] effect

Dear Editor

I thank Annika Larsson (without Facebook or LinkedIn account) for taking the bait and swallowing it.

She writes that, “if you promote [herbal remedies] as effective without adequate substantiation”, I am, effectively, a quack. That sounds reasonable. Have proof, may prescribe. But most general practitioners (GPs) and specialists I know prescribe the majority of their products based either on personal experience, or on hearsay. True, one would hope that protocols and recommendations are based on a “double-blind, placebo-controlled clinical study as the gold standard of evidence”. But for the GP, it remains hearsay.

Experience shows that “gold standard” research has largely been subverted by money. It is an open research secret that financial interests can be cleverly disguised in ways that make an auditor’s eyes glaze over. You do not have to take my word for it. Dr. Richard Horton, editor-in-chief of the prestigious Lancet, and former BMJ editor Fiona Godlee, agree.

Not only are there crooks in research (who knows how many), but the quality of medical science done over DECADES is very bad (ask Richard Smith, former editor of the BMJ, Doug Altman, statistician, and John Ioannidis “Why most published research findings are false”) for a primer.

Says Annika: “If he can’t [elicit … consensus from the scientific orthodoxy that synergy is a valid model] and he nonetheless avers this stance, then clearly he is a quack.” This turns all GPs in the world into quacks. Almost no patient walks out of a consultation with less than three items on the prescription. Yet it is a safe bet that no gold standard research was ever done on that particular combination. Ask the GP why (s)he does it and the answer is most likely, “The drugs support each other’s actions.” Why is the practice of synergy allowed in one field, but not in another?

As for placebo effect: It is so powerful, it should be a therapeutic option. Why not? With so many fake prescription medicines based on fake science, maybe that is how they work, anyhow? Who decides?

Sincerely

Dr Frank Muller

17 Apr 2018

My comment

Dr Muller clearly believes that science and scientific principles do not apply to him, nor do universal comprehensively studied pharmacological principles and knowledge. He claims these are “paradigms” – they are not. He claims that synergistic effects always and only occur with herbal remedies when it is well known that all pharmaceutical interactions, including for herbs, may be synergistic, antagonistic, or have none. (Synergistic effects are when the total effect is greater than the individual effects combined, i.e., 2+3=7)

Readers will not know that very few studies have evaluated for interactions between two herbals, and rarely for 3 or more. None have been conducted for the combinations used in Herbex products.

Even if one assumes that synergistic effects do occur, they cannot occur to the degree that Muller claims for Herbex Attack the Fat. This product contains among other, a combination of green tea at 1.7 mg/day with Garcinia at the same dose. Studies of dosages of 270 mg to 1200 mg/day and 1,000 mg to 5,000 mg, respectively, have not conclusively shown that these ingredients work effectively. 

Dr Muller claims that the public should be allowed to choose, even if a product is a scam. “Products that don’t work, will die out”. He claims that “surely the public will figure it out sooner rather than later?” Is it acceptable that some cancer patients die using an ineffective product before this becomes clear it is useless, simply to be able to then warn others? The scam anti-cancer product Laetrile is still being sold in parts of the world which suggests his argument is wrong. Even informed consumers can be manipulated, fed false facts, and duped into believing nonsense.

A (partial) autopsy of pseudoscience: Natasha Bolognesi and WAVEEX

Published in Synapses

Earlier this month, Prof. George Claassen of CENSCOM (Stellenbosch University) published a piece on GroundUp, detailing how science journalist Natasha Bolognesi became the subject of disciplinary action after refusing to copy edit a study on the cellphone-attachment WAVEEX, described by the manufacturers as

a composite chip of seven superposed layers, outside of plastic, inside five layers with silver ink printed circuits, which, if they are exposed to the electromagnetic waves, weaken the passing harmful radiation and balance it with the magnetic field of your body.

I won’t spend time focusing on how it’s well-established that low-frequency EMF radiation doesn’t pose a risk to humans, nor on the journalistic ethics of Bolognesi’s choice to refuse to copy edit the piece in question.

Instead, I’m struck by another feature, partly thanks to my experiences on Friday night, when I took part in a debate/discussion between myself, Max Jeganathan of Ravi Zacharias International Ministries, and Eusebius McKaiser, on the topic of whether the Christian God exists. (I’ll write about this event when the YouTube video becomes available).

One of the points I made on Friday evening – repeatedly – is that we should try to evaluate claims objectively, rather than from the perspective of an established norm (which is sometimes code for prejudice).

So for example, in the case of religion, or Christianity in particular, the fact that ‘the Bible says X’ needs to be weighed against not only the fact that the Bible is (partly) intended to support X, but also that the fact that we have centuries of cultural acceptance of X doesn’t add weight to X’s actual truth.

Religious apologists, similarly to apologists for pseudoscience, are quick to latch on to gaps in competing epistemic frameworks as evidence for their view, rather than recognising that an absence in argumentative virtue on “the other side” simply weakens the other side’s case, rather than providing positive evidence for your side.

And so it is with responses (in the comments) to the GroundUp article, where Dr Frank Muller offers a textbook example of not examining one’s own premises, instead either expressing fundamental misunderstandings, or choosing to misrepresent and obfuscate in an attempt to buttress an indefensible position.

Muller claims to have formulated the controversial Herbex range of products, which have attracted significant criticism from Dr Harris Steinman (among others). So, many of us might immediately be inclined to distrust Muller’s commitment to scientific prudence and the burden of proof. In response to the GroundUp WAVEEX article, Muller tells us (excerpted):

I am not defending Herbex or WAVEEX or any other -EX, nor their adverts. I have nothing to do with any of them. But I am defending freedom of choice and freedom of speech. If a “snake oil” item is promoted and sold to the so-called “unsuspecting public”, whose job is it to defend the public? I think it is terribly condescending and patronising for anybody to assume that the “unsuspecting” public is a collection of morons who cannot think for themselves.

Every therapeutic product has to cross two hurdles: Safety and Efficacy. Of these, safety is the most important. If a safe, but useless product is sold, surely the public will figure it out sooner rather than later? Why the need for one or more “Councils” to deliberate on this? If I, as a member of the public, choose to spend my R150 on a useless but safe weight loss product month after month, surely that is my choice? I don’t need some super-dooper academic to step in and protect me against my choice?

My cry is this: Allow the public to choose. Safety is important, so set up legal bodies to ensure stringent safety. But leave efficacy to Darwinian economics. Products that don’t work, will die out. Products that do work, will flourish.

There are (at least) three problems with this response. First, it depends on our only regarding direct harms as significant. But even in the absence of direct harm, we have the possibility of:

  1. Deception: whereby the medically-untrained public will have a default assumption of medical efficacy when something is presented to them in a “scientific” guise, rather than just the (more realistic) expectation that they might benefit from placebo effects. These products might be assumed to be as beneficial as mainstream ones.
  2. Financial harms – other products might be more effective, and consumers are led to waste money they could spend more productively.
  3. Physical harms – even if the product in question is marginally efficacious, the delay in seeking more effective medications could worsen whatever condition it is to such an extent that by the time conventional treatment is sought, the consumer is beyond help.

As for whether or not “Darwinian economics” is a good idea, we know that people (like Penelope Dingle) have died because they relied on (what seemed, to them) plausible-sounding claims regarding e.g. homeopathy, while their cancer progressed, unaffected by the taking of non-medicine. So it’s not enough to warn of only direct harms from ingredients – harms can be indirect also, and the customer-base is demonstrably not fully aware of this. 

Given the injunctions of the Hippocratic Oath, and our simple ethical obligations to other sentient beings, it is worrying that people like Dr Muller choose to take the path of treating people as “Darwinian” means to an end – because on his reasoning, they sometimes need to suffer, and even die, so that others can learn what the most efficacious treatments are.

His – and all our obligations – should be to minimise harms, which doesn’t involve the luxury of waiting for “the market” to decide, when you know in advance that trial data show that your product isn’t as beneficial as others – or beneficial at all – whether or not it’s (directly) harmful.

Muller has a later response (April 17), following a letter from Annika Larsson. In it, he tells us (excerpted, with responses interspersed):

She writes that, “if you promote [herbal remedies] as effective without adequate substantiation”, I am, effectively, a quack. That sounds reasonable. Have proof, may prescribe. But most general practitioners (GPs) and specialists I know prescribe the majority of their products based either on personal experience, or on hearsay. True, one would hope that protocols and recommendations are based on a “double-blind, placebo-controlled clinical study as the gold standard of evidence”. But for the GP, it remains hearsay.

This is a misrepresentation of what “hearsay” means, in context. Following current best-practice in medicine, as described in reputable journals and physical gatherings of peers at conferences and so forth, is not the same thing as “I heard this thing from my mate Barry down at the pub”.

If physicians are following that loose definition of epistemic authority that “hearsay” normally connotes – and as used in legal dramas on TV – in their diagnoses and treatment, then of course they are being negligent. But Muller is here not-so-subtly tainting the entire edifice of peer-reviewed science as mere “hearsay”, opening up the gap he needs, namely the gap that allows for “unevidenced-making-stuff-up” to be on equal epistemic footing.

Experience shows that “gold standard” research has largely been subverted by money. It is an open research secret that financial interests can be cleverly disguised in ways that make an auditor’s eyes glaze over. You do not have to take my word for it. Dr. Richard Horton, editor-in-chief of the prestigious Lancet, and former BMJ editor Fiona Godlee, agree.

Yes indeed, there are problems with established norms in research, publication, funding, paper-review and all the rest of it. But the (relatively few) examples of this that have been uncovered don’t discredit the entire project – they instead point to the fact that one shouldn’t be complacent about having blind trust in orthodox scientific bodies/research projects and their findings.

Not only are there crooks in research (who knows how many), but the quality of medical science done over DECADES is very bad (ask Richard Smith, former editor of the BMJ, Doug Altman, statistician, and John Ioannidis “Why most published research findings are false”) for a primer.

Yes, as above. But, failures in the conventional model indicate a need for extra vigilance with regard to assumptions, paradigms and findings we might previously have taken for granted. What they do not do is suddenly open up an evidentiary free-for-all: the fact that some findings that were thought to be robust ended up being questionable is not logically equivalent to the idea that all questionable hypotheses or findings are suddenly robust.

Says Annika: “If he can’t [elicit … consensus from the scientific orthodoxy that synergy is a valid model] and he nonetheless avers this stance, then clearly he is a quack.” This turns all GPs in the world into quacks. Almost no patient walks out of a consultation with less than three items on the prescription.

Yet it is a safe bet that no gold standard research was ever done on that particular combination. Ask the GP why (s)he does it and the answer is most likely, “The drugs support each other’s actions.” Why is the practice of synergy allowed in one field, but not in another?

Dispensing multiple medications is not a commitment to “synergy”. The more plausible explanation here is “patient X manifests symptoms a, b and c, and these three medications treat a, b, and c, and are not obviously contraindicated in combination”.

Admittedly, I haven’t been to very many GPs, but I’ve never heard one claiming that there is some magic in their combination, rather than that they address various aspects of my ailment, and are not obviously dangerous in combination.

There’s no appeal to “synergy” in cases I’ve encountered, and this seems an utterly illegitimate attempt to confer credence on the concept of “synergy” by re-describing “a combination of things” as being evidence of the sum amounting to more than the role of the individual parts.

As for placebo effect: It is so powerful, it should be a therapeutic option. Why not? With so many fake prescription medicines based on fake science, maybe that is how they work, anyhow? Who decides?

Well, I suppose because of informed consent, namely the ethical principle that patients should be made aware of what they are being given, and why? Perhaps a “synergistic” approach to medicine leaves room for deceiving patients, though – who knows what words really mean anymore.

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