“Most of the supplement market is bogus,” Paul Clayton*, a nutritional scientist, told the Observer. “It’s not a good model when you have businesses selling products they don’t understand and cannot be proven to be effective in clinical trials. It has encouraged the development of a lot of products that have no other value than placebo – not to knock placebo, but I want more than hype and hope.” So, Dr Clayton took a job advising Lyma, a product which is currently being promoted as “the world’s first super supplement” at £199 for a one-month’s supply.
Lyma is a dietary supplement that contains a multitude of ingredients all of which are well known and available in many other supplements costing only a fraction of Lyma. The ingredients include:
- kreatinin,
- turmeric,
- Ashwagandha,
- citicoline,
- lycopene,
- vitamin D3.
Apparently, these ingredients are manufactured in special (and patented) ways to optimise their bioavailabity. According to the website, the ingredients of LYMA have all been clinically trialled with proven efficacy at levels provided within the LYMA supplement… Unless the ingredient has been clinically trialled, and peer reviewed there may be limited (if any) benefit to the body. LYMA’s revolutionary formulation is the most advanced and proven super supplement in the world, bringing together eight outstanding ingredients – seven of which are patented – to support health, wellbeing and beauty. Each ingredient has been selected for its efficacy, purity, quality, bioavailability, stability and ultimately, on the results of clinical studies.
The therapeutic claims made for the product are numerous:
- it will improve your hair, skin and nails (80% improvement in skin smoothness, 30% increase in skin moisture, 17% increase in skin elasticity, 12% reduction in wrinkle depth, 47% increase in hair strength & 35% decrease in hair loss)
- it will support energy levels in both the body and the brain (increase in brain membrane turnover by 26% and increase brain energy by 14%),
- it will improve cognitive function,
- it will enhance endurance (cardiorespiratory endurance increased by 13% compared to a placebo),
- it will improve quality of life,
- it will improve sleep (reducing insomnia by 70%),
- it will improve immunity,
- it will reduce inflammation,
- it will improve your memory,
- it will improve osteoporosis (reduce risk of osteoporosis by 37%).
These claims are backed up by 197 clinical trials, we are being told.
If true, this would be truly sensational – but is it true?
I asked the Lyma firm for the 197 original studies, and they very kindly sent me dozens papers which all referred to the single ingredients listed above. I emailed again and asked whether there are any studies of Lyma with all its ingredients in one supplement. Then I was told that they are ‘looking into a trial on the final Lyma formula‘.
I take this to mean that not a single trial of Lyma has been conducted. In this case, how do we be sure the mixture works? How can we know that the 197 studies have not been cherry-picked? How can we be sure that there are no interactions between the active constituents?
The response from Lyma quoted the above-mentioned Dr Paul Clayton stating this: “In regard to LYMA, clinical trials at this stage are not necessary. The whole point of LYMA is that each ingredient has already been extensively trialled, and validated. They have selected the best of the best ingredients, and amalgamated them; to enable consumers to take them all in a convenient format. You can quite easily go out and purchase all the ingredients separately. They aren’t easy to find, and it would mean swallowing up to 12 tablets and capsules a day; but the choice is always yours.”
It’s kind, to leave the choice to us, rather than forcing us to spend £199 each month on the world’s first super-supplement. Very kind indeed!
Having the choice, I might think again.
I might even assemble the world’s maximally evidence-based, extra super-supplement myself, one that is supported by many more than 197 peer-reviewed papers. To not directly compete with Lyma, I could use entirely different ingredients. Perhaps I should take the following five:
- Vitamin C (it has over 61 000 Medline listed articles to its name),
- Vitanin E (it has over 42 000 Medline listed articles to its name),
- Collagen (it has over 210 000 Medline listed articles to its name),
- Coffee (it has over 14 000 Medline listed articles to its name),
- Aloe vera (it has over 3 000 Medline listed articles to its name).
I could then claim that my extra super-supplement is supported by some 300 000 scientific articles plus 1 000 clinical studies (I am confident I could cherry-pick 1 000 positive trials from the 300 000 papers). Consequently, I would not just charge £199 but £999 for a month’s supply.
But this would be wrong, misleading, even bogus!!!, I hear you object.
On the one hand, I agree.
On the other hand, as Paul Clayton rightly pointed out: Most of the supplement market is bogus.
*If my memory serves me right, I met Paul many years ago when he was a consultant for Boots (if my memory fails me, I might need to order some Lyma).
88 Responses to ‘Most of the supplement market is bogus’, but surely not the world’s 1st super-supplement!
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That is brilliant, an extra-super supplement.
However, at £199 a month, I can buy £50 worth of extra super nutritious food every week. I will have the food, thank you (And I won’t be checking to see if there Medline studies that ‘prove’ that food is good for health)
no, no no! my extra super is £999 per month.
Doctor,
Have you considered an intravenous extra super supplement? With any luck you might hit £9999 per month.
good idea!
I’ll speak to my accountant
I was referring to the other product.
Your product is slam dunk: only £999 for a product with 300 000 articles and 1000 clinical studies to back it up.
Linus Pauling mega dosed natural Vit C by IV all the time.
and?
Just commenting that large dose natural Vit C is safe, even IV.
Well apart from the diarrhoea…
And the kidney stones.
I participated in the discovery of a new molecule of Vitamin C. This botanical based discovery was significant, not only because of the new molecular discovery, the fist for Vit C since Vit C was first “discovered” in 1930’s, but this new molecules ascorbic acid is 10 times more dense then the original discovery and is covalently bonded with natural occuring NO. A real potent one two punch for numerous disease targets in the brain (cognitive), blood (cardiovascular) and lungs (respiratory). This is THE super fruits of super fruits.
I am not sure what you are trying to express in relation to this post
it might be safe – but, if you think that the Pauling anecdote proves this point, you are far from correct
Your article is accurate and spot on, the dietary supplement market is not only bogus, but dangerous as a result of the loose regs and oversight. This makes it almost impossible, certainly very frustrating when a legitimate discovery is made, which BTW, has been through numerous cell line studies, mouse models and double blind human clinicals to establish efficacy and response. We’re pursuing new drug development with pharma, which is a longer slog to market, but less frustrating competing with the abundance of fraudulent adulterated supplements making all kinds of unsubstantiated structure function claims, making it nearly impossible for a legit product to be even considered by understandably skeptical consumers.
@Jeff Moats
“. . . which BTW, has been through numerous cell line studies, mouse models and double blind human clinicals to establish efficacy and response.”
Funny that, your name doesn’t appear on a single publication listed in Medline or PubMed (since 1947).
No surprise. I work with CWRU, Temple, UF, KSU, Cleveland Clinic and University Hospitals of Cleveland, all of whom are conducting the research and accumulating the science from their research. I’m funding all their research and lab work.
So please provide references to publications.
“this new molecules ascorbic acid is 10 times more dense then the original discovery”
That would put it somewhere between the densities of lead and uranium.
Thank you for your comment Julian. Perhaps a poor word choice. The vitamin c in our botanical discovery / research revealed an astonishing level of natural occurring Vit C with a fresh fruit containing 22,000 mg/100 g vs an orange for example, and in our research indicated a concentration of Vit C 10 times that of an orange. Potent would have been the better choice over density. That said, the nutritional density of this compound matrix is as remarkable as the level of Vit C.
Actually I should probably be the one apologising. I realise from another comment that your expertise is in finance, not biochemistry. I shouldn’t be too hard on you outside your own field.
So I am going to take you to task on your arithmetic instead:
“an astonishing level of natural occurring Vit C with a fresh fruit containing 22,000 mg/100 g”
You are saying that over a fifth of the fruit itself is vitamin C, which seems very unlikely to me as that doesn’t leave very much for the water content, let alone other components.
“our research indicated a concentration of Vit C 10 times that of an orange”
The vitamin C content of an orange is of the order of 50mg / 100g, so that would make it 400 times the concentration found in an orange, not 10 times.
The subject of your research sounds very interesting and I would love to see what comes of it in due course. However, it is hard to take you seriously on the basis of your comments so far.
I understand your hesitation. I’ll let the science and research data speak for themselves. As you point put, this is not my wheelhouse. Thank goodness I don’t try or even attempt to interpret the Excel spreadsheet figures of all the HPLC MS/MS data. This has been and continues to be a very rewarding journey.
“As you point put, this is not my wheelhouse.”
We all have our own strengths and weaknesses – my experience of going into business is that if you don’t know what you are doing you get your hands burnt. My brother, on the other hand, lives in a world that I can’t comprehend where he may have trouble raising a mortgage but he can get a £100 million loan on a phone call.
@Jeff Moats
Sorry to be persistent, but you say here “I’ll let the science and research data speak for themselves.” But you have presented zero research data, despite my earlier request for references. In the normal line of medical product development, by the time something has successfully passed through ex vivo and animal studies so that it has entered human trials, publications in formal journals will have started to appear.
“I work with CWRU, Temple, UF, KSU, Cleveland Clinic and University Hospitals of Cleveland, all of whom are conducting the research and accumulating the science from their research.” And all of whose researchers are producing positive results that they’re keeping under wraps? Yet you can talk about them on a blog? I ask you again: please provide us with citations to the science, where possible.
On the web, you tell your story from 2013 about your near-fatal moped crash and recovery aided by the fruit, camu-camu. You also have a web post presenting oxygen radical absorbance capacity (ORAC) results from Brunswick labs for your freeze-dried powder product (52,000/g). You also state that “camu camu significantly reduces cellular free radical activity, inhibits the inflammatory agent NFkB and reduces UV-induced free radicals in the skin”. In the absence of any experimental details none of this is acceptable evidence of pre-clinical efficacy.
You registered a trademark, Nitro-C in 2017, but you now appear to be selling your product under the name Amaçari. On this linked page there appears the statement “The Camu Camu superfruit has demonstrated its superior performance in three different tests: (1).” Could “(1)” be a peer-reviewed reference? Nope. No footnote or reference 1 appears anywhere on the page.
The page also provides details of how to purchase Amaçari for “under $30 for a bottle of 60, 500 mg capsules, which is the recommended month’s supply.” So you’re already on sale: can you tell us how your product complies with any dietary supplement regulations?
On Thursday 14 March at 15:00 you posted “the dietary supplement market is not only bogus, but dangerous as a result of the loose regs and oversight.” But you have not, so far, provided anything but consistently inaccurate data and unsupported claims of efficacy. From the web, it seems you’re happy to support any sale of your product, even for indications such as infertility. Camu camu has been the topic of 27 publications listed in Medline. Most of these relate to its high vitamin C content, but one recent Lancet paper [Anhe FF, Gut 2018, UI 30064988] reports an animal study that camu camu might prevent obesity. I mention this just in case you’ve missed a possible outlet for your product.
Can you please counter the negative impression you’re creating here?
PS. A search of US patents reveals US 20160361373 A1, “Methods of extraction of nitrosylated or nitrated derivatives of ascorbic acid from myriciaria dubia and methods of synthesis thereof.” The inventor’s name is John P. Crow, Jr. This sounds exactly like your vitamin C “covalently bonded with natural occuring NO” and Myrciaria dubia is the botanical name for camu-camu, the fruit that’s your source for Amaçon. If the ascorbic acid linked to NO can be synthesized, why not join forces with John P. Crow, Jr. and produce a pure dietary supplement that can be properly tested for its medicinal advantages?
John Crow works for me. He’s listed as the “inventor” on the patent, but the patent is mine and being assigned to my company Nitro-C. As for the Amacari debacle, that was a business partner/investor that chose the unethical get-ric-quick route and I severed my ties to him back in 2014. I had him scrub my name for the company website and all company related materials. Chalk it up to you never know what someone is like until you either marry them or work with them. Live and learn. I continue to pursue my research work so I can learn what I don’t know and why this fruit delivered a quality of life I was absolutely guaranteed I’d never have again as long as I lived after my accident. My goal is to pay it forward and share, but I can’t and won’t feel comfortable doing so without the solid science proving MOA’s and proof oc concept. It’s a long slog.
Sorry that you had such a bad experience with the business partner. These things are sent to try us.
“I had him scrub my name for the company website and all company related materials.” Well, the link I posted to Amaçari yesterday now seems not to be working, but the page can be found here. A swift google of “Amacari Jeff Moats” still pulls up several hits bearing your name.
I guess the problem from my point of view is that you say things such as “I can’t and won’t feel comfortable doing so without the solid science proving MOA’s and proof oc concept.”, yet you posted a comment here claiming your product “has been through numerous cell line studies, mouse models and double blind human clinicals to establish efficacy and response” for which you can provide zero supportive documentation or data. Please don’t let your enthusiasm for something which may or may not have contributed to your problem-free recovery from the traffic accident (you may be merely propagating the post hoc fallacy with your anecdote) run ahead of the science you’re doing.
Good luck.
My enthusiasm is my passion for the full and complete recovery I am grateful to have had, against all conventional medical odds. As such, I have spent a significant amount of time and treasure with various universities and research institutes, including two very well know brain health institutes, to discover and confirm why this fruit delivered such efficacious repair and health, hoping to learn myself and to share with others less fortunate than me who are suffering with relentless inescapable pain. I have only reiterated what the researchers and scientists have told me personally as an investor for their research, obviously prematurely, but with only good intentions and unfortunately before the peer reviewed white papers are written, submitted and published.
the peer reviewed white papers???
what’s that, please?
Once again I”m only repeating what I’ve been told. I assume it’s their research and science that’s documented and published. I’m not of your world, so sorry if I’ve unintentionally misspoken yet again. These researchers and scientists, some of whom are very well known in their respective fields and specialties, know what they’re doing. I suggest we stop this back and forth because you’ve made it abundantly clear I’m an idiot and need to shut up. Good day.
I beg your pardon!
I hardly said a word to you in this long thread
Dear Edzard,
I noted your reference to me in your blog, and thought it merited a reply.
Our paths did indeed cross, albeit briefly, and almost two decades ago; and I am gratified to note that as we slip into our 7th age, we are both still capable of remembering such things – with or without pharmacological support.
I respect your skepticism, and share this value; you have certainly been consistent over the years, and this position is both sehr ansehnlich, and sehr bequem. Sometimes, maybe, a little to bequem …
With respect, I think that you may be missing the point of what Lyma is doing. The pharmacological attributes of the basic nutrients you cite are indeed well documented, and due to commoditisation they are cheap; but the data to show that they exert benefits over and above the satisfaction of basic nutritional needs is hardly convincing.
The phytonutrients that Lyma uses, on the other hand, are fairly new. Because they are produced by BtoB companies operating in a mixed economy they are hedged with various levels of I.P., so that the producers can recoup their investment. This is pretty much the basis of the pharma model, and due also to increasing regulatory requirements – which I generally support – and the requirement for producing the equivalent of drug master files for these phyto-extracts, the costs involved in making the extracts / actives available typically produce price points of $200 – $250 / kilo; to which must be added such things as marketing, packaging etc. In the final analysis, BtoC companies such as Lyma work with margins that are similar to most corporate entities in retail.
None of this matters, however, if what they sell has no real function. And here I think we are on more solid ground. I have had direct involvement with work done on the 1-3, 1-6 beta glucans, for example, and know many of the scientists who worked on K2 and lycopene. Given the quality of their work, and the sheer volume of work done by thousands of other scientists in labs all over the world on this kind of functional phytochemistry, it seems uncritical to label it all as being without merit.
As our understanding of the amazing complexity of mammalian metabolomics and its interaction with food derivates develops, it would be surprising indeed if we didn’t find multiple new points of functional entry into the system. I refer to functions ranging from enhanced endothelial responsiveness, neutrophil chemotaxis and epithelial resistance to ionising radiation, to stress alleviation via alarmin up-regulation and reduced inflammatory markers, all of which parameters are documented results from intervention with the various actives in Lyma.
I think it relevant also to point out that the actives in Lyma are all very different in nature, from amino acids to saponins, structural carbohydrates and carotenoids. These all utilise different route of entry into the body, and would not be expected to interfere with each other at all. It is not like the situation where one metal divalent cation might interfere with another because they share an uptake system; or where a physico-chemical reaction might take place in the gut that would impact on bioavailability, such as the well-known iron/polyphenol interaction.
The gut is rather good at taking up complex mixtures of different nutrients, as would be found in any meal; and that is what is most likely happening here.
However, a a scientist, I do share your purism and have advocated for a clinical trial of Lyma. The company is new, small and does not yet have the resources to conduct such a study, but the planning for one is already underway, and it will be initiated as soon as economic conditions allow.
One problem that has not yet been adequately addressed is, what outcomes should they be looking for? Does it really make sense to measure a parameter related to each active? The protocol would be incredibly unwieldy, and the trial prohibitively expensive. In the real world, therefore, they would have to be very selective. From an academic perspective this may be less than ideal, but commerce must be pragmatic.
I would be happy to continue this conversation, but the internet promotes howl around rather than civil discourse and I would prefer to talk in person. If you agree, I would be happy to meet at some mutually convenient time and location, and let the Hegelian chips fall where they may. In the best outcome, we may both learn something.
In the meantime, and if you are interested, I would be pleased to send you some recent books I authored which provide a hinterland for the Lyma snapshot.
Best regards,
Paul
Hi Paul,
thanks for this intriguing comment.
I think that you are nowhere close to the truth when you describe my insistence on rigorous trial evidence as ‘bequem, sometimes too bequem’ [comfortable, sometimes too comfortable – you might even have meant ‘lazy’, as comfortable does not make much sense in this context].
without one or more high quality trials you simply cannot be sure that the mixture works as you predict. I know this on the basis of scientific reasoning as well as from painful own experience [I too advised people who wanted to come out with a similar concept as Lyma].
and when you ask ” what outcomes should they be looking for? ” the whole things gets rather farcical: how about the outcomes you put in the claims made for the product [I assume you consulted them about those as well].
your comments are little more than an elaborate excuse for making claims that are not backed up by direct evidence. I think this is wrong and fear it is hardly better than the dodgy supplement market you like to criticise [perhaps doing THAT in your position is truly ‘bequem’!?!].
Hi Edzard,
I did indeed mean ‘comfortable’, as I think that the skeptical position can sometimes become a default mode and an excuse for resisting new ideas. I am sometimes guilty of that myself. I certainly do not think of you as lazy!
iThe claims that I referred to are based on work that has been done in different labs and repeated by different groups of researchers, and as there are both well-conducted pre-clinical studies and reasonably powered prospective double-blind, randomised clinical trials, I find it impossible to dismiss them lightly.
I am just about to board a flight so cannot add much at this time, but would be pleased – as I said – to explore these issues in more depth, n another occasion.
Best wishes,
Paiul
nobody asks you to dismiss these claims.
the claim that the mixture works as you predict is, however, a different claim – and that claim requires a proof.
Thank you, Edzard, for clarifying your position. If I understand you correctly, you concede that there is evidence for the various ingredients but maintain that there is no evidence for the combination.
I am not entirely sure why you think it so important to re-test for all the various effects simultaneously, as the active ingredients enter the body via different routes, and operate via very different mechanisms. There is no mechanism I am aware of that would generate interference. If you know of one, I would be grateful for any information you could supply. Failing that, I submit that you are actually on the wrong side of Occam’s Razor.
As for the proposed multiple end-point trial, your position – while absolutely understandable from a theoretical perspective – is not practical in the real world, for all the reasons I outlined in my earlier post. You are demanding standards which cannot ever be achieved, and in this way you are shutting down the debate while claiming the moral high ground.
In a way I see our discourse as the familiar mis-alignent between Germanic romantic idealism and louche Anglo-Saxon pragmatism. These positions both have well known strengths and weaknesses, and it is difficult to see how this gap could be bridged; but yet, it is important to try.
In the meantime I am left trying to make bricks with little straw and only modest amounts of clay, having to make scientific compromises and relying more than I want to on case histories. Low level evidence, of course, but it is where most medical research originates. The future trial will focus on a selection of the relevant parameters, and hopefully provide more meaningful data.
Best wishes,
Paul
no, my position is that there may be SOME evidence for the various single ingredients. whether that stands up to scrutiny is a different matter.
as to the mixture: you cannot possibly know all the mechanisms of the single ingredients [each of which presumably contains multiple active compounds. therefore you cannot exclude interactions. your statements are based on assumptions but claims should be based on evidence.
Paul
Some clarification would be appreciated:
1. Are your products medicinal products under s.2 of the Human Medicines Regulations 2012, and if so, do you have Marketing Authorisations for them?
2. If they are not medicinal claims, are you making specific or general health or nutrition claims and are these claims that are authorised on the EU Register?
3. Are the claims you make on your website compliant with the Advertising Standards Authority’s CAP Code?
Hello Alan,
This is a food supplement and must adhere to the appropriate regulations.
The company is young and inexperienced, and when they started they went a little too far, in my opinion, with the claims, some of which were implicit and others explicit. I advised them to review their product statements, and they are currently in discussions with personnel from the MHRA to ensure that any and all texts are acceptable from a regulatory point of view.
They have an appointment with the ASA next month, and if they are not currently in compliance (I am not an expert in these matters), they soon will be.
Paul
Paul
I hope you will tell us what the MHRA and ASA say and I look forward to seeing the changes.
Meanwhile, why are they advertising if they do not know that they are complaint? Surely due diligence would have ensured proper compliance before advertising and selling the product?
Anyway, let’s take one example. You claim:
I’m not entirely convinced this is not a medicinal claim but the MHRA will put you right on that.
Nevertheless, the EU Register of authorised claims is publicly available and very easy to use. Can you point to the entry that permits these claims?
Another point. KSM-66 ASHWAGANDHA® is identified as being a Registered Trade Mark. However, it doesn’t appear in the Intellectual Property Offices’ register of trade marks. Can you explain this? Who are the owners of the trade marks (COGNIZIN®, HYDROCURC™, K2VITAL™, KSM-66 ASHWAGANDHA®, LYCORDED LYCOPENE™, LYCORED LYCOPENE™, WELLMUNE®)?
The young couple who started this company jumped right in (from other businesses) and it is only when I started to get involved that some of the due diligence got underway. They are still at the beginning of the road, as far as that goes, but now know that they must reach compliance. The changes you look for will emerge from the discussions they are having with the various bodies that act as regulators in this space.
With regard to the trademarks, Wellmune is trademarked by Biothera (USA), LycoRed by the company of the same name (Israel, and a spin-off I believe from the Weizmann), HydroCurc belongs to Pharmako Biotechnologies (Australia), K2Vital belongs to Kappa BioScience (Norway), KSM-66 is the property of IxoReal, a sub-division of the Baldwa Group (India) and Cognizin is owned by Kyowa Hakko (Japan).
Paul
As for their previous business, am I right in thinking that they borrowed £300,000 last year to move from textiles to this?
They were certainly advertising the product last August so the beginning of the road started then, so that still leaves the unanswered question as to why they are making claims now yet don’t know the regulatory – and therefore legal – status of the product?
Since the product is being advertised and sold in the UK, can you confirm all these trade marks are UK trade marks?
But that simply raises another question: where is the product manufactured?
Hi Alan,
Some more info for you. Have just ascertained that the web redesign is due to be completed (and passed by reg) by mid-April, so let us say May, for safety.
I have no idea about the financing aspect, not my area at all; and as i only became involved fairly recently, I cannot comment about their history. You would do better to approach them directly if you are interested in this.
As the companies that generated the trademarks are mostly large companies – and some of them very large – it doesn’t seem likely that their trademarks are anything other than international, as that is an important element in their I.P. and international marketing. You could approach them directly if you want to know more, they are easy enough to find online.
The manufacture is done in a well-known UK BRC-accredited and GMP-certified facility, which is owned by a large multi-national group.
Curious to know why you would want to know this. I have been forthcoming, perhaps you could reciprocate.
Paul
I’m not the one making the claims here about a product that is on sale, but I’m curious to find out what due diligence had been done to ensure the public was not being misled by their advertising. It seems the answer to that question is, for the time being at least, not enough. Yet the claims are still being made… And, of course, a web redesign isn’t needed to fix that.
As an issue separate from the regulatory aspects, do you think there is robust scientific evidence that substantiates the claims made?
I do hope that they check the trade marks to ensure they are valid in the UK.
When I mentioned the web re-design I was in fact referring to the text and specifically the claims which will, in the relaunched version, meet regulatory requirements.
As for the evidence base, it is quite robust. There really are hundreds of studies, most of which can be found via PubMed. I would not associate myself with a commercial enterprise of this sort unless there was supporting data that I thought good enough to be worth defending. The reason I like the Lyma team is that they made a decision, when they started, to only use validated materials. There are plenty of companies which don’t do this, and I believe that the onus in this sector is to move to evidence-based nutrition, ie in parallel with EBM.
Yet the claims remain meanwhile…
You claim the evidence base is quite robust yet, as Prof Ernst has already said, what matters is what the mixture does, not necessarily what individual ingredients might do.
The ‘science‘ page of the website states there are “197 CLINICAL TRIALS
CARRIED OUT OVER THE PAST DECADE AND PUBLISHED IN RECOGNISED NUTRACEUTICAL JOURNALS.” and “15 YEARS OF RESEARCH WE ARE PASSIONATE ABOUT SCIENCE. IF AN INGREDIENT ISN’T PROVEN, WE WON’T USE IT.” yet it cites not a single one of them. Any idea why that might be?
But do you understand and appreciate the difference between the regulatory aspects of making claims and this alleged evidence?
I am not convinced that Edzard is correct when he insists on the multiple input trial – se my comments above. And as for the trials that have been done with the individual ingredients, links to these could indeed be made available on the Lyma site for anyone who is not familiar with the usual data bases. You obviously are, so you can in the interim use the obvious search terms on PubMed, Google Scholar etc. They relevant papers not hard to find.
As for the issue of science vs claims, this is a very problematic area. You are doubtless aware that there is a great deal of politics in the regulatory sphere, and that decisions are frequently made which have as much of a political and economic basis as a scientific one. One has to operate within the system as it is, however, not as one would wish it to be, and the final position regarding these issues will emerge from the ongoing discussions with the MHRA and ASA.
Paul
So what you’re saying is that you cannot provide a shred of evidence that:
a) the ingredients taken together are effective and
b) that they are safe.
Why is it you’re involved with this company?
There comes a point, Alan, when if you stretch logic too far, it merges seamlessly into absurdity.
Congratulations, you have arrived.
Let me respond first to your idea about safety.
Theophrastus Bombastus von Hohenheim taught us that everything is a poison – it is just a matter of the dose. If you pause for a moment’s reflection you will realise that all the actives bar one (the ashwagandha) are food derivates / extracts. The citicholine is a simple analogue. And with a little study, you will come to understand that all the actives are present at doses that are within dietary ranges. Not, I admit, the currently impoverished dietary ranges that prevail in the so-called developed nations, but the ranges found in the blue zones, and which are associated with better health than we enjoy. As for the ashwagandha, it is a well-characterized xeno-hormetic that operates by up-regulating a series of alarmins, an effect which is known to be beneficial; and it is included, in the Lyma formula, at a dose which has traditional useage, and more importantly full safety and toxicology behind it.
As to your idea of combinatorial efficacy, this too is absurd. The actives are, as I pointed out in an earlier post, chemically diverse, are taken into the body via different routes, and act on metabolic pathways that do not overlap. You query the idea that the actives taken together could be effective, but please remember, once again, that these are predominantly food derivates. Do you also believe that if I order white wine with the fish, these two foods will cancel each other out? That my enjoyment of the wine will make it impossible for me to incorporate the amino acids from the fish I digested from being incorporated into my own proteins?
This discussion has entered the realm of diminishing returns.
Is that confirmation that you can’t provide information of the efficacy or safety of the mixture?
Paul Clayton
You have provided superb answers, but what I have not been able to detect thus far is what the Lyma product is for? What condition(s) will it treat or what health benefit(s) will it provide over and above that which can be obtained from eating a well balanced diet?
Thanks
Thanks Greg, for a sensible question which deserves a response.
First and foremost, I heartily approve of the well-balanced diet, and believe that if everyone ate such a thing the supplement industry would be made redundant; as would a large fraction of the pharmaceutical industry and the medical profession also. The problem is that the well-balanced diet is a rather mythical beast. Americans consume nearly 2 out of every 3 calories in the form of ultra-processed food, the UK is close behind at about 51% and the rest of Europe is following suit. This is a diet with a pathologically low nutrient density, and in the last 2 months we have seen 2 rather good papers showing that each 10% increase in the consumption of such foods is associated with a 10% increase in cancer, and a 15% increase in early (ie preventable) death.
We eat such foods because we are time-poor, and the foods themselves are designed – via bliss point research – to be quasi-addictive.
To make matters worse, we are experiencing historically low levels of physical activity, and calorific throughput. The combination of low calorie intakes and a low-nutrient diet leads to widespread dysnutrition, as recognised by the US Institute Health Metrics & Evaluation study published in the Lancet Sept 2015. So while the well-balanced diet would be a very good thing, we have to distinguish between academic theorising and what is happening in the real world.
Back to Lyma. It is not designed to treat or prevent illness, although the data indicates that it will reduce the risk of certain conditions via inter alia CR3-occupation, HSP-upregulation, endothelial ‘calming’, osteocalcin and matrix Gla protein carboxylation, and other mechanisms. It is a prototype of what I think is a new kind of nutraceutical, which exclusively uses validated actives; actives which do not alleviate the lack of a vitamin or trace element, but confer fairly narrow benefits of their own, as per the mechanisms mentioned above.
What consumers actually report is that they feel and look better. These are hardly substantial issues, but it is what many people want. This sort of response is unsurprising, given the stress-alleviating effects of ashwagandha, the POMS data consistently linked to the 1-3, 1-6 beta glucans, and the photo-protective and probably BDNF-enhancing effects of lycopene.
It is a long and complex story. If you want to know more you might be able to find a second hand copy of my recent book ‘Out of the Fire’ which goes into this kind of thing in much more detail than there is space for here. Or, even better, study the original scientific literature.
“What consumers actually report is that they feel and look better.”
I thought you are against the dodgy behaviour of the supplement industry!
isn’t the marketing of supplements on the basis of testimonials dodgy?
Marketing on the basis of testimonials is indeed dodgy, but you have somehow missed the point.
Consumers talk about minor issues such as felling better. Frankly I don’t find this interesting at all, but given the current regulatory climate it is effectively impossible to talk about what supplementation may really be doing.
I listed some of the pharmacological / physiological mechanisms involved above, and this is the kind of science I can discuss with my colleagues; but this language cannot be used in marketing because it is a) close to or effectively illegal, and b) it is unintelligible to most laypersons.
I apologise for the mis-types and repetitions in some of my earlier posts. I am a stickler for detail and I hate sloppy prose almost as much as I loathe bad science, or prejudice posing as science. I have now written to you from three different countries, via a mobile phone. At some stage, do you not think it might be more useful to sit down and enjoy an open-ended conversation? Over, possibly, Dover sole and a good bottle of Verdicchio?
PS I appreciate the comment from Greg, who I do not know. The quote he uses is pretty much in line with my current thinking, and much of the evidence that underpins it is indeed in the book.
do I not think it might be more useful to sit down and enjoy an open-ended conversation?
thank you, but you would need to come to Britany for that and it would be langoustines and Muscadet.
coming back to the claims you make for Lyma:
it will improve your hair, skin and nails (80% improvement in skin smoothness, 30% increase in skin moisture, 17% increase in skin elasticity, 12% reduction in wrinkle depth, 47% increase in hair strength & 35% decrease in hair loss)
it will support energy levels in both the body and the brain (increase in brain membrane turnover by 26% and increase brain energy by 14%),
it will improve cognitive function,
it will enhance endurance (cardiorespiratory endurance increased by 13% compared to a placebo),
it will improve quality of life,
it will improve sleep (reducing insomnia by 70%),
it will improve immunity,
it will reduce inflammation,
it will improve your memory,
it will improve osteoporosis (reduce risk of osteoporosis by 37%).
how can these be justified in what you call ‘the current regulatory climate’?
and how can they be scientifically justified in the absence of a single trial of Lyma?
paul clayton said:
And making health claims in testimonials not substantiated by the required level of evidence would be a breach of the ASA’s CAP Code.
Did you know that?
Paul,
I agree that regular exercise and a well balanced diet are an essential part of maintaining health, and I understand that many people, for one reason or another, fall short here and end up ‘compensating’ for their health decline with medical interventions and/or resorting to health supplements to ‘give them a boost’. So, there is a market for Lyma and other supplements and, if you comply with marketing regulations (not that onerous), you may well end up selling your product.
The key thing will be to steer well clear of making (unproven) medical claims, but that weakens the marketing power of the product.
Your book and supplements could be sold in a ‘pack’. The summary of your book is sufficient for me thanks Paul:
‘Healthcare and the healthcare business is dominated by the pharmaceutical ‘magic bullet’ model. When the symptoms of a non-communicable, degenerative disease such as cancer or heart disease appear, doctors will generally reach for drugs. But this strategy is too little and far too late. Most drugs treat symptoms rather than the root causes of disease, and by the time symptoms emerge the disease has already progressed a long way; the ‘age-related’ diseases develop silently for many years before they finally emerge, and start to cause pain or disability. The drug model has also signally failed to prevent the gathering tides of diabetes, dementia, allergy, cancer, osteoporosis … Now, however, we have an alternative. The latest science shows that we can head trouble off at the pass, and stop disease from starting. We know now that all these diseases are driven by a silent killer called chronic inflammation, and we know also that this is due largely to nutritional and lifestyle choices that can be changed quite easily.This book will not take long to read, because the message is simple. If you take action against chronic inflammation, you and your family take a major step towards living healthier, longer lives. The actions to take are equally simple – and the positive changes start to take effect within weeks.’
https://www.amazon.co.uk/Out-Fire-Dr-Paul-Clayton/dp/1916411258
he should give you a cut in his book sales for this brilliant advertisement
I don’t agree with Paul’s product or the lifestyle choices of those that eventually have to resort to drugs and/or supplements ‘to keep going’.
I just try to treat people fairly, and he has got some points to consider.
Dear Edzard,
I’m fairly certain that the physiological and pharmacological effects of langoustines + Muscadet are very similar to those of Dover sole + Verdicchio. And I am frequently in Paris.
Back to the claims you mentioned. When the couple who started the company assembled their formula, they simply copied and pasted the claims being made by the B2B companies that make the extracts. As I mentioned previously, when I was approached for advice I recommended they clear their copy with the MHRA, EFSA and ASA. This is all basic due diligence which you and I are familiar with, but the founders were not.
All of the above copy is being processed by those same authorities as we speak, and the end product will emerge in due course.
My home in Britany is about 6 hours drive from Paris.
I did understand that the claims are being revised and checked. But should they be on the website until that has happened?
How does it fit to the Observer quote that first attracted my attention?
“Most of the supplement market is bogus,” Paul Clayton*, a nutritional scientist, told the Observer. “It’s not a good model when you have businesses selling products they don’t understand and cannot be proven to be effective in clinical trials. It has encouraged the development of a lot of products that have no other value than placebo – not to knock placebo, but I want more than hype and hope.” So, Dr Clayton took a job advising Lyma, a product which is currently being promoted as “the world’s first super supplement” at £199 for a one-month’s supply.
Dear Edzard,
The company founders obviously needed guidance, and I am trying to supply this. I became involved with them relatively recently, and I see my responsibility as helping to steer them into the paths of righteousness (and good science). I believe they will get there. They want to promote EBN; I think this is a good idea, and the way nutrition – and the supplement industry – should develop.
Best wishes,
Paul
do you not think that being involved with dodgy claims renders you dodgy as well?
or do you think the prospect of ‘getting there’ invalidates dodginess?
By the time I and the regulators have finished with Lyma, they will be squeaky clean. If that means making compromises in the early phases, I think it worth it. Validated nutraceuticals are the way forward, and I want to encourage this.
Paul
my prediction is different:
By the time you and the regulators have finished with Lyma, there will be no claims left to make [not least because you don’t have a single trial of Lyma to support them] and you might need to look for another firm for which you can say to an Observer journalist: all the others are dodgy, but this product is different.
A good scientist would not prejudge the situation, but wait to see the outcome. I may not always succeed in living up to this ideal, but apparently I am in good company.
Paul
you don’t have to go as far as calling yourself not a good scientist; I am sure you are an excellent one – perhaps just a bit biased in favour of your funders?
I am enjoying this conversation and would like to continue but must now go to teach a class. Perhaps we can pick up the threads tomorrow.
Let me just say, before I leave, that the fees I am receiving are not enough to buy me.
Every man (and woman) has their price, and mine is a good deal higher than is currently on offer.
Best regards,
Paul
who said you are bought?
bias is something else than corruption!
I hope your class is not about explaining the various form of bias.
Bias is merely a sub-set of corruption. Corruption does not have to involve money.
A pretty obvious point, I would have thought.
Sorry, but I really have to go. We can talk tomorrow, if you are interested.
I think you might be wrong about bias:
1. A line going diagonally across the grain of fabric: Cut the cloth on the bias.
2.
a. A preference or an inclination, especially one that inhibits impartial judgment.
b. An unfair act or policy stemming from prejudice.
3. A statistical sampling or testing error caused by systematically favoring some outcomes over others.
4. Sports
a. A weight or irregularity in a ball that causes it to swerve, as in lawn bowling.
b. The tendency of such a ball to swerve.
5. The fixed voltage applied to an electrode.
While I appreciate your cut ‘n paste skills, I think we can safely discard definitions 1 and 4. As for items 2 and 3, I regard them as a form of corruption in that they describe a willingness – at some level – to be displaced from the search for scientific or other truth, for the comfort of the confirmation of one’s prejudices. I regard this as an insidious form of corruption indeed, and it is issues like these that keep me awake at night.
I had assumed that as an intellectual and one of my generation, you would have understood my meaning, but it is a subtle point and I should perhaps have been more explicit.
Mea culpa.
Edzard wrote:
‘do I not think it might be more useful to sit down and enjoy an open-ended conversation?
thank you, but you would need to come to Britany for that and it would be langoustines and Muscadet.
coming back to the claims you make for Lyma:
it will improve your hair, skin and nails (80% improvement in skin smoothness, 30% increase in skin moisture, 17% increase in skin elasticity, 12% reduction in wrinkle depth, 47% increase in hair strength & 35% decrease in hair loss)
it will support energy levels in both the body and the brain (increase in brain membrane turnover by 26% and increase brain energy by 14%),
it will improve cognitive function,
it will enhance endurance (cardiorespiratory endurance increased by 13% compared to a placebo),
it will improve quality of life,
it will improve sleep (reducing insomnia by 70%),
it will improve immunity,
it will reduce inflammation,
it will improve your memory,
it will improve osteoporosis (reduce risk of osteoporosis by 37%).
how can these be justified in what you call ‘the current regulatory climate’?
and how can they be scientifically justified in the absence of a single trial of Lyma?’
Aren’t YOU promoting Lyma here? That is a lot of claims you have published, isn’t it?
it’s copied from the Lyma site!
I am sure everyone except your good self got that point.
I wasn’t aware that Out of the Fire was available on Amazon, my publisher didn’t think to inform me. And I doubt that it will find many friends on this site! But thank you for mentioning it anyway.
Paul
Paul Clayton said:
That’s not entirely the only aspect the MHRA looks at, of course, when deciding whether or not it’s a medicinal product…
This is my last comment on this Lyma post.
ASA seem to have more bark than bite. People who flaunt advertising standards seem to ‘get away’ with it for years. At this moment, Lyma’s yet to be registered products are making fantastic claims.
Res ipsa loquitur.
https://lyma.life/benefits/
I think you mean flout, not flaunt…
Some quacks are pretty reluctant to fall into line but most seem to comply. The more stubborn ones seem to need reporting to Trading Standards though, but there is quite a trail of them that are now compliant or had their websites taken down:
You’d hope that a responsible trader would ensure their advertising was compliant and happily correct it if it was found to be non-complaint.
But why do you call the products ‘yet to be registered’? Who do you think they need to be registered with?
“People who flaunt advertising standards seem to ‘get away’ with it for years. ”
I think you mean flout.
FLAUNT: display (something) ostentatiously, especially in order to provoke envy or admiration or to show defiance.
I think you guys are slow?
LOL!
They may have been flaunting their ignorance but they were not displaying any of the ASA’s rules, waving them about for all to see: they were flouting them.
Keep digging.
So says Mr Alan ‘The Digger’ Henness!
LOL!
LOL. But that was a nice attempt at a diversion, wasn’t it Greg?
Alan Henness is rather over estimating the power if the ASA. The ASA CAP code is not law. Go to https://www.asa.org.uk/codes-and-rulings/non-compliant-online-advertisers.html
to see the long list of non compliant advertisers who are ignored by Trading Standards because they are not breaking any law.
I have over-estimated nothing. As you probably know, the ASA is the established means of regulation of advertising and is recognised by the courts. The ASA’s codes are based on consumer protection and other legislation. They do try to get advertisers to comply and go out of their way to help but if they don’tt, they can rule against them, publicise their breaches of the codes and impose sanctions. If they are persistent, they can be referred to Trading Standards who then decide whether to prosecute under consumer protection legislation.
Many advertisers do want to comply and it’s in their interests to comply and most do and change or withdraw their advertising if found to be non compliant.
That list is the list of non-compliant advertisers: it is not a list of advertisers referred to TS so why do you say they are ignored by TS and are not breaking any law?
That is a really bogus statement: “most of the supplement market is bogus”! How do you scientifically measure bogosity?
Hospitals are starting to use Vit C to cure sepsis:
https://pulmccm.org/critical-care-review/vitamin-c-save-lives-sepsis/
I used Vit C and Vit E to cure sunburn. I also requested IV Vit C in a hospital situation and it killed pain.
EVery one of the B vitamins and Vit A, Vit D and Vit K have specific indications.
the statement is by Paul Clayton; try to understand what you read, please.
after all these discussions with doctor Clayton, one might have hoped that the worst nonsense has been stopped. one would have been wrong. I just received this email:
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Subscribe to LYMA within the next 3 days and we will gift a friend of your choice a 30-day starter kit when you complete your 3rd month with us.
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The LYMA effect
“I feel like a new person, every day. I’m focused in life, ready to take on anything and feeling so much more confident.”
– Samira.
It’s been awhile. Have there been any studies of Lyma’s efficacy? If Lyma is going to promise women who stop HRT that they will feel even better with Lyma, there should be evidence.
as far as I know, still no sound evidence.