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Nutritional Suppliments question

jimbob

Uncritical "thinker"
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Hi,

in th Multi Level Marketing thread the following post rasistd a few red lights for me:

Keep in mind that NewtonTrino apparently has listened to hardly any, and those he has listened to were all from just one of many different companies that supplies these types of materials to Amway business owners.

Here's some examples, the last two I listened to.

One was by the President of Alticor, Amway's parent company, speaking at a N21 seminar in the US, which I was not at. He was talking about the challenges they've been undergoing in the US this past year (yeah, that's motivating!) and giving some historical background about similar issues in the past and how the corp responded. He spoke about where they've gotten things wrong and where the company is heading in the future.

NewtonTrino would have us believe that this kind of information is not valuable. BTW, I personally think this type of speech should be made available, free of charge, by the corp. Nevertheless, still extremely useful information.

The second one was by a top IBO and talking about how to properly create volume in a network and help individuals be profitable. He spent a deal of time talking about some very exciting new products we have, including Gensona genetic testing and patented and clinically tested and supported nutritional supplements targetted towards folk with a particular gene which makes them significantly more susceptible to heart disease. He also spoke about how focussing on exclusive products like this help you build a "passive" income since it's not available anywhere else, and won't be any time soon, and once you get customers on it, they're on automatic delivery programs, and because of their heightened risk unlikely to want to stop ordering. He also gave advice about how to go about marketing these and other products.

All good business advice.

Especially this paragraph:

The second one was by a top IBO and talking about how to properly create volume in a network and help individuals be profitable. He spent a deal of time talking about some very exciting new products we have, including Gensona genetic testing and patented and clinically tested and supported nutritional supplements targetted towards folk with a particular gene which makes them significantly more susceptible to heart disease. He also spoke about how focussing on exclusive products like this help you build a "passive" income since it's not available anywhere else, and won't be any time soon, and once you get customers on it, they're on automatic delivery programs, and because of their heightened risk unlikely to want to stop ordering. He also gave advice about how to go about marketing these and other products.

Any comments about the validity or otherwise about this?

EDIT: As opposed to a balanced diet etc...
 
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That is probably the only group that supplements make any sense for at all.

There are proven disorders that are remedied by taking the particular supplement. Carnitine comes to mind, if you have the particular mitochondrial genetic disease. There are others too, in which the body lacks some enzyme to make a certain protein out of the amino acids in the diet.

Whether their testing will actually show up a particular disorder or is just a scam needs to be shown. Those diseases are each in the range of one per 5,000 to one per hundreds of thousands. I doubt that Amways business plan is to make a sale to one in 5,000 subjects.

I am truly a believer in the coming of pharmacogenetics. That will be when we get a real handle on our individual health. But gene testing is still waaaay too expensive to test subjects randomly.
 
I think you'd have to get them to substantiate what allele (they said "gene" but that's incorrect nomenclature) has been identified in the test, and what substance are they recommending these subjects take because they have this allele?

I agree with casebro that in principle someday we will be able to use genetic testing to identify vulnerable individuals and prescribe preventative supplements, I have no evidence that there are many examples that can be supported today. All the examples I have seen have been fraudulent.

See: [Quackwatch: Dubious Genetic Testing].

ETA: another relevant link (requires registration): [Maryannville: More criticism of dubious home genetic testing.].
 
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Thanks for the answers,

Shouldn't a dietician be able to prescribe appropriate diets?

Remember also that the company promoting this is Amway, which sales close to the wind in its entire business model...
 
With apologies for stating the obvious, but the interactions between genetics, health and diet/nutrient intake are very complex. Proper genetic testing is not simple enough to be recommended for use for home-testing or for use for testing of clients by a non-medically-qualified Amway supplier: a full clinical history etc is needed, and you need a professional who is competent to interpret this.

A company selling tests to those without appropriate qualifications - and allowing the tests to be used to make amazingly precise purchase recommendations - has either got a really groundbreaking product on their hands, or is selling tests which have a high risk of being used inappropriately. I don't see any peer-reviewed publications showing how Interleukin Genetics' tests have broken new ground in the field. In fact, it's not even clear whether they've verified that their testing has any clinical relevance whatsoever, let alone published the results of said verification.

And yes, a dietitician should be able to advise on diet (and, on the occasions where it is advisable, nutritional supplements).
 
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Sorry for the late response, but ILG does the testing, all that is done "in house" is an individual takes a swab, which is then sent off to ILG for genetic analysis and ILG does any recommendations. If you have a particular "bad" gene and particular nutrients have been shown to mediate it's expression, I fail to see why you'd need a full clinical history?

As for ILG studies, here's one which recently won the McKinney award for outstanding research -
http://www.ncbi.nlm.nih.gov/pubmed/17884346

This link explains some of the current commercial offerings -

http://www.ilgenetics.com/content/products-services/gensona.jsp
 
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From the OP: "including Gensona genetic testing and patented"

Patents are generally a matter of public record. Otherwise, how would I know what NOT to copy?

Anybody care try the USPTO site to search for a patented preventative for heart disease? Patents are registered in the inventor's name, or maybe the designated transferred rights holder.
 
Thank you icerat.

I notice that the press release contained these statements:

"Many botanical and nutritional supplements claim to provide countless health benefits without being subjected to rigorous clinical study."

"...is one of the few controlled clinical trials that has shown the value of specific nutritional products is dependent on an individual's genetic make-up."

The study looked at whether or not a specific biochemical marker changed, but did not look at any clinical outcomes. In particular, it did not look at whether changing CRP levels leads to changes in clinical outcome. It did not compare the use of the botanical with other lifestyle and pharmaceutical interventions known to reduce CRP and known to change outcome. And it did not compare the use of a supplement with specific dietary recommendations. In other words, while the study showed that a specific botanical had a specific biochemical effect in individuals identified through genetic testing, it did not answer those questions of most interest to us - does the use of this supplement provide any benefit? is that benefit greater than or in addition to the benefit provided by following dietary recommendations? is that benefit greater than or in addition to following lifestyle recommendations? is that benefit greater than or in addition to the use of other pharmaceutical agents or medical interventions?

So, this study does not tell us whether this botanical is useful, even in the setting of genetic testing, and is not sufficient to recommend the use of this supplement without substantial additional research. And yet, even though this study is not adequate, the press release states that this is one of the few studies available that even attempts to answer these questions. If the best available is not sufficient to provide evidence-based recommendations, then it means none of what ILG offers is evidence-based. And by extension, it suggests that what Amway offers is similarly not evidence-based.

Linda
 
From the OP: "Gensona genetic testing and patented and clinically tested and supported..."

Well, let's parse this:

"Gensona genetic testing" means Amway works with Gensona.

"patented" means the USPTO gives them exclusive rights, nothing in the USPTO says it has to work.

"clinically tested " probably means for safety only, not that it has been proven effective, in this case, at preventing heart disease.

Seems to me that the FDA says supplements can't be sold to treat medical conditions. IE, Statins are sold as a preventive, yet need a Rx.

I think, if there is such a strong link to a genetic disease, and a nutritional/supplement can prevent the heart disease, it would be all over the news. We would be talking Nobel Prize class of breakthrough.

Where was I? How come I didn't get the press release? Oh, nobody else did either?
 
fls - would it be possible for you to send me a copy of the study? I haven't seen anymore than summaries it and I don't recall what you are saying about it, in particular I didn't think it studied an actual supplement? As I recall it was what be early research that may lead to a product down the path, but you seem to be indicating it actually studied something in production?

casebro - Amway, or rather parent Alticor, owns ILG and Gensona.

There's plenty of evidence various supplements can mitigate risk of disease. Omega-3 and CHD being a classic example. I doubt any supplement can "prevent" disease, and in any case somewhat restrictive FDA regulations throw up all sorts of barriers even if it could - for a start it might no longer be able to be called a supplement!

There's an additional problem in the supplements industry in that while specific formulations can patented, it's generally very easy to tweak some things and copy it. One result is that even if you do clinical studies then you won't necessarily want them published as then they can be copied and you lose competitive advantage. Throw in the whole "disease/medicine" thing and it's a conundrum for any commerical enterprise.

So folk who want to see peer-reviewed, published, double blind placebo studies, which includes myself, we're pretty much out of luck. Even when they are published they'll be of the type "this changed this" in some clinical sense, but without leading through to a "real world" conclusion. There's quality clinical studies that show for example that Double X, Amway's "premium" supplement, significantly reduces DNA fragmentation. If you know the field this has all sorts of interesting ramifications.

Summary of one study here, by Yonsei University in South Korea

It also significantly decreased plasma homocysteine levels. I could tell you the importance of that, but then the FDA might come knocking :). Alas, no, the study isn't published for the types of reasons I gave above.
 
Sorry for the late response, but ILG does the testing, all that is done "in house" is an individual takes a swab, which is then sent off to ILG for genetic analysis and ILG does any recommendations. If you have a particular "bad" gene and particular nutrients have been shown to mediate it's expression, I fail to see why you'd need a full clinical history?

One may - for example - have a gene that gives one an increased chance of high cholesterol levels. However, before starting on drugs and/or supplements that can lower cholesterol levels, you'd want to check whether you actually *had* high cholesterol levels, and the LDL and HDL levels; you might also want to look into, for example, whether there would be opportunities to make lifestyle changes in order to improve matters, before moving onto supplements, drugs etc. There are also questions about general health - e.g., to be blunt, if you've got something that will kill you way before cholesterol levels, there may be a good argument for not bothering to treat them. Etc... You can't know this without having a clinical history.

You'd also want to know whether any interventions lead to improved health outcomes. In terms of treatment recommendations, what's interesting isn't just whether taking supplement X lowers cholesterol levels - but whether improved health outcomes result.

So folk who want to see peer-reviewed, published, double blind placebo studies, which includes myself, we're pretty much out of luck. Even when they are published they'll be of the type "this changed this" in some clinical sense, but without leading through to a "real world" conclusion

You get these - for example, http://www.badscience.net/2009/04/a...n-the-fascinating-issue-of-subgroup-analysis/
Or there were some large-scale, well-designed RCTs included in the last Cochrane review of the effects of antioxidant supplements on mortality rates http://www.cochrane.org/reviews/en/ab007176.html Have any supplements been withdrawn when research showed them to be ineffective for what they are sold for..?

It also significantly decreased plasma homocysteine levels. I could tell you the importance of that, but then the FDA might come knocking . Alas, no, the study isn't published for the types of reasons I gave above.

I appreciate that plasma homocysteine levels correlate with certain health outcomes. It seems pretty clear that certain supplement regimes lower plasma homocysteine levels (though you wouldn't need to buy Amway's 'premium' pills to do that - cheap, generic pills can also achieve this). As far as I'm aware, though, it doesn't look like these interventions lead to significantly improved health outcomes.
 
One may - for example - have a gene that gives one an increased chance of high cholesterol levels. However, before starting on drugs and/or supplements that can lower cholesterol levels, you'd want to check whether you actually *had* high cholesterol levels, and the LDL and HDL levels; you might also want to look into, for example, whether there would be opportunities to make lifestyle changes in order to improve matters, before moving onto supplements, drugs etc. There are also questions about general health - e.g., to be blunt, if you've got something that will kill you way before cholesterol levels, there may be a good argument for not bothering to treat them. Etc... You can't know this without having a clinical history.

Ok, I see what you're getting at there. As I recall a speaker (a medical doctor as it happens) saying at one nutrition seminar I went to "if you smoke, you can leave, nothing I tell you will help much". So I mostly agree, supplementation should not be done in isolation, however I'd also argue that in many cases an ongoing assessment procedure might cost more than the price of supplementation and with similar outcomes. Still, in general you are correct, there are plenty of non-supplement interventions that should have higher priority in most peoples lives.

You'd also want to know whether any interventions lead to improved health outcomes. In terms of treatment recommendations, what's interesting isn't just whether taking supplement X lowers cholesterol levels - but whether improved health outcomes result.

Absolutel - unfortunately due to the nature of the field itself, and regulatory restrictions, this is extremely difficult to do well. What can be done more easily is "high X is linked to increased risk of Y, taking B lowers X." - and that's why you tend to get that type of claim.


Yes, classic texas sharp-shooter stuff really.

Or there were some large-scale, well-designed RCTs included in the last Cochrane review of the effects of antioxidant supplements on mortality rates http://www.cochrane.org/reviews/en/ab007176.html

Meta-analyses are dangerous beasties at the best of times, and this paper was a classic example of why. It quite rightly came under a deal of fire, one quick writeup here . Can one say "self-selecting sample bias"?

It also wasn't reviewing the type of supplements I consider appropriate. In most cases I do not believe synthetic analogues can replace the effects of nutrients in food. This is one reason why epidemiological studies on fruit and vegetable consumption so often seem to show positive benefits whereas "vitamin" studies do not. The nutritional composition (and benefits) of food is far more complex than simple isolated vitamins. Many require different cofactors to work efficiently. Many of the commercialised synthetic forms don't even accurately chemically represent the natural forms. Take "Vitamin E" - 8 forms in nature, but you only need to synthesise one and stick it in a tablet to call it Vitamin E, and now there's research starting to indicate that the tocotrienol forms, once considered unusable by humans, may have significant health benefits, perhaps outstripping the classic "vitamin E".

The Nutrilite approach, which I like, is to identify plants high in particular nutrients, then selectively breed and cultivate to increase concentrations, then create a powder concentrate of the plants and put into tablet or capsule form, boosted with synthetic varients where the science supports it (ascorbic acid for example). The idea is you're getting nutrients in similar form to food, with all the accompanying cofactors. Now obviously processing always has risks of destroying some important compound we're not currently aware of, but as the knowledge improves so does the processing.

Have any supplements been withdrawn when research showed them to be ineffective for what they are sold for..?

Not withdrawn that I know of, but Nutrilite regularly reformulates their products as knowledge improves. I can't recall specific examples, but that has included removal of ingredients, yes.

I appreciate that plasma homocysteine levels correlate with certain health outcomes. It seems pretty clear that certain supplement regimes lower plasma homocysteine levels (though you wouldn't need to buy Amway's 'premium' pills to do that - cheap, generic pills can also achieve this). As far as I'm aware, though, it doesn't look like these interventions lead to significantly improved health outcomes.

Pill=lower plasma homocysteine, therefore take pill is a "magic bullet" type approach I don't prescribe to. Amway's "premium pills" aren't targeted to that approach. They actually incorporate 23 different plant concentrates as well as various other vitamins and minerals. Nutrilite does do studies comparing with the generic brands as well, and it does do a better job, as you would expect if you believe that it's better to get nutrients from food than from a chemistry lab.

Found this monograph you might find interesting, only versus placebo though.
 
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fls - would it be possible for you to send me a copy of the study? I haven't seen anymore than summaries it and I don't recall what you are saying about it, in particular I didn't think it studied an actual supplement? As I recall it was what be early research that may lead to a product down the path, but you seem to be indicating it actually studied something in production?

That information was available in the links you provided.

Linda
 
Absolutel - unfortunately due to the nature of the field itself, and regulatory restrictions, this is extremely difficult to do well. What can be done more easily is "high X is linked to increased risk of Y, taking B lowers X." - and that's why you tend to get that type of claim.

The problem is that these types of claims are unreliable. There is considerable drop-off between in vitro, in vivo, animal, Phase I, II, III trials of efficacy and trials of effectiveness. By stopping early, you increase the probability that what you are claiming is false.

Meta-analyses are dangerous beasties at the best of times, and this paper was a classic example of why. It quite rightly came under a deal of fire, one quick writeup here . Can one say "self-selecting sample bias"?

That criticism is not valid. It would only be relevant if the excluded studies were biased. And if they were biased, then their inclusion would lead to false conclusions.

Linda
 
The problem is that these types of claims are unreliable. There is considerable drop-off between in vitro, in vivo, animal, Phase I, II, III trials of efficacy and trials of effectiveness. By stopping early, you increase the probability that what you are claiming is false.

Of course, but it doesn't mean the claim (or implication actually) *is* false. And the more the connections between individual steps are proven, the more probably the full outcome is true. The commercial and regulatory reality is that we're simply not going to get what both you and I want in terms of studies, so you instead have to evaluate what *is* available and make a best judgement.

That criticism is not valid. It would only be relevant if the excluded studies were biased. And if they were biased, then their inclusion would lead to false conclusions.

The ultimate conclusion of this would be that if antioxidants bestowed immortality, then this would be evidence they don't work. Sorry for the silly example, but that really is were that leads.

In any case, in general as I said I think meta-analyses are problematic. They seem to have become rather fashionable in the 15 years since I left the research world, but fashioable doesn't mean they're appropriate. The less homogenous in design the included studies are, clearly the less reliable your result no matter what statistical hoops you jump through to try and clean it up. The studies included in the Cochrane analysis were far far from homogenous and I personally question even the validity of the hypotheses tested. Nutrition is not that simple.
 
Of course, but it doesn't mean the claim (or implication actually) *is* false.

Right, it is merely much more likely to be false than true.

http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.0020124

And the more the connections between individual steps are proven, the more probably the full outcome is true. The commercial and regulatory reality is that we're simply not going to get what both you and I want in terms of studies, so you instead have to evaluate what *is* available and make a best judgement.

Yes, that is the heart of evidence-based medicine. And that is why use of these supplements is not generally recommended.

The ultimate conclusion of this would be that if antioxidants bestowed immortality, then this would be evidence they don't work. Sorry for the silly example, but that really is were that leads.

No it doesn't - immortality would have to be conferred by taking the anti-oxidants and by not taking the anti-oxidants. There were 405 studies excluded because there were no deaths in both study groups, not that there were no deaths in the anti-oxidants group but some deaths in the control group. In addition to creating some statistical difficulties, these studies are unable to add any information about mortality. If they are well-balanced, at least they won't obscure mortality data from other studies. But if they are not, then all they will accomplish is to create the appearance of an effect that is based solely on group size and variability - something that is completely unrelated to the effect of the treatment. Including these studies can only have the effect of obscuring the results, they cannot add to the results. And even if they manage to not to obscure the results, you still obtain all your information about the results from the studies that were not excluded.

In any case, in general as I said I think meta-analyses are problematic. They seem to have become rather fashionable in the 15 years since I left the research world, but fashioable doesn't mean they're appropriate. The less homogenous in design the included studies are, clearly the less reliable your result no matter what statistical hoops you jump through to try and clean it up. The studies included in the Cochrane analysis were far far from homogenous and I personally question even the validity of the hypotheses tested. Nutrition is not that simple.

The studies included in the Cochrane analysis were tested for homogeneity and were found to be homogeneous. I agree that it is reasonable to be cautious about meta-analysis. But a careful reading of the study shows that it has the characteristics that allow one to form reliable conclusions - that is, it fulfills the criteria one uses to judge whether it is valid.

Linda
 

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