Unprincipled Healthcare: Part Two

Following on from my recent post about vitamin pill entrepeneurs Principle Healthcare, I bring you details of a letter I wrote to the authorities regarding the Consumer Protection from Unfair Trading Regulations 2008. Some of the claims made on the website I have been investigating are staggering.

One claim I noted was that for those finding it difficult to focus on a task: “unless you’re taking fish oil supplements or you’re eating an extraordinary amount of fatty fish, chances are those levels [of Omega 3] were too low”. This is a remarkable claim to make – it implies that maintaining adequate levels of Omega 3 fatty acids requires a very large intake that is only achievable by shovelling down masses of oily fish or popping fish oil pills. One wonders how vegetarians cope… [Incidentally, there are about 220 million strict vegetarians in India, according to the Anthropological Survey of India. I wonder if they are deficient in Omega 3 fatty acids and have difficulty focussing on tasks?] As far as I am aware, the only decent trials that have been conducted into Omega 3 fatty acids and mental performance have been in children with DCD or ADHD. As Ben Goldacre wrote in September 2007: “Even now, for all this pretending, there still has never been a single controlled trial, even a cheap one, of omega-3 fish oil supplements in normal children.” [http://www.badscience.net/2007/09/the-fishy-reckoning/]

Another was this: glucose tablets are, apparently, “A must for those with hectic busy schedules”. Really? Sugar pills are essential for those with hectic scehdules? This sort of stuff beggars belief. There’s plenty more where that came from. According to Principle Healthcare, Coenzyme Q10 is of benefit “to those exposed to pollution and stressful lifestyles” because it is an antioxidant. Are antioxidants now a cure for stressful lifestyles? That sounds frankly bizarre to me. Then there’s the assertion that homocysteine increases our risk of a problem with the circulatory system. I’m not sure whether there is any decent evidence to back up this assertion, but when I searched Pubmed for up to date evidence relating to homocysteine and the circulatory system I found only one paper with a link to free full text published in the last year. The conclusions of this paper did not seem to me to support the assertion made by the vitamin B pills salesmen.*There is more on homocysteine as a surrogate endpoint below.

As for Apple Cider Vinegar, well it almost sounds like a panacea. It “helps curb appetite, is a gentle detoxification agent, absorbs and blocks fat formation, boosts the immune system and supplies amino acids, minerals and vitamins”. Well it is if you believe Principle Healthcare, vendors of Apple Cider Vinegar pills. [There's a little bit more on ACV here: old blog post, please don't laugh at my amateurish early efforts at blogging.]

Now for the letter I wrote.

Dear Sirs or Mesdames,

I am writing to you with regards the following website: http://www.principlehealthcare.co.uk/. I have concerns that this site may be promoting food supplements in a manner contrary to The Consumer Protection from Unfair Trading Regulations 2008. I believe that it materially distorts or is likely to materially distort the economic behaviour of the average consumer with regard to the products being promoted on this website (Part 2; section 3 relating to “Prohibition of unfair commercial practices”; paragraph (3) (b) of the regulations). I believe that it may contain false information and is therefore untruthful in relation to at least one of the matters in paragraph (4) in that it may contain false information relating to the benefits and/or composition [1] of products. I believe that it or its overall presentation deceives or is likely to deceive the average consumer in relation to matters in that paragraph; and that it causes or is likely to cause the average consumer to take a transactional decision he would not have taken otherwise. I further believe that there may be promotion of supplements in a manner which is contrary to section 6 (relating to “Misleading omissions”).

On this webpage: http://www.principlehealthcare.co.uk/treating.cfm; it states that “it is often very difficult to achieve the optimal nutritional balance, all the more so if we consider the hectic and pressurised lifestyles many of us lead along with the poor quality of the foods available on our supermarket shelves”, which I consider to be misleading. I believe that the reference to the “poor quality of the foods available on our supermarket shelves” misleadingly implies that these foods are deficient in nutrients. On the same page, it is asserted that “Good health needs to be supported through positive diet and lifestyle choices” and this is followed by a list of suggested lifestyle choices – one of which is to “support your diet with supplemental vitamins, minerals and essential fatty acids as required”. The same page, again, states that children “certainly may also need nutritional support in the shape of vitamins, minerals, essential fatty acids and probiotics in support of a good diet to support their immune systems and their growth potential” but does not make clear that these nutrients can be found in foods, thus it could be interpreted as implying that supplements were essential. Another claim is this: “Have you ever had one of those days where you were really trying to focus on something but you just couldn’t master the task? It could be that your body’s levels of Omega 3 were way too low and unless you’re taking fish oil supplements or you’re eating an extraordinary amount of fatty fish, chances are those levels were too low.” I believe this to be false, and likely to mislead the average consumer to the extent that it is likely to materially distort the economic behaviour of said consumer. With regard circulation, the page states that “As well as helping to keep our cholesterol levels in check through diet we also need to keep our homocysteine levels in check as a high level of this amino acid also increases our risk of a problem with the circulatory system.” I do not believe that Homocysteine is recognised as a substance that increases the risk of problems with the circulatory system. This misleading information is used to promote folic acid, vitamin B6, vitamin B12, magnesium and zinc.

This page: http://www.principlehealthcare.co.uk/popup.cfm?p_n=411998&p_i=411998; claims that “Apple Cider Vinegar has the presence of a natural array of acids and minerals that help to maintain the body’s own acid balance and mineral metabolism. Apple cider can help curb appetite, boost the immune system and much more. Apple Cider Vinegar contains a balance of minerals, including potassium, sodium, phosphorus, magnesium, calcium, iron, fluorine and silicon”. I query whether their Apple Cider Vinegar contains sufficient minerals to make any measurable difference to anything in the human body. I note at the bottom of this letter that the USDA website has an analysis of the mineral content of Apple Cider Vinegar per 100 grams. [1] The advertised product presumably contains capsules that weigh considerably less than this amount. The page further claims that “Apple Cider Vinegar speeds up the body’s metabolic rate”; and that “It also helps curb appetite, is a gentle detoxification agent, absorbs and blocks fat formation, boosts the immune system and supplies amino acids, minerals and vitamins.” I question all these claims for the Apple Cider Vinegar product being sold by Principle Healthcare.

This page: http://www.principlehealthcare.co.uk/popup.cfm?p_n=434608&p_i=434608; contains claims that “The pomegranate plant is rich with antioxidants and is a natural source of vitamin C and iron. Pomegranate is believed to provide natural anti viral, anti fungal and anti bacterial benefits.” I challenge all of the claims from “natural source” onwards. I do not believe that pomegranate provides a significant amount of vitamin C or iron.  I do not believe that it provide natural anti viral, anti fungal and anti bacterial benefits or that a food supplement company should be able to make such claims – they strike me as being medicinal claims, which are barred from food supplements and can only be made for licensed medicines.

According to this: http://www.principlehealthcare.co.uk/popup.cfm?p_n=411997&p_i=411997; “Active defence contains the combined benefits that our Vitamin C and Zinc products provide – together helping maintain a healthy immune system.” I challenge this claim for truthfulness and also query the medicinal nature of the claim.

http://www.principlehealthcare.co.uk/popup.cfm?p_n=434612&p_i=434612: “We develop a deficiency of beneficial bacteria as we get older and therefore become more vulnerable to infections.” I challenge this claim on truthfulness and the ability of the company to substantiate the claim.

http://www.principlehealthcare.co.uk/popup.cfm?p_n=434611&p_i=434611: “A must for those with hectic busy schedules.” Untruthful – glucose tablets are not “a must” for anyone. Consumers should not be sold sugar tablets on the basis that they are essential, as this is clearly untrue.

http://www.principlehealthcare.co.uk/popup.cfm?p_n=412010&p_i=412010; “Co Q10 has also been shown to possess antioxidant qualities and is therefore of benefit to those exposed to pollution and stressful lifestyles.” Antioxidants are not beneficial to those exposed to stressful lifestyles and have not been proved beneficial for those exposed to pollution.

http://www.principlehealthcare.co.uk/popup.cfm?p_n=412011&p_i=412011; “Echinacea is a traditional herbal remedy that can help combat the common cold, stimulate the immune system and help in wound healing.” This page makes inappropriate medicinal claims, with no substantiating evidence.

Misleading omissions: the webpages I link to do not point out that supplements are generally considered to be unnecessary for those who eat a reasonably balanced diet (with specific exceptions such as folic acid for women hoping to conceive). They make no reference to the potential adverse effects of supplements (e.g., for antioxidant pills there was a Cochrane review that found that Vitamin A, beta-carotene, and vitamin E may increase mortality).

[1]

Minerals (per 100g) Apple Cider Vinegar (see above claim).
Calcium, Ca                  mg        7
Iron, Fe                         mg        0.20
Magnesium, Mg             mg        5
Phosphorus, P               mg        8
Potassium, K                mg        73
Sodium, Na                   mg        5
Zinc, Zn                         mg        0.04
Copper, Cu                    mg        0.008
Manganese, Mn             mg        0.249
Selenium, Se                 mcg      0.1

Yours faithfully,
James Cole

David Colquhoun discusses the Unfair Trading Regulations here. His post on whether most alternative medicine is illegal includes links to the relevant pieces of legislation. Here are some PDFs of the relevant webpages just in case they disappear: Active Defence Apple Cider CoQ10 Echinacea glucose tabs Pomegranate Probiotic PHC About Us page PHC Ailments

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*Homocysteine: is it a modifiable causal risk factor for vascular disease or simply a marker of risk burden? This is part of the background to this recent paper which found that “long-term homocysteine-lowering treatment with B-vitamins does not significantly reduce CIMT or increase FMD in people with a history of stroke” and that “the modest increase in FMD associated with short-term B-vitamin treatment does not appear to be translated into improved vascular structure or sustained in the longer term”. As the authors state in the abstract, “long-term homocysteine-lowering did not significantly improve FMD or CIMT in people with a history of stroke” (CIMT is carotid intima-medial thickness and FMD stands for flow-mediated dilation). A slightly older paper, meanwhile, concluded that “adjusting for renal function not only eliminates the relationship between tHcy and markers of vascular risk in subjects with proven cerebrovascular disease” and that “Our data are thus consistent with the hypothesis that mild renal impairment is an independent risk factor for vascular disease and elevated tHcy simply a marker for reduced GFR. The underlying relationship between tHcy and renal function is not altered by long-term B-vitamin supplementation and it is possible that, by treating homocysteine, we may be shooting the messenger rather than attacking the true risk factor.” [http://atvb.ahajournals.org/cgi/content/full/28/6/1158] A study that looked at biomarkers for PAD (Peripheral Arterial Disease) development in women did not find significant associations for homocysteine and other biomarkers. The authors “found the proinflammatory cellular adhesion molecule sICAM-1 to be the strongest predictor of confirmed clinical events” and noted three other biomarkers that were significant and one that was borderline significant. [http://circ.ahajournals.org/cgi/content/full/117/6/823] I’m not expert in medical matters (as you will probably have noted if you’ve read this blog before) but it seems to me that homocysteine could well be a false surrogate endpoint.