noseweek article: EYEWASH

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EYEWASH

Critics who question the product's safety are threatened with defamation charges 

Posted with kind permission from noseweek

WHO'S GOT TIME for R&D these days? Certainly not Solal Technologies, a company that distributes, inter alia, a complementary medicine called Lutein & Zeaxanthin (Eye Formula). The blurb says that it's for "lutein and zeaxanthin deficiency" and that it's also "highly protective of the eye and assists with age-related macular degeneration (AMD) and cataract". On top of that, "lutein and zeaxanthin also have cardiovascular and anti-carcinogenic effects". Good stuff then – but does it work?

It seems that clinical trials have not been done on humans. When the UK Advertising Standards Authority had to deal with an advertisement for a similar product called Bright Eyes whichclaimed it promoted eye health, it made the following finding: "We noted that a further study concluded that higher lutein and zeaxanthin intake reduced the risk of long-term incident AMD. However, we considered that Metabolics (the UK distributor) had not proved that a supplement containing these ingredients would be absorbed and utilised by the body in the same way as the ingredients in their naturally occurring states… we did not consider these studies sufficient evidence to substantiate the claim that the formulation of the ingredients in the Bright Eyes product maintained eye health. We considered that, in order to substantiate the claim, we would need to see robust human-based trials that showed that the formulation of the ingredients contained in the Bright Eyes Formula kept eyes healthy." 

When the product found its way to South Africa, consumer activist Harris Steinman posted the finding on Camcheck, a blog that "highlights various issues related to complementary medicine, pseudoscience, and what constitutes good evidence before a therapeutic product can be regarded as safe or to have efficacy". Steinman asked: was the UK ASA setting the bar too high? 

Brent Murphy, a pharmacist employed by Solal Technologies, had this to say: "In the same way as people are criticised not to refer to the You magazine as if it were a medical journal, I would advise you not to refer to the UK ASA as if it were one too. 

"Neither the You magazine nor the ASA are medical authorities. There are many good references showing the benefits of lutein and zeaxanthin for eye health. I have compiled a 52-page document with some of the research… Since we are speaking of eyes, I think the saying that there are none so blind as those who will not see applies to you." 

Steinman's response: "The point about the UK ASA is that they get independent experts to review the evidence before making a decision. They are acutely aware that if they get the decision wrong they can be challenged in a court of law – hence their decisions have to be backed by very credible assessment. I do agree with Brent Murphy that 'there are many good references showing the benefits of lutein and zeaxanthin for eye health', unfortunately there are many good references that show there is no – or minimal – benefit. The fact that there is such contradictory research substantiates the simple fact: we do not have conclusive evidence!" 

Professor Roy Jobson of the Faculty of Pharmacy at Rhodes University, then enters the fray: "The main point made by the UK ASA, as I read it, was that no evidence was provided to show that the specific formulation being advertised, called Bright Eyes Formula, had the claimed effects. In fact, they said they "would need to see robust human-based trials that showed that the formulation of the ingredients contained in the Bright Eyes Formula kept eyes healthy… It seems that neither of the companies – Metabolics in the UK, or Solal in SA – have done the research needed in human beings to provide robust evidence for the claims, or that their respective products  are adequately absorbed in humans." 

Murphy's riposte: "Must every  manufacturer of oranges prove that the vitamin C contained in their oranges prevents scurvy? No. They can rely on generic data published in medical journals on other brands of oranges. Generic evidence is quite acceptable. It is the standard the world over. Solal relies on generic evidence which is quite acceptable and is standard practice in the food, generic medicines and complementary medicines industry. And the evidence is compelling." 

Says Jobson, pointing out the obvious: "Your product is not a food. You have created a new medicine by combining lutein 6mg and zeaxanthin 2mg into a capsule… and recommended a dosing regimen of 1-2 capsules a day for adults, and half that for children. 

"How were these amounts and dosages determined? And how do you know that they have any effect? How do you know that children should take only a half dose to achieve the same blood levels of the substances? Maybe they should take a quarter dose — or a dose based on weight or BMI. Your… product does not, in fact, seem to be supported by any 'acceptable' generic evidence that I've seen." 

Time for a new name: a Rob Sykes then writes in: "I had a rather unpleasant surprise when, the day after I had been diagnosed with AMD, I found your discussion on lutein and zeaxanthin supplementation. My question to both of you is: since the supplementation may or may not be necessary, should I 'blindly' go ahead and purchase an expensive and unproven supplement, in case? If I do, can the pro-supplementation lobby give me an unequivocal assurance, backed by robust human testing, that there are no negative side-effects or consequences of such supplementation?" 

Murphy's had enough of this lark by now: "Best is, do your own research and make up your own mind." 

Sykes's astonished response: "I was under the impression your company promoted the supplementation based on your knowledge of the efficacy and safety in humans. "I am surprised that you recommend I do my own research, as I would have expected you to have performed this task before recommending your products to consumers." 

Meanwhile, there is an article entitled "How Solal uses legal threats to stifle legitimate criticism" on the website, www.quackdown.info. The author, Marcus Low, details complaints lodged at the Advertising Standards Authority (ASA) about Solal's adverts. Low says that Solal's lawyers threaten defamation charges against anyone who questions the company's products. 

"These defamation threats are clearly spurious," says Low. "I suspect they're   intended   to   intimidate critics and quash criticism of Solal's numerous   unsubstantiated   and misleading advertising claims." 

So does Noseweek. •

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