Professor Patrick Holford of Teesside University and Head of Science and Education at Biocare has an unerring sense for his endorsements (see, e.g., the qLink with the unconnected coil and the dLan that may enhance your exposure to EMR and YorkTest, the IgG food intolerance tests criticised by both the House of Lords and the ASA). Holford managed to procure some useful backing for the Food for the Brain project. One of the companies is Equazen. Equazen donated essential fat supplements to school projects. With an astonishing sense of inevitability, Equazen has just been criticised by the ASA and found to be unable to substantiate some of its advertising claims: e.g. “A Hi-EPA fish oil formula that may help maintain concentration levels and healthy brain development”.
Like YorkTest before it, Equazen attempted to refute the challenges made to their claims by citing papers that described research studies that could not support the standard of proof that was needed to support its optimistic interpretation of the research findings or their generalisability to the wider population.
[Equazen] said the claim was a standard omega-3 food supplement pack claim, which was used by several manufacturers of omega-3 products. They submitted examples of other marketers’ packaging and advertising, which showed that similar claims relating to children’s concentration and brain development were used by them. They also submitted a copy of the certificate given by the HFMA upon approval of the packaging.
Equazen explained that the UK population, and children in particular, did not have sufficient nutrient intake, including polyunsaturated fatty acids (PUFAs), which were usually present in oily fish. They sent a summary of available evidence which, they said, supported the importance of an adequate supply of key omega-6 and omega-3 PUFAs for optimal cognitive development and for promoting and preserving brain function throughout life. They added that there was also evidence to suggest a benefit from the use of omega-3 and omega-6 supplementation in the management of certain neurodevelopmental problems such as ADHD, dyslexia and developmental coordination disorder (DCD), also known as dyspraxia, where there could be an underlying PUFA deficiency or an abnormality of PUFA metabolism.
The ASA checked the exact meaning of the HFMA regulations and noted the following:
HFMA approval confirmed that the product’s packaging met with all regulatory requirements, such as Food Labelling and Food Supplements Regulations, but also noted it did not indicate approval of any claims used on the pack, or endorsement of the product. [Emphasis added.]
The ASA put up a pithy rejection of the studies that Equazen quoted in support of its scientific claims. Dr Ben Goldacre has more extensive discussions of some of the cited papers and studies at Bad Science. The ASA recognised that some of the studies had too few participants.
[T]he trial included only 49 participants. In the absence of further robust testing involving healthy subjects, we considered that that number was too low on which to base a claim for the general population.
The ASA also noticed that one study wasn’t using a comparable product.
Because the trial used a supplement with a different composition to Equazen’s eye q™ and because the recommended dosage of the two supplements was not comparable, we considered that we had not seen evidence to show that the results of the trial were likely to be achieved from supplementation with eye q™.
The keen-eyed researchers at the ASA astutely pointed out that the claims for the general population could not be substantiated by the papers that Equazen cited because the studies had been carried out with a sample that is not necessarily representative.
We noted, however, that three of the trials engaged with children who had been identified as having symptoms of ADHD or DCD and considered that those trials were unsuitable for use in support of a claim that was likely to be seen as referring to a general population.
It feels a little unkind to continue to describe the many ways in which the ASA gave a drubbing to the evidence submitted by Equazen; Holford Watch recommends that you enjoy the full splendour of the ASA’s critical thinking for yourself.
In summary the ASA ruled as follows:
We told Equazen to remove the claims “… may help maintain concentration levels and healthy brain development”, “the Clever Capsule”Scientifically tested in schools”, “proven in schools” and “proven by Science” from future advertising for eye q. We also told them to avoid implying in future that the advertised product could benefit the general population or that a trials results related to a product with exactly the same composition and dosage as the advertised product if that was not the case.
Le Canard Noir (LCN) has commented on this fishy story. He praised the ASA for their willingness to address:
a complex issue involving a lot of evidence and weighing of scientific viewpoints. This is something that many bodies wish to shy away from.
LCN has recently discussed a book that advises readers on the appropriate interpretation of evidence: Snake Oil Science: The Truth about Complementary and Alternative Medicine. Bausell argues:
just because someone with a Ph.D. or M.D. performs a clinical trial doesn’t mean that [it] possesses any credibility whatsoever … The vast majority are worse than worthless.
We would also add that just because you would like a study or paper to have a particular significance, there are many times when the papers findings just can not support your claims (e.g. the more supplements the healthier or the advisability of homocysteine tests for the general population).
Here at Holford Watch, we do wonder if Professor Holford needs to be a little more cautious in his readiness to endorse products or use them in projects as important as Food for the Brain. Particularly now that his appointment as Visiting Professor at Teesside means that he will be advising the next generation of researchers on the presentation of their claims and the correct conduct of trials. Won’t somebody think of the children?