“It’s not a trial… wait… it is… and the evidence does show… and… and it’s for the KIDS…”

October 3rd, 2006 by Ben Goldacre in bad science, equazen, fish oil, letters, nutritionists | 53 Comments »

Kelliher’s been busy with letters@guardian.co.uk

It’s a definite improvement on the really rather revolting blog postings from the Portwood camp but addresses none of the interesting questions, and simply re-states the blander aspects of the case which have already been torpedoed. There are now much more interesting things to say on this than go over old ground, but one thing that amuses me is: if their “initiative” hadn’t been presented as important scientific research, four weeks ago, but instead had been presented merely as a company giving a nice freebie to a council, how many peak time national terrestrial TV news flagships do you think would have put the fish oil tablet story in their running orders?

Letters
Durham council’s fish-oil initiative
Tuesday October 3, 2006
The Guardian

Readers of Ben Goldacre (Bad science, September, 9, 16 and 23) might come away with the idea that my company’s collaboration with Durham county council to supply free eye q capsules to all GSCE students for the 2007 academic year is a publicity gimmick aimed at generating bogus research data. Nothing could be further from the truth. Dr Goldacre’s criticism seems aimed at what the initiative is not, rather than what it is. It not is a clinical trial, just an initiative aimed at giving a simple nutritional input – omega-3 and omega-6 oils – to GCSE students in a region where children are underperfoming. It has the enthusiastic support of the schools, the pupils and their parents.

There is a lot of research, some of it using eye q, and a significant part of it undertaken in Durham, indicating that ensuring a good input of fatty acids in the diet can have real benefits for brain function. In the classroom, this can mean enhanced concentration, and ability to absorb information. So the initiative is purely to see if supplementation may enhance academic performance. If children taking part show better than expected results next summer, this may pave the way for a full clinical trial to find out exactly why. Every major nutritional authority around the world calls for us to have more omega-3 in our diets.

Equazen has collaborated with Durham council in various projects in the past. I am constantly impressed with the way that a local authority in northern England is, on it’s own initiative, investigating the linkage between nutrition and classroom performance. This idea is now widely accepted, thanks to many others, including Jamie Oliver. There is, however, a lot of further work to be done. So I have no doubt that in coming years, giving omega-3 supplements to school children will be standard practice. Much of the reason for this understanding will be the pioneering and progressive work undertaken by the Durham county council.

Adam Kelliher
CEO, Equazen

ps to refresh your memory, check out how thoroughly Durham, Equazen, and Portwood all didn’t call it a trial here in the extra quotes:

www.badscience.net/?p=297

It amazes me how we criticised Durham and Equazen for collecting data in such a stupid design of “trial”, but these people have all got completely preoccupied with the use of the word, “trial”, as if that was the point, whilst still cheerfully talking about collecting data from the exercise…


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53 Responses



  1. James said,

    October 3, 2006 at 3:15 am

    “…on it’s own initiative”, indeed. I wonder if Adam would care to reveal to us exactly who approached who over this while sordid affair. That entire reply is the literary equivalent of Mr Kelliher sticking his fingers in hears ears and screaming ‘la-la-la-la-la I can’t hear you’…

  2. billgibson said,

    October 3, 2006 at 8:26 am

    “a local authority in northern England is, on it’s own initiative,”

    Hands up who thinks grammar and punctuation lessons are more important that pills?

    Me! I do!

  3. Ben Goldacre said,

    October 3, 2006 at 8:56 am

    james: it’s interesting you think this was one leading the other. to me all parties profit, the company promote their wares in a news item, the council look effective, portwood gets to go on telly talking about the limbic system and looking like a science expert, and the media get a story involving pictures of kids (and science).

    what I find really interesting are the commonalitites in bad science stories. once again, just like mmr or any of the other stories, we have self appointed science experts, making assertions unsupported by the data, claiming they have research, but it is unpublished: they have expressly chosen to address their science not to the scientific community, the people capable of appraising it, but directly to the public and the media, the people who are not.

    it’s worth mentioning that every guideline woah my train is arrived bye

  4. coracle said,

    October 3, 2006 at 9:08 am

    billgibson,

    Hands up who thinks grammar and punctuation lessons are more important that pills?

    Me! I do!

    Want to rethink that statement? ;)

  5. MostlySunny said,

    October 3, 2006 at 9:21 am

    hoist by your own petard…

    just joshing with ya though Billgibson – you are of course entirely correct [:)]

  6. Scooby said,

    October 3, 2006 at 9:50 am

    “So the initiative is purely to see if supplementation may enhance academic performance. If children taking part show better than expected results next summer, this may pave the way for a full clinical trial to find out exactly why.”

    So nothing to do with the promotion that Boots is running for Omega-3 (some of which is branded Equazen) that references the Durham “Trials” in their fliers?

    If proof one way or another was really wanted, surely the trials could be run now….

  7. AitchJay said,

    October 3, 2006 at 11:12 am

    “So I have no doubt that in coming years, giving omega-3 supplements to school children will be standard practice”

    Meaning that there is no advantage left in taking them…

  8. profnick said,

    October 3, 2006 at 11:21 am

    I haven’t fully scrutinised the previous thread on this but it seems to me that no one (not even Durham/Equazen) has referred back to the earlier trials done at Durham, (see www.durhamtrial.org/).
    I’m not qualified to comment on clinial trials, but apart from the small numbers and the inpenetrability of the results presented, they do appear to at least resemble trials, with single cross over, and placebo controlled groups and all.
    Anyone care to comment?

  9. jdc325 said,

    October 3, 2006 at 11:29 am

    #7

    True, AitchJay. At which point someone will “discover” another substance that supposedly plays an even more important role in the brain. I’m actually a little surprised that other molecules present in the human brain haven’t been put forward as being the next big thing (yet). Does anyone want to start a sweepstake on which one will be first?

  10. coracle said,

    October 3, 2006 at 11:55 am

    Nick,

    There are some annotations on the Durham trials (and others) on the badscience wiki, you could take a look there.

    AitchJay,

    only if you are considering it from a pupil competativeness PoV, alternatively it could be considered that one would be raising performance of all pupils. To be hair-splitting this could be considered a benefit, rather than an advantage.

    jdc325,

    From some years ago I recall a newspaper article (or it may be new scientist) about the benefits of eating food high in Tryptophan (potatoes, pasta, etc). The concept being that Tryptophan is a precursor of serotonin and therefore eating higher levels would make you happier.

  11. superburger said,

    October 3, 2006 at 12:09 pm

    mentioning the fish oil trial in the same breath as Jamie Oliver isn’t cool.

    All jamie oliver suggests is that kids shouldn’t be eating deep fried processed food for lunc every day; instead they should eat sensible cooked meals. I’ve seen a few of his shows and he never employs a person in a white coat to justify his beliefs or pretends to be conducting any sort of reasearch.

  12. Delster said,

    October 3, 2006 at 1:48 pm

    If they took the money they are spending on the pills and added it into the school meals budget they might have enough money to implement the changes that Jamie Oliver was talking about.

    Whilst his series on the school dinners was not conducted as a clinical trial, all involved in interacting with the children in question agreed there was an improvement in behaviour, attention span etc.

    I think i know where i’d rather see the money spent….. despite the fact i find Mr oliver to be an annoying t**t

  13. kim said,

    October 3, 2006 at 3:18 pm

    I’ve never found Jamie Oliver as a convincing illustration of the idea that eating healthy food makes you more intelligent. This is a man who admitted on Desert Island Discs to never reading a book.

    Still, one example doesn’t prove anything. When it comes to this whole fish oil debate, rather than carry out short trials, wouldn’t it be more sensible to measure the IQ of populations that eat a lot of oily fish (such as the Inuit) and compare it with the IQ of populations that don’t eat any fish (such as the Hindu population of India)? I believe that India has one of the highest rates of science Ph.Ds per head of population in the world. That doesn’t destroy the thesis but it does make you question it.

  14. Dr Aust said,

    October 3, 2006 at 3:41 pm

    Unfortunately one could debate for days on what IQ tests actually measure…! Whatever it is, the better ones measure it fairly consistently, but that doesn’t prove they measure “intelligence”, even if we could agree what that is.

    Reams of evidence show that IQ tests, like other “intelligence” tests, are systematically most “answerable” (answered best) by people most like the question-setters in education, background etc etc. Famously in the US this meant IQ tests in the early to mid 20th century systematically “showed” white people to have higher IQs than black people.

    Reading Stephen Jay Gould’s “The Mismeasure of Man” is a useful way to to disabuse yourself of the notion that IQ tests tell you anything much.

    Put another way, I think it would be rather difficult to find an IQ test whose questions were equally answerable by an Inuit and an Indian.

  15. Dr Aust said,

    October 3, 2006 at 3:58 pm

    BTW, the fish oil saga is proving a most fruitful student discussion topic here at IvoryTower Univ. So far I have used it as a exercise for both 1st yr and final yr undergrad students doing biomedical sciences.

    It only took the 1st yr students 45 min to make mincemeat of the positive-spin-loaded Daily Mail story at:

    www.dailymail.co.uk/pages/live/articles/health/healthmain.html?in_article_id=403803&in_page_id=1774&in_a_source

    …I’m hoping they will maintain this level of scientific scepticism through their degree courses and beyond.

  16. j said,

    October 3, 2006 at 4:27 pm

    “It not is a clinical trial, just an initiative aimed at giving a simple nutritional input – omega-3 and omega-6 oils – to GCSE students in a region where children are underperfoming”

    So what he’s saying it that – because kids in a region are ‘underperforming’ (presumably at least in part due to the socioeconomic make-up of the region) – they can be given an untested pill, without going through the normal hassle with things like ethics boards (this is a ‘natural’ nutritional input, afterall). Imagine the response if a drugs company did this – used a drug (with known side effects including excessive bleeding and stomach upset, and anecdotes of other negative effects) to target kids in an economically relatively badly off area, not as part of a trial but to generate positive spin.

    So far, educational underperformance in the North has been used as a reason to give our children Vardy’s city academies, and snake oil. Marvellous.

  17. Dr Aust said,

    October 3, 2006 at 4:43 pm

    As ever, tackling the hard realities of improving education, and overcoming barriers to kids’ achievement resulting from poor social circumstances and large class sizes, is hard, long-term, expensive work.

    Politicians – and, it seems, education authorities – are highly susceptible to wanting easy, push-button (pop pill), quick fix, low-cost solutions.

    Being charitable, they want to be seen to be doing something, preferably without having to spend serious money (e.g. by employing extra teachers to reduce class sizes).

    Being less charitable, they want to be photographed repeatedly making butter-pat-from-mouth-removing speeches about how they are doing something “to leave no child behind” etc etc.

    Hence – fish oil tablets – a quick fix! Marvellous.

    And FREE fish oil – double triple marvellous!

    Remember that, until the Food Standards Authority rather rained on the parade by saying the evidence wasn’t there to justify it, it was widely trailed in the media that Alan Johnson was considering providing fish oil to ALL school kids:

    www.timesonline.co.uk/article/0,,2087-2220938,00.html

    In some ways I am amazed the FSA was able to return a “negative” verdict, given the pressure there must have been on them to come up with a positive one.

  18. le canard noir said,

    October 3, 2006 at 4:45 pm

    I think what is being missed by the equazen ‘trial’ is that i just one more nutritionistic example of the general subversion and destruction of any lingering atttitude to enjoying food in its own right that may exist amongst the English. Food is being seen as something that can only be described in terms of its health giving properties. Jamie Oliver appears to go against this by stressing what good food can really be like – as a pleasure – and not as some sort of carefully manipulated and fussed over, pseudoscientific Holfordian ‘optimum’ diet.

    Kids ought to be learning what a great pleasure in life food can be and that there is more to food than burgers. That is a lesson worth learning at school. As the saying goes, ‘the French live to eat, the English eat to live’.

  19. Delster said,

    October 3, 2006 at 4:59 pm

    (13) Kim,

    Never claimed young Jamie to be intelligent but he does know his food and promotes eating a nice balanced diet with plenty of fresh veg and reducing the amount of processed foods.

    Both of these are a good thing and now a shred of scientific mumbo jumbo in sight…. he tries to sell it on taste as well as generally better for you.

  20. Bob O'H said,

    October 3, 2006 at 5:04 pm

    “If children taking part show better than expected results next summer, this may pave the way for a full clinical trial to find out exactly why.”

    OK, so (1) the best way of finding out if the children get better than expected results is to do a clinical trial, (2) a clinical trial wil only show if the fish oils are the reason. for the increase

    So, they guy’s wasting a year’s work and at least £15-3-6d worth of oils to find out that he should have done things properly in the first place.

    Bob

  21. Dr Aust said,

    October 3, 2006 at 5:18 pm

    Bravo M. Le Canard.

    - and it works both ways – good food is enjoyable, so as you enjoy it you keep eating it.

    This is one of the reasons why organic food is good. Not that it is healthier (who the hell knows?)…. but, esp. obtained via markets / farmshops / veg-boxes, it is fresher and tastier and thus a pleasure to eat AS WELL as being “good” .

    All the piil-solutions remind me of the Sci-Fi movies common in my youth which postulated that by 2000 we would all be eating multi-coloured Nutri-gloop dispensed by big machines.

  22. inicholson said,

    October 3, 2006 at 11:30 pm

    Scooby:

    Re: “So nothing to do with the promotion that Boots is running for Omega-3 (some of which is branded Equazen) that references the Durham “Trials” in their fliers?”

    I’ve not seen the add you mean but if you’ve got one of those fliers I’d send it straight to the Advertising Standards Authority, along with a copy of Adam Kelliher’s letter denying the existence of a trial!

  23. Robert Carnegie said,

    October 4, 2006 at 1:40 am

    I suppose he really does say,

    “criticism seems aimed at what the initiative is not, rather than what it is. It not is a clinical trial,”

    - or is that just by courtesan of Hte Grauniad? Famed for its enlightenedly unionised print workers…

    Any chance of developing the Durham Trials to involve use of the ducking stool?

  24. kim said,

    October 4, 2006 at 9:05 am

    Dr Aust – I’m well aware of the problems with intelligence tests – and indeed of the problems with the concept of intelligence. That is one reason in itself to be sceptical of fish oil trials – if you take a group of schoolchildren, give them a set of tests, and then give them a similar set six months later, then some will inevitably have improved and some won’t. Children’s mental abilities develop at different rates. Even if you have a control group, I’d have thought that it would be difficult to pinpoint any particular improvement as being down to fish oil.

    I suspect that proponents of IQ tests would claim that they are able to devise culturally-neutral IQ tests.

    Anyway, it was just a thought. It was provoked by seeing the Horizon progrmame a while back on Omega-3 in which a King’s College expert (possibly Tom Sanders) who had studied vegetarian families for years said he had not found any evidence that lack of Omega-3 had made vegetarians any less intelligent.

    Apologies for the long URL, but this story is also critical of the Durham “trial”:

    icwales.icnetwork.co.uk/0100news/health/tm_objectid=17699489&method=full&siteid=50082&headline=omega-3-exam-study–is-not-good-science–name_page.html

  25. MostlySunny said,

    October 4, 2006 at 9:23 am

    re: Dr Aust’s post at #15 – the daily mail article:

    “The company hopes the results of the project will then spark orders all over the country. ”

    and there’s the rub as they say…

  26. Mojo said,

    October 4, 2006 at 2:20 pm

    From Adam Kelliher’s letter: “It not is a clinical trial, just an initiative aimed at giving a simple nutritional input – omega-3 and omega-6 oils – to GCSE students in a region where children are underperfoming. ”

    Later on: “So the initiative is purely to see if supplementation may enhance academic performance. ”

    Riiight. Not a trial, then.

    And a lovely non-sequitur in the last paragraph: “Equazen has collaborated with Durham council in various projects in the past. I am constantly impressed with the way that a local authority in northern England is, on it’s own initiative, investigating the linkage between nutrition and classroom performance. This idea is now widely accepted, thanks to many others, including Jamie Oliver. There is, however, a lot of further work to be done. So I have no doubt that in coming years, giving omega-3 supplements to school children will be standard practice. “

  27. pv said,

    October 4, 2006 at 5:41 pm

    Is Mr Kelliher a consumer of his own product? If so he’s not a shining example of an intellectual olympian. He must have been incredibly dense before he started taking the pills.
    But notwithstanding the bad (lack of) science here, his whole modus operandi reeks of exploitation and marketing. The route to an adult’s bank account is through the children. It is a well established practise and in some circumstances is illegal; e.g. in the UK, advertising to children on tv. Obviously Mr Kelliher’s activity in this respect isn’t actually illegal, but that’s about all one can positively say. He is certainly exploiting the vulnerable and gullible. What is all that flannel about childen’s nutrition and Jamie Oliver? It would be nice to know what Mr Oliver thinks about it. I’d say the extent of Mr Kelliher’s interst in children’s nutrition is that the infinitely more honest Mr Oliver has unwittingly created a marketing opportunity to a pill peddlar.
    What no-one has yet said, though, is the actual relationship between the shysters of Equazen and the air heads at the Durham Education Authority. Who initiated it and why?

  28. Kimpatsu said,

    October 4, 2006 at 5:49 pm

    “I am constantly impressed with the way that a local authority in northern England is, on it’s own initiative, investigating the linkage between nutrition and classroom performance.”
    And what does “…on IT IS own initiative…” mean, anyway…?

  29. Dr Aust said,

    October 4, 2006 at 6:41 pm

    I’m sure it has been said before on here, but a read of the Equazen website is eye-opening (or should that be “eye-q-opening”?)

    One point is that the words “Durham trial” appear on the front page, although the link from there is bust. This may relate to the older study, and the word “initiative” is now their preferred description of the latest wheeze, but still.

    The irony of having the bit on the site someone mentioned before about “how to conduct a proper blinded placebo-controlled trial” is, well…. quite something.

    The site emphasises the sincerity etc of the Kellihers “We would only sell what we already give to our own kids” (and they do give it to them, see details on the site).

    It seems to me that they are themselves 100% convinced it works, and it is hard not to think this underpins Kelliher’s attitude, as expressed in the letter to the Guardian. Matt and Cathra can’t understand why Ben and the rest of us curmudgeons are objecting to this.

    Neither Kelliher is a scientist, incidentally. Both are ex-journalists.

    The most disingenuous bit of Kelliher’s letter to me is that bit about “If children taking part show better than expected results next summer, this may pave the way for a full clinical trial to find out exactly why”.

    If they really wanted to do a proper study, this would be it, here, now. I find it difficult to imagine them forking over another million quids worth free for a proper trial if they get loads of positive publicity out of the present “initiative”.

    Perhaps Matt Kelliher would like to write to the Guardian again and this time give a public PROMISE in writing to fund a full double-blind placebo-controlled trial on the same scale as the current exercise?

  30. profnick said,

    October 4, 2006 at 7:16 pm

    OK, twenty one posts since I drew your attention to the 2004/5 Durham trials and only one reference to the entry on the badscience Wiki which gives less info than my original link, (see comment number 8). Do you just want to bitch or is anyone going to make an intelligent critique of the available evidence, (I thought that’s what we were about?).

  31. profnick said,

    October 4, 2006 at 7:18 pm

    Sorry the smiley got in there somehow instead of “8″, but just in case here’s that link again: www.durhamtrial.org/

  32. doctormonkey said,

    October 4, 2006 at 8:59 pm

    “So the initiative is purely to see if supplementation may enhance academic performance. If children taking part show better than expected results next summer, this may pave the way for a full clinical trial to find out exactly why”

    - if this is NOT the definition of a trial, what is?

    (quoted from the letter starting this thread)

  33. sophie said,

    October 4, 2006 at 10:01 pm

    I don’t think that we need expect that there will necessarily be an improvement in student performance. This is not a cohort of passive participants: these “children” are 15/16 year-old dudes and dudettes with minds of their own. As a teacher in the comprehensive education system I will bet that while some students may be proudly taking their fish oil expecting a miracle, there will be others who are already working out ingenious ways to subvert the programme and yet others, who read Ben’s column, who are raising difficult questions. One wonders what poor people are having to check that the students are taking their tablets.

    As a side comment, it would be interesting to see the Guardian send a reporter up there to interview students and teachers and get their inside story.

  34. Dr Aust said,

    October 4, 2006 at 10:43 pm

    Posts 30/31

    Prof Nick

    Unfortunately to analyse the published studies PROPERLY case by case one would have to be expert in analysing human clinical trials on behavioural problems in kids (how kids selected, how assessed, how data analysed, etc). Even as a grizzled biomedical scientist I’m not expert enough for this, although some people reading this may be. So I have to fall back on the expert and systematic reviewers who write the reviews and meta-analyses in this area.

    For instance:

    Richardson AJ

    Int Rev Psychiatry. 2006 Apr;18(2):155-72
    .
    Department of Physiology, Human Anatomy and Genetics, University of Oxford, UK. alex.richardson@physiol.ox.ac.uk

    Omega-3 fatty acids are dietary essentials, and are critical to brain development and function. Increasing evidence suggests that a relative lack of omega-3 may contribute to many psychiatric and neurodevelopmental disorders. This review focuses on the possible role of omega-3 in attention-deficit/hyperactivity disorder (ADHD) and related childhood developmental disorders, evaluating the existing evidence from both research and clinical perspectives. Theory and experimental evidence support a role for omega-3 in ADHD, dyslexia, developmental coordination disorder (DCD) and autism. Results from controlled treatment trials are mixed, but the few studies in this area have involved different populations and treatment formulations. Dietary supplementation with fish oils (providing EPA and DHA) appears to alleviate ADHD-related symptoms in at least some children, and one study of DCD children also found benefits for academic achievement. Larger trials are now needed to confirm these findings, and to establish the specificity and durability of any treatment effects as well as optimal formulations and dosages. Omega-3 is not supported by current evidence as a primary treatment for ADHD or related conditions, but further research in this area is clearly warranted. Given their relative safety and general health benefits, omega-3 fatty acids offer a promising complementary approach to standard treatments

    …plus others.

    Coming from someone with a research interest in FA supplements and their effecst on the brain, this is pretty cautious stuff. Note the sentence “Omega-3 is not supported by current evidence as a primary treatment for ADHD or related conditions”

    As I read the summaries of this and other reviews, the verdict is:

    “For specific DEFICITS like ADHD: some promising, though not startling, evidence for benefit, but trials too small or ill-designed to be confident – more bigger ones needed”

    “For normal children, little or no evidence at all, so no argument for giving it to loads of them” (this is what the Food Standards Authority seems to have said).

    Equazen can hardly not be aware of these verdicts, and similar ones which no doubt come from their own paid consultant experts.

    So the obvious thing for them to do doing would be to run:

    “Larger trials… to confirm these findings, and to establish the specificity and durability of any treatment effects as well as optimal formulations and dosages.”

    This is what they are spinning (or allow the media to spin) that they are doing in Durham.

    In fact they are not doing anything of the kind, as Matt Kelliher has now admitted.

    So I think we are justified in terming it a media operation, which will not get anyone any nearer to knowing whether the supplements have any effect, but will probably help Equazen sell the stuff.

    As Alex Richardson says at the end “further research is warranted”. But this isn’t research – it’s a PR stunt.

  35. Evidence-biased said,

    October 5, 2006 at 12:49 am

    Many thanks to Dr Aust for picking up on Profnick’s plea in #30-31, and for recapping so very neatly what this seems to be all about.

    As he points out, there’s just not enough evidence to go on yet, unless you look at the bigger picture (which I’ve tried to do in most of my reviews over the years… )

    But if anyone wants a copy of my 2006 review as cited in #34 and can’t get it directly from the journal, please could I ask that you request this via the website at www.fabresearch.org rather than using my University email address? The widespread availability of the latter means that it’s usually overloaded not just with spam (I thought you didn’t display email addresses on this site, Ben?) but with seemingly endless enquiries about the latest ‘Durham trials…’ and/or desperate parents wanting to know: ‘Will supplements help my child…?’
    It all gets a bit tiring after a while…

    Profnick – I’d also been hoping that someone else might answer your question #8. This issue did come up at least obliquely in earlier threads, but FYI, one of the several trials alluded to on durhamtrials.org certainly has been published – see www.fabresearch.org/view_item.aspx?item_id=805
    Sorry I can’t help you on the others, but they had nothing to do with me.

  36. pv said,

    October 5, 2006 at 10:36 am

    Profnick, Durham LEA themselves hype the scarce evidence for Omega-3 and Omega-6 oil on their page devoted to fatty acids: www.durhamtrial.org/fatty%20acids%20main.htm and elswhere in their site.
    They also consistently write about trials and studies, so the recent denial of Mr Kelliher that the current Durham LEA “initiative” is anything but a “trial” is all the more interesting. And Mr Kelliher is a businessman, not a scientist, with his main focus on profit and marketing. Given the lack of evidence to support the claims made by Durham LEA and Mr Kelliher’s oily business it is fair and appropriate to look at and comment on the other aspects of the affair. Marketing and publicity, competence, real motives (as opposed to public statements for the benefit of the press), who stands to gain most, who initiated the relationship and why, and so on, are all relevant. They are all areas the press should be exploring rather than lauding pseudoscience and dodgy business practices.
    As for the Durham LEA themselves, their testimonials (aka anecdotes) page www.durhamtrial.org/primary%20testimonials.htm is an example straight out of the CAM marketing manual, and one needs to ask who exactly is it aimed at. It’s difficult not to conclude that pages such as this have been constructed and written by peole whose expertise is marketing (fish oil marketing?).

  37. profnick said,

    October 5, 2006 at 12:04 pm

    Posts 34-36
    Thanks

  38. Delster said,

    October 5, 2006 at 3:09 pm

    Profnick,

    i took a quick look at the front page of that link… bit busy here to go through the trials themselves but i like this paragraph from the front page.

    “With current research revealing that fatty acid deficiencies may be a factor connecting these learning difficulties, it was possible that for some pupils an improved diet would lead to improvements elsewhere: however overturning the high-carbohydrate heavily- processed diets that children typically consume was going to be a momentous task.”

    So we have learning difficulties as the target group and the next bit is pure Jamie Oliver.

    Also they are going to review the results of this non trial trial on the basis of “expected results”. Who set’s the expectations?

    So they will be looking at the spread of grades in examinations… which if i remember new’s articles correctly are trending upwards all the time (exams getting easier?)

    Are they going to compare this result spread with other schools in the same area who are not participating?

    Also the degree of hype around this trial will affect the students who are part of it. They have also been told (no doubt) by the respectable men in white coats that this pill will help them concentrate and retain info. The very act of this may induce the desired results.

    The bottom line is that without proper scientific methods being applied this “trial” is actually a “farce” who’s sole measurable result will be to establish the amount of free media time and column inches they gain from it.

    But it cost’s them money to donate the product i hear you cry…. true it does, but let’s face it, the “street value” of this product is much greater than the cost to the company of manufacture and delivering it to the schools.

    So for the 1 million £ worth of product they are donating i would be surprised to see more than £100,000 of costs. How many column inches and prime time minutes would that buy them compared to what they are getting from the hype!

    Or am i just being cynical again?

  39. ceec said,

    October 5, 2006 at 3:14 pm

    Not just any old not-a-trial marketing ploy, but one which is using children and children’s wellbeing as its prop. So far we have:

    - No evidence of ethics committee approval so far (I wrote to Durham Council to ask. Got a reply but not one which addressed my questions, which included “what ethics committee approved this initiative”). I’m guessing this was not ever sent for ethics approval. Presumably if it had been turned down they wouldn’t have gone ahead but I can’t imagine any ethics committee allowing it to go ahead. I hear that you don’t HAVE to have approval for nutritional supplements experiments, but it’s obvious that a trial on children should be checked over, regardless of the letter of the law.

    - No possibility of the “trial”/”initiative” actually showing anything useful.

    Never mind though eh? Get the kids to swallow untested pills of uncertain effect and watch the money rolling in.

  40. Aisha said,

    October 5, 2006 at 8:57 pm

    Maybe I’m stupid, but why not just give the kids better food? Maybe, oh, I dunno, something like … fish?

  41. Ben Goldacre said,

    October 6, 2006 at 12:27 am

    my feelings precisely. as far as i am concerned, the pills are just a useful research tool, because you can’t be blinded to whether you’re eating a fish or not, but once their placebo controlled work has been done, you’re not going to say “eat space pills everyone” you’re going to get everyone eating fish. why eat a pill and miss out on all the other goodness?

  42. imagineyoung said,

    October 6, 2006 at 4:51 am

    Quote from a kid on the Durham testimonial site:

    ‘Now I am not so interested in the TV. I just like reading books. The best place in all the world is the library. I absolutely love it.’

    By including this quote they are suggesting that fish oil changes kids’ tastes like this. This goes far beyond any claims yet made.

    And they are giving these brain-changers out to thousands of kids in an uncontrolled study – sorry, initiative.

    What fun.

  43. profnick said,

    October 6, 2006 at 5:35 pm

    OK, I’ll give it one more go. Ben, (and others), some placebo controlled trials have been done and according to post 35 at least one has been published. Dr Aust makes a brave attempt in post 34 but the rest just seem to repeat the same data-free criticisms. I’m happy to believe it’s all a load of old bollocks but when we constantly call for research to be published, and here we have at least one, why doesn’t anyone make an informed critique of it; not related reports, not proposed studies, but the actual completed and reported trial?

  44. Dr Aust said,

    October 6, 2006 at 6:47 pm

    It’s “degress of convinced-ness”, Prof Nick.

    I suspect if you asked Alex Richardson, aka Evidence-biased, how convinced she is about the findings in her published trial AND WHAT THEY IMPLY, it would depend what you asked and how.

    I would assume she is convinced that the findings – fish oil supplements help certain problems in kids with developmental coordination disorder – are real, within statistical caveats described in the paper, and with some reservations about possible confounding effects (also mentioned).

    But as for the wider implications, how about this for a guess :

    “Are you convinced enough to say we should now run a bigger multi-centre DBPC trial of kids w different kinds of developmental difficulties to nail down if the supplements help?”

    (and by implication with a view to using the supplements more widely IF THEY ARE SHOWN TO WORK) NB DBPC =Double-blind placebo-controlled

    Ans I guess YES (from her published writings – there is some positive trial evidence for ADHD and dyslexia)

    “Are you convinced enough to say we should view it as a done deal and give the supplement to any kid with developmental problems?”

    Ans I am pretty sure NO

    “Are you convinced enough to say we should now run some proper trials on kids who don’t have identifiable developmental problems?”

    Ans I guess YES

    “Are you convinced enough to say we should view it as a done deal for it helping ALL kids and give it to the lot of them?” (What Durham are actually going to do)

    NO NO NO – because a study on the 5-8% of kids with specific identifiable developmental problems does not really tell you what you would expect in normal children – hence the need for a properly constituted study, not a PR stunt.

    Sorry, this is really just re-phrasing what I wrote above, and apologies to AR for taking her name in vain.

    The point is about what precisely the trials do, and don’t show. They say nothing about normal kids, and SHOW nothing about (e.g.) “slighly slower readers” (not tested) – although you might want to go on and study the latter group.

  45. Jeremy Zeid said,

    October 7, 2006 at 2:25 am

    I am highly sceptical of the vast majority of “conditions” and “Syndromes” that have sprung up over the last few years, ADD, ADHD, BBLB (Badly Behaved Little Bastard). Worryingly the number of camp followers eager for a piece of the pie are multiplying like a bad rash. Of course no-one considers the bloody obvious, such as the kids are bored out of their brains by the appalling National Curriculum and the stifling and cloying “Health and Safety” culture that, if it could get away with it, find a “team of scientists” and bribe them with a nice grant, to endorse a new “link” or scare, would have children wearing helmets in case they fall off the toilet and rubber gloves when using loo paper.

    Stir in the “paedo-hysteria” and no-one will let the wheezing, pasty, allergic, obese little muffins more than a foot from their front doors without a CRB checked adult. So they sit at home watching the box and playing “safe” games or in an “organized” event. No freedom, no risk, no adventure, everywhere an adult “just in case”, that is the REAL child abuse.

    And meanwhile when they get away from us for a few minutes, they go over the top in what they do. Drigs, sovenys, fags, booze, graffiti, train surfing… sex, anything that give some excitement. And meanwhile the official kiddie-fiddlers, the “responsible CRB checked Pc adults” keep nausing it all up.

    So carry on with the Omega-3, the Folic Acid, MMR, “Healthy bloody jamie bleeding Oliver Eating”, Lots of water, no salt, no crisps, no fizz, no chocolate and worst of all no Macdonalds. Loads of energy free salads, fruit and other sundry “healthy” by energy and nutrition free food, it will make no difference, because once our backs are turned, kids will stick two fingers up at the well-meaning kiddie-mind-f++kers and do exactly what they want.

    The State will throw their hands up in horror and propose a new “initiative” or “crackdown”, The Archbishop of canterbury will blame cartoon network instead of his boring the arses off of his congregations and the whole merrygoround will continue as adults, terrified of doing anything without “guidance” sign up to the whole ghastly agenda. Who’d be a child in 2006????

  46. Jeremy Zeid said,

    October 7, 2006 at 2:28 am

    Whoops, i missed something… While we bleat on about the dangers of drugs we then turn perfectly normal, or would be if allowed, children into state sponsored junkies by bending their brains with amphetamine derivatives such as Ritalin.

    Well, “we have to keep them calm and make them compliant”……… Yeah, ready for fingerprinting at school, ready for their national ID cattle tag. Well programmed duped ‘droids ready to serve the State and it’s intrusive database.

  47. Jeremy Zeid said,

    October 7, 2006 at 2:30 am

    The only “trial” that I advocate is of all of those “officials” and worthies who impose compulsory mass medication on innocents who have no say in the matter, with their parents made to feel guilty or even threatened with “social services” for resistance.

  48. Ben Goldacre said,

    October 7, 2006 at 2:39 am

    profnick: “OK, I’ll give it one more go. Ben, (and others), some placebo controlled trials have been done and according to post 35 at least one has been published. Dr Aust makes a brave attempt in post 34 but the rest just seem to repeat the same data-free criticisms. I’m happy to believe it’s all a load of old bollocks but when we constantly call for research to be published, and here we have at least one, why doesn’t anyone make an informed critique of it; not related reports, not proposed studies, but the actual completed and reported trial?”

    what completed and reported trial? on that site there is a whole bunch of mostly rubbish, and then a few bits taken from the published oxford-durham study. I’ve summarised this paper elsewhere at least twice:

    “Richardson, A.J. and Montgomery, P., The Oxford-Durham study: a randomized, controlled trial of dietary supplementation with fatty acids in children with developmental coordination disorder. Pediatrics, 2005. 115(5): p. 1360-6.

    “Kids with Developmental Coordination Disorder, no significant differences between placebo and fish oil groups for motor skills, but improvements for the fish oil group in reading and spelling (P= 0.04 and <0.01) and CTRS-L global scale (P<0.05) and some subscale improvements (P<0.05) for the fish oil group. 117 subjects, 6% dropped out.”

    this was performed by two researchers from oxford university, but with some research assistance from durham council as the study was done on durham children (although if you read it eg portwoods name is nowhere on the paper): however ownership of this paper seems to have been rather grandly adopted by the Durham fish oil posse, in ways that create rather more confusion. for example, there is no citation to the published paper, so no way of knowing what is published, where, by who, etc. so i can absolutely understand why you might find it a bit confusing, i think that anyone going there trying to make sense of it would be as rightly confused as you were. i would say this confusing lack of clarity is the dominant theme in the presentation by durham of their research.

    what about the rest of the “studies” on the site, with all the graphs? well, durham also claim to have many other randomised controlled trials, as we know, none of which are published, or even available to read in any public form that i can see, and this weeks column describes the bizarre difficulties i had in getting the most basic info out of durham.

    so, the other two studies on that durhamtrial.org site are frankly a bit of a joke. neither have placebo controls (that’s becoming a bit of a standard Durham research strategy by the looks of things) and they are reported so badly that for eg the secondary school study there are no stats, and they don’t even tell you how many children were in it!

    there’s not a lot you can do with that kind of “science”. it’s cargo cult stuff: looks like science on the outside, all thos nice graphs, but on closer inspection…. i mean, dude, it doesn’t even tell you how many kids were in the study! how much further do you go with a site like that in trying to find useful data?

  49. Jeremy Zeid said,

    October 7, 2006 at 10:13 am

    But if its “For the Children Who are our Future (FTCWAOF)” it MUST be true….. How can you be so heartless than to doubt anything that is pouted in the name of TCWAOF.

  50. profnick said,

    October 7, 2006 at 2:13 pm

    Ben & Dr Aust,
    Thanks for that guys. Also I now see that Ben was keeping his powder dry for this week’s column. I have to say that I was confused by the intertwining claims of the Durham group and the subject of the Oxford paper. I did say in my original post that the web-published Durham stuff was somewhat inpenetrable.

  51. Ben Goldacre said,

    October 7, 2006 at 5:00 pm

    it is very easy to be confused and misled by that site. i think the problem is that it’s driven more by ego than by a desire to present the facts plainly and clearly.

  52. inicholson said,

    October 17, 2006 at 9:52 pm

    Equazen are now referring to “The Durham Trial” in their own advertising (there’s a poster in a health food shop near me) and on their website ( www.equazen.com/default.aspx?pid=23 ).
    Surely they’re in contravention of advertsing rules if their own chief executive says it is “not a clinical trial”.

    I’ll try sending the link to the ASA and see what they say.

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