The Trial That Ate Itself

September 9th, 2006 by Ben Goldacre in adverts, bad science, channel 4, equazen, fish oil, ITV, mail, nutritionists, references, statistics | 121 Comments »

Ben Goldacre
Saturday September 9, 2006
The Guardian

Fish oil is clearly a matter of huge national importance. Channel 4 and ITV (and the Daily Mail, and the BBC) all report on a plan by education officials in County Durham to give £1 million worth of omega-3 fish oils, to 5,000 children as they approach their GCSE’s, and see how it improves performance.

http://www.lems.brown.edu/vision/people/leymarie/Images/Paintings/Magritte_pipe.jpg

Contrary to what the pill-peddlers would tell you, the evidence for omega 3 pills being beneficial in children is really rather thin: only a handful of small trials have been published in proper journals, and at last count 3 were positive, 2 were negative, and none were in mainstream children. All these “studies” you keep hearing about in the media are little more than cheap promos for the pill pushers, with no control group, and crippled by inadequate research methods. So bravo for Durham.

Oh hang on. The Eye-Q study is a cheap promo for Equazen’s Eye-Q range: there is no placebo, in fact there is no control group whatsoever. They’re going to the trouble of giving 5,000 children the tablets, 6 a day, under the watchful eye of the nation, hyping the study, with all their hopes pinned on success, and then they’re going to measure their performance against what the council predicts it should have been without the tablets. This is – let me be quite clear – a rubbish study, which has been specifically designed in such a way that it cannot provide useful results: it is therefore a waste of time, resources, money, children, and parents goodwill.

In the name of fairness, I decide to put this modest proposal to Dave Ford, Chief Schools Inspector for Durham, the mastermind behind the project. Then it all gets a bit weird. “We’ve been quite clear,” he says: “this is not a trial.”

Well hang on. I call up to tell you it’s a bad trial, and suddenly that’s okay because it’s not actually a trial? The Press Association called it a trial. The Daily Mail called it a trial. Channel 4 and ITV and everyone covering it all present it, very clearly, as research (damning quotes and clips at badscience.net). In four solid years of moron baiting, this is definitely the most surrealist defense I’ve come across. I check Durham Council’s own press release for it. They call it a “trial” twice, and a “study” once. You are giving something and measuring the result. Your own descriptive term for this activity is “trial”. How is this not a trial? To excuse you out of a hole?

Exasperated, I move on to Equazen. Their Eye-Q tablets cost £7.99 for a ten day supply, and they have given £1 million worth to Durham (street value, as the drug squad say). This has bought them flattering news items on peak time terrestrial television, and large colour photos of their products on prominent news pages.

Adam Kelliher, Director of Equazen, clarifies further: this is not a “trial”, so I cannot critique it as such. Nor is it a “study”. It’s an “initiative”. By now I’m losing the will to live. Dr Madeleine Portwood, the senior educational psychologist running the study, calls it a “trial” (twice in the Daily Mail). You are giving X and measuring change Y. Every write-up describes it as research. The Equazen press release, for God’s sake, calls it a “trial”. This is a trial, a stupid trial, and simply saying “ah but this is not a trial” is not an adequate – nor indeed a particularly adult – defense.

We do not have good evidence that omega-3 will improve normal childrens’ behaviour and intellect. We need proper research. It is clearly of burning interest to the nation. You could take this rubbish Eye-Q “trial” (yes: “trial”) and give half the kids placebo, and you’d have a perfectly serviceable bit of research, giving useful data. Add in a couple of baseline and endpoint tests, maybe shave off some of these thousands of children, and it would cost no more than this foolish promotional sham. You’d be sitting on a huge definitive study. The very thing that is needed. The very thing that mainstream academics are struggling to get funding for. It might well be positive. But what if the result is negative? Scary huh, Equazen?

So I asked the Director: would you give a million pounds worth of free supplements (and dummy pills without the active ingredient) to a research team who were doing a methodologically meticulous randomised double blind placebo controlled trial of omega-3 fatty acids in mainstream children? And he said: “Yes”. Let me know if they tell you “no”, at the usual email address.

Academic References

Voigt, R.G. et al., A randomized, double-blind, placebo-controlled trial of docosahexaenoic acid supplementation in children with attention- deficit/hyperactivity disorder. Journal of Pediatrics, 2001. 139(2): p. 189-96.

Richardson, A.J. et al., A randomized double-blind, placebo-controlled study of the effects of supplementation with highly unsaturated fatty acids on ADHD- related symptoms in children with specific learning disabilities. Progress in Neuro-Psychopharmacology & Biological Psychiatry, 2002. 26(2): p. 233-239.

Stevens, L.Z. et al. EFA supplementation in children with inattention, hyperactivity, and other disruptive behaviors. Lipids, 2003. 38(10): p. 1007-21.

Hirayama, S. et al., Effect of docosahexaenoic acid-containing food administration on symptoms of attention-deficit/hyperactivity disorder – a placebo-controlled double-blind study. European Journal of Clinical Nutrition, 2004. 58(3): p. 467-73.

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.

The Press Association call it a trial:

“The countywide trial at 36 schools will continue until the pupils finish their exams next summer. The first test of the supplement’s effectiveness will be when they sit their mock GCSEs in December.”

The Daily Mail call it a trial and talk about the results (next to a nice big glossy colour photograph of a box of Eye-Q brand omega-3 supplements, page 4 6/9/06).

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

“The trial will continue until their GCSE examinations next June – which will need £1 million worth of supplements supplied free. The company hopes the results of the project will then spark orders all over the country.” Quotes Ford talking about measuring the results, and Portwood calling it a trial too:

Mr Ford added: “We will be able to track pupil’s progress and measure whether their attainments are better than their predicted scores.” Dr Madeleine Portwood, senior educational psychologist at Durham county council, who has led much of the previous research into fish oils added: “The scale of this new trial is extraordinary. “Previous trials have shown remarkable results and I am confident that we will see marked benefits in this one as well.”

ITV call it research

www.itv.com/news/britain_30bc75bd5832b700ba24dc70f06a7994.html

Fish oil supplements have been heralded as the cure-all for everything from arthritis to heart disease and now research will see if they really do boost IQ.

Channel 4 news present it very clearly as a research project.

www.channel4.com/news/special-reports/special-reports-storypage.jsp?id=3191

They also feature Portwood spouting: “and if we can improve the connections in the cortex then the limbic system is dampened down so the children are less excitable.” “It sounds complicated…” says the narrator.

Dr Madeleine Portwood calls it a trial:

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

Dr Madeleine Portwood, senior educational psychologist at Durham county council, who has led much of the previous research into fish oils added: “The scale of this new trial is extraordinary.

“Previous trials have shown remarkable results and I am confident that we will see marked benefits in this one as well.” (my italics). I’m not surprised, love.

Durham county’s own press release calls it a trial. twice! and a study once.

www.durham.gov.uk/durhamcc%5Cpressrel.nsf/Web+Releases/6BA0B5675DBD5671802571E20033B592?OpenDocument

“The County-wide trial will continue until the pupils complete their GCSE examinations next June, and the first test of the supplement’s effectiveness will be when they sit their mock exams this December.”

“The trial has won the backing of Durham County Councillors, who are committed to making a difference to children’s outcomes and improving their life chances.”

“All Year 11 pupils at Durham County Council’s 36 comprehensive schools are to be offered omega-3 fish oil supplements to see whether the proven benefits it has already brought children and young people in earlier trials can boost exam performances too.”

Fish Oil Initiative Could Boost Gcse Pass Rate

County recruits 5,000 Year 11 pupils for unique study

Education chiefs in County Durham are to mount a unique back-to-school initiative today which they believe could result in record GCSE pass levels next summer.

All Year 11 pupils at Durham County Council’s 36 comprehensive schools are to be offered omega-3 fish oil supplements to see whether the proven benefits it has already brought children and young people in earlier trials can boost exam performances too.

“We are able to track pupils’ progress and we can measure whether their attainments are better than their predicted scores,” said Mr Ford.

oh and at the bottom it says “eye q is commercially available through retailers such as Boots and Superdrug. For more information 0870 241 5621 or go to www.equazen.com

And Equazen’s press release describes measuring the results, and calls it a trial

“The County-wide strategy will continue until the pupils complete their GCSE examinations next June, and the first test of the supplement’s effectiveness will be when they sit their mock exams this December. We are able to track pupils’ progress and we can measure whether their attainments are better than their predicted scores,” said Mr Ford.

“You will be invited to send a reporter and/or photographer to a media launch of the trial at a County Durham school on the morning of September 6 where key players in the initiative, including pupils, will be available for interview.”

In Conclusion

I win.


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121 Responses



  1. jackpt said,

    September 9, 2006 at 4:22 am

    I wonder how much benefit £1,000,000 spent elsewhere could bring. Although it’s not actually £1,000,000 because £1,000,000 is the street value. They should have street value in brackets every time they quote that figure.

  2. ACH said,

    September 9, 2006 at 7:25 am

    And not only are they calling it a trial, they are already talking about what the results will show. Duh – shouldn’t they wait until afterwards? I wonder who’s doing the predicting of what the kids will get? I guess it would be a wee bit cynical to suggest that there might be a bit of downgrading going on.

  3. crichmond said,

    September 9, 2006 at 8:01 am

    Adam Kelliher, who owns Equazen, is married to the daughter of David Horrobin, the controvesial promoter of evening primrose oil.
    In 2003, when Horrobin died (having made £8.3bn from the NHS for his worthless remedy from the NHS, on the strength of clinical trials that few coudlsreplicate) I wrote his obituary for the British Medica Journal. I seem to recall writing that evenign promrose oil was the remedy for which there is no disease, and that Horrobin will go down in history as the greatest snake oil salesman of his age.
    Now Keiilher posted

  4. crichmond said,

    September 9, 2006 at 8:11 am

    Now, and this was the bit I was coming to before I accidentally hit the ‘submit’ button, Keiilher posted lots of hostile rapid responses on the BMJ web site, and got his friends to do likewise. These friends included the novelist Sebastian Faouls, and a journalist called Victoria Macdonald. Macdonald mentioned that Horrobin was helpful when she interviewed him on television (well, he would be, woudln’t he) and that a fiend of hers married Horrobin’s daughter.
    She forgot to metnion that the lucky son-in-law was called Adam Kelliher.
    And Keiiher, when he posted his rpaid responses to my obituary, ticked the box that said he had no competing interests. Had he forgotten that he was founde rna ddirector of Equazen?

  5. faddy06 said,

    September 9, 2006 at 12:13 pm

    More at * cough * www.durhamtrial.org

  6. keyrawn said,

    September 9, 2006 at 12:13 pm

    Fish oils are not the only oils with high omeg-3 content. The less expensive linseed oil also has a high omega-3 content and does not involve perilous sea journeys. Due to its association with paint as a drying oil ( a property due to its unsaturated nature) many retailers prefer to call it “flax oil” refering to another product from the plant. The cost of feeding children linseed oil would be less than using fish oils.

  7. doctormonkey said,

    September 9, 2006 at 12:47 pm

    It seems a shame, a waste of a potential trial and of course, is any one looking into the SAFETY of fish oils (heavy metals?) in teenage girls – how many will get pregnant? how many babies could get heavy metal poisoning?

    But I am more disappointed by the loss of a potential placebo controlled double blind randomised trial, as I so often am in general with medicine – we need to move to a position more like cancer therapy where EVERYTHING is part of a trial because there are always more options – in this case like the linseed oil – good for brains and cricket bats!

  8. Pedantica said,

    September 9, 2006 at 12:54 pm

    I have invented a new sandwich that I call “The Pedantiwich” and I am offering for sale at £1,000,001 per ‘wich’. Really it’s that good.

    I’m happy to donate one to a local school to trump Equazen’s ‘donation’.

  9. Mojo said,

    September 9, 2006 at 4:00 pm

    If it isn’t a trial, and isn’t attempting to find out whether the snake, sorry, fish oil actually works, then what exactly is Mr. Ford expecting the “initiative” will achieve?

  10. Bob O'H said,

    September 9, 2006 at 4:52 pm

    An amusing thought struck me a few minutes ago whilst I was moving some boxes around.

    The council is going to predict the students’ performances, and compare those to the actual performances. Now, this can obviously be rigged, but the statistical methods for making such comparisons are reasonably well developed (hierarchical models etc.). So, if someone can get hold of the right data, it should be possible to put it through an analysis and estimate the effect of the fishy oils.

    And here’s the punchline: because there is no control group, the estimated effect will be harder to determine, so it will have a larger standard error. IOW, you’re less likely to conclude that there’s a positive effect than if you did the “trial” properly.

    Anyone know where we could get the data?

    Bob

  11. Tony Hatfield said,

    September 9, 2006 at 5:44 pm

    there’s another trial carried out by durham council. this fatty acid one uses all the scientific vocab, but it doesn’t seem to be reported elsewhere-a nutritional journal- where it can be reviewed.t

  12. cath having fun said,

    September 9, 2006 at 5:59 pm

    Dunno, Bob, but we could have some more fun with that the other psychologist (who-thinks-he’s-a-nutritionist-because-he-has-his-own-qualification-from-his-own-institute-unrecognised-by-UK-nutrition-bodies- HPC-or-Nutrition-Society) Mr Patrick Holford.
    awaiting with interest his ‘research’ outcomes on 11 autistic/ autistic spectrum kids given nutritionally compromised diets to fit in with dodgy blood tests used to ‘diagnose’ intolerance (not allergy, mind). Remember – you’ll see it on GMTV first! and likely to be within the next 2 weeks!

    incidentally, just what is is about psychologists in general that give them the impression they make good nutritionists/ dietitians, rather than enthusiastic amateurs dabbling in a field they find hard to comprehend? It’s unbelievable just how many psychologists and psychiatrists glibly recommend fish oil to patients (but usually at a homeopathic dose). Funny that they choose nutrition as their area to expand into, rather than brain surgery, for example. But perhaps they use the old adage ‘everyone eats, so everyone knows about nutrition’ when they trot out their simplistic interpretations of hard nutritional science. Who knows just how a psychologists brain is programmed to think about nutrition, or DHA in particular?

  13. stanleyd said,

    September 9, 2006 at 9:00 pm

    When attempting to predict the performance of pupils at GCSE one needs take account of a range of factors that impact on an individual’s chances such as social deprivation , sex , ethnicity etc. as well as their previous performance at KS2 and KS3.
    Relative success or failure is always a tricky thing for a school or a local authority to explain and only the very foolish would feel comfortable attributing success to a single factor such as blanket bombing the pupils with fish oil!
    With government pressure to meet local and national targets some educationalists are all too easily sucked in by the snake oil (or should that be fish oil) sales persons.
    In education as in most other fields the golden bullets are few and far between.

  14. stanleyd said,

    September 9, 2006 at 9:09 pm

    Oh … for Bob… the data required is collected from schools by local authorities and a a bunch of extremely dedicated and hard working statisticians at the Fischer Family Trust produce lots of useful analysis that schools use to develop their curricula and support their pupils.

  15. pv said,

    September 9, 2006 at 11:59 pm

    “If it isn’t a trial, and isn’t attempting to find out whether the snake, sorry, fish oil actually works, then what exactly is Mr. Ford expecting the “initiative” will achieve?”

    A kickback? Aka expenses?

  16. ashley said,

    September 10, 2006 at 7:10 am

    Isn’t this being a bit insensitive. These are just children taking GCSEs, not volunteering to be test subjects. Assuming there’s even a possibility that this quackology turns out to be true, is it not rather unethical to give half the children a possible advantage over the others? Yes it’s a shameless publicity stunt by a bunch of pseudoscientisfic conmen, but if you want a real trial, do it while they’re still doing their mocks instead of talking about them as if they were lab rats. Shame on you!

  17. Alfster said,

    September 10, 2006 at 11:40 am

    With the year-on-year increase in the pass-rates for GCSE’s the sellers of the pills are on to a winner whether they do actually work or not.

    No doubt they have already written their press release to trumpet the success of the trial next August.

    You can guarantee that when it is ‘shown’ to be successful it will become ‘a trial’

  18. evidencebiasedman said,

    September 10, 2006 at 11:58 am

    As a researcher in this field I am really pleased that you have drawn attention to the need for proper work trials in normal children…………..I hope Adam Kelliher will get his wallet out. Thanks.

  19. TimD said,

    September 10, 2006 at 12:13 pm

    Hi, I’ve been coming to the site for a while and love it (of course!), but not actually posted anything before. But I thought I’d point out a couple of things: first, as Ben points out in his article, there’s equivocal evidence as to the efficacy of omega-3 oils: it’s entirely *not* been shown to have no effect, as seems to be thought by some posters here: 3 trials finding evidence *for* and two against. I’m entirely not saying it should be believed that the stuff does work, just that there really is the need for a properly carried out trial.

    Secondly, it’s surprising the lack of understanding there is here regarding the work of academic psychologists at decent universities. In response to (12), I’m finishing my PhD in Experimental Psychology at the University of Bristol, and would therefore class myself as ‘a psychologist in general’. I do not have any belief that I’m a nutritionist…as I study applied visual perception…

    However, our former head of department, Prof Peter Rogers, feels he has the right to do so, as he has a first degree in biology, a masters in experimental psychology, a PhD in psychobiology, and has been the Head of Psychobiology in the Consumer Sciences Department, Institute of Food Research (psychology.psy.bris.ac.uk/people/peterrogers.htm). If you want to pull him up on his credentials then feel free, but he certainly knows a lot more about nutrition than a lot of ‘trained nutritionists’. And yes, he runs highly controlled, double blind trials using doses higher than homeopathic levels.

  20. stever said,

    September 10, 2006 at 12:17 pm

    ashley – assuming your not joking – theres nothing unethical about it, infact a proper trial would be prevent large scale unethical marketing. And emotive terms like lab rats arent useful, and wcould equally be applied to every subject of every human controlled trial ever done.

  21. pv said,

    September 10, 2006 at 2:46 pm

    It’s obviously the case that publicly funded schools have become a soft target for snake oil marketing executives to exploit. For example Brain Gym. Where else are they going to find such a huge impressionable audience. And even if the exercise, in this case, isn’t to be funded out of tax payers’ money it’s still a way of exploiting children to get at the funds of the parents which makes it pretty despicable.
    Surely, above all, stunts like this and the Brain Gym fiasco highlight a lack of appropriate competence and knowledge among the senior individuals responsible for making the decisions. Some education administrators are clearly susceptible to being taken in – I guess partly through a lack of understanding of how the worst marketing people think.

  22. Littleshim said,

    September 10, 2006 at 6:36 pm

    On a simpler level…
    What proportion of these kids will actually take the stuff? In my school days, they’d have been chucked around the class, used for impromptu experiments in chemistry, force-fed to smaller boys, or sold to the gullible as some more illegal kind of drug. The fact that some “official” bods were telling us to take pills to get better grades would just be an incentive not to. How exactly do they plan to make the kids take them, and monitor that?

    Let alone the likelihood of angry parents refusing to allow their Nigel to eat weird pills, and of course, the potential for some of the ‘placebo’ subjects to be taking omega-3 oils outside of the scheme.

  23. Mojo said,

    September 10, 2006 at 8:20 pm

    “…and of course, the potential for some of the ‘placebo’ subjects to be taking omega-3 oils outside of the scheme.”

    There aren’t any ‘placebo’ subjects.

  24. Nurn said,

    September 10, 2006 at 9:47 pm

    Isn’t linseed oil also used in oil painting? Let’s push linseed oil, just for the hell of it! We don’t need any “trials”, either, because it’s from nature, so it’s obviously good for you!

  25. doctormonkey said,

    September 10, 2006 at 10:47 pm

    Yay – go linseed oil! or did you not mean in a cheer-leader style?

  26. cath having fun said,

    September 10, 2006 at 11:58 pm

    well, TimD @ #19. working with nutrition does not necessarily a nutritionist make. I trust the knowledge and opinions of my dentist and my gynaecologist entirely – but my opinion would change if they wanted to swap ends….

  27. roobish said,

    September 11, 2006 at 12:16 am

    If fish oil is so flippin’ good for the brain… why aren’t fish smarter? Eh?

    It’s all tosh. QED.

  28. Mojo said,

    September 11, 2006 at 5:47 am

    “If fish oil is so flippin’ good for the brain… why aren’t fish smarter?”

    Maybe they are. We have no idea how smart they’d be without it.

  29. Gleamhound said,

    September 11, 2006 at 8:43 am

    Ashley:
    the key concept here is CLINICAL EQUIPOISE. That is, a situation where one genuinely does not know whether one treatment is better than another. If there is clear knowledge that there is an advantage (ie penicillin v. water for menigococcal meningitis) then there is no equipoise, and a trial would not fly past the ethical comittee. On the other hand, if there are two valid treatments where there is no established advantage of one over another (ie North American v. European chemotherapy for breast cancer) then a trial might be ethical and justified.

    There may be separate ehtical issues when comparing two substances where there is no known benefit of either.

    Questions to put to the Durham education authority:

    Has this “trial” been passed by any legitimate Research Ethics panel? (experiments on children and all that.)
    Are the “trial” subjects signing an informed consent consent form ?(assuming they are of the age of consent.)

    It is difficult and laborious enough to get ethical approval for an observational study on consenting adults in the setting of a university hospital. Trials with children are understandably a lot more difficult.

  30. Coobeastie said,

    September 11, 2006 at 9:17 am

    The reason fish oil is pushed over Linseed is that it has higher levels of EPA and DHA, which are apparently the ‘magic’ bits of the omega-3s. Again, no idea if this has actually been tested.

    Has anyone thought about obesity/weight gain? Local dietician advises when using fish oils (generally in ADHD & Autism) to give high doses, probably around the six a day these kids are getting. He also advises that this is a very big calorie increase. For a lot of kids with ADHD & ASD this isn’t an issue – Ritalin is an appetite suppressant, and those who aren’t on it tend to be more active, and a lot of kids with ASDs have restricted diets. But for normal school kids? Are the Eye-Q people going to be held responsible for the likely weight gain that they are sponsoring?

  31. sven said,

    September 11, 2006 at 10:24 am

    Sorry to be picky, but blog is a “masculine” word in French. The correct sentence is “Ceci n’est pas un blog”.

  32. Pro-reason said,

    September 11, 2006 at 10:54 am

    What’s with the “defense”? That’s not an English word. The Guardian style guide says “defence”.

  33. smad1 said,

    September 11, 2006 at 11:18 am

    Brainwave! Surely one of you Brits has a cheeky little ankle-biter enrolled in GCSE-level classes in Durham who’s willing to stand up to his teacher and say this trial is a load of fishpiss? Maybe, Ben, you can champion him/her as a cause celebre? Get the news photogs to turn up to his school when the trial starts to show him/her chucking their fish pill out the window, &c?

  34. bad chemist said,

    September 11, 2006 at 11:42 am

    I don’t have a child in a Durham school, but I do have friends who teach the sciences in the area. I’ll have a word and see if they’ve been told much about this – maybe I can get them to point out what an utterly futile exercise it is.

  35. icarus said,

    September 11, 2006 at 1:00 pm

    Falling foul of UK Medicines for Human Use Act might be a good reason to not want this called a Trial. However if an individual is given a drug (a CTIMP)- with a view to making a medical diagnosis or to restore, correct or modify physiological functions in human beings for a medicinal purpose, it automatical falls under UK legislation. However, food products are often not an investigation medicinal product, and therefore fall through the law. As such it is clinical research – but this then needs to be governed by the local NHS within the catchment areas – which will still reqiure it to fall under the Governance Framework.

    Some how or other – if anyone gives a child a commercial product to see an effect – under UK law/ NHS Research Framework – its Research (with possibilty of being a CTIMP). I’ll follow up with the MHRA, see their coments (if any) as the 2004 legislation was brought into place to stop this type of qwack research, even outside of a hospital ward.

  36. Teek said,

    September 11, 2006 at 2:03 pm

    ceci n’est pas science, en fait c’est merde.

    the worst thing is that by endorsing the “trial” (ahem), as i assume durham council and/or the local education authority will have done, they’ve given it a veneer of authenticity, an appearance of being based on solid, sensible research.

    you can spend a lifetime bemoaning the ills of BadScience, but once a terribly-designed, non-controlled, badly drawn-up and ill concieved “study” of this nature gets this much publicity, it’s time to give up and admit that as we sure as well beat ‘em, we may as well join ‘em.

    right, i’m off for a coffee enema, some homeopathic arnica, followed by crystal therapy to help me stop smoking – anyone wanna join me…?!

  37. Teek said,

    September 11, 2006 at 2:04 pm

    and maybe some fish oil too, if it’s good enough for Co. Durham i’m in…!!

    *exasperated sigh*

  38. ACH said,

    September 11, 2006 at 2:32 pm

    You’re on your own, Teek. I’m just having my coffe in the conventional way. Only possible other route of admission I’d consider is intravenous.

    Re: Linseed oil – isn’t that also what you use on cricket bats? A most versatile substance!

  39. TimD said,

    September 11, 2006 at 2:37 pm

    Hi to Cath #26:

    Firstly, I assume you’re talking about the kind of nutritionist as mentioned perviously here: www.badscience.net/?p=258 and here: www.badscience.net/?p=259 that is, people with a ‘RNutr’ after their name? And you’re likening them to medical professionals? As I think both of these articles indicate, this really is an entirely hit-and-miss field full stop.

    To quote: “On the one hand, they are a respectable and august research body, representing some of the sharpest academics in the country, doing research work on nutrition in both people and laboratories, publishing academic journals…On the other hand, they “run” a “register” that I suspect consists mostly of those commercial “nutritionists” who make good money peddling lifestyle advice to the public.”

    Now, there are people who have trained as nutritionists in whatever formal capacity it is you feel warrants such praise as to be likened to medics and dentists in both of these camps quoted above (Not meaning to have a go at nutritionists, as I know there are some very good ones out there). And there are most certainly people who have not had that formal training in both camps, I definitely know that the group working in my department are of the decent research variety, and reading some of the papers listed on the previous link provide a lot of evidence for this. Interestingly, I’m sure I could find nutritionists who would recommend taking omega-3 on the basis of few or no studies. Which is the whole point I was making in the first place:

    It seems very easy for people to extrapolate unduely from the work of some dodgy guy to ‘psychologists in general’. But doing a brief google of this ‘Mr Patrick Holford’ guy I see no evidence to call him a psychologist at all. Doing an undergraduate degree in psychology makes you no more a psychologist than doing an undergraduate degree in physics or chemistry. It is the people who are doing methodical, scientific academic research in all of these disciplines that get the title of ‘ist’. So no, he probably isn’t a nutritionist either.

    Just a thought… :)

  40. Kimpatsu said,

    September 11, 2006 at 2:53 pm

    “This is not a trial” is not an adult defence, Ben? Well, nah nah nah nah nah.
    I was going to be your bestest friend, but after you were so horrid about us, I’ve decided I don’t like you anymore. So I’m taking my ball back.
    Oh, and I’m telling Miss on you.

  41. Teek said,

    September 11, 2006 at 3:06 pm

    ACH: linseed does wonders for my cricket bat, therefore i’ll give it to my kids by the litre. good call!!

    as for administration routes for coffee, i cant see the Starbucks Enema taking off to be honest, so perhaps a latte is the way forward after all…

  42. Coobeastie said,

    September 11, 2006 at 4:00 pm

    You can also use linseed as an egg replacer. Truly a wonderful thing. And as someone who’s taken both cod liver oil and linseed, I’d go for the linseed simply because it mings so much less when you accidentaly pop a capsule. Also means that own intestines are of tip-top cricketing standards at all times. Huzzah.

  43. Dr Aust said,

    September 11, 2006 at 4:34 pm

    Linseed oil makes a filthy smell when you try and polymerize it in a sort of analogous-to-making-nylon reaction, though. Remember the stink driving us out of the chemistry lab for a whole afternoon in distant A-level days. Top chemistry lesson, that… …though bugger all to do with the syllabus.

    Wonder how many directives it would contravene nowadays?

  44. coracle said,

    September 11, 2006 at 5:07 pm

    Dr Aust,

    Couple of questions, why would one want to, and did it work? What were the conditions?

    I’m fascinated.

  45. Ben Goldacre said,

    September 11, 2006 at 5:20 pm

    just got this interesting email from someone who works in the same field:

    “Re: Ben Goodacre’s piece on Durham County Councils efforts to improve GCSE scores.

    “I don’t know if Ben realised that DCC stands to get £1.2 million in 2009 from the Government as reward for increasing this ‘performance’ indicator. Quite an incentive for a cash-strapped organisation to take a load of free pills, even if the link to better performance is unproven.

    “All local councils are expected to sign a Local Public Service Agreement with the Government – the deal is that if the council can ‘stretch’ performance (against some pre-selected national and some elective local priorities) sufficiently beyond what they predicted it would have been (anyone got a wet finger?), the nice man at the Treasury will show his munificence for being able to say ‘look, our schools are much better’.

    “DCC have agreed to increase by 3 points the average no. of points students achieve ‘at Key Stage 4′ in 2009. For the lowest grade (G) a student gets 16 points and each grade above that is worth 6 points. In June 2005 the average in DCC schools was 335 compared national average of 355. By June 2009 they need to get this up by 10 points to 345, by fair means or fish oil. I managed to work that out without the aid of Omega 3 supplements…

    “I’m not surprised that the official wasn’t describing it as a trial. That would have frightened local parents who, surely, wouldn’t want to jeopardise their child’s chances of being ranked as highly as possible – how will they get on in life otherwise? The worrying thing – for non-stakeholders in Equazen – is that should GSCE performance in DCC schools get ‘stretched’ it will be attributed to the doses of oil and then all LEAs will want some. That will mean having to use money they currently spend on other inputs that (presumably) contribute to ‘performance’.

    “There does need to be a climate that promotes good science in testing what produces improvement in public services (and not just for education, or should I say schools) but this is not fostered locally by the system of targets and financial rewards (or punishments) which the Government has designed nationally. I recommend a course of fish oil supplements for ministers – perhaps the director of Equazen would be happy to oblige.”

  46. Dr Aust said,

    September 11, 2006 at 5:55 pm

    A classic.

    So a win-win situation for Equazen.. the County Council virtually HAVE to produce the “improvement” or they don’t get the Govt’s cash… and when they do the company will be able to use the “data” as a major marketing tool to roll out the supplements to other CCs – aided, no doubt, by the clamour from parents anxious for their kids too to get the benefit.

    Trebles and large pay-rises all round, as Private Eye would say.

    Anyone else apart from me struck by the echoes here of what is happening in the Health System with “targets” (ad nauseam) and Pay-By-Results?

    ….and with all sorts of other Govt-funded or influenced spheres of endeavour.

    Basically, with “incentives” like this, who can afford NOT to generate the required improvements? (See also A level results…).

    The trade term for the kind of statistics-massaging bean-counting this sort of thing causes County Councils / schools / hospitals / Universities / the whole of the pubilc sector to engage in is “Gaming”. Enough said.

  47. stever said,

    September 11, 2006 at 6:58 pm

    I quite like smad’s idea of sabotaging the project. maybe a decently written leaflet (outlining what a load of old bollocks it is in clear concise bulleted points) handed out to the pupils and parents at the gate would be enough to crash the whole thing.

    who lives near there?

    we’ll all write it, ill do the layout and printing, and a couple of local vols could do the leafleting.

    1 mill and a stupid exploitative scam torpedoed for a few quid and a couple of hours work. .

  48. The Reverend AG said,

    September 11, 2006 at 8:00 pm

    I think a better method of sabotage would be sneak into the pill factory and replace half the pills with a placebo. Screw it up to the point that it becomes a real trial!

  49. ashley said,

    September 11, 2006 at 8:49 pm

    Stever

    No I wasn’t joking, but there may have been a bit of intentional melodrama. I’m not objecting to testing on children per se, just that you don’t have to do it on children while they’re actually doing important exams. I guess Gleamhound is right and it only really matters if you think this will actually have a significant impact, which I don’t see happening, but there seemed to be a rather gung-ho attitude that if you have 5000 children in school and you fail to extract some sort of useful empirical data then you’ve somehow wasted their education. And I’m allowed to use emotive language whenever I want; I don’t have to be helpful.

  50. Dr Aust said,

    September 11, 2006 at 9:53 pm

    A cynical thought –

    WHY wouldn’t the company be desperately trying to have this done as a PROPER trial? Surely a demonstration that the Fishy Goodness works in a RDBPCT (randomized double-blind placebo-controlled trial) would do wonders for their selling… proven efficacy! The stuff would fly out of the stores. Or swim.

    Unless….

    …they suspect it wouldn’t work… or they even already have data like that and it didn’t work. So now they’re trying this non-trial trial.

    And if you think I’m getting too paranoid, note that this nasty little idea comes from Mrs Dr A, the battle-hardened hospital doctor, who is even more cynical than me.

  51. Dr Aust said,

    September 11, 2006 at 10:07 pm

    On a total tangent:

    Coracle wrote: “Couple of questions, why would one want to [polymerize linseed oil], and did it work? What were the conditions?”

    I think the idea was to show that ANY compound with c=c double bonds in could potentially be polymerized, and maybe also that it worked best on a “thin layer” of the oil. And possibly also cricket bats/musical instruments (see below)

    As I remember it he floated the linseed oil in a thin layer on top of a beaker of water on a gently heating bunsen burner.

    [NB the nylon polymerization is/was done at the INTERFACE of an aqueous and organic layer - the diamine is in the aqueous layer, the di-acylchloride in the organic layer. "Threads" of nylon formed at the interface and could be "rolled up" on a glass rod. Good experiment, that. Hope it's still in the school chemistry labs.]

    Found the following on a site about VIOLIN VARNISHES (really) no less:

    “When linseed oil is exposed to heat and or atmospheric oxygen a thickening occurs and it eventually becomes a solid, rubbery mass. If the exposure is to thin layers the result is a clear hard solid. The process of oxidization and subsequent polymerization forms aggregates of higher molecular weight. The final product is a solid, homogenous lattice-work of three dimensional molecules of exceptional stability.”

    www.violinvarnish.com/linseed.htm

    Unfortunately, my teacher over-heated it and filled the lab with intensely irritant linseed-y vapours, hence the evacuation.

    The man in question was an ex-industrial chemist who never needed much encouragement to veer off the syllabus at wild tangents of various kinds. I loved it but I have to admit we “lost” half the class of 16 between the start of the A level years and the end. Though not to chemical mishaps, you understand.

  52. cath having fun said,

    September 12, 2006 at 12:03 am

    Hi Tim#39
    for a beautiful demonstration of what our pseudonutritionists such as ‘MR’ Holford is up to with vulnerable children with autism/autistic spectrum at Cricket Green school Mitcham, watch the ‘clinical presentation of intermediate results’ and weep at the ‘evidence by media’ supporting MR (not DR) Holfords oleaginous performance aping himself as ‘leading clinical nutritionist’. (or perhaps for this event he wil assume the title ‘Director of the Brain Bio Centre, or there again, maybe instead Clinical Director of the Institute of Optimum Nutrition – who can tell which alter-ego it is this time?)…..

    Where is this ‘scientific research’ to be presented I hear you ask?

    Answer – that leading independent and objective medium – GMTV (from 8.30 on the 12/9 folks! …. and just remember to listen hard to find where you can buy the vits/fish oils/patricks books etc)

  53. Robert Carnegie said,

    September 12, 2006 at 1:48 am

    I’d be suspicious of the company providing remedy and “placebo” for the experiment. Instead of a placebo they could slip in sleeping tablets or tranquilisers. Unlikely but possible.

    The same with homeopaths. In clinical trials, what’s to stop them giving their subjects aspirin or codeine to make them feel better, instead of homeopathic stuff? Well, scrutiny.

    As for the ethics of a placebo trial… If you don’t give fish oil to any kids then no kids get the claimed benefits of fish oil. It doesn’t seem likely that giving them the stuff will do them much harm. Now actually taking it… I presume that what actually happens is that it’s handed free to parents, who may or may not persuade or allow their children to take the diet supplement. Now those who do take it may be predominantly those who are already open to, and mindful of, healthy eating.

  54. ceec said,

    September 12, 2006 at 8:43 am

    I’m interested in the ethics of conducting this “trial”.

    1. There are possible disadvantages to the supplements that have been pointed out (e.g. excess calories consumed) and it seems unwise to assume that a (putatively) active drug would have only positive effects.

    2. It is clearly unethical to involve children (or adults for that matter) in a trial which is so badly designed that it cannot show anything – waste of time, money, exposure to possible side effects etc., however valuable the drug in monetary terms (they seem to be pushing this as a delightful freebie, rather than a drug with uncertain effects)

    When my students want to go and interview 10 people about things like what they eat for breakfast, they have to go through the institutional ethics committee. This may be going too far, but I’m amazed that this type of intervention can be proposed with nobody batting an eyelid.

    Are any of you lot consitutents? If I were, I’d write to the council requesting details of the ethical approval obtained for the trial, i.e. was it obtained, and if so, who from?

  55. Junkmonkey said,

    September 12, 2006 at 9:04 am

    OK. Linseed oil is a major constitient of putty and Linoleum. Both substances replaced in recent years by ‘synthetic’ substitutes. If there was anything in Omega 3 levels being good for the brain there should have been a marked decrease in the IQ of glaziers and linoleum workers who must have ingested vast amounts of the stuff over the years. I don’t know how you would collect statistics on glaziers but Kirkcaldy, in Fife was, 100 years ago, the “largest producer of linoleum in the world, with no fewer than six floorcloth manufacturers in the town”. (Wikipedia)
    Is there any evidence that the people of Kirkcaldy got thicker when the bottom fell out of the Linoleum business?

  56. billious said,

    September 12, 2006 at 9:50 am

    All very good and noble, folks. However, we all know how this ‘trial’ will turn out; with the increased attention on the children, the year on year GCSE improvement and the possibility of skewed predictions for the candidates in question.

    Does anyone know where to get Equazen shares?

  57. TimD said,

    September 12, 2006 at 10:09 am

    Cath #52 – I think we’re in agreement! Funnily enough without seeing your post I turned on the TV this morning and saw Mr Patrick Holford’s face gurning back at me. I couldn’t really stomach anything he had to say at this time in the morning. I did realise, as you seem to be emphasising, that he is ‘Mr’ – again that was my point. He’s not a psychologist. That’s the main thing I hope people realise. Nor does he claim to be. He claims, on false pretenses and random it appears uncertified diplomas to be a nutritionist. But yes it certainly is worrying that he seems to have free reign testing in the young populations he does. On that note, would you recommend a certified nutritionist as being the person to run, say, a trial on autistic kids? Because nutritionists have no knowledge of autism, which is surely a key factor? This would probably require a collaboration between a properly trained nutritionist and a properly trained educational psychologist – neither of which are Mr Patrick Holford.

  58. Dr Aust said,

    September 12, 2006 at 11:11 am

    Robert Carnegie wrote:

    “I’d be suspicious of the company providing remedy and “placebo” for the experiment…

    …The same with homeopaths. In clinical trials, what’s to stop them giving their subjects aspirin or codeine to make them feel better, instead of homeopathic stuff? Well, scrutiny.”

    This “Oops – real chemicals in Alt remedy..!” is a well-desribed problem with some Traditional Chinese Medicine (TCM) products – they turn out to have real drugs in them which (e.g.) lower blood glucose. Quite a few examples reported.

    Another analogous example I seem to remember is the “body-building protein supplements” that turned out to contain anabolic steroids or their precursors.

  59. MJ Simpson said,

    September 12, 2006 at 11:23 am

    Do we know in which schools this ‘trial’ will take place? If so, why can’t we just nominate some comparable schools with 5,000 other GCSE students as our own control group?

    In fact, surely every school outside the ‘trial’ group is a control. The kids who take fish-oil may improve on predicted results, but if we can show that kids at other schools improve on predicted results too (as they seem to every year, hem hem), wouldn’t that nullify the ‘results’?

  60. Gleamhound said,

    September 12, 2006 at 11:43 am

    Ceec re your #54,
    it would be worth writing even if not a constituent. There is a good opportunity for red faces for all involved.

    It would be interesting to see what the BMA, or the RCPaeds have to say about the matter. Might even be worth getting a quote from the Minister for Education. If there are any medically qualified doctors involved, then I suspect the GMC might have something to say about them supervising a clinical study (which is what this is, semantics aside) which we assume has no formal ethical approval.

    If by some chance there has been a formal protocol approved by an ethics comittee, then it would be nice to know:
    What ethics comittee?
    What is the protocol ? eg Interim analysis, statistical measures, early stopping rules, endpoints, follow-up.

  61. Gleamhound said,

    September 12, 2006 at 11:44 am

    And of course, if this study ever gets published in a peer-reviewed journal, it will be interesting to see what conflicting interests are declared.

  62. Coobeastie said,

    September 12, 2006 at 12:03 pm

    Oooh, remembered something else about side effects. Fish oil is an anti-coagulant, and shouldn’t be taken by people on warfarin, or who have haemophilia. It certainly increases bruising in people I’ve met who take it. So if Durham pupils get into any nasty car accidents, nasty bangs on the head while this is going on it could get nasty.

    Rivers of blood!

  63. wotsisnameinlondon said,

    September 12, 2006 at 1:54 pm

    I wonder if it has occurred to Durham County Council that they are letting themselves in for a long term commitment to buy this snake oil for their students. As has been shown in previous responses, this “trial” is guaranteed to produce positive results as it is in the interests of all concerned for it to be so.

    Once the trial is over and the benefits of snake oil have been “proved” successful, DCC will be in a difficult position. If they do not fund future purchase of the snake oil then they will be accused of damaging their students’ future prospects, and if they do then they will have to stump up a lot of cash to buy the capsules at 79.9 pence per child per day. I am assuming that to have a continuing effect the dose must be taken every day and not just weekdays during term time. This then comes to over £290 per child per year. If there continues to be 5000 students involved, then that is mote than 1.45 million pounds per year. Who will fund this?

    Not a bad investment for the Equazen people!

  64. Dr Aust said,

    September 12, 2006 at 2:04 pm

    Would anyone like to comment on the relationship between :

    “80 pence / child / day”

    ..for the tablets…

    ..and the cost of a decent nutritious school meal / kid? And then to what they actually spend?

    What children need is a good nutritious breakfast at home, and a good balanced lunch with fresh ingredients at school.

    Compare this with the short-cutting FishOilOption. Special knowledge! Miracle supplement!

    ..sound familiar?

    BTW, wotsisname, I suspect if they use it long-term they will get the parents to meet the cost. .. maybe the kids with free school dinners will also get free FishSnakeOil.

    As ever, what is really needed (proper food) is BLINDINGLY BLOODY OBVIOUS – but the commercial opportunities for someone to make LARGE PROFITS out of feeding school kids proper food are missing. So no one is bothered.

    Welcome to the Brave New World of free corporate enterprise.

  65. j said,

    September 12, 2006 at 2:10 pm

    “There are possible disadvantages to the supplements that have been pointed out (e.g. excess calories consumed) and it seems unwise to assume that a (putatively) active drug would have only positive effects.”

    Yep, and there’s at least one known drug interaction which is possibly damaging: “may increase the blood-thinning effects of aspirin or warfarin.” (www.umm.edu/altmed/ConsSupplements/Interactions/Omega3FattyAcidscs.html)
    I’m presuming that this is unlikely to be an issue with kids, but without a placebo control then if other side effects or drug interactions do show up then it may be hard or impossible to attribute them to the fish oil.

    So the manufacturer gets a trial which is almost certain to give positive results, and which means any negative effects are less likely to be spotted.

  66. Coobeastie said,

    September 12, 2006 at 2:22 pm

    j – kids on it certainly bruise more easily, so yes, I think it is an issue.

  67. Dr Aust said,

    September 12, 2006 at 2:37 pm

    Coobeastie

    If that is really a clinically recognised effect in children, and at the doses they are using, I cannot believe they are going to be allowed to run this without a proper ethical approval / consideration of the safety aspects.

    It just shows how lauguably lax the licencing / regulation is if you class something as a “food supplement” rather than a “medicine”. At least the US have one agency – the FDA – which is supposed to cover both, so there is some joined up thinking.

    Note that there are very few (no?) herbal remedies SOLD in the UK as “herbal medicines”. They are all sold as “supplements”. No prizes for guessing why.

  68. smad1 said,

    September 12, 2006 at 2:41 pm

    Okay… but back to the sabotaging business (sorry, I must be a closet anarchist or something). I’d love to see you guys whip up a nicely-designed leaflet and have some Durhamites do some picketing. Maybe you can dress up in a salmon costume and stand outside the school gates handing them out, clad in a sandwich board reading: “REAL SCIENCE SAYS NO TO FISHY BUSINESS”? I’d be glad to help… I know my way around InDesign!

  69. j said,

    September 12, 2006 at 2:55 pm

    coobeastie, that’s interesting to know. Have there been trials showing increased bruising in kids/adults? And is this something you could achieve by eating more fish (how high a dose of oil are they giving the kids, anyway?)

    One other thought – what do the teachers/unions make of this. My bet is that if they meet/exceed targets, the pills will get credit; if not, the teachers still get the blame…

  70. smad1 said,

    September 12, 2006 at 3:43 pm

    Sorry, couldn’t resist — another salmon costume sandwich board suggestion: “REAL; SCIENTISTS SPEND ALL DAY SWIMMING UPSTREAM JUST TO GET FUCKED IN THE END”

  71. Dr Aust said,

    September 12, 2006 at 4:01 pm

    Love it. Story of my life…

    But not specific to scientists, real or otherwise.

    An old one in similar vein, although not fish-specific, was:

    “Real scientists only do it with proper controls”

    ..and multiple variants.

  72. Coobeastie said,

    September 12, 2006 at 4:08 pm

    “Very high doses of fish oils may increase the time it takes for you to stop bleeding if you’ve been cut (doctors call this bleeding time). But the studies we looked at did not find this was a problem.”
    www.besttreatments.co.uk/btuk/conditions/5180.html

    Beyond that, all I have are anecdotes. Sorry. But this isn’t something that has been used in children in large doses until recently, so I don’t know that the evidence would be there? Again with the anecdotes – the increased bruising/longer bleeding has not been a problem for the children I know that are on it, but it really is something that has to be considered. Informed consent?

  73. Tristan said,

    September 12, 2006 at 5:00 pm

    A CALL TO ANYONE WITH A CAMERAPHONE:

    This weekend I was in Northern Ireland when I happened upon a health shop with and Eye-Q display in the window, and bugger me if there wasn’t a picture of a speech bubble with the words: “Look mum, it’s that fish oil from the Durham School Trials!”

    Unfortunately I didn’t have my phone, and when I went back the next day the place was closed, with a big grille covering the window.

    So, all you keep an eye out in the windows of health shops and if you see a similar display take a photo and email it in to Ben.

    Tris

  74. Tristan said,

    September 12, 2006 at 5:01 pm

    Oh, and if any of you live in Newcastle, County Down, the shop is on the high street and is called “Essence”.

  75. Ben Goldacre said,

    September 12, 2006 at 5:15 pm

    i want any pics you can get of adverts, shop displays, newspaper billboard things, literature given out to parents, anything.

  76. j said,

    September 12, 2006 at 5:27 pm

    “This weekend I was in Northern Ireland when I happened upon a health shop with and Eye-Q display in the window, and bugger me if there wasn’t a picture of a speech bubble with the words: “Look mum, it’s that fish oil from the Durham School Trials!””

    Does it specify which one :) Eye Q was also used in a (apparently double blind) trial on kids with learning difficulties – see www.equazen.com/default.aspx?pid=120 and www.durhamtrial.org/ They did provide oil *and placebo* pills for this free of charge. Interesting that they don’t do this for the larger-scale trial they’re now planning…

  77. Registered Dietitian said,

    September 12, 2006 at 6:53 pm

    Hi, I am loving this debate.
    In response to post no 57, I am a member of a group of dietitians that see children and adults with autistic spectrum disorder, and we are doing our best to produce some leaflets by the end of the month through our professional body on these issues of diet and autism, and diet and behaviour and learning. One of our members is involved in a pilot trial of looking at exclusion diets and autism, with other professionals.
    In response to post no 30, i have been informed that the capsules used have only 5kcal each, so the risk of weight gain on these is low.
    I think in general the professionals involved in these ‘studies’ are very well meaning but it is a pity that they haven’t been well-designed. The way i look at it is that at least it is raising the issue of diet being important for the well-being and performance of school-children, something which didn’t seem to have been taken too seriously by the media and general public before the likes of Jamie Oliver and Patrick Holford.

  78. pv said,

    September 12, 2006 at 7:52 pm

    “…the likes of Jamie Oliver and Patrick Holford”

    How can you mention these two people in the same breath? One is a chef with a brain, the other is a quack.

  79. Ben Goldacre said,

    September 12, 2006 at 8:03 pm

    i agree, jamie oliver promotes good cheap healthy edible food on the basis of common sense, whereas patrick holford promotes himself and his pills on the basis of what often turns out to be flimsy nonsense.

  80. Dr Aust said,

    September 12, 2006 at 9:02 pm

    Long article by Tim Radford on the Durham Fish Trials in today’s Education Guardian. The two things that strike me are (i) that the company are nowhere quoted (keeping their head down) and (ii) the Education Authority bureaucrats just parroting the same mealy-mouthed neo-Govt speak evasions about “we weren’t trying to do a trial, I’m afraid; just moving forward together on a raising Durham’s standards trajectory”

    At one point the lead idiot is quoted saying something like: “Well, if this produces suggestive evidence, it will be up to the scientists to nail down the effect”

    Hands up ANYONE who thinks that the company, having coughed up £ 0.5 M worth of FishOil to run a non-trial which will almost certainly generate positive spin and hence sales, would possibly be daft /honest enough to run another study on this scale, but this time using a proper RDBPCT basis that might not give “adjustable” / biddable results?.

    Anyone?

    Anyone at all?

    It would be a first in the entire history of “supplements”, that’s for sure.

  81. Robert Carnegie said,

    September 13, 2006 at 2:30 am

    Re bruising and dosage, the kids collectively are being given a million quid’s worth of this stuff. The epidemiology is probably similar to radiation exposure.

  82. Filias Cupio said,

    September 13, 2006 at 2:34 am

    The Reverend AG (48) said:

    “I think a better method of sabotage would be sneak into the pill factory and replace half the pills with a placebo. Screw it up to the point that it becomes a real trial!”

    But you also need to know who took the placebos and who took the drug. This is hard to do without the knowledge and assistence of those administering the “trial”. Fortunately, I have a solution:

    We sneak into the pill factory and replace half of the pils with a *radioactive* placebo! Then you just have to wave a Geiger counter over the sprogs to discover whether they were experiment or control.

  83. CB said,

    September 13, 2006 at 9:03 am

    MJ Simpson, post 59

    yes that would be a control group of sorts (and worth doing to an extent) but you’d really need kids from the same classes to compare with each other, as kids in other schools have different teachers etc who may be better/worse at predicting grades and improving performance.

  84. zuclopenthixol said,

    September 13, 2006 at 1:00 pm

    For comparative data, I know in my neck of the woods a group called the The Fischer Family Trust (www.fischertrust.org/) provide all the schools in my area with comparative data. I’ve also read internal school documents that list each childs expected grades, which is predicted form their first , key stage 1, 2 etc results. All data external to the schools.

    Whilst there maybe confusion about what the study should be called, it is a study, albeit one which is hypotheses generating rather than confirming.

  85. Chris said,

    September 13, 2006 at 9:07 pm

    I emailed Durham County Council to ask them if they felt they were being dishonest about this fish oil “trial”.

    Here with my original email is the response I got:

    Dear Chris,

    The County Council has already carried out previous clinical trials and the current initiative, and our comments we have made about it, are based on the evidence, or “meaningful data” as you put it, from those.

    Thank you for writing.

    Regards,

    Fraser Davie
    Press & Publicity Officer
    Durham County Council

    We received the following feedback/enquiry from yourself on 09/09/2006 12:44:26 pm:

    Dear Sir / Madam,
    Re: “Fish Oil Initiative Could Boost Gcse Pass Rate” 6/09/06.
    Your trial does not appear to have a control group, and cannot therefore be called a trial in the scientific sense of the word. No meaningful data can possibly be produced from this exercise.
    However, your stated intention to “mount a unique back-to-school initiative … which [you] believe could result in record GCSE pass levels next summer” is bound to excite the hopes of many parents who do not have the background necessary to evaluate the outcome.
    Don’t you think that that’s just a little bit dishonest?
    Yours Faithfully,
    Chris

    I don’t recall mentioning their previous trials, I meant the “initiative” referred to in their press release as a trial. My original email does not make this plain, and the officer seems to have responded to the words of my email, rather than its point.

    Is it just me, or is there some dissembling going on?

  86. cath having fun said,

    September 13, 2006 at 9:58 pm

    so Filias Cupio at 82 –
    so the kid will glow in the dark as well as the classroom!

  87. cath having fun said,

    September 13, 2006 at 10:17 pm

    …and Chris at 85

    …well, after Dr Alex Richardsons closest-thing-to-an-objective-trial (the Oxford-Durham study) your reply from the press officer at Durham probably refers to Dr Madeline Portwoods ‘extension trials’. She was apparently involved in the original trial, before Durham appeared to distance themselves from repeating Dr Richardsons work, and allowing Dr Portwood and her psychologist ilk to continue the ‘performance’.
    the ONLY place I can find Dr Portwoods research ‘publications’ are on the Equazen website, and on Durham County Councils press releases – where the ‘stunning’ results are promoted thus (oh, they’re ‘stunning’ because Madeline says they are)… www.durham.gov.uk/durhamcc/pressrel.nsf/vweb/0322C57D3701C7B68025713E0043D03E?opendocument

    funny that on the same page, it states what an educational psychologist at Durham actually does.

    www.durham.gov.uk/durhamcc/usp.nsf/pws/School+Support+-+What+is+an+educational+psychologist

    … and I must be missing something. It doesn’t mention ‘meddling in nutrition as enthusiastic amateurs attempting to make a cod hypothesis fit our predefined conclusions’

  88. Andrew Clegg said,

    September 14, 2006 at 7:34 am

    “cod hypothesis” — like it.

    Andrew.

  89. ceec said,

    September 14, 2006 at 2:21 pm

    I just sent this letter by email to Dave Ford and Claire Vasey, both of whom are named on the press release as having something to do with this trial, and both of whom work at Durham council.

    Dear Claire Vasey and Dave Ford

    I am writing to express concern at the announcement that you will be conducting a study on school children in Durham. This study appears to have serious ethical problems.

    “All Year 11 pupils at Durham County Council’s 36 comprehensive schools are to be offered omega-3 fish oil supplements to see whether the proven benefits it has already brought children and young people in earlier trials can boost exam performances too.”

    From the press release there seem to be serious flaws in its design, which would render this project unethical. I am happy to discuss these flaws in detail if you are not aware of them. As you know, it is unethical to carry out research which by design cannot achieve its stated aims (waste of time and money, potential for harm, misleading participants etc.). This is particularly true for research on children, where any intervention should be subject to very careful scrutiny. I hope the reasons for this are obvious.

    I’m afraid to say that this project looks like a rather thinly-disguised promotional exercise for the company that manufactures these oils. If this is the case, and there is no scientific basis for the study, Durham County Council is effectively using its own and its schools’ resources in promoting one company’s product. This is at best corrupt, and at worst harmful for the children involved.

    I have three questions:

    1. Which ethics committee approved this study?

    2. What systems are in place to monitor side effects or harms resulting from this study?

    3. How will consent be obtained?

    4. Is there any reason to believe that this study is not simply using school children in a cynical promotional exercise for the supplements company?

  90. Delster said,

    September 14, 2006 at 3:57 pm

    ceec,

    good letter and worded so they have to address the issues raise but i do hope you said 4 questions in the actual letter :-)

  91. ceec said,

    September 14, 2006 at 4:18 pm

    oops. Added the last one at the last minute. Never mind – the general gist is still obvious enough. Annoying though…

  92. Mojo said,

    September 14, 2006 at 4:20 pm

    Nobody expects the Spanish Inquisition!

  93. Registered Dietitian said,

    September 14, 2006 at 6:39 pm

    hi again, In response to 78 and 79 – i wasn’t meaning to imply Jamie Oliver is in the same league as some of the nutrition ‘experts’ discussed in this stream, as i agree that what he is promoting is much more credible and useful. I

    I suppose what i was trying to point out is that it was a sad sign of our celebrity-orientated times that he achieved what many community dietitians have been trying to achive for years, through his media status. In an area i have worked with, the local council had refused to meet with us to discuss the appaling school meal service, but within a week of Jamie’s programme had requested a meeting with us.

    I also felt that the way in which the School Dinners work was evaluated could have been more useful – i understand that teachers were asked to subjectively rate whether they thought there had been an improvement in their classes after the changes had been made, and it could have carried more weight if they had objectively scored behaviour and performance before and after the changes to give us more useful data.

  94. George_S said,

    September 15, 2006 at 2:00 am

    My big fear about trials like this is the marketing after effects. Of course they will find that omega 3 fatty acids increase the test scores by some marginal amount. Then everybody will jump on the bandwagon and start eating the 1+ pound of ocean fish (or 4.5 cans of sardines canned in oil) per week that everybody thinks you need to eat to get your 7 to 11 grams of omega 3 fatty acids per week that your body needs. This will lead to further degradation of fish stocks which are in super bad shape already. I am of course assuming that nobody is going to spend the $800/year on the supplement.
    1 tablespoon of flaxseed oil contains 6.9 g of omega fatty acids and 1 tblsp of canola oil contains 1.3 grams. Flaxseed oil is different than linseed oil the same as Canola oil is different than rapeseed oil, both having their fatty acid profile changed through plant breeding to make them an edible rather than industrial oil. (These crops were developed in the city where I live)
    On the website that I looked this all up in the intro theh said how cold water fish is the best source of omega 3 fatty acids and then in their tables there were all these way better vegetable sources.
    If you use non hydrogenated canola oil margarine or canola oil in your cooking you will likely get enough omega 3 fatty acids just by having a slice or two of buttered toast each day. Ground flax (readily available in stores here in Canada) is an excellent addition to cookies, bread and porridge. One cookie a week is likely enough. A handful of walnuts has enough too.
    The marketers do not want you to know this though. They want you to worry and fret that your children are going to be defective because you aren’t feeding them right.

  95. three tigers said,

    September 15, 2006 at 10:54 am

    When did the connection between omega-3 fatty acids and brain function start? When I was first learning about eicosanoids, their synthesis and metabolism, we were told that omega-3 FA in cell membranes were metabolised to anti-inflammatory prostaglandins (PGs) and that omega-6 was converted into pro-inflammatory ones such as PGE2 via arachadonic acid (AA). This is the rationale for using fish oil suppliments in people suffering from inflammatory arthritis reduce the PGE2 production in the joints and reduce the pain. Obviously PGs and their relatives have cardiovascular actions too, is this the link?

  96. three tigers said,

    September 15, 2006 at 10:56 am

    Sorry submitted to quickly

    Obviously PGs and their relatives have cardiovascular actions too, is this the link, more blood to the brain – brain works better?

  97. Gleamhound said,

    September 15, 2006 at 1:18 pm

    Ceec,
    good, clear letter.

    Can I suggest that you Cc the following:

    The Professor of Paediatrics at Durham University.
    The President of the RCPaeds
    The Chief Exec of Durham County Coucil
    The Consumers Association
    The Secretaries of State for Health and Education

  98. nomde plume said,

    September 15, 2006 at 1:21 pm

    Portwood started work in Durham back in 1990 as an EP with remit for children with EBD. At this time she surveyed 100 such children at a school and found 75% had symptoms of Dyspraxia (co-ordination problems). She also found 50% of children at a young offenders institution had the condition! As this is 15 times more prevalent than in the general population she started research into the condition.

    Over the next 6 years she developed a structured movement programme that not only corrected gross motor deficits but also as a side effect improved children’s perception and handwriting. This predates the Dore programme and is available in her book Dyspraxia: a practical manual for parents and children – which is available for a lot less than the cost of attending the Dyscovery centre or DDAT centre.

    County Durham is the only County that has a specialist Dyspraxia service and the programmes are administered throughout the County. This is one, but obviously not the only or main, of the reasons why such an area of deprivation has a relatively high level of success at GCSE.

    Whilst most children improved remarkably using her programmes, she discovered a cohort that did not. However on reading an article in the Independent (Stordy et al) that claimed that EFAs could ‘cure’ many conditions she was asked by the Dyspraxia Foundation (of which she was a trustee) to comment.

    Her research led her to research (Taylor et al) that showed that children being fed breast milk in the first month did much better than formula/ pre-term milks and that the key feature was that mothers milk provided increased levels of DHA – an w-3 EFA during the first period. – Most formula milks now recognise this and include elevated levels of DHA. DHA is a structural fatty acid – so is needed when the brain is expanding, not only immediately after birth but also uring pregnancy. EPA is a functional fatty acid that enables the neurones in the brain to operate effectively.

    She then wanted to try and see whether increasing levels of EFAs could improve children’s dyspraxia. This led her to persuading the council to allow a trial (double-blind placebo one-way crossover) in County Durham, which was set up in conjunction with Oxford University. Although one paper has been released there are other findings that have not been (mainly because the Oxford University Researcher had a spat with the supplier of the supplement/ placebo and now works for a competing EFA manufacturer.) It is therefore unlikely that other papers will be released.

    Following on the results of the trial (Durham Council have seen the analysis even though it has not been published), other double-blind trials have been held. However there have also been (subjective) trials involving Secondary aged pupils with ADHD and pre-school children through Sure Start. These trials have been through ethics committees.

    Again the results of these trials have been so encouraging that Durham feel that it would be in the best interests of children of they moved on and brought the use of the supplement into the real world – in other words they have moved beyond the laboratory. We should not forget that at the end of the day we are not talking about trials we are talking about children. The initiative could have been done on a double blind, placebo basis, but this would not be fair on those children given placebos – even if the trial was on a cross-over basis, as , for many, the results of the exams in May/ June 2007 will determine their future academic career.

    Above is a mention of pro and anti inflammatory EFAs. Our current diet is not only lacking in w-3 anti inflammatory EFAs it is also high in w-6 inflammatory (especially high levels are found in corn and sunflower oil for instance) which is one possible reason for the increase in asthma and eczema in children. Also w-6 EFAs are very competitive and will replace w-3 should they be present in large amounts – thus affecting the operation of the brain.

    Currently there is much debate about our pre-school children. Ask any nursery teacher and they will confirm that children these days are poorly developed in motor skills and attention. There are several causes – certainly diet is one but lack of interaction with parents, lack of movement and exercise in playing (motor movement is one of the best ways to improve brain function) all contribute. Durham nurseries have to run special motor development classes in order to try and get their children to an adequate level of motor skill – I am not sure about other counties.

    Boots are pro-active in the pre-school area and have recently launched a ‘Child Development Programme’ to encourage parents to work with their children and develop their skills.

    So feel free to mouth off about whether this is a ‘trial’ and the ‘science’ about it. You are not in full possession of the facts and at the end of the day your reactions can only have a damaging effect on the children of this country. Is that what you want?

  99. Ben Goldacre said,

    September 15, 2006 at 2:01 pm

    thanks for that. i see from your email address that you may be lynn portwood, do you mind me asking if you are related to madelaine portwood?

  100. cath having fun said,

    September 15, 2006 at 2:18 pm

    Ben – You’ve SPOILT it!

    was ploughing my way through #98, with cynical smile on face convinced Madeline was replying to us, and lo! posting #99 blows it!
    perhaps #98 would like to reflect that

    1. brain growth and neural networks are developing at a different speed in newbie babes vs durham delinquent toddlers – and there’s more to a healthy brain than fish oil makes (assuming it does – any biopsies??)
    2. its rather unprofessional to diss the main author of the original work – which was actually PUBLISHED in a bona fide medical journal (vs ‘publication’ in parent school newsletters genre)
    3. it shows one’s crassness to come out with a comment like ‘We should not forget that at the end of the day we are not talking about trials we are talking about children. ‘
    Memo: I think you will find correspondents #1 to #97 are talking exactly that – plus the concern about exploiting such vulnerable groups with dodgy scientific ‘practices’ the potential side effects of which even the nutritional experts (ie NOT clinical or educational psychologists) know nothing about….
    4. IMHO, methinks we are more in ‘possession of the facts’ than nomde plume

    Ben – any reward for the first century in the forums?

  101. Ben Goldacre said,

    September 15, 2006 at 2:47 pm

    heh, this isnt the first century by a long shot, brain gym, for example, went to several hundred!

    this “you’re hurting kids” guilt trip stuff. wow. i was ready to leave the story alone but now i’m not so sure, it’s not that it’s offensive, but it does make me worry that the point has not been understood:

    * the research is not yet there to show that this intervention is effective.

    * this “initiative” was represented as a “trial”.

    * in my opinion it would be unethical to do a trial which cannot give meaningful data

    * in my very strong opinion it is unethical to mislead the public about trials, wherever the blame for that lies here, because it undermines goodwill for participating in clinical trials: this is something people only do because they accept on faith that they are doing something which will contribute to the greater good. in this case, they will now see that what was represented as a trial turned out to be, not a trial, but what I see as a public relations exercise.

  102. imagineyoung said,

    September 15, 2006 at 3:32 pm

    Nahh, screw them hard. Politicians and jobsworths are getting better and better at corruption and bs.

    Squash them fast. It’s the only way to train them to behave.

    It’s always the cry of the sleazy – we’re doing it for your own good.

  103. ceec said,

    September 15, 2006 at 3:45 pm

    On top of Ben’s 4 points, these are experiments on children, who are not necessarily able to give sensible informed consent on their own behalf.

    Given that their parents are likely to have been seriously misled (e.g. is it or isn’t it a trial? Is there evidence or isn’t their evidence that the drug works? Is this or isn’t this a way to see if “oils = grades”?), any consent to participate they may have given on behalf of their children is meaningless.

    This sort of manipulation of children is horrifying. The whole “it wouldn’t be fair to give them placebo” stuff is disingenuous at best. You might as well use leeches to improve school performance, or branding with hot irons, if you can’t even be bothered to see what happens when you don’t intervene. I’ve heard a bit of caning never hurt anyone.

    Actually I’ve got a failsafe new business plan. It involves some unpublished experiments, a great deal of hyperbole, and a special new vitamin formula. Who’s in?

  104. j said,

    September 15, 2006 at 4:06 pm

    Lyn Portwood wrote: “the results of these trials have been so encouraging that Durham feel that it would be in the best interests of children of they moved on and brought the use of the supplement into the real world – in other words they have moved beyond the laboratory. We should not forget that at the end of the day we are not talking about trials we are talking about children.”

    A couple of other things:
    – so far as I know, all the trials which generated positive results have been in kids with ‘learning difficulties’. Even if these trials are conclusive, it doesn’t seem to follow that all kids will benefit from the pills. Wouldn’t this be something we’d need, um, a trial to check…
    – couldn’t this be integrated with attempts to improve school meals in Durham: basically, feed kids more fish at lunch time. If the pills really cost 90p/kid/day, you can buy a lot of good food for that… This would let you improve kids’ diets further, and if you get kids used to eating fish this might be a habit that sticks after they leave school…
    – if this isn’t a trial – and the evidence is there that kids need this type of pill – what is the Equazen hoping to gain from this? If Durham decides to spend so much money on pills year after year, I’d expect them to put this out to tender – is Equazen hoping to gain an advantage by giving some free-bees first?

  105. nomde plume said,

    September 15, 2006 at 4:10 pm

    No relation (sorry).

    Maybe you would like to ask the ‘main author’ of the original work why they have not produced any more reports in the last three years? Whilst you’re at it you might ask her about certain comments she made in Inverness about Madeline & Adam.

    I would also point out that it is unprofessional to release e-mail addresses – if you wanted to contact me you should have sent the request direct to the e-mail address.

    Of the 97 previous commenst

    1: not related to children
    2: uninformed – education authorities have already got teacher estimates of potential grades throughout primary and secondary school.
    3: Personal attack on Horrobin – not related to children
    4: Personal attack on Kelliher defending his father in law – not related to children
    5: Link to durhamtrial.org – which DOES refer to a double-blind placebo-controlled one-way crossover trial.
    6:Comment about linseed oil – not related to children
    7: Confuses marine fish oil and cod liver oil. Production is different. Ben confirms Equazen use high quality materials
    8: immature sarcastic comment – not related to children
    9: Mr Ford expects the initiative will help children in real life not in a scientific journal
    10: Number of children 5000: should be a good normal distribution with low error compared to scientists doing research on 5, 10 or 15 children!
    11: Another link to www.durhamtrial.org
    12: Does not refer to Durham initiative.
    13:misinformed – Durham approached Equazen I understand – not vice versa
    14:a sensible factual comment
    15:libellous attack on Mr Ford – not related to children
    16:misinformed – all children offered (not compelled) supplement
    17:naive – results can take into account overall increase in pass grades in Nation
    18:attack on Kelliher – no relevance to children. Mr Kelliher has supplied supplements to Durham free – as well as other countries and has declared on this website that if a bona-fide research group come along he will be only too willing to provide supplement/ placebo.
    19:a sensible factual comment
    20:a sensible factual comment
    21:comment about Brain Gym. I cannot comment on this but why tar one company with the failings of another?
    22: misinformed – there is no placebo. Parents have to give permission for their kids to be enrolled. Children won’t be ‘forced’ to have capsules. Capsules will be offered and consumption recorded.
    23:Confirms above statement
    24:facteious comment about linseed oil – not related to children.
    25:see 24
    26:fair comment – but since Durham have been using EFAs for 5 years I think that they may have some idea of the benefits having observed the children.
    27: Facetious comment – not related to children
    28: ditto
    29: YOu wil have to ask Durham but they are presumably of the opinion that there is no equipoise based on their previous clinically controlled trials.
    30: I belive that a tablet of Eye-Q has about 6 calories in it! Weight gain will be minimal. Also – if you are recommending Ritalin then you are well behind the times – suggest you research ritalin-cancer in google.
    31:irrelevant comment
    32:irrelevant comment
    33:Good idea – if you can find one – it is a free country after all.
    34:Why don’t you do just that – and then report their comments – if you dare. Not related to children.
    35:will await your findings.
    36:As mentoined repeatedly by Durham – this is an intiative – the fact that the organisers were misquoted is neither here or their.
    37: I’m sure if you contact Adam Kelliher and say who you are he will be only too pleased to supply you with his supplement. (not related to children)
    38:not relavant to children
    39:An interesting comment
    40:not relavnt to children
    41:silly comment abnout linseed oil – nor relevant to children
    42:ditto – not relavant tochildren
    43:ditto – not releavnt to children
    44:ditto – not relevant to children
    45:conspiracy theory i’m afraid – what if durham did get the average result up to the average (or above) ‘by fair means or fish oil’. It’s results that count and the beneficiaries are going to be the children with better grades.
    46:comment on 45: not relevant to children. Personally I agree that setting targets in public services may not be the best way forward – but how else could government measure any improvement?
    47: silly comments about ‘sabotaging system’ – not relevant tochildren
    48: ditto
    49:valid concerns about children and taking exams – however can anyone find any evidence that taking fish oils can reduce grades? All trials in Durham have been positive – especially on child concentration so that will surely help them revise.
    50:The original Oxford-Durham trial WAS a randomised double blind one way crossover placebo trial.
    51:interesting story – but not related to this forum: not relevant to children
    52:Comment on another ‘trial’ – not Durham
    53:valid point if this was a trial to investigate improvement in children and print results in a peer reviewed journal – but it is not. The sole reason for this initiative is to offer all children the opprotunity to benefit by taking supplements – whether they take them or not is a free choice.
    54:Calories in Eye-Q – negligable. Evidence of bad effects on taking supplements – none. Evidence on taking benefits – plenty.
    55:Linseed oil again – irrelevant to children.
    56:We can hope that children obtain improved grades. I understand Equzen is privately owned so shares cannot be bought.
    57:comments on Mr Holford: not relevant to Durham initiative
    58:Valid but irrelevant: no placebos being given in this initiative.
    59:All secondary schools 36 in Durham will be offered the chance to join in. Please feel free to select 36 schools in another deprived area.
    60:comments based on mistaken thought that this is a clinical trial
    61:unlikely that result swill be published in a peer reviewed journal. However you can look at the school league tables for GCSE results when they come out next year.
    62:Parents are asked about child medical conditions before being given product. Of course having anticoagulents will reduce the risk of heart attacks/ thrombosis etc but as that is a benefit I suppose you don’t want to mention it.
    63:no financial commitment undrtaken by Durham. Of course according to this site there will be no discernable advantages in taking the supplement. . .
    64:I would much rather have children eating sensible food with a balance of all nutrients rather than relying on supplements. Regrettably this is not happening and the education system is in such straights trying to cope with all these children with poor concentration that they are having to take steps. If you don’t feed your child correctly would you prefer a) ritalin or b) fish oil – the effect on concentration is similar?
    65:Genuine concerns. As before you can see the results in August next year and then decide.
    66:An agreement to a valid concern.
    67:comment on 66
    68:ditto
    69For the original durham trial all the capsules in term time were handed out by teachers. It is a measure of their dedication in county durham to the wellbeing of the children that they achieved a compliance rate of 75%.
    70:silly comment – not relevant to children
    71:general comment- not relevant to childen
    72:a posting quoting research
    73:Irrelevant: Eye-Q was used in the Oxford Durham Trial, The Middlesbroug hTrial, The Sure Start Trial, The Autism Trial and the Greenfield study so: yes it was used in the Durham trials.
    74:an addendum
    75:Good luck – not relevfant to Children. Ben you haven’t been in a dispute with Equazen have you in the past?
    76:Refers to my reply to 73: Durham obviously belive so much in the benfits of fish oil that they don’t wnat to disadvantage children by offering placebos.
    77: Agree: changes in diet (+ exercise) would be much more benficial – a pro-active treatment is better than a reactive one – but that is the situation at the moment.
    78:Irrelevant to the discussion
    79:Agreement with 78: not relevant to discussion on Durham initiative
    80:Why not ask Mr Kelliher direct? – Oh you did didn’t you – why not publish his reply.
    81:So?
    82:Should the moderator report you to the anti-terrorism police for the comment about poisening children with radioactive materials.? In fact if i remember correctly it is a criminal offence if he doesn’t. Otherwise I’ll treat this with the contempt it deserves.
    83:A sensible comment
    84:A sensible comment
    85:Factual but misinterpreted
    86:Comment on 82: not relevant tochildren (at least not fish-oil ways)
    87:Dr Richardson knows the reason why Durham distanced itself from her. Also as she is in the pay of another company (MorEPA) she is unlikely to want to promote research done by another company is she.
    88:irrelevant comment.
    89: This e-mail was sent under the users work e-mail at the centre for tropical diseases. It is interesting that her employer would allow the use of their computers during office hours.
    90: comments on 89:irrelevant to children
    91: comments on 90-irrelevant to children
    92:toy poodle rather than spanish inquisition: irrelevant to children
    93:shows power of celebrities – you all seem to be eulogising about Jamie when there certainly wasn’t any science in his methods. Although I agree with his aims and applaud his efforts the sad fact is that giving a child 5 good meals a week is not going to have as good an effect as we would like if the remaining 16 are full of ****.
    94:Valid concerns about omega-3. The problem is that reasearch has shown that in adults higher levels of DHA produce much lower (if any) benefits anbd that it is EPA that is important. Highest levels of EPA are found in fish. Regrettably, of course, many foodstocks, not just fish, are being depleted.
    95: Alreaday commented on this – useful for people to read.
    96:Not my field
    97:A suggestion – not related to children
    98: agree with every word said.
    99: unprofessional
    100:From the above you can see that of coments 1 – 97 most are off topic, many are filled with ignorance, antipathy and prejudice and many are just a load of ****.

  106. cath having fun said,

    September 15, 2006 at 4:59 pm

    … and the plural of anecdote is anecdotes, not data

  107. Ben Goldacre said,

    September 15, 2006 at 5:22 pm

    lynn, i see no reason to make this personal, and i’m not sure i agree with the analysis of your 1680 word post that the posts here: “most are off topic, many are filled with ignorance, antipathy and prejudice and many are just a load of ****.”

    you will understand that as the admin i see a slightly different version of the page from you, for example i can see that a great many of the people here are posting from academic servers and email addresses, and i guess you can also understand that when i see a very long and rather hostile comment, in a public forum, making personal comments about people involved in this research (which i find frankly a little distasteful) from an email address that looks a little like it might be from someone called lynn portwood, from a company in county durham, naturally i might think to ask whether you are related to the madelaine portwood from county durham. frankly i don’t believe you’re not, but everyone can make their own mind up.

    i havent disclosed your email address to total strangers, nor would i, if only to protect from spambots. if you’re suggesting i should have checked whether someone typing their work email address in to my webpage whilst making personal comments about academics was trying to be discrete then i will very happily bear that in mind next time.

  108. Dr Aust said,

    September 15, 2006 at 5:24 pm

    Nom de Plume gives some back-story / history which sets out how the Durham Ed people got to this point. Understandable, but it doesn’t address the basic point:

    Why is this being hyped all over the place as a trial, which is what the COMPANY wants, when it clearly ISN’T a trial as medical science would understand it?

    I completely agree with Ben’s points above in post (Room?) 101.

    I can accept (just about) that the Durham education and ed psychology people have “pure” motives; they want the kids to do better, no argument that kids w behavioural problems are a major challenge to the education system, here’s something that MIGHT help with all of this, they’re getting it for nothing. THink Gift Horse.

    ..That said, they have allowed it to be PRd / publicized / talked-up hyped as a TRIAL, which it evidently isn’t. This is dishonest.

    And note that the response Chris got (post 85) came from a “Press and Publicity” Officer – I trust them about as far as I can… well no, I don’t trust them at all. Press Officer = hired liar. Let’s hear Durham’s psychologists, the scientists, defend it, not press flacks or politician-alike positivity-speak Chief Execs or Dept Directors.

    Assuming the Durham Education peoples’ motives are pure, I think they have not looked the gift horse hard enough in the mouth.

    THE DURHAM “INITIATIVE” AS CURRENTLY CONSTITUTED PLAYS RIGHT INTO THE HANDS OF THE COMMERCIAL PARTNER.

    Equazen will probably get a positive result – see e.g. post 45 – and all the subsequent marketing benefit, without the “risk” of a proper controlled trial At the end of it they will be selling loads more of the stuff, citing the Durham “evidence”, even though we will be no nearer knowing if it works.

  109. RS said,

    September 16, 2006 at 12:14 pm

    Is the problem here, as always, that the people making these decisions don’t really understand how to evaluate the evidence? They are responsive to the trappings of scientific imprimatur, but unable to truly understand it.

    I notice on the press release the claim “This year, the percentage of pupils gaining five or more A*-C grades topped 56 per cent , 5.5% up on last year and the biggest increase ever in a single year in the County. It is likely to bring the County’s pass rate very close to – or even on a par with – the national average pass rate.” so what kind of increase in pass rate do we reckon DCC and Equazen would call a ‘significant’ improvement due to eye q fish oil then?

    I wonder if the backers of this trial, making arguments about how unfair it would be on students to have a proper trial, have actually considered what the financial implications for education are in the long run? Equazen are not going to fund supplements for Durham students forever, and without real scientific evidence one way or the other how can DCC make an informed decision about whether to plough huge sums of money into fish oil supplements or alternative educational initiatives? This seems like short-termism of the worst kind, and has repurcussions outside of Durham when Equazen start to spin their results and pressure other authorities (and parents) to spend a considerable sum on their product.

  110. RS said,

    September 16, 2006 at 1:19 pm

    Quick back of the envelope projection based on the GCSE-Key stage 3 relationship in Durham suggests you might expect a GCSE pass increase of 3-7 percentage points – that’s without any additional non-specific effects (e.g. placebo), so I reckon they need an increase of over 10% to even attempt to conclude anything from their ‘study’. It’ll be interesting to see the effect size, although I imagine the solution is to concentrate on those subjects wth the biggest increase (wow, fish oils improve performance in GCSE History!!!).

  111. Mojo said,

    September 16, 2006 at 4:49 pm

    nomde plume said, “9: Mr Ford expects the initiative will help children in real life not in a scientific journal”

    What evidence does Mr Ford base this expectation on? And why this distinction between science journals and “real life”? Science journals don’t allow contributors to just make things up. In contrast, this “initiative” seems to be based on, at best, wishful thinking.

  112. Therowans said,

    September 16, 2006 at 7:37 pm

    Is anyone aware of any other ongoing ‘trials’ (or similar!) for fish oil?

  113. BorisTheChemist said,

    September 17, 2006 at 1:04 pm

    Mojo,

    Comment number 9 deeply troubles me too. This is just a backhanded dismissal of scientific research and the need for peer review publishing as well as a massive dig at the published research that has gone before.

    Experimenting on such a large group of children without a solid scientific case built on publicly accessable, peer-reviewed literature is very unethical to say the least. As a parent I am deeply concerned that not all the facts are available here, should the ‘trial’, sorry, ‘initiative’ become national without such disclosure I would certainly be making a fuss.

  114. Evidence-biased said,

    September 17, 2006 at 3:04 pm

    As leading author on the Oxford-Durham study (Pediatrics 115 (5) 1360-1366), I’ve tried to stand back from this debate – but for the benefit of #98 and #105, I must make clear that:

    1) Durham LEA have all the data collected for our trial, so if they wanted to publish any further papers, they’re very free to do so. (By contrast, some questionnaire data was never provided to the Oxford researchers; and the final data on motor skills – a primary outcome measure – only came across in summer 2004). To suggest that my well-known dislike of Equazen’s promotional activities makes it ‘unlikely that other papers will be released’ is thus misleading in the extreme. I do wonder why Durham LEA haven’t got on with this themselves – but presumably they’re too busy. Or maybe it’s because they know we’d insist on checking their sums.

    2) Unfortunately, media attention dogged our study from early 2002 when data collection first began. The Oxford researchers repeatedly asked Durham LEA to desist from such activities until this trial was completed, analysed and published – but to no apparent avail. This constant premature leakage of information to the media, and its apparent exploitation for commercial purposes, was the reason why our previously good relations with Durham LEA broke down.

    3) In recent years, I’ve given lectures and/or acted as scientific advisor for many different companies who produce and/or sell omega-3 supplements. This is duly noted in my ‘conflict of interest’ disclosure as required on my academic publications on this subject – including the Pediatrics paper. I’ve given many more talks at health or education conferences (where real science actually goes down better than the hype or waffle that often fills ‘training’ days – quite encouraging). And I give almost all my fees to charity – see www.fabresearch.org/. All my research is independent of commercial influences, and most has been funded by charities. Read my recent book for parents and professionals (trying to stop them falling for the ‘hype’ surrounding both nutrition and child behaviour – all royalties to charity again) and you’ll see that it doesn’t name any supplements; because I don’t ‘work for’ any companies, nor is it my role to advertise their products for them.

    4) As for why I’ve not produced more papers from this particular study myself? Give me a break. Getting the last data mid-2004 and having main results peer-reviewed and published in a major journal by May 2005 was no mean feat. I’ve many other research projects ongoing; and this one was never fully funded in the first place, even before it overran its supposed timescale. (I’ve also had a rather major bereavement recently – as well as writing my book – but what’s that to you?) And if you’d like to ask me about any comments you think I’ve made, why not contact me directly? My e-address isn’t hard to find, but please keep correspondence brief and to the point. I share your apparent desire to ‘help the children’ – but in my view that’s best done by finding out what really works – which means doing proper trials. (Any potential donors out there – please get in touch, as I’d far rather hear from you, actually).

    Finally, I knew absolutely nothing about Ben’s article here until after this appeared. Some people seem to think I helped him write it. Not remotely the case (and I’m not sure which of us should feel more insulted at the suggestion). But he’s done a great job of flagging the real issue – which is that we need more good evidence, not more advertisements.

  115. pv said,

    September 19, 2006 at 6:54 pm

    nomede Plume wrote:
    “21:comment about Brain Gym. I cannot comment on this but why tar one company with the failings of another?”

    Why tar one snake oil vendor with the the failings of another? Did I do that? I think not, though I undoubtedly should have done so. I believe I was questioning the integrity of the LEAs that fall for this tripe. How incompetent can they be? Next thing you know there will be astrology readings at assembly and the first-aid kit will consist of homeopathic remedies (sugar pills and water).

    nomede plume also wrote in an earlier post:
    “Boots are pro-active in the pre-school area and have recently launched a ‘Child Development Programme’ to encourage parents to work with their children and develop their skills”
    Boots also sell homeopathic remedies and other snake oil.

    Basically there are rather too many commercial interests interfering with child development and education in the UK. And frankly its naiive to think they are doing it out of the goodness of their hearts. Children have always been a sought after target or cover for unscrupulous companies, because of the emotional baggage attached to that section of society. Now another way has been found to get at children in order to generate big profits…

  116. cath having fun said,

    September 19, 2006 at 8:48 pm

    hi there ‘evidence-biased’
    thought i ought to post some support of your statement, a)having a good idea that you are indeed Dr A R, and b) in support of your valid concerns about commercial exploitation.
    My dietetic colleague was aghast to find her local Boots stores positively pushing fish-oil-plus-vits ‘starter’ supplement packs at any mum-with-baby-or-child as they shopped. Is this what is known as their ‘Child Development Programme’ ?

  117. zuclopenthixol said,

    September 20, 2006 at 2:23 pm

    Therowans said ‘Is anyone aware of any other ongoing ‘trials’ (or similar!) for fish oil?’

    Therowans, if you go to www.controlled-trials.com/mrct/ and put fish AND oil% in the search box, making sure the ‘all registers’ box is selected, you will get 103 hits. There is bound to be duplication of records as results are not duplicate checked, and studies can be reported in more than one register, but it’s an attempt at having prospective registers of trials.

    If you go to www.nelh.nhs.uk/, select The Cochrane Library, and enter The Cochrane Library through the Wiley site, and try fish AND oil* in the search box there, you will find several systematic reviews which mention fish and oil, and there is a hyper link to a clinical trials section of the library. Here you will find over 800 hits of reports of past trials which mention fish and oil. Some relevant, some not.

  118. mrstrellis said,

    September 21, 2006 at 1:42 pm

    I spotted the Boots promo as well, whilst looking at the new improved homeopathic medicine packaging for a cheap laugh. I had a look at the ingredients: there were more colourings, flavourings and sweeteners than a six-pack of Panda Pops. Presumably these were in the vitamins rather than the fish oil?

    Parents who are convinced their child’s ADHD is caused by “additives” could be in a quandary: will the fish oil and vitamins improve the hyperactivity, or make it worse because of the added ingredients?

    Alternatively they could just give their kid a proper diet and plenty of exercise…

  119. psybertron said,

    September 27, 2006 at 4:01 am

    Can’t fault you on this one Ben. This bad science that needs to be called out as such.

    It may be witty word association to pick up on “this is not a trial” and make the Magritte connection, but it misses Magritte’s point … about the distinction between an object and its image. I don’t believe it helps your cause of being pro-good-science to ridicule art by association. (A picture paints a thousand words, only after the thousand words have been understood.)

    Regards
    Ian

  120. stratty said,

    April 7, 2007 at 12:25 pm

    Hello. I’m new to this site and found the fish oil topic and the comments interesting.
    Forgive me if I’m wrong, but I don’t see an indication that the following videos have been seen and wonder whether various views would change or not after having viewed them?

    OMEGA 3 NIH WORKSHOP VIDEOS

    videocast.nih.gov/ram/omega1.ram (introduction)

    videocast.nih.gov/ram/omega2.ram

    videocast.nih.gov/ram/omega3.ram

    videocast.nih.gov/ram/omega4.ram

    videocast.nih.gov/ram/omega5.ram

    videocast.nih.gov/ram/omega6.ram

    videocast.nih.gov/ram/omega7.ram

    Best
    Stratty

  121. mel21 said,

    November 30, 2007 at 6:35 am

    Although I’m only an individual of one person omega 3 fish oil has changed my life.

    I am a sufferer of Bipolar disorder, 4 attempted suicides, and negative effects from Zoloft, Effexor, Lithium, and Prozac.

    I started taking Omega 3 fish oil 6 months ago, not knowing it can affect your thinking and behaviour through Amway, they sent me a trial of their vitamin product when I signed up to their business.

    Two months ago I wondered why I had been in MUCH better moods, able to control my temper, better memory, feel like I had more energy, wasn’t getting depressed anymore, no suicidal thoughts and genuinely a better person to be around. I was no longer feeling irritable during hypomania or had anger outbursts, excessive impulses to drink alcohol ceased, impulse to gamble decreased and have been a very happy person.

    I looked up Omega 3 fish oil on the internet and came across many different studies on the effects it’s had on mood and violence decrease etc and was amazed at how nothing I tried was working for me but this one simple thing, fish oil, that is natural, no side effects, no withdrawal effects, no doctor visits, no prescriptions could change my life so soon.