Just… Show… Me… The… Data…

November 11th, 2006 by Ben Goldacre in bad science, equazen, fish oil, references, statistics | 190 Comments »

Ben Goldacre
Saturday November 11, 2006
The Guardian

I don’t know if you’ve ever tried using the Freedom of Information Act: it’s an excellent trouble making tool, and you do feel quite James Bond, but the act has its flaws. One being that if you ask for too much, as one lone, obsessive, disproportionately pedantic science columnist, they turn you down on grounds of cost. Quite spuriously and unfairly, to my mind. So now I’m offering a kind of skills swap: I’ll teach you all how to do an FoI request (it’s easy) if you help me get a bunch of data.

Contain your boredom and exhaustion, because it’s the Durham fish oil pill people again, but think of this more as an experiment in what happens when you just won’t let go. You’ll remember that this story bore the cardinal hallmark of quackery: they claimed they had proven that expensive Equazen fish oil pills improved school performance in various trials, and were eager to sing about this in the media, but when I approached to ask about the science, with a loaded postgraduate medical qualification in my back pocket, they shut up shop and fled. Dr Madeleine Portwood, eager to appear on Channel 4 promoting her “trials” and bamboozling non-science journalists, did not return my calls, or my emails, and the press office – bless them – weren’t much help. The durhamtrial.org “results” website is a superficially plausible but ultimately uninformative sham.

So I made an FoI request to get the data, and they refused to give me anything. The refusal, I ought to say, took them the full statutory 4 weeks (nice!). And why are they turning me down? “It is estimated that it would take 30 hours to fully respond to this second request, which would cost £750 when calculated using the statutory rate of £25 per hour.”

This is a joke: all I asked for, essentially, was the basic information you’d find in any write up of any scientific experiment: the trial methods in sufficient detail to decide if they were a “fair test” of the treatment, and the results in full. Oh, and a few leaflets. You can witness the full, formal anality of my FoI request online: I just used the CONSORT guidelines as a template, since they’re the gold standard for writing up any trial. If Durham and Dr Portwood really are in a position to bang on about their positive results, they should have this information at the tips of their fingers.

But no. And not only did they turn me down, they also – rather censoriously to my mind – pointed out that any cleverdick “multiple small applications” shenanigans from me would be totted up and rejected. And this is why, gentle reader, I need your help.

Some of it was bland stuff: copies of blank consent forms, leaflets for parents, the eligibility criteria for participants, the trial locations, that stuff. Some of it is more nerdy. “Nullius In Verba”, as it says on the Royal Society’s headed notepaper: “on the word of no-one”. That’s what science is about. It’s not that I think they’re lying, it’s that the devil is in the detail. Science isn’t about telling a journalist you’ve proved something in your brilliant trials, and then seeing your name in the paper, it’s about methods and results.

Did they deviate from the protocol during the studies, I asked, for example, and if so, why? How were the studies blinded? Bread and butter stuff. Were there any analyses they did, but which weren’t reported because they were, well, negative? As we all know, the more different analyses you do on your data – it’s called “data dredging” in the trade – the more likely you are to stumble on a positive result, simply by chance. Likewise, I wanted the protocols for studies that are not yet completed, because it’s always a nice idea to know the protocol before people start their study, otherwise they might change it halfway through, which can stop the trial from being a fair test.

This is bog standard science. That’s the information I wanted. It’s what I still want, and I intend to get it, even if I have to break in to Durham Town Hall and take hostages. Before we get that far, I need your help, and there are full instructions for your FoI requests below. Durham Council, Madeleine Portwood, et al, just so that you know: I very simply will not let this lie.

 

How To Make Your Freedom Of Information Act Request:

The FoI Act is an excellent way to observe whether public figures and bodies are behaving in a generally appropriate and open fashion. The mechanics of making a request are unspectacular. Most public bodies will accept an informal email. Peter Dinsdale is the Freedom of Information / Data Protection Coordinator at Durham Council, and he has said to me in the past that he would accept FoI requests by email. His email address peter.dinsdale@durham.gov.uk and he is very nice and helpful. Put “Freedom of Information Request” in the subject line. If they change their mind and insist on you using their tedious FoI form then you can find that here: they have 20 working days to reply to your request (or not), and if you're feeling ubergeeky you can read more about FoI here.

The trick with requests is to be very specific about the information you require. I lifted the list of what I wanted, essentially, from the CONSORT guidelines: they are an internationally respected set of standards for the information that should be presented for a clinical trial, and they represent the basic things you would need to know about a study to assess its quality and results. There is more on the CONSORT project and its history here, and the CONSORT checklist is here.

Pasted below is a copy of the request I sent to Peter Dinsdale which was rejected, on the grounds that it was asking for too much. I suggest that each person requests just 2 or 3 sections each, going through them in order to avoid confusion, and then posts what they requested, and ideally the full email request they sent, in the comments below, so everyone can see how far we've got and what is left to be requested. Remember, for each request, to say that you want the information for each and every one of the many different trials or studies into omega-3 fish oils that have been performed in children by Durham employees in the past 5 years. God knows how many there really are.

Good luck, have fun, and don’t forget to post the replies you get from Durham in the coming weeks. Don't worry about doubling up with what other people have requested, it's better to be belt and braces. And naturally if you prefer you can also just email me your requests and responses without posting them below. Thanks again and good luck!

 

Dear Mr Dinsdale

many thanks for your assistance with my FoI request, which I made two weeks ago.

As I have unexpectedly encountered difficulty exploring the details of the trials and studies performed by Durham I would like to make a further FoI request.

As you may be aware, Durham Council's representatives (primarily Madeleine Portwood but also Dave Ford and the press office) have been reporting to the media since 2002 that they have performed numerous studies on the efficacy on omega-3 fatty acids on various outcomes in children and adults.

To the best of my knowledge these have been performed in pre-school children, primary school children, and secondary school children in Durham, students in Durham and Edinburgh, schools in Middlesborough, schools in Sunderland, and possibly elsewhere. As per my previous FoI request I would be grateful for a comprehensive list of studies both completed and ongoing, regardless of whether they had positive or negative results, including studies that were not completed.

For each of these studies I would like details of who was involved, what intervention was given, what was measured, what the results were, etc, further details are below. The positive results of these studies have been discussed extensively in the public domain and the media by Durham staff (going back several years) but I have been unable to obtain details that would enable me to assess these claims. Generally when researchers go to the media to promote positive results of completed studies, since the studies have been completed, and the researchers have been able to appraise the results, they are willing and able to explain the technical aspects of those studies.

The specific details of what I need to know - which are the bare minimum any scientist would expect in order to appraise a study - are as follows below. I would be grateful if you could give me this for each of the studies separately.

I'd be grateful if you could also confirm receipt of this email.

Many thanks,

Dr Ben Goldacre

119 Farringdon Road

London

EC1R 3ER

Fax: 020 7117 3593

 

For studies that have been performed and discussed:

METHODS

Participants

Eligibility criteria for participants and the settings and locations where the data were collected.

Interventions

Precise details of the interventions for each group and how and when they were actually administered.

Objectives

Specific objectives and hypotheses.

Outcomes

Clearly defined primary and secondary outcome measures and, when applicable, any methods used to enhance the quality of measurements (e.g., multiple observations, training of assessors).

Sample size

What the sample size was, how sample size was determined and, when applicable, explanation of any interim analyses and stopping rules.

 

Randomization

 

Were the participants randomly allocated to different treatments? Method used to generate the random allocation sequence, including details of any restrictions (e.g., blocking, stratification)

 

Method used to implement the random allocation sequence (e.g., numbered containers or central telephone), clarifying whether the sequence was concealed until interventions were assigned.

 

Who generated the allocation sequence, who enrolled participants, and who assigned participants to their groups.

Blinding (masking)

Whether or not participants, those administering the interventions, and those assessing the outcomes were blinded to group assignment.

How the success of blinding was evaluated.

Statistical methods

Statistical methods used to compare groups for primary outcome(s); Methods for additional analyses, such as subgroup analyses and adjusted analyses.

RESULTS

Participant flow

Flow of participants through each stage: specifically, for each group what were the numbers of participants randomly assigned, receiving the intended treatment, completing the study protocol, and analyzed for the primary outcome.

Describe protocol deviations from study as planned, together with reasons.

Recruitment

Dates defining the periods of recruitment and follow-up.

Baseline data

Baseline demographic and clinical characteristics of each group. Numbers analyzed

Number of participants (denominator) in each group included in each analysis and whether the analysis was by "intention-to-treat". Could you please state the results in absolute numbers when feasible (e.g., 10/20, not 50%).

Outcomes and estimation

For each primary and secondary outcome, a summary of results for each group, and the estimated effect size and its precision (e.g., including a 95% confidence interval).

Ancillary analyses

Address multiplicity by reporting any other analyses performed, including subgroup analyses and adjusted analyses, indicating which of those were pre-specified and which were exploratory.

Adverse events

All important adverse events or side effects in each intervention group.

Interpretation

Interpretation of the results, taking into account study hypotheses, sources of potential bias or imprecision and the dangers associated with multiplicity of analyses and outcomes.

Generalizability (external validity) of the trial findings.

General interpretation of the results in the context of current evidence.

 

For studies not yet completed

I would be grateful if you could let me know the protocol for studies that are in progress or not yet completed.

Material relating to each study

I would be grateful if you could give me, for each study, the participant information leaflet, any material given to parents/teachers regarding their participation in the study, and any paperwork relating to how consent to participate was obtained, eg blank consent forms.

 
And if that all sounds like too much effort… 

… then I'll also be appealing their rejection, and pursuing other avenues behind the scenes, so do drop an email to peter.dinsdale@durham.gov.uk and let him know that you support this attempt to obtain adequate supporting scientific information for scientific claims made directly to the media.  Copy me in if you like, ben@badscience.net. This circular time consuming farce and secondary formal communication is quite absurd.

It really would have been much easier if the "lead researcher" Dr Madeleine Portwood – to whom you are directed with all technical questions – had simply been polite enough to even return a phone call or email. Meanwhile we got this kind of rather unpleasant activity from someone saying they were not related to Madeleine Portwood. Absolutely, stunningly bizarre. I hate this kind of thing really. Oh well. And did you ever think, if fish oil is so important, how come vegetarians aren't stupid? 


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190 Responses



  1. rvcx said,

    November 11, 2006 at 4:02 am

    Requested “participants”, “sample size”, and “randomization” (together they seem to fit the “participant selection” theme. Email is as follows:

    Dear Mr Dinsdale,

    I am very interested in the claims in the media as to safety and efficacy of omega-3 fatty acids in producing various outcomes, which are allegedly backed by studies performed on children (and possibly adults) in Durham, Edingurgh, Middlesborough, Sunderland, and elsewhere.

    I’d like to make a freedom of information act request for details of how participants were selected and assigned, for all studies into fish oil performed by Durham employees in the past 5 years. Specifically, for each separate study I’d like the following information:

    Eligibility criteria for participants and the settings and locations where the data were collected.

    What the sample size was, how sample size was determined and, when applicable, explanation of any interim analyses and stopping rules.

    Were the participants randomly allocated to different treatments? Method used to generate the random allocation sequence, including details of any restrictions (e.g., blocking, stratification)
    Method used to implement the random allocation sequence (e.g., numbered containers or central telephone), clarifying whether the sequence was concealed until interventions were assigned.

    Who generated the allocation sequence, who enrolled participants, and who assigned participants to their groups.

    I’d appreciate it if you could confirm receipt of this request.

    Many thanks in advance for releasing this information,

    >

  2. imagineyoung said,

    November 11, 2006 at 7:57 am

    Unlikely that the FOI extends to residents in Japan, but please keep your teeth well sunk into Durham’s behinds.
    Durham is claiming that fish oil changes kids’ behavior and brain functions, and yet they see nothing wrong in doling out these allegedly mind-altering substances like candy to further their careers and politics AND refuse to reveal any real details about their evidence.
    Of course, I realise that they are getting a £1000,000 of free stock for their non-trial, and nobody can find the extra £750 needed to prepare the evidence that supports their decision.
    Just a thought, but if lots of people made exactly the same request as you, Ben, wouldn’t the cost of preparing the documents for each request plummet – or could they still weasel out of it by claiming that they would take 30 hours to fulfill each request?

  3. tickmc said,

    November 11, 2006 at 9:18 am

    Requested “Protocol for studies not yet completed” and “Material relating to each study”. Ben Goldacre deserves some major award for campaining against the non-science nonsense in the world today. I wish hime all the very best with it.

    Copy of the email I sent:

    Dear Mr Dinsdale,

    I am very interested in you omega-3 ‘trial’ and would like to make a freedom of information act request for the protocol for studies that are in progress or not yet completed.

    Also, I would be grateful if you could give me, for each study, the participant information leaflet, any material given to parents/teachers regarding their participation in the study, and any paperwork relating to how consent to participate was obtained, eg blank consent forms.

    Please confirm receipt of this request.

    Kind regards,

    >

  4. LovePanda said,

    November 11, 2006 at 9:22 am

    Dear Mr Dinsdale

    I have been following the stories of the reported ‘Eye Q / Equazen Fish Oil’ trial in the press and I am worried that the company involved is making genuine profit out of fake science.

    As you may be aware, Durham Council and Equazen representatives have been reporting to the media since 2002 that they have performed numerous studies on the efficacy on omega-3 fatty acids on various outcomes in children and adults.

    To the best of my knowledge these have been performed in pre-school children, primary school children, and secondary school children in Durham, students in Durham and Edinburgh, schools in Middlesborough, schools in Sunderland, and possibly elsewhere. I would like to make a freedom of information request for

    1) The specific objectives and hypotheses of studies.
    2) Whether or not participants, those administering the interventions, and those assessing the outcomes were blinded to group assignment.
    3) How the success of that blinding was evaluated.
    4) A summary of the results obtained
    5) The interpretation of the results, taking into account study hypotheses, sources of potential bias or imprecision and the dangers associated with multiplicity of analyses and outcomes.
    6) Generalizability (external validity) of the trial findings.
    7) General interpretation of the results in the context of current evidence.

    I would be grateful if you could give me this for each of the studies separately. Also, if you could include past studies and any ongoing studies.

    I would expect that the data I have asked for is really the minimum one can expect to have already been compiled in order for representatives of Durham Council or Equazen to be able to evaluate or report the success of any trial.

    I’d be grateful if you could also confirm receipt of this email.

    Many thanks,

  5. LovePanda said,

    November 11, 2006 at 9:26 am

    Just noticed my spell checker offers to replace Equazen with brazenly :-)

  6. skjg said,

    November 11, 2006 at 9:42 am

    Request posted for “Specific objectives and hypotheses”, “baseline data” and “how the interpretation of the results took the hypotheses into account”

    Copy of the email I sent

    Dear Mr Dinsdale,

    I am intrigued by the ongoing project involving giving fish oil pills to pupils in Durham schools.

    I would like to assess the validity of the results for myself. To do this I need details of the specific objectives and hypotheses used to design the project and also need to determine the reliability of the results obtained. To check the reliability I need details of the actual results, not a summary, so I can compare the results from different tests. It would be very helpful if you could also include details of how the interpretation of the results took the hypotheses into account.

    Thank you in advance for helping me on these points.

  7. scox said,

    November 11, 2006 at 9:45 am

    I would really like Durham to release this info. But I fear this plan may not work. They may have badscience, but we have badlaw.

    Imagineyoung – it works the opposite way round to what you had hoped:

    Regulation 5 of the Freedom of Information and Data Protection (Appropriate Limit and Fees) Regulations 2004 says that “where two or more requests for information . . . are made to a public authority (b) by different persons who appear to the public authority to be acting in concert or in pursuance of a campaign, the estimated cost of complying with any of the requests is to be taken to be the total costs which may be taken into account by the authority of complying with all of them”: www.opsi.gov.uk/si/si2004/20043244.htm.

    Ben’s plea on this site and in today’s Grauniad clearly makes this a campaign. Durham will simply lump together all the requests and refuse again as exceeding £750. . I think the better way forward is for Ben to appeal the decision and/or ask for disclosure of the cheaper information (eg which will come in below the cash limit). Or perhaps a well-wisher (one of Equazen’s competitors?) can stump up £750?

    Even limited info released will give more leverage.

    Ben – is Durham’s reply on the net? If it were, there might be some suggestions about how to take it forward in a different direction.

    Also, Are there any Durham councillors out there who can use their position as councillors to get the info?

    Or how about 75 of us stump up £10 each? I will.

  8. strathers said,

    November 11, 2006 at 9:54 am

    This is inspired and inspirational! I went for “Interventions” and “objectives”

    Dear Mr Dinsdale

    I would like to make an FOI request concerning experiments that I understand Durham council says have been carried out on the effects of fish oil in improving children’s performance. I would like information for each and every one of the trials or studies into omega-3 fish oils that have been performed by Durham employees in the past 5 years. My personal interest is in the methods. I would like to know:

    Interventions

    Precise details of the interventions for each group and how and when they were actually administered.

    Objectives

    Specific objectives and hypotheses.

    I look forward to hearing from you.

  9. jobrag said,

    November 11, 2006 at 9:56 am

    I’m good for a tenner in such a worthy cause, perhaps Ben could set up something on E-Bay so that we would have a means of getting the dosh to him?

  10. stewartmacdonald2000 said,

    November 11, 2006 at 9:56 am

    asked for Protocols of studies not completed and material relating to each study.

    Dear Mr Dinsdale,

    I am very interested in the claims in the media as to
    safety and efficacy of omega-3 fatty acids in
    producing various outcomes, which are allegedly backed
    by studies performed on children (and possibly adults)
    in Durham, Edingurgh, Middlesborough, Sunderland, and
    elsewhere.

    I would be grateful if you could let me know the
    protocol for studies that are in progress or not yet
    completed.

    I would be grateful if you could give me, for each
    study, the participant information leaflet, any
    material given to parents/teachers regarding their
    participation in the study, and any paperwork relating
    to how consent to participate was obtained, eg blank
    consent forms.

    I’d appreciate it if you could confirm receipt of this
    request.

    Many thanks in advance for releasing this information.

    Regards,

    Stewart Macdonald

  11. imagineyoung said,

    November 11, 2006 at 9:59 am

    Yup, I’ll go for the tenner too.

  12. scox said,

    November 11, 2006 at 10:01 am

    Hey, £30 already. A few other ideas:

    1. How does it take 30 hours to collate the informaiton from their files. I think that sounds too long. Remember, if its only 18 hours, we don’t have to pay (it is Xmas soon)
    2. Durham may have sent info to Govt departments, who probably have it in more accessible form. I’ll bang of an FOI email to the DFES (or whatever it is) and the DOH asking them for it.

    S

  13. Seahorse said,

    November 11, 2006 at 10:03 am

    Delighted to help out with this one – though I’ll follow the replies to scox’s posting above to work out how best to do this.

    Meanwhile, just to make life slightly easier (for those of us on the side of righteousness and enlightenment), I believe the Council cannot require that requests be made on their FoI form. So long as requests are in writing, include a name and address, and specify what’s requested, they are perfectly valid as emails (Freedom of Information Act 2000 section 8).

  14. Seahorse said,

    November 11, 2006 at 10:04 am

    That was section eight, not section smiley, by the way.

  15. PK said,

    November 11, 2006 at 10:05 am

    I think Durham Council’s obstruction is getting quite serious. Since this is about the health of our children, it might be effective to get Panorama or Newsnight involved to make a big public stink.

  16. megachicken said,

    November 11, 2006 at 10:05 am

    Re post 6

    The Guardian surely have a budget to support investigative journalism?

    MC

  17. doctormonkey said,

    November 11, 2006 at 10:26 am

    i think an appeal is worthwhile to the information ombudsman or whatever as their refusal on the grounds of cost is

    a) spurious, cost should not be a limit on these requests, this is in the public interest and the results will be spread across the Guardian and internet (via badscience)

    b) they should have a centralised research list with all of this information if they are going to responsibly monitor their own actions

    by the way, if you are still getting no where i will put in an FOI request but i think there are more avenues to pursue

  18. scox said,

    November 11, 2006 at 10:41 am

    Requests gone by email to the DFES and DH website. I’ll say how I get on.

    doctormonkey (post 15) goes a bit far with ‘spurious’: under s12(1) of the FOIA (www.opsi.gov.uk/acts/acts2000/00036–b.htm#12) Durham is entitled to refuse the rquest on costs grounds. But is point is still solid – Durham is not *required* to refuse it. They can still decide to release it and bear the cost themselves (which of course, works out at a lot less than £25 p/h). If their studies are solid – they would be doing the world a service. If their studies are bad – then they will be avoidin a lot of public and private money on supplements that dont work.

    Ben – please post Durham’s reply (or say where it can be found) in case we have some ideas.

    S

    S

  19. stonybonytony said,

    November 11, 2006 at 11:03 am

    Have requested blinding and statistical methods.

    Dear Mr Dinsdale,

    I was very impressed and interested to see the media reports as to the effects of Omega 3 fish oils based on the trials on children in Durham. I was curious to know more about the specifics or carrying out such a trial.

    Could I make a request under the Freedom of Information Act as to whether and how the participants, those adminstering the tests and those evaluating the results were kept unaware of which participants were in which group, and how the success or otherwise of this blinding was assessed?

    I would also like to know which statistical techniques were used to compare the groups, and which additional analyses such as subgroup analyses or adjusted analyses were used, if any.

    I would be grateful if you could acknowledge receipt of this request, and look forward to your response.

    Yours,

    Tony Evans

  20. beebhack said,

    November 11, 2006 at 11:18 am

    Hi

    I sent this — sorry, I’m just an ageing arts grad but I’m pretty sure I understand! Good luck.

    Dear Sir

    I write in relation to recent claims about the properties of omega-3 fatty acids, particularly in respect of studies performed in Durham and elsewhere.

    Accordingly, I would be grateful if I could make a Freedom of Information Act request for details of the following aspects of all studies into fish oil performed by Durham employees in the past five years, for each separate study:

    RESULTS

    Participant flow

    Flow of participants through each stage: specifically, for each group what were the numbers of participants randomly assigned, receiving the intended treatment, completing the study protocol, and analyzed for the primary outcome.

    Describe protocol deviations from study as planned, together with reasons.

    Recruitment

    Dates defining the periods of recruitment and follow-up.

    Baseline data

    Baseline demographic and clinical characteristics of each group. Numbers analyzed.

    Number of participants (denominator) in each group included in each analysis and whether the analysis was by “intention-to-treat”. Could you please state the results in absolute numbers when feasible (e.g., 10/20, not 50%).

    Thank you in anticipation for your attention

    Yours faithfully

  21. Domo said,

    November 11, 2006 at 11:22 am

    Asked for the stuff under blinding and statistical methods.

  22. pseudomonas said,

    November 11, 2006 at 11:27 am

    I’ll throw in a tenner. Will the Guardian be persuaded to match our contributions?

  23. Domo said,

    November 11, 2006 at 11:30 am

    I wouldn’t wat to be in this chap’s shoes when he gets into work on Monday and opens up his emails.

  24. CityBill said,

    November 11, 2006 at 11:31 am

    Used the basis of someone else’s letter, hope everyone is OK with that – I don’t know enough about stats to write my own!

    Dear Mr Dinsdale,

    As a teacher I am extremely interested in the claims in the media as to the efficacy of omega-3 fatty acids in producing better focussed and performing school-children, which you say are backed by studies performed on children (and possibly adults) in the north of the United Kindom.

    I’d like to make a freedom of information act request for details of how participants were selected and assigned, for all studies into fish oil performed by Durham employees in the past 5 years. Specifically, for each separate study I’d like the following information:

    Eligibility criteria for participants and the settings and locations where the data were collected.

    What the sample size was, how sample size was determined..

    Were the participants randomly allocated to different treatments? Method used to generate the random allocation sequence, including details of any restrictions (e.g., blocking, stratification)

    Method used to implement the random allocation sequence (e.g., numbered containers or central telephone), clarifying whether the sequence was concealed until interventions were assigned.

    I’d appreciate it if you could confirm receipt of this request.

    Many thanks in advance for releasing this information,

    Bill McClelland

  25. BobP said,

    November 11, 2006 at 12:05 pm

    I’m with doctormonkey et al – there are serious issues of public policy and public interest at stake, this should be appealed to the information ombudsman.

    Would it help to get together a petition?
    Are you getting any input from the good folks of Durham?

    I’m also seriously concerned about the ethics of giving unproved goo to children -especially as it appearsto be under the guise of “education”. What information have they given to the parents?

    Oh, and count me in for a tenner as well, if that would help

  26. Nigel Coe said,

    November 11, 2006 at 12:13 pm

    I’d give a tenner too, if it comes to it.

    I asked the 3 questions about interpretation of the results.

    Dear Mr Dinsdale,

    I’m very interested in the effects of fish oil supplements and am therefore intrigued by the trials reported by Durham Council into the efficacy of Omega-3 fatty acids. I therefore request, under the Freedom of Information Act, information on the interpretation of all these trials and studies, whether they involve pre-school children, primary school children, secondary school children, students or other people:

    - The interpretation of the results, taking into account study hypotheses, sources of potential bias or imprecision and the dangers associated with multiplicity of analyses and outcomes.

    - The generalizability (external validity) of the trial findings.

    - The general interpretation of the results in the context of current evidence.

    Many thanks in anticipation of your help.

    Yours faithfully,

    Nigel Coe

  27. lozzer said,

    November 11, 2006 at 12:14 pm

    Copy of my email, basically asking for ‘outcomes and evaluation’ and ‘anillary analysis’

    Dear Mr Dinsdale,

    As a teacher of 35 years and now a consultant on matters connected with science education, I am very interested in obtaining more information about the Durham trial of ‘Fatty Acids’. I believe this can help me in providing very relevant statistical material for use in teaching, as well as being inherently of interest. Unfortunately, the results published on your website www.durhamtrial.org/primary%20results%20new.htm , have been generalised, for public consumption, with all the data removed that would help use the study as an exemplar.I would like to make a FoI request for the following information please:

    1. A summary of the results for each group of children (with actual numbers not proportions)

    2. The estimated efffect size, and its precision

    3. Any other analyses that were performed, other than those published on the website, with an indication of which were designed into the trials from the start and which were identified as relevant after the results were obtained.

    Thank you for any help you can give.

  28. Dr Aust said,

    November 11, 2006 at 12:21 pm

    Like the idea of a petition… what about an online one like the one Sense about Science did for the MHRA Homeopathy rule changes?

    Ben, maybe if you contact Sense about Science

    enquiries@senseaboutscience.org

    and address it to Tracey Brown (the Director) or to Ellen Raphael (who was handling their stuff re. homeopathy and the MHRA) they they could perhaps set up an online petition for you, as they obviously know how?

    They cite “Status of Evidence” and “Peer Review” on the website as themes they are interested in, so it seems well within their purview.

    ..if we got a petition going I’m sure I could round up some academics to get onboard, and maybe even an FRS or two.

    Another idea; if they keep refusing the FoI requests, why not email Ian Gibson MP and get him to ask a question in parliament about why they’re refusing to release info on a matter of clear public concern?

  29. Humphrey said,

    November 11, 2006 at 12:54 pm

    Ben

    I’m a faceless lackey of the state who’s processed quite a few FoI cases since the act came in. So I feel I ought to provide a few pointers.

    You’re approaching the FoI request as a scientist, not a bureaucrat. Freedom of Information really means freedom of access to documents and records. The people dealing with case will be bureaucrats, not scientists.

    The reason why you’re hitting the cost threshold is that you’re asking laypeople to extract information from the reports, rather than providing you with the reports themselves (which would take a lot less time). Also you are not only asking for information, you are asking for analysis and processing of that information – which adds time, and is likely to be outside the scope of the Act. . For example “how did you deviate from protocol” – get the report, check that for yourself.

    You and others on this forum ought to be asking some basic questions – you can always refine the request/ask follow-up questions. You have to be delicate with these things. Some thoughts on the types of things you should be asking for.

    Firstly, I’d suggest that you get to the bottom of the relationship between Durham and the fish oil people. This could be one request. 1) The agenda, list of attendees and notes of all meetings between X company and officials of Durham Council. 2) Copies of all correspondence between X company and Durham Council. That shouldn’t get aggregated with the rest.

    Secondly, getting the reports out of them, and finding out whether the medical trials actually had anything to do with the decision to progress with the project.
    1) ) Copies of all documents (including those held electronically) relating to the approval of this project by officials of Durham Council. 2) Copies of all medical trial data, reports and analysis involving fish oils, which are in the possession of Durham Council.

    This isn’t perfect (I don’t draft well on saturdays), but you get the general idea.

  30. pseudomonas said,

    November 11, 2006 at 1:03 pm

    You’ve prompted comment (supportive but pessimistic) here.

  31. HeronsGreen said,

    November 11, 2006 at 1:16 pm

    One way or another (out of the 3 now proposed) I should think this campaign will succeed real soon now. Certainly hope so — but I point out that another FoI exemption is that a holder of information can refuse to release research results if the copyright holder says that there is an intention to publish the study fully in due course. When I heard about this exemption, it was being used under very disreputable circumstances (bad management rather than bad science, though) — but in reality, I’m afraid it’s hard to see how the rules could be different from this. It wouldn’t be reasonable to be able to force a researcher working for a public institution to give you his results before he’s ready to publish them, would it?

  32. MarkS said,

    November 11, 2006 at 1:17 pm

    Done and done.

    Requested baseline data, outcomes and adverse events, email below.

    Oh and I’m in for a tenner if necessary!

    Dear Mr. Dinsdale,

    I was very interested to read about your trials performed on children with omega 3 oil and would like to request some information about these trials.

    Specifically, the baseline demographic and clinical characteristics of each group, the number of participants in each group included in each analysis and whether the analysis was by “intention-to-treat”. Please Could you state the results in absolute numbers if possible (e.g., 50/100, not 50%).

    For the results, (each primary and secondary outcome), a summary of results for each group, and the estimated effect size and how accurate it is (e.g. a per cent confidence interval).

    Finally, any adverse events or side effects in each group where omega 3 oil was given to the subjects.

    Would it be possible to supply, for each study, the participant information leaflet, material given to parents/teachers regarding their participation in the study, and any paperwork relating to how consent to participate was obtained, for instance blank consent forms?

    I’d be grateful if you could acknowledge receipt of this email

    Thanks in advance

    etc

  33. Frank said,

    November 11, 2006 at 1:29 pm

    it warms the cockles of my heart to see such a sea of responses.

    keep up the tenacity!

  34. Brock said,

    November 11, 2006 at 1:59 pm

    Dear Peter Dinsale,

    I have some sympathy for a local education authority that is essentially trying to increase scholastic performance of its school children. This is an admirable attempt and more forward thinking than a great many local authorities. It would be a shame if the campaign by bad Science in the Guardian puts off other local authorities from performing similar studies. Positive examples include health eating studies of providing free fruit and food education to parents and pupils in Glasgow.
    However, it is important to be clear that the results that are publicised achieve what they claim to do so that future public money is not squandered on false claims. As a member of the public with an interest in both scientific methodology and public transparency I respectfully request under the Freedom of Information Act that you provide me with details of statistical methods used to compare groups for primary outcome(s) as well as the methods for additional analyses, such as subgroup analyses and adjusted analyses so that I can understand some of the results expressed.

    Yours sincerely,

    Dr. Brock Chisholm

  35. Brock said,

    November 11, 2006 at 2:00 pm

    and.. surely the several days work needed to process all the comments from Guardian readers will costy them more than £750?

  36. Michael Harman said,

    November 11, 2006 at 2:11 pm

    And a tenner from me.

  37. Eileen said,

    November 11, 2006 at 2:25 pm

    I have asked whether there were any blind controls, and also the following:

    “My request is in relation all all such studies, whether yielding positive or negative results. Please provide me with information as to how many studies are involved.

    In particular I wish to have information about whether there were any “blind” comparisons i.e. was there in each (or any of the studies) a cohort of participants who did not receive the fish oils?

    Please let me have full details of the interpretation of the results of each study, taking into account the number of participants, the hypothesis on which it was based, and the statistical reliability of the results.

    As the Council is relying on these studies in its wide publicisation of the studies and the current trial, and especially as a representative of the company providing the fish oil has been on Woman’s Hour promoting the studies, I imagine that the information I request will be readily available in a form which can be provided to me easily.”

    Just let me know when you want the tenner

  38. rogerl said,

    November 11, 2006 at 2:37 pm

    email sent on Saturday 11/11/06

    Dear Mr Dinsdale,

    I am very interested in your omega-3 ‘trial’ and would like to make a freedom of information act request for information that you have to hand regarding the following:

    1. Outcomes, in particular, clearly defined primary and secondary outcome measures and, when applicable, any methods used to enhance the quality of measurements (e.g., multiple observations, training of assessors).
    2. Sample size – what the sample size was, how sample size was determined and, when applicable, explanation of any interim analyses and stopping rules.

    Please acknowledge receipt of this request and indicate how long you think it will take for you to provide the information.

    Thanks in anticipation

  39. kellar said,

    November 11, 2006 at 3:25 pm

    I think Humphrey (comment 29) has hit the nail on the head : this is at least in part a bureaucratic exercise.

    —-

    Dear Peter Dinsdale,

    With regard to the recently publicised trials of Equazen products (omega-3 oils &c) by Durham CC, I would like to register a request for data from you under the Freedom of Information Act.

    Given the nature of these trials, in schools and with public money and with what purport to be extremely favourable results, I desire to establish with complete clarity the nature of the relationship between the private company Equazen and public officials of Durham CC.

    So my F.o.I. request is as follows :

    1) Please provide me with copies of the agenda, list of attendees and minutes of all meetings between representatives of Equazen and officials of Durham CC.
    2) Please also provide me with copies of all correspondence between representatives of Equazen and officials of Durham CC.

    If available electronically I should be happy to receive this information by email; otherwise, my regular mail address is [hidden]

    I look forward to your reply.

    —-

  40. deryck said,

    November 11, 2006 at 3:52 pm

    I’ll put in a tenner.

  41. Ben Goldacre said,

    November 11, 2006 at 6:15 pm

    a truly brilliant response already, i’m so glad people feel the same way about this as i do. it really is important that if people go to the media banging on about their trials and studies and research proving stuff then they should also have basic trial info to back it all up.

    i don’t know if we’re allowed to pay the £750, but if it comes to that, i’ll try and come up with an imaginative way of getting it together.

    FoI strategic problems notwithstanding, i think in many respects this is a bit of a win-win situation. they may finally cave in and give the information, but i think the real victory is in showing that they are having such tremendous difficulty getting it together and handing it over. that really is risible. the information itself is almost secondary now. they’ve been prancing about on telly and in the newspapers for so long, going on and on about their brilliant studies and trials, bamboozling journalists with “science”, but portwood can’t return an email, answer a phone call, or cough up basic trial information without a huge fuss. ridiculous.

  42. hinschelwood said,

    November 11, 2006 at 6:15 pm

    As a resident in Germany, I don’t think I qualify for this. However, if necessary, I pledge a tenner to help get the information released.

    Freedom of information eh?. Pah.

  43. stever said,

    November 11, 2006 at 6:45 pm

    Theres been alot of discussions going on recently about the govt trying to cut down on
    over -zealous media organisations making FoI requests (one of whom was infact the guardian) and putting a charge on such requests was one of the ways of being discussed. If cost really is the issue its hard to see how they could then refuse if the money was produced, especially given that such a precise figure hgas been delivered. Regards the anti-campaign measure (fair enough really) , i think thats irrelevant. All this attention amounts to sufficient cause for the information to be provided and they will need to come up with some better excuses. I dont suppose Dinsdale is in cahoots with a conspiracy to conceal embarassing information (or lack of) so im sure if the case is made clearly and repeatedly he will will have to conceed.

    I have had FoI requests for Government documents rejected on the basis that they contained ‘sensiitive national security information’ or ‘contained priviledged advice to ministers’ . The documents in question were subsequently leaked to the media anyway and on examination clearly contained nothing of the sort. It was very clear that the minister in question had sought to find an excuse for not releasing potentially embarassing (as it turned out – actually embarassing) information that portrayed govet policy in a bad light. Ministers have the power to yay or nay FoI requests personally and since you usually dont get to check the validity of the reasons given for rejectinbg them you are basically powerless – beyond the questionable appeals process.

    In this case however – the fish oil stuff – there’s no ministers involved, an obvious public interest, easily obtainable information, and no credible reason for it being withheld. i totally support the efforts to get it released and will happily help front the cash as required.

  44. Suw said,

    November 11, 2006 at 7:55 pm

    I have created a pledge on Pledgebank for anyone willing to stump up a tenner to support Ben’s request.

    www.pledgebank.com/fishoils

    Even if the money isn’t ultimately required, I think that getting enough people to promise to cover the costs will indicate to Durham Council, and others, that we are serious about this issue, and that obfuscating this data is not acceptable. So please do go along and sign up. It only takes 75 of us, and I see we have 10 willing donors already!

  45. yellowfog said,

    November 11, 2006 at 7:58 pm

    I’m sure that the request will get nixed under the cost exemption clause, since as previously stated it allows the authority to roll up the requests “by different persons who appear to the public authority to be acting in concert or in pursuance of a campaign”. On this basis I’ve sent not a specific FOI request but a general email expressing my support for the existing requests.

    Having looked at the FOI regulations, though, I think it’s worth noting the second clause:

    “(2) This regulation applies in circumstances in which-
    (a) the two or more requests referred to in paragraph (1) relate, to any extent, to the same or similar information, and
    (b) those requests are received by the public authority within any period of sixty consecutive working days.” (www.opsi.gov.uk/si/si2004/20043244.htm)

    So the worst case scenario is (unless I’m reading this wrongly) that we wait for about three months without putting in any more requests, then put in one of the more limited ones.

    Of course, if we can get them to give us the info by paying for it, count me in for the standard tenner.

  46. sammcgregor said,

    November 11, 2006 at 8:01 pm

    Evening

    I went to the simple approach regarding the relationship.

    Dear Mr Dinsdale,

    I’m very interested in the recent trials of fish oil products by Durham CC and would like to register a request for data from you under the Freedom of Information Act. Please could you provide me with:

    1) Copies of all documents (including any held electronically) relating to the approval of this project by officials of Durham Council.

    2) Copies of all medical trial data, reports and analysis involving fish oils, which are in the possession of Durham Council.

    If available electronically I should be happy to receive this information by email; otherwise, I can provide a mail address.

    I look forward to your reply.
    Best wishes

    Sam McGregor

  47. ginger_parkin said,

    November 11, 2006 at 8:02 pm

    Have posted the following, and also forwarded to science student at Cambridge (she obviously ate lots of fish!!)

    Dear Mr Dinsdale

    This email is in support of Dr Goldacre’s FoI request, which he made a few weeks ago. He unexpectedly encountered difficulty exploring the details of the trials and studies performed by Durham. I am very interested in these studies.

    As you may be aware, Durham Council’s representatives (primarily Madeleine Portwood but also Dave Ford and the press office) have been reporting to the media since 2002 that they have performed numerous studies on the efficacy on omega-3 fatty acids on various outcomes in children and adults.

    To the best of my knowledge these have been performed in pre-school children, primary school children, and secondary school children in Durham, students in Durham and Edinburgh, schools in Middlesborough, schools in Sunderland, and possibly elsewhere. As per my previous FoI request I would be grateful for a comprehensive list of studies both completed and ongoing, regardless of whether they had positive or negative results, including studies that were not completed.

    For each of these studies I would like details as listed below. The positive results of these studies have been discussed extensively in the public domain and the media by Durham staff (going back several years) but I have been unable to obtain details that would enable me to assess these claims. Generally when researchers go to the media to promote positive results of completed studies, since the studies have been completed, and the researchers have been able to appraise the results, they are willing and able to explain the technical aspects of those studies.

    The specific details of what I need to know are as follows below. I would be grateful if you could give me this for each of the studies separately.

    I’d be grateful if you could also confirm receipt of this email.

    Yours sincerely

    [name and address]

    Baseline data

    Baseline demographic and clinical characteristics of each group. Numbers analyzed

    Number of participants (denominator) in each group included in each analysis and whether the analysis was by “intention-to-treat”. Could you please state the results in absolute numbers when feasible (e.g., 10/20, not 50%).

    Outcomes and estimation

    For each primary and secondary outcome, a summary of results for each group, and the estimated effect size and its precision (e.g., including a 95% confidence interval).

    Ancillary analyses

    Address multiplicity by reporting any other analyses performed, including subgroup analyses and adjusted analyses, indicating which of those were pre-specified and which were exploratory.

  48. Chris said,

    November 11, 2006 at 10:28 pm

    Dear Mr Dinsdale,

    I would like to request information on trials investigating the efficacy of
    Omega-3 fatty acids performed on adults and children by, or on the behalf
    of, employees of Durham Council.

    Specifically, I am interested in any and all studies, both completed and
    ongoing, whether published or unpublished, and without regard to whether the
    results were positive or negative.

    For studies that have been completed I would like to know:

    Outcomes and estimation

    For each primary and secondary outcome, a summary of results for each group,
    and the estimated effect size and its precision (e.g., including a 95%
    confidence interval).

    Ancillary analyses

    Address multiplicity by reporting any other analyses performed, including
    subgroup analyses and adjusted analyses, indicating which of those were
    pre-specified and which were exploratory.

    Adverse events

    All important adverse events or side effects in each intervention group.

    Interpretation

    Interpretation of the results, taking into account study hypotheses, sources
    of potential bias or imprecision and the dangers associated with
    multiplicity of analyses and outcomes.

    Generalizability (external validity) of the trial findings.

    General interpretation of the results in the context of current evidence.

    And for studies in progress or completed I would like to know what the
    protocols were.

    I would be grateful if you would give me an acknowledgement of this email.

    Thank you in advance for your assistance in this matter. As a concerned
    member of the public I am interested to know that there is adequate
    supporting information for scientific claims made directly to the media.
    After all, you can’t be too careful, as the Royal Free Hospital found out
    after the Wakefield MMR fiasco. I imagine the authorities at the University
    of Utah are still licking their wounds from the damage inflicted to their
    reputation when their cold fusion claims
    turned out to be so much cold er – water.

    Yours Faithfully,

    Chris

  49. adamf said,

    November 11, 2006 at 10:38 pm

    Have requested base data. Really hope Durham take the hint and get this right.

  50. DaveF said,

    November 11, 2006 at 10:46 pm

    Suw (44)

    A couple of hours ago I entered my name and email address to the PledgeBank site and got a message to say I’d been sent an email so I could continue, but haven’t received anything. Is there a problem I need to do something about or is it just slow?

    Ben and everyone

    Brilliant response. Let’s keep in there.

    Dave

  51. Statistician_04 said,

    November 11, 2006 at 11:13 pm

    I made the following request

    “Dear Mr Dinsdale,
    Freedom of Information Request

    Representatives of Durham Council (in particular Madeleine Portwood and Dave Ford ) have been making claims to the media since 2002 that they have undertaken trials on the effects of omega-3 fatty acids on children and adults. These trials are said to have demonstrated beneficial effects of omega-3 fatty acids.

    I am concerned to ensure that such claims are based on sound science. Therefore, I would like to make a Freedom of Information (FoI) request for details of these studies that would enable me to assess their scientific validity.

    In particular, the following (FoI) requests:

    As I am a statistician, I would particularly like to know details of the statistical methods used in the analysis of each trial to compare the outcome across different groups (for example, those given different doses of omega-3 and control groups).
    I would also like to know whether any future trials of the efficacy of Omega-3 are planned to be carried out under the auspices of Durham Council, whether directly by council employees or through contracted researchers.
    Can I please obtain copies of the scientific study protocol for such future trials.
    I look forward to hearing from you.”

  52. madscientist said,

    November 12, 2006 at 12:14 am

    I took a look at the Equazen website and read the slide show on how their reseach is conducted (which as you all already know has no real info). The last slide mentions that their data cannot be made public (I assume they mean “be published in a scientific journal”) until after peer review. I’d love to know which scientific journal they plan to submit to, and whether they have already submitted their manuscript. It is true that you won’t be likely to get hard numbers from them if they have not published yet, but then, claims should not be made to the public until such a time as that either by my way of thinking. Equazen admits freely that they can’t publish until peer review, but are making claims without it. One must also be skeptical of the reviewers and potential for conflict of interest.

  53. Robert Carnegie said,

    November 12, 2006 at 1:47 am

    Oh, forget it. Put in print in black and white that it’s a load of bollocks. It clearly is or they’d have published something.

    That, or can someone get some rats and some fish oil and poison the rats with the fish oil? That’s got to be feasible. Maybe just put one of the kids up to giving their pill to the class hamster which then turns up its toes. They always do anyway, but this way it was the fish oil that did it.

  54. Suw said,

    November 12, 2006 at 10:29 am

    Dave (50), if you’re Dave Ferris, then you’ve managed to sign up because I can see you on the list! No idea why Pledgebank was acting odd. I guess, like all websites, it has its moments.

  55. cassin said,

    November 12, 2006 at 10:32 am

    As another local government employee I agree with Humphrey’s comment about the cost of Durham’s time to pull out the information, and the better route being just to ask them for copies of documentation. In any case it looks as if the specific things mentioned by Dr Goldman have been requested, sometimes several times. I have added my ha’porth as follows:
    ——-
    Dear Peter Dinsdale

    II am interested in the process and results of the Omega 3 initiative, and would like to make a Freedom of Information Request as follows:

    A request for copies of any documentation about communication with staff in Durham schools about the project, both before it started, during the process, and subsequently. This should include letters to headteachers, including of schools in the authority that did not take part in the initiative, and minutes of meetings at which staff from the local authority and from Durham schools discussed the project.

    I am happy to receive these by email or by post. My postal address is

    [hidden]

    I understand that you have 20 working days to respond to my request, and I would be grateful if you would let me know that you have received this email.

    Best wishes
    ——-
    I’d also add that requests from Durham residents might well have more force, and that if their local paper is anything like ours in its keenness to investigate council doings, it is likely to be very interested.

  56. BHJ said,

    November 12, 2006 at 10:51 am

    I have explored Durham County Council site where you can get access to minutes etc. Trying Equazen just brings up their press releases. However, I did find that Dr Portwood had a collaborator – Dr Alexander Ruichardson from Mansfield College, Oxford. By accesscing the college site I found him and his list of publications which include some on the use of fish oil. I realize this does not solve the FOI problem, but it does provide some published scientific data.

    www.mansfield.ox.ac.uk/study/people/richardson.aspx

  57. pesch909 said,

    November 12, 2006 at 12:03 pm

    Done it, as follows:

    Dear Mr Dinsdale
    I am extremely interested in the claims in the media as to safety and efficacy of omega-3 fatty acids in producing various outcomes, which are allegedly backed by studies performed on children (and possibly adults) in Durham. I have a fish rich diet, and so would like to know what I might be doing to my brain.
    I’d like to make a freedom of information act request for details of how participants were selected and assigned, for all studies into fish oil performed by Durham employees in the past 5 years. Specifically, for each separate study I’d like the following information:

    Were the participants randomly allocated to different treatments? Method used to generate the random allocation sequence, including details of any restrictions (e.g., blocking, stratification)
    Method used to implement the random allocation sequence (e.g., numbered containers or central telephone), clarifying whether the sequence was concealed until interventions were assigned.
    Who generated the allocation sequence, who enrolled participants, and who assigned participants to their groups.

    Many thanks in advance for your help in this matter

  58. Ben Goldacre said,

    November 12, 2006 at 12:19 pm

    “As another local government employee I agree with Humphrey’s comment about the cost of Durham’s time to pull out the information, and the better route being just to ask them for copies of documentation.”

    although this is useful and interesting advice, we should remember there are really two issues at stake here.

    one is: can we get hold of whatever interesting bits of info durham/portwood do have.

    but the second is: can durham/portwood easily and unobstructively produce the kind of thorough information that one might expect a body to easily have before aggressively asserting positive trial data in the media over a long period of time?

  59. Ben Goldacre said,

    November 12, 2006 at 12:26 pm

    and can i just say how overwhelmed with joy i am to see members of the public demanding of a public body stuff like protocol deviations, intention to treat analyses, and randomisation strategies? hurrah!

  60. Seahorse said,

    November 12, 2006 at 1:31 pm

    Requested the three criteria under ‘Randomization’ in Ben’s posting above.

    I’m not going to post my email here as it makes it just fractionally harder to prove that I’m not requesting this as part of a campaign.

    Just fractionally!

  61. RobertK said,

    November 12, 2006 at 1:34 pm

    Everything seems to be covered. I’d suggest writing to the councillors (and getting people here to do the same) as a possible next step if this doesn’t work, It would be better if there are any Durham residents that could be convinced to write of course. Getting an MP to submit a request on your behalf could be handy as well.

    That not so useful advice aside, I’d just like to say that I’m a big admirer of your work. It’s great that people like you do this sort of work, even at times when it isn’t what most newspaper readers want to read more of. (I of course do want to see it).

  62. yellowbrickchick said,

    November 12, 2006 at 2:44 pm

    Emailed Peter Dinsdale giving my support for Ben’s FOI request, since it seems that any request I make myself would probably just be seen as part of a ‘campaign’.

    Great column- I just wish the rest of the media approached their scientific reporting in this way.

  63. Gordon said,

    November 12, 2006 at 3:35 pm

    I just had a quick look through Richardson and Puri (2002) and it looks like a decent pilot study on the effects of fatty acids supplements on the test scores of kids with a ADHD diagnosis. Double blind and placebo controlled as it says in the title. There were 15 kids in the active group and 14 in the placebo group and scores were comapred using some sort of comparison involving z-scores.

    Here’s the abstract if you’re interested:

    “(1) The authors tested the prediction that relative deficiencies in highly unsaturated fatty acids (HUFAs) may underlie some of the behavioral and learning problems associated with attention-deficit/hyperactivity disorder (ADHD) by studying the effects of HUFA supplementation on ADHD-related symptoms in children with specific learning difficulties (mainly dyslexia) who also showed ADHD features. (2) Forty-one children aged 8–12 years with both specific learning difficulties and above-average ADHD ratings were randomly allocated to HUFA supplementation or placebo for 12 weeks. (3) At both baseline and follow-up, a range of behavioral and learning problems associated with ADHD was assessed using standardized parent rating scales. (4) At baseline, the groups did not differ, but after 12 weeks mean scores for cognitive problems and general behavior problems were significantly lower for the group treated with HUFA than for the placebo group; there were significant improvements from baseline on 7 out of 14 scales for active treatment, compared with none for placebo. Group differences in change scores all favored HUFA, reaching conventional significance levels for 3 out of 14 scales. (5) HUFA supplementation appears to reduce ADHD-related symptoms in children with specific learning difficulties. Given the safety and tolerability of this simple treatment, results from this pilot study strongly support the case for further investigations.”

  64. abahachi said,

    November 12, 2006 at 3:41 pm

    Have also e-mailed to support Ben’s FOI request, stressing – in the vague hope that we’re dealing with reasonable people – that we have no intention of trying to bring Durham Council to a standstill by sending in multiple requests (which is the problem that the ‘no campaigns’ rule is intended to tackle) but are simply eager to see a single copy of the relevant information; that this is our aim should be abundantly clear from Ben’s original article and from the discussion here, both of which I’ve referenced.

  65. Dr Aust said,

    November 12, 2006 at 3:41 pm

    Re post #56 (BJH) -

    Dr Alex Richardson (who sometimes posts under the nom de blog “Evidence-Biased”) is connected to the charity “Food and Behaviour Research” which has a website at

    www.fabresearch.org/view_item.aspx?item_id=3

    - which is an excellent archive of fish-oil related stuff. Dr Richardson is a she, BTW.

    ..On the more general point, think Ben is right in post 58, there are two separate issues here:

    (i) will they cough up what they’ve got (which they can’t really refuse on cost grounds since it only amounts to collecting and photocopying).

    (ii) Does what they’ve got include the kind of info Ben would like, because if it doesn’t, they are clearly grossly incompetent and are not running anything other than a publicity stunt – as he says, quite opposite to what they have repeatedly “spun”.

    It’s good that we have people requesting both, but if I were being lawyerly, I might think it would be better to start with (i) (which I can’t see they have grounds to refuse under FoI) and then if/when they cough something up, to follow up with (ii), perhaps under the guise of “surely there must be further info”?

    Talking of (ii), they would presumably HAVE to have had all the kind of info Ben wants collated – or at least the pre-initiative “study design” bit of it – if they were going to get an Ethics Committee to approve it – Ethics Cttes inspect precisely this kind of info, and without it you would never get approved. So for the Richardson study that got published, all this would HAVE been done properly. The obvious implication is then that they avoided going this route for the “big initiative” – again, question is why.

    I think the idea of the requests coming from Durham people is a good one, as they are the ones to whom the Council is accountable. The Northern Echo

    www.thisisthenortheast.co.uk/

    which is the local paper, is a pretty serious set-up and should be well into what Durham Council and its Ed Dept are up to.

    Ben – how about emailing their health editor, Barry Nelson, (barry.nelson@nne.co.uk) who has written several stories about the fish oil initiative, some indicating an awareness of the scepticism, e.g.

    www.thenorthernecho.co.uk/search/display.var.910018.0.daily_fish_oil_capsules_will_make_a_difference_to_lives_of_teenagers.php

    If he isn’t reading these threads, why not??

  66. magenta said,

    November 12, 2006 at 4:54 pm

    Great stuff, although I expect that scox in comment 7 is correct in saying that it will be all too easy for Durham to repeat the earlier rejection on costs grounds. However, this is by no means an insurmountable problem. Humphrey is absolutely right in saying that , to keep costs down, it is better to ask for the raw information than to ask for specifics, which require people to sift through the information. We’re not talking about copying costs here, but about thinking costs.

    Those dealing with your requests have an obligation to provide reasonable assistance to you in making those requests. One of the things that means is that they should help you refine your request until it becomes answerable. Therefore, it’s acceptable to say “how should I amend my request in order that the cost of complying with it comes within the guidelines.”

    To imagineyoung and others: FOI applies no matter where you make your requests from; your location and citizenship is irrelevant (indeed, you don’t need to tell the public body who you are: a hotmail alias, or some equivalent non-geographical identify, is sufficient, as long as it can be used to provide the answer to your request.)

    As for the possibility that the publication exemption may apply (as Heronsgreen says in comment 31), that can only be used successfully if there is a realistic prospect of publication within a defined time period (as in “we will publish this information by March 2007″ or something similar.) If there isn’t, an appeal should succeed.

    And I take your point, Ben, that if all was well, they should have this information readily to hand and it would therefore be cheap to provide it. I think it’s still worth pursuing its release, or getting an admission that it doesn’t exist.

    I had come onto the site today intending to join your mission to get the information piecemeal. I suspect now it may be worth waiting a while to see what the reaction is to the requests you’ve got already. I have working knowledge of FoI from both sides and am happy to help with this if I can. But I’m fairly sure the people in Durham are feeling a bit under siege, and it’s always harder to get information out of people once they feel that way (it shouldn’t be so, but it’s true.)

  67. curranhung said,

    November 12, 2006 at 5:50 pm

    Mr Dinsdale will not be a happy bunny on Monday morning when he sees his Inbox. Maybe flattery will get a bit further, so I’ve posted the following:

    “Dear Mr Dinsdale

    “May I say how delighted I am that Durham Council is supplying Equazen fish oil to school children in order to boost their academic performance. It is an excellent way of spending public money and I hope Durham parents are grateful.

    “Is it possible to provide me with the reference to Madeleine Portwood’s study on fish oil (her “double-blind, randomised, one-way crossover placebo-controlled trial”), as I should like to persuade my local authority (the London Borough of Merton) to follow Durham’s lead in this.

    “Yours sincerely”

    On second thoughts, maybe I’ve overdone it. He’ll see through the sarcasm, won’t he. Ah well, too late now.

    And, yes, put me down for £10 if it’s needed to get the information.

  68. gazza said,

    November 12, 2006 at 5:53 pm

    My letter for the cause, as sent to Durham…….

    Dear Sir,

    I am very interested in the media coverage of an Omega 3 fish oil study based in Durham and elsewhere. Given the consequences of the work it is very important that the work is outlined publically in detail. This is how science works most effectively. If the details of such work are hidden from inspection then there is simply no way to analyse it or possibly build upon it, and the effort associated with the study can become a waste of time and money.

    Consequently I am making a Freedom of Information request for information on each and every one of the many different trials or studies into omega-3 fish oils that have been performed in children by Durham employees in the past 5 years

    Specifically, I am interested in the detailed results analysis;

    RESULTS
    Participant flow
    Flow of participants through each stage: specifically, for each group what were the numbers of participants randomly assigned, receiving the intended treatment, completing the study protocol, and analyzed for the primary outcome.
    Describe protocol deviations from study as planned, together with reasons.
    Recruitment
    Dates defining the periods of recruitment and follow-up.
    Baseline data
    Baseline demographic and clinical characteristics of each group. Numbers analyzed
    Number of participants (denominator) in each group included in each analysis and whether the analysis was by “intention-to-treat”. Could you please state the results in absolute numbers when feasible (e.g., 10/20, not 50%).
    Outcomes and estimation
    For each primary and secondary outcome, a summary of results for each group, and the estimated effect size and its precision (e.g., including a 95% confidence interval).
    Ancillary analyses
    Address multiplicity by reporting any other analyses performed, including subgroup analyses and adjusted analyses, indicating which of those were pre-specified and which were exploratory.
    Adverse events
    All important adverse events or side effects in each intervention group.
    Interpretation
    Interpretation of the results, taking into account study hypotheses, sources of potential bias or imprecision and the dangers associated with multiplicity of analyses and outcomes.
    Generalizability (external validity) of the trial findings.
    General interpretation of the results in the context of current evidence.

    Many thanks for your time and effort in considering this request,

    etc., etc……

  69. BobP said,

    November 12, 2006 at 6:03 pm

    There’s inconsistency as regards the relationship with Dr Alex Richardson. The website www.durhamtrial.org says:

    “The Education Authority was delighted that the Dyslexia Research Trust – an Oxford-based charity that has done much research into the causes of learning conditions, and Dr Alex Richardson, senior fellow of Mansfield College at Oxford University, whose specialty is on how fatty acids can help with learning conditions were keen to support this study”

    However the Northern Echo article (post 65) says:

    “Nutritionalist Dr Alex Richardson, director of charity Food and Behaviour Research, expressed doubt about the value of the scheme. “Durham is really going to struggle to come up with some hard evidence to prove they have made a difference,” he said.

    Could it be that Durham have taken a step too far?

  70. Ben Goldacre said,

    November 12, 2006 at 6:03 pm

    dinsdale is not the bad guy, he’s the FoI and data protection coordinator for the whole council, seems like a perfectly nice straight-up bloke in the emails i’ve had from him, he’ll simply have approached the appropriate people, mainly madeleine portwood i guess, passed on the request, advised them of the regulations, got an answer from them, and passed it on.

    i dont know about ambiguity in r’ship tween richrdson and durham, but i would guess she did a proper RCT in drham, with some help from durham staff (as it says in her paper on it), and then like any sane scientist she thinks their recent autonomous and ridiculous no control group “trials” are a farce.

  71. Farceside said,

    November 12, 2006 at 7:02 pm

    I have posted the following to Mr Dinsdale, although it should perhaps best be sent to an education officer.

    Dear Mr Dinsdale,

    I am sure that you share the government’s concern about the decline in numbers of students prepared to study sciences at A level. It is necessary, not only to the future health of British technology and engineering, but to the ability of non-scientists to make well-founded decisions on issues that affect their lives, that all pupils should be equipped with an understanding of the principles and procedures of scientific inquiry. For this reason, the columns of Ben Goldacre in the Guardian newspaper should be of real interest to anyone interested in supporting the integrity of scientific research and exposing the claims of false, or distorted, or (especially dangerous) secretive science, in which the cardinal obligation to make one’s results open to public scrutiny is ignored. It is public scrutiny of scientific results that makes science powerful, and this is what children can be helped to understand by examining the history of Durham County Council’s reluctance to make public results for which claims have been publicly made. They might be asked to consider what the grounds might be of such reluctance. They might be shown the refusal of the Council to meet the perfectly legal and reasonable Freedom of Information requests to examine the details of the advertised trials of the effects of fish oil supplements to the diets of Durham school children.

    If the cost of meeting the request is regarded as unreasonably high, I and many others would be happy to contribute. However, it is strange that there should be any great cost, since Ben Goldacre has asked for no more than the minimum information to be expected in any analysis of results of any such trial as advertised by Dr Madeleine Portwood, wherever such information is stored. In the end, it may be that the drama of comparing what Dr Portwood has claimed with what public scrutiny reveals will encourage many more children to pursue science as a subject of study.

    Please forward this email to others on the Durham County Council who may be interested.

    Your sincerely,

  72. Dr Aust said,

    November 12, 2006 at 7:33 pm

    BobP (post 69):

    ..for an insight into the relationship between Dr Alex Richardson and Durham see:

    www.badscience.net/?p=297

    - post 114 is the one you want.

    Basically as per Ben’s post 70 above.

  73. northern_pedant said,

    November 12, 2006 at 8:19 pm

    Only one ‘o’ in Middlesbrough .

  74. Ben Goldacre said,

    November 12, 2006 at 11:26 pm

    brilliant letter #71. dave ford at durham might be the right person to address that to, or possibly his boss, don’t know who that would be. or perhaps the council.

    i especially agree with your last comment, i think that cases like this are an excellent teaching example for critical appraisal of scientific data and claims, which is where all the action in science is, it’s a thousand times more interesting than “it’s true because ‘science’ says it is”, and in my experience kids (and adults) are really into probing behind the claims of grand authority figures to see if they can undermine them.

    i did some completely rocking teaching materials around bad science for kids with NESTA, which are available here:

    www.planet-science.com/sciteach/index.html?page=/sciteach/badscience/index.html

    i really ought to publicise them more widely at some stage.

  75. three tigers said,

    November 13, 2006 at 8:21 am

    As an ex-pat, ex-resident of Sunderland, I’ll write a letter to my parents MP (Chris Mullen – Sunderland South) asking him about these studies, since children in Sunderland are also involved.

    Last time I complained to him, about the UK’s totally pathetic recycling efforts, something actually happen to improve matters about 6 months later. Probably a coincidence, but I’ll write anyway.

  76. csrster said,

    November 13, 2006 at 10:06 am

    Perhaps Mr. Dinsdale can’t help because he’s too busy hiding from Spiny Norman?

  77. kim said,

    November 13, 2006 at 10:20 am

    Just had a look at the teaching materials and thought they were excellent – I particularly like the fact that they combine lots of things, ie learning how to carry out a scientific experiment, finding out how to approach information critically, and developing an understanding of how advertising works. Definitely ought to be disseminated more widely – has there been anything about them in the TES?

    Will be very interesting to see what Durham does now. Surely it will be easier for them to give out the information asked for rather than to spend weeks and weeks dealing with hundreds of emails.

  78. BobP said,

    November 13, 2006 at 10:27 am

    Thanks, Dr Aust. There’s a lot in thread 297 which I had missed.

  79. Kells said,

    November 13, 2006 at 11:10 am

    I’ve done my bit and asked for copies of the results for the outcomes and how the precision was estimated.
    Humphreys comments were noted and this should be staight forward for Durham.

    I will wait with baited breath
    (bait – fish get it?)

  80. Dr Reid said,

    November 13, 2006 at 11:57 am

    Let’s hope that Portman and colleagues can substantiate their claims in the very near future. My contribution is set out below.

    Dear Mr Dinsdale.

    I recently read, with considerable interest, the information posted on Durham County Council’s website (www.durhamtrial.org/index.htm) concerning the clinical efficacy of Equazen’s “EyeQ” formulation in improving certain behavioural outcomes in schoolchildren children diagnosed with a variety of behavioural and attentional difficulties.

    At first glance the data presented on the website appears to be encouraging. However, in the absence of more detailed information concerning the study design and statistical analyses employed to support the stated conclusions it is impossible to form a considered personal view.

    As a parent and a neuroscientist currently involved in investigating the neurochemical basis of attentional deficits I have a personal and professional interest in this work.

    I understand from your website, reports in the media, and elsewhere that studies have been performed in pre-school, primary and secondary children in Durham.

    Consequently, I would like to request the following information under the Freedom of Information Act.

    1. An exhaustive list of all studies completed, irrespective of whether they had positive or negative behavioural outcomes.

    For each of these studies, I would also like to request the following information concerning study design, statistical methodology and the underlying rationale for stated interpretations. This information is highlighted below in red.

    On a final note, it will not have escaped your notice that this request has been informed by Dr Ben Goldacre’s recent commentary in ‘The Guardian’. In my view, Dr Goldacre is pursuing a laudable and entirely legitimate avenue of enquiry. After all, if the claims set by Dr Madeleine Portwood and her colleagues are legitimate it is in their interest to ensure that the scientific methodology they employed is completely transparent and available to scrutiny by their scientific peers and by the public in general.

    I would be grateful if you could confirm receipt of this request

    Your sincerely

    ******************
    Dr Lee Reid
    Brighton

    METHODS

    Participants

    Eligibility criteria for participants and the settings and locations where the data were collected.

    Interventions

    Precise details of the interventions for each group and how and when they were actually administered.

    Objectives

    Specific objectives and hypotheses.

    Outcomes

    Clearly defined primary and secondary outcome measures and, when applicable, any methods used to enhance the quality of measurements (e.g., multiple observations, training of assessors).

    Sample size

    What the sample size was, how sample size was determined and, when applicable, explanation of any interim analyses and stopping rules.

    Randomization

    Were the participants randomly allocated to different treatments? Method used to generate the random allocation sequence, including details of any restrictions (e.g., blocking, stratification)

    Method used to implement the random allocation sequence (e.g., numbered containers or central telephone), clarifying whether the sequence was concealed until interventions were assigned.

    Who generated the allocation sequence, who enrolled participants, and who assigned participants to their groups.

    Blinding (masking)

    Whether or not participants, those administering the interventions, and those assessing the outcomes were blinded to group assignment, and if so, how.

    How the success of blinding was evaluated.

    Statistical methods

    Statistical methods used to compare groups for primary outcome(s); Methods for additional analyses, such as subgroup analyses and adjusted analyses.

    RESULTS

    Participant flow

    Flow of participants through each stage: specifically, for each group what were the numbers of participants randomly assigned, receiving the intended treatment, completing the study protocol, and analyzed for the primary outcome.

    Describe protocol deviations from study as planned, together with reasons.

    Recruitment

    Dates defining the periods of recruitment and follow-up.

    Baseline data

    Baseline demographic and clinical characteristics of each group. Numbers analyzed

    Number of participants (denominator) in each group included in each analysis and whether the analysis was by “intention-to-treat”. Could you please state the results in absolute numbers when feasible (e.g., 10/20, not 50%).

    Outcomes and estimation

    For each primary and secondary outcome, a summary of results for each group, and the estimated effect size and its precision (e.g., including a 95% confidence interval).

    Ancillary analyses

    Address multiplicity by reporting any other analyses performed, including subgroup analyses and adjusted analyses, indicating which of those were pre-specified and which were exploratory.

    Adverse events

    All important adverse events or side effects in each intervention group.

    Interpretation

    Interpretation of the results, taking into account study hypotheses, sources of potential bias or imprecision and the dangers associated with multiplicity of analyses and outcomes.

    Generalizability (external validity) of the trial findings.

    General interpretation of the results in the context of current evidence

  81. Lave said,

    November 13, 2006 at 12:13 pm

    Wow, 79 comments. I don’t have time to read them all right now and work out what still needs asking for. But I’ll look through it as soon as I get a moment, and send an email off. Even if I’m just repeating requests.

    I like this. A lot.

  82. Ben Goldacre said,

    November 13, 2006 at 12:32 pm

    this is excellent, i wonder if some public spirited type who is at home with nothing to do today could be bothered to go to

    www.badscience.net/wiki

    and use that to collate what’s been requested, what’s remaining, maybe make a skeleton for when the information starts coming back?

    this really is distributed journalism in action, you lot are a work of art.

  83. criv said,

    November 13, 2006 at 12:36 pm

    I currently work in Phase III clinical trials and know all too well about how much effort goes into conducting a ‘proper’ clinical trial that give results that actually mean something. I’d be happy to offer any advice/support I can or join the FoI march. Think all the data items have been requested – but I’ll watch this space for any developments. My friends are already sick of my b!tching about bad science at the pub, but I predict they’ll be getting another earful about all this . . .

  84. Lave said,

    November 13, 2006 at 12:52 pm

    I’ve copied over the “list of demands”. People could annotate in what they have requested?

  85. criv said,

    November 13, 2006 at 12:53 pm

    Ok – just had a quick look on the ISRCTN website (where all clinical trials who want to be clinical trials should be registered, Darling) and there’s one Equazen related trial listed – www.controlled-trials.com/ISRCTN27741572/equazen
    Seemingly they have not had ethical approval (but ISRCTN website is not always updated that often). You usually apply for an ISRCTN number at the same time as submitted ethical approval, but can do it afterwards – making me think perhaps there’s been a hold-up with the ethics approval? COREC guidelines (Central Office for Reseach Ethics Committees – where all ethical approvals in the UK go through) state the ethics committee must give a decision in 35 days of receipt of the application – however, the committee can come back to the applicant once with questions, during which time the ‘clock stops’.

    I’m not entirely sure, but I think that once a trial/study has ethical approval, the protocol is actually in the ‘public domain’ – I will check with COREC and see if there’s a way to access protocols through them . . . .

  86. icarus said,

    November 13, 2006 at 1:00 pm

    Well, I have finally got a reply from the MHRA on this:

    “It is not clear from the press release whether this is a clinical trial of a medicinal product or a food supplement. Unfortunately if any information had been provided to the MHRA we would be unable to discuss it with anyone other than the trial sponsor. The press release names contacts in both the company and the county council who may be able to help you with your enquiry.”

    Glad to see even the MHRA can’t figure out if its a CTIMP or not.

  87. Ben Goldacre said,

    November 13, 2006 at 12:58 pm

    i know the prof running that one ADHD/omega-3 registered trial and i can guarantee you he is meticulous and beyond reproach. that’s why, for example, it’s registered! prof taylor is in a different league from the durham characters and it’s unthinkable that he should ever be tarred with the same brush.

    interestingly, as a general point, people who do sound nutrition research are just starting to wake up and start complaining about the questionable activities that are being associated with their field and giving it a bad name.

  88. jdc325 said,

    November 13, 2006 at 2:51 pm

    Cheers coracle

  89. tjb said,

    November 13, 2006 at 2:51 pm

    Hopes that the disappearance of this page is for positive reasons….

  90. RobertK said,

    November 13, 2006 at 3:11 pm

    The story so far:

    Requested “participants”, “sample size”, and “randomization” (together they seem to fit the “participant selection” theme.
    (-rvcx)

    Requested “Protocol for studies not yet completed” and “Material relating to each study”.
    (-tickmc)

    1) The specific objectives and hypotheses of studies.
    2) Whether or not participants, those administering the interventions, and those assessing the outcomes were blinded to group assignment.
    3) How the success of that blinding was evaluated.
    4) A summary of the results obtained
    5) The interpretation of the results, taking into account study hypotheses, sources of potential bias or imprecision and the dangers associated with multiplicity of analyses and outcomes.
    6) Generalizability (external validity) of the trial findings.
    7) General interpretation of the results in the context of current evidence.
    (-LovePanda)

    Request posted for “Specific objectives and hypotheses”, “baseline data” and “how the interpretation of the results took the hypotheses into account”
    (-skjg)

    I went for “Interventions” and “objectives”
    (-strathers)

    asked for Protocols of studies not completed and material relating to each study.
    (-stewartmacdonald2000)

    Have requested blinding and statistical methods.
    (-stonybonytony)

    RESULTS

    Participant flow

    Flow of participants through each stage: specifically, for each group what were the numbers of participants randomly assigned, receiving the intended treatment, completing the study protocol, and analyzed for the primary outcome.

    Describe protocol deviations from study as planned, together with reasons.

    Recruitment

    Dates defining the periods of recruitment and follow-up.

    Baseline data

    Baseline demographic and clinical characteristics of each group. Numbers analyzed.

    Number of participants (denominator) in each group included in each analysis and whether the analysis was by “intention-to-treat”. Could you please state the results in absolute numbers when feasible (e.g., 10/20, not 50%).
    (-beebhack)

    Asked for the stuff under blinding and statistical methods.
    (Domo)

    Eligibility criteria for participants and the settings and locations where the data were collected.

    What the sample size was, how sample size was determined..

    Were the participants randomly allocated to different treatments? Method used to generate the random allocation sequence, including details of any restrictions (e.g., blocking, stratification)

    Method used to implement the random allocation sequence (e.g., numbered containers or central telephone), clarifying whether the sequence was concealed until interventions were assigned.
    (-CityBill)

    I asked the 3 questions about interpretation of the results.
    (-Nigel Coe)

    basically asking for ‘outcomes and evaluation’ and ‘anillary analysis’
    (-lozzer)

    Requested baseline data, outcomes and adverse events
    (-MarkS)

    details of statistical methods used to compare groups for primary outcome(s) as well as the methods for additional analyses, such as subgroup analyses and adjusted analyses
    (-Brock)

    I have asked whether there were any blind controls, and also the following:

    “My request is in relation all all such studies, whether yielding positive or negative results. Please provide me with information as to how many studies are involved.

    In particular I wish to have information about whether there were any “blind” comparisons i.e. was there in each (or any of the studies) a cohort of participants who did not receive the fish oils?

    Please let me have full details of the interpretation of the results of each study, taking into account the number of participants, the hypothesis on which it was based, and the statistical reliability of the results.

    As the Council is relying on these studies in its wide publicisation of the studies and the current trial, and especially as a representative of the company providing the fish oil has been on Woman’s Hour promoting the studies, I imagine that the information I request will be readily available in a form which can be provided to me easily.”
    (-Eileen)

    1. Outcomes, in particular, clearly defined primary and secondary outcome measures and, when applicable, any methods used to enhance the quality of measurements (e.g., multiple observations, training of assessors).
    2. Sample size – what the sample size was, how sample size was determined and, when applicable, explanation of any interim analyses and stopping rules.
    (-rogerl)

    1) Please provide me with copies of the agenda, list of attendees and minutes of all meetings between representatives of Equazen and officials of Durham CC.
    2) Please also provide me with copies of all correspondence between representatives of Equazen and officials of Durham CC.
    (-kellar)

    1) Copies of all documents (including any held electronically) relating to the approval of this project by officials of Durham Council.

    2) Copies of all medical trial data, reports and analysis involving fish oils, which are in the possession of Durham Council.
    (-sammcgregor)

    Baseline data

    Baseline demographic and clinical characteristics of each group. Numbers analyzed

    Number of participants (denominator) in each group included in each analysis and whether the analysis was by “intention-to-treat”. Could you please state the results in absolute numbers when feasible (e.g., 10/20, not 50%).

    Outcomes and estimation

    For each primary and secondary outcome, a summary of results for each group, and the estimated effect size and its precision (e.g., including a 95% confidence interval).

    Ancillary analyses

    Address multiplicity by reporting any other analyses performed, including subgroup analyses and adjusted analyses, indicating which of those were pre-specified and which were exploratory.
    (-ginger_parkin)

    For studies that have been completed I would like to know:

    Outcomes and estimation

    For each primary and secondary outcome, a summary of results for each group,
    and the estimated effect size and its precision (e.g., including a 95%
    confidence interval).

    Ancillary analyses

    Address multiplicity by reporting any other analyses performed, including
    subgroup analyses and adjusted analyses, indicating which of those were
    pre-specified and which were exploratory.

    Adverse events

    All important adverse events or side effects in each intervention group.

    Interpretation

    Interpretation of the results, taking into account study hypotheses, sources
    of potential bias or imprecision and the dangers associated with
    multiplicity of analyses and outcomes.

    Generalizability (external validity) of the trial findings.

    General interpretation of the results in the context of current evidence.

    And for studies in progress or completed I would like to know what the
    protocols were.
    (-Chris)

    Have requested base data.
    (-adamf)

    As I am a statistician, I would particularly like to know details of the statistical methods used in the analysis of each trial to compare the outcome across different groups (for example, those given different doses of omega-3 and control groups).
    I would also like to know whether any future trials of the efficacy of Omega-3 are planned to be carried out under the auspices of Durham Council, whether directly by council employees or through contracted researchers.
    Can I please obtain copies of the scientific study protocol for such future trials.
    (-Statistician_04)

    A request for copies of any documentation about communication with staff in Durham schools about the project, both before it started, during the process, and subsequently. This should include letters to headteachers, including of schools in the authority that did not take part in the initiative, and minutes of meetings at which staff from the local authority and from Durham schools discussed the project.
    (-cassin)

    Were the participants randomly allocated to different treatments? Method used to generate the random allocation sequence, including details of any restrictions (e.g., blocking, stratification)
    Method used to implement the random allocation sequence (e.g., numbered containers or central telephone), clarifying whether the sequence was concealed until interventions were assigned.
    Who generated the allocation sequence, who enrolled participants, and who assigned participants to their groups.
    (-pesch909)

    Requested the three criteria under ‘Randomization’ in Ben’s posting above.
    (-Seahorse)

    “Is it possible to provide me with the reference to Madeleine Portwood’s study on fish oil (her “double-blind, randomised, one-way crossover placebo-controlled trial”),
    (-curranhung)

    RESULTS
    Participant flow
    Flow of participants through each stage: specifically, for each group what were the numbers of participants randomly assigned, receiving the intended treatment, completing the study protocol, and analyzed for the primary outcome.
    Describe protocol deviations from study as planned, together with reasons.
    Recruitment
    Dates defining the periods of recruitment and follow-up.
    Baseline data
    Baseline demographic and clinical characteristics of each group. Numbers analyzed
    Number of participants (denominator) in each group included in each analysis and whether the analysis was by “intention-to-treat”. Could you please state the results in absolute numbers when feasible (e.g., 10/20, not 50%).
    Outcomes and estimation
    For each primary and secondary outcome, a summary of results for each group, and the estimated effect size and its precision (e.g., including a 95% confidence interval).
    Ancillary analyses
    Address multiplicity by reporting any other analyses performed, including subgroup analyses and adjusted analyses, indicating which of those were pre-specified and which were exploratory.
    Adverse events
    All important adverse events or side effects in each intervention group.
    Interpretation
    Interpretation of the results, taking into account study hypotheses, sources of potential bias or imprecision and the dangers associated with multiplicity of analyses and outcomes.
    Generalizability (external validity) of the trial findings.
    General interpretation of the results in the context of current evidence.
    (-gazza)

    METHODS

    Participants

    Eligibility criteria for participants and the settings and locations where the data were collected.

    Interventions

    Precise details of the interventions for each group and how and when they were actually administered.

    Objectives

    Specific objectives and hypotheses.

    Outcomes

    Clearly defined primary and secondary outcome measures and, when applicable, any methods used to enhance the quality of measurements (e.g., multiple observations, training of assessors).

    Sample size

    What the sample size was, how sample size was determined and, when applicable, explanation of any interim analyses and stopping rules.

    Randomization

    Were the participants randomly allocated to different treatments? Method used to generate the random allocation sequence, including details of any restrictions (e.g., blocking, stratification)

    Method used to implement the random allocation sequence (e.g., numbered containers or central telephone), clarifying whether the sequence was concealed until interventions were assigned.

    Who generated the allocation sequence, who enrolled participants, and who assigned participants to their groups.

    Blinding (masking)

    Whether or not participants, those administering the interventions, and those assessing the outcomes were blinded to group assignment, and if so, how.

    How the success of blinding was evaluated.

    Statistical methods

    Statistical methods used to compare groups for primary outcome(s); Methods for additional analyses, such as subgroup analyses and adjusted analyses.

    RESULTS

    Participant flow

    Flow of participants through each stage: specifically, for each group what were the numbers of participants randomly assigned, receiving the intended treatment, completing the study protocol, and analyzed for the primary outcome.

    Describe protocol deviations from study as planned, together with reasons.

    Recruitment

    Dates defining the periods of recruitment and follow-up.

    Baseline data

    Baseline demographic and clinical characteristics of each group. Numbers analyzed

    Number of participants (denominator) in each group included in each analysis and whether the analysis was by “intention-to-treat”. Could you please state the results in absolute numbers when feasible (e.g., 10/20, not 50%).

    Outcomes and estimation

    For each primary and secondary outcome, a summary of results for each group, and the estimated effect size and its precision (e.g., including a 95% confidence interval).

    Ancillary analyses

    Address multiplicity by reporting any other analyses performed, including subgroup analyses and adjusted analyses, indicating which of those were pre-specified and which were exploratory.

    Adverse events

    All important adverse events or side effects in each intervention group.

    Interpretation

    Interpretation of the results, taking into account study hypotheses, sources of potential bias or imprecision and the dangers associated with multiplicity of analyses and outcomes.

    Generalizability (external validity) of the trial findings.

    General interpretation of the results in the context of current evidence
    (-Dr Reid)

    I’m afraid that after that, I can’t now be bothered to compare it with the original list, but it should be helpful to anyone else who wants to give it a go.

  91. Teek said,

    November 13, 2006 at 3:14 pm

    same here – is there something rotten in the state of Denmark (aka Durham)…?!

  92. Dr* T said,

    November 13, 2006 at 3:29 pm

    It seems it’s alive here

    www.badscience.net/?p=321

    but not from the normal route, here:

    www.badscience.net

    I’m too simple to understand why :)

  93. Ben Goldacre said,

    November 13, 2006 at 4:33 pm

    yeah my fault, reckless posting from PDA at lunch… back now.

  94. Jon Griffith said,

    November 13, 2006 at 7:06 pm

    Here is my £10 worth:

    Dear Mr Dinsdale

    I would be grateful for a comprehensive list of the Council’s Omega-3 Fatty
    Acid studies, both completed and ongoing, regardless of whether they had
    positive or negative results, including studies that were not completed.

    My reason for asking this is that Durham County Council administers fish-oil
    medecine to its students, whilst withholding the scientific evidence
    justifying this action. The Council can protect itself from any suspicion
    of malfeasance by exposing this evidence to scientific peer-review.
    Moreover, if the faith of council officers in the efficacy of fish-oil is
    justified by the evidence, then there should be a duty to publish and inform
    the rest of the world of these benefits.

    I note that a similar recent FoI request from Mr Goldacre has been declined
    by the Council on the ground of cost. Please note that I am willing myself
    to pay a portion of the cost.

    I am copying this email to Councillor Ernie Foster, the Chairman of Durham
    County Council, so that he may also be aware of the importance of
    scientifically assessing the benefits of fish oil.

    Jon Griffith

  95. Filias Cupio said,

    November 13, 2006 at 8:01 pm

    A little off-topic, but here is a gem:
    Smith, G.C.S and Pell, J.P. “Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials” BMJ 2003;327:1459-1461.

    www.bmj.com/cgi/content/full/327/7429/1459?maxtoshow==10=10&RESULTFORMAT==parachute&andorexactfulltext=and&searchid=1112120657192_15640&stored_search=X=0&sortspec=relevance&resourcetype=1

    Some quotes:

    “Our search strategy did not find any randomised controlled trials of the parachute.”

    “It is a truth universally acknowledged that a medical intervention justified by observational data must be in want of verification through a randomised controlled trial.”

    “…individuals jumping from aircraft without the help of a parachute are likely to have a high prevalence of pre-existing psychiatric morbidity. Individuals who use parachutes are likely to have less psychiatric morbidity and may also differ in key demographic factors, such as income and cigarette use.”

  96. q said,

    November 13, 2006 at 8:07 pm

    Dear Mr Dinsdale,

    I appreciate that you have your hands full with Freedom of Information Act requests this week, and I am genuinely reluctant to add any further to your workload. However, I’ve been following recent media reports of Durham County Council’s fish oil “trials” and I am worried that the Council’s actions do not meet basic scientific and ethical standards.

    I was particularly concerned when I read in Saturday’s Guardian that you had refused a Freedom of Information Act request from Ben Goldacre on the grounds that “It is estimated that it would take 30 hours to fully respond to this second request, which would cost £750 when calculated using the statutory rate of £25 per hour.” As Dr Goldacre noted in his article, his request was for basic information which Durham County Council should have to hand before making public claims about its trials. Moreover, I’m sure you can appreciate the overwhelming public interest in making the results of these trials fully known.

    I would like to make a Freedom of Information Act request for all correspondence relating to Dr Goldacre’s Freedom of Information Act request (including, but not limited to, any discussion of grounds for refusal of his request, and the source of the estimate that it would take 30 hours to fully respond). Please include the agenda and notes of any meetings at which his request was discussed.

    I would appreciate if you could confirm receipt of my request. Thank you in advance for your cooperation.

    Kind Regards,

  97. chas said,

    November 13, 2006 at 9:02 pm

    OK just got round this after reading it at the weekend. I live in Durham city, with two kids at school in Durham (not at the age for fish oil tho’) and I’m also an an ex school governor. Apart from a general complaint to my City and County councillors, anything specific I could go for, given the activity of the rest of you already?

  98. sc_ww said,

    November 13, 2006 at 9:09 pm

    Am a bit late getting round to this but the effort has my whole-hearted support! From the wiki, most things seem to have been covered, so this was my 10 cents worth:

    Dear Mr Dinsdale,

    I read with interest your Council’s web-site on its fish-oil trial (www.durhamtrial.org/) which purports to show significant improvements in the abilities and behaviour of students receiving fish-oil supplements.

    As part of an effort to scrutinise the scientific merit of this study – which seems not to have been published in a peer-reviewed journal, I would like to request the following information under the terms of the FOI Act.

    For the studies described on your website:

    What were the eligibility criteria for participants and the settings and locations where the data were collected?

    What are the precise details of the interventions for each group and how and when they were actually administered.

    What were the specific objectives and hypotheses of the study?

    What were the primary and secondary outcome measures and, where applicable, what methods were used to enhance the quality of measurements (e.g., multiple observations, training of assessors).

    What were the sample and control group sizes and how were they determined?

    Thank you for your help in this matter.

    Best wishes,

    Dr Stephen Curry

  99. McCruiskeen said,

    November 13, 2006 at 9:09 pm

    On 31st October, I e-mailed Councillor Claire Vasey, Cabinet Member for Children’s Services, Durham County Council. Being concerned at the “pasting” DCC was taking in the national media and the “stonewalling” backtracking and general obfuscation that was apparent from the council, I wanted to know what the position of council members was, in view of the fact that it is reported (in the You and Yours broadcast, for example) that the “trial” (sorry – initative) had the full support of councillors.

    I further expressed the hope to Councillor vasey that a robust enquiry into how this sorry state of affairs, that has done so much to damage DCC’s good reputation, came about and who carries responsibility for it.

    In order to assist her thinking in the matter, I suggested the following questions she might care to use in order to make some pertinent enquiries into this debacle, that is so damaging to her council:

    Did DCC approach Equazen, or vice versa?

    Have there been any financial or other inducements from equazen in cash or in kind?

    Who planned the trial (or initiative)?

    What are its stated aims and objectives?

    Have they changed at all following the recent events in the national media?

    Who sanctioned its implementation in schools?

    Was a written plan for the trial (or initiative) prepared?

    is so, by whom?

    What supporting documentation (if any) was given to the participating schools?

    Was a coherent evaluation strategy for the trial (or initiative) prepared as part of the plan?

    If so, how was the trial (or intiative) to be evaluated?

    Who is leading the trial (or initative)?

    Who is responsible for its evaluation?

    Who prepared the material for the DCC press releases on the trial (or intiative)?

    Why was it that nobody, including Dr Portwood, senior educational Psychologist, and David Ford, Chief Education Inspector (whose main subject in teacher training was science) could see that without appropriate controls, any results would be worthless?

    Why did david Ford, following ridicule of the trial by ben Goldacre in his Bad Science column, suddenly declare that that the trial was, in fact, an initiative?

    Why was it reported by the You and Yours team that the trial (or initiative) has the full backing of County Councillors?

    Has the trial (or initiative) been discussed and agreed in any committee of members of DCC?

    If so, what briefing papers were provided and was the “initiative” described as a trial?

    Were the methodological implications of the trial (or initiative) explained to members?

    Were the evaluation implications of the trial (or initiative) – that any results would be meaningless – explained to members?

    Did members raise any questions or doubts and if so, how were these dealt with?

    If questions were asked by members, what discussion, if any, took place regarding the ethical considerations of becoming involved with a company such as Equazen, which has a clear commercial imerative?

    Who signed the “deal” with Equazen?

    Do members actually realise the damage that has been done to DCC through being pilloried in this way in the national press?

    Why has no-one in DCC realised that what eleven-year old children are taught in Science in the authority’s primary schools about controls in experiments and “fair testing” would enable those very children to understand why this particular trial (or intiative) was not only fatally flawed, but also a travesty of scientific method?

    Students in Year Eleven, being given fish oil capsules and studying science, will be more than capable of understanding the glaring flaws in the methodology of the trial (or intiative) in which they are participating as part of its cohort. Does a scientist like david Ford, who presumably inspects Science teaching, or indeed anyone else in his department, not appreciate the inherent irony here; that the students could certainly have designed a trial that would have yielded significant data?

    Now that the trial is now an initiative (although somewhat worryingly, David Ford had trouble remembering that when interviewed by the You and Yours reporter last Thursday) from which no reliable conclusions can be drawn, what is the point of continuing with it and thereby heaping further opprobrium upon DCC, especially as the summer of 2007 approaches, when the GCSE results are published and the media engage in a “feeding frenzy”?

    Who has been co-ordinating the “climb down” and “face saving” strategies so apparent in the You and Yours broadcast?

    Now that DCC is a virtual laughing stock in intelligent society, who carries the responsibility for that and has any form of of inquest been undertaken by members?

    What has been the role of the Director of Children’s Services in all of this?

    What has been the role of the Lead Member for Chilodren’s services in this?

    I can report that Councillor Vasey replied on 9th November as follows:

    “I have forwarded your e-mail to Chief Inspector Dave Ford in order for him to address the issues you have raised. I hope this is helpful.

    Claire Vasey, cabinet member for Children’s services”

    Talk about passing the parcel!!

    Reading the first line of her reply, I thought she had passed my letter to the police!

    I have suitably replied to Councillor vasey, in fairly robust fashion asking, among other things, “Are you telling me that as Lead member for Children’s Services, you do not understand the issues I have raised?”

    I have also asked if the tail is wagging the dog in DCC and has she really forwarded my direct questions that only she, as Cabinet Member for Children’s Services, can answer, to the Chief Education Inspector, so that he can answer them for her?

    I conclude by asking her to grasp the nettle and let me have her own views.

    McCruiskeen

  100. McCruiskeen said,

    November 13, 2006 at 9:24 pm

    A thought occurs to me:

    What does one of David Ford’s Link Inspectors say when he or she goes into a secondary school and observes a science lesson in Year Eleven, in which the concepts of “fair testing” and the control of variables are being taught, when those very students are being dialy fed fish oil capsules as part of a trial (sorry – initiative) being carried out by that inspector’s chief, that is methodologically contrary to everything those students are being taught as “Good Science”?

    ‘Twas ever thus – “Don’t do as I do; do as I say!”

    (Tablets from Mount Sinai, anyone, beautifully carved in stone – buy one, get one free!)

  101. Neil Desperandum said,

    November 13, 2006 at 9:31 pm

    In addition to all this impressive distributed journalism, have you though about opening another front via the schools themselves?

    I would love to know what the science teachers in the Durham secondary schools think about this fish oil saga. Are they asking questions of their Heads and education authority contacts? I know if this was happening in my school I’d be making a right pain of myself at staff meetings and LEA network meetings, asking pertinent questions.

    So why not get your team of researchers and assistants to write directly to the heads of science at all 36 Durham secondary schools, to ask their opinion of the “trial”, what they have been told, and if they have used it in their lessons.

  102. Neil Desperandum said,

    November 13, 2006 at 9:33 pm

    Another thought has just occured to me (two in one day – it must be the fish oil that’s doing it).

    What will Adam Kelliher and Dave Ford do when they get wind of all this? They may see their PR triumph turning into a PR disaster. Assuming there is no scientific basis for the fish oil claims, so Ben’s requests can’t be answered, what do they do?

    Try to regain the PR upper hand again, that’s what.

    And one way to do that would be to stop the “trial” and claiming loudly to all the journalists that the poor children of Durham have been denied a wonderful opportunity to improve their GCSE grades by intolerable interference from mean old Ben Goldacre and his Guardian-reading cronies. They could make quite a story (they are experts after all) and we could name loads of journalists and newspapers who would lap it up.

    Could it happen?

  103. Ben Goldacre said,

    November 14, 2006 at 12:02 am

    mmm i dont think there’ll be NO scientific basis to the fish oil claims, what i think is that they have been diving in for a long time adopting the cloak of scientific authority, talking about their trials, saying they’ve performed them, assessed them, they’re “positive”, but they don’t seem to be very willing to discuss the details. all things considered this, combined with their, er, intellectually weak deportment over the “trial-no-wait-initiative” nonsense, the fact that portwood is not a published trial researcher, the superficiality and rubbishness of their “results” website, etc etc etc, all leads me to suspect that whatever they have done, it may not turn out to be of the highest standard.

    i should mention – and i bet you durham are going to come back with this – that like i said the last time i wrote about this, portwood, who is falling over herself to get on channel 4 news and bamboozle nonscience journalists, and talk to local newspaper reporters, didnt reply to emails or phone calls, i can only get answers, rather censorious ones too, with a huge delay, through the durham press office, even though they say they know nothing and can only pass on my questions to their experts, and they turned down the FoI request, after the full 4 week wait…. they DID, in their defense, invite me to go up there. so i can’t get a courteous answer, any answer at all, to an email, or a phone call, or get info in my FoI request, but if i travel hundreds of miles up north, IN PERSON, oh, then they will talk to me…

    right.

    a bunch of timewasters.

  104. beebhack said,

    November 14, 2006 at 7:23 am

    (Maybe) interestingly, the Durham stuff, or at least some of it, appears to have been taken off the Equazen website. It you follow their online tried-and-tested demo, and select the ‘Durham Trial’ link, you’re directed here www.equazen.com/default.aspx?pid=120 — which doesn’t, at time of writing, exist.

  105. ayupmeduck said,

    November 14, 2006 at 7:36 am

    I tried a slightly different approach. Hopefully we can appeal to DCC’s common sense since I figure that if Durham Council don’t accept Ben’s request then many of us will be making a whole bunch of piecemeal FoI requests. I’m not convinced that DCC could resist these requests under Reg. 5 since we would at that point no longer be acting in concert.

    Dear Mr. Dinsdale,

    I trust that by now you have read the article by Ben Goldacre in the Manchester Guardian of 11th September? This explains why the FoI request filed by Dr. Goldacre is not only of interest to myself and others, but is a matter of public interest. In a nutshell, Ben Goldacre requires Durham Councils assistance with his FoI request so as to validate the scientific basis of the claims made by Durham Council representatives such as Madeleine Portwood.

    I do not wish to add to your workload by making my own FoI request at this time, since I fully expect that Durham Council will find a way of accommodating Dr. Goldacre. I don’t know what other support I can offer you or Ben Goldacre at this time except that maybe you can point out to your management that if Dr. Goldacre is not given reasonable access to the information he requires, the only method left to the rest of us will be to make our own FoI requests. I expect that there would a rather large number of these individual requests, and the cost of dealing with each and every one would be far higher than simply accepting Dr. Golacres original request.

    Thanks for you support in this matter

  106. ayupmeduck said,

    November 14, 2006 at 8:42 am

    Oh, and I forgot, count me in for 10 quid if needed.

  107. Teek said,

    November 14, 2006 at 8:56 am

    i’m in re: £10 if and when needed, drafting e-mail in between cloning plasmids at work…!!

  108. Suw said,

    November 14, 2006 at 10:14 am

    OK… so Durham are only willing to talk to Ben in person. Is there anyone here who lives in Durham and who would be willing to pop in on his behalf with a list of questions and a tape recorder?

  109. kim said,

    November 14, 2006 at 10:38 am

    If all else fails, Ben could make a complaint to the Information Commissioner.

  110. Tristan said,

    November 14, 2006 at 1:11 pm

    Here’s my request. Hope they don’t find it somewhat patronising. That wasn’t my intention at all! Cuuldn’t resist a dig at national science press reporting though!

    Oh, and I’m in for a tenner too!

    Dear Mr Dinsdale,

    I have read with great interest in the media details of the Omega-3 fish oils supplement initiative taking place in Durham school with the support of Equazen. It shows great corporate social responsibility that a company such a Equazen would be so willing to devote funding and resources so selflessly to help children reach their full potential, and I am also greatly impressed by Durham County Council’s involvement in this. Well done you!

    Unfortunately, the national press science output being what it is I have found it particularly difficult to find out more information on the details of this trial. I’m sure DCC and Equazen have tried to be as clear as possible with the press but they never report these kinds of things particularly well I find.

    I would therefore like to make a Freedom of Information Request for details of the results of this trial. More specifically, I was wondering if you could provide me with the following information:

    Outcomes and estimation
    For each primary and secondary outcome, a summary of results for each group, and the estimated effect size and its precision (e.g., including a 95% confidence interval).

    Ancillary analyses

    Address multiplicity by reporting any other analyses performed, including subgroup analyses and adjusted analyses, indicating which of those were pre-specified and which were exploratory.

    Adverse events

    All important adverse events or side effects in each intervention group.

    Interpretation

    Interpretation of the results, taking into account study hypotheses, sources of potential bias or imprecision and the dangers associated with multiplicity of analyses and outcomes.

    I look forward to your reply.

    Yours sincerely,

    Tristan O’Dwyer

  111. MJ Simpson said,

    November 14, 2006 at 1:37 pm

    I’m intrigued about where this cost of £25 per hour to look stuff up comes from. I make that the equivalent of an annual salary of £48,000 for whoever has to do that filintg and photocopying. I wouldn’t mind that job.

  112. Tristan said,

    November 14, 2006 at 2:37 pm

    Err, on a 37 hour week, over 225 days in a year (take off weekends, 25 days annual leave and a few bank holidays) I make it an annual cost of £41,625.

    Now, assume a standard overhead rate of 40% (EPSRC allow 42% for universities, so 40% probably isn’t a million miles away).

    This leaves £24,975 for salary costs. Take off employers NI and pension contributions and your left with a smidgen over £20,000/year.

    Still want that job MJ?

  113. Dr Aust said,

    November 14, 2006 at 3:12 pm

    £ 48,000 pa… if only!

    I think the cost will be inflated by including all sorts of overhead, MJ, and by assuming some kind of formula of “expensive important person to spend 10 min indicating what should be sent, mid-level person to make a more detailed list and indicate where it is in the files, cheap person to find it, collate it, copy it and send it.”

    Suspect the overhead will probably be costed to be at least a third of the 25 quid / hr, and probably nearer a half. Perhaps one of our posters in local govt or the civil service can be more specific.

  114. jdc325 said,

    November 14, 2006 at 3:26 pm

    Just out of interest, did they “confirm or deny” that they held the information?
    According to Section 1.1 (a) of the FoI act:
    “an applicant is entitled ‘to be informed in writing whether it holds information of the description specified in the request’ this is known as ‘the duty to confirm or deny’.”

    The guidance notes for compliance with the act at ico make clear what Durham have to do.

    I followed the link in the Ben’s article to ico.gov.uk (I was feeling ubergeeky) and found all sorts of goodies – including an 11 page pdf on vexatious and repeated requests.
    Apparently, to qualify as a repeated request it has to come from the same person.
    I don’t think the requests on this page will qualify as vexatious either.

    You can count me in for a tenner if it will help.

  115. jdc325 said,

    November 14, 2006 at 3:31 pm

    Bollocks. That wasn’t meant to be a link. The link to ico is at the top of this page under the heading “How To Make Your Freedom Of Information Act Request”. Sorry.

  116. Nenya said,

    November 14, 2006 at 4:26 pm

    SUW 108

    I live near Durham and would be MORE than happy to go and get some answers. Where do I begin?

  117. Noah Quiescence said,

    November 14, 2006 at 6:56 pm

    hugely relieved that there is so much rightful interest in accounting for what seems to me a great big scam.

    I too – like all parents of children with ADHD, Dyslexia etc – was put under enormous pressure to buy these expensive fish oils (well, you are made to feel a right bastard, quasi abuser and all round neglecter if you don’t).

    I approached the task with as scientific a mindset as my “Research Methods In Psychology” module at Uni allowed. I did a lot of research on the net. I studied the composition of the various brands available and their respective claims. I calculated the necessary dose according to my son’s weight (as suggested) and spent twice as much on the three months recommended period to “build up the levels” and bigged the capsules up with my son no end. Unfortunately (life would be much easier otherwise, in these Dark Ages) both myself and my son are placebo-resistant, so these things don’t do it for us, but I thought I would give it a good, fair try anyway.

    I can assure you from close, constant and consistent observation of my son (and, unlike Equazem – with only my son’s welfare foremost in my mind) that these purest fish oils have never made any difference whatsoever in my child’s symptoms.

    Most infuriatingly, however, the hysteria seems to have generated a kind of placebo effect in the adults my son has been in contact with. Their simply surreal claims, AFTER BEING TOLD THAT HE HAD BEEN TAKING THE SUPPLEMENTS, that he was “much better” on the strength of limited interaction with him (and we know that children are on much better behaviour with outsiders anyway) is really worrying.

    Count me in immediately for the tenner, a signature in a petition, or even turning up in person in Durham (yes, I feel THAT strongly about it!) because the inevitable is starting to happen: the pressure on individual parents is transferring to pressure on schools. The college my son attends is starting their own fish oil trial. How long before this spreads to the whole nation?

    Ben, you’re a star.

  118. smacks said,

    November 14, 2006 at 10:25 pm

    If this was a pharmaceutical product, promoted by ‘big pharma’ there would need to be robust ( that’s actual robust rather than Dr Portwoods version) data in to show that such an agent was not detrimental to healthy adult subjects, before they even considered using it in children.

    Then, I’d like to think that Equizen would have to show the same in children not suffering from ADHD or Dyslexia before they start experimenting in young people who have been diagnosed with, what is at best, a poorly understood vague spectrum of different, possibly unrelated disorders.

    How can an LEA be aiding and abetting such a corporate sham? These folk are in charge of who teaches our children about, among other things, science and decision making and how can the local government condone it?

    I guess i’m in for a tenner. Or maybe I’ll save it for a coach to Durham too. People Power.

    Or maybe we shouuld all spend the £10 on the actual fish- someone in the fish industry should do a supplement versus the real thing trial…

  119. Dr* T said,

    November 14, 2006 at 10:26 pm

    Everything seems to have been requested, so I tried to come up with something else, so I sent this. Not sure if it will yield anything or even be of interest….

    Dear Mr Dinsdale,

    I have been enjoying the newspaper reports recently regarding the
    Omega-3 fish oil trials currently in progress in some Durham Council
    schools.

    Under the Freedom of Information Act, I would be grateful if you could
    send me copies of all paperwork relating to the risk analyses undertaken by
    Durham Council and associated bodies of administering unnatural amounts
    of omega-3 fatty acids to minors, including any relevant toxicology
    studies.

    I look forward to your response.

    Kind Regards,

    Dr* T

  120. smacks said,

    November 14, 2006 at 10:38 pm

    Dr T

    My point exactly- a slight tangent but on the radio today, apparently some gang (herd? Troupe?) of Morris dancers had to complete a risk assessment before circling the maypole.

    I’d like to think there was some sort of equivalent precaution in place before Equizen pumped all these little boys and girls full of unproven potential toxins but probable placebos.

  121. pv said,

    November 14, 2006 at 10:51 pm

    “How can an LEA be aiding and abetting such a corporate sham?”

    How about money? Funding? A desperate bid to climb up that UK lottery otherwise known as the school league table? The same kind of desperation / wishful thinking / woolly-mindedness that leads schools to squander scarce resources on propping up the brain gym spiv CEO’s impoverished standard of living?
    It all speaks volumes for the naiivety of UK education chiefs and LEAs who appear to be keen to undermine their own credibility at every conceivable opportunity.

  122. curranhung said,

    November 14, 2006 at 11:01 pm

    Looking through Durham Council’s press releases, I see that the trials “have also produced clear evidence to show how the fatty acid supplement can improve ‘bonding’ between very young children and their parents”. Wow!
    www.durham.gov.uk/durhamcc/pressrel.nsf/Web+Releases/0322C57D3701C7B68025713E0043D03E?OpenDocument

    Here’s Dr Madeleine Portwood’s own account of this trial:
    childrenfirst2006.co.uk/the-effect-of-diet-on-behaviour-and-learning-a-sure-start-initi.html

    It seems to me that she’s measured improvements in Behaviour and Concentration simply on parents’ ratings. Am I missing something or have I read this correctly? She reports that there was a control group in the Language Development part of the trial but there’s not much detail given.

    The same press release says that “Pre-trial assessment of a group of students aged between 12 –15 at Greenfield Community Arts College in Newton Aycliffe showed that 94 per cent had moderate or severe ratings for Attention Deficit-Hyperactivity Disorder (ADHD), 94 per cent had the same Inattention Scale rating and 89 per cent were rated as having severe impulsivity”.

    Now I’m not an educational psychologist but those figures seem to me rather high. This is an ordinary comprehensive school we’re talking about – not an EBD unit. Surely this can’t be right? What is the percentage of ADHD in children in the country as a whole?

    And, btw, it seems that Evening Primrose Oil is also essential. So now you know.

  123. wewillfixit said,

    November 15, 2006 at 8:12 am

    “Now I’m not an educational psychologist but those figures seem to me rather high. This is an ordinary comprehensive school we’re talking about – not an EBD unit. Surely this can’t be right? What is the percentage of ADHD in children in the country as a whole?”

    I think these were just the baseline figures for the group studied. Ie they had already been selected for ADHD.

    Interestingly, there is no indication of where or if this study will be published, but “It will be possible to provide contact details for parents, whose children were on the trials, to be interviewed.” More peer review by media going on here.

  124. criv said,

    November 15, 2006 at 9:22 am

    For the record Ben, I wasn’t tarring the Prof with the same brush – I was just saying that he might be a good person to ask for some ‘good science’ background to this debacle.

    It is encouraging, however, that Equazen is sponsoring at least one bit of ‘good science’ – I liaise with industry a lot, and I am frequently completely flabbergasted at some of the statements they come out with, e.g. ‘it’s not fair to do a year of research and not have any positive results’ . . . ummm . . . **insert-look-of-utter-disdain-and-a-quick-jumping-down-the-throat-with-how-science-should-really-be-done-tirade**

    Incidentally, has said Prof had ethical approval and started his study? Perhaps he can air a view on this Durham Dilemma?

  125. Gleamhound said,

    November 15, 2006 at 9:22 am

    Telling comment from Dr Portwood, when challenged on R4 the other week,

    “There is a wealth of anecdotal evidence.”

  126. JQH said,

    November 15, 2006 at 11:19 am

    Like Dr*T’s request. As all bases have been covered, I’ve requested copies of the reports submitted to senior officials and elected members of the council. Wonder what the science content, if any, will be?

  127. PhilipSargent said,

    November 15, 2006 at 11:37 am

    Added my request and recorded it on the wiki.

    I am a regular reader of your articles. This is some of the most important journalism in the UK.

  128. criv said,

    November 15, 2006 at 12:34 pm

    I know this has probably been done (given that I know I’ve read somewhere that the Equazen website has been scoured thoroughly) but has anyone contacted any of Equazen’s Scientists? It’ll probably be a bit of an exercise to try to find out who the scientists on staff are (I’m assuming they have them – most companies do to employ on small in-house projects/case studies), but they may be able to provide a list of references to critique? I know they are working ‘for the man’ but they are likely to have some dedication to ‘good science’ still.

  129. David Mingay said,

    November 15, 2006 at 1:14 pm

    There seems to be a job going as Research Manager at Equazen. Any unempolyed moles out there?

  130. wewillfixit said,

    November 15, 2006 at 2:13 pm

    I am qualified to do that job…just shows how seriously they take their research!

  131. fulltartanjacket said,

    November 15, 2006 at 2:32 pm

    As a Durham City resident, here’s my tuppence-worth (could be persuaded to up it to a tenner, esp if I get to see Peter Dinsdale’s face across the A167)

    Dear Mr Dinsdale,

    I am very interested in the claims in the media as to safety and efficacy of omega-3 fatty acids in producing various outcomes, which are allegedly backed by studies performed on children (and possibly adults) in Durham, Edinburgh, Middlesbrough, Sunderland, and elsewhere. As a resident of Durham City, and a contributor to Durham County Council’s tax revenue, I feel particularly entitled to some clarification of these studies.

    I would like to make a freedom of information act request for details of how participants were selected and assigned, for all studies into fish oil performed by Durham employees in the past 5 years. Specifically, for each separate study I’d like the following information:

    For studies that have been performed and discussed:

    1) Participants ;

    Eligibility criteria for participants and the settings and locations where the data were collected.

    2) Objectives ;

    Specific objectives and hypotheses.

    3) Outcomes

    Clearly defined primary and secondary outcome measures and, when applicable, any methods used to enhance the quality of measurements (e.g., multiple observations, training of assessors).

    4) Adverse events;

    All important adverse events or side effects in each intervention group.

    5) Interpretation ;

    Interpretation of the results, taking into account study hypotheses, sources of potential bias or imprecision and the dangers associated with multiplicity of analyses and outcomes.

    I would be most grateful if you could confirm receipt of this request.

    Many thanks in anticipation of your early release of this information.

    Best regards

    Actually, if you do need to visit Durham in person, I’ll put the tenner towards the train fare, Ben, AND meet you at the station. In fact, I’ll even put you up at ours overnight to save on the hotel expenses – it’s dead handy for County Hall…

  132. fulltartanjacket said,

    November 15, 2006 at 2:34 pm

    Oh, and btw, I forgot to add – Ben, you’re funnier than Marina Hyde – and THAT’s high praise in our house…

  133. fulltartanjacket said,

    November 15, 2006 at 3:24 pm

    But, alas, not better looking…

  134. TimW said,

    November 15, 2006 at 4:08 pm

    (129)

    I wonder what happened to the previous Research Manager at Equazen?

  135. BrickWall said,

    November 15, 2006 at 5:57 pm

    Re post 125. As I try to point out to anyone who’ll listen the phrase “anecdotal evidence” is always better understood when replaced by “a bloke down the pub says”, unfortunately not many people listen to me!

  136. plg said,

    November 15, 2006 at 6:36 pm

    My first year psychology students, who have only had three lectures on stats and research design here, all said, “so where’s the control group “…. who says education has dumbed down.

  137. sophie said,

    November 15, 2006 at 7:27 pm

    #129, #134

    Maybe after all the hoo-ha they’ve decided they’d better get one!

  138. Noah Quiescence said,

    November 15, 2006 at 7:44 pm

    Oh dear, just realised that for some unconscionable reason I wrote “Equazem” instead of “Equizen”. I invoke overwork: that’s what happens to us over-stretched Mums of children with ADHD (despite having pumped them full – as has become virtually compulsory – with the Emperor’s new fish oils…)

    I continue to be thrilled with the response Ben’s initiative has created: may I just post a reminder that this is a matter that concerns ALL children – with particular pressure on those diagnosed with ADHD, Dyslexia etc. – and their parents, and that this is clearly a campaign in the best interests of the public, of all parents and children (and – now – schools) who are being manipulated en masse by the dubious Durham goings-on.

    Please can we all continue as passionately as ever about this – do count me in for any show of hands/wallet/presence that may be called for.

  139. John Denby said,

    November 15, 2006 at 8:36 pm

    Another way of hitting this.
    Just suppose there is some unforseen side effect of this chemical experiment , say huge willys or Jug Ears .
    Was Durham Council Insured at this time to carry out medical experiments, and if not , someone acted recklessly and should be sacked immediately.

  140. curranhung said,

    November 15, 2006 at 9:44 pm

    Re message 123.

    But if they had been selected for ADHD, then they would all have had it, whereas the press release says that 94 per cent had moderate to severe ratings for ADHD. I don’t get it. What were the other 6 per cent for?

  141. Boiling tube said,

    November 16, 2006 at 7:17 am

    Someone has asked on a Time Educational Supplement forum, if any noticeable improvements in behaviour have been observed in Durham schools. The only sensible reply so far makes me query if the feeding of oils is actually going ahead.

    “Not sure if it has actually started yet. I don’t think that the school/council is actually paying for eye-Q either. We’re one of the schools who is taking part in this. I have seen results for the primary schools and the data was very, very interesting. There was a definite positive correlation between those pupils who received the fish oils and improvement in school. People need to remember that they don’t work for everyone, only those who have a deficiency of the chemical (can’t remember which one though.”

    Please don’t be picky about this persons’ science.
    If the feeding of oil hasn’t started yet, how long does it take for the oil to act on the brain? The exams are in May and June.
    I wonder they are going to do the mock exams with no oil consumed and then give it afterwards in a double-blind trial. I think we should be told!

    I will continue to monitor this Forum for you.

  142. ACH said,

    November 16, 2006 at 9:22 am

    ROFLOL! Part of the person specification for Equizen’s research manager job:

    “The ability to critically appraise published scientific reports would also be a strong advantage. ”

    And, presumably, the ability to get the report via FoI

  143. TimW said,

    November 16, 2006 at 9:47 am

    A strong advantage, fantastic. Not absolutely essential then.

  144. jdc325 said,

    November 16, 2006 at 9:56 am

    Noah Quiescence -
    I sympathise with your predicament. I think it is a real shame that people can be made to feel guilty over not using an unproven remedy. Perhaps your friends believe that the science has confirmed that Omega 3 Fatty Acids benefit children with ADHD, however the media coverage has been both premature and exaggerated. Dr Alex Richardson has done some interesting work in this field (try www.fabresearch.org for more info) and made the following statement(s) in a review of Omega 3 and ADHD:
    “Dietary supplementation with fish oils (providing EPA and DHA) appears to alleviate ADHD-related symptoms in at least some children, and one study of DCD children also found benefits for academic achievement. Larger trials are now needed to confirm these findings, and to establish the specificity and durability of any treatment effects as well as optimal formulations and dosages. Given their relative safety and general health benefits, omega-3 fatty acids offer a promising complementary approach to standard treatments.”
    People seem to be given the impression via coverage of Equazen etc… that you need the pills to get EPA and DHA – but sardines, salmon and mackerel are all good sources (and cheaper??) and you can find out more about the EPA/DHA content of fish (if you wish) on www.nutritiondata.com (or you can just tell people to mind their own bloody business). Hope you don’t mind me poking my nose in.

    Regards
    jdc

  145. jdc325 said,

    November 16, 2006 at 9:58 am

    Re post 139 – funnily enough, I’ve been taking fish oil capsules for some time and I have jug ears – should I report this to someone?

  146. Tristan said,

    November 16, 2006 at 10:23 am

    Just got this back from Peter Dinsdale today:

    This is to confirm receipt of your request for information on omega-3 fish oil studies involving Durham County Council.

    Your request is being considered and if the information requested is held by the County Council it will be sent to you within the statutory timescale of 20 working days as defined by the Freedom of Information Act 2000, subject to the information not being exempt.

  147. Nigel Coe said,

    November 16, 2006 at 10:27 am

    Received today:

    FREEDOM OF INFORMATION ACT 2000 – INFORMATION REQUEST

    This is to confirm receipt of your request for information on omega-3 fish oil studies involving Durham County Council.

    Your request is being considered and if the information requested is held by the County Council it will be sent to you within the statutory timescale of 20 working days as defined by the Freedom of Information Act 2000, subject to the information not being exempt.

    Yours sincerely

    Peter Dinsdale
    Freedom of Information / Data Protection Coordinator
    Durham County Council

  148. Noah Quiescence said,

    November 16, 2006 at 10:32 am

    Tristan, and everybody, I have just received the very same answer from Peter Dinsdale. I noted the wording “if the information requested is held by the County Council” – IF?!

  149. Dr Reid said,

    November 16, 2006 at 11:06 am

    Everyone.

    I too have just received the same e-mail from Mr Dinsdale. And I quote,

    “This is to confirm receipt of your request for information on omega-3 fish oil studies involving Durham County Council.

    Your request is being considered and if the information requested is held by the County Council it will be sent to you within the statutory timescale of 20 working days as defined by the Freedom of Information Act 2000, subject to the information not being exempt.

    Yours sincerely

    Peter Dinsdale
    Freedom of Information / Data Protection Coordinator
    Durham County Council”

    My reply is below:

    Dear Mr Dinsdale.

    Just to thank you for your confirmation of my recent request for information on the omega-3 fish oil studies involving Durham County Council.

    I look forward to receiving the requested details on, or before, 8th December 2006.

    In the meantime,

    Best wishes.

    L.

    One point I would like to make:

    We may all be surprised by the luminosity of the replies that we eventually receive. However, if we are all subject, once again, to an exercise in obfuscation we should take this to a higher court. We should, as has been previously suggested, complain to the freedom of information commisioner. I agree entirely with philip sargent: this is an extremely important point of principal. In the meantime, perhaps we should all suspend our disbelief and give those involved the benefit of the doubt until we can form a considered view based on the entire data set. Let’s not let this degenerate into a witch hunt until we have proof positive that those involved are actually guilty of massaging data to support a priori conclusions.

  150. JQH said,

    November 16, 2006 at 12:33 pm

    Got the same reply from Peter Dinsdale. Obviously a standard response to such requests since the info I requested consists of council documents.

    Dr Reid, I am willing to suspend my disbelief but I would like to point out it was the spin and bullshit put out by the council that created my disbelief in the first place.

  151. Dr Reid said,

    November 16, 2006 at 12:49 pm

    JHQ.

    Quite.

    All I am suggesting is that we should perhaps refrain from choosing forms of words which suggest that we might also be guilty of making a priori conclusions.

    L.

  152. Noah Quiescence said,

    November 16, 2006 at 2:10 pm

    jdc325 – I do not mind your poking your nose in: in fact, as somebody who is affected very closely by this whole circus, I consider this thread to be an invaluable instrument of reason and sanity, and everybody contributing to as an ally.

    Re: omega-3 in ordinary oily fish and children with ADHD (or indeed omega-3 in ordinary oily fish and ANYBODY ELSE). Although I grew up on an Italian island in the Med and was therefore put under daily pressure to consume oily fish, I decided early on in my life to be an awkward, obstomate. eminently-smackable (as was the custom in those days) brat and constistently refused to eat anything remotely healthy looking.

    Although I realise that my experience is only anectodal, in my academic life
    I have only ever known As, First Class, Distinctions, Magna Cum Laude etc. (and all this without putting much effort in it either), and not a sardine in sight.

    I think that the current levels of (dis)information have reached irrational proportions, and I have had it up to here with people making a living/feeling worthy/considering themselves children’s saviours and/or perfect parents on the basis of scientifically illegitimate claims.

    Whilst I know that the people in the pharmaceutical industry are fulfilling their private business agenda through GPs, Paediatricians etc, in their case I am able to make more or less independent checks on their research (including input from the very interesting www.worstpills.com), in the knowledge that they will have had to comply with minimum requirements.

    The case is very different where alternatives – the chief one being fish oils, and that’s official – are concerned. Of course I would very much love to tell people to mind their own business. Unfortunately, do you seriously think that it is still possible to question the efficacy of fish oils supplements in most schools/parent groups etc. without your children being universally pitied for having such obtuse, ignorant, out-of-touch parents? I do have to think of the possibility of my son being singled out and teased for having a mad mother.

    Enough of this rant.

    Do we adjourn co-ordinating our response to Peter Dinsdale to the 8th December then?

  153. Noah Quiescence said,

    November 16, 2006 at 2:14 pm

    oops, “obstinate” of course

  154. glutam9 said,

    November 16, 2006 at 6:16 pm

    I go away for a holiday and look what kicks off! Great stuff. I read the article and all sort of miscievous ideas sprung to mind, most have been covered in the huge number of responses.

    I have a bit of FOI experience from the recieving end. Mr Dinsdale, if he is anything like the equivalent in my organisation, should be considered the “good guy” from “our” perspective. Its definatley worth taking the “duty to assist” route to try to get the request answered under the cost threshold.

    Indentifying documents seems like an excelent idea, surely some kind of report was submitted to the cabinet/council to approve the trialiniatiave. I might put in for that one.

    I would suggest writting to councilors and the local press, just to keep the presure on.

    My other suggestion, appologies if anyone has come up with it is to try to get the Advertising Standards Agency in on it. If they have had made claims on anything which could be counted as an advertisement, I think there is a fairly broad definition which likely includes any promotional material. The ASA have ruled several times recently on unsubstantiated claims so could be worth a try. All depends on it being in a form on which they can rule on.. Perhaps there aren’t any and that why the choose to (mis)use the media reporting.

    In for £10 of course.

  155. skjg said,

    November 16, 2006 at 6:19 pm

    I got the identical resonse to my e-mail, so I won’t post their reply again.

    I wait with interest to see what happens, December 8th sounds about right.

    Does anyone know if Durham has an automatic system to reply to these e-mails with a polite letter, or has someone actually read the original?

  156. TimW said,

    November 16, 2006 at 7:07 pm

    Probably poor Mr Dinsdale has set up an autoreply so that every e-mail he receives gets sent the reply “This is to confirm receipt of your request for information on omega-3 fish oil studies involving Durham County Council.”

  157. glutam9 said,

    November 16, 2006 at 8:28 pm

    Its normal to send some kind of holding reply while the request is considered.

    Has the refusal to relase the information been posted anywhere?

  158. r0bb1e said,

    November 16, 2006 at 9:42 pm

    One option is simply not to take ‘no’ as an answer. They should have advised you of your right to complain to the Information Commissioner’s Office (if they didn’t that in itself is grounds for a complaint to ICO), so step 1, go through Durham Council’s complaints procedure (ICO expects that as a first recourse), then assuming they still turn you down, step 2, complain to the ICO (it’s free, and fairly simple – instructions of how to do it on the ICO website), Durham Council will then have to justify their refusal to the IC’s satisfaction. If you can persuade him it’s in the public interest hat it should be disclosed he can make a formal “decision” requiring them to publish

  159. Teek said,

    November 17, 2006 at 9:21 am

    apologies for the late arrival to this e-mail malarkey, just got round to it – here goes:

    Dear Mr. Dinsdale,

    Following the recent media coverage of the use of omega-3 supplements in schools across Durham, I am writing to make a formal request for further details on these alleged studies under the Freedom of Information act.

    Specifically, I am interested in how well, if at all, the subjects in these studies were blinded, assigned treatment groups and assessed with regards to outcome measures. All of these criteria are integral to a well-conducted scientific study, and it is of vital importance that the company concerned (Equazen) share their methods and findings with the general public so that we may make informed choices when they promote the use of their product in school children.

    Below are the specific points I would like addressing as part of my FOI request.

    Baseline data

    Baseline demographic and clinical characteristics of each group. Numbers analyzed

    Number of participants (denominator) in each group included in each analysis and whether the analysis was by “intention-to-treat”. Could you please state the results in absolute numbers when feasible (e.g., 10/20, not 50%).

    Blinding (masking)

    Whether or not participants, those administering the interventions, and those assessing the outcomes were blinded to group assignment.

    How the success of blinding was evaluated.

    Randomization

    Were the participants randomly allocated to different treatments? Method used to generate the random allocation sequence, including details of any restrictions (e.g., blocking, stratification)

    Method used to implement the random allocation sequence (e.g., numbered containers or central telephone), clarifying whether the sequence was concealed until interventions were assigned.

    Who generated the allocation sequence, who enrolled participants, and who assigned participants to their groups.

    Statistical methods

    Statistical methods used to compare groups for primary outcome(s); Methods for additional analyses, such as subgroup analyses and adjusted analyses.

    I appreciate your help in this matter, and request that you acknowledge receipt of this message.

    In anticipation of a prompt response,

    Best regards,

  160. Big_Les said,

    November 17, 2006 at 10:19 am

    AFAIK, you aren’t allowed to send a holding reply as such in response to an FOI enquiry, and it certainly doesn’t “stop the clock” as far as FOI is concerned.

  161. johnlil said,

    November 17, 2006 at 10:39 am

    …added my 5 penn’orth…

    Dear Mr Dinsdale,

    I participated as a ‘guinea pig’ in a fish-oil study at Southampton University and consequently I am interested in the evidence supporting the claims regarding the use of omega-3 fatty acids. I have been following the analysis by Dr Goldacre of your studies and am very disappointed you have not seen fit to respond with the information he is asking for. You may think this is one troublesome journalist nit-picking about details, but I assure you it is far more important than that. The very structure of scientific method depends on publishing all of the observations regarding one’s hypothesis for public scrutiny and informed debate on their implications. Much of the confusion about foods and medicines in the public’s mind today is generated by unsubstantiated claims, often by unscrupulous individuals seeking their own ends. I am sure you would welcome the opportunity to show that the Durham studies do not fall into this category.
    As you are no doubt aware, Equazen use your study as a marketing reference on their website and hence you are, in effect supporting a commercial company’s marketing efforts and hence it is vitally important to demonstrate publicly that the findings are valid. Let me point out that at this stage, I am not doubting the claims made by Durham CC or Equazen, but I do need to see the evidence, either directly or analysed by a trusted third party such as Dr Goldacre.

    If you are worried about the cost-effectiveness in time needed to respond to one FoI request, I am adding my voice in making a formal request to help you justify the effort.

    Accordingly, under the Freedom of Information Act, I am asking you for documents concerning the Durham studies which reference the following:-

    – Interpretation of the results, taking into account study hypotheses, sources of potential bias or imprecision and the dangers associated with multiplicity of analyses and outcomes.

    – Generalizability (external validity) of the trial findings.

    – General interpretation of the results in the context of current evidence.

    To underline the formality of this request, I am also sending you a letter restating the request.

    Please acknowledge receipt of this email.

    John Lillywhite

  162. stever said,

    November 17, 2006 at 1:44 pm

    1. Lets be careful not to have a go at Dinsdale here. He’s simply the person that fields the Foi requests and has nothing atall to do wih the trial, Portwood, Equizen, or the Government. Im sure he’d be more than happy to pass on any information that he had – if it had been forthcoming. I’ve also no doubt that given all the requests, he will be doing his best to chase up the relevant info and will be energetically reviewing the situation given the volume of very well arguied and reasonable requests flooding in.

    2. A holding reply is totally standard procedure – especially bearing in mind that people had specifically asked for a confirmation of reciept. You can only complain if the time period for a full reply elapses, so dont be worrying about that yet. He will no doubt be reading this thread, and we need to see him as an ally in these attempts to clarify the durham research – he certainly isnt the problem, so reserve your ire for those unwilling to release there research info, and dont shoot the messenger.

  163. Ben Goldacre said,

    November 17, 2006 at 3:14 pm

    i agree, peter dinsdale, the FoI coordinator is very helpful. couple of mentions for this project elsewhere,

    press gazette:

    www.pressgazette.co.uk/blog/2006/11/11/networked-journalism-distributed-foi-requests/

    and the bbc’s “pods and blogs” show, in the coveted radio5 2am slot:

    www.bbc.co.uk/radio/aod/shows/rpms/fivelive/podsandblogs.ram

    it’s 32 minutes in, i say “erm” and “sort of” a lot, because even the pre-rec was after my bedtime and i’d been up since 7am. and because it is very very weird doing an interview over skype in an echoey kitchen. i express my gratitude to you lot, otherwise nothing new to what’s here really.

  164. Fyse said,

    November 17, 2006 at 4:29 pm

    No formal request, but have added my support to the cause…

    Dear Mr Dinsdale,

    I am writing with regards to the FoI request placed by Dr Ben Goldacre for details of the Fish Oil trials conducted in schools in your area. I am not at this stage making a formal request of my own, but wish to register my support for the claims already made. I realise the lack of positive response is likely not your fault, but wish to register my views so they can be added to the voices already present and passed along to the relevant person. The issue of transparency in science is very important to me and I am willing to make my own formal requests if this will help to speed things along.

    Thank you for your time,

    —- —–

  165. chloella said,

    November 18, 2006 at 12:37 pm

    Re: Post 154 and the ASA.

    Equizen are indeed advertising as being scientifically proven to improve behaviour – I picked up a flyer in Boots on the subject. In fact it claims that the Durham scools trial has already proved it useful.

    I put it away meaning to get in touch with you guys but promptly lost it again – been a bit busy lately. I’m going to try and get hold of another one as I think the ASA might be another route to try.

    BTW, are fish oils really safe? Because I thought oily fish weren’t any more, what with being full of mercury residues etc.

  166. oneoffmanmental said,

    November 18, 2006 at 10:44 pm

    BTW, are fish oils really safe? Because I thought oily fish weren’t any more, what with being full of mercury residues etc.

    Most aren’t no. Some fish oils are advertised as “pharmaceutical grade”, implying that they’ve been cleaned up as regards to contaminants. MorEPA, for example claim that 100 gallons of fish oil are used to create a single gallon of their concentrate.

    What concerns me is the environmental impact. These companies are using deep sea arctic fishes for their lower contaminant levels, but yet many fish stocks have collapsed in these areas. We’re clearly doomed to be stupid after 2050 if the ecologists are correct…

  167. Dr Aust said,

    November 19, 2006 at 10:21 pm

    As of now the “pledge to pay a tenner towards Durham’s photocopying costs” has reached £660 (66 people) – see:

    www.pledgebank.com/fishoils

    Strikes me as near enough to £ 750 that Durham’s comments about cost are out of the picture. Let’s see if they have any other objections, or whether FoI will win the day.

  168. stever said,

    November 20, 2006 at 11:21 am

    and the remainder is less than bens fee for the column so I think weve made the target.

    nice

  169. DavidJ said,

    November 21, 2006 at 9:49 am

    I’ve just added my tenner. Just 3 to go.

  170. Scooby said,

    November 21, 2006 at 2:22 pm

    I was wondering if there is any mileage in similar FOI requests to Middlesbrough Council?

    According to a press release from Swinburne University in Australia

    www.swin.edu.au/corporate/marketing/mediacentre/core/releases_article.php?releaseid=757

    Dr Portwood, is Specialist Senior Educational Psychologist at the Durham Learning and Education Authority in the UK, and has conducted extensive research into the effect of fatty acids on children’s behaviour and learning. She is the lead researcher for two major UK studies in the field known as The Durham Trial and The Middlesbrough Trial.

    Her research shows the potential of particular essential fatty acids in assisting children suffering with various learning disorders such as Dyslexia, Dyspraxia, Attention Deficit and Hyperactivity Disorder (ADHD) and Developmental Coordination Disorder (DCD).

    The Durham Trial showed dramatic results in school age sufferers of DCD. Within just three months of the six-month study, children who previously had difficulties in coordination, concentration, perception and reading, showed spelling, reading and behaviour gains over and above their chronological age. The group that were given a placebo showed no overall improvement.

    “In some cases, we saw reading age gains of between 18 months and four years and attention gains of as much as 400 per cent,” Dr Portwood said.

    The Equazen leaflets that Teek pointed out refer to both the Durham and Middlesbrough Trials without noting that it was the same lead researcher…

  171. stever said,

    November 21, 2006 at 4:16 pm

    Im the 76th pledger – so theres a bit extra to buy the good mr dindale a frothing pint of ale or two in thanks for all his hard work.

  172. Ben Goldacre said,

    November 21, 2006 at 5:05 pm

    hah! what a larf. i don’t think they’re able to take our money in return for the data but it’s very very very very very very funny indeed to be able to offer.

  173. TimW said,

    November 21, 2006 at 7:15 pm

    Meanwhile it’s 10 days since the first follow-up FoIs went in. Does anybody think there’s a chance there will be anything forthcoming before the 8th December? Maybe we could start placing bets.

    Or are you just a bunch of cynics who think the council will delay any response as long as legally possible?

  174. Eric T Zipper said,

    November 24, 2006 at 10:40 am

    Hm! I have been watching this develop for a while. The interest in fatty acid research over the past few years has produced some good research but equally there does seem to be some stretching of conclusions. It may also be that some people from the science community are making money by lending their names and credentials to companies who are only interested in making a fast buck. So, I have joined up and sent off a nice email to Dinsdale. I just hope that he doesnt have a brother called Doug!

  175. Tristan said,

    November 28, 2006 at 4:14 pm

    I’ve had a response. Not good news I’m afraid. I think we’ve been rumbled!

    FREEDOM OF INFORMATION ACT 2000 – REQUEST FOR INFORMATION

    Your request for information on the fish oil trials / studies / initiatives at Durham has been considered.

    It has become apparent that the recent influx of requests received by Durham County Council on this subject is as a result of an article by Ben Goldacre, published in The Guardian (11 November 2006) and on the website www.badscience.net. It is also apparent that these requests have been sent by different persons who are acting in concert or in pursuance of a campaign. We consider these requests to be vexatious, and they are therefore refused under section 14(1) of the Freedom of Information Act 2000 (“the FOI Act”).

    Section 14(1) of the FOI Act states that:
    “Section 1(1) does not oblige a public authority to comply with a request for information if the request is vexatious.”

    In his guidance note No. 22 on Vexatious and Repeated Requests, the Information Commissioner gives further detail as to what may constitute a vexatious request:
    “Where a request, which may be the latest in a series of requests, would impose a significant burden and:
    · Clearly does not have any serious purpose or value;
    · Is designed to cause disruption or annoyance;
    · Has the effect of harassing the public authority; or
    · Can otherwise fairly be characterised as obsessive or manifestly unreasonable.”

    Between 11th and 26th November 2006, Durham County Council received 106 requests for information as a result of this campaign, along with 18 further emails of support for Ben Goldacre. In 2005 as a whole, Durham County Council only received 165 requests under the FOI Act. This clearly demonstrates that these requests have imposed a significant burden on the Council.

    In determining that these requests are vexatious we also had regard to what appeared to be the purposes of these requests, which became evident from comments in the emails themselves and on the Bad Science website:
    · As an attempt to circumvent the Fees Regulations, as Ben Goldacre’s second FOI request had been refused as the cost of complying exceeded the appropriate limit of £450. In his article in The Guardian he had suggested that readers might send in parts of his request under their name, as he believed that this might enable the information to be fully disclosed, albeit in small parts to several individuals;
    · To pressure Durham County Council into disclosure of information in response to Ben Goldacre’s second FOI request, even though a legitimate refusal notice had been issued and, at the time, no appeal had been received against this refusal notice;
    · As the campaign appears to be solely concerned with pressuring the Council into providing information to Ben Goldacre, it is apparent that the requests have been sent in as a form of protest against the decision to refuse Ben Goldacre’s second FOI request. They are designed to cause disruption or annoyance and they have had the effect of harassing the public authority.

    It is for these reasons, taking into account the effect of the requests in imposing a significant burden on the Council and the apparent purposes of the requests, that we consider your request to be vexatious. This is therefore a refusal notice under section 17 of the FOI Act.

    While we are refusing your request for information under the FOI Act, we do recognise that there is an interest in the disclosure of information relating to these studies. Attached is a document that outlines published scientific studies into dietary polyunsaturated fatty acids. This information was provided to Ben Goldacre on 16 October 2006 in full response to the first of his two requests for information under the FOI Act. This clearly sets out all of the studies that have been undertaken by Durham County Council. You will note from the details that there have been three randomised controlled trials and other open label studies carried out using fatty acid supplements by staff employed by Durham County Council.

    The Oxford-Durham Trial – Dr AJ Richardson (a Research Fellow at Mansfield College, Oxford University) published the preliminary results: – Clinical trials of fatty acid supplementation in dyslexia and Dyspraxia: in Glen AIM, Peet M, Horrobin DF. (eds.) Phospholipid Spectrum Disorder in Psychiatry and Neurology. Carnforth: Marius Press, October 2003: 491-500.

    The first peer-reviewed results were published by Dr Richardson and Dr Paul Montgomery (Lecturer, Department of Social Policy and Social Work, Oxford University): – The Oxford-Durham study: a randomized, controlled trial of dietary supplementation with fatty acids in children with developmental coordination disorder. Pediatrics. 2005 May;115(5):1360-6

    In accordance with scientific protocol, you should address any requests for further details on this study to the authors of the paper, at Mansfield College.

    Sunderland – Dr Madeleine Portwood presented the first paper on 31st October 2006 at the World Autism Conference, Cape Town, hence the details of this study are now in the public domain. Please find attached a copy of the paper.

    Middlesbrough – It is intended that details of this study will be submitted for publication next year. In common with accepted scientific practice, we will not release unpublished detailed information, as that would prejudice its ultimate publication in a peer-reviewed journal. We are, however, attaching a copy of the recruitment and trial protocol.

    Greenfield / SureStart open label studies – The paper detailing the results of these two studies has now been published (Nutrition and Health, 2006, Vol. 18(3), pp233-247), hence the details of this study are now in the public domain.

    Ethical approval was sought before any of the three randomly controlled trials were carried out: the protocol of the Oxford-Durham Study was approved by the Durham Local Research Ethics Committee; the protocols of two further trials completed last year were submitted to the University of Sunderland and Sunderland Primary Care Trust ethics committees, and the Middlesbrough Primary Care Trust research ethics committee respectively. The former was approved by those two committees, and the response of the second was that ‘as this trial was being implemented by the education authority it would not require their ethical approval and that the trial could simply proceed’.

    The respective research ethics committees did not at any time instruct the investigators of these trials to make a clinical trial application to the Medicines and Healthcare Products Regulatory Agency (MHRA), regarding the use of supposed ‘investigational medicinal products’ in human trials. Therefore as the researchers of the trials believed that they were using safe levels of nutritional supplements, the need for registration to trials databases was not deemed essential at the times that they commenced, as they are in the case of drug trials. In addition, the researchers believe that publications resulting from these trials will be considered for peer-review publication because the International Committee of Medical Journal Editors’ published policy (2004) states that only clinical trials starting patient enrolment on or after 1st July 2005 would not be considered. Each of the three trials started enrolment before this date and should therefore still be publishable without the existence of a EUDRACT code or equivalent.

    In addition to these, Ben Goldacre was also supplied with the details of many other studies that are detailed in the attachment that outline the rationale for Durham’s support and involvement in research and initiatives relating to fatty acids and learning.
    If you are dissatisfied with the handling of your request please contact me at the address below, or by telephone (0191 370 8803) or e-mail (peter.dinsdale@durham.gov.uk) to appeal under the County Council’s Corporate Complaints Procedure.

    After you have exhausted our internal appeals procedure you also have a right of appeal to the Information Commissioner at:
    Information Commissioner’s Office
    Wycliffe House
    Water Lane
    Wilmslow
    Cheshire
    SK9 5AF
    Telephone: 01625 545 745
    Fax: 01625 524 510
    Email: enquiries@ico.gsi.gov.uk

    Most of the documents that we provide in response to Freedom of Information Act requests will be subject to copyright protection. In most cases the copyright will be owned by Durham County Council. The copyright in other documents may be owned by another person or organisation, as indicated on the documents themselves.

    You are free to use any documents supplied for your own use, including for non-commercial research purposes. The documents may also be used for the purposes of news reporting. However, any other type of re-use, for example, by publishing the documents or issuing copies to the public will require the permission of the copyright owner.

    For documents where the copyright is owned by Durham County Council, please contact me for details of the conditions on re-use.

    For documents where the copyright is owned by another person or organisation, you would need to apply to the copyright owner to obtain their permission.

    Yours sincerely

    Peter Dinsdale
    Freedom of Information / Data Protection Coordinator
    Durham County Council
    Culture & Leisure
    Rivergreen Centre
    Aykley Heads
    Durham
    DH1 5TS

  176. stonybonytony said,

    November 28, 2006 at 4:23 pm

    If anyone is still reading this…my request under the FOI has just been refused, as it is considered ´vexatious´ as being part of a group effort which is placing an unfair burden on the poor council. Apparently I am causing disruption or annoyance, and am harassing the public authority.

  177. Tristan said,

    November 28, 2006 at 4:38 pm

    That’s exactly what my letter above said too. Booo to the council!

  178. Noah Quiescence said,

    November 28, 2006 at 4:43 pm

    Fresh from Durham Council

    FREEDOM OF INFORMATION ACT 2000 – REQUEST FOR INFORMATION

    Your request for information on the fish oil trials / studies / initiatives at Durham has been considered.

    It has become apparent that the recent influx of requests received by Durham County Council on this subject is as a result of an article by Ben Goldacre, published in The Guardian (11 November 2006) and on the website www.badscience.net. It is also apparent that these requests have been sent by different persons who are acting in concert or in pursuance of a campaign. We consider these requests to be vexatious, and they are therefore refused under section 14(1) of the Freedom of Information Act 2000 (“the FOI Act”).

    Section 14(1) of the FOI Act states that:
    “Section 1(1) does not oblige a public authority to comply with a request for information if the request is vexatious.”

    In his guidance note No. 22 on Vexatious and Repeated Requests, the Information Commissioner gives further detail as to what may constitute a vexatious request:
    “Where a request, which may be the latest in a series of requests, would impose a significant burden and:
    · Clearly does not have any serious purpose or value;
    · Is designed to cause disruption or annoyance;
    · Has the effect of harassing the public authority; or
    · Can otherwise fairly be characterised as obsessive or manifestly unreasonable.”

    Between 11th and 26th November 2006, Durham County Council received 106 requests for information as a result of this campaign, along with 18 further emails of support for Ben Goldacre. In 2005 as a whole, Durham County Council only received 165 requests under the FOI Act. This clearly demonstrates that these requests have imposed a significant burden on the Council.

    In determining that these requests are vexatious we also had regard to what appeared to be the purposes of these requests, which became evident from comments in the emails themselves and on the Bad Science website:
    · As an attempt to circumvent the Fees Regulations, as Ben Goldacre’s second FOI request had been refused as the cost of complying exceeded the appropriate limit of £450. In his article in The Guardian he had suggested that readers might send in parts of his request under their name, as he believed that this might enable the information to be fully disclosed, albeit in small parts to several individuals;
    · To pressure Durham County Council into disclosure of information in response to Ben Goldacre’s second FOI request, even though a legitimate refusal notice had been issued and, at the time, no appeal had been received against this refusal notice;
    · As the campaign appears to be solely concerned with pressuring the Council into providing information to Ben Goldacre, it is apparent that the requests have been sent in as a form of protest against the decision to refuse Ben Goldacre’s second FOI request. They are designed to cause disruption or annoyance and they have had the effect of harassing the public authority.

    It is for these reasons, taking into account the effect of the requests in imposing a significant burden on the Council and the apparent purposes of the requests, that we consider your request to be vexatious. This is therefore a refusal notice under section 17 of the FOI Act.

    While we are refusing your request for information under the FOI Act, we do recognise that there is an interest in the disclosure of information relating to these studies. Attached is a document that outlines published scientific studies into dietary polyunsaturated fatty acids. This information was provided to Ben Goldacre on 16 October 2006 in full response to the first of his two requests for information under the FOI Act. This clearly sets out all of the studies that have been undertaken by Durham County Council. You will note from the details that there have been three randomised controlled trials and other open label studies carried out using fatty acid supplements by staff employed by Durham County Council.

    The Oxford-Durham Trial – Dr AJ Richardson (a Research Fellow at Mansfield College, Oxford University) published the preliminary results: – Clinical trials of fatty acid supplementation in dyslexia and Dyspraxia: in Glen AIM, Peet M, Horrobin DF. (eds.) Phospholipid Spectrum Disorder in Psychiatry and Neurology. Carnforth: Marius Press, October 2003: 491-500.

    The first peer-reviewed results were published by Dr Richardson and Dr Paul Montgomery (Lecturer, Department of Social Policy and Social Work, Oxford University): – The Oxford-Durham study: a randomized, controlled trial of dietary supplementation with fatty acids in children with developmental coordination disorder. Pediatrics. 2005 May;115(5):1360-6

    In accordance with scientific protocol, you should address any requests for further details on this study to the authors of the paper, at Mansfield College.

    Sunderland – Dr Madeleine Portwood presented the first paper on 31st October 2006 at the World Autism Conference, Cape Town, hence the details of this study are now in the public domain. Please find attached a copy of the paper.

    Middlesbrough – It is intended that details of this study will be submitted for publication next year. In common with accepted scientific practice, we will not release unpublished detailed information, as that would prejudice its ultimate publication in a peer-reviewed journal. We are, however, attaching a copy of the recruitment and trial protocol.

    Greenfield / SureStart open label studies – The paper detailing the results of these two studies has now been published (Nutrition and Health, 2006, Vol. 18(3), pp233-247), hence the details of this study are now in the public domain.

    Ethical approval was sought before any of the three randomly controlled trials were carried out: the protocol of the Oxford-Durham Study was approved by the Durham Local Research Ethics Committee; the protocols of two further trials completed last year were submitted to the University of Sunderland and Sunderland Primary Care Trust ethics committees, and the Middlesbrough Primary Care Trust research ethics committee respectively. The former was approved by those two committees, and the response of the second was that ‘as this trial was being implemented by the education authority it would not require their ethical approval and that the trial could simply proceed’.

    The respective research ethics committees did not at any time instruct the investigators of these trials to make a clinical trial application to the Medicines and Healthcare Products Regulatory Agency (MHRA), regarding the use of supposed ‘investigational medicinal products’ in human trials. Therefore as the researchers of the trials believed that they were using safe levels of nutritional supplements, the need for registration to trials databases was not deemed essential at the times that they commenced, as they are in the case of drug trials. In addition, the researchers believe that publications resulting from these trials will be considered for peer-review publication because the International Committee of Medical Journal Editors’ published policy (2004) states that only clinical trials starting patient enrolment on or after 1st July 2005 would not be considered. Each of the three trials started enrolment before this date and should therefore still be publishable without the existence of a EUDRACT code or equivalent.

    In addition to these, Ben Goldacre was also supplied with the details of many other studies that are detailed in the attachment that outline the rationale for Durham’s support and involvement in research and initiatives relating to fatty acids and learning.
    If you are dissatisfied with the handling of your request please contact me at the address below, or by telephone (0191 370 8803) or e-mail (peter.dinsdale@durham.gov.uk) to appeal under the County Council’s Corporate Complaints Procedure.

    After you have exhausted our internal appeals procedure you also have a right of appeal to the Information Commissioner at:
    Information Commissioner’s Office
    Wycliffe House
    Water Lane
    Wilmslow
    Cheshire
    SK9 5AF
    Telephone: 01625 545 745
    Fax: 01625 524 510
    Email: enquiries@ico.gsi.gov.uk

    Most of the documents that we provide in response to Freedom of Information Act requests will be subject to copyright protection. In most cases the copyright will be owned by Durham County Council. The copyright in other documents may be owned by another person or organisation, as indicated on the documents themselves.

    You are free to use any documents supplied for your own use, including for non-commercial research purposes. The documents may also be used for the purposes of news reporting. However, any other type of re-use, for example, by publishing the documents or issuing copies to the public will require the permission of the copyright owner.

    For documents where the copyright is owned by Durham County Council, please contact me for details of the conditions on re-use.

    For documents where the copyright is owned by another person or organisation, you would need to apply to the copyright owner to obtain their permission.

    Yours sincerely

    Peter Dinsdale
    Freedom of Information / Data Protection Coordinator
    Durham County Council
    Culture & Leisure
    Rivergreen Centre
    Aykley Heads
    Durham
    DH1 5TS

  179. Kells said,

    November 28, 2006 at 5:02 pm

    Ditto on the response – I would disagree entirely that my request was vexatious according to any of the points in their definition

    “Where a request, which may be the latest in a series of requests, would impose a significant burden and:
    · Clearly does not have any serious purpose or value;
    · Is designed to cause disruption or annoyance;
    · Has the effect of harassing the public authority; or
    · Can otherwise fairly be characterised as obsessive or manifestly unreasonable.”

    I am more than vexed by this I am positively irritated. I feel the need to contest their judgement with an appeal.

  180. stewartmacdonald2000 said,

    November 28, 2006 at 5:35 pm

    I assume all of us will get this response. I’m looking forward to Saturday’s article.

    My concern is with “has the effect of harassing the public authority” by that means any sustained campaign for information would be harassment.

  181. skjg said,

    November 28, 2006 at 6:15 pm

    I got the same response, and it is worrying. When is asking for information “harassment”? does that have a legal definition?

    So what now?

    I looked at the attachments to the e-mail – and they are no help. The autism paper and the recruitment and protocol for trials have no data from results in them. The Bryan, Stevens and Richardson papers only deal with children with ADHD, the Fontani paper looks promising, but gives no details of who was tested (except that they were “healthy”), the other Richardson paper looked at children with DCD, the Morale, Auestad, Helland and Colombo papers looked at infants or very young children (NOT year 11!), the Hamazeki paper looked at aggression, the Portwood study says they got good results but gives no details.

    Would it be possible for one person to ask Durham, politely, how we can get this information in a way that they do not find “harassing”?

  182. Noah Quiescence said,

    November 28, 2006 at 6:37 pm

    I’m crap at maths, but indulge me for a minute (unless I am getting this horribly, horribly wrong – I plead for your understanding, I’m only the Mother of the original (as opposed to the, later extended, main) target of this fish oil scam. P. Dinsdale & Co. (Durham) state that

    “Between 11th and 26th November 2006, Durham County Council received 106 requests for information as a result of this campaign, along with 18 further emails of support for Ben Goldacre. In 2005 as a whole, Durham County Council only received 165 requests under the FOI Act. This clearly demonstrates that these requests have imposed a significant burden on the Council. ”

    Come again?

    2006 – 106 + 18 = 124. Definitely vexatious

    2005 – “as a whole” “ONLY” 165. ? …………………….

    I think that there is a definite improvement in the burden imposed on Durham Council in the last year, all things considered.: 41 fewer requests, to be exact. So it should be a piece of cake for them this year. No?

  183. Noah Quiescence said,

    November 28, 2006 at 6:52 pm

    Just in case I have been horribly wrong, I just sent this:

    Thank you for your e-mail and its attachments.

    I am intrigued by your statement that:

    “Between 11th and 26th November 2006, Durham County Council received 106 requests for information as a result of this campaign, along with 18 further emails of support for Ben Goldacre. In 2005 as a whole, Durham County Council only received 165 requests under the FOI Act. This clearly demonstrates that these requests have imposed a significant burden on the Council”.

    and would be most interested in knowing – as a measure of the general interest in these trials (about which, as the mother of a main-target child, I am extremely interested in) – what the 2006 total of the requests for information was as at 26th November 2006.

    Do they have a year-on-year, month-by-month clause somewhere?

  184. scox said,

    November 28, 2006 at 8:35 pm

    Good to know (from Mr Dinsdale’s reply quoted at #175) that he’s reading this thread, so ‘Hello, Mr Dinsdale! – don’t be a lurker – be a poster!’

    Durham’s long reply (#175) is surely a partial victory for the ‘mass FOI’ approach, even if is a grudging PS to a ‘vexed’ formal response (unless they had already sent all that to you, Ben)? Anyway, the Portwood paper to the World Autism Conference is new.

    Some stock-taking:

    - one real beef is that Durham/Equazen plug the product on the basis of research which isn’t ready for publication yet (the Midlesbrough study) – which suggests an ASA approach about inappropriate advertising – the code is on the ASA website and is useful on these kinds of issues (#165 and passim)

    - a second concern is that Portwood is quick to say what she’s found, but slow to back it up. Does her paper to the World Autism Conference relate only to children with autism – or does it make wider claims ? Since Durham seem to know a lot about this work, maybe FOI for the protocol and data for that should be pursued.

    Anyway, we now have the money pledged now to meet Durham’s charge for responding to Ben’s original request (£790! – though worryingly my name seems to be there twice). So why not call in the money, Ben, and send them a cheque? (On second thoughts, probably best to ask DCC first since if they won’t take the money, you’ll spend it getting it back to us). That will pull the rug (morally, at least) from under ‘vexatious’ and ‘harrassment’.

    The Department for Education and Science’s “SCHOOL FOOD & HEALTHY SCHOOL’S TEAM” (punctuation as per original!) wrote me today saying:

    “I refer to your request received on 11 November under the Freedom of Information Act 2000 for information provided by Durham County Council (DCC) to the Department for Education and Skills (DfES) since January 2005 about the studies conducted by DCC into the effect of the consumption of fish-oil supplements by children.

    I am writing to advise you that following a search of our paper and electronic records, I have established that the information you requested is not held by this Department.”

    So its not just the public DCC don’t want to know the detail- they don’t want central government dealing with school food to know anything about it!

    No reply yet to other FOI requests to central government departments.

  185. Seahorse said,

    November 29, 2006 at 12:54 pm

    I haven’t the heart to do this, but it would be interesting to make a FoI request for the cost of the legal services that were used to draft the reply that we’ve all apparently received.

  186. TimW said,

    November 29, 2006 at 2:18 pm

    I notice that the decision notice says:

    “it is apparent that the requests have been sent in as a form of protest against the decision to refuse Ben Goldacre’s second FOI request. They are designed to cause disruption or annoyance and they have had the effect of harassing the public authority.”

    That’s not true though, is it? It’s not a protest; the requests have been sent in to find out what trials Durham have any info about. And the requests are not “designed to cause disruption or annoyance”; they’re designed to obtain the information, bit by bit.

    The “apparent purpose” of the requests is one of the reasons the FoIs were refused, and it seems a flakey excuse to me.

  187. Chris said,

    November 29, 2006 at 7:47 pm

    I’ve just got my refusal.

    I agree with TimW. Perhaps the words “form of protest” are mentioned in the Act as being valid reasons for an information holder to refuse to disclose. Obviously receiving a number of requests in one go in response to a plea in a national newspaper is going to look fairly “protesty” on the face of things – if you don’t want to look too deeply into it.

    The reality is completely different: I didn’t send in my request as a way of protesting against DCC. I sent it because I genuinely want to know what data they have on the trials they conducted; data that any organisation that had conducted their trials responsibly would have at their fingertips, no matter how great the number of requests.

    We’ve been sold short here. Perhaps skjg has a point (posting #181): one of us should make a request in a few months’ time, when DCC can’t use the same excuse. I’d be happy to do it.

  188. Chris said,

    January 2, 2007 at 6:10 pm

    Just for the record, I submitted an appeal to Durham against their decision not to release information on trials they had conducted. The appeal was refused. Below is a record of the correspondence.

    Dear Mr. Dinsdale,

    Thank you for your recent letter refusing my request for information under the Freedom of Information Act 2000.

    I would like to appeal against the refusal on the following grounds:

    1) In determining the request as vexatious, you have pointed out the sudden increase in FOI requests between 11th and 26th November. I note that there were 106 requests. If the trials you have done have been performed in a scientific manner, then the information I require should already be in a convenient format, for example a pdf file, or easily rendered into such a format. Emailing this information to one or a hundred and six recipients should not therefore be an issue for you. My own computer is used regularly to email information to thirty or more recipients, and usually does not take longer than fifteen minutes to do so. I cannot see that the number of people wanting the information should place a significant burden on your council’s computers.

    2) Your assumptions about the purpose of my request aggregates the emails you have received into one body and fails to take into account the reasons I clearly stated on my original email. I said “As a concerned member of the public I am interested to know that there is adequate supporting information for scientific claims made directly to the media.” Why does it make a difference that the information about your trials was conveyed to me and others by a third party?

    3) I believe that your description of the purpose of my email as a “form of protest” is an attempt to twist my intentions into a framework that makes it easy for you to refuse my request under a provision of the Act. My email was sent for the reasons stated in (2) above, and I resent your implication that it was otherwise.
    I find the tone of your email to be both condescending and disapproving. Your council has acted as though a newspaper columnist is the only person interested in obtaining information from you.

    I would be very grateful if you would send me confirmation of this email.
    Yours Faithfully,
    Chris

    Here is the reply I received from the Assistant Head of Legal Services (curly brackets are mine):

    2 January 2007

    Dear {Chris}

    Re Request for Information Under the Freedom of Information Act

    The complaint arises out of your appeal against a response from Peter Dinsdale, the Freedom of Information/Data Protection Coordinator indicating the Council considered your request to be vexatious and refused it under Section 14(1) of the Freedom of Information Act 2000.

    The response, was not however a blanket refusal to provide information and acknowledging, that there is a public interest in disclosure of information relating to the fish oil trials, supplied information regarding the studies and in particular, three papers.

    Freedom of Information Act

    Section 14(1) of the Act removes the obligation of a public authority to reply with a request for information if the request is “vexatious”.

    Mr Dinsdale quoted guidance note 22 from the information commissioner. Within paragraph 2 of that guidance, the Commissioner states the following:

    “The Commissioner considers that the exception in the Act for vexatious and repeated requests is important, especially as no fee would be charged for most requests. His approach will be influenced by the desirability of keeping compliance costs to a minimum and to avoiding damage to the credibility or reputation of the Freedom of Information framework”.

    Whilst stressing that Authorities should not conclude that a request is vexatious or repeated unless there are sound grounds for such a decision, the guidance goes on to say:

    “While giving maximum support to individuals, genuinely seeking to exercise the new right to know, the Commissioner’s general approach would be sympathetic towards Authorities where a request, which may be the latest in a series of requests, would impose a significant burden and clearly does not have any serious purpose or value, is designed to cause disruption or annoyance, has the effect of harassing the Public Authority or can otherwise be fairly characterised as obsessive or manifestly unreasonable.”

    There is no definition of vexatious request. Whilst referring to a case of Attorney General -v- Barker in 2000 which suggested a definition of:

    “Designed to subject a Public Authority to inconvenience, harassment or expense.”

    -The guidance goes on to say that a wide approach is necessary in the context of FOI requests “made without charge and with the minimum of formality to Public Authorities”. It suggests that effect needs to be considered as well as intention.

    Thus, although it may not be the intention of the enquirer to cause inconvenience or expense, if a reasonable person would conclude that the main effect of the request would be disproportionate inconvenience or expense, then it will be appropriate to treat the request as being vexatious.

    Your request for information was one of 106 requests for information on this subject received between the 11th and 26th November. Within that period, this Authority received 18 further e-mails of support for Ben Goldacre.

    On 11th November 2006, Mr Goldacre’s Bad Science contained an article advising readers that this Authority had declined a Freedom of Information request that he had made and advising, if not encouraging readers, to make their own application and refers them to the Consort Guidelines. At one point he states:

    “I suggest that each person requests just two or three sections each, going through them in order to avoid confusion, plus what they requested and ideally the full e-mail request they sent in the comments below, so everyone can see how far we have got and what is left to be requested. Remember, for each request to say that you want the information for each and every one of the many different trials or studies into Omega-3 fish oils that have been performed in children by Durham employees in the last five years, God knows how many there really are.”

    Later, he adds:

    “Good luck, have fun and don’t forget to post the replies you get from Durham in the coming weeks. Don’t worry about doubling up with what other people have requested. It’s better to be belt and braces …”

    Peter Dinsdale advised in his response to you the reasons for regarding your request as vexatious.

    It needs to be stressed that the reasons are based upon the fact that yours was one of many requests for information about this matter within a short period of Mr Goldacre’s article and that in the year 2005, the County Council received only 165 requests in total under the Freedom of Information Act. This influx of enquiries, all on the same subject was an unusual pattern and I do not consider it unreasonable for Mr Dinsdale to have concluded that they were sent in pursuance of a campaign.

    When giving reasons for finding your claim to be vexatious, Mr Dinsdale took into account the purposes of the request, comments in the e-mails themselves and the bad science website and reached the following conclusions:

    1. This was an attempt to circumvent the fees regulations as Mr Goldacre’s second FOI request had been refused because of the costs of compliance and that in his article he had suggested that readers might like to send questions, albeit in smaller parts.

    2. That its purpose was to pressurise Durham County Council into disclosure of information in response to Ben Goldacre’s second FOI request, even though a legitimate refusal notice had been forwarded to him and at that stage no appeal had been lodged against that refusal.

    3. That the campaign appears to be solely concerned with pressurising the Council into providing information to Ben Goldacre, it was apparent that the requests had been sent as a form of protest against the decision and were designed to cause disruption or annoyance and that they have the effect of harassing the Public Authority.

    When he reached that conclusion, Mr Dinsdale informed you that his response was a refusal notice under Section 17 of the Freedom of Information Act.

    Having considered: -

    • The circumstances in which the requests were received
    • Their apparent purpose
    • Their effect
    • That your request was one of that of a large number of applications previously described

    - I uphold Mr Dinsdale’s view.

    I note your view that the information you requested should be easily accessible and your objection to your request being aggregated with e-mails from other enquiries. I also note that you found the tone of Mr Dinsdale’s e-mail to be both condescending and disapproving.

    Having looked carefully at Mr Dinsdale’s response, I do not consider it to be condescending and disapproving. In my view it carefully explained why the request was being turned down and included some published information; signposts for any remaining enquiries that you had with an explanation why currently unpublished information would not be revealed prior to being published in a peer review magazine.

    This is not to suggest that Durham County Council considers you to be vexatious, but Mr Dinsdale’s approach of taking into account the contents of the bad science website; the intensity of the requests in a short period of time immediately following publication of the article, supports the view that this was part of a campaign instigated by the article and had the apparent purposes set out by Mr Dinsdale in his response as the reasons for deciding that the applications were vexatious.

    I would also add that regardless of the apparent purpose, taking into account the information Commissioner’s advice, the effect of the requests in total were to cause disproportionate inconvenience and expense to a Public Authority dealing with FOI requests without charge and the minimum formality.

    I therefore regret to inform you that your appeal is not upheld.

    If you are dissatisfied with the outcome of this appeal, you have a right to appeal to the Information Commissioner at:

    Information Commissioner’s Office, Wycliffe House, Water Lane, Wilmslow, Cheshire, SX9 5AF, telephone 01625 545 745, website www.informationcommissioner.gov.uk.

    Yours sincerely

    Colette Longbottom
    Assistant Head of Legal Services

  189. BobP said,

    January 11, 2007 at 11:13 am

    Oh dear, Durham has plummetted in the national schools league tables.
    Reported here – www.sunderlandtoday.co.uk/ViewArticle2.aspx?SectionID=1512&ArticleID=1966882

    Quote
    ……while Durham has fallen 30 places to 103

    Unfortunately, I can’t find the table which this is based upon – the detailed statistics are at www.dfes.gov.uk/performancetables/ but I can’t find an overview.

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