Monday, September 29, 2008

Equazen demonstrate rigourous and independent clinical trials

It's true. It's on their website, they even give a step-by-step guide (pdf) on how they should be done - and you know what? It's pretty good.

Why is this of interest? (Or perhaps, why has your irony-meter gone up to eleven?)

Equazen are the company behind the Durham Fish Oil "initiative". (I say 'initiative' because it used to be a 'trial' and then someone retrospectively changed the press release to read 'initiative')

A great whirlwind of media announcing the scheme proclaimed that Durham County Council had teamed up with Equazen to provide their EYE Q product to 3000 school children to see if it postively affected their performance. As a reminder, Equazen were slapped by the Advertising Standards Authority in 2007 and were told by ASA to
remove the claims "... may help maintain concentration levels and healthy brain development", "the Clever Capsule - Scientifically tested in schools", "proven in schools" and "proven by Science" from future advertising for eye q.
Also, as background, Equazen is owned by Swiss pharma company, Galenica, and EYE Q was their third biggest product in terms of sales in 2007.

[There are soooo many problems with this whole affair that have been covered better elsewhere (see links throughout this blog) that I'll direct you there rather than regurgitate. (Euuuugh fishy burps.....)]

Let's have a look at this trial, using Equazen's 5 steps which show "How we know it's effective":
1. Identical active and non-active (placebo) dosages are prepared.

Hmmmm....fallen at the first hurdle. What we had here was 3000 kids who were giving some EYE Q with the view to seeing whether their grades improved. (When they didn't, Durham changed what was being measured to a "pairing" of similar kids who didn't take the pill. Oh, and rather than measure the 3000, only 832 had 80%+ compliance and they only used 629 matched pairs - what happened to the other 200-odd? Let's not forget we have NO IDEA as to what any of the kids were eating outside of school. The "non Equazen" might have been drinking litres of fish oil in their spare time - who knows?)

Anyway, the nub is there was no placebo, no oil-filled capsules that gave fishy burps but didn't have Omega3 or 6 in them. In fact, nobody really seems to know what was in the capsule. A Freedom of Information request (others here) suggested that all the products were Generally Regarded As Safe and therefore there was no need for a risk assessment. I personally am not in favour of child experimentation.
2. The subject panel is divided into two groups - the Test and control

Already covered this above - no placebo, no control. i.e. no idea and certainly no value.
3. Effects on both test group and control are recorded and analysed

Hmmm.... more difficulties. With no control, what to compare?
4. All data is combined and the initial results are written up

This section is mind-blowing. Here is what happened - Durham & Equazen press released what they were going to do, i.e. a trial. Then they press released that it wasn't a trial it was an initiative. Then they changed the goalposts and press released skewed results that make no sense statistically or scientifically. We have no idea of what their methods were, the contents of pills, how they manipulated the data, what they were measuring. Allow me to quote from EQUAZEN's OWN PUBLICATION:

Once the data has been analysed, the researchers will compile the results and write up a paper. But they can’t publish it yet: there is one final hurdle before the information is made public.

The editor of the selected journal will put the paper through Peer Review by submitting it to a group of independent leading experts in the particular field of research. The researchers do not know the identity of the reviewers who must be completely free to comment on the findings. Only after this scrutiny will the paper be published and the clinical value confirmed. Clinical trials of this nature allow researchers to establish the average efficacy of a treatment. This helps evaluate recommendations of the correct intake for any given and any side effects can be identified and bias can be eliminated.

Have another read through that and then have a look at what Equazen, the company doling out this advice, actually did. This is (and forever will be a textbook example of) RESULTS by PRESS RELEASE. No methods, no peer review, no criticism, just a docile press ready to publish anything handed to them.

Not only that, but they have a link on their website to "PROOF", the perfect example of churnalism - PR dressed as news. Only Equazen aren't in charge of the comments section, which are a lot more discerning than the automaton that wrote the article.

David Ford, head of achievement for Durham County Council’s Children and Young People’s Services, is the chap behind this waste of money/time/effort. I think it is terrible that he still has a job. I believe his integrity has disintegrated, he has allowed a private company to legitimately make millions on the back of free advertising of a trial that was (in terms of column inches and revenue) designed to succeed, but in statistical and scientific terms, was of no value whatsoever. Let me make myself clear - £1 million has been spent on fish oils and given to children and nobody knows whether it did anything.

The fish oil was donated by Equazen who I would think, feel they got value for money.

Interestingly, the Press Association has put out a press release which may indicate an end to Durham Council's stupidity, and Equazen's relationship with them.
Dave Ford, of Durham County Council's Children and Young People's Services, said there was no plan to continue providing children with the fish oil capsules now that the donated pills had run out.

He said he had been "upset" by the level of criticism the project had attracted from the scientific community. But he said the council had never set out to conduct a scientific experiment.


Up is down, black is white, square is round. Poor David - all that help that was offered to him when he began and now he is upset. Nasty scientists with their 'methods'. He has performed irrelevant experiments on children, let his position be abused by a private company, made Durham Council look idiotic, gave unrealistic hope to thousands of parents that a pill would solve all the complex social problems as to why their kid isn't so hot at maths or french or economics or music or biology and he feels 'upset'?

Dave, mate, just apologise for your momentous cock-up. Personally, I think you should resign.


A few other blogs add extra (and admittedly better) angles to this story

HolfordWatch
Dr Aust
Bad Science - this link has a few previous Guardian columns from Ben Goldacre.

And a newcomer, MacCruiskeen. MacCruiskeen (possibly a "Third Policeman" reference?) has been painstakingly following this story and is the Daddy when it comes to Durham's disaster. The blog is new, but a goldmine for any journalist wanting to actually write a critical story on this.

BPSDB

11 comments:

  1. heh - nice post, i love the fact that Equazen are basically putting up a document on trials with so much rope that they're bound to get hung.

    as for Ford - he is employed by the public sector is he not? what happened to accountability? someone should start a petition to demand his resignation if he handles public funds

    ReplyDelete
  2. Excellent work, Dr T!

    Teekblog - I don't think David Ford will resign because the council has backed him (possibly after the event). Regarding public money, one e-mail to schools that I have seen, indicates that financial assistance from DCC to schools was made available to help with the management of the project. This was probably an entirely legitimate action.
    I have just put episode 6 of the saga of the great Fish Oil Farce on my blog at
    http://maccruiskeen@wordpress.com

    ReplyDelete
  3. Thanks MacCruiskeen.

    Just for accuracy, MacCruiskeen's blog can be found here:

    http://maccruiskeen.wordpress.com

    ReplyDelete
  4. Chapter 7 of my blog is now available at:

    maccruiskeen.wordpress.com

    Chapter 8 will be ready in two weeks and will cover the moment when DCC got asked some pertinent questions by MacCruiskeen in their own council chamber in February 2007 and tried to avoid answering one of them.

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  5. Dr T - thanks for pointing out the mistyping in my blog address! I'm on a learning curve. Maybe fish oil would help!!

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  6. thx for the info. but i dont agree with you i have been bought for my little girl equazen 6 months to aldut product. it worked pretty good.

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  7. she was very hyper active baby. and when she started the product about after 2 weeks she has been come really clam kid and also its has been devolep her speech. she pay attention when i read books and stuff. its really working.

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  8. look i am a person who is against goverment system and the other politic stuff. i am also against the vaccines plus in my country its a rule give a shot vaccines. and i did not now my child is 2.5 did not get any shots off all. i am telling it could be adverstion stuff for you and sure its a expensive one but its really working.

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  9. Anonymous's postings defy comment!

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  10. well i am not defending anybody i am not anbody's lawyer. and i hate this system who has money buys everything. by the way my name is OZGUR and i am from Turkey.

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