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

Helios Homeopathy remove their Malaria sugar pills (but keep their Malarial Owl's Blood)

**UPDATE** 05/2009 - HELIOS Homeopathy no longer sell Malarial Owl's Blood on their website.

Back in Oct 2006, BBC's Newsnight broadcast an investigation by Simon Singh (in association with Sense About Science) into how some homeopaths were advising people to use homeopathic products for malaria instead of referring them to a GP or conventional travel clinics where proven effective medicines are available.

Then in April this year, BBC's southwest regional program Inside Out broadcast a piece on how Neal's Yard were selling homeopathic remedies to prevent and treat serious diseases like malaria.

The MHRA (Medicines and Healthcare Products regulatory Agency) were pretty quick in slapping down Neal's Yard and getting them to remove the product from their shelves (although Neal's Yards press release didn't mention the MHRA demand).

In my recap of the events since the Newsnight Sting, I mentioned that Helios Homeopathy, a UK-based pill peddler, was still selling Malaria Officinalis. Thanks to a complaint to the MHRA, the link now looks like this, i.e. product gone. It seems they have also been reprimanded by MHRA and dropped the product from their range, and added the legend:

Please note that any reference to a disease name does not indicate a treatment for this disease. Helios remedies are without therapeutic indications.

Without therapeutic indications, eh? So what exactly are they for then? Or, to analyse the products a bit further what exactly is Malarial Owl Blood used for?

Seriously.

It has been a few years since the old double, double toil and trouble routine, but can we really be able to buy homeopathic malarial owl's blood? And what the dickens can it supposedly be used for? Funny enough, even Google only references back to Helios Homeopathy.

For once, I'm really glad there isn't the remotest chance of getting even the hint of a molecule of malarial owl's blood. Homeopathy is placebo-based nonsense, but this is just weird.

BPSDB

A Birthday Result - Artrosilium website gone

It's been a year since this blog started so it seems very appropriate to mark the occasion with a little success (and a pleasant return to serious blogposting).

Back in April 08, I wrote about Artrosilium - one in a very long line of dodgy products aimed at the 5 million or so Britons who have arthitis or similar diseases. Despite having been slapped by Advertising Standards Authority in May 2004 and made the MHRA hitlist for unregistered medical products in 2003 and so not allowed to be sold in the UK, the product was still being sold via the website at www.artrosilium.co.uk.

(Incidentally, the parent company IntraMed Ltd has recently been slapped again by the ASA for another product Ginkgo Biloba in Sept 08)

I wrote again about the parent company IntraMed Ltd (and Artrosilium) with regards to their other dealings in the world of quack medicines.

In the time from then til now, the largest hit rate from search engines coming to this blog has been with searches relating to Artrosilium. My concern was that a product that had been identified by MHRA as not suitable for sale in UK was being sold in the UK via a .co.uk registered website and fellow arthritis sufferers were being suckered for more money in search of elusive long term pain relief.

With the help of Steve Rolles, I approached my local MP, who listened attentively and was immediately on side, and agreed to follow up the case.

The response I got at the time from Dawn Primarolo (Minister of State for Public Health) was helpful, but not as much as I'd hoped - mainly that because Artrosilium was being sold by a Swiss company and the payment was on a Swiss website (only the advertising was on a UK website) then there wasn't much they could do, although she did say:

...the internet service provider has been contacted in an effort to seek compliance with UK medicines regulatory requirements.

However

The importation of medicines by individuals for their own personal use or for use by a family member is exempt from regulatory controls, and this includes purchases from the internet.

I'll hopefully be taking this up with my MP in the near future, as I don't think this situation is completely satisfactory, but nonetheless appreciated the help and replies from those in charge.

She also made me aware that another IntraMed Ltd product, www.themicrodoctor.co.uk is currently being investigated by MHRA so perhaps it's not so bad.

To my happy surprise, I clicked on the Artrosilium website today to find:

Thankyou for your interest in Artrosilium. This website is currently unavailable.

So hoorah. Providing it doesn't rear its head again, I'll claim that as a minor victor for this blog and for arthritis sufferers everywhere.

BPSDB

Bizarre dietary advice from Yahoo!

At the risk of references to that Truss woman, Yahoo! have today tried to relay good dietary advice, but journalistic skill has meant they've given the direct oppposite. Whaddya reckon?
(original here)

No More Rath Sewage

Matthias Rath is a vitamin entrepreneur (or pill salesman) who claimed his treatments could cure AIDS. In addition, he claimed the AZT treatments from pharmaceutical companies were toxic and dangerous.

Ben Goldacre and The Guardian were in the process of being sued by Rath for articles such as this, this and this. South Africa has 5 million people infected with HIV, one person in nine. Fewer than 40,000 are taking proper medication. Matthias Rath didn't like anyone suggesting that people were dying as a result of not getting AZTs and that he might be to blame. Rath maverickly dropped his lawsuit against them this weekend and has been ordered to pay costs, initially £220,000, however the Guardian says it will be looking for around £500,000.

Yesterday's Guardian carried it as a full front page spread, as well as on page 2 & 3 will other snippety bits throughout the paper. And well they should. Lesser papers may have folded at the thought of such a hefty suit and the Guardian is to be credited fully for standing by its integrity and providing the full backup for this frivolous waste-of-time lawsuit.

Of course, Matthias Rath has form - he had previously sued the excellent, worthy, hardworking, admirable and debatably unsung charity, Medecins Sans Frontieres in 2006, which he also maverickly dropped. Not content with spreading false information about AIDS drug treatments, thereby denying life to those AIDS victims who believed it, his own pills were vitamins hence useless against AIDS and yet he has the amorality to sue a charity with limited resources who work hard to provide basic health care to the poorest, toughest parts of the planet. If ever the c-word could be used to describe someone, it is here.

I'm reminded of two conversations which this case brings to my mind:

The first was a discussion with a work colleague about Patrick Holford. I said I strongly disliked the guy because of the nonsense he writes about nutrition, how he is just a pill peddlar but more dramatically, how he ended up being associated with Matthias Rath in his efforts to sell Vitamin C instead of AZTs in South Africa. My colleague's response was to reason that someone trying to selling vitamin C instead of AZTs in South Africa was such a big story, that if it was true, it would be all over the press.
In fact, it was picked up by some of the media, not least the Guardian, but this law suit has meant that Ben Goldacre has had to remove a chapter from his book (more on that soon - it's a corker, incidentally he has suggested he will write a second book purely on the Rath case).

We've seen plenty vexatious time-wasting sewage recently from CAM quarters - remember Society of Homeopaths, Odd Obi, herbal blood cleanser Ann Walker , New Zealand Chiroquackters, British Chiropractic Association - all ended in bloggers winning and the quacks losing more face, ground and credability than they'll ever realise.

What's more intriguing is the deafening silence from the slimy world of the Vitamin pill sales industry about this landmark event. I'll keep an ear out for any words of wisdom from Patrick Holford's camp.

Secondly, when I discussed the above conversation over a beer with the good Dr Goldacre earlier this year, he was unable to talk about the courtcase for obvious reasons, which led to a very interesting conversation about anti-quackery blogging; Ben had the Guardian to back him up for the lawsuit, the majority of bloggers have nothing. This makes for a very asymmetric situation where the Big Vita companies can use legal muscle to silence their puny opponents, thanks to draconian British libel laws. Hence the tendency for many bloggers to try and maintain their anonymity, but equally, as we have seen time and time again, a demonstration that a lawsuit for libel/defamation from a Quack is an admission from the Quack that they have everything to lose from rational dissent.

But still, at this moment, the Anti-quackery blogs are tiggerish with the news, while the silence from the vitamin sales industry is deafening. Full marks to the Guardian and full marks to BG.

BPSDB

Back to Skool for TESCO

Seeing as it's silly season everywhere else, I spotted these mathematical beauties in TESCO Axminster:





Time to get that calculator out.......

Hip to be positive or negative?

Hands up who likes the NHS? Hands up how many of you step in to defend the NHS when the general conversation has descended down to slightly implausible anecdotes about how rubbish it is, and how just by parking near a hopital you can get a LETHAL SUPERBUG!

It shouldn't come as a big surprise I suppose, that NHS-bashing always gets the front page. The media (some more than others) are generally tilted towards printing material which will fill the preconceptions of the readers, thereby allowing them reasoning for their outrage - irrespective of the truth involved. The image we are given is of a crumbling, slow, out-of-date NHS system, filled with vermin, superbugs, 'bomb' Doctors to name a few.

Is this a true representation of what the NHS is like? I don't believe that it is - certainly (anecdote alert) in my experience I have been amazed by the speed, efficiency & cleanliness of the whole system.

Admittedly, I haven't had too much interaction, but that will change over the coming months as I'll explain below.

What happens when good news is mixed with bad news? What gets the headline and what doesn't get read because it is buried half way down in the small print?

Here's an example from the Guardian:

Hospital superbugs: Sharp rise in C difficile deaths

This was posted last week. Why is the media suddenly not worried about MRSA and now only discuss C. Diff? The article explains clearly why:

The number of death certificates that mentioned MRSA decreased from 1,652 in 2006 to 1,593 in 2007.

This is the first time the number of MRSA-related deaths has fallen since ONS records began in 1993

and so we had childish political posturing from Lib Dem Normal Lamb saying:

These are horrifying statistics.

Are they? All of them? ALL of them? Why didn't the Guardian print "MRSA on the downturn for first time in 14 years", or even seperate the two points, because the C.Diff situation is clearly deteriorating.

The impetus to write this entry came from a report out today from the Public Library of Science Medicine called Revision Rates after Primary Hip and Knee Replacement in England between 2003 and 2006.

As someone who is undergoing major hip surgery in the next 6 - 8 weeks, you can understand why I was keen to stick my nose amongst this and sniff out the result.

The basic idea of the paper was to have a look at the National Joint Registry (NJR) collected data on patient characteristics, types of prostheses implanted, and the type of surgical procedures used, since its initiation in April 2003. It covers only England and Wales. The researchers linked the records of the NJR and the Hospital Episode Statistics (HES) for patients treated by the NHS in England who had undergone a primary hip and knee replacement between April 2003 and September 2006. What the researchers wanted to compare were the patient outcomes for different types of joint replacement, to see if there is any difference in the length of time before the replacement has to be replaced. Interestingly, a number of other countries have adopted a similar data gathering system and so the NHS can be compared to other countries' health systems.

[As a nice little aside on the dubiety of the media, I thought it might be fun to see how accurate the actual numbers reported are. The report says the number of hip and knee replacements carried out in England and Wales in 2006 was 160,000. The Telegraph made no mention of the geography. The number of joint replacements included in the study was 167,076 but this was reported as 150,000 in the BBC, nearly 170,000 in the Times and the misleading (and mistaken) values of 327,000 and 327,557 from the Daily Mail & Telegraph respectively.]

From the report:

They identified 327,557 primary hip or knee replacement procedures performed during that time period, but only 167,076 could be linked between the two databases.

76,576 patients in the linked database had undergone a primary hip replacement. The overall revision rate was 1.4% (95% confidence interval [CI] 1.2%–1.5%) at 3 years, with the lowest revision rates experienced by patients who had cemented prostheses. Women were found to have higher revision rates after hip resurfacing, and the revision rate was about twice as high in patients who had had a hip replacement for other indications than osteoarthritis. A patient's age did not appear to affect revision rates after hip surgery.

80,697 patients in the linked database had undergone a primary knee replacement. The overall revision rate was 1.4% (95% CI 1.3%–1.6%) at three years, again with the lowest rates of replacement experienced by patients who had cemented prostheses. Revision rates after knee replacement strongly decreased with age.

So, about one in 75 patients required a revision (replacement within 3 years) of their joint replacement, which is considered low, when compared with other countries here - e.g. for a cemented prosthesis (hip), the 3 year revision rate in England on the NHS is 0.9% compared with 1.8% in Norway, 2.14% in Australia and 1.2% in New Zealand.

That's excellent news. Isn't it? Let's look at how the meeja attacked the story:

BBC - NHS 'excels at hip and knee ops'
The Times - ‘Quick-fit’ knee and hip replacements that can wear out in three years
The Daily Telegraph - New hip and knee replacements 'more likely to need repeat surgery'
The Daily Mail - New hip and knee replacements may wear out in just three years

In fairness, the BBC has written a pretty good account of the research, while the traditional newspapers have decided it would be much more prudent to tell their readers that things are worse than they are, and that despite being better than many other comparable countries in the world, the NHS is a bit rubbish.

The Daily Mail & The Times refused to even admit in the text that The Royal College of Surgeons had trumpeted this as a credit to the nation's orthopaedic surgeons, whereas The Telegraph gave the same positive quote as the BBC.

Where is the patient rights agitator telling us all that this is all very reassuring, and shows a health system delivering outstanding results when compared to more expensive systems in other countries? Where are the banner headlines telling the public that the NHS is really pretty fantastic at this surgery?

There is a good discussion of this disappointing media exposure on the Bad Science website - unfortunately time is not allowing me to vent my spleen fully......

BPSDB

With thanks to El Pollo Diablo and Little Papi. I don't think I did your comments justice.

EDITED TO ADD (4th Sept)

Another example of negative reporting here from the BBC:

RISE IN UNDER-18 REOFFENDING RATE

Which contains this positive nugget:

However, figures for adults indicate reoffending rates have fallen to their lowest rate for at least six years.

Who cares? No-one wants to hear about the government doing well.