How Life Healthcare Coped with the Terror of an ASA Investigation.

Wednesday, May 14, 2008

The Advertising Standards Authority is one of the few regulatory bodies in the UK regularly prepared to tackle the untruthful and unsubstantiated claims made routinely in the alternative health industry. It is also one of the weakest regulatory bodies in the UK. Nothing could highlight that more than how Life Healthcare (trading under the url http://www.reverseageing.com/) dealt with an investigation.

Life Healthcare had made an advertising leaflet for a product called Thyroid Support Formula and had a heading on the front page that stated "New Scientific Studies Prove That There Is Hope, Read On, and You'll learn the Secrets That Your Doctor Might Not Be Telling You about an Under-Active Thyroid". Particularly worrying was the claim that,
But the truth is that conventional medicine does not have the best testing or treatment methods for an under active thyroid. Just because your test results have come back negative for an under active thyroid doesn't mean you don't have it.

A complainant to the ASA expressed concerns that a leaflet from Life Healthcare was
potentially harmful because it discouraged people from seeking proper medical treatment or from following the advice of their doctor

and doubted that,
the claims made in the ad for the product's efficacy could be substantiated

The ASA took a look a the advertisement and also challenged Life Healthcare if they had proper authorisations to market their products and whether the testimonials and photos included in the ad were genuine.

So, pretty serious charges. How did Life Healthcare respond? They didn't. They completely ignored requests by the ASA to explain themselves. The ASA upheld all complaints and said,
The ASA was concerned by Life Healthcare's lack of response and apparent disregard for the Code, which was a breach of CAP Code clause 2.6 (Non-response). We reminded them of their responsibility to respond promptly to our enquiries and told them to do so in future.

Their action was,
We told Life Healthcare not to repeat the claims in future advertising. We urged them to seek guidance from the CAP Copy Advice team before advertising again and asked CAP to inform its members of the problem with Life Healthcare.

I, for one, am not convinced that this direction will be adhered to.

Life Healthcare appears to make a business from evading legal restrictions on its practice. The from page of its website informs us,
With draconian EU legislation pending for the UK marketplace your right to buy optimum dose nutritional supplements may be limited, and some ingredients may no longer be available. Fortunately as we are based outside the EU (in the Channel Islands), Life Healthcare can continue to supply these high potency supplements that may have to be withdrawn from the UK and Europe in the coming months and years.

The current weakness of consumer protection laws in the UK will indeed be strengthened in the next few weeks as vastly improved consumer trading legislation comes into force. Whether this makes any difference to companies such as Life Healthcare remains to be seen.

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Postscript

It would appear that fleeing to the channel island might not be the get out of gaol free ticket Life Healthcare hope for. Yesterday in parliament, the Minister for Health Dawn Primarolo, responded to a question asking what the Government was doing about such loopholes. She replied,
The FSA continues to work with the Ministry of Justice, the Department responsible for the Crown Dependencies, and the administrations in the Crown Dependencies regarding implementation of the food supplements directive and Nutrition and Health Claims Regulation to prevent trade in food supplements that would be illegal in the United Kingdom.

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How to become a Daytime TV Expert: The Jayney Goddard Story

Wednesday, May 07, 2008

Professor Jayney Goddard is the president of the Complementary Medical Association (CMA), "the world's largest professional membership body for complementary medicine" and has been elected a Fellow of the Royal Society of Medicine. She studied homeopathy at Imperial College for five years and has won numerous awards. According to various sites, she is "considered to be among the world’s leading experts in complementary and integrated medicine."

Impressive stuff. No wonder she was invited onto today's The Wright Stuff to debate with Simon Singh on the subject "Homeopathy: A Waste of Money". Indeed, Jayney Goddard is a regular guest on the show and boasts an impressive appearance list in other shows, including being resident 'Expert' on Discovery TV. But Jayney appeared to state a number of surprising factual errors and have some over optimistic interpretations of the research literature (and I will come onto these). How could such a eminent expert make such mistakes? I thought a little background research might be in order.

So, President of the CMA, "the world's largest professional membership body for complementary medicine". What is the CMA? Well, the CMA web site does not appear to be what I expected. It offers some articles, sells a few books and food supplements and offers marketing services for members. Looking at Company House records, the CMA is registered address is Chase Bureau Services, a supplier of 'off the shelf companies' and other company secretarial services. So, no 'head office' for the CMA then. The web site for the CMA is registered to a private individual with an address given in a residential block of flats in Wandsworth. I'm disappointed. The CMA is not sounding so grand as I first thought. However, the CMA does usefully offer viewers of the Wright Stuff options to buy products that Jayney mentions on air. It looks to me like Jayney Goddard is president of a shop.

So, what about being Professor Jayney Goddard? We are told that Jayney was "recently awarded a Professorship from Mahendra Sanskrit University in Kathmandu, Kingdom of Nepal". The university was set up to promote the Sanskrit language in Nepal. However, when I tried to contact the University to find out more about Jayney's Professorship, I found their website is permanently down. Unfortunately, it would appear that in 2002, a hoard of women Nepalese Maoist rebels reduced the University 'to cinder' and destroyed all the ancient Sanskrit texts, University buildings, furniture, and all university records. The rebels had previously planted a 'crude but powerful bomb' there too. It is not clear if Jayney Goddard makes frequent visits to fulfil her Professorial duties.

And what of these claims to have studied homeopathy at Imperial College? The University is one of Britain's most prestigious degree level teaching and research institutions. It does not offer a degree in homeopathy. Elsewhere we are told that her qualifications are "diploma in hypnotherapy and is a Licentiate of the London College of Classical Homeopathy". No qualifications from IC then? This is a puzzling one.

And finally, Jayney says she has been elected a Fellow of the Royal Society of Medicine. What does it take to become a Fellow of the Royal Society of Medicine? The answer looks to be about £356 for a London resident. You can join online. I filled in the form and elected myself to become a Regional Fellow for £287. Bargain! Le Canard Noir, Fellow of the Royal Society of Medicine. Magnificent! My mum will be so proud. It looks like Jayney could become a Fellow as her 'presidency' of the CMA is obviously a 'senior management' role in healthcare.

There is so much more on Jayney's CV that we could explore. But enough for now.

So, what of these errors she made on the Wright Stuff? Simon Singh was arguing that the totality of scientific evidence for homeopathy showed that it was ineffective and a placebo based therapy - unsurprising given that it is just plain sugar pills. Jayney tells us though that 'outcome trials' are the way to measure homeopathy. These trials almost always give you positive results for homeopathy - they are just not very good as they do not compare homeopathy against any control group. It is impossible to know if the effect was caused by homeopathy or it was just people getting better on their own. Simon argues this, so Jayney went into animal experiments and this is where she lost the plot.





There is just some research printed recently, I think it was actually in Immunology which is one of the worlds leading scientific journals and it showed that mice exposed to something causes Chagas disease (guffaws) ... these mice were treated homeopathically, prior to being infected. It was a properly run double blind placebo controlled trial - the gold standard that Simon is actually talking about - and what actually happened was the untreated mice died, the mice that were treated did not get the disease.

Wow. But is it true? Well, no.

The research was done, but not published in Immunology. It was published in the in-house comic of the Faculty of Homeopaths, Homeopathy - a rag with as much scientific integrity as the Beano. The paper, "Effects of homeopathy in mice experimentally infected with Trypanosoma cruzi ", did not say that the untreated mice died or that the treated mice did not get the disease. It reported that more mice died in the control group but that this was not statistically significant. But the main criticism would be that the statistical certainty of effects were low (only p<0.05) and that multiple measurements were being made in five groups that would undoubtedly result in many false positives. If Professor Jayney Goddard thinks this is the best evidence for homeopathy, then we can be pretty sure it does not work. What is certain, is that this TV show was not the right forum for discussing p-values.

But Jayney went on to discuss homeopathy for childhood diarrhoea. She talks of trials 'all over the world, in developing countries' where children with diarrhoea have been treated with homeopathic medicines and also placebos and Jayney claims that the children who have been treated homeopathically had shorter periods of diarrhoea. Jayney tugs the heartstrings and tells us that the poor children of Burma, after the recent cyclone, could benefit enormously from such treatment. Undoubtedly, it is the sceptic scientists like Singh who get in the way of saving the children. Again. Is this true? Again, no. Diarrhoea and homeopathy is really just one researcher's passion - Jacobs. She has been involved in a number of trials in places such as Nepal and Nicaragua. Individually, these trials did not show a strong significant effect for homeopathy. But when Jacobs did her own meta analysis on three trials, she claims to be able to show a statistically significant effect. Jacobs suggests that "larger sample sizes be used in future homeopathic research to ensure adequate statistical power".

As meta analyses go, doing your own analysis on just three papers that you have been involved with is not really showing multiple independent confirmation of your result and is unlikely to be sufficiently self-critical of the work and take adequate precautions usually found in competent meta-analyses. Tellingly, Jacobs did go on to do another larger trial in Honduras in 2006. The conclusion was,
The homeopathic combination therapy tested in this study did not significantly reduce the duration or severity of acute diarrhea in Honduran children.
Showing his own biases, the paper did not discuss the possibility that homeopathy could not work, but rather that the homeopathic pills had been stored incorrectly and so on.

In discussing the Chagas and diarrhoea trials, Jayney Goddard misled her TV audience. It would have taken half an hour for Singh to untangle that lot, even if he had the relevant papers to hand. Given the the show host was acting like a moron pretending him and his friends did not need protection in malarial areas, Simon Singh did not have a chance of getting clear science across.

The most telling moment came when one of the other guests asked,
Simon, you've got trials that prove your case, Jayney, you've got trials that prove your case, which makes it very difficult for us to know where the truth lies.
Well, if Simon's colleague, a real professor of complementary medicine from Exeter University, Edzard Ernst, had come on, then perhaps there could have been a rational and fruitful discussion about the role of homeopathy in the NHS. But instead of Professor Ernst, we had to have a Professor from a long-since burnt down Nepalese Sanskrit University who runs a web site selling homeopathic books and pills. That, in my opinion, creates the obvious confusion shown on this show.

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Neal's Yard Remedies 'rapped by medicines regulator'

Tuesday, May 06, 2008

In a recent post, I described how Neal's Yard Remedies had withdrawn their Malaria homeopathy pills. Their press release said,



as this is obviously a contentious issue which is causing customer concern, we have decided to withdraw the product, Malaria Officinalis 30c from sale with immediate effect.

I described this as bullshit, just like the rest of their press release. The much more likely cause was that they were being investigated by Trading Standards and the MHRA - the medicines regulator in the UK - after a BBC investigation had 'stung' one of their branches.





Well today, the MHRA have issued their own press release, which I will reprint here...

The Medicines and Healthcare products Regulatory Agency (MHRA) has clamped own on a homeopathic remedy intended to be viewed as a treatment or preventive for malaria sold by the cosmetic chain, Neal’s Yard Remedies. The MHRA has received confirmation from the company that the remedy, Malaria Officinalis 30c, will be removed from sale immediately.

All homeopathic remedies are classed as medicines and require prior authorisation by the MHRA before being placed on the market. The MHRA was concerned that no record of an authorisation had been given for Malaria Officinalis 30c and therefore concluded that it was an offence to sell, supply or to advertise this product which had not been authorised.

David Carter, Head of the Borderline Team at the MHRA said, “This product was clearly intended to be viewed as a treatment or preventive for malaria, which is a serious and potentially life-threatening disease. We regard the promotion of an unauthorised, self-medicating product for such a serious condition to be potentially harmful to public health and misleading. We are pleased that Neal’s Yard Remedies have complied with our request and removed this product from the market.”


So, Neal's Yard ethical bullshit has been exposed.



Now, I emailed their MD, Jonathan Hook, to ask if he supported the claims made by his unmedically qualified Medicines Director, Susan Curtis. In her book Homoeopathic Alternatives To Immunisation she describes how similar remedies could prevent malaria. Some of them are still for sale. No reply so far.



The book is still for sale on Neal's Yard's website. It continues to make alarming claims...


An invaluable guide for all trevellers[sic]. This book contains practical
information on preventing and treating major infectious diseases, including hepatitis, flu, measles and whooping cough.

Only the claim for malaria has now been dropped.

It looks like Neal's Yard has done the absolute minimum to avoid prosecution. This is shameful and is contemptuous of its customers. When is Neal's Yard going to come clean and do the right thing?

And let us not forget, Neal's Yard were only acting as resellers for Ainsworths. Are the MHRA going to anything about that company too?

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The BBC have now picked up on this story. "Firm 'misled' over malaria drug". Of course, it wasn;t a 'drug' they were selling, but a plain sugar pill.

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