Challenging misleading healthcare claims

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Alternative

We hope you had a great summer and many thanks to everyone who is keeping us informed with their various complaints.

This isn't a standard NC newsletter; one of those will follow soon. We'd just like to publicise the new comedy play, Alternative, by Trunkman Productions, which runs from 13th to 18th September at the Etcetera Theatre in Camden.

We enjoyed a preview of this play a few weeks ago and Trunkman very kindly promoted the Nightingale Collaboration in their publicity material. Predictably, this has led to speculation from certain quarters that we are helping to fund the play, but we're not! As it says on our website, we run on a shoestring budget. However, we are pleased to offer our support in helping to publicise this work, which has attracted some excellent reviews and has annoyed some proponents of alternative therapies!

Tickets are available from Ticketweb on 020 7482 485 or at the door.

From Trent and Melinda Burton of Trunkman Productions:

Back in August we previewed our new comedy play 'Alternative'. The show is about a man with a mystery illness and his quest for a diagnosis. He's stuck between a relatively clueless GP, a nagging girlfriend and a homeopath for a sister. She's positive she can help… It's all about how the rational can become irrational when their health is on the line.

The previews went rather well with a sold out opening night audience that included Simon Singh and Edzard Ernst. We got some great reviews as well. The Pod Delusion declared us, 'The best peer reviewed show in London' and leading theatre critics site The New Current called it 'Consistently hilarious.' The Alliance for Natural Health called us 'Flat-Earthers'. Bless them.

Our first aim — with any show — is to entertain our audience and we hope that through entertaining we can inform and also spark debate about issues. The issue we've delved into with this show is alternatives and specifically that of alternative medicine. It's not a common subject on London theatre stages, I grant you, and it's certainly ruffled a few feathers but that's the way we like it!

For us at Trunkman Productions, producing 'Alternative' in association with The Nightingale Collaboration isn't just a privilege but also a natural fit, if you'll pardon the pun. We're trying to introduce Nightingale to the theatre-going public, who may not be aware of their work, or even the issues surrounding alternative medicine. Likewise current supporters of Nightingale like yourselves may not be aware that there are shows out there on the London stage tailored to your interests.

'Alternative' is a character-driven comedy set in the world of alternative medicine rather than one that simply aims to take pot shots at it. Let's be honest — that'd be too easy. This focuses on the often all too familiar situations that can arise that lead people to alternatives. Hopefully the theatre-goer who has never considered alternative medicine to be an issue that even needed debating in the first place, might now see things differently.

And for the skeptic in the crowd, here's ninety minutes of comedy in a world and a debate we're very accustomed to. Also there's a slew of in-jokes you can take pride in getting that others may not!

So we hope you enjoy the show as, together with Nightingale, we continue to spread a rational message with our own brand of comedy.

Pseudo science by degrees: a response

A month ago, we encouraged all those concerned with our universities giving undeserved legitimacy to pseudo science by offering science degrees in subjects such as acupuncture and naturopathy to write to the University of Westminster to express their concern. Our thanks to all who did so.

In response to the email we sent to the Vice-Chancellor, Professor Petts, we received the following reply:

Thank you for your e-mail and interest in the courses the University offers in Complementary & Alternative Medicine (CAM). This, I understand, has been sent at the suggestion of the Nightingale Collaboration which I note is keen for the University to discontinue these courses.

With an estimated one in ten people in the UK consulting CAM practitioners each year, for the last 15 years the University has been at the forefront of offering courses that will enable students to practice their chosen therapy safely and effectively. To this end, the courses have at their core the study of the health sciences, research and practitioner development, with students developing their clinical skills in the University's Polyclinic. As with other practitioner based courses, they have been deemed to warrant the award title of a BSc.

Whilst I understand that critics of CAM consider Westminster (and the 21 other HE institutions that currently offer courses in CAM) as devaluing science, the approach taken at Westminster is very much a scientific one. Students, as part of their learning, are taught to engage with the relevant literature, to be aware of the limits of their therapy, to reflect critically on what they observe and learn, as well as to refer on to doctors where appropriate. In this way, they apply the scientific method to their learning and their future practice.

The University has a long tradition in providing courses that are relevant to the local community and to the population at large. Whilst areas of CAM have come under considerable criticism - in some cases justifiably - it is likely that the public will continue to want access to well qualified and professionally trained CAM practitioners for some time to come, especially given the current crisis in health funding. Universities such as Westminster are in the best position to provide such training, to undertake the research underpinning CAM practice (as we are doing), and to work closely with the relevant professional bodies. The recently announced regulation of herbal medicine should also ensure that the public is duly protected and that standards of practice are raised further.

Whilst I understand your concerns, colleagues of the School of Life Sciences where these courses are offered do not share them. They are not teaching pseudo-science, as you claim, but rather teaching students who are keen to work in this area, to discern for themselves what is found to work (or not) in practice, to be critical of current practice, and to develop the necessary skills so they can become safe and competent practitioners.

Yours sincerely,

Professor Geoffrey E Petts

Vice-Chancellor

University of Westminster

It looks like the same response sent to everyone who contacted Prof Petts.

There are numerous problems with this reply and it doesn't answer the questions we asked: it simply highlights the problems even more.

The most telling phrase is that they are "teaching students…to discern for themselves what is found to work (or not) in practice". This is the crux of many of the problems with alternative therapies: their proponents like to favour personal experience over robust and independent studies, completely unaware of the many biases that are likely to be present, making it extremely difficult to accurately discern what works from what doesn't. Such patient encounters fail to differentiate between any effects of the therapy itself from any benefit brought by an empathetic 'consultation' with their customer; the specific versus the non-specific effects. Indeed, a recent study on homeopathy showed that it was the consultation and not the sugar pills that had an (inconsistent) effect on participants with rheumatoid arthritis.

Regardless of whether there is any clinical evidence to support the use of, say, homeopathy or reflexology, there is still the huge problem of the lack of a plausible scientific mechanism of action for therapies such as homeopathy and reflexology, so it's difficult to see what could be being taught that would merit the award of a BSc or an MSc degree.

We will be writing again to Prof Petts and our supporters might like to do the same.

If anyone got a different response or if you do write to Prof Petts again, please let us know.

Other campaigns

The Advertising Standards Authority should have started their monitoring of the homeopathy websites they received complaints about in March to ensure they now comply with the CAP Code and dealing with any that still don't. We will need to wait till the ASA complete this mammoth task before deciding if any further project is required.

In the background, we are working on various other projects and we'll let you know about these as soon as we can.

Tools & Resources

If you haven't already, you might like to read about some of the tools and resources we provide:

Slimming spray manufacturer sues complainant

The Australian company that was suing a critic of their slimming product for defamation, appears to have gone into liquidation.

The manufacturers of SensaSlim — a 'miracle' slimming spray — took action against public health physician Dr Ken Harvey, an adjunct professor at Melbourne's La Trobe University, after he made a complaint to the regulatory body, the Therapeutic Goods Administration (TGA), over claims being made for the product. SensaSlim claimed the action was because of an article on a website that Dr Harvey says he did not write. Because of this legal action, the TGA halted their investigation.

Subsequently, the Australian Competition and Consumer Commission (ACCC) took action against SensaSlim, alleging it engaged in misleading and deceptive conduct. The ACCC obtained a restraining order from the Federal Court freezing SensaSlim's bank account.

The claims being made by SensaSlim can be found on their website and include:

A staggering 87.2 percent of subjects lost 10 percent or more of their body weight

The average weight loss of the participants was 15 kilos over the trial

Some people lost more than 45 kilos in the six-month study.

The results confirmed that SensaSlim Solution is unquestionably the most effective slimming solution available in the world today.

Their UK website mostly just links to the main website, but it also still claims:

20 years of research.

11,453 people tested.

146,040 kilos lost.

There appears to be major controversy over the status of this 'research', which doesn't seem to have been published anywhere, and the alleged endorsement of the product by Dr Matthew Capehorn, Clinical Director of the UK's National Obesity Forum and Clinical Manager of the Rotherham Institute for Obesity, in a white paper he wrote. Dr Capehorn has since distanced himself from SensaSlim.

More details of the story can be found here.

The latest details of the case were announced by Mel Vickers of the Victorian Skeptics on Twitter:

SenaSlim’s lawyers did not submit an updated statement of claim, the libel case against Dr Ken Harvey has lapsed

A liquidator now runs SensaSlim in Aus. Dr KH may get costs awarded but still will be out of pocket for legal.

Pseudo science by degrees

Current ASA complaints

Our thanks to everyone who sent us their examples of craniosacral websites making questionable claims. We have selected a few of these as 'specimen' complaints and have submitted them to the Advertising Standards Authority. We included details of trade bodies and a comprehensive list of craniosacral websites to make the ASA's job a bit easier, providing them with a Google Custom Search of these websites. This will allow them see for themselves the extent of the problem of questionable claims being made on craniosacral websites and realise that misleading advertising is not restriced to the few websites we have highlighted, but is endemic in the industry.

While we wait for the Advertising Standards Authority to deal with the large number of complaints our supporters have submitted about homeopathy websites and our craniosacral complaints (and, no doubt, numerous complaints submitted by others), we are deliberately avoiding giving the ASA even more work until we see the outstanding complaints being resolved. We are also requesting our supporters do the same to give the ASA time to catch up. It is not in our interests to overwhelm them with complaints.

Meanwhile, we want to focus on the problem of what some therapists are being taught in our institutions of higher learning.

The problem of training

When Simon Perry complained to the Complementary and Natural Healthcare Council (CNHC) in 2009 about claims being made by some of its members, they thanked him for bringing the matter to their attention, upheld his complaints, asked the members in question to stop making unjustifiable claims and informed Simon of their intention to contact all registered members to issue advice to all registered practitioners.

How successful they have been in the intervening 18 months will be the subject of a future article.

However, the CNHC realised that they needed to be seen to get to the root of the problem: what are their members being told during their training? Are they being told they can help/cure/alleviate all sorts of medical conditions?

In an attempt to curb future misleading claims, the CNHC resolved, for all the 'disciplines' they register, to:

…contact complementary health course providers and authors to instruct them not to make claims without justification.

Higher learning

For the therapies the CNHC regulates, much of the training is carried out by private companies. However, there are several UK Universities offering courses in reflexology, acupuncture and naturopathy. Not only that, but they are providing Bachelor of Science and Master of Science degrees in these subjects.

A full list of these courses and the institutions running them can be found on the UCAS website by searching for 'complementary', 'reflexology', etc.

David Colquhoun, Professor of Pharmacology at UCL, has been fighting a battle against pseudo scientific courses like these at our Universities for several years and has made tremendous progress. Using the Freedom of Information Act, he has obtained course materials from several universities. These were not given up easily, but Prof Colquhoun was able to persuade the Information Commissioner that his requests for course materials were in the public interest and the Universities were instructed to hand over them over, enabling Prof Colquhoun to highlight the nonsense taught on them.

One such course was the BSc Hons Homeopathy course at the University of Central Lancashire — which was closed in 2008 — in which students were taught about the intricacies of diluting and shaking water to turn them into hightly potentised 'medicines'. Students at the University of Westminster's BSc in Complementary Therapies were taught that 'amethysts emit high yin energy'.

For further details of this battle, see Prof Colquhoun's blog posts:

{pullquote}amethysts emit high yin energy

–University of Westminster{/pullquote}

Universities still providing these 'science' courses include Edinburgh Napier University and the University of Central Lancashire, but search the UCAS list of subjects to find many more.

University of Westminster

However, the University of Westminster provides more of these courses than any other University in the UK. Their courses include herbalism, acupuncture and naturopathy at BSc, MSc and MSci:

BSc Honours Herbal Medicine

it maintains a holistic approach to treatment, focusing on illness in the person rather than symptoms of disease.

MSc Chinese Medicine: Acupuncture

The Chinese Medical (CM) model has developed from a world view which focuses on qi and cyclical change, expressed in the concepts of yin yang and wuxing (five phases). CM applies these concepts to the person, and describes health and disease in terms of harmonious or disrupted patterns of qi. The concept of ’pattern’ (bianzheng) offers profound insights into the processes of illness and good health, which are becoming increasingly relevant to Western society.

BSc Honours Complementary Medicine: Naturopathy

The core naturopathic techniques include dietary and lifestyle advice, hydrotherapy, the use of compresses and packs, therapeutic massage and soft tissue manipulation. In addition students are introduced to the philosophy, principles and practice of other complementary medicines, particularly homoeopathy and herbal medicine, which provide a wider contextual awareness of complementary healthcare.

Note that homeopathy slips in under the guise of 'naturopathy'.

Such courses devalue the proper science courses taught. At the University of Westminster, these legitimate science courses include biochemistrymicrobiology and molecular biology and genetics. If you think these are incompatible with an institution providing courses in pseudo science, you're not alone.

Prof Colquhoun told the Nightingale Collaboration:

Over the last few years, many universities have closed degrees in several sorts of anti-scientific medicine. Usually the teachers on these courses seem to really believe the dangerous nonsense they teach. Vice-Chancellors of the universities that run these courses presumably do not believe that "amethysts emit high Yin energy", so why do they allow it to be taught?

Is the University of Westminster listening?

In his last blog post (More dangerous nonsense from the University of Westminster: when will Professor Geoffrey Petts do something about it?), Prof Colquhoun asks the University of Westminster's Vice Chancellor, Prof Geoffrey Petts: "Are you listening? I believe it is you, not I, who is bringing your university into disrepute."

Prof Colquhoun also reveals the text of a leaked internal email:

The following courses have been closed/identified for closure due to poor recruitment :

  • BSc degrees in Homeopathy and Remedial Massage & Neuromuscular Therapy, students completing by September 2011
  • MA degrees in International Community development, Community development and Faith-based Community development, students completing by September 2011
  • BSc degree Complementary MedicineGraduate diploma BMS

The following courses have been identified as ‘at risk’ (School definition) and will be discussed at the APRG and University Review Group2, due to poor recruitment and high cost of delivery:

  • Integrated Health Scheme: BSc Complementary Medicine, Naturopathy; BSc Chinese Medicine; BSc Nutritional Therapy; BSc Herbal Medicine

We want to help Prof Petts make up his mind to drop these pseudo scientific and anti-scientific courses.

So, we'd like our supporters to let the University of Westminster know what they think of these courses that give unearned credibility to pseudo science and devalue the real science courses his university offers.

We are focussing on the University of Westminster because they are the biggest provider, but please feel free to choose any other university, particularly if it is your alma mater.

You can email Prof Petts at This email address is being protected from spambots. You need JavaScript enabled to view it., or by post to:

Prof Petts
University of Westminster
309 Regent Street
LONDON
W1B 2UW

There are many ways of expressing your concerns, but here are some suggested words. Feel free to use them as they are or adapt them to your own style, but it will create a bigger impact if you could write entirely in your own words.

Dear Professor Petts

I am disappointed to see that the University of Westminster is offering courses in naturopathy, herbal medicine, acupuncture and complementary medicine, leading to the award of BSc, MSc and MSci degrees.

I am sure you will be familiar with the powerful arguments against offering these courses, but I would be grateful if you could answer the following:

1. Are you fully aware of the content of these courses?

2. Do you believe that what is being taught in these courses is legitimate and of the required standard of a science degree?

3. Do you agree that offering unscientific courses undermines the legitimate science courses?

4. Do you agree that offering these courses gives false credibility to pseudo scientific nonsense?

5. Do you think that offering these courses is in keeping with the integrity of your institution?

I look forward to receiving your reply.

Yours

Another example is:

Dear Professor Petts

I am dismayed to learn that the University of Westminster offers science degree courses in questionable therapies such as naturopathy, herbalism, complementary medicine and acupuncture. Judging by the content of these courses, some of which has been exposed on the internet as pseudo scientific nonsense, it is clearly wrong to describe these subjects as 'sciences' and doing so gives them a credibility they don't merit and I believe this is misleading to applicants and therefore unethical.

That you should offer these courses at all reflects poorly on the University of Westminster as an academic institution. Please stop running them.

Yours

Finally, please let us know what reply you receive.

Prof Edzard Ernst retires

In 1993, Sir Maurice Laing, a supporter of complementary therapies, founded the Complementary Medicine Research Group, now at the Peninsula Medical School at the Universities of Exeter and Plymouth.

Laing appointed Edzard Ernst, then chair of physical and rehabilitation medicine at the Medical Faculty of Vienna, to set it up and Ernst became the first occupant of the Laing chair in Complementary Medicine. In 2002, Ernst became its Director.

It is to the defining attributes of science and the scientific method that Laing wanted — and needed — Ernst to adhere.

In 2008, Ernst explained his attitude to alternative therapies:

For us [Ernst and Dr Simon Singh], there is no such thing as alternative medicine.

There is either medicine that is effective or not, medicine that is safe or not. So-called alternative therapies need to be assessed and then classified as good medicines or bogus medicines.

Hopefully, in the future, the good medicines will be embraced within conventional medicine and the bogus medicines will be abandoned.

This was shortly after Enrst had been critical of misleading claims being made by Prince Charles' beloved, but now defunct, Foundation for Integrated Health. It was this that heralded the end of Ernst's career.

A few days ago, Prof Ernst announced his retirement as Director of the Complementary Medicine Research Group.

To better understand the situation and future plans, we asked Prof Ernst some questions and he was kind enough to answer:

 

What does the Complementary Medicine Research Group at the Peninsula Medical School do and why?

From the early beginnings in 1993 we had defined our aims as follows.

  • To conduct rigorous, interdisciplinary and international collaborative research into the efficacy, safety and costs of complementary medicine (CM)
  • To be neither promotional nor derogatory but struggle for objectivity.
  • To promote analytical thinking in this area
  • The overreaching aim of all of our research is to maximise the benefit and minimise the risk of CM for the patient.

I believe that, vis-à-vis the high levels of usage and the abundance of misinformation bombarding consumers on a daily basis, these aims are important.

 

What was the original vision of Sir Maurice Laing?

Sir Maurice Laing was a good and clever man. He wanted foremost rigorous research. I'm sure he would have wished our results to have been more often positive, but he told me repeatedly that it was more important to conduct good research to a standard that would be acceptable even to sceptics, than to bend over backwards in an attempt to generate positive findings.

 

What have been the Group's greatest achievements?

This is hard for me to say. There have been many. We published more than 1,000 papers in the peer-reviewed medicinal literature. Several independent reviews thus identified us as the most productive CM research group in the world. We also did a few books as a group; the most important two are The Desktop Guide to Complementary and Alternative Medicine. 2nd edition. Edinburgh: Elsevier Mosby. 2006 and Oxford Handbook of Complementary Medicine. Oxford: Oxford University Press; 2008.

We also created a journal, Focus on Alternative and Complementary Therapies. But these achievements are trivial compared to the fact that, I think, we changed the climate of CM research worldwide. When we started, there was hardly any critical thinking within CM at all. We have worked very hard to introduce this into CM through our articles, books, lectures, annual conferences, etc. I'm not saying that the field is known for its self-criticism. In fact, we are still the only centre that consistently does critical evaluations. But the principle has been established and will grow, I hope.

 

Why are you choosing to retire now as Director of the Group?

I am still two years before the official retirement age. Yet I am retiring because the £2 million donated by the Laing Foundation is running out. My University had signed a contract to match this sum, but fund raising was never successful. After Prince Charles complained to the Vice Chancellor about me five years ago, it stopped altogether. Instead of fulfilling their promise, the University told us that they will close us down in May 2011. It was only because I could persuade the new dean who started in September 2010 to reconsider that complete and final closure was averted. The 'deal' we struck was that I officially retire, then get re-hired half-time for a year to help find a successor and provide the continuity. Personally, I am over the moon with this solution. I have fought so many battles that the scars are beginning to show and I feel exhausted with all of this.

 

Why is it important that your Group continues its work?

We are the only group who is doing full-time CM research not for proving that this or that therapy is effective and safe but for testing whether that is the case. This is such an important difference! It is the difference between a scientist and a promoter. The latter we don't need in academia, promoters; they already populate every other strand of society.

 

I understand you'll be working part time for the next year to help find a successor. What qualities will you be looking for in your replacement?

I am looking for a person who is a good scientist with energy and enough courage to stand up against the often quite overpowering forces of quackery. The university wants someone who can bring in money — and that is, of course, equally important.

 

There has been a lot of speculation about the Group being closed down because of a lack of funding. How secure is its future?

Without money, it clearly will not work. The trouble is that it is relatively easy to get research funds if you have the reputation of being "sympathetic" to CM. If you are critical, it is much harder. But if you're not critical, you are not a scientist — and, in that case, it is better not to do the research in the first place.

 

There have been a lot of very personal attacks on your integrity, impartiality and your qualifications to comment on complementary medicine. Has this affected you personally or the work you are doing?

Yes, of course! Over the years I have become rather thick-skinned. But it affects me nevertheless. The best strategy, I find, is to see the funny side of it. Homeopaths attack me for not having qualifications in homeopathy. Think of it! If that's not really hilarious, I don't know what is.

 

What will you do when you fully retire?

Become really outspoken about quackery and charlatans. I look forward to that. Hopefully, UK libel law has changed by then.

 

This is an extract from a longer article written for Zeno's Blog: The end of an era.

Campaign News: May 2011

Homeopathy

In March, we tackled homeopathy websites. We had a tremendous response from our supporters and the Advertising Standards Authority are still dealing with the websites we all complained about. They are also working with the various homeopathy trade bodies to ensure they fully understand their obligations and responsibilities under the ASA's CAP Code and this is communicated to their members.

Once their members become aware of what they can — and cannot — say on their websites and other advertising materials, we expect to see a huge reduction in misleading claims being made.

The ASA gave the homeopaths a further three months to comply and change their websites:

We are giving you three months to review and amend the claims you make on your website. At three months, we will monitor compliance. We think this provides all advertisers with sufficient time to make the necessary changes. We will visit your website, along with all the other advertisers' complained about after 1 July 2011. If your website does not comply with the Code in the ways outlined in this letter we may have to take action.

Just in case the message doesn't get out properly, or some are reluctant or tardy in changing their websites, we will be focusing on them again. This won't be another ASA complaints campaign — we want to allow the ASA to take whatever action they see fit to obtain industry-wide compliance — but it will be something that we will need will need a lot of help with and we will let you know later how you can become involved.

More details nearer the time.

Craniosacral Therapy

Again, we've had a fantastic response from our supporters and we believe we have some excellent example CST websites to send to the ASA. We will use the ones with the worst misleading claims as 'test' cases and submit the remainder to illustrate to the ASA the extent of the problem. We will also give the ASA full details of the various trade bodies that have CST members. We anticipate this will help the ASA in ensuring industry-wide complaince, as they are doing with the homeopathy trade bodies. It is hoped that these trade bodies will take responsible and decisive action to ensure their members comply with the CAP Code.

We will keep you informed of our progress.

Other projects

We are working on several other projects including having discussions with the Medicines and Healthcare products Regulatory Agency (MHRA) on several topics of interest including homeopathy, herbals and another one we'd like to keep to ourselves for the time being!

Herbal products

This is a good time to say a bit about the regulation of herbal products.

Herbal products are significantly different from most other forms of alternative therapies in that they frequently contain pharmacologically active chemicals that can cause physiological effects in humans and other animals. They can therefore be dangerous: either intrinsically or because they have been contaminated or adulterated during or after the manufacturing process. It is therefore essential to safeguard the public that these products are regulated.

It's a long and complicated story, but a hot topic of discussion amongst herbalists — whether western, traditional Chinese or ayurvedic — is the ending of a very long transition period on 30 May. This transition period has to do with the implementation of the EU Traditional Herbal Medicinal Products Directive (2004/24/EC). We wouldn't recommend you try to understand it unless you have a penchant for such legalese, but a good, simple summary of what it means to the advertising and selling of herbal products has been produced by the EU: Q&A: Registration of Traditional Herbal Medicinal Products.

Essentially, after 30 May, it will be illegal to sell over-the-counter manufactured herbal products that are not registered by the MHRA under their Traditional Herbal Medicines Registration Scheme (THMRS). There are just over 100 licences that been issued by the MHRA and these will be the only herbal products making medicinal claims that will be allowed to be sold. Other herbal products will be allowed to be sold, but only if they are sold as food supplements, do not make medicinal claims and do not have a physiological or immunological effect.

The MHRA publish Public Assessment Reports for each of the THMRS licences they issue. It's worth looking through one of these to get an idea of what data are required to comply with the THMRS. Taking this one for a Black cohosh product as an example, the main body of the assessment comprises a scant nine pages. It includes:

No clinical efficacy data are required for registration of Traditional Herbal Medicinal Products (THMP).

No studies have been carried out to determine if drug interaction occur with this product.

The safety of the product during pregnancy and lactation has not been established, therefore it should not be used during pregnancy or lactation or by women attempting to become pregnant.

No studies on the effect of this product on the ability to drive or use machinery have been performed.

Pharmacodynamic properties: Not required.

Pharmacokinetic properties: Not required.

Preclinical safety data: The preclinical toxicology data are limited. Tests on reproductive toxicity, genotoxicity and carcenogenicity have not been performed.

However, herbalists are up in arms about this restriction, seeing it as an unwarranted intrusion into their right to freely choose to purchase whatever herbal products they wish. Essentially all the THMRS does is ensure some safety aspects of the products through Good Manufacturing Practice. No evidence of efficacy is required and the scheme is a pale imitation to the requirements that pharmaceutical companies have to comply with to obtain MHRA Marketing Authorisation. But it seems that even this two-tiered system is too much for some herbalists and many are so incensed that they have collected £90,000 to mount an eleventh-hour legal challenge against the EU Directive.

So, if we find unlicensed herbal products that are making medicinal claims for sale in May, can we complain and who to?

Unfortunately, it's not quite that simple. Although the transitional period ends on 30 May, unlicensed products that are already in the supply chain can continue to be sold until they are used up. What is not allowed is for a manufacturer or EU importer to place on the market any unlicensed product after 30 May. The full details of this can be found in the MHRA's guidance.

What this means is that we cannot be certain that any unlicensed product on a shop shelf or being sold on the Internet is illegal. Not knowing the details of a typical supply chain, it's impossible to estimate when unlicensed product placed on the market before 1 June will be used up.

However, we will be monitoring the situation and we will let you know when we think it would be a good time to do some checking. We will also keep you informed of the Government consultation to regulate herbal practitioners.

Focus of the Month

Because of all this activity and planning that's going on behind the scenes, we've decided that we won't have a Focus of the Month for May.

But don't worry, there will be plenty of opportunities to help challenge misleading claims in the near future!

ASA adjudications

The following recent ASA health related adjudications may be of interest:

Comfort Click Ltd

LighterLife UK Ltd

Nuga Best UK & Ireland

Equine America (UK) Ltd

The International Centre for Nutritional Excellence Ltd

Vitabiotics Ltd

Coca-Cola Great Britain

Dr Batra's Positive Health Clinic (UK) Ltd (see here for further details)

The Maperton Trust

Tony Ferguson UK Ltd

Focus of the Month — April 2011: craniosacral therapy (CST)

01 April 2011

Our first Focus of the Month has been a remarkable success and thanks to everyone who has supported our focus on homeopathy by submitting complaints to the ASA and particularly to those who've let us know about the complaints they submitted. (We regret that because of a server problem for a day or so last week, not all of these received acknowledgement but rest assured they were all received and recorded by us.)

We believe that we've done enough for the time being to ensure that homeopaths nationwide are being alerted to the requirement to comply with the ASA's Code of Advertising Practice. The ASA have told complainants that a further three month grace period is being allowed to practitioners to remove misleading claims from their websites (see previous news for further details).

It is encouraging that the ASA are telling advertisers of homeopathy that:

We have seen the most recent, authoritative and comprehensive review of the scientific evidence by the House of Commons Science and Technology Committee entitled “Evidence Check 2: Homeopathy”. This provided an analysis of evidence and opinion submitted by a range of proponents and opponents of homeopathy, including some of the organisations representing homeopathy in the UK and practising homeopaths. The conclusion made clear that there was a lack of objective scientific evidence to substantiate the efficacy of homeopathy. Because the documents submitted for the “Evidence Check 2: Homeopathy” report provided a comprehensive collection of data for assessment, and homeopaths and the various bodies that represent them were invited to submit evidence as part of a consultation process, we do not intend to duplicate that process or assess the evidence again. We know that some studies suggest a positive effect from homeopathy; however, we understand that the evidence, when taken as a whole, does not support the conclusion that homeopathy in and of itself is proven to help or treat health conditions.

The ASA told all the complainants that they believed the best way to achieve industry-wide compliance — something the ASA has considerable experience in doing — was to work with the various trade bodies. They said:

We will however publish specific, up-to-date advice to the industry and its representative bodies in due course and we will work with them to ensure that advertising for homeopathy is compliant with the Code.

We believe this is the right approach. While there are many practitioners who will not be members of a trade body, the message will be heard by a large number of them and will undoubtedly spread to others.

We think the most efficient way forward is not to send any more complaints about homeopathy to the ASA at present but to give them time to complete their ongoing investigations and compliance monitoring.

April 2011: craniosacral therapy (CST)

So, for our new focus of the month — craniosacral therapy — we'd like to try a different approach.

Instead of submitting complaints directly to the ASA, we'd like you to gather the information about CST websites and send it to us so we can submit 'test' cases to the ASA.

arroworangeTo find out how you can help, click here.

arroworangeTo find out more about craniosacral therapy, click here.

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