The CNHC wishes to place on formal record their thanks to Simon Perry

The Complementary & Natural Healthcare Council, or CNHC, started its operation of registering practitioners at the beginning of 2009. Its stated key purpose is to:

“protect the public by means of regulating practitioners on a voluntary register for complementary and natural healthcare practitioners.”

Practising evidence-based medicine has some difficult constraints. Firstly, you need to be able to show your intervention to be effective. It’s considered unethical to just make up ideas ad-hoc and market them as an effective medical intervention. Secondly, in order to avoid a repeat of the thalidomide disaster, you need to be able to demonstrate that your intervention is safe.

But all this is very difficult. It requires a lot of training. It means you can’t get your products and services to market without checking them. But what if there was a way we could avoid the hassle of checking the evidence for efficacy? What if there was a way we could practice without checking our interventions were safe? What if instead of going through the trouble of medical training, we could take a part-time evening course at a local college and be guaranteed a pass because the course content consists of no actual knowledge?

Welcome to the world of Complementary Healthcare.

Now I don’t think I’m the first person to point out that if you are going to regulate any type of healthcare, then the fundamental points you need to cover are (i) ensuring interventions work, (ii) ensuring interventions are safe, and (iii) ensuring practitioners are adequately trained.

But this is already subject to statutory regulation. It’s what we call medicine. The whole point of Complementary health is that the practitioners can’t be bothered with all that.

What on earth does the CNHC intend to regulate?

The CNHC’s Code of Conduct, Performance and Ethics states:

15. You must follow CNHC guidelines in relation to advertising your services
Any advertising you undertake in relation to your professional activities must be accurate. Advertisements must not be misleading, false, unfair or exaggerated. You must not claim that your personal skills, equipment or facilities are better than anyone else’s.
If you are involved in advertising or promoting any other product or service, you must make sure that you use your knowledge, healthcare skills, qualifications and experience in an accurate and professionally responsible way. You must not make or support unjustifiable statements relating to particular products or services. Any potential financial rewards to you should be made explicit and play no part at all in your advice or recommendations of products and services that you give to patients, clients and users.

The key line in that paragraph is:

You must not make or support unjustifiable statements relating to particular products or services.

Now have I missed something here? The whole point of Complementary health is that you can make claims of efficacy without justification. Don’t get me wrong, I personally believe justification to be extremely important. My point is simply that the regulatory body is exclusively for practitioners who don't share this view.

So I started a little project. The CNHC’s web site allows you to search for practitioners. Each day, I would look at which new practitioners had joined, check their web sites and report them if they made any unjustifiable claims. If they did, I reported them via the CNHC’s complaints procedure. I knocked these complaints out in a few minutes – quick enough to get the point across but so hastily that I failed on my first complaint to correct a copied & pasted spelling error and even added my own grammar hiccup at the end.

The ad suggests that reflexology is suitable for treating babies with colic, IBS and arthritus. She also claims to have experience in treating fertility issues. There is no reliable evidence to suggest that reflexology is capable of treating this issues.

But even with the bad English, it was sufficient to make the point: if the CNHC is going to regulate healthcare then it needs to deal with the question of efficacy.

I intended to send these in every day as new members joined. My persistence lasted about 5 days – it takes time and is very boring work. I drew it back to looking every week, but by that time there were so many members that the task of checking was daunting. In total, I think I only complained about 14 practitioners.

These were the first complaints that the CNHC has received. At this time of writing, I believe I am the only person ever to have complained to the CNHC.

Yesterday I received a call from the Maggie Dunn, the CNHC’s Chief Executive Officer to update me on the status of my complaints.

The CNHC had received evidence from the practitioners to defend their claims. They had also been in touch with the Advertising Standards Agency. The investigative committee met on Tuesday 24th November to discuss the cases.

They decided that my complaints were indeed covered by paragraph 15 of the code of conduct. All fourteen of my complaints were upheld. The practitioners will now be told to stop making these claims.

Sadly however, the CNHC decided that fitness to practice was not impaired because the unjustifiable claims were not made deliberately. The CNHC has a number of “Profession Specific Boards”. Someone from the board relating to reflexology had advised the investigative committee that it is likely the practitioner had been trained to believe that they could treat these diseases.

Now while I do not find it at all surprising that the practitioner was trained this way, I still take issue with this decision. If a practitioner has undergone training that tells them they can treat specific diseases for which there is no evidence then the practitioner has not undergone proper training. An untrained or poorly trained practitioner is surely unfit to practice.

What’s more positive however, is what else the CNHC now plans to do. It makes no sense for the CNHC to allow new registrants to join, only to be immediately reported by me. Instead, I’m told, the CNHC will now look at the evidence and provide advice in advance.

The evidence review will go beyond reflexology; it will extend to all of the disciplines covered by the CNHC.

The CNHC will then be contacting all registrants to explain what they are allowed, and not allowed, to claim.

I confirmed with Maggie that this advice will not solely relate to advertising. I was told that the advice will make clear that practitioners are not permitted to make these claims within the day to day interactions with their clients.

I also expressed a concern to Maggie over the training received by the practitioners. There are undoubtedly many courses out there teaching that reflexology is an efficacious treatment for many diseases. Would the CNHC be doing anything about these courses?

Maggie told me that as a regulator, the CNHC sees it as their duty to get in contact with alternative health course providers and authors. Given the nature of my original complaint, I expect this will enforce the view that claims must be justifiable.

But what would a course on reflexology consisting only of justifiable claims cover exactly? How to spell reflexology?

This is so important, and so surprising I feel I need summarise in bullet points:

• CNHC will tell practitioners to remove claims they cannot justify.
• CNHC will conduct a review of evidence base for regulated therapies.
• CNHC will contact all registrants to instruct them not to make claims without justification.
• CNHC will contact complementary health course providers and authors to instruct them not to make claims without justification.

It is my view that adhering to the CNHC’s guidelines will make it impossible to practice complementary medicine.

Could this the end of the CNHC? It would be hugely ironic if forcing its members to act ethically became the cause of its demise.

Finally, Maggie told me that the investigations committee had decided that they wished to “place on formal record their thanks to Simon Perry for bringing this matter to their attention.”

You’re welcome.

The GCC Is Avoiding FOIA Requests

On the 6th October 2009, I sent two Freedom of Information Act Inquiries to the General Chiropractic Council. At this point in time, the GCC had just finished its resolution with the Adverting Standards Agency and as a result of this it became known to me that the GCC had commissioned a review of the evidence for the use of chiropractic in the treatment of various diseases that were not related to the spine.

The first request asked them to hand over all communications between the GCC and the ASA.

My second request simply asked:

• Has the GCC commissioned a review of evidence concerning the effectiveness of chiropractic in the treatment of colic or other diseases?
• If so, please provide me with copies of all communications surrounding the commissioning of this review.
• Please provide the final specification detailing how the review is to be performed.

The GCC’s previous behaviour, and especially their response to questions from Trading Standards officers, has clearly demonstrated that they are not interested in regulating the profession of chiropractic, but instead of protecting the interest of practitioners.

I was obviously interested in how they were planning to perform this review, for instance had they agreed the criteria for inclusion and perhaps more interestingly if there had been an attempt to sway the outcome of the trial during the commissioning phase.

I received a reply from Paul Ghuman the next day confirming receipt and asking me to confirm if my request for communications between the GCC and the ASA related to my complaint made about the GCC’s Patient Information Leaflet. I quickly clarified that this was the case.

It took until the 2nd November until I received a response. They were more than happy to respond to the first request, but the second was completely avoided. They acknowledged that they had commissioned a review, but gave no details.

2. Please note that the current request needs to be defined more clearly in the respect of the information required. For example, it could be that the request is for who approved/agreed the final specification or who made the decision on reviewers. I need more clarification in respect of what information it is that is being requested.

Now they could have asked for this on the 7th October when they responded to my first FOIA request. Why did they wait until the 2nd November to ask this question? If I am not being clear enough, that should be obvious enough from the first time they tried to find the information.

I replied to clarify:

To clarify on (2), I assume the GCC has outsourced the evidence review to a scientist, group of scientists, research group or elsewhere. I also assume that in order to find a supplier for the research you may have contacted several organisations/people.

I am looking for copies of all communications to and from those organisations/people that are relevant to the review - both those that were commissioned and those that were considered.

Is that clear? Any questions just ask.

Since I replied, now 2½ weeks ago, I have emailed Paul Ghuman to chase up, phoned him twice and left a message and emailed Margaret Coats.

No response.

The GCC is acting very much like they’ve got something to hide.

Edzard Ernst shows Society of Homoeopaths break their own code of conduct

In this excellent article in the BMJ, Zosia Kmietowicz interviews Edzard Ernst on the Society of Homoeopaths breaking their own code of conduct. Similar observations were made on Gimpyblog back in 2007. Apparently they didn't learn too much from that then.

Homoeopath society breaks own ethics code by making speculative claims on website, says expert Zosia Kmietowicz

The Society of Homeopaths is in breach of its own code of ethics by posting "speculative," "misleading," and "deceptive" statements on its website, claims a leading UK expert in complementary medicine.

Edzard Ernst, professor of complementary medicine at the Peninsula Medical School in Exeter, identified numerous statements on the society’s website that he claimed could be seen as contravening the code. He was writing in the International Journal of Clinical Practice (doi:10.1111/j.1742-1241.2009.02249.x).

The code of ethics, which runs to 23 pages, sets out the rules that the society expects its members to abide by. These state that advertising should not make claims to "cure named diseases" or be "false, fraudulent, misleading, deceptive, extravagant or sensational." It adds that "all speculative theories will be stated as such and clearly distinguished."

However, a review of some members’ websites showed a series of violations of the code that led Professor Ernst to scrutinise the society’s own website.

Despite there being no good clinical evidence to substantiate such claims, says Professor Ernst, the society’s website carried statements claiming that homoeopathy can help with various symptoms and illnesses, including fever, sore throat, toothache, arthritis, eczema, asthma, anxiety, insomnia, chicken pox, erectile dysfunction, and prostate problems.

"In my view, they [the statements] do ‘expressly or implicitly’ claim ‘to cure named diseases,’" writes Professor Ernst. "If this is so, they violate the SoH’s [Society of Homeopath’s] own Code of Ethics."

He concludes, "If the SoH wants its members to behave ethically it should evaluate its own website carefully and deliberate whether it is responsible for a professional organisation to make health claims which are not supported by the current best evidence."

Professor Ernst told the BMJ that advertising by members of the Society of Homeopaths "should be more than lip service to evidence based medicine, otherwise it is confusing and potentially harmful."

Paula Ross, the society’s chief executive, said she was grateful to Professor Ernst for highlighting his concerns and that the society would be investigating the concerns and making amendments "where appropriate."

BMJ 2009;339:b4605

Why making large numbers of complaints about chiropractors was the right thing to do

I've been criticised recently for making large numbers of complaints against chiropractors for making unsubstantiated claims to treat colic. Criticism has come from comments on my blog, from posts and comments on Lanigan's blog, and from the Shadow Minister for Mumbo-Jumbo David Tredinnick MP.

The justification for my complaints is simply that there is no evidence that chiropractic is an effective treatment for infant colic. For the purpose of clarity, I'd like to add that there is also no evidence that chiropractic can help alleviate the symptoms of infant colic.

But some criticism has pointed out that I'm not suggesting an alternative treatment, and while no evidence-based treatment for infant colic exists, it makes sense to use a treatment with no evidence for its effectiveness.

I will now explain why this position is wrong.

What do we mean by "no evidence"? We mean, simply, that there is no sensible reason to believe that a given intervention is effective. There is no evidence that bathing your child in tomato juice is an effective treatment for infant colic. There is no evidence that hanging your child upside down for two hours a day is effective in alleviating the symptoms of infant colic. These might sound like strange things to suggest, but that's my point: there is no evidence base for these being effective. Chiropractic, as an intervention for treating colic, is no different in this respect.

I am aware that chiropractors do use chiropractic as a treatment for colic, but this isn't a reason to suspect it may work.

Some chiropractic colleges teach that chiropractic is effective in treating colic, but this isn't a reason to suspect it may work.

Some chiropractors notice that symptoms of colic appear to subside after chiropractic treatment. But this is equally consistent with the hypothesis that it is ineffective: we know that symptoms subside over time without treatment anyway.

Until there is a valid reason to suspect that chiropractic may be effective in treating colic, chiropractic as a treatment stands equal beside bathing your child in tomato juice and hanging your child upside down.

But chiropractic takes it one stage further. Because despite the fact that there is no evidence to suggest that bathing your child in tomato juice is effective, nobody has ever tried to look for the evidence. With chiropractic, the evidence has been searched for. Double blind trials have been performed. And they have failed to show it is effective.

If there are three hypotheses, all without evidence for them and one where evidence has been looked for but not found, then that one is clearly the least plausible hypothesis.

There are billions and billions of possible things you could do to a small child that might be effective in alleviating the symptoms of infant colic. Only a tiny fraction of them will work. It is completely unreasonable to suggest that any one of those billions of possible treatments may work without some sort of evidence. If you've looked for evidence that one of those billions of treatments works and failed to find it, then it is completely irresponsible to promote it as a treatment - especially, when like most interventions, it is not 100% safe.

With my complaints, I am not trying to deny patients the right to try whatever they want as a treatment. What I am trying to prevent is a group of people profiting by telling their patients that their treatment is effective when there is not only no evidence - but there is actually evidence to the contrary.

Form letter to your MP

OK, sorry - I've hashed this out in 10 minutes. It's rough, but it needs to go out now so tough.

Go to http://www.writetothem.com/, fill out your postcode to find your MP. Copy and paste this letter in. Send it.

Quick, do it NOW.

Thanks.

Dear ???????,

Tomorrow there is a debate in parliament on the subject of libel reform.

English libel laws are being used to stifle scientific debate in the UK, to the point where many scientists are not bothering to make their opinions heard. Those that do criticise others are being heavily punished for doing so.

Medical doctor and journalist Ben Goldacre was recently involved in a libel battle following his criticism of a vitamin salesman who claimed that anti-retroviral drugs were ineffective in treating AIDS and offered his vitamins as an alternative. Despite the fact that Goldacre won, they still came out of it £150,000 poorer. The science author Simon Singh is going through a similar situation right now.

In 1961, the German paediatrician Widukind Lenz criticised the drug Thalidomide. By this time, at least 10,000 children had been born with birth defects. If he, and all other scientists since, had refused to make their criticism known for fear of legal action, the deformities may still be continuing today.

If we put a stop to criticism, we not only put an end to our ability to know which of our current treatments are effective and safe, but we also make it impossible to evaluate the treatments of the future.

We must do everything we can to reform our uniquely repressive English libel system.

The future health of everyone in this country and the world depends on it.

Yours,

The General Chiropractic Council is knowingly and deliberately violating its own code of practice

The General Chiropractic Council is knowingly and deliberately violating its own code of practice and continuing to mislead the very patients it is meant to protect.

My previous post detailed how the General Chiropractic Council resolved my Advertising Standards Authority complaint against them informally. I also noted that as yet, the GCC has not removed their Patient Information Leaflet from their web site.

About a week after the informal resolution was made (but before it was published), I spoke to the ASA on the telephone about the fact that they were continuing to make these unsubstantiated claims. A concerned ASA voice told me:

"We would have hoped they would have taken this down by now."

So on the 6th October I emailed the GCC to ask their intentions:

"I notice that despite your informal resolution with the ASA, that the text still appears on your patient information leaflet here: http://www.gcc-uk.org/files/link_file/WhatCanI_142_5(Web-Version).pdf

Are you intending to take down or change this leaflet?"

And on the 8th, I received a reply in the post:

I emailed the ASA by email to get their take on this:

"I contacted the GCC following my finding that they had not removed the Patient Information Leaflet from their web site. I had a rather surprising reply from them this morning. They said that they will take it down in reasonable time - and suggested that this would happen once they had taken the time to re-write the document and translate it into several languages.

This is shocking. Surely it makes sense for them to take it down now if it breaches ASA standards - or not at all if it doesn't. Surely while they are re-printing they should not be continuing to distribute the material?

Can you clarify the ASA's position on this?"

And the ASA's reply was fairly clear:

"We’d normally expect an advertiser to implement the changes as soon as is 'reasonably practicable' (bearing in mind the time involved in printing new leaflets).

However, if it’s a leaflet on a website then it should be taken down as soon as possible."

So the ASA (rather unsurprisingly) agrees with me that it is unreasonable to continue to make unsubstantiated claims solely on the grounds that you haven't got around to writing and translating anything honest yet.

Based on the informal resolution and the above text from letters and emails, I can't draw any conclusion other than:

• The Chief Executive of the GCC is fully aware that its Patient Information Leaflet violates ASA guidelines.
• The Chief Executive of the GCC is aware that this leaflet is continuing to be made available on their web site.
• The Chief Executive of the GCC is in no rush to do anything about it.

How can the GCC be expected to regulate the chiropractic profession when it knowingly and deliberately violates the very guidelines it is meant to be enforcing?

I think it's time for a complaint against the GCC itself.

Hopefully they'll take my complaint seriously, clean up the regulatory body, start properly regulating the chiropractors and move towards a future of evidence-based chiropractic.

Then I can get back to my game of World of Warcraft.

General Chiropractic Council to Change Patient Information Leaflet

My complaint to the Advertising Standards Authority about the General Chiropractic Council’s Patient Information Leaflet has now gone through the ASA’s process.

The ASA has managed to deal with my complaint as an “Informally Resolved Complaint” rather than pushing it through to a formal adjudication.

This is a very interesting outcome.

What this means is that the General Chiropractic Council has withdrawn the claims as soon as they were approached and asked the ASA’s guidance in how they can make their advertising comply. There is an important point to note here: if the General Chiropractic Council believed they had the evidence to back up the efficacy of using chiropractic as a treatment for asthma, headaches, migraine and infant colic – then they simply could have produced it.

The ASA would have assessed this for them free of charge and either upheld the complaint asking them to remove the advertising, or not upheld the complaint. There is only one reason for backing off from the complaints: the GCC must have appreciated that that they simply do not currently have the evidence.

This is a significant change, and has huge implications for the circa 600 complaints currently being handled by the GCC.

By backing off and removing their claims before the ASA investigates, the GCC is acknowledging that even their loosely worded, slightly ambiguous leaflet (text below) is in breach of ASA guidelines.

There is some evidence, though more research is needed, that you may see an improvement in some types of:
• asthma
• headaches, including migraine
and
• infant colic.

If the GCC believes this loosely worded text to be in breach of ASA guidelines, then they must also believe that every complaint made to the GCC surrounding this subject is valid.

Am I being too optimistic in anticipating a vast number of guilty verdicts against chiropractors in the forthcoming months?

It also brings up a second potentially interesting outcome. If you’ve been following this blog, you will be aware of the letter that the GCC sent to Trading Standards in defence of their members. The advice given in that letter includes the exact text within the patient information leaflet that I complained about.

Will the GCC now follow that letter up with another saying that they are now withdrawing that claim? I will be putting that question to them.

Perhaps I'm being a bit optimistic – especially considering that more than a week after agreeing to informally resolve the complaint, the patient information leaflet remains on their website in its original form.

I am now beginning work on my second ASA complaint about the same Patient Information Leaflet.

While you're in the mood for chiro woo, I highly recommend Zeno's post on his recent ASA complaint - published at the same time.