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.

The dodgy posters in Leicester Highcross TCM shop

I went into the Traditional Chinese Medicine place in Leicester's Highcross centre today and took photos of all the posters on display. In total there are 20 photos of 31 posters or signs.

See if you can count how many of these 31 posters are not breaking the Consumer Protection Regulations.

If you can't read the text, click on the image for higher resolution.

A

B

C

D

E

F

G

H

I

J

K

L

M

N

O

P

Q

R

S

T

U

V

The public isn't interested in why the GCC is trying to mislead Trading Standards

I received the GCC's response to my Freedom of Information Act Inquiry yesterday evening. The GCC avoided responding to almost every point. You can read the full text of their response here and here.

Two points stand out. Firstly, I was very clear in asking for all previous versions of the document, yet they only returned the final version without specifically stating that it was the only version.

Secondly, and more interesting is their response to my request for copies of internal communications discussing the content of the letter.

The emails are considered to be exempt under S36 of the FOIA because the disclosure of the information would, or would be likely to, inhibit the free and frank exchange of views for the purposes of deliberation. The GCC considers it is important that an exchange of views can take place between relevant parties to allow for proper space for deliberation without the exchange being made public. Additionally, the GCC needs to be able to think through the implications of particular options and consider how to properly approach the trading standards offices. Consequently, the public interest test has been applied by the "qualified person" at the GCC and the decision was that the public interest in withholding the information outweighed the public interest in disclosure and therefore it was considered appropriate to rely on FOIA s36 in this case.

Now the only way I can see this inhibiting the free exchange of ideas is if those ideas are not in the public interest. If those ideas included strategies for deliberately misleading trading standards by misrepresenting evidence, then you'd expect that the free exchange of those ideas may be inhibited. But then I'd have thought that inhibiting those ideas was very strongly in the public interest.

But if the ideas exchanged were how best to represent the evidence and how important it is to be honest with trading standards, then it is important that these ideas are not inhibited. But then honest ideas that are genuinely intended to help the public are not likely to inhibited by the prospect of them being made public.

Now I am willing to accept that some of the GCC's staff may have been less than complimentary when referring to me in their internal communications. And I don't have a problem with that.

Paul Ghuman of the GCC, I make you an offer to protect your staff from embarrassment. Pop those communications over to your lawyers at Capsticks and let them know what you want to remove. Then ask them to send the censored copy to me, declaring that nothing material to the decision making process was removed.

If you'd prefer not to do this, I'll ask my MP to send the next request for information. He has been very helpful before when I have been campaigning against quackery.

His next open bureaux is at 5pm on the 18th September.

Quick Update on the Chiropractic Stuff

Just a quick post to keep you up to date. Firstly, thank you to everyone who signed the letter to Trading Standards. Once I got to 500 signatories I sent it off, reporting 56 chiropractor practices. The sites have started to change. 12 have completely removed the claims, and another 5 have diluted what they are claiming - not ideal, but I'm not sure we can do much better right now.

So we're looking at 39 remaining. Not bad when we started with 160.

I'm still keeping an eye on these complaints, but for now my focus has changed the GCC. The organisation has done nothing to make sure its members are not practicing quackery. It promotes chiropractic for babies with colic and asthma in its patient information leaflet, and it has been actively defending its members from the Trading Standards complaints I've been making.

Having received a copy of their leaflet, I have now reported the GCC to the Advertising Standards Authority. The complaint has been slightly stalled when they questioned if I should be submitting the complaint as coming from Skeptics in the Pub. I'm not sure why that is relevant - and Skeptics in the Pub doesn't even exist as a legal entity, but I'm sure we'll work out the details soon. The ASA have made some very good decisions recently so I'm looking forward to seeing them deal with this.

My letter is below.

New Complaints

Advertising Standards Authority

Mid City Place

71 High Holborn

London

WC1V 6QT

To Whom It May Concern:

I have attached a copy of a leaflet entitled “What can I expect when I see a chiropractor?”. This leaflet is published by the General Chiropractic Council and used to promote the chiropractic profession. The GGC’s address is:

General Chiropractic Council

44 Wicklow Street

London

WC1X 9HL

020 7713 5155

My complaint is that this leaflet breaches the following ASA standards:

3.1 Before distributing or submitting a marketing communication for publication, marketers must hold documentary evidence to prove all claims, whether direct or implied, that are capable of objective substantiation. Relevant evidence should be sent without delay if requested by the ASA or CAP. The adequacy of evidence will be judged on whether it supports both the detailed claims and the overall impression created by the marketing communication. The full name and geographical business address of marketers should be provided without delay if requested by the ASA or CAP.

The claims I would like to focus on in this leaflet are as follows:

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

First I would like to focus on asthma. The statement “There is some evidence, though more research is needed, that you may see an improvement” is misleading. The evidence from trials quoted by the GCC themselves in a letter they recently wrote to trading standards (available at http://www.dcscience.net/gcc-response-to-TS-050609.pdf), they cited the following:

Brønfort concluded in 1997 that there is moderate evidence (Level B) that SMT is a non-efficacious therapy for chronic to moderately severe asthma in adults. There was insufficient data (Level D) to draw conclusions about the efficacy of spinal manipulative therapy (SMT) for other respiratory diseases (including childhood asthma)

I was not actually able to find this paper. However, you can see from the above that the GCC acknowledge that the conclusion of this paper is that the treatment was ineffective.

In 2001, Brønfort et al ( see c. below) concluded that after three months of combining chiropractic SMT with optimal medical management for childhood asthma, the children rated their quality of life substantially higher and their asthma severity substantially lower. The observed improvements were thought unlikely to be as a result of the specific effects of chiropractic SMT alone, but other aspects of the clinical encounter that should not be dismissed readily.

This is a misrepresentation of the study’s findings to make it appear that the outcome was positive (study is attached with this letter - Bronfort2001 asthma.pdf). In fact, the study also concludes that there were “no important changes in lung function or hyperresponsiveness at any time.” In addition, the patient rated outcomes were not even compared between the control and treatment groups. Even the GCC admits in their abstract above “The observed improvements were thought unlikely to be as a result of the specific effects of chiropractic SMT alone”. My conclusion from this evidence is that if you go for a chiropractor for asthma then you might think you’ve got better, but (a) if you had received the sham treatment you may have thought that too, and (b) objective measures will show you wouldn’t have got any better.

In their letter, they also list the following studies:

a. Nielsen NH, Brønfort G, Bendix T. et al 1995. Chronic asthma and

chiropractic spinal manipulation: a randomized clinical trial. Clin Exp

Allergy Jan;25(1):80-8

(see Nielsen1995.pdf)

b. Balon J, Aker PD et al 1998. A comparison of active and simulated

chiropractic manipulation as adjunctive treatment for childhood

asthma. NEJM 339 (15): 1013-1020

(see Balon1998.pdf)

c. Brønfort G , Evans RL, Kubic P, Filkin P 2001. Chronic pediatric

asthma and chiropractic spinal manipulation: a prospective clinical

series and randomized pilot study. JMPT 24(6):369-77

(Bronfort2001 asthma.pdf)

These studies all come to the conclusion that this treatment does not work.

Study (a) concludes:

The results do not support the hypothesis that chiropractic spinal manipulative therapy is superior to sham spinal manipulation in the management of pharmaceutically controlled chronic asthma in adults when administered twice weekly for 4 weeks.

And study (b):

In children with mild or moderate asthma, the addition of chiropractic spinal manipulation to usual medical care provided no benefit.

I have already described study (c).

I have also attached “Spinal manipulation for asthma: A systematic review

of randomised clinical trials, E. Ersnt, 2009.” (09-000 SM4Asthma.pdf). Which states within its conclusion:

Systematic reviews often conclude that ‘‘more evidence is needed’’. In this particular instance, however, I am not convinced that more studies of spinal manipulation should be funded with public money. The current evidence is clearly not positive, not even encouraging. If clinicians or organisations nevertheless imply (as they do) that spinal manipulation is an effective therapy for asthma, the onus is on them to fund, conduct and publish rigorous trials that demonstrate this claim to be true.

By making the statement “There is some evidence, though more research is needed” I believe that the GCC is being misleading. This statement implies that there is a mixture of positive and negative findings and we don’t really if it works or not. In reality, the evidence from RCTs overwhelmingly suggests that this treatment is ineffective.

I have also attached “Chiropractic spinal manipulation for infant colic: a systematic review of randomised clinical trials, E. Ernst, 2009” (09-000 SM4InfantColic.pdf). As you can see from the text, the best evidence studying the use of chiropractic in the treatment of colic is also negative.

I would like to confirm that I have no commercial interest in the outcome of this investigation.

Yours sincerely,

Simon Perry.