Humpty Dumpty regulation
The phrase Humpty Dumpty chiropractic cropped up in a Google Alert a few days ago. It was the fitting title of an editorial (cached) in the December 2010 issue of Clinical Chiropractic, which discussed the slippery and nebulous meaning of vertebral subluxation complex (VSC).
‘When I use a word,’ Humpty Dumpty said in rather a scornful tone, ‘it means just what I choose it to mean — neither more nor less.’
Such equivocation is typical of on-line conversations with chiropractic supporters discussing the VSC, but it applies elsewhere as well.
It has been a long and winding road, but we’re finally getting to the end of my complaints after 18 months. Although the General Chiropractic Council (GCC) recently published some of their Professional Conduct Committee (PCC) decisions (‘Notice of Finding’) about complaints I had made about chiropractors misusing the title ‘Dr’ on their websites (I’ll have more to say about them another time), they have just published the first decisions on actual claims.
The two PCC decision notices published last Tuesday are 11 pages long but make fascinating reading. I thoroughly recommend you wade through one to get the full flavour of them.
I’m going to take a look at one: the Notice of Finding for Michelle Carrington (cached). It’s a pretty long, yet interesting, process, and one that needs to be documented. However, the next section cuts to the chase and is a summary of what I believe went wrong and what the GCC needs to correct before any further cases are considered by the PCC. Read that if you read nothing else.
The process the GCC follow is, in summary: the GCC receive a complaint; the Investigating Committee (IC) investigate it; if the IC considers there is a case to answer, they draw up the allegations; the GCC prosecute the allegations on my behalf before the PCC; the PCC, on the basis of what’s presented in the allegations, consider the allegations and decide whether or not they are proved; if proved, the PCC decide the punishment. (Please note that it is sometimes easy to confuse GCC and PCC!)
It should be noted that the PCC are selected from a pool of 11 non-chiropractic members and 8 chiropractors. However, I do not know which ones heard my complaints. I also note that at the start of December, Sheila Hollingworth, who had been the Chair of the Investigating Committee became a member of this pool of PCC members. I do not know whether she was on the PCC that considered my complaints, but I note the Chiropractors Act 1994 says at Schedule 1:
24.—(1) A person may be a member of more than one statutory committee.
(2) No member of the Professional Conduct Committee or the Health Committee shall take part in dealing with an allegation referred to either committee by another committee if he is also a member of the committee which referred the allegation.
However, for my complaint against this chiropractor, the PCC found that (in summary), although claims were being made that were not supported by high or moderate positive evidence from randomised controlled trials (RCTs), the chiropractor was not misleading the public and therefore not guilty of unacceptable professional misconduct. She was let off with no sanction.
How did this happen? Read below.
As I see it, there are numerous things wrong with the way the case was presented to the PCC and the way the PCC came to their decision.
1. The PCC totally ignored the requirement of the Code of Practice (CoP) C1.6 that:
…information used must be factual and verifiable. The information must not be misleading or inaccurate in any way.
They appear to have decided that, because it’s on paper somewhere, it must be factual and verifiable, but they have completely ignored the ‘misleading and inaccurate’ requirement. Carrington’s observations on my complaint were similar to most of the others I received and it referred to a plethora of guidelines, leaflets, articles, opinion pieces, papers and books (I was not allowed to comment on any of it). In view of the fact there is very significant high quality contradictory evidence, I cannot see how this amounts to a balanced view of all available evidence and is thus a serious breach of the CoP.
2. The GCC did not justify their setting of the threshold for evidence as RCTs, allowing any evidence to be admitted as substantiation.
The GCC interpreted the ‘relevant law’ as being the Consumer Protection from Unfair Trading Practices Regulations 2008 (CPUTR) and opined that ‘advertised claims for chiropractic care must be based on best research of the highest standard’ and that this ‘will almost certainly mean randomised controlled trials that produce high or moderate positive evidence’. However, they failed to anticipate that the PCC could consider that the use of other, far less robust evidence might not constitute ‘a failure to attain the standard of the reasonable chiropractor’.
3. The GCC failed to get a definitive view from Trading Standards or their lawyers as to what standard of evidence was required by the CPUTR.
This is a serious failing. The GCC had had some discussions with Trading Standards (the guardians of the CPUTR) about evidence, but had not justified their ‘interpretation’ of the required standard of evidence. The PCC ‘noted’ the GCC’s interpretation, but didn’t bother to query further. The IC should have foreseen that all the complaints hinged on standards of evidence and should have put a robust case for the prosecution — one that fully protects the public from being misled, not one that could be knocked down with a feather.
4. The PCC failed to form a view of what standard of evidence was required by the CPUTR. Instead, they simply and erroneously decided that, since the GCC had assumed that claims that ‘do not rely on RCT evidence are relying on inconclusive evidence’, there was no threshold at all.
There is probably a whole other blog post that could be written about the CPUTR and what it has to say about misleading actions and misleading omissions. In allowing the Respondent to rely on all sorts of evidence to substantiate the claims, they have ignored the requirements of the CPUTR.
5. In setting the evidence bar so low, the PCC has failed to protect vulnerable members of the public.
Also, the CoP also says:
[advertising] must not, in any way, abuse the trust of members of the public nor exploit their lack of experience or knowledge about either health or chiropractic matters.
By allowing chiropractors to cite any evidence, they have ensured that members of the public will not be given a balanced view of the available evidence. This restricts choice and could lead the vulnerable to believe that chiropractic is effective for many conditions and may delay or prevent them from seeking proper medical advice from a registered medical practitioner. Caveat emptor should not apply to health claims.
6. The GCC submitted that it was reasonable for chiropractors to rely on information published by the GCC in their Patient Information Leaflets.
The GCC’s Code of Practice (CoP) is not binding on the GCC, but it is binding on all chiropractors. The CoP is absolutely clear that it is the chiropractor’s own responsibility to ensure all advertising is compliant with the clause C1.6. It might have been hugely embarrassing and costly for the GCC to admit the information they published in their leaflets was wrong, but that is not the concern of the case against a chiropractor making misleading claims.
7. The GCC only provided evidence for manual therapies and the GCC did not anticipate the question of what else a chiropractor might do.
This is something that should have been anticipated by the GCC because it was mentioned forcefully in many of the observations chiropractors made about my complaints. This has opened a huge loophole, allowing all sorts of misleading claims to slip through. The GCC must now grasp this nettle. If they don’t, they are still left in the position of not having a clue about what their charges do and what the evidence for them is.
8. The PCC declared that ‘general words’ on websites were not claims and therefore could not be verified by RCT evidence.
If they are serious about protecting the public, they need to look at it from the point of view of the public. The GCC need to decide that, in line with the guidance issued by the Advertising Standards Authority (ASA), indirect claims are claims nonetheless. It is not credible that a member of the public, viewing a web page that lauds the experience and training in treating children would not believe that the chiropractor was claiming to treat children.
9. The PCC did not take into account the requirement of complying with all ASA guidance as required by the CoP.
The ASA guidance that chiropractors are required to follow has been consistently ignored by the GCC. It should be remembered that ‘the guidance issued by the Advertising Standards Authority’ consists of the CAP Code and other guidance, including adjudications. This will be the subject of a future blog post.
10. The PCC — somewhat oddly — did refer to the ASA, saying that ASA guidance required robust evidence, but that there was ‘no explicit reference to high or moderate positive evidence from RCTs’.
Whilst the ASA’s guidance may not repeat the phrase the GCC used in the allegation, it is very clear that the ASA have a requirement for a very high standard of evidence. This is formed in their Codes, other guidance and their adjudications and many ASA adjudications have reinforced this. However, it is curious that the PCC used the ASA as a measure of what standard of evidence was acceptable, but ignored the requirement for chiropractors to comply with the guidance the ASA have issued (see point 9).
With each of these issues — and taking them as a whole — it’s an interesting exercise to consider whether Hanlon’s razor can be applied to this contorted mess, but several of these issues amount to errors in law and grounds for appealing the decisions.
The GCC need to show some backbone and provide a decent prosecution case to the PCC for all future cases. It is not too late. The Notices of Allegation have already (conveniently, some might say) been issued to other chiropractors. However, the GCC still have the option to submit applications to amend the particulars to take into account these first decisions and ensure all future cases are prosecuted robustly.
If the GCC does not do this, all credibility as a competent regulator, with a statutory duty to protect the public, is utterly lost.
Now, let’s get back to the Decision Notice itself and see what went wrong.
There is obviously a need for some legal technicalities. However, after some preliminaries, there is a section titled Abuse of process submission. This concerns submissions by some chiropractors that the whole process should be stayed (ie halted) because of an ‘abuse of process’. This concerns the (flawed) Bronfort Report that the GCC commissioned a year ago to look at what evidence existed for the list of conditions I complained about. The crux of the abuse of process submission is that the Registrar (Margaret Coats) had ‘tainted the process’ with her involvement in obtaining the report.
Until its publication, the GCC seemed to have had little idea about the evidence for any particular condition that their charges were making claims about. This is a disgraceful state of affairs for a statutory regulator, charged with regulating such a narrow field. How could they discharge their duty to protect the public if they had little or no idea of the evidence for chiropractic? How have they managed to regulate chiropractors for the last ten years? Perhaps they relied on what the chiropractic members of their Council and Committees told them? How would they class that level of evidence? If there was ever a case for having a truly independent regulator, this is it.
Having been forced to consider the evidence because of my complaints, they commissioned the Bronfort Report from five chiropractic experts.
However, in this case, the chiropractor concerned didn’t make that abuse submission specifically, but submitted a document headed ‘Further Submissions’. I was told about ‘addendum submissions’ by some chiropractors on 03 November 2010 and I assume these are the ‘Further Submissions’ now referred to. I thought it perfectly reasonable that I be informed what these further submissions were, but was eventually told:
Having taken advice, we will not be supplying you with any detail in respect of the addendum submissions received by the Professional Conduct Committee. Following referral of an allegation to the Professional Conduct Committee, the original complainant is no longer a party to the proceedings and therefore information provided to the Committee, such as submissions, is not disclosed to the complainant.
The PCC considered the submission to stay the process at a meeting on 17 November and had decided not to. It saw no reason to change that decision, but it wasn’t clear to them whether this chiropractor wanted to renew an application to stay the proceedings. In fact, it made little difference:
Rather than adjourn the meeting in this case, the Committee decided to look first at the strength of the evidence in this case. In view of the outcome of this process, any application for a stay is now likely to be academic. Accordingly, the Committee has determined the case, as set out below.
This does not bode well.
The decision notice moves on to the substantive issue: what my complaint was all about. The chiropractor has a right to attend the hearing but she waived that right and it was held ‘on papers’, ie with just the PCC members meeting and without either parties being present (I get no choice in this and I am not asked). Note that, as the quote above says, they are no longer my complaints: the GCC takes them over at this stage and becomes the prosecutor on my behalf, with the chiropractor being the Respondent.
We are reminded that the standard of proof for any allegation to be found proved is the civil standard, which is the balance of probabilities.
The ‘Particulars’ of the allegations are the ‘charges’ that the IC think are appropriate. The PCC have to decide whether each of them is proved or not proved. In summary:
Particular 1: Establishing who the chiropractor is.
Particular 2: That he/she was responsible for the statements on the website I had complained about.
Particular 3: That the highlighted statements were not ‘supported by high or moderate positive evidence from randomised controlled trials’.
Particular 4: That these statements were ‘potentially misleading’.
Particular 5: That these had the potential to ‘put pressure on members of the public…and had the potential to exploit the lack of experience or knowledge of members of the public’.
Once these have been decided, the PCC considers whether this amounts to ‘unacceptable professional conduct’ and what punishment, if any, should be meted out.
In this case, the Respondent admitted the first two particulars and they were therefore found proved. Before looking at the other particulars, we need to look at the statements I complained about and the Bronfort Report.
The PCC accepted the Bronfort Report as part of the GCC’s submission, but declared that it was just ‘an academic report and not an expert report’.
This Committee regarded the Report as a comprehensive statement of those conditions for which randomised controlled trial (RCT) evidence exists for the efficacy of manual therapy. The Report provides a summary of the scientific evidence regarding the effectiveness of ‘manual treatment’ in relation to a number of conditions.
At least they noted it was about ‘manual treatment’ and not just chiropractic — see Where the evidence leads.
Getting back to the point of my complaints:
The Committee considered each of the Particulars of the Allegation and in doing so it was mindful of the provisions of Cl .6 of the Code of Practice (effective from 8 December 2005).
The PCC created three categories for the statements made on her website:
(1) Statements which were incapable of being verified by RCT evidence, such as statements about the usual practice of the registrant or general words and headings.
(2) Statements which were capable of being verified by RCT evidence but which, in the opinion of the committee, fell within the categories where the GCC had decided to offer no evidence.
(3) Other statements which were capable of being verified by RCT evidence, typically claims that chiropractic could provide effective treatment for a particular condition.
These three categories are interesting. I’ll pick through some of the choicest claims and see how they have been dealt with by the GCC.
The claims on this chiropractor’s website at Haselmere Chiropractic Clinic (current website) that I highlighted in my complaint were:
Back & leg pain, sciatica, “Trapped nerves”, Tension & migraine headaches, Neck, shoulder and arm pain, Hip, knee and foot pain, Tennis & golfers elbow, Jaw pain, Sports injuries, Birth trauma, Colic, vomiting & wind, Feeding problems, Persistent crying, Positional discomfort, Irritability, Crawling and gait problems, Ear infections, Constipation, Sleep disturbance, Asthma, Bedwetting, Dyspraxia, ADHD, Learning difficulties, Cerebral palsy, Cranial support for orthodontic work.
Compare this with the list in the decision notice and see how the PCC categorised the claims.
The claims made on the ‘Welcome‘ page were:
Our team of highly trained and experienced chiropractors offers post-graduate expertise in rehabilitation, antenatal care, paediatrics and cranial work.
This ‘Welcome’ page will usually be the first page a visitor will see: the words ‘rehabilitation, antenatal care, paediatrics‘ are in bold and link to the relevant pages. The PCC have decided that this belongs in Category (1) and they are therefore ‘incapable of being verified by RCT evidence’. Are these claims to treat? If not, why are they there?
But the GCC’s Investigating Committee have already stated to me and many of their chiropractors:
The Investigating Committee did note the reference to ‘Paediatric care’. The Investigating Committee considered that this could give a member of the public reading the webpage the impression that you provide treatment to babies.
It was mindful that there is no high or moderate positive evidence from randomised controlled trials that would support a claim to treat children using manual therapy.
So which is it? Is chiropractic for children incapable of being verified by RCT evidence or is there no RCT evidence that supports chiropractic for children?
However, last time around, the IC concluded:
In the absence of such evidence, it concluded that it could be inappropriate to make such an advertised claim.
Regardless, whether there is no evidence for the treatment of children and babies with chiropractic or whether the GCC think that such things are incapable of being verified, it remains that they are still stating that such claims should not be being made by chiropractors.
Before Carrington’s case was considered by the IC, she made some observations on my complaint, and admitted:
This complaint has caused me to reflect on the content of my website and modify it accordingly.
She also received advice from her ‘professional association’ and removed references to the following conditions:
Until such time that more robust research evidence becomes available…
- trapped nerves
- jaw pain
- colic, vomiting and wind
- persistent crying
- feeding problems
- positional discomfort, crawling and gait problems
- ear infections
- bed wetting (nocturnal enuresis)
- sleep disturbance
- learning difficulties
- cerebral palsy
- cranial support for orthodontic work
- abdominal discomfort
- foetal positioning
- preparation for labour
- aching between the shoulder blades
- ‘back and leg pain’ replaced by ‘low back and leg pain’
This is an excellent result and many other chiropractors have done the same, leaving fewer opportunities for the public to be misled by claims for which there is no good evidence. It’s just a pity it needed my complaint to make this happen.
Chiropractic treatment is suitable for children of all ages, including new born babies.
Michelle Carrington is our chiropractor who has a special interest in treating babies, and cranial work.
You are welcome to bring your child along to discuss any specific problems that they are experiencing, and whether chiropractic treatment might be able to help – Ring Reception on 01428 642778 and book a 20 minute “Free Screening” with Michelle.
At Haslemere Chiropractic Clinic we are pleased to offer you chiropractic care from an experienced practitioner with training in techniques specially developed for younger patients. These skills combine to provide a gentle and safe treatment for babies and children.
It looks like there is still more to be done.
These were claims for which the PCC said were capable of being verified by RCT, but fell within the categories where the GCC had decided to offer no evidence.
Curious. Why decide not to offer any evidence?
Remember the saga of the Patient Information Leaflets? Some chiropractors I complained about asserted that they were only repeating claims made by the GCC in their Patient Information Leaflet and the BCA in their Happy Families leaflet (cached) leaflet.
I’ve already mentioned the untenable position the GCC would get themselves into if they tried to pursue such complaints. But that legal quagmire is of no concern here. The issue at hand is very simple: whether claims were being made by chiropractors in violation of their Code of Practice. The CoP says that claims must be ‘consistent with the law and the guidance issued by the Advertising Standards Authority’ and that ‘the information used must be factual and verifiable’. There is no additional ‘but it’s OK to repeat claims that the GCC or BCA make whether or not there is any good evidence for them’. That would allow all sorts of claims and is no way to protect the public from misleading information.
Having neatly disposed of a whole load of claims, there is one more sleight of hand to be performed.
The Committee went on to consider Particular 3 [that claims were not supported by robust RCT evidence] only in relation to the statements highlighted in Schedule I that fell into Category 3. The Committee noted that the [Bronfort] Report did not identify any high or moderate positive evidence from RCTs in respect of manual therapy to support a publicised claim in respect of these conditions. Therefore, the Committee has found Particular 3 proved in respect of the statements highlighted in Schedule I that fall into Category 3 (as set out in Appendix I).
This is about the claims they decided could be verified by RCT. These claims included golfer’s elbow, jaw pain, abdominal discomfort, poor foetal positioning, sleep disturbance, birth trauma, feeding problems, positional discomfort, irritability and persistent crying and ear infections.
Most of these did not appear in the Bronfort Report, so they were unable to find any relevant RCT for them, as confirmed by the GCC to Skeptic Barista:
Where any condition does not appear in the [Bronfort] report, this is because no relevant randomised controlled trials were identified.
So, the PCC decided that my complaint against these claims was found proved because they were not supported by moderate or high positive evidence from RCTs (Particular 3).
However — and there has to be a ‘However’ — they added:
However, the Committee is mindful that this conclusion only relates to manual therapies. The Committee has not been provided with any comprehensive evidence about RCTs relating to other forms of treatment practised by chiropractors.
But then they stop and move on to whether making any of these claims, including the ones for which there was no RCT evidence, were misleading. But don’t worry, the question of what constitutes evidence has not been forgotten and I’m sure many of you will see what’s coming…
Were any of the three categories of claims misleading?
After sensibly disposing of the issue of whether someone actually had to have been misled by a claim for the claim to have been misleading, they dealt with the Category 1 and 2 claims.
The Committee found Particular 4 [that the statements were misleading] not proved in respect of the general statements in Category 1. The Committee was not satisfied, on the balance of probabilities, that such statements were inaccurate.
The Committee found Particular 4 not proved in respect of the conditions falling into Category 2 as no evidence was offered by the GCC.
So, the PCC’s decision is that claims such as:
Chiropractic treatment is suitable for children of all ages, including new born babies.
Michelle Carrington is our chiropractor who has a special interest in treating babies, and cranial work.
Back & leg pain, Sciatica, “Trapped nerves”, Tension & migraine headaches, Neck, shoulder and arm pain, Hip, knee and foot pain, Tennis & golfers elbow, Jaw pain, Sports injuries, Many other joint and muscle disorders.
…were not misleading, despite the GCC and Bronfort saying that there was no good evidence to substantiate such claims.
What does it take for a chiropractor to have been considered to have mislead the public? Suggestions on a postcard, please.
But Category 3 is where it gets even more interesting.
The Committee concluded that the statements highlighted in Schedule 1 which fell into Category 3 were not misleading. These were statements to the effect that chiropractors provide treatment for the conditions in question. The Committee considered the submissions made by the Respondent in relation to these conditions. In each case the respondent provided evidence that there was support from a variety of sources for the chiropractic treatment of these conditions. These included undergraduate and postgraduate training and/or materials by the Anglo European College of Chiropractic (“AECC”); research, peer reviewed journals and publications from a variety of bodies including the GCC and the British Chiropractic Association (“BCA”).
On this basis, the Committee has concluded that it was not misleading or potentially misleading for the Respondent to make the statements highlighted in Schedule 1, which fell into Category 3 and, therefore, this Particular is not found proved.
So, even though the PCC decided it was proven that there was no good evidence for the treatment of these conditions with chiropractic, they decided that making these claims was not misleading. And they decided this because the Respondent had provided evidence that there was support for chiropractic for these conditions. And this ‘evidence’ included AECC training materials, ‘research’, peer reviewed journals and leaflets from the GCC and the BCA.
So what the decisions boil down to is what counts as evidence. Is it the robust scientific evidence that the ASA require for advertising claims; the ‘randomised controlled trials that produce moderate or high positive evidence’ of the GCC’s IC; or is it the leaflets, case studies and teaching materials the PCC would have us believe is all that is required? The PCC have set out an unbelievably low threshold — in fact, it’s difficult to see how they could have set a lower one.
The ASA have far higher standards; why should a statutory body, charged with protecting the public set such low standards?
Does this mean that chiropractors now have carte blanche to advertise whatsoever they want? It would seem so. But this cannot be good for the public: if such a low threshold continues, then the public is not being protected. Chiropractors can claim to treat anything. Presumably they could claim to treat ADHD? After all, there is evidence in a peer-reviewed journal to support it, so (presumably) the PCC would be quite happy with such a claim.
Chiropractors may rejoice at this decision, but I don’t think they should be popping champagne corks — or backs — just yet.
The PCC then move on to deliberating whether the particulars they have found proven (that the claims highlighted were not supported by high or moderate positive evidence from RCTs) amounted to unacceptable professional conduct.
They did not.
The problem was that, although the GCC argued that there was no robust evidence (ie from high or moderate positive evidence from RCTs, as the GCC had stated in the particulars), there was still other evidence. And because there was other evidence, and because the CoP didn’t specifically demand robust evidence, the charge of not having robust evidence could not amount to unacceptable professional misconduct.
That was a whirlwind tour of one decision but the GCC, as prosecutors of all the cases, now have a dilemma. They could just sit back and let the remaining cases go ahead on the same basis and, no doubt, the PCC would decide them all the same way and all the remaining 500-odd chiropractors would be found not proven.
I would urge them to examine the failings of the cases so far and decide whose interests they are there to protect. And, to protect the public, the question the statutory regulator of chiropractors has to ask itself — and then comprehensively answer — is: what exactly are the meanings of the words chiropractic, evidence, regulation and protecting the public?
‘You seem very clever at explaining words, Sir,’ said Alice. ‘Would you kindly tell me the meaning of the poem called “Jabberwocky”?’
‘Let’s hear it,’ said Humpty Dumpty. ‘I can explain all the poems that were ever invented — and a good many that haven’t been invented just yet.’
This sounded very hopeful, so Alice repeated the first verse:
‘Twas brillig, and the slithy toves
Did gyre and gimble in the wabe;
All mimsy were the borogoves,
And the mome raths outgrabe.
‘That’s enough to begin with,’ Humpty Dumpty interrupted: ‘there are plenty of hard words there. “Brillig” means four o’clock in the afternoon — the time when you begin broiling things for dinner.’
‘That’ll do very well,’ said Alice: and “slithy“?’
‘Well, “slithy” means “lithe and slimy.” “Lithe” is the same as “active.” You see it’s like a portmanteau — there are two meanings packed up into one word.’