The BCA's Reply

Back on 3 November 2008, the British Chiropractic Association served a formal "Reply" to Simon Singh's Defence.

However, for some unknown reason this Reply was not on the Court File as late as 16 December 2008 (you may also remember the rather patronising response I got from the BCA's PR company when I chased this) and so I could not then obtain the Reply so as to Blog about it.

The Reply has now been obtained from the Court Office under the relevant provision of the Civil Procedure Rules.

(Any person can do this - just pop along to the nice staff at the Royal Courts of Justice in London, apply for the Statements of Case for Case Number HQ 08X02657, and pay for the photocopying.)

I set out my summary of this Reply below.

However, the Reply first requires to be put in context.

A Reply is a formal Court document with a specific purpose. It enables a claimant - here the BCA - to set out its response to the Defence of the defendant - here Simon Singh. It is not a document addressed to the world. It is not even a document which is addressed to the Court generally, other than in response to the pleaded Defence. The summary and (importantly) the quotations which now follow need to be put into this context.


Form and Content

My initial reaction to the Reply was to its size. The Defence was just twelve pages long; the Reply runs to some thirty-six pages.

Often a Reply is quite short - usually shorter than the Defence - just picking up points in the Defence which may not have been anticipated when the Claim was originally made.

The length of the Reply is a testament to how much work was required by the BCA to meet Simon Singh's Defence. You may recall that the Defence set out full defences on fair comment and justification, and in both respects putting the BCA to test on the evidence for chiropractic for various children's non-spinal ailments.

Indeed, it appears that pleading "Fair Comment" led to the BCA creating the (now discredited) "plethora" list of evidence. I understand the BCA served this list on Simon Singh on the same day as the Reply, so to put him to test as to the evidence of which he was aware when he wrote the original article: the BCA would have to show that he hadn't reviewed the appropriate evidence to displace the Fair Comment defence.

The High Court, however, ruled that the Fair Comment defence was not available to Simon Singh and so, technically (and subject to Appeal), the "plethora" is no longer relevant to the case.

Nonetheless, the "plethora" probably would never have been created had Simon Singh not pleaded the Fair Comment defence; a defence - of course - the BCA has consistently maintained he was not even entitled to plead.


The Start of the Reply

The Reply commences with a general attack on the Defence. For example:

"It is open to the Defendant to apologise for and to withdraw the defamatory allegations he made. The Defendant has not offered to do so. Further, the Defendant has not offered to make the position as to the Claimant clear publicly; he has not even offered to clarify publicly that (it it were to have been the case) he had not intended to impugn the integrity of the Claimant as the Claimant complains he had." (Para 2(3) of the Reply.)

Then there is a passage which, out of context, seems extraordinary:

"Instead, the Defendant has sought to mount a defence to different allegations (not the ones complained of in this action); and, in order to mount such a defence, he has resorted to place [sic] a strained and unnatural interpretation on the plain word, "evidence", he used. The Defendant seeks to depart from its ordinary meaning (as it would have been understood by readers of his article) and to treat "evidence" as if it meant only "evidence from randomised controlled trials". This artificial approach departs from the proper approach of medical scientists."

It would rather appear that the BCA regards RCTs constituting the appropriate evidence base for assessing chiropractic to be a "strained and unnatural interpretation..[an] artificial approach".

This may well be the case, but please remember that in this paragraph the BCA are not directly making such an admission to the public, but are instead seeking to head off Simon Singh's pleaded Defence as to what "not a jot of evidence" meant.


The Reply on Chiropractic generally

The Reply then provides a lengthy ten page exposition on chiropractic generally, its regulated nature in the UK (statutory regulation is mentioned frequently), and the background of the BCA and the ill-fated "Chiropractic Awareness Week".

In this plethora of detail, most of which is not directly related to the Defence, the following information is provided:

- the BCA define Chiropractic as "a health profession concerned with the diagnosis, treatment and prevention of mechanical disorders of the musculoskeletal systems and the effect of those disorders on the function of the nervous system and general health" (Para 3(1) of the Reply);

- and Chiropractors are defined by the BCA as "independent practitioners, with responsibility for patients in the primary care setting. Chiropractors take a holistic approach to health and wellbeing, considering its physical, psychological and social aspects. By restoring normal function to the musculo-skeletal system, chiropractors can play a major part in relieving disorders, and accompanying pain or discomfort, arising from accidents, stress, lack of exercise, poor posture and everyday wear and tear." (Para 3(2) of the Reply);

- the BCA states that the over-riding consideration in chiropractic is that "[t]he treatment and techniques used by a chiropractor in any individual case will depend upon the health and health needs of the patient", but subject to this consideration, there is an emphasis on manual treatments, including manipulation or adjustment, and that other forms of treatments regularly used include "exercise and rehabilitation; preventative measures; advice, explanation and reassurance (for example, as to the kinds of activity and behaviour that promote recovery and advice as to nutrition and diet)" (Para 3(3) of the Reply);

- the GCC Code of Conduct "lays down standards of personal and professional conduct expected of registered chiropractors. Chiropractors must meet high standards of conduct and practice." (Para 3(9)(a) of the Reply);

- the BCA state that "chiropractors take great care that any treatment they administer to patients is effective and safe" (Para 3(10) of the Reply), and this includes that "Chiropractors will explain the care and treatment proposed to the patient, including any known risks in any particular form of assessment or care. The chiropractor will also explain any need to refer the patient to another health professional." (Para 3(10)(d) of the Reply);

- the BCA list the additional requirements for the care of children, including obtaining consent (Para 3(12) of the Reply) and that there are various "red flags" which mean the child should be referred to a GP or hospital; the BCA also notes that chiropractors "have regard to the fact that a child's neuro-muscular-skeletal structure is less rigid and more flexible than that of an adult; and that young and developing tissues are more susceptible to damage and injury". (Para 3(13) of the Reply;

- the BCA "is committed to the highest standards of excellence in chiropractic, patient care, standards of practice and continuing professional development" and that it has a "professional statement" (not quoted) and a professional standards committee (Para 4(3) of the Reply);

- the BCA is not, and does not purport to be, "a research establishment offering a complete guide to all research information published and/or available in relation to chiropractic." (Para 4(6) of the Reply); and

- the BCA "generally promotes chiropractic on behalf of its members" (Para 4(7) of the Reply).


The BCA and Simon Singh

The BCA then issue a couple of challenges to Simon Singh.

Having stated that they do not purport to be "a research establishment offering a complete guide to all research information published and/or available in relation to chiropractic" they nonetheless assert that Simon Singh "is put to strict proof as to the extent of his research into, and the extent of his knowledge about, chiropractic...and, in particular, what research papers he had read and the extent of his consideration and independent evaluation of them" (Para 5(1) of the Reply).

Furthermore, Simon Singh "had a duty, as a scientist with Cambridge PhD, to acquaint himself with the state of the published literature as to the effectiveness and risks of chiropractic before making public claims about it." (Para 5(2) of the Reply.)

This is a remarkable line of argument.

The BCA are stating that Simon Singh has to meet a far higher standard of knowledge of chiropractic research in criticising the BCA than the BCA itself has to meet in promoting chiropractic in the first place.

The BCA later in the Reply make this contrast clear. In Paragraph 9(20), they state that whilst their website "does not purport to cite, and does not cite, all available evidence in respect of chiropractic...it is for the defendant to establish,on the basis of a comprehensive review of all available evidence (whether published or unpublished) that there was not a jot of evidence that chiropractic can help with the specified matters".

Indeed, the BCA will accept only a lesser duty to "acquaint itself with the state of the published literature as to the effectiveness and risks of chiropractic and that, in terms of what it publishes, the claimant has a moral duty not to mislead the public." (Para 9(29) of the Reply.)

(In passing, I fail completely to see the relevance of the PhD being from Cambridge University. Whilst I am - in principle - all for Cambridge graduates having a more onerous time in life than the rest of us, holding a Cambridge PhD should not really create an obligation which, say, a Durham or Middlesex PhD would not have. And, presumably, with my simple MA, I would escape this duty altogether.)


The BCA and Professor Ernst

The BCA also attack the research of Professor Ernst to which Simon Singh refers in his Defence.

For example, in respect of Ernst and Cantor's important "A systematic review of systematic reviews of spinal manipulation" in the Journal of the Royal Society of Medicine, we get the quite wonderful:

"The JRSM is a peer review publication, but does not have a high impact factor; it is not, for example comparable to the British Medical Journal or Spine in scientific quality." (Para 9(19)(a) of the Reply.)

Which leads to the rather brilliant:

"the authors' approach was subjective; their assessment of the quality of the reviews included in the study was loose, although more robust and clinemetrically sound approaches were available. This may have led to the paper being published in the JRSM, rather than a higher-status publication" (Para 9(19)(b)(ii) of the Reply).


The BCA and "Research"

And now we come to a really interesting part of the Reply: what the BCA has to say about evidence.

The BCA admit that "a systematic review of studies can be a valuable means of assessing the published evidence for and against the effectiveness (or lack of effectiveness)of interventions. However, a systematic review is valuable and effective only if there is sufficient data available to be reviewed. Where, as in the case of chiropractic, there is very limited RCT data available, it is difficult to extract any definitive conclusion from a systematic review of that data" (Para 9(15) of the Reply).

The BCA then proceeds to state that Simon Singh's approach in his Defence to evidence "is wrong in principle and fundamentally misguided" (Para 9(18) of the Reply).

Indeed, "the proposition that 'evidence' is meaningful only if it comes from RCTs is wrong and not supported by good medical practice" (Para 9(18)(c) of the Reply).

"RCTs are one form, but by no means the only form, of evidence. other forms of evidence include: historical control trials, non-randomised contemporaneous controlled trials, case control studies, before and after designs and case series and case reports. All of these constitute 'evidence', as is recognised by various systems that have been devised to reate (or grade) forms of 'evidence' in the medical context." (Para 9(18)(c)(i) of the Reply.)

The BCA further state that the primary role of RCTs has been in the context of new drug treatments where a placebo can be used, but that RCTs are not the only form of evidence. Moreover, "Trials without placebo are a standard part of the UKs Medical Research Council's funding policy." (Paras 9(18)(c)(ii) and (iii) of the Reply.)


Chiropractic and the Children's Ailments

It is page 26 of the Reply before the BCA finally address the actual points made by Simon Singh about the efficacy of chiropractic for the six children's ailments.

This part of the Reply begins with a stunning concession by the BCA in respect of three of the ailments:

"Prolonged crying, sleeping problems and feeding problems may (together or separately) be a symptom of colic or otitis media. Those conditions are dealt with further below, including the evidence that chiropractic has helped." (Para 9(21) of the Reply.)

In other words, the BCA does NOT have any separate evidence for three of the six ailments listed in the original Happy Families leaflet.

We then turn to Asthma:

"So far as the treatment of asthma is concerned, there is some positive evidence and some negative evidence. While, on the one hand, there is insufficient evidence to prove definitively that treatments is effective, there is, on the other hand, insufficient evidence to prove that it is not effective." (Para 9(22) of the Reply.)

The BCA then discusses Balon/Aaker (1999), the Kukurin lettter, Bronfort (2001), Bockenhauer (2002), Balon/Mior (2004), Hondras (2005), Guiney (2005), and Ernst (2006). (I will set out this discussion out in a future post.)

And then Colic:

"There is positive evidence that chiropractic can help to treat infantile colic." (Para 19(23) of the Reply)

Here the BCA rely on Klougart (1989), Mercer & Nook (1999), Wiberg (1999), and Olafsdottir (2001).

(Again I will set out what the BCA says for each of these studies in a future post.)

Lastly, frequent ear infections:

"It is admitted that the reference on the website was to the ongoing Eisenberg trial, which has not published results." (Reply 19(24) of the Reply.

The BCA then cite a single study: Mills et al (2003) on the use of osteopathic manipulative treatment (not chiropractic). After summarising this study, the BCA states: "There is, therefore, good evidence from this single trial that chiropractic can help treat frequent ear infections".

No other study for ear infections is mentioned.

(The BCA then move on the Reply to discuss the research as to the general safety of chiropractic, relying on the Thiel Report (2007) and the Cassidy Report (2008).)

So, in stark terms:

- the BCA cannot produce any separate evidence for the efficacy of chiropractic for three of the six named ailments and seek to merge these ailments with the others;

- the BCA cannot produce any evidence for the efficacy of chiropractic for ear infections, other than one dealing with osteopathy;

- the BCA admits the evidence for for the efficacy of chiropractic for asthma is inconclusive; and

- on their "strongest" ground - colic - the BCA relies on evidence which (presumably) failed to even satisfy the ASA.


Conclusion

The heart of this case has been the efficacy of chiropractic for six particular children's ailments.

Buried under the sheer mass of legal paperwork has always been a quite simple issue: what was the quality of evidence for the claims of the BCA in their now-withdrawn and discarded Happy Families leaflet.

Until and unless this basic evidential issue was squarely addressed by the BCA, any legal action would be misconceived.

By casting his defence in wide terms - putting chiropractic on trial for those ailments - Simon Singh forced the BCA to address these points.

Together the Reply and the "plethora" indicate that the BCA's claims may have had no proper evidential basis all along.

One wonders why the BCA did not spend a fraction of the legal costs on just providing this "evidence" in the first place; and then we all could have assessed whether it constituted a "jot of evidence" and whether the happily promoted treatments were "bogus".



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