Monday 9 June 2014

ASA bias. What every complementary practitioner should know.


Here's a great letter which every homeopathic practitioner should keep a copy of. If the (Biased) Advertising Standards Authority (BASA) ever writes you a letter about your website claims, just send them a copy of that and tell them that as far as you are concerned they have no standing to pronounce on anything to do with homeopathy until they have publicly answered to your satisfaction the points made in Messrs Matthiessen and Bornhoft's letters and weeded out of their organisation all the individuals with anti-complementary healthcare bias (which goes right to the top).

Authors of the Swiss HTA report write to ASA and Secretary of Health

ASA – documented evidence – a story of evasion and bias

Our readers will be interested to read some specifics on how the ASA acts arbitrarily and chooses evidence to suit their own agenda. Nothing could be more apparent than in the case of Homeopathy: Medicine for the Twenty-first Century (H:MC21), as can be seen from the following exchange of correspondence between the ASA and the authors of a Swiss report on homeopathy. Here follows some explanation of the background to the exchange.
One important piece of evidence on the workability of homeopathy submitted to the ASA by H:MC21 (whose advert had been challenged by the ASA) was a copy of the Swiss Health Technology Assessment (HTA) on homeopathy. This provides solid evidence that ‘homeopathy has a history of success in chronic disease’.  

The Swiss HTA was founded in 1999 for the scientific evaluation of medical technologies on the basis of their effectiveness, appropriateness, and efficiency, as well as social and ethical aspects and implications. All government agencies, all University Institutes, several University Hospitals dealing with Technology Assessment and the Swiss Medical Association are members. It is also important to know that homeopathy is integrated into the Swiss National Health system.

The ASA rejected this HTA report outright and stated that ‘the robust evidence we are looking for’ is that of Randomised Control Trials (RCTs). The ASA’s report (which Sir Hayden Philips, the Independent Reviewer of ASA Adjudications, confirmed as having been written under his ‘personal supervision’) bizarrely stated that the HTA contained no such evidence. More bizarre still was the belief of Sir Hayden and his ‘expert’ that the HTA’s main conclusion that homeopathy is safe, effective and cost-effective, was based on a re-working of just one negative analysis (apparently that of Shang, another report on homeopathy which chose to selectively interpret in a negative way a small number of specific studies) -  seehttp://www.asa.org.uk/Rulings/Adjudications/2013/7/Homeopathy-Medicine-for-the-21st-Century/SHP_ADJ_139800.aspx.

The authors of the HTA report (Prof. Dr. Peter F. Matthiessen and Dr. Gudrun Bornhöft) responded to the ASA by pointing out to Mr Guy Parker (Chief Executive of the ASA) that their work contained well over one hundred RCTs whilst, on the matter of their conclusions being based on the alleged rewriting of just one study, Sir Hayden had but to glance through the contents pages ‘to reveal the falseness of this absurd claim’.

The HTA authors further told Mr Parker:

“In conclusion, we state that your writing does not even begin to approach a professional standard. We take great exception to your untenable allegation that we researched this important subject with the superficiality that you suggest, an implication which we consider defamatory.

“It is customary that authors whose work is misrepresented should have the right of a reply to be published in the same location as the attack was published. We therefore demand that you please place our reply on your website, with equal prominence to your own text”.

The HTA authors sent two letters to Mr Parker who declined to answer either of them, delegating the task to a Rob Griggs. ‘Rob’ (as he affably signs himself) wrote:
‘We disgaree (sic) with your interpretation of the wording of our adjudications.  During our investigation processes, we recieved (sic) expert advice on the various studies submitted by the advertisers as evidence supporting their marketing claims.  We stand by that advice and our use of it’.
‘Rob’ was unfortunately unable to shed any light on why, and in what way, the ASA ‘disgareed’ with Professor Matthiessen and Dr Bornhöft, or why it was that the ASA felt entitled to deny the undeniable. As for the ‘recieved expert advice’, Mr Griggs also omitted to mention that the ASA’s ‘advisor’ appears to have had no training, experience, qualifications or indeed knowledge or understanding whatsoever in homeopathy, in clear contradiction of the requirements of ASA’s own Code of Practice. The ‘expert in homeopathy’ has instead pursued a career in conventional medicine pharmacology (with financial interests clearly opposed to homeopathy).

In any normal process of justice, an expert witness is cross-examined by the defence. No such process exists within the ASA; the ‘expert witness’ - hand-picked by the ASA - is just automatically deemed to be correct.

The ASA’s whole process of ‘justice’ gives rise to massive concern. This organisation is a private company, acting not only as its own self-appointed judge, jury and executioner, but more worryingly still, acting also as Counsel for both prosecution and defence, able to censor out anything from the Defence that they don’t wish the judge and jury to see. Not even the show trials of Stalinist Russia or Maoist China went that far.

Returning to Mr Parker‘s refusal to reply in person: could that by any chance have been due to the HTA authors’ use of the word Misrepresentation, a word which can be interpreted either in a general context or in a legal framework (see section two of the Fraud Act 2006)? And should other junior members of the ASA be wary in future of allowing the buck to be passed to them in this way?

 The correspondence in full

Letter from the authors of the HTA to CEO of the ASA Mr. Guy Parker

Dear Mr. Parker,

We have read your ‘analysis’ of our ‘Homeopathy in Healthcare’ Health Technology Assessment: we find your writing frankly disquieting.

In your ‘discussion’ of homeopathy’s success in treating chronic disease, you say, bizarrely, that our HTA contains no 'robust evidence' such as RCTs. In fact, pages 130 - 140 of the HTA, for example, discuss 17 homeopathic RCTs, all conveniently summarized on page 207. Pages 103 – 106 refer to homeopathic RCTs in the hundreds.

It is certainly correct that RCTs are generally accepted as a ‘gold standard’ in conducting clinical trials. This is however only a convention (i.e. an ‘agreement’) and, albeit science based, is not free from a considerable quantity of biases. Notwithstanding that, our HTA book in any event fully satisfies the requirements of RCT research conventions.

Additional to that, Chapter 5 of Homeopathy in Healthcare examines, within the scientific paradigm of Evidence-Based Medicine, the problems and likely inherent bias of RCT methodology. This is a chapter of central importance which we would expect you to take seriously. You are of course entitled to examine and debate the points that we make, provided you do so from a logically and scientifically evidenced rationale. But to sweep this whole debate under the carpet as if it doesn’t even exist is patently unacceptable: to furthermore airbrush out of existence, so it would appear, all the RCT research that Homeopathy in Healthcare contains is deeply disturbing.

Your ‘analysis’ of our work becomes still more extraordinary. You say our ‘main conclusion regarding efficacy was drawn from a reconsideration of a previous meta-analysis of qualifying trials which found no significant difference between placebo and homeopathic treatment’ (seemingly referring to Shang et al).
Even a glance at our contents page would reveal the falseness of your absurd claim: reading our book in any detail at all would verify that our conclusions are, on the contrary, based on an analysis of:

·                 Well over 100 homeopathic RCTs
·                 22 meta-analyses, involving the results of thousands of patients (20 of the 22 found at least a trend in favour of homeopathy - many of them strongly so – while the remaining two were of low validity). 
·                 a detailed study of homeopathy’s success in treating upper respiratory tract infections. Six out of seven controlled studies showed at least an equivalence with conventional-medical interventions, whilst a further 8 (out of 16) RCT studies showed results from homeopathy treatment that were significantly the superior.
·                 studies into beneficial homeopathic effects on animals and plants.
·                 changes which homeopathy has been shown to produce on cells in test tubes. An explanation of any kind of how this can be effected by mere ‘placebo’ has to our knowledge never yet been postulated.

On the other hand, and as a fact, Shang did not examine over 100 trials, but only 8, and the reasons for exclusion of other trials were not explained, contrary to scientific protocol. Selection of any data other than the 8 chosen trials would have produced a marked result in favour of homeopathy, in line with the overwhelming majority of meta analyses [seehttp://www.dokterrutten.nl/collega/ShangIJHDR.pdf  ].
Throughout our HTA 'Homeopathy in Healthcare', the Shang study is mentioned only briefly in the discussion section.Your claim that we based our result on a reworking of Shang is therefore as false as is your statement that Shang carried out ‘a substantial review of over 100 placebo controlled trials showed no convincing evidence that homeopathy was superior to placebo’.

In conclusion, we state that your writing does not even begin to approach a professional standard. We take great exception to your untenable allegation that we researched this important subject with the superficiality that you suggest, an implication that we consider defamatory. You accuse us of basing our conclusions largely on a reworking of one deeply flawed paper, the Shang study. Yet this is the one paper on which you appear to have based your own conclusions, which are flatly contradicted by swathes of contrary evidence of which you revealingly make no mention. We find this bizarre. 
It is customary that authors whose work is misrepresented should have the right of a reply to be published in the same location as the attack was published. We therefore demand that you please place our reply on your website, with equal prominence to your own text.

Yours sincerely,


Prof. Dr. med. Peter F. Matthiessen                                            Dr. med. Gudrun Bornhöft
cc Jeremy Hunt, Secretary of State for Health.
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Letter to Mr Hunt, UK Minister of State for Health

Dear Mr Hunt,

We appreciate that you are not personally responsible for the actions of UK university professors, nor of the UK Advertising Standards Authority Ltd. But as Minister of State for Health, we wish to bring to your attention the continuation of falsehoods that have emanated from your country concerning our Health Technology Assessment Homeopathy in Healthcare, which examined and found homeopathy to be safe, effective and cost-effective.

We enclose a copy of our reply to the Advertising Standards Authority  Ltd., also of our earlier published replies to Professors Ernst and Shaw, both of whose writing we considered to be defamatory. We expect ASA Ltd. to publish our reply, just as others have agreed so to do in the past.

We request that you will act in all ways that your power permits to persuade the ASA Ltd, on the subject of homeopathy and our work, to remain within the boundaries of scientific actuality, to correct factual errors already made, and to refrain from issuing defamatory texts on our work in the future.


Yours sincerely,

Prof. Dr. med. Peter F. Matthiessen                                                Dr. med. Gudrun Bornhöft

Attachments: 
Reply to Mr Parker, Advertising Standards Authority  (ASA) Ltd. (email from 24th July 2013)
Familiarity, objectivity – and misconduct
Counterstatement to Shaw DM. The Swiss Report on homoeopathy: a case study
of research misconduct. Swiss Med Wkly. 2012;142:w13594

Letter from to the authors of the HTA report from “Rob” of the ASA

Dear Prof. Dr. med. Peter F. Matthiessen & Dr. med. Gudrun Bornhöft,

Thank you for contacting us.  

You might be aware that the ASA is the UK’s independent advertising regulator, recognised by the Government, Courts and UK Trading Standards Services as the ‘established means’ for regulating misleading and comparative ads in non-broadcast media in the UK.

I’d first like to make clear that it is not the ASA’s role to question the validity of alternative or complementary therapies in and of themselves; nor do we seek to restrict the right of individuals to choose treatment.

We are, however, charged with protecting consumers from potentially misleading advertising.  When advertisers make claims about their products or services, in any sector, they must hold robust evidence to back up those claims.  If they do not, the ASA has no choice but to ensure those ads are amended or withdrawn.

Your work was considered by the ASA, having been submitted by an advertiser as evidence to substantiate claims made in their advertising about the efficacy of homeopathy in treating medical conditions. Having sought expert advice, we considered however that 'Homeopathy in Healthcare' did not move the case forward in favour of the efficacy of homeopathy, in light of conventional standards for efficacy.  

I appreciate that you disagree with this assessment. It would, however, be irresponsible for the ASA, as an advertising regulator, to ignore mainstream scientific and medical opinion when considering claims about products that are used in a medical or therapeutic context.  The ASA’s current position on the evidence-base for the efficacy of homeopathy is supported by the findings of the House of Commons Science and Technology Committee’s report ‘Evidence Check 2: Homeopathy’, published in 2010.  That report included a thorough review of a wide range of evidence on the efficacy of homeopathy (much of it submitted by homeopaths themselves), but it concluded that “there is a lack of evidence supporting the efficacy of homeopathy”. 

Ultimately, if practitioners are concerned that existing methods for considering the efficacy of treatments or therapies are not fit for the task, they should raise these issues with the relevant expert bodies – for example the National Institute for Clinical Excellence or the Department of Health here in the UK.  

Whenever the ASA makes a ruling, advertisers have recourse both to an Independent Review process and to judicial review, the latter providing a means for advertisers to have our decisions tested in the courts. If through this process our ruling is found to have been flawed, it will be amended, and the new ruling published on our website. 

Thank you for taking the time to contact us. 

Regards,     Rob
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Letter from the authors of the HTA report to Chairmain of the ASA, Mr. Guy Parker

Dear Mr Parker,

We refer to the reply we received from Mr Griggs, which we found irrelevant to our Email of 24th July which we addressed personally to you.

We do not comment on other countries’ health policies unless specifically invited by that government to do so, and we said nothing about your ‘position’ on homeopathy. Neither have we made any statement on the Science and Technology (2010) committee report: others such as Lord Baldwin and David Tredinnick MP have done so already -http://www.homeopathyevidencecheck.org/MPs.htm

Our complaint, unaddressed by Mr Griggs, concerned exclusively your organization’s false statements about our work; not a matter of ‘opinion’ nor of ‘policy’, but of plain Misrepresentation of Facts.

You say, on the internet, that our book’s conclusion is based largely on a reworking of Shang: as a fact, this is totally false. You say our book contains no RCTs: as a fact, this is equally false.

Aside from a legal incumbency to present facts truthfully and to correct errors made, I hope we can agree as a question of basic morality that members of the public should not be subjected to false or misleading communications - including yours.

Yours sincerely,
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Email to authors of the HTA report from Rob of the ASA

Dear Prof. Dr. med. Peter F. Matthiessen & Dr. med. Gudrun Bornhöft,

Thank you for your further email.  Mr Parker has asked me to respond on his behalf.
We disgaree with your interpretation of the wording of our adjudications.  During our investigation processes, we recieved expert advice on the various studies submitted by the advertisers as evidence supporting their marketing claims.  We stand by that advice and our use of it.  As you might know, advertisers and complainants involved in investigations have the right to request an Independent Review of our decisions.  However, I’m afraid our published processes do not give other parties that right. 
I‘m sorry that you remain unhappy with the wording of our adjudications, but we cannot assist you further at this time.

Best wishes,

Rob

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