Last week I reported that a top quack delegation was visiting the Advertising Standards Authority to tell them that they were being very mean to quacks by asking them not to make unsubstantiated claims in their websites.
Well, once more, a leaked email landed in my inbox. And we also have an ‘official’ press release. And it shows a profession, if I can call it that, that is immature, confused and irresponsible. No big surprises.
So, first the leaked email. From Jayney Goddard. Much of it speaks for itself.
The ASA Meeting of Friday 29th July
Dear Colleague,
First of all, a huge thank you to the hundreds of you who were so kind to respond to our email last week. I am emailing now to let you know how the meeting went.
As you’ll be aware, in attendance were Dr Rob Verkerk and Meleni Aldridge from the Alliance for Natural Health and Dave Hawkins and I represented The Complementary Medical Association. The ASA side was led by Vena Raffle – Head of Investigations – and a group of other ASA and CAP staff.
We went to the meeting with several items on our agenda. We wished to discuss the following points:
The nature of the communications received by practitioners from the ASA
Whether the ASA is perceived by practitioners to be a “legal” entity with “legal powers”.
The scientific competence of the ASA to be able to understand the specific issues involved in CAM (and should they not have expertise in our area we wanted to offer assistance from established CAM/Science experts)
We wanted to clarify the use of true patient testimonials on advertising and websites
On the first matter: It is deeply shocking to see just how many practitioners had received letters from the ASA and how these letters had provoked such deep distress. We continue to look into the ASA communications with practitioners – so don’t hesitate to send us your response to our first email – if you have not yet done so. Rest assured that any communications on this matter are held in the strictest confidence.
As a result of the amazing and positive response from our profession, I was able to take just short of 80 emails to the meeting – the only reason that I didn’t take more was because of the time frame – it wasn’t possible to print more than that.
I put it to the ASA that the large number of emails I had bought with me demonstrated conclusively that the ASA communications to practitioners are perceived to imply threat – and have provoked anxiety and distress. Furthermore, that practitioners generally believed – based upon the communications they had received from the ASA, that the ASA is a ‘legal’ body with legal powers. The ASA denied that their letters cause any anxiety or distress and are not threatening. We found this odd as the dossier I took with me demonstrated conclusively that this is not the case.The ASA did not comment regarding the impression they give of being a legal or governmental body.
Dr Rob Verkerk questioned the ASA and CAP regarding their understanding of science, research and CAM. This led to a discussion about the procedures that the ASA take when investigating a health advertising related complaint. The ASA and CAP representatives explained that they have no scientific background at all and certainly no knowledge of complementary medicine and that they are just ‘doing their job’. They are simply ‘experts’ in making judgements about adverts. They explained that the procedure is the same whether they are “looking into a complaint about roofing and guttering or complementary medicine”.
We asked the ASA what would happen (i.e. what the investigative procedure would be) if a practitioner did supply supporting evidence to back up their claims of their discipline’s efficacy – following a complaint. The ASA responded that this had not yet happened – that ‘no one has yet submitted evidence that they needed to examine’. We found this odd as we know that practitioners have submitted evidence for their disciplines.
On the basis that the ASA and CAP told us that they do not have any knowledge of our field at all, we offered to assist them by providing a science/CAM expert. They declined this offer of help. We have grave concerns about the ASA’s ability to make judgements about research in our field.
Regarding the use of testimonials in advertising, this appears to be a very subjective matter, with the ASA deciding how to adjudicate based on the overall impression – or ‘feel’ that they get from the advert. We believe that there is much room for improvement in this area – as this process ought to be objective – and not simply based upon how each adjudicator ‘feels’ on a given day. Again – we’d like your opinion about this.
We suggested in parting that the ASA might like to open a dialogue with a wider audience – and suggested that perhaps they might like to come to “camexpo” in October – where we could hold a round-table discussion with them. The CMA and the ANH will discuss the possibility of this with “camexpo” as both our organisations are members of the “camexpo” Advisory Board.
Obviously there is much more work that needs to be done although we feel that incredibly valuable points have been raised in this first meeting. We would appreciate your feedback on the points raised and the ASA responses to them.
Warmest wishes
Jayney
Jayney Goddard
President, The Complementary Medical Association
Central to the complaint from Jayney, apart from the ‘distress’ being caused, is that somehow the ASA do not have competence to judge the claims being made by homeopaths, acupuncturists and so on.
It is something of an odd claim and completely fails to understand hoe the ASA operate. They do not have hundreds of specialists in the background who are experts on all fields of advertising, including cosmetics, builders, food, electronics and health. The ASA operate in a very simple way – they expect advertisers to hold robust evidence to substantiate the claims they make. The onus is on the advertiser to hold the relevant specialist information, not on the ASA to hold that information. If a complaint is made against an advertiser then they will be asked to supply that evidence. The ASA can then assess the nature of that evidence – and call in specialist advice if needs be.
However, for health complaints, the ASA do indeed have guidelines as to the nature of that evidence. For example, they have very strict rules governing the use of patient testimonials, as these are not good indications of the effectiveness of any treatment.
(I do like the invitation to CAMExpo – a forum where it would be harder to find a greater number of unsubstantiated claims under one roof.)
The Alliance for Natural Health have issued their own press release on the meeting.
Although quite long, it is perhaps safest to reproduce it all here so that it cannot be ‘removed’.
CAM LEADERS QUESTION THE COMPETENCE OF UK MEDIA WATCHDOG TO ASSESS CAM-RELATED COMPLAINTS
The Advertising Standards Authority (ASA), the UK’s media industry watchdog and self-regulator, has brushed off concerns raised by complementary and alternative medicine (CAM) leaders at Alliance for Natural Health International (ANH-Intl) and The Complementary Medical Association (The CMA) over its scientific competence to adjudicate complaints against CAM advertisers.
In a meeting at the ASA’s London office on Friday, 29th July, ANH-Intl representatives Dr Robert Verkerk and Meleni Aldridge, and Jayney Goddard and Dave Hawkins from the CMA, were told by senior ASA Head of Investigations, Vena Raffle, “You don’t need to worry. This is what we do. We deal with advertising complaints in all areas from roofing to guttering. We can’t be experts in everything, but we work to standards across all areas.”
In the meeting, Dr Verkerk drilled the six ASA representatives over their respective backgrounds and skillsets. Despite somewhat defensive and indirect responses from the ASA, it seemed that none of the relevant staff possessed scientific qualification. Concerns by the CAM sector over the ASA’s approach have escalated as of 1st March 2011, when the ASA expanded its remit to cover the Internet. Additionally, the ASA appears to have accepted the highly controversial approach taken by the European Food Safety Authority (EFSA) toward health claims, one that has resulted in the rejection of some 80% of general function claims for foods and food ingredients submitted for evaluation.
“Evaluating the extremely complex processes that occur when practitioners and patients interact is not something that we think can be done by a non-scientist”, stated Dr Verkerk after the meeting. “Human metabolism is complex enough, yet you have another dimension of complexity when you’re looking at the practitioner–patient relationship”, he continued. Many claims made by CAM practitioners, assert ANH-Intl and The CMA, are the result of many decades of clinical experience, and are not necessarily limited to what can be found in the peer-reviewed literature, which tends to be both very limited and reductionist in nature.
Commenting on the non-transparent procedure used by the ASA, Dr Verkerk stated: “I was astounded to find that the ASA appeared to have no comprehensive and transparent system of evaluation. It evaluates complaints in isolation, using only the evidence given to them by the advertiser. The ASA also told us that no practitioners had given evidence in response to a complaint, whereas both ANH-Intl and the CMA are aware of evidence having been submitted.”
The CMA and ANH-Intl both believe that the future practice of CAM will be increasingly eroded if the ASA continues with its current heavy-handed policy. This includes sending threatening letters to CAM practitioners who, according to the ASA, appear to have breached the ASA’s British Code of Advertising, Sales Promotion and Direct Marketing (The CAP code).
Jayney Goddard said, “We have asked our members how they feel when they get a letter from the ASA and many feel threatened and intimidated, with some being concerned that they may be sent to jail if they don’t comply. It’s not surprising that some practitioners feel they have no option but to shut down their practice.”
The two groups representing CAM consider the ASA’s approach, in conjunction with that of the anti-CAM skeptic group, the Nightingale Collaboration, to be akin to a “witch-hunt” against CAM practitioners.
“If the basis of adjudications was transparent and took into account the full gamut of evidence, we would not be so concerned,” added Jayney Goddard, “but what we have here is an independent watchdog that appears incompetent to evaluate the field of CAM. Not only that, but the ASA is now dealing with a greatly increased level of complaints from the over-zealous, CAM-skeptic Nightingale Collaboration. Practitioner–patient relationships can’t, unfortunately, be evaluated in the same way as roofs and guttering.”
The ANH-Intl and The CMA aim to encourage the ASA both to increase the transparency of its evaluation and adjudication methods, and to expand the type of evidence that can be used to substantiate specific claims. The two organisations urge CAM practitioners not to simply ‘roll over’ when challenged by the ASA, but to attempt to justify their claims with the best and broadest range of available evidence.
So, as well as claiming the ASA is incompetent to assess the claims of quacks, it is also claiming that there is a lack of transparency here. I am not sure how they have arrived at this conclusion. What extra elements do they require in order for the ASA to be more transparent in what they do?
There is an obvious question that Goddard and the ANH need to ask themselves. The ASA is a widely respected body, fully supported by all major advertisers as a cheap and light handed way of ensuring UK advertising is ‘legal, decent, honest and truthful’. If the ASA can be accepted as adjudicating on claims as diverse as double glazing to vitamin pill benefits why are they incompetent when it comes to homeopathy and herbalism?
Verkerk appears to believe that the answer is in something to do with the “extremely complex processes that occur when practitioners and patients interact”. However, the ASA are not going to adjudicate on the alleged mechanisms by which, say, homeopathy works, but on whether or not there is robust evidence to substantiate claims that such ‘extremely complex’ processes actually have specific effects on people. That is no different from any other form of treatment – and the ASA are quite happy to look at adverts where there is undoubted complexity in mechanisms in mainstream health claims. If I go to a homeopath expecting my child’s asthma to improve, the ASA will want to see evidence that asthma symptoms are alleviated under homeopathic care.
Their request to ‘expand the range of evidence’ and to include their own people in assessing claims is also misconceived. Expertise is required to help assess health claims. Practicing homeopaths, herbalists and acupuncturists cannot be considered experts as their beliefs are clearly false. What does it mean to be an expert in something that is not true?
I also find it incredible that the quacks have not worked out that the ASA’s lack of direct statutory powers is also a very good thing. It allows advertising claims to be managed without recourse to the courts at every opportunity. It is in advertisers very best interests to use the ASA as a resource to check what is legal and to accept their judgements when they are made so that legal action does not follow.
And that is what could and will happen. If a homeopath refuses to work with the ASA, then the next steps do involve criminal proceedings. Instead of denouncing the ASA as incompetent and threatening, they should be cooperating fully to ensure they are not subjected to more serious sanction.
In all, it shows a group of people seriously out of touch with reality. The quack world has enjoyed decades of nearly no regulatory interference. What regulation does exist is never enforced. Slowly, they are being dragged into a world where people are held to account for the claims they make and the actions they take. That is something they are not used to. And that is why it is bothering them so much.
UPDATE 7/8/11
The ASA have now published the ‘threatening’ letters that they sent to homeopaths. Scary stuff…
This has just been published: CAM industry tension rises as UK advertising watchdog claims clampdown continues
I find the ANH’s position puzzling. The Traditional Herbal Medicines Registration Scheme in combination with the Medicines (Advertising) Regulations 1994 are much more of a problem for them than the ASA.
Bitching about the ASA’s light touch regulation is just silly when the MHRA are staring to investigate herbal remedy vendors.
Well, the ANH have clearly lost their fight with the EU over the regulation of herbal medicine. Nothing like starting another fight to distract from the one you have just lost.
But it’s a fight they can’t win and it’s meaningless. The ASA do understand the law and will consult with the MHRA. Misleading claims are one thing and is probably the CMA’s beef, but the ANH are completely aware that there is a bunch of legislation sitting behind some of the ASA’s adjudications.
Complaints to the ASA regarding illegal advertising of unlicensed medicines will become more common. Non-compliance is likely to result in the ASA referring the matter onto the MHRA.
An excellent article and very well argued. The quacks want a ‘special case’ to be made for their whole range of nonsense. All they have to do is fund some proper clinical trials, like every one else, and there would not be a problem as they would have repeatable scientific evidense on which to base the claims.
I’ve always assumed that the ASA people dealing with the complaints I’ve sent in haven’t had PhDs in biochemistry or medical degrees or whatnot. I don’t either. I do assume that both of us can have a reasonable stab at assessing evidence and asking for help when needed.
This is why I always do a bit of background research first myself, to learn more about what’s being claimed and to get an idea of what is and isn’t reasonable. It helps me find out a bit more about the topic.
And when I send in my complaint about some CAM nonsense I include evidence on how I’ve come to the conclusion that it’s crap 🙂 Quite often blog about it too.
I also think it’s time we speak about homeopathy in the past tense 😉
You don’t need to be an expert in a subject to assess the evidence for it – which is what advertisers are supposed to have before they make their claims.
But the ASA can and do call in expert advice when they need it.
Amen.
Goddard’s emails crack me up. She really doesn’t get it, does she?
JG: “The large number of emails I have bought with me demonstrate conclusively that the ASA communications to practitioners are perceived to imply threat – and have provoked anxiety and distress.”
ASA: “OK, but where’s your conclusive evidence for homeopathy?”
Verkerk has stated publicly that he thinks Edzard Ernst, MD, PhD, FMedSci, FRCP, FRCPEd, is a crap scientist who isn’t competent to assess the evidence so who does he think he’s kidding making a fuss about the lack of scientific qualification of ASA staff?
Just other quacks, I suppose.
‘In all, it shows a group of people seriously out of touch with reality. The quack world has enjoyed decades of nearly no regulatory interference. What regulation does exist is never enforced. Slowly, they are being dragged into a world where people are held to account for the claims they make and the actions they take. That is something they are not used to. And that is why it is bothering them so much.’
I think you have it right there, Andy. For too long these people lived in a world where thought they were above the law, unlike the roofer. They would want the protection of that law from an unscrupulous roofer but do not want to conform themselves. They forget that those laws actually protect them too.
I want to take this chance to congratulate the Nightingale Collaboration for working to protect the public in this way. I am also proud of those people I know who are working in this way to make all of us safer.
The ‘victim’ attitude is sickening. As you correctly say, Andy, all they have to do is to be sensible and conform, just like the roofer. If it is 30mph for the roofer, it is 30mph for the homeopath, and those speed signs were put there to keep all of us safer.
I ampersonally glad to see homeopaths having to recognise and obey the laws that apply to all of us.
Thanks, Wendy.
Meanwhile, the MHRA continue to issue licences for herbal products without a jot of robust evidence that they work or are safe, giving them undeserved legitimacy. One just announced is for Moveze. I’ll let you guess what misleading indications they are now allowed to make for that.
So, some are quite happy to take advantage of regulation when it suits them, while others throw their rattle out of the pram when they don’t get their own way.
SHIT!! Just looked at that Moveze document. Need to do some digging, but I am sure there is a serious problem here. How the help can the MHRA have done this? I’m not at a proper computer, but I am sure that Devil’s Claw, if it has real effects, is simply a herbal NSAID with all their associated side effects, but with bugger all efficacy. If patients take NSAIDs as well then there is the potential for serious harm, but the product is wrapped up as a harmless herbal with no mention, that I could see, of the existence of this dangerous interaction.
As I said, needs some work.
Is Devil’s Claw not a COX-2 inhibitor? One thinks of Vioxx.
Yes, I’m not claiming great expertise in this but a bit of googling suggests I’m right. Devil’s Claw is a COX inhibitor just like properly characterised NSAIDs smother side effects will be synergistic.
e.g. http://www.ncbi.nlm.nih.gov/pubmed/14646256
It’s just bloody weird that the MHRA have not forced this to be acknowledged in the customer information leaflet.
Oooh! Not that could be VERY interesting.
LCN
Just realised the title of this post needs an ellipsis.
“Quacks…Incompetent and Threatening”
That’s even more appropriate.
“I put it to the ASA that the large number of emails I had bought with me demonstrated conclusively that the ASA communications to practitioners are perceived to imply threat – and have provoked anxiety and distress.”
Poor, poor Jayyyneyyy. But I’m confused. Even my quack-believing girlfriend (sleeping with the enemy, I know…) could recommend a Bach flower BS remedy which would sort out all that anxiety and distress in about, ohhh, five minutes flat (say).
Honestly, have they forgotten how powerful their own products are in combatting the day-to-day nastiness of those who perversely simply don’t want people to be fed BS a lot more noxious than their pathetic witch doctor magic potions?
Not a brain cell amongst them by the looks of it.
I predict that the ASA may very well get a bloody nose out of this. Note that what in the US busted up the National Council Against Health Fraud’s suit against a homeopathi pill manfucturer was a similar issue regarding ASA and homeopathy.
The NCAHF sued homeopathy mfg. King Bio for making false claims. But the trial court enied the suit, and concluded that the NCAHF failed to prove a false or misleading statement.
King Bio’s expert testified the products were safe and effective and that the products were included in the Homeopathic Pharmacopoeia of the US and complied with FDA guidelines. And so the NCAHF lost, big time, having to pay court costs.
Here with the ASA we have something I think is similar. If there is truly a case against homeopathy, as is implied by Lewis’ constant charaterization of the profession as”quacks” and the products it uses as inert, then he, the ASA and like interests should have no problem winning a settlement in court.
And likewise . . if the homeopaths are abiding by the law and not making claims that can be proven to be misleading, then it would seem to me that the ASA could, and should be held accountable for defamation and interference of trade.
Given whatever you or I may think doesn’t really mean a damn thing when its end up in court, now does it? And as was demonstrated in the NCAHF v. King Bio, it turned out the plaintiffs really didn’t know what they were talking about there either, they demo’ed very little lnowledge of homeopathy, just as has been shown here y the ASA.
It follows then that the ASA has yet to spell out just what the law provides for and prevents regaring homeoapthy.
The NCAHF alleged the primary violation of law was false advertising, that there was some form of false, deceptive or misleading statements or representations in the labeling or advertising used by Defendants in marketing of their products.
In cross, the Plaintiff admitted that there was no evidence of a violation of laws by Defendants; Plaintiff didn’t dispute that Defendants’ products were squarely within the definition of legal, non-prescription homeopathic “drugs” under both federal and state laws.
Maybe things are different in England, but explain to me what is substantially different between the ASA’s claims against UK practitioners and King Bio.
The Plaintiff argued that the claims stated in Defendant’s advertising were scientifically unsupportable and therefore false.
The problem with this is that since there was no violation of law, therefore no remedy for the plaintiff. There was no case found in California to support the shifting of the burden of proof to the Defendant in a case of this type. And so the Defendant won.
I might add another thing, which was not brought up. I see nothing in the trial reports that state that the Plaintiff had been harmed by the Defendant’s advertising.
Anyone can quickly see that there is indeed scientific evidence to support homeopathy by simply doing an online earch for it. That there isn’t evidence is a putative myth. So if the ASA chooses to impose sanctions on homoepaths, it would seem to me they could simly respond by simply pulling out the preclinicals, the biochemical reports to begin with.
But even this would be moot, because as of to date, I not see any particular allegation that UK homeopaths have broken English law and . . their pharma holds a Royal Warrant.
How do you beat that?
John Benneth, Homeopath
John, you are not understanding how this works in the UK.
Firslty, the ASA is not contesting this in any court. The ASA exists as a buffer between advertisers and legal action in that most advertising complaints are adjudicated here. Only if advertisers do not comply with the ASA does the possibility of legal action loom.
Secondly, both the approach of the ASA and our legal system differs significantly from the Californian system where NCAHF vs King Bio took place. There, and quite perversely, the court decided the burden of proof was on the NCAHF – that is, they had to prove that King Bio’s claims were false. If no research had been done, then this is near impossible. This reverse burden is a quack’s charter – it does not exist here.
The ASA expects advertisers to hold robust evidence that their claims are true. If an advertiser cannot provide such evidence then they are in breach of the CAP code. If an advertiser ever goes to court, then consumer regulations put the burden of proof firmly on the advertiser. This is the ethically correct way to do things – make health claims? You provide the evidence.
If, as you claim, there is evidence for homeopathy, then the advertisers should have no problem. But your idea that ‘pre-clinical and biochemical reports’ (if they exist) are sufficient evidence to support health claims, then you are sadly mistaken. The ASA will want to see specific and robust evidence relating directly to the health claim being made.
The ASA are discovering that homeopaths are routinely selling unlicensed medicines. A Royal Warrant from their manufacturers will mean nothing. There is a time bomb ticking here for homeopaths – and while they play out their silly fantasies that this is all a witch hunt, the possibility that many will start getting criminal records increases.
Homeopaths are being given every chance to get their house in order. It is up to them now to respond as a mature profession. We shall see.
Like this, or even this.
You haven’t been paying attention, have you?
US and UK regulation of homeopathic medicines is rather different. UK regulation derives from various EU directives. In theory, UK regulation is very tough.
Basically, in the UK, homeopathic remedies need to be registered with the MHRA. They then can be advertised and sold over the counter. If a remedy is not registered, it is an “unlicensed medicine”. The Medicine (Advertising) Regulations forbids the promotion of unlicensed medicines. The rules covering the supply of unlicensed medicines are complicated but very restrictive.
Misleading claims are one thing, but the binary decision of whether advertising of a particular product is legally permitted at all is rather different.
Andy is right that the ASA are acting as a buffer between advertisers and legal action from statutory regulators. Some of what goes on in the world of UK homeopathy would appear to breach various laws.
For too long many in UK homeopathy have believed themselves somehow immune from legal and ethical constraint. What may have been tolerated in the past or escaped notice is now very much in the public domain. As the complaining voices of homeopathy grow more shrill, as they become more strident, they achieve exactly the opposite of what they want. They merely draw attention to their questionable actions.
By trying to “save” homeopathy, they drive another nail into its coffin.
All this is just the usual special pleading we get from homoeopaths: RCTs show homoeopathy doesn’t work and are therefore not an appropriate way to assess it, the ASA has concluded that homoeopaths are unable to present evidence substantiating their claims therefore the ASA is not an appropriate body to assess the evidence…
Excellent article, thanks for keeping us up to date on what’s going on!
Y’know, if Homeopathy would just set aside some of the vast fortune it makes each year to do some really rather simple clinical trials, in order to prove, conclusively, that Homeopathy works, they wouldn’t need to go through this. But of course, they’re not going to, because they don’t know how to run a real study and don’t want to do it anyway, because they know damn and well that it doesn’t work.
Here’s one they published last month.
Although, as Mojo points out, they do sometimes do CTs they really shouldn’t and it’s hard to understand how they are getting the approval they (presumably) are getting: http://en.wikipedia.org/wiki/Ethics_Committee_%28European_Union%29 In fact a CT of homeopathy is not (not even)¹ pathological science² and would not show that a homeopathic remedy works even if it yielded strong positive results.
¹ http://en.wikipedia.org/wiki/Not_even_wrong
² http://en.wikipedia.org/wiki/Pathological_science
This is the quacks’ Waterloo.
Show us the evidence, says the ASA, or stop your ads
Will the homeopaths fight or run ?
Thanks for another great article Andy.
The more I read about Jayney Goddard, and the more I read her emails, the more often I picture a baby’s pram and a dummy flying through the air.
When it comes to John Benneth, I see him as a deluded old man in a home for the elderly, sitting in his seat by the fire, jowls jangling back and forth, as he continues to promote the efficacy of snake oil for his rheumatism.
I’d also like to second Wendy’s expression of thanks to the Nightingale Collaboration.