The random thoughts of a sceptical activist

Nightingale Collaboration

Paying the price of homeopathic research

Do homeopaths’ claims that trials are too expensive and that they can’t afford them hold water?

Science is simply a systematic way for carefully and thoroughly observing nature and using consistent logic to evaluate results. Which part of that exactly do you disagree with?

— Dr Steven Novella

Homeopaths have an ambivalent attitude to research: they are quick to jump on any results they think support their pseudo scientific beliefs, yet any paper that shows homeopathy to be no better than placebo is denounced, usually with cries that the ‘homeopathic system of personalised, holistic medicine’ is just not suited to being tested using flawed ‘conventional’ double-blind randomised controlled trials (DBRCT). And sometimes Big Pharma tell lies.

But homeopaths have a problem: all advertising in the UK has to comply with the Advertising Standards Authority’s CAP Code and this rightly demands a high standard of evidence for any claim, regardless of whether it’s about how clean a soap powder makes your whites, how efficient double-glazed windows are or how much a skin cream reduces the appearance of wrinkles. So it is with homeopathy: high quality evidence is required.

There have been several ASA adjudications recently against homeopaths (eg  Steve Scrutton), homeopath trade bodies (eg the Society of Homeopaths — and you must watch this superb demolition of their ‘evidence’) and homeopath advocacy groups (eg H:MC21) and these have shown the paucity and extreme poor quality of homeopathic research.

researchBut there doesn’t seem to be that much new research being conducted that might allow claims to be made in the future. Instead, there are moves to try to persuade the ASA to lower their standards in the hope their evidence will meet this easier threshold, campaigns to oppose the ASA, petitions raised to force the ASA to change its ways, with frequent shouts of ‘Censorship!’, ‘Bias!’, ‘Freedom of speech!’ and double standards.

There are even moves afoot to ‘re-categorise’ the literature on homeopathy. This is in the early stages and will probably take a few more years to complete, but there will be no prizes for guessing what the conclusions are likely to be — a comparison with the farce surrounding the Swiss report on homeopathy is inevitable.

Patient success stories Anecdotes

But homeopaths insist there is ample proof that homeopathy works already, and are keen to point out the large numbers using homeopathy as if that was an indication of efficacy. Ah, that old canard — evidence in the form of anecdotes — doesn’t wash with anyone even vaguely aware of the problems of bias and with an interest in getting to the truth of the matter; and certainly not up to the ASA’s standards.  Many websites of homeopaths laud their customer testimonials and there are several websites that actively gather anecdotes (or ‘patient success stories’ as they sometimes like to call them) such as Homeopathy Worked for MePatient Testimonials and a relatively new one, Making Cases Count. And of course there are their celebrity endorsements; where would homeopaths be without their celebrity endorsements?

A number of anecdotes may indicate that something is worth looking at in more detail, but they are no indication of the efficacy of homeopathy and they certainly don’t change the state of the robust, independent evidence for homeopathy — or rather, the lack of it.

Many homeopaths rubbish science of course, dismissing it as reductionist and entirely unsuitable as a means of testing their precious homeopathy. But they fundamentally misunderstand science. As Dr Steven Novella puts it:

What do you think science is? There’s nothing magical about science. It is simply a systematic way for carefully and thoroughly observing nature and using consistent logic to evaluate results. Which part of that exactly do you disagree with? Do you disagree with being thorough? Using careful observation? Being systematic? Or using consistent logic?

Yet homeopaths crave scientific respectability — they laud (erroneously), for example, the neutral Swiss Government for their highly positive homeopathy HTA and just about every half-baked study they can twist to make it support their favourite hobby-horse. They know that they will not make the progress they believe they deserve unless they can, finally, provide that good scientific evidence they just know is waiting to be found. As I’ve mentioned, it was this lack of good evidence that lost both the Society of Homeopaths and the homeopathy advocacy organisation, Homeopathy: medicine for the 21st Century (H:MC21) their Advertising Standards Authority adjudications for claims they had made in adverts. Not just on a few minor points here and there, but a complete and utter demolition of their homeopathic claims.

Academia

There are even some university academics who spend their time researching homeopathy, such as homeopath Dr Clare Relton, Senior Research Fellow at the  University of Sheffield and homeopath Dr Elizabeth Thompson, Consultant Homeopathic Physician [sic] and Honorary Senior Lecturer in Palliative Medicine at University Hospitals Bristol. There are many others as well who see themselves as legitimately researching their sugar pills.

There are even organisations whose sole purpose is to improve research into homeopathy. Take the Homeopathy Research Institute (HRI):

The Homeopathy Research Institute is an innovative international charity created to address the need for high quality scientific research in homeopathy. We use our resources and expertise to foster new projects and to improve the quality of research being carried out in the field.

They may well think they are an ‘innovative international charity’, but you’d be forgiven for doubting that looking at their registered address of 39 Great Windmill Street, London W1D 7LX.

Anyway, the HRI heralded that their conference in Barcelona this year would be, “A significant step forward for homeopathy research“. A critical thinker might be considerably less than underwhelmed by what actually happened.

But at least they are trying to do some research; and scientific to boot. Indeed, they have seven research projects running at the moment:

  • Case series of 20 children diagnosed with ADHD treated with homeopathy for a year
  • Depression – What is the role of treatment by homeopaths?
  • Irritable Bowel Syndrome (IBS) randomised controlled trial
  • Online database of homeopathic scientific literature
  • Physico-chemical properties of homeopathic dilutions
  • Physics of homeopathic dilutions
  • Theories of homeopathic dilutions

Well, by ‘running’, I mean that they are trying to raise the money to fund them.

This list certainly covers a lot of ground; most don’t require any research to answer, though…

But the one on depression says it’s simply part of a PhD:

This project will evaluate the acceptability and the comparative effectiveness of adjunctive treatment provided by homeopaths for patients with self-reported depression, in addition to usual care.

So it’s guaranteed to give positive results even before it’s started!

Follow the money

But how much does this research cost and how on earth could they raise the money?

We are continually told that DBRCTs cost a fortune to conduct and poor homeopaths could not possibly afford them. Dr Michael Dixon has said:

In conventional medicine, pharmaceutical companies have the advantage of having funds for research. Alternative medicine lacks that.

It seems like homeopaths are so adept at coming up with excuses, anyone would think they can anticipate the outcomes…

But, other than tapping the likes of leading homeopathy manufacturer Boiron — with its market capitalisation value of just under 1 billion Euros — how on earth can they afford this very necessary research? Until they have positive results from robust, high quality trials, they will not be able to make the claims they might like to in their advertising, so the onus is definitely on them to do whatever’s required to advertise their businesses honestly.

Fortunately, the HRI have an answer: they want to raise money for their research from the public using JustGiving and BT’s MyDonate donation websites:

 

Title
Target
Online
donations
Number
Offline
donations
Gift Aid
Total
% online
% total
Total

ϣ196,000

£œ11,510

20

ϣ28,000

£œ5

ϣ39,515

6%

20%

Depression: What is the role of treatment by homeopaths?

£œ98,000

ϣ10,020

2

£œ0

ϣ5

ϣ10,025

10%

10%

Homeopathy Research Database

£œ40,000

£œ0

0

£œ0

£œ0

£œ0

0%

0%

IBS Trial: Phase 2 Fundraising Appeal

£œ15,000

£œ1,490

18

ϣ0

£œ0

£œ1,490

10%

10%

Irritable Bowel Syndrome (IBS) randomised controlled trial

£œ10,000

£œ0

0

ϣ5,000

£œ0

£œ5,000

0%

50%

Physico-chemical properties of homeopathic dilutions

£œ10,000

ϣ0

0

£œ10,000

£œ0

ϣ10,000

0%

100%

A new quantum theory to explain homeopathy

ϣ10,000

£œ0

0

£œ10,000

£œ0

ϣ10,000

0%

100%

Physics of homeopathic dilutions

ϣ5,000

£œ0

0

£œ0

£œ0

£œ0

0%

0%

Theories of homeopathic dilutions

£œ5,000

£œ0

0

ϣ0

£œ0

ϣ0

0%

0%

ADHD case series

ϣ3,000

£œ0

0

ϣ3,000

£œ0

£œ3,000

0%

100%

 

Of course, these are just the target amounts they want to raise from donations and they could have additional funding secured from elsewhere, but note that four of them have offline donations already.

moneybagThis could also answer the question about how much a homeopathic trial costs and it won’t go unnoticed that the Q-word rears its ugly head.

Positive by design

Their two IBS projects (IBS Trial: Phase 2 Fundraising Appeal and Irritable Bowel Syndrome (IBS) randomised controlled trial) are raising funds from two different websites: one with a target of £15,000 and the other of £10,000. However, in the past 12 months, excluding a one-off online donation of £10,000, they have raised a grand total of just £1,490 from the public.

But maybe these are one and the same trial? They certainly appear to be — and it is this trial that is discussed by Prof Edzard Ernst: Homeopathy for IBS? When will we stop wasting resources on such useless pseudo-research?

Prof Ernst links to a new study and this has the same trial registration number as the one on the HRI’s website: ISRCTN90651143. As he points out:

We are again dealing with an A+B versus B design, on top of it without patient- or therapist-blinding. This type of analysis cannot ever produce a negative result, even if the experimental treatment is a pure placebo: placebo + usual care is always more than usual care alone. IBS-patients will certainly experience benefit from having the homeopaths’ time, empathy and compassion – never mind the remedies they get from them. And for the secondary analyses, things do not seem to be much more rigorous either.

He concludes:

Obviously, I have not seen the data (they have not yet been published) but I think I can nevertheless predict the conclusions of the primary analysis of this trial; they will read something like this: HOMEOPATHY PROVED TO BE SIGNIFICANTLY MORE EFFECTIVE THAN USUAL CARE. I have asked the question before and I do it again: when does this sort of ‘research’ cross the line into the realm of scientific misconduct?

Indeed.

That protocol document says:

This trial has received NHS approval and results are expected in 2013.

It received Barnsley Hospital internal approval on 14 December 2009, ethics committee approval on 9 December 2010, and the protocol paper was  published a further two years later, on 6 November 2012.

So, having published the protocol, and with the Current Controlled Trials entry saying it is completed, with an anticipated end date of 31 December 2012, what is the current status of this research? I don’t know. Perhaps they still need money to analyse the results and write up the paper?

Touting for money

Various homeopathic organisations were advertising this trial last December: Australian Homeopathy Plus and the HRI issued an urgent fundraising appeal in December 2012:

Vital IBS trial needs your help
Funding needed: £15,000 Total raised so far: £1,900

Then in March 2103, they said:

Fundraising
IBS trial fundraising appeal – update

On behalf of the researchers at Barnsley Hospital involved in the Homeopathy for Irritable Bowel Syndrome trial (HIBS), HRI would like to thank everyone who donated to our fundraising appeal last November in support of this project. There was a hugely positive response to our appeal, with many warm messages of support as well as donations which totalled just over £2,000. In these hard times, it was a fantastic response from individuals. Click here to find out exactly how these funds are going to be put to use.

“There was a hugely positive response to our appeal”? It doesn’t matter what the true figure is, whether it’s £1,490, £1,900 or even £2,000, it falls dramatically short of the £15,000 they said they needed. I think they mean ‘a truly homeopathic response to our appeal’.

But they go on to give the bad news:

However, shortly after these funds were raised, changes at Barnsley Hospital meant that it would no longer be possible to carry out a second phase of the trial (involving recruitement [sic] of more patients) as intended. Instead, the aim now is to publish the existing HIBS trial results which, in the opinion of Prof Kate Thomas (an expert in Health Services Research) form a “robust pragmatic pilot study”.

After much discussion with stakeholders and those who made donations, the money raised by HRI will be used to provide seed funding for Jackie Raw RSHom (homeopath and HIBS project manager) to carry out a one-year prospective service evaluation of her work providing individualised homeopathic treatment for patients with IBS at Barnsley Hosp NHS Foundation Trust. Jackie would be aiming to treat ~ 30 patients and the total cost of the project has been estimated at £5,000.

It’s just not clear to me what’s going on but I sincerely hope they weren’t raising money for a project that has already been completed!

Bringing home the bacon

But after failing to raise very much funding from their supporters, the HRI now want the taxpayer to pay for research! In their submission to the House of Commons Science and Technology Committee inquiry into antimicrobial resistance (AMR), they want the Department of Health to consider using magic sugar pills to combat the very real threat of resistant bacteria, viruses, etc.

Without a hint of irony, they ask:

1.3 HRI recommends that the Department of Health conducts research to determine definitively whether homeopathy is efficacious for [ear infections in children] (we suggest a multi-centred randomised placebo-controlled comparative trial).

1.4 HRI recommends that Defra conducts research to determine definitively whether the homeopathic medicine Coli 30K is efficacious for reducing the incidence of E.coli bacteria in neonatal piglets (we suggest a multi-centred observer blinded, randomised placebo-controlled trial).

Unbelievable.

And of course:

1.10 HRI would welcome the opportunity to assist the Department of Health and Defra in investigating the potential for homeopathy to play a role in tackling AMR.

I’m sure they would.

elephantElephants by the herd

Of course, the elephant in the room is the fact that, even though these fund-raising campaigns have been running for over a year, they have only managed to scrape together a measly 20 online donations. They do seem to have an anonymous offline benefactor, but even taking all donations into account, all they have managed to muster is 20% of their total.

So it seems that homeopaths and their customers aren’t too willing to pay for research.

Maybe we’re expecting too much here. Maybe the money just isn’t there in these straitened, austere times?

But maybe we also need some alternative thinking here: rather than wringing hands and saying it can’t be done, how much could be raised by practitioners with a small levy on each appointment? That sounds like an easy way of raising funding: from the very people who desperately need to keep on the right side of the rules for their advertising and who will benefit most from being backed by good scientific evidence.

After all, there are several thousand homeopaths plying their trade in the UK. The FindAHomeopath website boasts 3,032 who are members of either the Society of Homeopaths, the Alliance of Registered Homeopaths or the Homeopathic Medical Association. (They also claim to include members of the Faculty of Homeopathy/British Homeopathic Association, but none are listed.)

So, what could be raised if a small levy was charged on each appointment?

Shock! Horror!

shockGasps of horror from homeopaths!

You can imagine the objections:

  • We can’t afford it!
  • Our customers can’t afford it!
  • It’ll never work!
  • It’ll be too difficult!

Well, let’s see. Let’s find out how they could raise the funds for dozens of trials — let’s play with some numbers with a handy calculator and see what drops out.

How to use the research funding calculator

Enter:

  • the number of practitioners working in the therapy
  • the average number of appointments per day
  • the average number of days per week worked
  • the average number of weeks worked in a year
  • the average cost of an appointment
  • the percentage levy to be used to generate funds for research

The calculator will show the number of appointments per practitioner per year, the practitioner’s income per year, the total number of appointments per year, the levy per appointment and the total raised per year.

Calculator

50pSo, using these default values of 3,000 practitioners, doing just four appointments a day, four days a week, 40 weeks of the year, asking for just 1% (50p) more from each customer — or donating that small amount from profits — means that they would raise a research fund of just under £1 million — each and every year.

This 50p would cover the HRI’s puny total of £196,000 nearly five-times over; 10p would still just about cover it.

Even if the default numbers I’ve used are optimistic (perhaps lots of them just work part-time), it’s very easy to see how they could raise a significant amount of money very easily, with just a little effort.

Try some figures for yourself.

Alternative funding

Of course, these simple calculations can be applied to any therapy that is lacking in positive research such as reflexology, reiki, Bowen therapy, craniosacral therapy or any similar pseudo scientific nonsense.

If any practitioners — or their trade bodies — really wanted to try to come up with the good evidence they’re probably convinced exists, then what’s stopping them? After all, if they were able to produce good evidence, they might be able to convince the ASA to accept their advertising claims.

However, if they don’t even try to get good trials done, they will forever pay the price in their advertising.

WDDTY: Waging war on “doctor-induced disease”

What does the two-decade-old ‘endorsement’ by The Times really say?

Any reader not aware of the current fuss and bother over the What Doctors Don’t Tell You magazine can find a comprehensive list of blog posts, etc curated by Josephine Jones: WDDTY: My Master List.

In a recent spat — after The Times published an article by Tom Whipple (Call to ban magazine for scaremongering) — WDDTY posted a scan of part of a 1989 Times article that appeared to praise their original (online subscription) publication of the same name, saying it was “A voice in the silence”.

WDDTY use this same endorsement 24 years later on their main website, the WDDTY subscription website for their latest glossy, supermarket edition (although they get the quote mixed up with others) and in the glossy magazine itself.

Despite calls for them to publish the complete article, its editor, Lynne McTaggart, has not obliged, so I will.

The Times

Note the charming cartoon of WDDTY being used to beat up a doctor.

I’ll leave you to ponder the full article, but here are some quotes:

[WDDTY] promises to reveal all those irritating little things the GP has been keeping to himself, such as the potential side-effects of drugs.

McTaggart: “[WDDTY] will wage war on “doctor-induced disease” — illnesses triggered by prescribed drugs.”

McTaggart: “We are not gunning for doctors and we are not an alternative medicine journal. We feel that the cure should be worth the side-effects, and that people have a right to as much knowledge as possible so they can make an informed decision.”

[McTaggart] feels her magazine is needed because people may be willing to lose their hair to achieve remission from cancer — but not to cure a headache.

McTaggart: “We will be exposing alternative therapists, too”

McTaggart: “[doctors are] being taught that vitamins and diet are not important and there is a pill for every ill.”

McTaggart: “It is impossible for the average doctor, unless he has a computer, to understand how all these drugs can react and overlap. They can only trust the regulatory bodies.”

McTaggart: “If we ever make any money out of this I’d like to use it as a lobbying body in Britain.”

McTaggart says her journal will accept no advertising — “we have to remain pure”

WDDTY is not without promotional gimmicks. Subscribers will receive a free copy of the What Doctors Don’t Tell You guide to the side effects of drugs — a “ready reference guide” to fit into a Filofax [a kind of portable, tree-based information retrieval system — Zeno]

One of the future stories puffed in the sample issue is “New tests for candida sufferers”, together with “Alternative cancer therapies: what’s really working?”, “Why you should think twice about immunizing your child” and “Why to avoid ultrasound tests if you’re pregnant”

The sample [magazine] leads on a report entitled “The breakthrough that backfired” and accuses doctors of over-using antibiotics “once reserved for life-threatening illnesses” because of an “unholy alliance” between doctor and patient that all illnesses can be treated with drugs.

Antibiotics, the article goes on to say, can weaken the immune system, leaving the body open to candida, “gastro-intestinal or hormonal disorders, severe allergies, psoriasis or even multiple schlerosis [sic]

Quackbusting

The article goes on to quote Caroline Richmond, founder of the Council Against Health Fraud (now known as HealthWatch), dismissing the publication as a “scaremongering crusade” and saying “my quackbusting detector is working overtime at the sound of this.”

She also questioned WDDTY’s ‘volunteer advisory panel’ of “top medics”, asking why there were so few real doctors. Blogger Josephine Jones has recently had to ask a very similar question: WDDTY: The Editorial Panel. The answer Josephine gives may not be all that surprising.

McTaggart was asked if she was “worried about protests from the multi-billion pound drug industry which should find the new publication a bitter pill to swallow?”, apparently. Her answer:

My first book was on baby stealing in the United States, attacking six powerful lawyers. They didn’t like what I had written but they had to admit it was fair. Accuracy is a powerful weapon

Has What Doctors Don’t Tell You lived up to this billing? Has it been successful? Have they exposed alternative therapists? Has its attitude to doctors, conventional treatments and evidence changed in the intervening two decades? Have they been a voice in the silence?

I’ll leave that for you to decide.

Out with the old…

When I submitted my complaints about claims made on chiropractic websites in June 2008, a fundamental requirement regulating what chiropractors could claim — firmly embedded in their Code of Practice — was that they only advertise consistent with guidance issued by the Advertising Standards Authority (ASA).

At that time, the General Chiropractic Council‘s Code of Practice that was in effect was the 8 December 2005 version and the relevant clause was C1.6. Let’s put it fully in context:

Chiropractors must justify public trust and confidence by being honest and trustworthy.

C1 Chiropractors must act with integrity and never abuse their professional standing.

Specifically chiropractors:

C1.6 may publicise their practices or permit another person to do so consistent with the law and the guidance issued by the Advertising Standards Authority. If chiropractors, or others on their behalf, do publicise, the information used must be factual and verifiable. The information must not be misleading or inaccurate in any way. It 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. It must not put pressure on people to use chiropractic.29

______________________

29 For example, by arousing ill-founded fear for their future health.

This clearly mandates chiropractors to ensure any advertising complies with ASA guidance, remembering that ASA guidance includes the CAP Code, other guidance and their adjudications.

In prosecuting my complaints, the GCC inexplicably forgot all about the requirement to be consistent with ASA guidance and came up with some arbitrary standard of evidence for compliance. The Professional Conduct Committee begged to differ even with that and effectively allowed any old evidence to be used to substantiate chiropractors’ claims. To understand the whole story, see Humpty Dumpty regulation.

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Pseudo science down on the farm

I liked Yeo Valley yoghurt, particularly their vanilla one. Big pots of the stuff didn’t last long.

They are organic, but this isn’t why I used to buy it. I just liked the rich, creamy taste.

Yes, I used to buy it.

On Twitter yesterday, @GhostOMichael, a follower of @RhysMorgan, tweeted a link to a page on Yeo Valley’s website (cached) that I found worrying: it told how Yeo Valley ‘treat’ their cows with homeopathy. (That page has disappeared and has been replaced with this one. Thanks to Jaxxson for pointing it out.)

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