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Dangerous advice

The Medicines and Healthcare products Regulatory Agency (MHRA) (an executive agency of the Department of Health) states that

“We enhance and safeguard the health of the public by ensuring that medicines and medical devices work, and are acceptably safe.”

They have just utterly betrayed the important job with which they are charged, “ensuring that medicines . . . work”, by allowing homeopathic products to be labelled with indications without requiring any evidence that the claims are true (they aren’t).

The MHRA chief executive, Professor Kent Woods, should be fired immediately for dereliction of the duty of the MHRA to protect the public from medicines that don’t work.

The MHRA was founded in 2003 by merging the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA). The MCA was created by the UK Medicines Act 1968, in the wake of the thalidomide disaster.

he MHRA have, incredibly, made it legal to advertise things like this gem from Nelsons

“Nelsons Coldenza is a homeopathic remedy specifically designed to bring fast, effective relief for the symptoms of cold and flu.”

“Active [sic] ingredients: 6c homeopathic potency of Gelsemium sempervirens.”

“Precautions: Keep out of the reach of children. If symptoms persist or worsen, consult your doctor or homeopath.”

Needless to say there isn’t the slightest reason to think that these sugar pills will influence the course of a cold or flu. Thiis is not “information” for the patient.

It is misinformation.

It is lies, endorsed by the MHRA. Take a look at Ben Goldacre’s comments on this.

Who is responsible for this farce?

MHRA staff are listed here. My latest information suggests, though, that the MHRA were acting under instructions from the Department of Health, and the Executive Board failed to resist bad instructions.

The Executive Board

Professor Kent Woods qualified in medicine from Cambridge in 1972, followed by higher clinical training in Birmingham and epidemiological training at Harvard School of Public Health. In 1984 he was appointed Senior Lecturer in Clinical Pharmacology at Leicester University, where he now holds a personal chair in therapeutics.

As CEO of the MHRA, he must take responsibility

For other members, see here.

The Agency Board

Professor Sir Alasdair Breckenridge , CBE, was most recently Professor of Clinical Pharmacology at the University of Liverpool. He has been Chair of the Committee on Safety of Medicines (CSM) since 1999, a role which he relinquished when he became chair of the MHRA on its creation in April 2003.

Professor Angus Mackay , OBE, is Mental Health Service Director / Consultant Psychiatrist at the Argyll and Bute Hospital.

Michael Fox has been Chief Executive of the Prince of Wales’ Foundation for Integrated Health since 1998.

Shelley Dolan has worked at the Royal Marsden NHS Trust since 1989, now as Nurse Consultant Cancer & Critical Care

Charles Kernahan is Chief executive of the National Kidney Research Fund, the leading organisation supporting research into renal disease in the UK. His career in healthcare products and service provision spans over 25 years, having held the positions of Vice President Marketing EMEA for ConvaTec (a division of Bristol Myers Squibb) and Group Managing Director for Allied Healthcare (UK) Ltd,

Garry Watts is a Chartered Accountant employed as Chief Executive of SSL International plc, an international healthcare company with a turnover of circa £540m,

Lisa Arnold is currently involved on a voluntary basis with RAFT, a medical research charity, both as a Trustee and on a consultancy basis. Prior to that she had more than fourteen years’ experience as a senior pharmaceuticals and healthcare marketing analyst in the investment banking sector,

So the group that is responsible for advising on whether or not medicines work consists of one pharmacologist, one psychiatrist, a representative of an organisation devoted to crackpot medicine, a nurse and three accountants/bankers/marketers with strong industry connections.

Perhaps that accounts for their bizarre decision. One can only assume that the one pharmacologist was outvoted. The MHRA now seems to regard its role as promotion of the “homeopathic industry”

The decision of the MHRA to allow indications to appear on the label of sugar pills was not required by European legislation. It was a decision of the MHRA by itself (or perhaps as a result of pressure from ministers?). Their discussion document says (with my comments)

“The industry as a whole will benefit from the opportunity to gain indications for products for which use within the homeopathic tradition can be demonstrated, but cannot currently carry indications.”

[what part of the MHRA’s brief says that it is their job to promote any industries?]

“Legislation enabling the products to be labelled with indications is also considered to be of significant benefit to patients.

[how does lying to patients benefit them?]”

“Reviewing the PLRs will provide an opportunity to rectify any cases where products are being marketed with inappropriate indications.”

[and who will decide what indications are ‘appropriate’ for pills that contain nothing whatsoever?]

Read the statement at Sense About Science, and sign it!

See more comments

The Times Doctors attack natural remedy claims
By Nigel Hawkes and Mark Henderson. They quote

“Professor Kent Woods, chief executive of the MHRA, said: “This is a significant step forward in the way homoeopathic medicines are regulated. Products will have to comply with recognised standards of quality, safety and patient information.””

Patient misinformation is more like it. There is NO reason to believe the claims that will now appear on labels!

BBC News “Michael Baum, emeritus professor of surgery at University College London said: “This is like licensing a witches’ brew as a medicine so long as the bat wings are sterile.”

Sense about Science quotes comments on the MHRA’s bizarre behaviour. Here are three examples.

Dr Evan Harris MP, Liberal Democrat Science Spokesman, said:
It’s wrong that this country’s medicines regulatory arrangements, which need to be scientific and rigorous, are being diluted and polluted by processes which allow ineffective products to be licensed as medicines without having to provide any scientific evidence of effectiveness. There are very tight standards for proper medicines for very good reasons ”the need to protect vulnerable consumers from exploitation.”

Professor David Colquhoun, Professor of Pharmacology, University College London
“The new government regulations allow claims to be made that sugar pills can treat illnesses when there isn’t a fragment of reason to believe the claims are true. This is simply government-endorsed lying.”

Professor Edzard Ernst, Professor of Complementary Medicine, University of Exeter
“This makes a mockery out of evidence-based medicine.”

The Department of Health seems to be responsible

On 1 October 2006 I had a reply from the MHRA (from Sue Harris, Assessment Team Manager, Licensing Division), in response to my question about how the decision was made.

“The decision to implement the National Rules Scheme was agreed by the Executive Board in response to the ministerial request and not by the Agency Board as the Agency Board does not have executive responsibility. The Chair and non-executive board members were not involved in the decision making process and the final decision was taken by the Minister.”

This certainly suggests that the MHRA made their bizarre decision on instructions from above (not, perhaps, surprising in view of the Minister of State’s views). It does not explain why the MHRA knuckled under and implemented a policy that is in direct contradiction to their mission.

“Drug regulators too seem unequal to their task.”

That was the opinion offered by the editor of the BMJ, Fiona Godlee, in editorial comment on an problems with suicide by patients on antideoressants, e.g that by David Healy. She wrote

“Drug regulators too seem unequal to their task. Critics focus on their close relationship with industry; their lack of transparency; and an emphasis on efficacy over patient safety, which favours industry”

Which? magazine (October 2006, pages 24-25) published an article, Drugs watchdog fails public, and quotes the MHRA as responding thus.

“our role is not to protect industry interests. We have a responsibility to ensure that regulation is designed to enable rather than hinder the development of new products that would improve health.”

Quite right too. But this claim stands in stark contrast with the MHRA’s “Explanatory Memornadum“, which says this (my emphasis).

“Although the development of national rules by Member States under Directive 2001/83/EC is optional, failing to introduce the scheme would inhibit the expansion of the homeopathic ndustry by the prevention of the development of new products with indications.”

The Australasian Society of Clinical Immunology and Allergy (ACAI) has issued a superbly reasoned analysis of about 30 allergy-related tests and treatments that “have been promoted in the absence of any scientific rationale.” [Mullins RJ. Unorthodox techniques for the diagnosis and treatment of allergy, asthma and immune disorders.

ASCIA Position Statement, Oct 2004

Among the many things they find to be useless of dangerous are

Diagnosis.

Cytotoxic testing (Bryans’ test),
Oral provocation and neutralisation,
Vega testing (electrodermal testing),
Kinesiology,
Radionics (psionic medicine, dowsing)
Iridology,
Tests for “dysbiosis”,

Treatment.
Homoeopathy,
Acupuncture,
Reflexology (zone therapy),
Autogenous urine therapy,
Physical Therapies: Chiropractic therapy, Osteopathy, Cranial therapy
Allergy elimination techniques (also known as “Advanced Allergy Elimination”, “Nambudripad’s Allergy Elimination”),
Vega MRT (Matrix Regeneration Therapy),
Clinical Ecology/ Environmental Illness

Among the many scams that are discussed is the infamous Vega test (as used in George Lewith’s private clinic).  The conclude “Results are not reproducible in blinded studies, and do not correlate with results from conventional testing.”  And " substitution of homeopathic ‘vaccines’ for those with proven effectiveness has both individual and public health implications. "

The US National Center for Complementary and Alternative Medicine (NCCAM) has had $842 million of taxpayers’ money and has wasted most of it.

Why the National Center for Complementary and Alternative Medicine (NCCAM) Should Be Defunded

This article by Wallace I. Sampson, M.D. describes clearly what is wrong with NCCAM. This organisation had government funding of $122.7 million in 2006. Since its foundation (as the Office of Alternative Medicine), it has received not much short of a billion dollars ($842 m). What has the US taxpayer had for this money?

“. . it has not proved effectiveness for any “alternative” method. It has added evidence of ineffectiveness of some methods that we knew did not work before NCCAM was formed. NCCAM proposals for 2002 and 2003 promise no
more. Its major accomplishment has been to ensure the positions of medical school faculty who might become otherwise employed –in more productive pursuits.”

“NCCAM is ridden with potential and actual conflicts of interest. Ten individuals account for 20% of NCCAM awards. None of them has produced a definitively positive or negative report. Most recipients have produced no report at all. Two individuals originally on the Advisory Council that approves NCCAM policy were awarded over $4 million and $5 million in repeated awards. ”

“NCCAM recently awarded $15 million to nine medical schools to develop teaching of these subjects—all by advocates of “CAM.” It gave no funds to the five medical school courses with curricula already developed that teach about the subject rationally. In other words, NCCAM’s research agenda fits its congressional supporters’ ideological vision and finds unproductive ways to use up its ballooning appropriations. ”

“NCCAM could be dissolved, its functions returned to other NIH centers, with no loss of knowledge, and an economic gain. Funds could be invested into studies of how such misadventures into “alternative” medicine can be avoided, and on studying the warping of human perceptions and beliefs that led to the present situation. ”

Unbelievably, this prime piece of postmodernist bollocks is even worse than Barry’s paper!

Download  the full paper here (if you can bear it). Dave Holmes RN PhD, Stuart J Murray PhD, Amelie Perron RN PhD(cand) and Genevieve Rail PhD, Int J Evid Based Health 2006; 4: 180, 186.

The authors of this paper are from Department of English, Ryerson University Toronto, Ontario, Canada, and Faculty of Health Sciences, School of Nursing, University of Ottawa, Ottawa. Ryerson University is an ex-polytechnic which became a university in 1971. It runs courses in Traditional Chinese Medicine (but, at least, no homeopathy). In Canada, as here, it seems that such institutions are the first to damage their new reputations by encouraging gobbledygook like this.
Stuart J. Murray lists his interests as “phenomenology, Foucault, bioethics, biopolitics, and psychoanalysis. Currently researching a project on posthuman “life” in digital and mediatized contexts.” In his contribution to the McLuhan International Festival of the Future he says (apropos of McLuhan) “We will be frustrated if we look here for a firm, communicable content.”   Well that’s very true.

Abstract

Background Drawing on the work of the late French philosophers Deleuze and Guattari, the objective of this paper is to demonstrate that the evidence-based movement in the health sciences is outrageously exclusionary and dangerously normative with regards to scientific knowledge. As such, we assert that the evidence-based movement in health sciences constitutes a good example of microfascism at play in the contemporary scientific
arena.

Objective The philosophical work of Deleuze and Guattari proves to be useful in showing
how health sciences are colonised (territorialised) by an all-encompassing scientific research paradigm “that of post-positivism ” but also and foremost in showing the process by which a dominant ideology comes to exclude alternative forms of knowledge, therefore acting as a fascist structure.

Conclusion The Cochrane Group, among others, has created a hierarchy that has been endorsed by many academic institutions, and that serves to (re)produce the exclusion of
certain forms of research. Because ‘regimes of truth’ such as the evidence-based movement
currently enjoy a privileged status, scholars have not only a scientific duty, but also an
ethical obligation to deconstruct these regimes of power.

. . .
Unfortunately, the nature of this scientific fascism makes it attractive to all of us the subjected. In Foucault’s words: the major enemy, the strategic adversary is fascism. . . . And not only historical fascism, the fascism of Hitler and Mussolini which was able to mobilize and use the desire of the masses so effectively but also the fascism in us all, in our heads and in our everyday behavior, the fascism that causes us to love power, to desire the very thing that dominates and exploits us. (p. xiii) Fascism does not originate solely from the outside; it is a will within us to desire, although often unwittingly, a life of domination. Such a “lovable” fascism requires little more than the promise of success (grants, publications, awards, recognition, etc.) within its system to get us to participate wholeheartedly. Perhaps it is time to think about governing structures that impose their imperatives (academic, scientific, political, economic) on academics and researchers, and
to ask ourselves what drives us to love fascist and exclusionary structures.

The Cochrane Group has created a hierarchy that has been endorsed by many academic institutions, and that serves to (re)produce the exclusion of certain forms of knowledge production. Because EBM, as a “regime of truth”, currently enjoys a privileged status, there exists a scientific and ethical obligation to deconstruct such regime. Given the privileged relation to knowledge defining the intellectual mission, intellectuals are well located to deconstruct the ‘truth’ and to ‘speak truth to power’, to use Foucault’s expression. Unfortunately, most would prefer not to hear alternative, marginalised discourses because the latter tend to expose the very power relations that create our current situation and prop up those academics/scientists with a vested interest in the status quo. However, we believe that one of the roles of the intellectual is to decolonise, to deterritorialise the vast field of health sciences as it is currently mapped out by the EBM.

.
.
Final remarks

Critical intellectuals should work towards the creation of a space of freedom (of thought), and as such, they constitute a concrete threat to the current scientific order in EBHS and
the health sciences as a whole. It is fair to assert that the critical intellectuals are at ‘war’ with those who have no regards other than for an evidence-based logic. The war metaphor speaks to the ‘critical and theoretical revolt’ that is needed to disrupt and resist the fascist order of scientific knowledge development.

Raymond Tallis, in his review of Intellectual Impostures, said

“The profound significance of S & B’s [Sokal and Bricmont’s] wonderfully written, deeply passionate and authentically erudite book, is that, by shining real light on the fake jewellery of the leading postmodernist theorists, it has shown what has happened to academic humanities over the last thirty years under the influence of individuals like Kristeva for whom intellectual legerdemain has become a way of life.”

“Academics intending to continue as postmodern theorists in the interdisciplinary humanities after S&B should first read Intellectual Impostures and ask themselves whether adding to the quantity of confusion and untruth in the world is a good use of the gift of life or an ethical way to earn a living. After S & B, they may feel less comfortable with the glamorous life that can be forged in the wake of the founding charlatans of postmodern Theory. Alternatively, they might follow my friend Roger into estate agency — though they should check out in advance that they are up to the moral rigours of such a profession.”

And it seems that some people still haven’t noticed. But then the abuse of scientific language by people who don’t understand it (or whose intent is to deceive) has been the mainstay of quackery for several hundred years. Plus ca change.


What can one say in the face of such gross betrayal of everything we have learned since the enlightenment? I suppose one simple explanation that its paranoid style, and its imagined conspiracies are all a manifestation of a giant chip on the shoulder from people who feel that their genius has not been recognised appropriately by those who fund research. But that is a matter for psychiatrists, not me.

Ben Goldacre, who first drew my attention to this paper, comments on his Badscience site,and has now written about it in his regular column in the Guardian.

“Even from looking at the title, you just know this academic paper from the September edition of the International Journal of Evidence-based Healthcare is going to be an absolute corker. And it uses the word “fascist” (or elaborate derivatives) 28 times in six pages, . . .”

The Independent has a good medical column br Dr Fred Kavalier. The column has an insert for readers’ letters. On 1st August 2006 the ‘readers write’ section had this letter “I know homeopathy has taken a bit of a bashing recently but homeopathic remedies for travel sickness have a long and excellent reputation for working. The most important ones are cocculus, petroleum and tabacum.”.
Dr Kavalier was appropriately apologetic about this, and published my response on 15th August.

Readers write

DC, a scientist from London, replies to last week’s homeopath:
“The homeopath from Devon commented last week that ‘homeopathy has taken a bit of a bashing recently’. So it should. Selling pills that contain nothing whatsoever but sugar as medicines isn’t just delusional, it’s fraud. One of the recommendations for travel sickness was for cocculus. That is a plant that contains the poisonous alkaloid, picrotoxin. Luckily, the label on the bottle is untrue and the pills contain none. Travel sickness is known to be influenced by expectations. That makes it a good candidate for placebo effects. And also good for the income of charlatans.”

The question of where delusion ends and fraud begins is an interesting one. A book by Robert Park of the American Physical Society discusses the question particularly well.

Voodoo Science: the road from foolishness to fraud (Oxford
University Press) is an excellent read. [Amazon].

Robert Park deals with everything from perpetual motion macines to homeopathy. His thesis is that those who propagate these ideas often start with a genuine belief that what they say is true. Rejection of the ideas by sensible people just makes them more determined. Eventually, though, it probably dawns on many of them that they have made a terrible mistake. At this point, some recant, but more often they have so much reputation to defend, and frequently too much income to protect, that they will continue to propagate their ideas even after they have realised that they are wrong.

That is when foolishness becomes fraud.  I have often wondered how many middle-aged homeopaths still really believe their own nonsense?

“Alas, to wear the mantle of Galileo it is not enough that you be persecuted by an unkind establishment; you must also be right.” (Robert Park)

The Institute of Science in Society purports to be about promoting a socially responsible approach to science. It combines some reasonable stuff about global warming with a lot of utter rubbish about homeopathy (mainly written by the Institute’s director, Dr Mae-Wan Ho).

(This item has been transferred from the old IMPROBABLE SCIENCE page.)

I just stumbled across this organisation. At first sight, its theme of “science, society and sustainability” sounded right up my street. It seems to be predominantly an anti-GM, pro-organic farming, organisation. Although some of their contributors seem to be somewhat paranoid, there is much that I can agree with in what they say about that.

But they completely ruin their case by including quite barmy homilies about homeopathy (and here), water structure and traditional chinese medicine. There is also an amazing piece of sheer pseudo-scientific nonsense, “Homeopathic Medicine is Nanopharmacology” by Dana Ullman (though elsewhere on the site, nanotechnology gets a bad press).

Most of the nutty content seems to be written by the director of the Institute herself. Dr Mae-Wan Ho, who is listed as “Reader in Biology at the Open University” (that’s odd -no trace of her on the Open University web site). In fact some doubts have been cast on her biography. Wikipedia says “She is former head of the Bio-Electrodynamics laboratory at the Open University in Milton Keynes after either having been fired for incompetence or resigning because of personal reasons.” Whatever the truth in that may be, she clearly doesn’t understand homeopathy.

The board of directors of the Institute includes Zac Goldsmith (editor of The Ecologist) and it is advised by some apparently respectable scientists.

It is sad that an organisation with a respectable sounding title like the Institute of Science in Society is being used to propagate some pure pseudo-scientific gobblydegook. Is it any wonder that journalists and the general public get confused?

The Newsnight TV programme did an undercover investigation. Ten out of ten homeopaths, including two big companies Nelsons and Helios, told patients that malaria could be prevented by homeopathic pills alone. So much for the idea that homeopathy is harmless.

It is often said that, although homeopathy does no good,at least it does no harm. But that is not true if using homeopathy delays diagnosis of serious disease like cancer. It is not true if homeopaths persuade you not to be vaccinated, and as a consequence you get smallpox, mumps, measles, and spread them in the community. And it is not true if you listen to the ill-informed advice that is given by many homeopaths about how to avoid malaria when you visit countries where it is common.

The Newsnight programme on BBC2 TV (13th July 2006) did a marvelous bit of secret filming.

“Newsnight followed up their research with a hidden camera. A researcher went to Nelsons Pharmacy off Oxford Street in London, which claims to be Britain’s biggest manufacturer of homeopathic remedies – and that was all they recommended for malaria.

Even when the researcher said she planned to go to Malawi – a high risk area – Nelsons only suggested the addition of garlic, oil of citronella and vitamins rather than a trip to the doctors.

The Nelsons adviser told the researcher that the homeopathic compounds would protect her. “They make it so your energy doesn’t have a malaria-shaped hole in it so the malarial mosquitos won’t come along and fill that in.”

This last bit of advice means nothing whatsoever. It is sheer gobblydegook. It would just be silly if its effects were not so potentially serious.

On the programme, Melanie Oxley, from the Society of Homeopaths, wriggled uncomfortably when faced with the evidence (and Simon Singh). She protested that members of her organisation do not advise against proper malaria prevention, or against vaccination (and here). Well, they DO. So much for “professional regulation”. You cannot regulate the delusional. and the attempts of organisations like Oxley’s clearly don’t work. Apart from their inability to stop their members giving lethal advice, the regulators themselves are deluded.

Peter Fisher (see here and here), from the Royal London Homeopathic Hospital (and here) said “I’m very angry about it because people are going to get malaria – there is absolutely no reason to think that homeopathy works to prevent malaria and you won’t find that in any textbook or journal of homeopathy so people will get malaria, people may even die of malaria if they follow this advice.” The Queen’s homeopathic physician has the sense to acknowledge that homeopathy does not work for serious conditions, yet persists in his delusion that it works for milder illnesses.

What the homeopaths recommended

Malaria nosodes 30C
The source material is so diluted that not a single molecule is left. The medicines therefore contain no medicine. They are nothing but sugar pills. To sell pills that contain nothing whatsoever and to pretend that they will protect you against malaria strikes me as nothing short of criminal. In the EU in 2000, 15 528 cases of malaria were reported to the World Health Organization in returning travellers. The source material is, incidentally, not stated. One source says it is made from “African swamp water containing impurities, algae and plants as well as mosquito slough, larvae and eggs.” Luckily there is none of it left in the pill you get.

China
China Off is made from Cinchona bark which should contain quinine (how much is not stated. China Sulph is made from quinine itself (presumably purified, it is not stated). Quinine in large (potentially toxic) doses can cure malaria but is not a recommended treatment. But these preparations contain only minute amounts of quinine that cannot possibly have any effect at all. There is not the slightest reason to think that these pills could protect you against malaria, and to recommend them for that purpose is no more than fraud. The only recommended use for quinine is for treatment iof malaria in pregnant women. The dose is 600 mg, three times a day. because of the inadequate labelling it is impossible to know exactly how much quinine is present in China Sulph 8X,, but it is probably about 100 millionth of the recommended dose.(less than 1 nanogram)

The consequences.
“The fourth case was a 26-year-old man who visited Ghana and Burkina Faso in October and November 1994. He used China D-6 for prophylaxis. This is a homeopathic preparation of the bark from the cinchona tree. Not even trace amounts of quinine were found in the tablets with a very sensitive high-performance liquid chromatographic method.2 Four days after returning from Africa he fell ill with P. falciparum malaria ” (Quotation from Carlsson et al. J Travel Med. 1996 Mar 1;3(1):62. (PMID: 9815426)
In another case of a patient who resorted to homeopathy “for two months she received intensive care for multiple organ system failure due to P falciparum .This case confirms the inefficacy of homoeopathic drugs for malaria prevention and treatment. ”

Natrum Mur.
Natrum Muriaticum is sodium chloride. Just common salt (except that it is so dilute that there is little or no salt there). If you believe this will prevent malaria, you will truly believe anything. Yet it is being recommended and sold.

What the papers say about it

“Malaria risk for tourists who trust alternative practitioners”. A long report by Mark Henderson, in The Times.

“Homoeopathy: voodoo on the NHS” by Jamie White in The Times on the next day (July 15th)

“It is outrageous that the NHS should knowingly promote this quackery. And it is knowing. The NHS Direct website points out that homoeopathy is contrary to everything we know about chemistry and medicine, and that there is no experimental evidence to support its preposterous claims. Yet the NHS still promotes it, because “despite the lack of clinical evidence, homoeopathy remains one of the most popular complementary therapies in the UK”.”

“Homeopaths ‘endangering lives’ by offering malaria remedies” in The Guardian

“Do not rely on homeopathy to protect against malaria, doctors warn”. Excellent health advice (for a change) in the Daily Mail. They quote Dr Evan Harris (Lib Dem) of the all-party parliamentary malaria group, as saying

“This sort of outrageous quackery is unacceptable. Vulnerable people are being duped into handing over cash for useless remedies and are having their health put at risk through grossly inadequate advice. People need to consider homeopathy in the same way as the treat faith-healing and witchcraft – that is not to risk their life or health on it.”

Talk show interview, DC with Tania Shillam on Colourful Radio (“Colourful is a new national digital Talk, cross-cultural radio station. Launched on 30 May 2006, the station’s format is a rich mix of news, current affairs and journalism, agenda-setting coverage, short documentaries, drama, panel discussions, phone-ins and a liberal sprinkling of music”). Listen to it.

Originaly posted on the oldl IMPROBABLE SCIENCE page.

George Lewith, who is an advocate of CAM research, appears to have rather different standards in his private clinic.

Some interesting emails have come into my possession recently. They concern the Centre for Complementary and Integrated Medicine, which gives its address as Harley House, Brunswick Place (Formerly Upper Harley St.), London NW1 4PR (don’t you just love “formerly Upper Harley Street”?).

This centre lists its doctors as Dr Nick Avery, Dr Mike Clark and Professor George Lewith.

Their web site claims “There are several approaches that we use in complementary medicine that may be of help to people with fibromyalgia. There is at least one positive clinical trial that indicates that homeopathy can help this condition.”

An enquiry was sent to the clinic, as follows.

My GP diagnosed my pain as fibromyalgia almost 2 years ago, but I have not had much relief from the treatment I’ve had so far. I have never tried alternative treatments, but I have looked at your web site and I see that you say “There is at least one positive clinical trial that indicates that homeopathy can help this condition”.

I wonder if you could give me some more details about that before I commit myself to trying it?

After some delay, a polite response came from Dr Avery.

We treat an enormous number of patients with fibromyalgia and there are many things that can help. In practise [sic] we tend to use combinations of diet, nutrition, homeopathy and acupuncture.In my experience fibromyalgia patients are almost all suffering from magnesium deficiency which, once corrected, can have an enormous impact on symptoms. If this is not corrected, then conventional treatment cannot help.

Homeopathy seems to be a fundamental part of treating the (whole person) and it is the combination that seems to be so helpful.If you would like to come and see me then please ring my receptionists

But no mention there of a trial. A second enquiry gave a fascinating
result.

I am forwarding you the information you requested about the clinical trial for homeopathy used in helping with Fibromyalgia. I will pass Dr. Lewith’s reply to Dr. Avery who will be able to write to you with more detail when he’s at the clinic this Thursday.

Best wishes

Catherine (Reception)


—– Original Message —–

From: “Lewith G.” < gl3@soton.ac.uk>

To: “CCIM” < harley@complemed.co.uk >; < nickavery@tiscali.co.uk>

Sent: Friday, May 26, 2006 10:50 PM

Subject: RE: Message from Dr Avery

Its a BMJ paper in the late 1980’s by Peter Fisher. He used Rhus Tox 6C and it was a small positive trial.He will have it.

G

This paper must be the one that I was asked to check by the producer of a television programme (QED), (Fisher, P., Greenwood, A., Huskisson, E. C., Turner, P., & Belon, P. (1989). Effect of homoeopathic treatment on fibrositis (primary fibromyalgia) British Medical Journal 299, 365-366.).

But surely some mistake here? The problems with this paper have already been here. Fisher et al. had made a naive mistake in their statistical analysis, and in fact the homeopathic treatment had no demonstrable effect whatsoever, a result that was published soon after in the Lancet: Colquhoun, D. (1990), Reanalysis of a clinical trial of a homoeopathic treatment of fibrositis. Lancet 336, 441-442.). [Get the pdf]

So why does Professor Lewith cite the Fisher paper without mentioning that it provides no evidence at all? Professor Lewith says that he was unaware of this history. That does seem odd for someone who is devoted to assessment of CAM (all you have to do is search for ‘fibromyalgia and homeopathy’ in Medline). Very baffling.

Despite these puzzles, when I showed a draft for this site to Prof Lewith he said “Nick [Avery] and I have thought very carefully about the responses and we are very happy with them”.

There are now more papers on the treatment of fibromyalgia, as Prof Lewith has pointed out to me. They are all from the University of Arizona, and all appear to refer to the same set of patients. One of these suggests that homeopathic treatment is effective (Bell IR; Lewis DA; Brooks AJ; Schwartz GE; Lewis SE; Walsh BT; Baldwin CM, Improved clinical status in fibromyalgia patients treated with individualized homeopathic remedies versus placebo. Rheumatology. 2004; 43: 77-582).

But a second paper about the same patients seems much less sure. The trial was organised as an ‘optional crossover trial’, and there was no significant difference between the proportion of patients who opted to swap treatments between those who were initially on placebo and those who were initially on homeopathy. Evidently they couldn’t tell the difference! (Bell et al., 2004, J. Alt Comp Med, 10, 269 383).


Both of these papers, incidentally, have as a co-author the famous (or perhaps infamous) Gary Schwartz, of the “Centre for Frontier Medicine in Biofield Science”, which is, believe it or not, part of the University of Arizona, and which, even more incredibly, gets NIH funding. He “photographs” non-existent “energy fields” and claims to be able to communicate with the dead (critique here).Well I guess the immortality is an even better seller than homeopathy. The picture on the right is what the “Biofield science” centre uses on its web site.

The AMI test and the Vega test

Dr Avery also sent “our information leaflet on Fibromyalgia”. This document was rather interesting.

We find that a lot of patients with this condition suffer from food intolerance, which can be identified and treated. . . .Other measurements using the “AMI” which measures imbalances in the body can also indicate the whereabouts of the most significant internal dysfunction.Dietary and nutritional approaches can be enhanced by using acupuncture, classical and, in particular, complex homeopathy. Remedies can be identified using the Vega test, which measures energetic imbalances in the body, helping the practitioner to target the most appropriate areas in each individual patient.




The Vega test and the AMI machine

What are these tests? The Vega test is one of the older con tricks. Dr Avery seems to be misinformed. The Vega test does not measure “energetic imbalances” (whatever that means), it measures skin conductance. So it resembles the infamous lie detector (perhaps it should be tried on its advocates). It has been the subject of several legal actions (listed here, by the Quackwatch site). Here are three of many examples.

  • In 1985, the FDA notified a distributor that Vegatest devices could not be marketed as a medical devices without FDA approval (which they do not have).
  • In 1990, the New Zealand Medical Journal described how a homeopathic physician had used a Vega device to diagnose allergies in three infants. In each case, the device was applied to the mother with the child on the mother’s lap or roaming about the examining room. The doctor also diagnosed “miasms,” which, if not removed, would prove fatal later in life. The Medical Practitioners Disciplinary Committee ordered that he be censured, pay a penalty of NZ$900 plus NZ$25,000 for costs and expenses, and follow certain standards of care for three years
  • In 2002, the British Advertising Standards Agency concluded that a leaflet offering Vega testing as a “complete test for hidden problems” was misleading and advised the advertiser to withdraw it .

In 2003, the BBC did its own investigation.

“We sent Inside Out’s Chris Packham to three Holland and Barrett stores across the South to find out more.

Chris took the Vega test in Newbury, Chichester and Farnborough, only to discover that his allergy results differed from store to store.

In total, Chris was sensitive to over 33 different foods, including staples like wheat, potatoes, milk, tomatoes, tea and coffee. But out of the 33 products, there was only two that all three testers agreed on – cheese and chocolate.

Chris was also advised by Holland and Barrett staff to take a total of 20 different vitamins and minerals. But again, the testers can’t seem to agree and all three testers advised different supplements.

It seems your allergies may not be determined by food alone, but also your location.

Professor Lewith told me, when I asked about the Vega test,

“I use it to help with homeopathic diagnoses, your next question of course is why on earth would you want to make an irrational diagnosis about a completely irrational subject.”

Yes, indeed it is! But that question has not been answered.

To make matters still odder, Professor Lewith has himself published a paper showing that the Vega test does not work. Why, then, does he use it in his private clinic? The paper in question is in British Medical Journal, 2001;322:131-4. It concludes “Electrodermal testing cannot be used to diagnose environmental allergies.”
Despite his own conclusion in the BMJ, the homeopathy page of the Rosedale Clinic concludes

The Vega offers one of the most exciting advances in modern medicine to appear in recent years, an accurate method of non-invasive deep physiological investigation

I would like to dedicate this section to Dr’s LEWITH, KENYON and SCHIMMEL for their tuition and helpful guidance with the Vega technique.

Wow!

The AMI machine is much less well-known. It presumably refers to “Apparatus for Measuring the Functions Of the Meridians and Corresponding Internal Organ”. Again it is said the the mysterious and undefined “imbalances”. The most likely interpretation seems to be that it just another galvanometer.

For a sane description of bizarre ‘allergy tests’, look here.

This letter was sent to the chief executives of 476 NHS Trusts (acute and primary care trusts). It was the main headline in The Times, and the lead item on the BBC’s Today Programme.

From Professor Michael Baum and others 19th May 2006


Dear

Re Use of ‘alternative’ medicine in the NHS


We are a group of physicians and scientists who are concerned about ways in which nproven or disproved treatments are being encouraged for general use in the NHS. We would ask you to review practices in your own trust, and to join us in representing our concerns to the Department of Health because we want patients to benefit from the best treatments available.


There are two particular developments to which we would like to draw your attention. First, there is now overt promotion of homeopathy in parts of the NHS (including the NHS Direct website). It is an implausible treatment for which over a dozen systematic reviews have failed to produce convincing evidence of effectiveness. Despite this, a recently-published patient guide, promoting use of homeopathy without making the lack of proven efficacy clear to patients, is being made available through government funding. Further suggestions about benefits of homeopathy in the treatment of asthma have been made in the ‘Smallwood Report’ and in another publication by the Department of Health designed to give primary care groups “a basic source of reference on complementary and alternative therapies.” A Cochrane review of all relevant studies, however, failed to confirm any benefits for asthma treatment.


Secondly, as you may know, there has been a concerted campaign to promote complementary and alternative medicine as a component of healthcare provision. Treatments covered by this definition include some which have not been tested as pharmaceutical products, but which are known to cause adverse effects, and others that have no demonstrable benefits. While medical practice must remain open to new discoveries for which there is convincing evidence, including any branded as ‘alternative’, it would be highly irresponsible to embrace any medicine as though it were a matter of principle.


At a time when the NHS is under intense pressure, patients, the public and the NHS are best served by using the available funds for treatments that are based on solid evidence. Furthermore, as someone in a position of accountability for resource distribution, you will be familiar with just how publicly emotive the decisions concerning which therapies to provide under the NHS can be; our ability to explain and justify to patients the selection of treatments, and to account for expenditure on them more widely, is compromised if we abandon our reference to evidence. We are sensitive to the needs of patients for complementary care to enhance well-being and for spiritual support to deal with the fear of death at a time of critical illness, all of which can be supported through services already available within the NHS without resorting to false claims.


These are not trivial matters. We urge you to take an early opportunity to review practice in your own trust with a view to ensuring that patients do not receive misleading information about the effectiveness of alternative medicines. We would also ask you to write to the Department of Health requesting evidence-based information for trusts and for patients with respect to alternative medicine.


Yours sincerely


Text Box: Professor Michael Baum   Emeritus Professor of Surgery, University College London  and Professor Frances Ashcroft FRS
University Laboratory of Physiology, Oxford

Professor Sir Colin Berry
Emeritus Professor of Pathology, Queen Mary, London

Professor Gustav Born FRS
Emeritus Professor of Pharmacology, Kings College London

Professor Sir James Black FRS
Kings College London

Professor David Colquhoun FRS
University College London

Professor Peter Dawson
Clinical Director of Imaging, University College London

Professor Edzard Ernst
Peninsula Medical School , Exeter

Professor John Garrow
Emeritus Professor of Human Nutrition, London

Professor Sir Keith Peters FRS
President, The Academy of Medical Sciences

Mr Leslie Rose
Consultant Clinical Scientist

Professor Raymond Tallis
Emeritus Professor of Geriatric Medicine, University of Manchester

Professor Lewis Wolpert CBE FRS
University College London


As soon as this appeared the phone started ringing.

Michael Baum did an excellent job on the Today Programme, and on BBC Birmingham, BBC55, BBC world service, ITN news (interviewed for 20 minutes outdoor in the rain), Sky News live, and as well as all that he saw patients, and missed lunch while in the operating theatre. Michael comments ” How was your day your Royal Highness? “.


Leslie Rose did BBC Breakfast TV interview and various radio stations.


I did interviews for BBC News24, BBC1 News, Chanel 5 News, Sky news, the Jeremy Vine Show (radio 2), BBC Radio Solent, and wrote something for the Scotsman. Today it’s Radio London at 10.35 pm and tomorrow, Radio Foyle (Derry).

Listen to the Today Programme 08.10 interview


John Humphrys, on the Today Programme, interviews Michael Baum (lead signatory on the letter), and Peter Fisher of the Royal London Homeopathic Hospital (For more on Peter Fisher, see here, and here, and here). Listen to the interview [mp3 file, 4.4 Mb]

Leslie Rose interviewed on BBC
Breakfast
TV. Watch the interview (Realplayer file).

Interview for Sky News.

The Jeremy Vine show interview (Radio 2)

The Late Show on BBC Radio London (24 May), host Stephen
Rhodes, DC versus Gary Trainer: click to listen

Radio Foyle (N. Irelend) Talk show with Mark Patterson. The local health
food shop manager told me that ‘arthritis is a build up of toxins in the body’,
and that glucosamine and chondroitin are herbal! Click to listen


Michael Baum’s 2004 Open letter. “An open letter to the Prince of Wales: with respect, your highness, you’ve got it wrong”. Download pdf file.

Coverage in The Times, 23 May 2006. The front page headline.

New International has forced me to remove the pictures of the front page, but the front page headline was

NHS told to abandon alternative medicine

Top doctors say money should go to conventional treatment

Here is Mark Henderson’s article.

NHS told to abandon alternative medicine

By Mark Henderson, Science Editor

Top doctors say money should go to conventional treatment

A GROUP of Britain’s leading doctors has urged every NHS trust to stop paying for alternative medicine and to use the money for conventional treatments.

Their appeal is a direct challenge to the Prince of Wales’s outspoken campaign to widen access to complementary therapies.

Public funding of “unproven or disproved treatments” such as homoeopathy and reflexology, which are promoted by the Prince, is unacceptable while huge NHS deficits are forcing trusts to sack nurses and limit access to life-saving drugs, the doctors say.

The 13 scientists, who include some of the most eminent names in British medicine, have written to the chief executives of all 476 acute and primary care trusts to demand that only evidence-based therapies are provided free to patients.

Their letter, seen by The Times, has been sent as the Prince today steps up his crusade for increased provision of alternative treatments with a controversial speech to the World Health Organisation assembly in Geneva.

The Prince, who was yesterday given a lesson in crystal therapy while touring a complementary health unit in Merthyr Tydfil, will ask the WHO to embrace alternative therapies in the fight against serious disease. His views have outraged clinicians and researchers, who claim that many of the therapies that he advocates have been shown to be ineffective in trials or have never been properly tested.

The letter criticises two of his flagship initiatives on complementary medicine: a government-funded patient guide prepared by his Foundation for Integrated Medicine, and the Smallwood report last year, which he commissioned to make a financial case for increasing NHS provision.

Both documents, it is claimed, give misleading information about scientific support for therapies such as homoeo-pathy, described as “an implausible treatment for which over a dozen systematic reviews have failed to produce convincing evidence of effectiveness”.

The letter’s signatories include Sir James Black, who won the Nobel Prize for Medicine in 1988, and Sir Keith Peters, president of the Academy of Medical Science, which represents Britain’s leading clinical researchers.

It was organised by Michael Baum, Emeritus Professor of Surgery at University College London, and other supporters include six Fellows of the Royal Society, Britain’s national academy of science, and Professor Edzard Ernst, of the Peninsula Medical School in Exeter, who holds the UK’s first chair in complementary medicine.

The doctors ask trust chief executives to review their policies so that patients are given accurate information, and not to waste scarce resources on therapies that have not been shown to work by rigorous clinical trials.

They conclude: “At a time when the NHS is under intense pressure, patients, the public and the NHS are best served by using the available funds for treatments that are based on solid evidence.”

Professor Baum, a cancer specialist, said that he had organised the letter because of his “utter despair” at growing NHS acceptance of alternative treatments while drugs of proven effectiveness are being withheld. “At a time when we are struggling to gain access for our patients to Herceptin, which is absolutely proven to extend survival in breast cancer, I find it appalling that the NHS should be funding a therapy like homoeopathy that is utterly bogus,” he said.

He said that he was happy for the NHS to offer the treatments once research has proven them effective, such as acupuncture for pain relief, but that very few had reached the required standards.

“If people want to spend their own money on it, fine, but it shouldn’t be NHS money.”

The Department of Health does not keep figures on the total NHS spending on alternative medicine, but Britain’s total market is estimated at £1.6 billion.

There’s no remedy for the Prince of Quacks

This is the title of a piece by Francis Wheen in the London Evening Standard, 16 May 2006. Francis Wheen is the author of the Top ten delusions.

“Prince Charles travels to Geneva next week to deliver the keynote speech at the annual assembly of the World Health Organisation. Some mistake, surely?”

“The WHO describes Charles as the president of the Prince’s Foundation for Integrated Health and “patron of a number of health charities”. It omits to add that his views on medicine are barmy – and pernicious. ”

“WHO delegates from 192 nations have plenty to discuss during their five-day meeting – HIV/Aids, sickle-cell anaemia, preparations for a flu pandemic, the eradication of polio and smallpox. Why waste precious time listening to the heir to the British throne, who has spent more than 20 years displaying his ignorance of medical science?”

“The prince has never met a snake oil vendor he didn’t like. A couple of years ago he urged doctors to prescribe coffee enemas to cancer patients, a suggestion which provoked this rebuke from Professor Michael Baum of University College London: “The power of my authority comes with a knowledge built on 40 years of study and 25 years of active involvement in cancer research. Your power and authority rest on an accident of birth.” ”

The Prince’s Foundation for Integrated Health publishes Complementary healthcare: a guide for patients which is full of wishful thinking. For example, it tells the unfortunate patient that

“Homeopathy is most often used to treat chronic conditions such as asthma; eczema; arthritis; fatigue disorders like ME; headache and migraine; menstrual and menopausal problems; irritable bowel syndrome; Crohn’s disease; allergies; repeated ear, nose, throat and chest infections or urine infections; depression and anxiety.”

but says nothing at all about whether or not they work. That is just irresponsible.  And to describe pills that contain no trace of the substance on the label as ”very diluted” is plain dishonest .

This item was transferred from the old IMPROBABLE SCIENCE page.