Download Lectures on Biostatistics (1971). Corrected and searchable version of Google books edition
Download review of Lectures on Biostatistics (THES, 1973).
David Colquhoun
The MHRA’s new policy towards CAM has already received a well-deserved drubbing in the House of Lords. Now have the first example of the MHRA allowing totally misleading labels to be put on over-the-counter treatements.
A press release dated November 8th 2006 gives the shocking news.
MHRA grants landmark registration for Traditional Herbal MedicineThe Medicines and Healthcare products Regulatory Agency (MHRA) has granted the first UK product registration under the European Directive on traditional herbal medicinal products. . Professor Kent Woods, Chief Executive of the MHRA said:“This first product registration is an important landmark. We hope that Atrogel Arnica Gel will be the first of many products to receive a traditional herbal registration. Our aim is to enable those consumers who wish to take herbal medicines to make an informed choice from a wide range of products which have been made to assured standards of safety, quality and patient information.” |
What is the evidence that Arnica Gel does the slightest good for the conditions that will appear on the label? The answer is essentially none. There are only two papers in Medline. The first shows no detectable effect of arnica gel (compared with vehicle alone) (Alonso D, Lazarus MC, Baumann L., Effects of topical arnica gel on post-laser treatment bruises. Dermatol Surg. 2002 Aug;28(8):686-8.)
The second paper claims a positive effect, but it is worthless because it was an open trial with no proper controls. (Knuesel O, Weber M, Suter A. Arnica montana gel in osteoarthritis of the knee: an open, multicenter clinical trial. Adv Ther. 2002 Sep-Oct;19(5):209-18.). The last author on this paper, incidentally, gives his address as Bioforce AG.
So yes, the MHRA’s press release is indeed a landmark. It is the first time that they have allowed a medicine to be labelled with a therapeutic claim when there is no reason to believe it to be true.
The bottom of the press release says (my emphasis) “The MHRA is the government agency that is responsible for ensuring that medicines and medical devices work, . . .”.
Uhm, surely some inconsistency there.
But no, Kent Woods tells me “The strap-line you refer to is a highly simplified statement of our role in making regulatory judgements based on risk/benefit analysis in the real world. ”
The bizarre behaviour of the MHRA is based on European Directive 2004/24/EC.This contains (para 6) the following prime example of pre-enlightenment thought.
“The long tradition of the medicinal product makes it possible to reduce the need for clinical trials, in so far as the efficacy of the medicinal product is plausible on the basis of long-standing use and experience. Pre-clinical tests do not seem necessary, where the medicinal product on the basis of the information on its traditional use proves not to be harmful in specified conditions of use.â€
Evidently the MHRA have decided to go along with the licence for snake-oil salesman that this provides. It isn’t clear that they were compelled to do so (MHRA’s response here).
This is what the packet looks like. On the right, one panel is enlarged. The claim “It helps relieve symptoms including:” is quite outrageous. There isn’t the slightest reason to believe anything of the sort. I know the bit above that says “based exclusively on long-standing use”, but it certainly won’t be obvious to most shoppers that this is meant to imply that the clear claim that “it helps to relieve symptoms” may be so much nonsense.
In a recent speech and interviews, Tony Blair confirms that he thinks science is just for making money, and that homeopathy and creationism don’t concern him.
Read full entry on the original IMPROBABLE SCIENCE page.
The regulations that allow unjustified claims to be made for homeopathic pills were the subject of an annulment debate in the House of Lords on 26 October 2006. The regulations were introduced as a statutory instrument.
“Statutory Instruments (SIs) are a form of legislation which allow the provisions of an Act of Parliament to be subsequently brought into force or altered without Parliament having to pass a new Act.”
In other words a minister just decides to do it without any debate or parliamentary approval
“The instrument is laid after making, subject to annulment if a motion to annul (known as a ‘prayer’) is passed within 40 days.”
The BBC Today programme covered the event before the debate. Lord (Dick) Taverne put the view of reason and common sense superbly, against some totally evasive fantasies from Imogen Spencer of the Society of Homeopaths. He is the author of “The March of Unreason: Science, Democracy, and the New Fundamentalism“). [Listen to the interview: mp3 file, 5.6 Mb]
Read the debate
The debate can be read in Hansard. In the archaic language of the House.
“Lord Taverne rose to move, That an humble Address be presented to Her Majesty praying that the regulations, laid before the House on 21 July, be annulled (S.I. 2006/1952). [44th Report from the Merits Committee].”. Here are a few quotations.
Lord Taverne
“There is one very important, absolutely fundamental objection to this regulation. For the first time in the history of the regulation of medical products, it allows claims of efficacy to be made without scientific evidence. It is an abandonment of science and the evidence-based approach. Under this new regulation, the sole basis on which claims of efficacy can be made for homeopathic products quite legally is "homeopathic provings". There is no need for clinical or scientific tests. Homeopathy is not based on science and is not a science in any sense whatever.”
.Let me read just three of the comments, the first from the British Pharmacological Society. I quote it first because two members of the MHRA, including the chairman, have pharmacological qualifications. The society says:
“The British Pharmacological Society believes that any claim for a medicine must be based on evidence, and that it is the duty of the regulatory authorities, in particular the MHRA, to ensure that no claims can be made for the efficacy of any form of medicine unless there is good evidence that the claim is true. Despite many years of investigation, we have no convincing scientific evidence that homeopathic remedies work any better than placebo”.
.
“What it has done is to promote what is in effect the selling of snake oil. This statutory instrument should be withdrawn;it is a disgrace. I beg to move.”
Lord Rees of Ludlow (Martin Rees, President of the Royal Society)
“ My Lords, the Royal Society, of which I have the honour to be president, believes that all complementary and alternative medicines should be subject to careful evaluation of their efficacy and their safety. All treatments so labelled should be properly tested and patients should not receive misleading information.
There are no great concerns about the safety of homeopathic treatments. What is at issue is their effectiveness. Obviously placebo effects can be powerful, nobody denies that. It is, however, quite different to assert that homeopathic treatments offer benefits beyond a placebo. Indeed, if medicines can really work even when so diluted that barely a single molecule is left, this would entail some fundamentally new scientific principle with amazingly broad ramifications. It would mean that materials like water carry imprints of their past and can remember their history, as it were, in some quite novel and mysterious way. If that were the case, it would have fundamental implications for precise experiments over the whole of science.
So it seems to me that the burden of proof on homeopathic remedies should actually be higher, not lower, than for conventional ones. Extraordinary claims demand extraordinary evidence. To put it mildly, so-called “homeopathic provings”; seem to fall far short of that. That is why I wholeheartedly support what the noble Lord, Lord Taverne, is saying on this issue.
Excellent speeches were made on the side of reason by Lord Turnberg (ex-professor of medicine and ex-president of the Royal College of Physicians) and Lord Jenkin of Roding . (who, as Patrick Jenkin, was a member of Margaret Thatcher’s government).
The 30th Countess of Mar
All of this counted for little with the Countess of Mar, a heriditary peer and organic farmer who opposed the annulment. She was, I fear, rather selective with the evidence. She quotes, for example,
“Professor Madeleine Ennis of Queen’s University, Belfast, with a large pan-European research team led by Professor Roberfroid of the Catholic University, Louvain, set out to show that homeopathy and water memory were utter nonsense. This was an exercise conducted with extreme scientific rigour.” . . . “In the end, she had to concede that high dilutions of the active ingredients in homeopathic solutions worked, whether or not the active ingredient was present in the water”
Bits of Lady Mar’s speech bear an extraordinary resemblence to an article written in the Guardian in 2001, by Lionel Milgrom (maverick chemist and apologist for homeopathy). I wonder who wrote it for her?
The Noble Countess appears not to have noticed that the first author on both of Ennis’s papers was Philippe Belon. who is a director of the huge French homeopathic company, Boiron. In fact the address on the papers is not the University of Belfast (or Louvain), but it is “Boiron, 20 rue de la Liberation, 69110 Sainte-Foy-Les-Lyon, France.”
Boiron makes profits from homeopathy of about 20 miilion euros a year, on net operating revenues of about 300 million euros. It is big business. Philippe Belon has an interesting record.
He was one of the authors of the notorious Benveniste paper which lead to Beneveniste’s dismissal form INSERM in disgrace. The Countess also seems to have missed the careful refutation of Benveniste’s results by Hirst, Hayes, Burridge, Pearce and Foreman (1993, Nature.366, 525-7.
Belon was also senior author in 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.). That is the paper which I was asked to check (by a TV programme). After Peter Fisher gave me the raw data I found that a naive mistake had been made in the statistical analyis. There was NO evidence for the effect of the treament at all, as described below. This correction was published (Colquhoun, D. (1990). Reanalysis of a clinical trial of a homoeopathic treatment of fibrositis. Lancet 336, 441-442.), though the correction is usually ignored by homeopaths (see below). [Get pdf].
How odd that all Belon’s papers seem to favour homeopathy.
Lord Colwyn
(The Rt Hon Lord Colwyn, CBE, a Conservative peer) also supported mumbo jumbo. Don’t you love this bit?
“I went on a course about 15 years ago on the relationship between quantum physics and homeopathy. I probably did not understand a word I was told at the time, but at least there was evidence that the two were linked.”
But he shouldn’t worry if he didn’t understand a word: it was just gobbledygook.
Lord Colwyn finished his speech thus.
“It is interesting to consider why homeopathy, which of all complementary therapies is probably at most variance with orthodox medicine, should have received sufficient support from the Government to be able to maintain a number of specialised hospitals.”
Well, agreed again, it is interesting -in fact it’s quite incredible.
What a pity, though, that Lord Colwyn quite forgot to declare his interests. He is vice-president of the Blackie Foundation Trust. This trust was “founded by Dr Margery Blackie in 1971, at that time homoeopathic physician to Her Majesty, the Queen. Dr Blackie saw the need to promote homoeopathic remedies to the wider community and to educate the public about the success of homoeopathy in treating illness.”.
He also forgot to mention that he is a patron of the National Federation of Spiritual Healers.
Lord Warner
(Lord Warner of Brockley, Minister of State at the Department of Health) defended quackery on behalf of the government. He says the legislation
“will, for the first time since the PLR scheme in 1971, allow homeopathic products to be marketed with information to the consumer about what they can be used for. This will provide better information to the consumer and reduce the risk of confusion. “
Lord Warner makes no comments about how claims made for efficacy in the absence of evidence can be called “better information” for the consumer
“We have done much as a Government to support science and research, and will continue to do so. Homeopathic products are, however, in a different category. Provided that such products are safe, properly manufactured and clearly labelled without making false claims, which they will be under the new national rules scheme, patients should not be denied access to them for the conditions to which they relate. “
What, one wonders, does “a different category” mean? The magic category? And since the manufacturers have just been excused from producing any evidence of efficacy, who is to judge what are “false claims”.
Some reports
The BBC report before the debate
The Daily Mail -pretty good stuff.
Interview with DC, vainly trying to counter the bunkum from the two previous speakers.
Read full entry on the original IMPROBABLE SCIENCE page.
The Consumers’ Association has had a good record in distinguishing true claims from false in washing machines and dishwashers. But in CAM, they seem to be out of their depth. They have been giving some very bad advice, of the sort you might expect from the lifestyle pages of the Daily Mail.
Read full entry on the original IMPROBABLE SCIENCE page.
Wearing magnets in the hope of benefit is one of the best know delusions (see below). It was therefore a shock when the NHS said it would pay for magnetic bandages. Using the Freedom of Information Act (FoI) II asked the Prescription Pricing Authority (PPA), and then the Department of Health (DoH), for documents that referred to this bizarre decision. Both refused, as related below.
When the Department of Health refused my FoI request, I asked for an internal review. Nothing happened for months, but on 10th Oct 2006, a parcel of papers arrived.
Michael King is Director of Planning and Corporate Affairs at the PPA He said (see below)
“There is no judgement offered about whether a product in the Drug Tariff is more (or less) efficacious than any other, or the placebo effect.”
This is not true, The papers from the DoH show that the PPA considered at length the evidence provided by the manufacturer, Magnopulse Ltd.
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And in an email dated 19 Dec 2005
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So the ‘efficacy’ of the product was assessed. It was just assessed incompetently.
The PPA do not seem to have noticed that a quite different conclusion about the paper in the Journal of Wound Care was reached by a different bit of the NHS. The NHS National Electronic Library for Health concludes (and also the NHS Clinical Answers Service)
“Therefore, no firm conclusions can be made on the basis of this study alone.”
The PPA do not seem to have noticed the endless evidence from other sources that magnets are boloney (see below)
And the the PPA do not seem to have noticed that the author of this paper is the is the Founder, CEO and Medical Director of one of the wackiest alternative medicine clinics, the Chiron Clinic (see below). He will charge you £135 for a consultation for which you’ll get magnets and phony nutrient treatment.
Follow-up
The regulations that allow unjustified claims to be made for homeopathic pills were the subject of an annulment debate in the House of Lords on 26 October 2006. The regulations were introduced as a statutory instrument.
“Statutory Instruments (SIs) are a form of
legislation which allow the provisions of an Act of
Parliament to be subsequently brought into force
or altered without Parliament having to pass a
new Act.”
In other words a minister just decides to do it without any debate or parliamentary approval
“The instrument is laid after making, subject to annulment if a motion to annul (known
as a ‘prayer’) is passed within 40 days.”
The BBC Today programme covered the event before the debate. Lord (Dick) Taverne put the view of reason and common sense superbly, against some totally evasive fantasies from Imogen Spencer of the Society of Homeopaths. He is the author of “The March of Unreason: Science, Democracy, and the New Fundamentalism“).
[Listen to the interview: mp3 file, 5.6 Mb]
Read the debate
The debate can be read in Hansard. In the archaic language of the House.
“Lord Taverne rose to move, That an humble Address be presented to Her Majesty praying that the regulations, laid before the House on 21 July, be annulled (S.I. 2006/1952). [44th Report from the Merits Committee].”. Here are a few quotations.
Lord Taverne
“There is one very important, absolutely fundamental objection to this regulation. For the first time in the history of the regulation of medical products, it allows claims of efficacy to be made without scientific evidence. It is an abandonment of science and the evidence-based approach. Under this new regulation, the sole basis on which claims of efficacy can be made for homeopathic products quite legally is “homeopathic provingsâ€. There is no need for clinical or scientific tests.
Homeopathy is not based on science and is not a science in any sense whatever.â€
.Let me read just three of the comments, the first from the British Pharmacological Society. I quote it first because two members of the MHRA, including the chairman, have pharmacological qualifications. The society says:
“The British Pharmacological Society believes that any claim for a medicine must be based on evidence, and that it is the duty of the regulatory authorities, in particular the MHRA, to ensure that no claims can be made for the efficacy of any form of medicine unless there is good evidence that the claim is true. Despite many years of investigation, we have no convincing scientific evidence that homeopathic remedies work any better than placebo”.
.
“What it has done is to promote what is in effect the selling of snake oil. This statutory instrument should be withdrawn—it is a disgrace. I beg to move.â€
Lord Rees of Ludlow (Martin Rees, President of the Royal Society)
“ My Lords, the Royal Society, of which I have the honour to be president, believes that all complementary and alternative medicines should be subject to careful evaluation of their efficacy and their safety. All treatments so labelled should be properly tested and patients should not receive misleading information.
There are no great concerns about the safety of homeopathic treatments. What is at issue is their effectiveness. Obviously placebo effects can be powerful, nobody denies that. It is, however, quite different to assert that homeopathic treatments offer benefits beyond a placebo. Indeed, if medicines can really work even when so diluted that barely a single molecule is left, this would entail some fundamentally new scientific principle with amazingly broad ramifications. It would mean that materials like water carry imprints of their past and can remember their history, as it were, in some quite novel and mysterious way. If that were the case, it would have fundamental implications for precise experiments over the whole of science.
So it seems to me that the burden of proof on homeopathic remedies should actually be higher, not lower, than for conventional ones. Extraordinary claims demand extraordinary evidence. To put it mildly, so-called “homeopathic provings†seem to fall far short of that. That is why I wholeheartedly support what the noble Lord, Lord Taverne, is saying on this issue.
Excellent speeches were made on the side of reason by Lord Turnberg (ex-professor of medicine and ex-president of the Royal College of Physicians) and Lord Jenkin of Roding . (who, as Patrick Jenkin, was a member of Margaret Thatcher’s government).
The 30th Countess of Mar
All of this counted for little with the Countess of Mar, a heriditary peer and organic farmer who opposed the annulment. She was, I fear, rather selective with the evidence. She quotes, for example,
“Professor Madeleine Ennis of Queen’s University, Belfast, with a large pan-European research team led by Professor Roberfroid of the Catholic University, Louvain, set out to show that homeopathy and water memory were utter nonsense. This was an exercise conducted with extreme scientific rigour.†. . . “In the end, she had to concede that high dilutions of the active ingredients in homeopathic solutions worked, whether or not the active ingredient was present in the waterâ€
Bits of Lady Mar’s speech bear an extraordinary resemblence to an article written in the Guardian in 2001, by Lionel Milgrom (maverick chemist and apologist for homeopathy). I wonder who wrote it for her?
The Noble Countess appears not to have noticed that the first author on both of Ennis’s papers was Philippe Belon. who is a director of the huge French homeopathic company, Boiron. In fact the address on the papers is not the University of Belfast (or Louvain), but it is “Boiron, 20 rue de la Liberation, 69110 Sainte-Foy-Les-Lyon, France.”
Boiron makes profits from homeopathy of about 20 miilion euros a year, on net operating revenues of about 300 million euros. It is big business. Philippe Belon has an interesting record.
He was one of the authors of the notorious Benveniste paper(see also below), which lead to Beneveniste’s dismissal form INSERM in disgrace. The Countess also seems to have missed the careful refutation of Benveniste’s results by Hirst, Hayes, Burridge, Pearce and Foreman (1993, Nature.366, 525-7.
Belon was also senior author in 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.). That is the paper which I was asked to check (by a TV programme).
After Peter Fisher gave me the raw data I found that a naive mistake had been made in the statistical analyis. There was NO evidence for the effect of the treament at all, as described below.
This correction was published (Colquhoun, D. (1990). Reanalysis of a clinical trial of a homoeopathic treatment of fibrositis. Lancet 336, 441-442.), though the correction is usually ignored by homeopaths (see below). [Get pdf].
How odd that all Belon’s papers seem to favour homeopathy.
Lord Colwyn
(The Rt Hon Lord Colwyn, CBE, a Conservative peer) also supported mumbo jumbo. Don’t you love this bit?
“I went on a course about 15 years ago on the relationship between quantum physics and homeopathy. I probably did not understand a word I was told at the time, but at least there was evidence that the two were linked.â€
But he shouldn’t worry if he didn’t understand a word: it was just gobbledygook.
Lord Colwyn finished his speech thus.
“It is interesting to consider why homeopathy, which of all complementary therapies is probably at most variance with orthodox medicine, should have received sufficient support from the Government to be able to maintain a number of specialised hospitals.â€
Well, agreed again, it is interesting -in fact it’s quite incredible.
What a pity, though, that Lord Colwyn quite forgot to declare his interests. He is vice-president of the Blackie Foundation Trust. This trust was “founded by Dr Margery Blackie in 1971, at that time homoeopathic physician to Her Majesty, the Queen. Dr Blackie saw the need to promote homoeopathic remedies to the wider community and to educate the public about the success of homoeopathy in treating illness.”.
He also forgot to mention that he is a patron of the National Federation of Spiritual Healers.
Lord Warner
(Lord Warner of Brockley, Minister of State at the Department of Health) defended quackery on behalf of the government. He says the legislation
“will, for the first time since the PLR scheme in 1971, allow homeopathic products to be marketed with information to the consumer about what they can be used for. This will provide better information to the consumer and reduce the risk of confusion. “
Lord Warner makes no comments about how claims made for efficacy
in the absence of evidence can be called “better information” for the consumer
“We have done much as a Government to support science and research,
and will continue to do so. Homeopathic products are, however, in a different
category. Provided that such products are safe, properly manufactured and
clearly labelled without making false claims, which they will be under the
new national rules scheme, patients should not be denied access to them for
the conditions to which they relate. “
What, one wonders, does “a different category” mean? The magic category? And
since the manufacturers have just been excused from producing any evidence of
efficacy, who is to judge what are “false claims”.
Some reports
The BBC report before the debate
The Daily Mail -pretty good stuff.
The Royal Society , the UK’s national academy of science, has put a statement about alternative medicine on its “science issues” web site.
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The Royal Society believes that complementary and alternative medicines, like conventional medicines, should be subject to careful evaluation of their effectiveness and safety. It is important that treatments labelled as complementary and alternative medicines are properly tested and that patients do not receive misleading information about the effectiveness of complementary medicine. Furthermore, NHS provision for complementary and alternative medicines, as for conventional medicines, should be confined to treatments that are supported by adequate diagnosis together with evidence of both effectiveness and safety.
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Notice the very proper insistence that patents are not deceived about whether the “medicine” works or not. This is in stark contrast to the attitude of the MHRA, which has just endorsed misleading labelling.
A correspondent has passed on to me a letter from Caroline Flint, Minister of State at the Department of Health. She describes herself as “New Labour [sic] Member of Parliament for the Don Valley constituency in South Yorkshire.”
My correspondent describes himself as “a non-scientist member of the general public who has nevertheless become very concerned about the continuing rise of pseudoscience and quackery, particularly its penetration of the government and some institutions who ought to know better.”. Join the club! His reaction to this reply was “I am speechless”.
The minister offers the opinion that homeopathy works and refers him to the Faculty of Homeopathy, “which has a network of advisors around the country who are pleased to offer advice to members of the public about homeopathic issues”. They, of course, will tell him the usual lies. What are Ms Flint’s qualifications for offering this appalling advice?. BA Hons in American Literature & History, University of East Anglia, Former local government officer, and Senior researcher/political officer GMB 1991-7.
Ill-informed views like these are certainly consistent with the view that the recent bizarre decision by the MHRA, to allow dishonest labelling of homeopathic products, was taken under instructions from the Department of Health.
O2 AUG 2006 Thank you for your letter of 25 July to Patricia Hewitt enclosing correspondence from your constituent *** about homeopathy on the NHS. I am replying as the Minister responsible for this policy area. I understand Mr *** is concerned that homeopathic therapy has been made available on the NHS. The Department of Health acknowledges that there are now numerous complementary therapies available in the UK. Some of these therapies have been known to alleviate the symptoms of certain illnesses in cases where orthodox medicine does not seem to have offered a complete solution. However, it is the responsibility of local NHS organisations to commission healthcare packages for NHS patients, be it complementary or orthodox. Complementary and alternative medicine treatments are clearly attractive to a number of people and so in principle could feature in a range of services offered by local NHS organisations. Primary Care trusts (PCTs) often have specific policies on the extent to which their patients can be given access to complementary medicines and within these policies, it is open to GPs to give access to specific therapies where they consider it is in the interests of the individual patient. The cost-effectiveness, availability and evidence in support of specific therapies are all issues that are taken into account when deciding what treatment to provide. Mr *** may wish to contact his local PCT and find out what their policies are on complementary therapies including homeopathy. The contact details are: Kennet and North Wiltshire PCT Mr *** may also wish to contact the Faculty of Homeopathy, which has a network of advisors around the country who are pleased to offer advice to members of the public about homeopathic issues: Faculty of Homeopathy Tel: 020 7566 7810 I hope this reply is helpful. Yours
Caroline Flint Approved by the Minister’s Private Office and signed electronically in her absence. |
The two chiropodists who run the Marigold Homeopathic Podiatry clinic (no, honestly, it’s real) at the Royal London Homeopathic Hospital seem to be spending much of their budget with a company that they themselves own. The UCLH Trust did not receive any notification of this until I told them about it.
This has been re-posted from the story on the old IMPROBABLE SCIENCE page.
It’s about time I dealt with the health fraud on my own doorstep. University College London Hospitals (UCLH) is not part of UCL, but is a National Health Service Foundation Trust. The trust is responsible for eight hospitals: University College Hospital, The Middlesex Hospital, Hospital for Tropical Diseases, National Hospital for Neurology & Neurosurgery, Elizabeth Garrett Anderson & Obstetric Hospital, Eastman Dental Hospital, The Royal London Homoeopathic Hospital and The Heart Hospital.These are all (but one) absolutely first class teaching hospitals, with responsibility for clinical teaching for UCL medical students. The one blot on the landscape is the Royal London Homeopathic Hospital. This hospital was acquired by UCLH in April 2002. Why on earth is a respectable NHS trust promoting quackery? The UCLH web site says
“The merger enables closer collaboration between complementary therapies and conventional medicine to provide better care for NHS patients. The merger co-incides with the government’s commitment to integrate complementary and conventional care within the NHS, where there is evidence of the effectiveness of complementary therapies.” Notice that the crucial proviso in this statement.
“. . . where there is evidence of the effectiveness of complementary therapies.”
That would be fine If there were evidence of effectiveness, but there is next to no such evidence. Why does UCLH brush this inconvenient fact under the carpet?
The Trust actually has an absolutely first class way of assessing the effectiveness of treatments that are used within UCLH. It is called the Use of Medicines Committee. All NHS Trusts are required to have such a committee, and UCLH’s committee was singled out for praise after a visit by the Parliamentary Select Committee on Health, in their 4th report. These committees are required to obtain good evidence that a proposed treatment works, and their evaluations may be more stringent than those of NICE.
Hansard records
“ During the inquiry, we visited University College London hospital to hear about its Use of Medicines Committee. We were incredibly impressed with its drug formulary, which is used not only by the hospital trust but by the nearby primary care trusts. Because members of those trusts are on the committee, it is also well accepted by the GPs in the area.”
So does the UCLH formulary contain homeopathic and herbal products? If so they will have bypassed entirely the high standards of evidence that are required by the Use of Medicines Committee for any other sort of medicine. If these standards were applied to homeopathic and herbal treatments, the Royal London Homeopathic Hospital would have to close down, because few of these alternatives to medicine would pass an evidence-based assessment. Presumably UCLH Management has foreseen this, and would rather adopt a double-standard than deal with the political fall-out that would result from applying rules of evidence to alternative medicine.
A fine example of the abuse of language: Homeopathic podiatry
The UCLH web site says (somewhat ungrammatically): “The Royal London Homoeopathic Hospital is celebrating the first decade of its Marigold Clinic which provides complementary treatment of homeopathic podiatry. ”
“ Dr Peter Fisher, RLHH Clinical Director, said: “It is an honour for the hospital to host the Marigold Clinic which has been tremendously successful. The Royal London Homoeopathic Hospital has a history of acting as a test bed for NHS innovation. The complementary cancer service and acupuncture are just two examples of therapies the RLHH has been the first to introduce on the NHS. I foresee the same thing happening with homoeopathic podiatry. It’s time has come, current reforms and patient choice are working in our favour.” ”
To describe as “innovation” a reversion to a totally discredited 19th century bit of delusional thinking, is a usage that defies belief. See, for example, here and here.
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It is embarrassing to a real university like UCL to see a conference, sponsored by RLHH, on ‘Improving the success of homeopathy’ branded with a logo that looks very like UCL’s own (old version) logo. The title carries the assumption that there is something to be ‘improved’. The conference dealt not only with marigold for bunions, but also HIV/AIDS |
What does the Royal London Homeopathic Hospital cost you, the taxpayer?
Guess what? Nobody knows. But with the help of the Freedom of Information Act 2000, I have been able to make some good guesses.
For a start, at least £18 million has been spent on refurbishing the RLHH. The recurrent costs are not so easy to discover. By use of the Freedom of Information Act 200, this is what I discovered.
The direct cost of running the RLHH is £3.379 million per year of which £3.175 million per year are paid by the NHS. Approximately 75% of the direct costs are for salaries.These are the salary cost of staff working at the RLHH. The staff are medical, nursing, pharmacy, administrative and managerial, and ancillary. The balance of cost is for purchase of drugs, laboratory tests, use of patient beds in other Trust hospitals, building and office running costs.
As well as this, the NHS pays also for indirect services, but nobody seems to know the cost of these (and still less, their value). Indirect services are those not charged directly to the RLHH and will include the following. Payroll, payment and income services, accountancy, recruitment , training, personnel, governance and clinical audit, R and D management and governance, medical and nursing education, training and professional support, communications, I.M. and T., estates maintenance management and planning, catering, cleaning, security, insurance, depreciation, payment of public dividend. These sevices are supplied by the Finance Directorate, Workforce Directorate, Chief Nurse Directorate, Capital Investment Directorate, IM and T Directorate, R and D Directorate, Governance Directorate, Directorate of Corporate Sevices, Communications Directorate.
For the UCLH Trust as a whole, indirect costs amount to 39.2 percent of direct costs. If that proportion applies to RLHH, then the total annual cost of RLHH would be £4.7 million.
That sounds to me like a lot of money for a placebo effect.
The RLHH is 97.7 percent homeopathic
Their web site lists eight consultants, all described as “homeopathic consultants” and a ninth has been added recently, Dr H. Roniger. Thus it seems that Lord Winston made an error of fact when he defended the RLHH in the House of Lords by saying “My Lords, perhaps I may be allowed to break with tradition and come to the assistance of my noble friend. Is it not the case that the national homeopathic hospital conducts perfectly normative medicine and is it not justified in doing that, irrespective of the efficacy or otherwise of homeopathy, which I believe is only a small part of its practice?”
This is the breakdown of prescribing at the RLHH (audit taken August 2004, provided under the Freedom of Information Act). It refers to the number of items dispensed, not their value (which I am still trying to discover).
| Valid Percent | ||
| Valid | Homeopathy | 53.2 |
| Herbal tinctures and potencies <6x | 5.7 | |
| Iscador products | 2.8 | |
| Aromatherapy | .2 | |
| Marigold products | 4.2 | |
| Creams/ointments | 13.5 | |
| Tablets/nutritionals | 1.3 | |
| Supplements/homeopathic (New Era Products) | 7.8 | |
| Nutraceuticals | 3.4 | |
| Anthroposophicals medicine | 1.2 | |
| Allopathic products | 2.3 | |
| Weleda | 2.0 | |
| Flower essence | 1.5 | |
| other | 1.0 | |
| Total | 100.0 | |
NB: Creams are herbal or homeopathic.
And the cost of CAM in Glasgow
A freedom if Information Act request elicited the following costs. Much of
the information I asked for is not even recorded.
The cost of the Glasgow Homoeopathic Hospital.
The running costs for the Homoeopathic Hospital were:
2004/05 £1,658k
2005/06 £1,881kThe cost of all CAM services at Baillieston Health Centre
There is no record of any specific costs associated with CAM incurred at Baillieston Health Centre.There was many years ago a Baillieston Childrens’ Homoeopathic Clinic but this service was subsumed into the new Glasgow Homoepathic Hospital. That hospital opened in 1999 at a total capital and building cost of £2,780,189.The total cost came from the New Homoeopathic Hospital Endowment Fund.
3) The cost of CAM provided by GPs or any other part of the Trust.
There is no record of specific costs associated with GPs or others employed by the NHS Board providing complementary and alternative medicine. If homoeopathy, hypnosis, acupuncture or any other form of complementary medicine is provided it is not as a costed, discrete service.
A conflict of interest at RLHH
The table shown above shows the precribing habits at the Royal London Homeopathic Hospital, The 4.2 percent of precriptions labelled ‘Marigold products’ in the Table were for the products of a company called Marifold Footcare Ltd.
The UCLH Trust web site says
“Dr M Taufiq Khan founded the Marigold Clinic in 1981 at St Pancras Hospital, London, and then established it in 1992 at the RLHH. Dr Khan is the Director of Homeopathic Podiatory Sevices at the RLHH and specialises in the treatment. His son Dr Tariq Khan, is the Deputy Director.”
| The list above shows that 4.2% of all precriptions at RLHH were for “Marigold Products”. This company is Marigold Footcare Ltd., 134 Montrose Avenue, Edgeware, Middlesex, HA8 0DR. |  From left to right: Dr Taufiq Khan, Dr Peter Fisher, Lord Paul of Marylebone and Dr Taufiq Khan open the Sick Feet – Healing Flowers exhibition. |
According to a Current Appointments Report obtained from Companies House. Marigold Footcare Ltd has three directors.
- Dr Mohammed Taufiq Khan, PhD of 134 Montrose Avenue, Edgeware, Middlesex
- Mr Mohammed Taufiq Khan of Bedford House, 17 New North Street, London
- Mrs Shamim Fatima Khan of 134 Montrose Avenue, Edgeware, Middlesex
It appears that the director and deputy director of the Marigold Clinic are paying substantial amounts of NHS money to their own company.
Research-based? Which research?
The web site of the Marigold Clinic makes the following claim.
Research-based medicine:
Marigold therapy is an integral part of homoeopathic podiatry. It comprises specially formulated medication applied topically in conjunction with podiatry. It is research based medicine which has been clinically evaluated in double blind placebo controlled trials at British Universities and NHS Trusts.
And Marigold Footcare Ltd claims
“The safety and efficacy of Marigold Therapy have been demonstrated through extensive clinical use in podiatry clinics and numerous studies and in randomised, double blind, placebo controlled trials: (1) at the University of Brighton (Faculty of Health); (2) University of East London (Institute of Health and Rehabilitation, Faculty of Health and Science); (3) University of London (Faculty of Medicine, School of Pharmacy and the Royal London Homeopathic Hospital).”
This sounds impressive, but what exactly is this research? All I can find in Pubmed about marigold treatment in podiatry is two papers. One is in the Journal of Pharmacy and Pharmacology (1996, 48, 768-770) and one is in Phytotherapy Research (1996, 0, 211-214).
And who is the first author on both of these papers? You guessed: M.T. Khan.
The first paper (Khan, 1996) is from the School of Pharmacy, the second (Khan, Potter and Birch, 1996) is from School of Pharmacy and the podiatry department, Leaf Hospital, Brighton. I can find no trace of publications from the University of East London or from RLHH. Repeated requests for references elicited no reply at all for a long time.
Eventually, I had a reply from M. Tariq Khan in response to my request for references to back the claim on their company’s web site. He sent a list of 54 assorted conference communications and student projects, and 28 “papers” published in Journals. Every one of these 82 items bore the names of one or both M. T. Khans. There were no more ‘serious’ papers than Pubmed had revealed. There appears to be no independent verification whatsoever of their claims.
Reaction of the UCLH Trust
The UCLH Trust, when notified about what was going on, referred the matter to Dr Peter Fisher, the homeopath and clinical director at rhe RLHH. Tonia Ramsden, Director of Corporate Services for UCLH told me on July 27 2006
“I can confirm that I have received and registered the declaration of Interest.”
Quite true, It was only later that I was told that the declaration of interest was received by the Trust only after I had told them about what was going on!
Peter Fisher, assured me that he was aware of the Khan’s behaviour. Rather surprisingly, he seemed to think that no conflict of interest was involved. He said
“Thank you for drawing to my attention the potential conflict of interest in relation to podiatry. The management of the RLHH has always been aware of the situation”
That was it. No comment at all was made on the propriety of the Khans’ behaviour. Dr Fisher also assured me that the evidence for the efficacy of marigold products was good, without actually citing what this evidence was. I replied thus.
“I find it quite disturbing that you say below that “the RLHH is committed to evidence-based practice”, but that you seem to regard as evidence two small papers, both from the same people with a financial interest in the outcome, and not replicated elsewhere. Incidentally neither of these papers declared the authors’ financial interest. It is equally disturbing that your letter to me does not seem to give a realistic idea of the strength of the evidence. I had to find that for myself. ”
Declarations of interest shoud be public, but are not,
A declaration of conflict of interest is, I suppose, better than nothing. But these pieces of paper sit in a drawer in the Trust. They are kept secret from both the public and the patients. The patient should know when the prescriber has a financial interest in what he prescribes, but they are kept in the dark. When I wrote to the UCLH clinical governance committee to suggest a bit more openness would be desirable, they did not even bother to reply. That is when I decided to make this information public.
The BMJ published yet another inconclusive paper on acupuncture, but misrepresented it in their press release.
Read full entry on the original IMPROBABLE SCIENCE page.
Gerald Weissmann, editor-in-chief of FASEB journal, talks straight.
It seems that our letter to NHS chiefs has crossed the Atlantic. In a gloriously scholarly and funny editorial, Gerald Weissmann MD, of New York University, puts the knife into homeopathy and its royal advocate. Click here to read the whole thing. Here’s something to whet your appetite.
After publication of our letter . . .
“Prince Charles was unfazed—on the day the Open Letter was published, he stopped at St Tydfil’s Hospital in South Wales to watch alternative medicine at work. He accepted a “spiritual” crystal, as if he were Albus Dumbledore, headmaster of Hogwarts School, accepting the Philosopher’s Stone. Unlike Dumbledore, however, who only professed witchcraft and wizardry, Prince Charles called up every form of “integrative therapy” against Alzheimer’s disease (9). One notes that when Prince Charles and other fans of unproven or disproved medical practices use terms such as “integrated therapy” or “alternative medicine”, they’re following the lead of creationists who hide under the term “intelligent design”—these are all convenient slogans that permit the credulous to con the gullible.”
“Hogwarts is certainly on the move! If the trend persists, perhaps MIT or Cal Tech will march in step with the medical schools and offer prizes for integrative alchemy or alternative engineering. But Dr. Oliver Wendell Holmes, dean of the Harvard Medical School before age of Oprah had the last word on homeopathy:
“Some of you will probably be more or less troubled by that parody of medieval theology which finds its dogma in the doctrine of homeopathy, its miracle of transubstantiation in the mystery of its dilutions, its church in the people who have mistaken their century, and its priests in those who have mistaken their calling.”
[Oliver Wendell Holmes, Medical
Essays. The Young Practitioner, [A Valedictory Address delivered to the Graduating Class of the Bellevue Hospital College, March 2, 1871.] ”
For more delightful writing by Gerald Weissmann, click here.
Special recommendations
Darwin’s Audubon: Gerald Weissmann on the Art of Science.
Swift-boating Darwin: alternative or complementary science
The facts of evolution: fighting the Endarkenment. . The word ‘endarkenment’ sums up only too well much of what appears here.
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 prince’s unconstitutional interventions in public policy continue as he launchs an organisation called Integrated Health Associates (IHA).
Read full entry on the original IMPROBABLE SCIENCE page.
An even more than usually crackpot idea from homeopath Carol Franske is that shaking the bottle splits atomic nuclei. And a discussion on recent work which suggests that the real memory of water is even less than a millionth of a millionth of a second.
Read full entry on the original IMPROBABLE SCIENCE page.