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Moved accordingly, and, on Question, Motion agreed to.
Medicines for Human Use (National Rules for Homeopathic Products) Regulations 2006
2.13 pm
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].
The noble Lord said: My Lords, I declare an interest as the chairman of a charity, Sense About Science, which is concerned with the promotion of good science and an evidence-based approach to the public understanding of scientific issues. The statutory instrument which I seek to annul regulates the marketing of homeopathic products. It was laid before Parliament in July this year, a few days before the House rose for the summer Recess, and there has been no opportunity to debate it. It took effect on 1 September.
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Under European law, there was no obligation for the Government to introduce the regulation. EC Directive 2001/83 left it explicitly to nation states to decide how to regulate homeopathy, provided they meet the basic safety requirements of manufactured products. This regulation was made by the Medicines and Healthcare products Regulatory Agency—the MHRA—explicitly for the benefit of the manufacturers of homeopathic products. As the Explanatory Memorandum explains, the law as it stood formerly did not allow new homeopathic products to make claims for therapeutic benefits on their labels and failure to change the law would, in the words of the MHRA,
There was nothing to stop products being sold under what is known as the “simplified scheme” introduced in 1992, but a claim for efficacy could not then be made which was not scientifically tested.
The new regulation, by the way, is concerned solely with homeopathy, not with alternative medicines in general. It has nothing to do with other so-called complementary medicines such as herbal medicines and acupuncture. I mention that because there has been some confusion about it.
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. It is a system originally based on two laws proclaimed by the German physician Hahnemann in 1796. The first was that “like cures like”. For this there is no evidence, any more than there is for the medical practice common at the time of suppressing symptoms by the treatment of opposites. However, as treating “like with like” could mean administering a poison, which is not exactly beneficial, he added a second law: the “law of infinitesimals”, which states that the more a substance is diluted, the greater the benefit. Most homeopathic medicines are just about infinitely diluted in water, commonly by 10 to the power of 30—that is, one followed by 30 noughts. What remains is one part in 1 million million million million million. Nothing of the original substance remains.
Not surprisingly, when homeopathic substances have been tested scientifically by double-blind experiments, no evidence has been found that they work any more than as a placebo. This was recently confirmed by a review in the Lancet of more than 100 different studies, which found that there was insufficient evidence that homeopathy is efficacious for any single clinical condition. The mechanism just cannot work. If it does work, it can only be by magic or miracle.
Of course, a placebo can be helpful, because when people believe that something works, it often does—or they get better anyway—but it is the equivalent of witchcraft. Placebos work in odd ways,
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Evidence-based medicine has brought huge benefits to mankind. It is disgraceful that this regulation rejects the evidence-based approach. It undermines the value of a licensing regime. There is still much public concern about tragedies such as thalidomide, and we have gradually improved the regulation of medicines based on scientific evidence. The Medicines Act 1968 was part of this progress. There have been further improvements since. That is what we have come to expect. Now we get this regulation. It is not surprising that it has come as a shock to the medical and scientific world.
Those who support evidence-based medicine in the strongest possible terms know that what is at issue here is the relationship of trust between the public and drug regulation. At Sense About Science, we have been inundated with expressions of concern. These include comments from the Royal Society, the Academy of Medical Sciences, the Medical Research Council, the Royal College of Pathologists and very many other scientific bodies. 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”.
Please note that that comes from the chairman of the MHRA, himself a professor of pharmacology.
The Royal College of Pathologists made the following statement:
“For the first time in its history the regulation of medicines has moved away from science and away from clear information for the public. The College is deeply alarmed”.
Thirdly, I quote the Biosciences Federation, which represents just about every relevant professional society in this field and has also expressed its extreme concern. It declared:
“The new regulations do not comply with the MHRA’s duty to ensure safety and efficacy of medicines, and to provide clear, honest advice to the public”.
How can the Government ignore these concerns? How could the MHRA possibly justify this regulation? As the Biosciences Federation points out, the MHRA is in breach of its statutory duties, yet no one from that official body has come forward to defend its regulation since it became clear that there is
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Can we envisage as a next step that the MHRA will weaken the requirements of scientific testing of drugs, because failure to do so would inhibit the expansion of the pharmaceutical industry? As I said, that is the reason explicitly given for this regulation in the case of the homeopathic industry. 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.
Moved, 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].—(Lord Taverne.)
The Countess of Mar: My Lords, it was very easy to predict that the noble Lord, Lord Taverne, would pray against these regulations, for his views on homeopathy are well known. I declare my interest in that I use homeopathy for minor ailments and as preventive measures. I see a qualified homeopath if I have something a bit more complex and I see my GP if I feel that I need his intervention. I firmly believe that those of us who do not wish to clog up our doctors’ surgeries with trivial complaints should be allowed to treat them in whatever way we wish so long as we are armed with accurate information.
These regulations are the result of protracted and wide consultation. They iron out existing anomalies whereby homeopathic medicines that existed before 1971 can carry therapeutic indications on their labels while those registered subsequently cannot. The regulations bring homeopathic medicines into line with the 2005 legislation on “traditional-use” herbal medicines. The information provided is required to be accurate.
Homeopathy is widely used by the general public, who will benefit by being able to choose remedies for minor, self-limiting ailments such as nausea, headache, and the common cold. While there have been no clinical trials for over-the-counter remedies such as cough expectorants, and their efficacy is refuted in the March 2006 51st edition of the British National Formulary, homeopathic medicines have been used for more than 200 years and there is wide bibliographic evidence to support their use and effectiveness. They are safe and, unlike many newly developed drugs for which strict testing is required, have never killed anyone. As the noble Lord, Lord Taverne, should know, the first principle of any therapy is, first of all, do no harm.
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The noble Lord complains that homeopathy is not evidence-based. His charity, Sense About Science, claims:
I agree that it is essential to protect the public from powerful new drugs, as has been clearly demonstrated by the recent Northwick Park drug trial that nearly killed six healthy young men. But what about the case of the withdrawal of Vioxx, in which the drug, used to treat arthritis, has been estimated to be responsible for between 88,000 and 140,000 extra cases of serious coronary heart disease in the USA?
The evidence base for many conventional medical treatments is still extremely weak. According to the recent British Medical Journal clinical evidence review of 2,404 conventional treatments, only 15 per cent were rated as beneficial, 22 per cent as likely to be beneficial, 7 per cent as a trade-off between benefits and harms, 5 per cent as unlikely to be beneficial, 4 per cent as likely to be ineffective or harmful, and 47 per cent of unknown effectiveness.
Sense About Science claims that homeopathy is not “evidence-based medicine”. This is utterly untrue. Despite a chronic underfunding of research, the effectiveness of homeopathy in many conditions is supported by randomised clinical trials including for childhood diarrhoea, hay-fever, post-operative ileus and osteoarthritis, all of which were the subject of meta-analyses with positive conclusions. It has proved effective with asthma, fibromyalgia, influenza, glue ear, side effects of radiotherapy or chemotherapy, pain, sprains, upper respiratory tract infections and vertigo—each of which has undergone at least two positive randomised control trials—as well as with anxiety, ADHD, CFS, IBS, migraine, PMS, seborrheic dermatitis and tissue trauma, each of which has been the subject of a single randomised control trial with positive results.
In addition, the six-year study at the Bristol Homeopathic Hospital, part of the United Bristol Healthcare Trust and one of five NHS homeopathic hospitals in the UK, published in the Journal of Alternative and Complementary Medicine, involved over 6,500 consecutive patients with chronic diseases. All were referred by their GP or hospital specialist and many had tried conventional medicine first. There is a group of patients for whom conventional chemical treatments either do not work or are contra-indicated. Many find homeopathy helpful. Over 70 per cent of the Bristol patients in this study reported positive health changes after homeopathic treatment.
The noble Lord states that the rules for the regulation of medicines should not allow homeopathic products to make unsubstantiated health claims. Two hundred years of bibliographic evidence, provings and traditional use are not unsubstantiated health claims. A proving is a qualitative research study observing and recording the experience of a group of healthy subjects who experimentally take a particular drug. Contemporary, qualitative, narrative-based research methods, which are becoming increasingly accepted in conventional medicine, are very similar to the techniques used in homeopathic provings.
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It seems extraordinary to me that, when faced with a phenomenon like homeopathy which is shown to work, normally credible scientists discard all the findings of numerous scientists such as Preparata, Del Guidice, Kunio Yasue and Louis Rey. 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. The results obtained were statistically significant. This was put down to human error. Professor Ennis then applied an automated counting protocol to the figures. 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. She is quoted as saying:
“The results compel me to suspend my disbelief and to start searching for rational explanations for our findings”.
2.30 pm
As is the way with the establishment that so readily dismisses evidence it does not like, the Royal Society attempted to debunk these results in a BBC2 “Horizon” programme. The experiment appeared on television but the findings were never published in a proper scientific journal, unlike Professor Ennis’s research. The 1994 publication in the Lancet of the results of the double-blind placebo controlled studies conducted by Dr David Reilly in Glasgow, which showed that homeopathy worked for asthma, were accompanied by an editorial comment:
“What could be more absurd than the notion that a substance is therapeutically active in dilutions so great that the patient is unlikely to receive a single molecule of it? Yes, the dilution principle of homeopathy is absurd; so the reason for any therapeutic effect presumably lies elsewhere”.
Perhaps the noble Lord, Lord Taverne, and his Sense About Science friends could be persuaded to suspend their disbelief for a while and, instead of looking for a biochemical answer, look for a nano-pharmacological or a bio-physical one. Quantum physics provides a tauntingly fascinating window on life and it may just be that, instead of opposing something that he does not understand, his eyes will be opened to a set of totally new concepts. I remind the noble Lord of a speech he made on 24 June 2004, at col. 323 in Hansard. He might recall that he was critical of radiation safety standards. In advocating the benefits of low doses of radiation he described an effect known as hormesis. The toxicological definition of hormesis is:
“A dose response phenomenon characterised by a low dose stimulation, high dose inhibition, resulting in either a J-shaped or an inverted U-shaped dose response. A pollutant or toxin thus has the opposite effect in small doses than in large doses”.
If that is what the noble Lord believes, he should be well on the way to accepting the principles of homeopathy.
I am glad that the Government have agreed to bring in these regulations. The range of products is limited to the treatment of relatively minor, self-limiting conditions. The regulations will bring uniformity to complementary medicinal labelling and provide consumers with informed choice. I ask the Minister to resist the Prayer of the noble Lord, Lord Taverne.
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Lord Turnberg: My Lords, my question for my noble friend the Minister concerns referral to NICE of homeopathic remedies. I should declare my interests as an ex-professor of medicine and ex-president of the Royal College of Physicians.
I can well understand the Government’s desire to try with these regulations to remove some of the confusion that can arise in the public’s mind, given that homeopathic water marketed before 1971 as a remedy could include an indication of what it was meant to treat, while water marketed after that date could be said only to be safe. Now we have the possibility that water that has been subjected to a “homoepathic proving”, in the words of the regulations, can have indications attached. It is unclear to me whether homeopathic proof is simply proof that is so dilute that none of the original is left, or something else. One way to find out is to refer this whole question to NICE so that it can examine it properly. Can I persuade my noble friend to refer homeopathic remedies to NICE?
Then there is the question of reporting of adverse events. That can be best illustrated by the case of homeopathic remedies for malaria, where I understand that patients seen at the Hospital for Tropical Diseases have had their definitive treatments delayed because they have been taking homeopathic remedies. That is a dangerous side effect of homeopathy, albeit indirect: it delays curative treatments. The problem here is that such reports go unreported, either through the adverse events system or through the drug side-effects route. Will my noble friend consider how such potentially dangerous effects of homeopathy can be reported in a systematic way?
Lord Jenkin of Roding: My Lords, I am glad the noble Countess is able to enjoy the benefits of homeopathic remedies, even if she does not know why. I find these regulations very disturbing, as the noble Lord, Lord Taverne, has already outlined. I referred back to Complementary and Alternative Medicine, the report in November 2000 of the Select Committee of this House chaired by the noble Lord, Lord Walton of Detchant. It is, as so many of these reports are, a mine of information and advice. In the summary of recommendations, the committee reported:
“In our opinion any therapy that makes specific claims for being able to treat specific conditions should have evidence of being able to do this above and beyond the placebo effect. This is especially true for therapies which aim to be available on the NHS and aim to operate as an alternative to conventional medicine, specifically therapies in Group 1”.
The House will no doubt be aware that homeopathy was listed by the committee in group 1.
However, looking through the report for greater clarification, I read that: “Many CAM”—that is, complementary and alternative medicine—
- “therapies are based on theories about their modes of action that are not congruent with current scientific knowledge. That is not to say that new scientific knowledge may not emerge in the future. Nevertheless as a Select Committee on Science and Technology we must make it clear from the outset that whilst we accept that some CAM therapies, notably osteopathy,
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It is noteworthy that the Select Committee did not include homeopathy in that list. That report was published six years ago. Has anything changed since then? Would a Select Committee looking at that today have included homeopathy in the list with the other treatments mentioned?
I turn to the question of research. I listened to the noble Countess with great interest. I hope the Minister will be able to confirm or comment upon what she said. The report says in chapter 7, “Research and Development”:
“To conduct research into CAM disciplines will require much work and resources, and will therefore be time-consuming. Hence, we recommend that three important questions should be addressed in the following order:
(i) To provide a starting point for possible improvements in CAM treatment, to show whether further inquiry would be useful, and to highlight any areas where its application could inform conventional medicine—does the treatment offer therapeutic benefits greater than placebo?
(iii) To help patients, doctors and healthcare administrators choose whether or not to adopt the treatment—how does it compare, in medical outcome and cost effectiveness, with other forms of treatment?”.
Has this research been done on homeopathy? If so, where, by whom and with what results? Has it been peer-reviewed? I hope the Minister will be able to answer those questions in his reply.
My central objection to the new regulations is that by bending the rules—the reference to “proven” results is quite different from the normal rules about effectiveness and safety—they appear to give an official imprimatur to treatments for which there is no scientific evidence of safety and efficacy. I find that very disturbing, as did the noble Lords, Lord Taverne and Lord Turnberg. I hope the Minister will be able to reassure the House.
Lord Rees of Ludlow: 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.
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