Medicines for Human Use (National Rules for Homeopathic Products) Regulations 2006

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. The noble Lord complains that homeopathy is not evidence-based. His charity, Sense About Science, claims: "““Evidence-based medicine has been a major public gain of the 20th century””." 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 health 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. 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””." 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.