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© Charles Lowe, August 2002 23 Heythorp Street London SW18 5BW Tel: 020 8874 2399 Mr David Byrne European Commissioner Health and Consumer Protection Bruxelles 3 rd August 2002 Dear Mr Byrne Re: The Traditional Herbal Medicinal Products Directive, the Food Supplements Directive, and the revised Medicines Directive I write to express my extreme concern. My information is that (i) 1000s of effective and popular dietary supplements (vitamins, nutrients and minerals) will be banned in their current high-dose form (ii) most safe and popular herbal remedies, some used for hundreds of years, will be forced off the market as they become subject to unnecessary tests and expensive licensing procedures (iii) flower essences, such as those invented by Dr Edward Bach and Dr Arthur Bailey, will be similarly controlled (iv) in future, it is planned to bring in impossibly-expensive licensing mechanisms for homeopathic remedies. The sector most affected by these moves is the alternative medicine sector, which includes western herbal doctors, traditional Chinese medical doctors, homeopaths, naturopaths and flower essence prescribers. As you will no doubt be aware, this sector provides effective treatment to hundreds of thousands of satisfied patients in the UK, and millions all over Europe. It is understandable that yourself and MEPs feel you are not experts in medical science and should follow the advice of the experts in the European Scientific Committees on Food and on Medicine. But there is something genuinely sinister about the motivations behind these moves against alternative medicine, and for this reason alone I think one has to be very sceptical about them. There is simply no representation from experts in alternative medicine on those committees. As the Commissioner, are you not concerned about this? At the very least, is there reason to doubt the validity of the recommendations which led to the new regulations. If I can show you that these medicines do not need regulating, I hope you will support the campaign to have the Directives undone. My concerns are: First , these moves have not been prompted by public disquiet , and they have been introduced with almost no public discussion or media comment. It was a revelation to hear that crucial votes had been taken in Brussels in March and then May. I understand that further important votes will be taken in August. In the UK, when votes are approaching in the Commons, there is usually a good deal of public discussion which can inform them. In European Commission and Parliament votes, there is precisely none, at least none that is discernable. This is not only undemocratic, it is wrong, and can not be accepted in a modern democracy. To add insult, there appears to be (i) no way for Directives to be repealed, amended, or improved, once they have gone into law (ii) inordinate speed in passing the law once it is drafted, thus allowing little time for the pubic to track its progress. Second, the issue of the make-up of the EU scientific committees. These committees' advice is the basis on which decisions are made, and on which EuroParl members place their votes. In other words, experts sit on committees which inform regulators. In a Reuters article (Feb 5 2002), a Professor Detsky of Toronto Hospital found, in a survey, that over half of the members of regulatory advisory boards were paid supplementarily by pharmaceutical companies. It is surely obvious that this will lead to the pursuance of the wider interests of those companies when policy recommendations are made. The independence of these experts must clearly be in inverse proportion to the commercial power of the organisation which funds them. All I ask for is (i) that those committees be seen to include experts from the alternative medical sector, when the object of the legislation is alternative medicines (at present, both European Commission scientific committees relevant to this matter contain exactly zero alternative medicine experts) (ii) the type of science used in analysing the medicines is in accordance with the principles of the specific alternative medicine under scrutiny, and is not the science of the prevailing medical orthodoxy (it has been clear for years that placebo-controlled double-blind trials can not be used, for instance, to test homeopathic medicines, acupuncture, or herbal medicine, because those medicines all treat individuals not diseases). Third, the issue of the type of science used to evaluate the substances concerned, and the nature of ‘evidence'. The paradigm used for research into medicines is (i) not the only paradigm that exists (ii) not suitable for individualised medicinal treatment, especially acupuncture and homeopathy, and including herbal treatment. The prevailing paradigm has colonised the norm so that people think it the only way it can be done. The aim of the orthodox paradigm is to find a generalised principle for a particular drug, by using the same drug on a group of people in a statistical, randomised, placebo-controlled, double-blind trial. The aim of the alternative paradigm is to show how longitudinal individualised treatment is effective on the basis of individualised diagnosis, by using individual remedy sequences on individual patients. Any general observations that can be made are derived from collecting and collating the clinical evidence in those case histories, but those general observations are then used to enhance practitioners' awareness of individual remedy action, not to make drugs for general application. For example, in the orthodox paradigm a new asthma drug will be tried on a large group of people. In the alternative paradigm, a group of patients with asthma will all be given individual treatment over time, and will be given different prescriptions depending on their individual constitutions. The success of treatment by alternative medicines can only be assessed in this way. Fourth, the issue of public safety . It is said that the motivation of these directives is to protect the public, which of course is a laudable and indisputable claim. But where is the evidence that the public need protecting more than they already are? There is already professional regulation, as in the case of herbal, acupuncture/TCM, and homeopathy. And there is ample UK law requiring safe labelling of vitamins and minerals on dietary supplements. This is a really important issue (i) because a reduction in the availability of high-dose vitamins really will be detrimental to public health (I have personal experience of combining high Vitamin E and Magnesium which have dramatically improved the health of my lungs) (ii) there is plain evidence from some Euro MPs who have written to me that the rationale for these trans-European changes was commercial harmonisation not public health. There is a spurious claim that there are side-effects to vitamin and mineral supplements, and to herbal remedies, and that the public need to be protected against these. If this were true, we would surely have heard of instances of these side-effects. But there have been no recorded deaths or serious illnesses from vitamin use, and in the hands of qualified practitioners, overdose of herbal medicine is virtually impossible. And as for homeopathy, it is widely known as ‘the gentle and safe medicine'. Compare this with even the most basic pharmaceutical medicine, Paracetomol. In the UK alone some 260 people a year die from accidental overdose from over-the-counter Paracetamol poisoning. Yet this is not to be banned. Indeed an antidote could be included in the tablets to protect the liver and so save all these lives, but because it would approximately double the production cost, the drug companies have not done it. Moreover, it has been estimated that the side-effects of cholesterol-blockers and other pharmaceutical drugs have become the 4th most common cause of premature death in the industrialised world. Even the pharmacists' handbook, the British National Formulary, lists potential side-effects and warnings for every pharmaceutical drug. Fifth, it is implied that the alternative medical sector has behaved partially and uninformedly in this matter , and that they are not interested in public safety. The alternative medicine sector is interested in public health , and has proved this commitment for decades. Firstly, for an undemocratic institution such as the European Commission to deny freely chosen public access to alternative medical treatment is unprincipled and wrong. Secondly, apart from one single death from self-administered Chinese herbs, there has literally been no public anxiety about the safety of herbal or homeopathic medicines – only about whether they worked, which is another matter! Compare this with the 1000s of deaths a year from pharmaceutical drugs. The effect of reducing the availability of high-dose dietary supplements, and herbal medicines, which will be the inevitable result of the testing regimes imposed by the new laws, will harm public health, just when complementary and alternative treatment is beginning to have a truly remarkable effect across Europe and the US. Euro MPs do know this is true, in their hearts. And yet they seem prepared to stand back and let it happen. To let the conventional orthodoxy dominate, to let alternative treatments become prohibitively expensive just when we desperately need less expensive healthcare, and to effectively emasculate CAM at a time when the public is more and more turning to it, is absolutely wrong in my view. Sixth, the move to limit freedom of choice goes against everything in the European Union charters , and everything in the original ideals that produced the social, cultural, political, and economic adventure that is Europe. I am only interested in protecting my health by methods which work and which I choose for myself, not by methods forced on me by European Union diktats. These methods include herbal and flower essence medicine, high-dose vitamin, nutrient and mineral supplements, and homeopathy. It is absolutely wrong that the public should ever be prevented from having these choices. Seventh, there will be a decline in public health if these cheap, popular and effective alternative medicines are forced into oblivion. This is not a small issue. For instance, it has been shown by many studies since the 30's that liberal access to high-dose vitamins (especially ‘C') would dramatically improve patients' ability to prevent, and reverse(!), heart conditions, lung conditions, cardiovascular conditions, osteoporosis, diabetes, and a range of other ailments. Indeed, in the USA, vitamin-therapy has been largely deregulated, and UK law already requires food supplements to be safe and properly labelled. It is clear that the patients of alternative practitioners get better from combined and holistic treatments. If their remedies are curtailed, the consequences for patients will be unconscionable. European legislators need seriously to consider whether they have the will to oblige millions of patients into orthodox medicine against those patients' express will. Eighth, the issue of anti-nutrients. Perhaps an area of total non -involvement by Brussels will serve to highlight the irony and absurdity of these moves still further. Anti -nutrients are those trace chemicals in processed food, food packaging, and in our environment, that chronically and insidiously debilitate the body's ability over time to detoxify itself and fight disease. They include: food additives (e.g. tartrazine), organophosphate pesticides, synthetically carbonated drinks, phthalates and bisphenol-A in soft plastic food wrapping, and so on and so on. What is the European Parliament doing to control these substances? Is the European Commission even interested? In conclusion, I am not against orthodox medicine at all. Indeed, in areas like accident, emergency and life-enhancing surgery, it has a strong place in the whole range of health medicine. And I always support moves genuinely to protect the consumer against aggressive marketing and unsafe products. But there is evidence that these moves are not genuinely motivated by the principle of consumer protection – commercial harmonisation and protection of the pharma-medical industries being the other two motives suggested to me in several MEPs' letters. It is not tolerable, in the modern world of free choice and under the apparent respectability of official regulation, that my right of access to already safe and effective natural treatments, and also my right to health and well-being, are being violated. The planned laws banning vitamin therapies and other side-effect-free natural health treatments are not improving my health, so who do they benefit? I think these moves to change the status quo are wrong. As well as the economic drain on state health services across Europe, there is the threat to the small but significant alternative medicine industry which treats a great number of people in this country and Europe; there is the threat to consumer freedom; and above all there is the threat to the health of millions.So finally, I am asking you to do everything in your power , both administratively and politically, to prevent these draconian Directives from going forward in their present guise. Can I ask you especially to ensure the inclusion of alternative medicine experts on all legislative consultative bodies. And can I ask you to as well, to make sure that the legislation that is passed can be amended and improved in the future, as necessary. Please would you also keep me informed of developments. With thanks in advance. Yours sincerely Charles Lowe |
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Southfields Homeopathic Practice |