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Letters to the Editor Issue 129

by Letters(more info)

listed in letters to the editor, originally published in issue 129 - November 2006

Vitamins Fight Multiple Sclerosis

New research confirms that niacinamide, also known as vitamin B-3, is a key to the successful treatment of multiple sclerosis and other nerve diseases.1 Niacinamide, say researchers at Harvard Medical School, “profoundly prevents the degeneration of demyelinated axons and improves the behavioral deficits.”

This is very good news, but it is not at all new news. Over 60 years ago, Canadian physician HT Mount began treating multiple sclerosis patients with intravenous B-1 (thiamine) plus intramuscular liver extract, which provides other B-vitamins. He followed the progress of these patients for up to 27 years. The results were excellent and were described in a paper published in the Canadian Medical Association Journal in 1973.2

Mount was not alone. Forty years ago, Frederick Robert Klenner MD of North Carolina, was using vitamins B-3 and B-1, along with the rest of the B-complex vitamins, vitamins C and E, and other nutrients including magnesium, calcium and zinc to arrest and reverse multiple sclerosis.3,4 Klenner’s complete treatment program was originally published as “Treating Multiple Sclerosis Nutritionally,” Cancer Control Journal 2:3: p 16-20. His detailed megavitamin protocol is now posted for all interested persons to read at www.tldp.com/issue/11_00/klenner.htm

Drs Mount and Klenner were persuaded by their clinical observations that multiple sclerosis, myasthenia gravis, and many other neurological disorders were primarily due to nerve cells being starved of nutrients. Each physician tested this theory by giving his patients large, orthomolecular quantities of nutrients. Mount’s and Klenner’s successful cures over decades of medical practice proved their theory was correct. B-complex vitamins, including thiamine as well as niacinamide, are absolutely vital for nerve cell health. Where pathology already exists, unusually large quantities of vitamins are needed to repair damaged nerve cells.

Nutritional therapy is inexpensive, effective and, most important, safe. There is not even one death per year from vitamins.[5]

Vitamin supplementation is not the problem; it is under-nutrition that is the problem. Vitamins are the solution.

Restoring health must be done nutritionally, not pharmacologically. All cells in all persons are made exclusively from what we drink and eat. Not one cell is made out of drugs.

References
1.    Kaneko S, Wang J, Kaneko M, Yiu G, Hurrell JM, Chitnis T, Khoury SJ, He Z. Protecting axonal degeneration by increasing nicotinamide adenine dinucleotide levels in experimental autoimmune encephalomyelitis models. J Neurosci. 26(38): 9794-804. 2006. www.ncbi.nlm.nih.gov/entrez/query.fcgi?CMD=search&DB=pubmed
2.    Mount HT. Multiple sclerosis and other demyelinating diseases. Can Med Assoc J. 108(11): 1356-1358. 1973.
3.    Frederick R Klenner. Response of Peripheral and Central Nerve Pathology to Mega-Doses of the Vitamin B-Complex and Other Metabolites. Journal of Applied Nutrition. 1973. www.tldp.com/issue/11_00/klenner.htm
4.    Frederick R Klenner Clinical Guide to the Use of Vitamin C (which discusses orthomolecular therapy with all vitamins, not just vitamin C) is now posted in its entirety at www.seanet.com/~alexs/ascorbate/198x/smith-lh-clinical_guide_1988.htm It includes a multiple sclerosis protocol, which takes up about five pages. See also: www.doctoryourself.com/klennerpaper.html
5.    Watson WA et al. 2003 annual report of the American Association of Poison Control Centers Toxic Exposure Surveillance System. Am J Emerg Med. 22(5): 335-404. 2004. www.aapcc.org/Annual%20Reports/03report/Annual%20Report%202003.pdf

Further Information
Correspondence: Andrew W Saul, Editor omns@orthomolecular.org drsaul@doctoryourself.com www.orthomolecular.org

EU Directive Update: Nutritional Therapy at Risk

by Robert Verkerk BSc MSc DIC PhD

Anyone with an interest in nutritional therapy better heed some of the madness going on in the EU. We at the ANH are working flat out to help create a paradigm shift in EU risk assessment and management because, without it, therapeutic dosages of food supplements could be made illegal within a year or two.

Food Supplements Directive
This Directive is in force, but, being a framework Directive, it only presently applies to vitamin and mineral ingredients allowed in food supplements. The EU is in the process of developing approaches that allow it to set maximum levels (dosages) of vitamins and minerals that can be used across the EU. They will effectively set the borderline between food and medicinal use of nutrients. You may recall that we challenged this first aspect of the Directive in the High Court London and were then successfully referred to the European Court of Justice. When the European Court handed down its ruling in July 2005, it was apparent that there were a number of key areas of clarification and narrowing of scope that were at odds with the European Commission and Member States’
interpretations of the Directive (including that of the UK). We will be going back to Court (funds permitting) in an attempt to translate these gains into the UK Statutory Instruments, which should in turn trigger similar changes in other Member States.

Risky business
The approach being used masquerades as ‘scientific risk assessment’ but really it reeks of pseudo-science, big dollops of politics and is the product of over-zealous precautionary thinking, designed to neuter nutritional therapy. In short, it runs the risk of making
illegal virtually all doses of vitamins and minerals that clinical nutritionists consider to be therapeutic.

Interactions between natural
products and the huge array of human genotypes, which are in turn affected by a diversity of different environmental conditions, internally and externally, are intrinsically complex. Any scientist will tell you if you use a model to establish a biological parameter, that model should be as simple as it can be, while still out-putting data which can be separately validated as realistic. The models under consideration by the European Commission are in the main at least in part those that have been used to establish Upper Safe Levels (USLs) by various regulatory authorities around the world, and they are fundamentally extremely simple (too simple we say), are steeped in the precautionary principle, and avoid any consideration of the benefits of nutrients. They are also applied to nutrient groups, not individual forms, meaning that maximum levels for the most toxic form within a given group will then be (mis)applied to all other members of the same group.

Models Used to Establish Nutrient Safe Limits

The model has two parts. The first uses ‘scientific risk assessment’ procedures to determine the so-called USL, while the second part – the political, risk management part – starts with the USL and ends with the regulator’s end-point, the Maximum Permitted Level (MPL). The first USL part relies on the risk assessor to review the literature, including both human and animal studies, and select papers (while ignoring key ones in the process!), which allow the No Observable Adverse Level (NOAEL) to be deduced. Clinical experience and medical records are off the agenda entirely. This NOAEL thus provides a level that is known to be safe, with no indication of the dose above it that might induce an adverse effect. This already safe dose level is then divided by an arbitrary Uncertainty Factor (UF), which is used to account for the fact that animal, or even human, data might not be that accurate – and the UF is varied according to the seriousness of the likely adverse effect. So it might be just 2 for a mild effect like flushing caused by niacin, or 3 for bowel intolerance caused by vitamin C, while it might be 100 if there is the potential for liver toxicity. So this process yields the USL and gives us familiar levels such as 1000 mg for vitamin C, 50 mcg for vitamin D, 25 mg for vitamin B6, and so on.

Flawed Risk Calculations by Risk Managers

This is all very well if these were going to be the regulatory end-points (as many have wrongly assumed) – but we now have to hand the process over to the Risk Managers and let them dilute the USL further to give us politically-influenced, non-therapeutic levels of nigh on nothingness! The Risk Manager’s job is clearly described in Article 5 of the Food Supplements Directive, and involves simply subtracting dietary intakes from the USL and adjusting for any known sensitivities in population sub-groups. Don’t be surprised that European Risk Managers are subtracting the highest (not average) levels (95th centile) of dietary intake, and they are using sensitivities that are derived from either irrelevant or flawed studies. The results, to use the examples given above, as determined by the German Federal Institute for Risk Assessment, which has largely masterminded and controlled this process in the EU, are 225 mg for vitamin C, 5 mcg for vitamin D and 5.4 mg for vitamin B6. Are these levels compatible with nutritional therapy? I think we all agree they are not…

Robert Verkerk BSc MSc DIC PhD
Executive & Scientific Director, Alliance for Natural Health Tel: 01306 646 550
robv@anhcampaign.org www.anhcampaign.org

Further Information
Please visit www.anhcampaign.org and download the recent consultation response by the ANH to the European Commission on the setting of maximum levels at: www.alliance-natural-health.org/ _docs/ANHwebsiteDoc_251.pdf

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