NATURAL HEALTH PRODUCTS TO INCLUDE ANIMAL SOURCED MATERIALS

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The CAM in UME Project ‘This material is made available through The CAM in UME Digital Resource Repository and is owned and copyrighted by the credited author(s). Materials are provided for educational purposes only. All copied materials ‘must contain clear and proper citation. HERBAL DRUGS: NATURAL HEALTH PRODUCTS TO INCLUDE ANIMAL SOURCED MATERIALS Kanji Nakatsu, PhD Queen’s University March 2005 URL: http://www.caminume.ca/drr/resources/00020.ppt 33 slides ‘The CAM in UME Project does net warrant or assume any legal liability or responsibility for the ‘accuracy, completeness, or usefulness of any information presented herein. 

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Herbal Drugs Natural Health Products to include animal sourced materials Medical Pharmacology March 2005 Dr. Kanji Nakatsu © K Nakatsu, 2005 

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Outline * Relevance * Definitions * Regulation * Common Herbals © K Nakatsu, 2005 

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Relevance * Over % (perhaps1/2) of the Canadian adult population have taken a natural health product in the past year. * More than 1/2 of Canadians using complementary or alternative medicine did not disclose this to their physicians. Increasing number of natural health products for sale in Canada. Most of these are sold through stores (including mail order) other than pharmacies ۰ Estimated sales >$1 Billion * Potential adverse interactions with conventional treatments. The potential for this increases when the doctor does not know that the patient is taking NHP. © K Nakatsu, 2005 

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Why are people using NHPs? * Influx of web-based information. As with other topics the quality of the information is uneven, spanning the range from good, useful information to misinformation. * Concern over the safety of conventional medication * Cost of conventional medication * Lack of faith in conventional medication ¢ Hope for a cure of incurable/chronic disease- cancer amygdalin * Belief that natural is non-toxic © K Nakatsu, 2005 

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Definitions * Drug (conventional medicine) - chemical substance, non-nutritive ¢ Traditional Herbal Medicine (THM) - “a finished drug product intended for self-medication that contains, as active principles, herbal ingredients that have received relatively little attention in world scientific literature but for which traditional or folkloric use is well documented in herbal references” © K Nakatsu, 2005 

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Definitions ¢ Natural Health Product - “a plant or its extract, a vitamin, mineral, amino acid, probiotic or essential fatty acid whose purpose is to prevent or treat disease, restore or correct an organic function, or maintain and promote health. - Example- St. John’s Wort, chondroitin sulfate © K Nakatsu, 2005 

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Scope of NHPs . Aplant or a plant material, an alga, a bacterium, a fungus or a non-human animal material . An extract or isolate of a substance described in item 1, the primary molecular structure of which is identical to that which it had prior to its extraction or isolation . Any of the following vitamins: biotin folate niacin pantothenic acid riboflavin thiamine vitamin A vitamin B, vitamin B,, vitamin C vitamin D vitamin E 4. An amino acid 5. 6. A synthetic duplicate of a substance described in any An essential fatty acid of items 2 to 5 7 ۷۸۵۲۵۲۵1 

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Exclusions ¢ Vitamin K * Foods - Garlic is used by some people as a herbal remedy but mostly it is used as food * Prescription drugs prepared from natural sources * Products made by practitioners, such as naturopathic doctors © K Nakatsu, 2005 

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‎Mili UL soo pVitove 1 ۸‏ ا ‎Conventional Medicine to‏ ‎Complementary & Alternative‏ ‎Medicine (CAM)‏ ‎© Utter disdain, nut they stin accept that some of their ‎patients are using CAM ‎٠ Reluctant acceptance ‎* Acceptance that CAM may have a place, depending on the form © Participation some doctors do some forms of CAM ‎© K Nakatsu, 2005 

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Natural Health Products, Quackery or Quality * Alternative 1- NHPs are dangerous, poisonous, ineffective ¢ Alternative 2- NHPs are good drugs that just haven’t received formal approval ۰ Alternative 3- between 1 and 2 © K Nakatsu, 2005 

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Position of NHPs Poison Real Drug Aristoloc St. 7 Artemesin hic Acid John’s in Wort © K Nakatsu, 2005 

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Prescription Drugs from Natural Sources ۰ Digoxin- heart failure- foxglove ٠ Atropine-autonomic-Deadly nightshade * Ephedrine- autonomic- Ephedra * Quinidine- anti-arrhythmic- Cinchona tree bark * Penicillin- antibiotic- mold * ~25% of prescription drugs have botanical roots (no pun intended) © K Nakatsu, 2005 

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Current NHP > Prescription Drug * Moss Extract from Traditional Chinese Medicine 4perzn serrcs Sed for improving memory * Identification of huperzine A as active ingredient ۰ Recruiting for phase II clinical trials in USA by NIH for Alzheimer’s Disease http://www.clinicaltrials.gov/show/NCT0008359 0 © K Nakatsu, 2005 

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Huperzine No 2 0 ‏بجاو / زر‎ Nu ۱ 1 Huperzin Huperzin eA eR © K Nakatsu, 2005 

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Concerns with NHPs * Lack of efficacy data; often information is anecdotal * Lack of safety data- public often assume that they are safe to use because they are “natural” * Intentional adulteration - Rx medications found in NHPs. See Health Canada Warnings; NSAIDS, heavy metals, steroids etc * Confusing literature * Unknown active ingredients Marker molecules can be used to standardize products. These are anticipated to either be the active ingredient or associated with the content of active ingredient in the product. © K Nakatsu, 2005 

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Concerns with NHPs (cont’d) ¢ Lack of quality control. * Unknown active ingredients. Marker molecules can be used to provide some consistency. * Poorly designed studies ¢ Toxicities poorly defined. Some are mild, but some can be lethal. Aristolochic acid is carcinogenic and nephrotoxic ¢ Drug interactions with prescription drugs © K Nakatsu, 2005 

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Regulation * Little attention until 1990s * Creation of Natural Health Products Directorate, NHPD ٠ New Regulations- implementation started January 2004. - Expect evolution as this is new work for Health Canada ¢ Affect manufacturers, distributors, importers, packagers and labelers ٠ All products that fit under the NHP definition must obtain their product licenses by December 31, 2009 ¢ Future Regulations: - Claims: structure-function, risk-reduction, and treatment - Standards of Evidence: varies with type of claim © K Nakatsu, 2005 

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Application for license ¢ An application for a product license must include specific information about the NHP, for example, the quantity of the medicinal ingredients it contains, the specification it complies with, the recommended use or purpose for which the NHP is intended to be sold, and the supporting safety and efficacy data. The NHPD is developing a standards of evidence framework and guidance documents © K Nakatsu, 2005 

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Safety and Efficacy * performance standard, applies to an application which references a monograph in the Compendium of Monographs developed by the NHPD. Medicinal ingredients are the focus of the monographs, and are developed based on public literature. The Compendium of Monographs will ease the administrative burden on industry and ensure more efficient processing of product license applications. Development of single- medicinal ingredient monographs is ongoing. The monographs provide support for the safety and the claim of the NHP, and therefore additional safety and efficacy data are not required in the application for a product license. © K Nakatsu, 2005 

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USA Regulations * Covered by Dietary Supplement Health and Education Act, 1994 * NHPs are considered to be food supplements and not regulated as drugs ¢ Affords less control than Canadian Regulation - Androstendione has just been ruled as not being a food supplement in USA - Makes people like baseball players famous © K Nakatsu, 2005 

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NMFS and 1160111 01 Population ٠ Include consideration of NHPs as part of the drugs that people are taking- interactions & toxicities * General knowledge of extent of NHP usage * Knowledge of source of information Good reliable web sites and books. ¢ Evidence based medicine should be applied to NHPs - achallenge because there is so little evidence for the basis of judgment © K Nakatsu, 2005 

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Evidence-based Medicine * Standards of evidence * Prospective, double-blind controlled trial is desirable * Not all current conventional practice is based on such evidence ٠ Hormone replacement therapy - started well - currently evidence against original © K Nakatsu, 2005 

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Where to find information + Natural Health Products Directorate - hittp://www.he-sc.gc.ca/hpb/onhp This is anticipated to be a stable site with valuable information. + Camline - www.camline.org. This site has valuable information but its stability is uncertain. Much depends on whether good people continue to develop and maintain it. * Chandler, F. Herbs: Everyday Reference for Health Professionals. Ottawa: CPhA & CMA, 2000. This is a very useful reference with credible sponsors. It is limited in its coverage. Its continuing value will depend on regular revisions. + National Centre for Complementary and Alternative Medicine ~ http://nccam.nih.gov - This anticipated to be a stable site with valuable informtion. ¢ Bracken Library- Natural Standard © K Nakatsu, 2005 

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Common Herbals ¢ Glucosamine * Black Cohosh * Garlic ¢ St. John’s Wort * Echinacea * Ginsing * Ginkgo Biloba © K Nakatsu, 2005 

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Glucosamine -collagen component Uses: osteoarthritis, prevent inflammation C/I-none known A/E-mild GI, drowsiness, h/a Dosage: 1500mg po div TID, or 400 mg IM/IV (caution in diabetics) © K Nakatsu, 2005 

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Glucosamine * Chuoosuvice- uview-wouwsupcharide ‏لوص لمم‎ io Kuwoos. (sed ia bivspuhesis ‏مس له‎ poswpoords, suck us ‏له محر ,مور‎ ‏,ات تور‎ ¢ Reduces pain in humans, increases joint space in rats * Evidence indicates efficacy in osteoarthritis of the knee © K Nakatsu, 2005 

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Black Cohosh Estrogen-like activity? Uses: menopausal symptoms, PMS, dysmenorrhea C/I: preg/lact, estrogen dependent tumours, estrogen receptor activity?. A/JE: h/a, GI Dosage: dried extract equivalent to 160 mg of dried root or rhizome per day © K Nakatsu, 2005 

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Garlic Allicin, diallyl sulfide, ajoene (sulfur based compounds) Uses: hyperlipidemia- some evidence of mild effect -immune enhancer etc no evidence C/I: none known A/E: odour, t bleeding time Dosage: fresh garlic 1-5 cloves/day, oil 0.25mg/kg Intxns: anticoagulants © K Nakatsu, 2005 

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St. John’s Wort ¢ Hypericin, hyperforin * Uses: depression (comparable to TCAs and SSRIs, SAD, anxiety) * Evidence of effectiveness in mild- moderate depression, but not severe depression * C/I: none * A/E: photosensitivity, restlessness * Intxns: theophylline, warfarin, indinavir,cyclosporine, SSRIs induces Cytochrome P4503A4 

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Echinacea E. angustifolia (N.A.), E. purpurea (Germany) Uses: immune stimulation, cold, flu, prevent of yeast infections Treatment of upper respiratory tract infections in adults- some evidence C/I: autoimmune diseases A/E: hepatotoxicity, | sperm ability to penetrate egg Intxns: cancer chemo, immunosuppressants, warfarin © K Nakatsu, 2005 

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Ginseng Panax quinquefolius (N.A.), Panax ginseng (Oriental); white vs. red ginseng, do not confuse with Siberian Ginseng (Eleuthero) Uses: stress, impotence, BP Probably useful for improving mental performance and type 2 diabetes. C/I: preg/lact, hyperactive children A/E: HTN, diarrhea, insomnia, mastalgia, vaginal bleeding Intxns:warfarin, BP meds, estrogen, hypoglycemics, MAOIs, caffeine, psychotherapeutics © K Nakatsu, 2005 

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Ginkgo Biloba Uses: ischemia assoc with periph arterial disease, dementia C/I: caution in pts on meds affecting hemostasis A/E: 7 risk of bleeds, GI upset, h/a Intxns: anticoagulants, NSAIDs © K Nakatsu, 2005 

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Important issues regarding NHPs ¢ Wide use in Canada * Possibilities of useful therapies * Possibilities of harmful effects and interactions * Evolving regulation * Quality control © K Nakatsu, 2005