Website editor’s note: The information below is a press release about the Natural Health Products bill by Dr Guy Hatchard. For background information on the impact that the Natural Health Products bill could have on New Zealanders’ health; for more information about this bill (and a link to a petition about the bill) please click HERE.
PRESS RELEASE 27th May 2016
Ten Reasons Why The Assessment Process For Herbs Adopted By Medsafe Under The Natural Health Products Bill Lacks Scientiﬁc Credibility
Why are hundreds of commonly used traditional herbal ingredients being restricted or banned by the Natural Health Products Bill; so many in fact that traditional herbal medicines and many supplements are at risk of disappearing from retail shelves? Natural health product producers are now required to apply to Medsafe for permission to continue to use all their traditional ingredients. Traditional herbal ingredients have been used safely and effectively for thousands of years. 50% of New Zealanders use natural health products. Many people with serious conditions rely on natural health products to stay healthy. Many of these will no longer be available. Yet a scientiﬁc report compiled in the EU rates the risk of natural health products as de minimus, — effectively zero.
So what has gone wrong? Contrary to assurances given to Parliament, the approval process is being administered by Medsafe, our pharmaceutical regulator. Medsafe is unqualiﬁed to regulate natural health products because it knows very little about herbal products or traditional medicine. Doctors receive minimal training in nutrition and none in traditional medicine. Despite the appointment of an advisory committee of herbalists, and despite clauses in the draft Natural Health Products Bill mandating that evidence of safe traditional use should be accepted, Medsafe is still insisting that evidence of traditional use is often insufﬁcient and has decided to utilise the pharmacological models of testing it is familiar with.
Here are ten reasons why the assessment methodology used by Medsafe to compile its draft list of controlled substances has gone drastically wrong.
1) Medsafe is using a pharmaceutical assessment model which is only appropriate for single ingredient allopathic drugs. This will impose huge costs on the industry and lead to invalid results.
2) Medsafe is using toxicology data gathered from synthetic copies of plant alkaloids to restrict the plants themselves ignoring the well established fact that synthetic copies hardly ever exactly match the originals (see Addendum 1 below).
3) Medsafe proposes to permit the use of 3000 synthetics and chemicals in natural health products without adequately testing for safety, relying on the discredited principle of substantial equivalence.
4) Medsafe is committed to the ‘active ingredient’ paradigm of allopathic medicine which ignores the established fact that the whole plant has actions that are different from its component parts.
5) Medsafe ignores the fact that a whole plant is more easily recognised and assimilated by the body’s digestive and metabolic processes.
6) Even if there is a long history of safe use, Medsafe is applying the so called ‘rule of doubt’ to restrict the use of many herbs, which has been ruled inappropriate by EU courts (See addendum 2).
7) Medsafe has no knowledge of traditional herbal preparation procedures speciﬁc to particular plants which enhance digestion and ensure their effects are purely beneﬁcial.
8) Medsafe is ignoring the scientiﬁc fact that a history of safe use is a far better measure of safety than research based on Random Controlled Trials (RCTs) (see Addendum 3 below).
9) Medsafe has no knowledge of the synergistic effect of combining herbs which is understood by herbal traditions and which is increasingly being recognised by modern scientiﬁc research.
10) Medsafe has no knowledge of carrier ingredients of multi-ingredient herbal products which are used to facilitate the digestion and metabolism of key healing herbs. Dr Guy Hatchard, a researcher, is formerly the Natural Health Products Director at Genetic ID, a global food testing company. With an alliance of Natural Health companies, practitioners, scientists, and individuals, he is mounting a legal challenge to the Natural Health Products Bill. Contact: Dr Guy Hatchard
Ed note: Emails to our Contact Form will be forwarded to Dr Hatchard on request.
PRESS RELEASE 27th May 2016 Addendum
1) Plant alkaloids and other plant components have complex molecular structures which are very difﬁcult to synthesise in the laboratory. Almost always synthetic copies are compromises with apparently minor differences in structure. However results of clinical trials show that even the shape of a synthesised molecule, or other minor differences between the synthesised molecule and the plant molecule, can radically affect metabolic and pharmacological action. Some studies have concluded that small differences, such as a difference of even few degrees in the angle between a benzine ring and a hydroxide group, can be sufﬁcient to completely change its action in the human body. In some cases this generates unexpected toxic effects. Moreover the process of isolating a single component of a plant from the whole plant can be sufﬁcient to nullify or change its metabolic action. Therefore results of toxicological assessments of synthetic copies of plant alkaloids or isolated single components cannot not be reliably used to assess the safety of whole plants.
2) Some herbs are being restricted under the NZ Medical Regulations 1984 by Medsafe, who are insisting applicants are responsible for the huge cost of building a scientiﬁc case if they disagree. In a similar way, some states in the EU had sought to justify this kind of strict interpretation of medical regulations by referring to the so called ‘rule of doubt’ under Article 2(2) of the Medicinal Products Directive. They argued that they were justiﬁed in restricting a plant as a medicine because they were in doubt as to its exact physiological effect. This approach was thrown out by the courts who stated that if there is doubt, the authorities themselves must conduct and fund detailed research to justify their position before imposing restrictions on a plant or herbal supplement. The court ruled that the Medicinal Products Directive “does not apply to a product in respect of which it has not been scientiﬁcally established that it is a medicinal product by function, even if that possibility cannot be ruled out” (ECJ Judgment of 15 January 2009, Hecht-Pharma GmbH v Staatliches Gewerbeaufsichtsamt Lüneburg, Case C-140/07). Thereby plants fall out of the scope of medicine regulations unless the authorities, having regard to the whole of the products’ characteristics, prove to the contrary. In any case, classiﬁcations of traditional medicinal herbs as restricted medicines violates international patent law and the traditional rights of indigenous communities.
3) Modern allopathic medicines assessed by clinical trials have accepted a far, far greater degree of risk than traditional medicine. The FDA reported that in 2014 123,000 people in the USA died from the side effects of ‘properly’ prescribed allopathic medicines, while 800,000 had serious adverse outcomes. The FDA report also records that adverse reactions to prescription drugs have tripled during the last ten years. Adverse drug reactions are now the third leading cause of death after heart disease and cancer for all age groups. In the UK, one third of hospital admissions for the over 75s are due to adverse drug reactions and one quarter of those patients die as a result. There is no documented case of a death occurring in NZ through the consumption of a natural product. Therefore according to the core regulatory principles of the NHP bill there is little or no justiﬁcation for any regulation beyond veriﬁcation of a history of safe use and the veriﬁcation of safe manufacturing processes which is already taking place here under existing law. The epidemic of side effects from modern medicine has arisen under a safety process dominated by random controlled trials (RCTs). In most cases serious side effects are not anticipated by the results of clinical trials. It important to note that widespread use over time is considered a better indicator of safety and efﬁcacy than the results of clinical trials even when considering allopathic medicine. RCTs are a poor indicator of safety because they tend to focus only on one or two outcomes, when in fact safety requires an examination of a great number of variables or potential outcomes. This level of safety is only available when long term safe use is veriﬁed. This is the case with traditional systems of medicine. In fact, it is far, far safer to take a traditional herbal medicinal product than it is to consume a bowl of salad. A signiﬁcant history traditional safe use is considered to be the premium criteria to use when evaluating any medicinal product and should be used for herbs.
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