Health Matters
From "Maple Street Co-op News", Jun/Jul 2004

Natural Health Products: Guilty Until Proven Innocent? – Part 3
by Kathryn Alexander, DThD

It is estimated that between 40% and 90% of the entire world's population use complementary medicine. Cultures that are particularly dependent on traditional medicine include India and Africa, while elsewhere, such as China, Latin America, Chile and Colombia, traditional medicines are still used widely. In the developed countries, 90% of the German, 75% of the French, 70% of the Canadian, 46% of the British and 48% of the Australian populations have all used complementary medicine at least once in their life. In Australia, personal expenditure on complementary medicine is twice the amount spent on pharmaceuticals. In the UK during 1998, 90% of the 450 million euros was met by out-of-pocket expenditure;[16] while in Malaysia, the estimated personal outlay on complementary medicine considerably outstripped that spent on modern medicine.[17]

Given these statistics, it is far from the minds of governments and pharmaceutical companies to destroy the complementary medicine industry. No, they want to replace it, control it and, if necessary, regulate natural products out of existence to secure investment. Their ethical stance on natural substances that have been safely and effectively used by millions of people for thousands of years, with little or no track record of harm (unlike pharmaceutical drugs), can be summed up by the words of Professor Ivor Ralph Edwards, Director of Drug Monitoring for the Collaborating Centre (USA):

"About 80% of all therapies in use in many countries are made from herbs according to tradition and experience, and most of these are multi-molecule herbal medicines that previously could not be standardized into pharmaceutical versions. As a result, it was previously impossible to clinically establish whether or not they perform as intended and some may even cause harm if used incorrectly."[18]

PharmaPrinting botanical drugs

With the market in place, the health industry has been waiting for the ripening of a technology that will enable it to patent new products based on natural medicines.

Natural products cannot be patented, but what can be patented is the technology that isolates and measures the bioactivity of each active compound of a natural health product and then replicates this in a laboratory. In the industry, this is known as PharmaPrinting, or the production of pharmaceutical versions of natural health products that are standardised and clinically tested as a pharmaceutical for government approval.[19] There are now patents in the making (or possibly approved by now) for pharmaceutical versions of mistletoe, saw palmetto, echinacea, ginkgo, St John's wort and valerian.

What are the costs involved in PharmaPrinting a botanical drug? The initial cost is approximately US$0.5 million (including the costs of validating manufacturing under Good Manufacturing Practice guidelines and filing for patent protection), and the clinical trials cost between US$6.5 million and $21.5 million.[20] The total process takes four to five years to be completed. But unless market exclusivity is assured, investors will not invest.

In order to guarantee market exclusivity, the removal or banning of the natural product is essential. If they are able to ban the use of natural health products under the guise of protecting consumers from themselves and the well-publicised unscrupulous rogues of the natural health industry, then this potentially gives multinationals the right to require a royalty to be paid to them each and every time a patient or consumer uses one of their replacement products.

The estimates on the size of this market potential vary dramatically, making it almost impossible to calculate the actual revenue that the industry is trying to acquire; but if you consider the entire natural, holistic, alternative market, including that covering foods (e.g., juicing for health benefits), and factor in the existing healthcare market (last year in the USA alone it was worth US$1.5 trillion), that is the magnitude in scale of the market that a few multinationals are trying to corner and control.

Future of our food supply and environment

If we factor in genetically modified foods, we have quite an ugly scenario. As many of our natural foods are increasingly producing ‘side effects' and allergic reactions (which may be fatal in some cases) in a significant number of the population, I have to ask what the future holds for us regarding legislation on our food. Will the offending compounds be isolated and replaced by new genetically engineered/modified foods and, if so, will our natural foods be banned as unsafe, with global regulations enacted to enforce legislation and the use of GE/GM foods? Or will we be allowed to return to sustainable, organic, farming practices and a clean food chain – and enjoy a diet that has sustained the human population for thousands of years?

In a millisecond of time, we have managed to devastate the environment to a point where it may no longer be sustainable, and we are watching the increasing toll of cancer, heart disease and diabetes – the so-called affluent diseases – on human life. The most worrying aspect is that history shows us how the powerful chemical companies appear to enjoy 30 years' grace in which to market a product that has previously been found to have toxic effects on the environment. Despite the catalogue of environmental disasters (DDT, dioxins, PCBs, PVC) that have taken such a human toll, the companies responsible have been able to avoid true accountability on the basis that correlative evidence is inadmissible. In the meantime, we and our children carry the cost and the burden.

Will we be able to afford medical treatment?

Within the next decade, most people may not be able to afford medical treatment. A report from the USA indicates that due to the rising costs of new patented drugs and procedures, the industry is expected to account for 17% of US gross domestic product by 2012, leaving those consumers – who already pay the equivalent of their annual mortgage on full healthcare insurance – unable to absorb these rising costs.[21] How much of our disposable income does this industry want, especially if it corners the alternative sector as well?

Do you care now? Will you care if you become locked into a system where you may not be able to afford healthcare and are impotent to rectify it? Will you care if you're robbed of tools with which to handle your own health? You probably will.

Implications for the healthcare industry

Looking to the immediate future, the changes we may face within the next few years will have impact on various sectors of our community:
• Manufacturers who supply raw materials may bear the brunt, and those for whom it isn't cost effective to provide dossiers and funding for ingredient or product approval may sell out to the pharmaceutical companies.
• Companies that formulate the products, if their raw materials are not approved, will be unable to produce and supply their products and may sell out to the pharma-industry.
• Distributors of products that are banned for over-the-counter sale (dosages exceed the upper limit) may be able to continue with existing products (providing they are not banned) or new products, providing they supply to a practitioner market.
• Those who have built businesses through network marketing and sell to the general consumer will find that both the restrictions on dosage and the banning of some of the more bio-available nutrients will limit the range of their stock and be the death of any exclusivity factor that their brand may have offered in the past.
• Retailers will not be happy to see the size of their stock diminish; but if something comes along to replace lost stock, then this may suffice.
• Practitioners may still have access to certain products but, again, many products may be banned. It will be extremely difficult for practitioners to do their job without the tools of their trade. The TGA has also raised questions as to the professional ethics of practitioners who prescribe and dispense products, indicating that commercial incentive could bring bias in product choice. It is possible that chemists may be required to undertake this role of dispensing all natural health products. Practitioners who genuinely supplement their income from profits made on products will have no choice other than to raise their fees.
• Consumers for whom the medical industry can give no hope and who are getting good results with their chosen natural therapy will be devastated.
• Consumers may not tolerate the inflated prices of previously low-cost, safe products. We experienced this inflation when tryptophan, a common amino acid, became a "drug": the price nearly doubled. Many products will become prescription-only, and this will incur the additional cost of a consultation.
• Some consumers will oppose the legislation on ethical grounds, but many may not care at all.

What is certain is that the full force hasn't hit yet because these changes are being phased in gradually. By the time we wake up, it would take an unlikely event such as mass consumer outrage to reverse legislation in a single country; and even if this were to occur, it's likely that the country in question would evoke retribution from the WTO through trade sanctions. But consumers have never been so well organised due to the Internet, and we may well see this battle being strong enough to generate the world's first global consumer rejection of international policy.

What you can do to make a difference

If you feel concerned about these issues, there are many ways you can support these efforts. You can write to, or set up your own e-petition to, members of Parliament.

Fundamentally the issue is simple, and I have listed a few important points that you may like to consider when making your representation:
• We feel that natural health products have a long track record of safety; they are not dangerous and therefore should not be banned.
• We wish to see the high standards of manufacture maintained.
• We wish to maintain the current listing and registration of products on the ARTG [Australian Register of Therapeutic Goods], which presently lists around 16,000 products, and encourage the TGA [Therapeutic Goods Administration] to broaden its lists to include products which are currently available from other countries, such as the USA, which have equally stringent regulations.
• Any new compliance framework should be economic and not unduly onerous for low- to medium-risk products.
• Public funding should be made available for research into complementary medicine, as it is for pharmaceuticals.
• The burden of proof should lie within the government to produce evidence to show lack of safety of any natural health product before its removal from the market. We are not making the statement "Innocent until proven guilty", as the compounds used in formulations are already rigorously controlled before approval – and in the case of herbs, have been used for thousands of years to no ill effect. Legislation which bans or removes complementary or natural health products upon any other basis can only raise the question of collusion with multinationals.

You can support the UK-based Alliance for Natural Health, which is legally challenging the European Union on its Pharmaceuticals Directive, Food Supplements Directive, Traditional Herbal Medicinal Products Directive, Health Claims Regulations and Codex Alimentarius. What happens in Europe at a legislative level paves the way for the rest of the world. By addressing these issues through the European courts, we stand the best chance of legally halting the process, negotiating fair terms and, most importantly, preserving our access to natural health products in their natural state. You can make a donation via the Alliance's website, http://www.alliance-natural-health.org/.

In Australia, you can join and contribute financially to the Natural Health Care Alliance via http://www.nhca.com.au. This group's primary aim is to speak with a united voice for natural therapies, lobby at governmental level and respond to industry needs.

Endnotes
16. Thomas, K.J., Nicholl, J.P., Coleman, P., "Use and expenditure on complementary medicine in England: a population-based survey", Medical Centre Research Unit, School of Health and Related Research, University of Sheffield, UK, http://www.ncbi.nlm.nih.gov/
17. Postgraduate Course: Research Methodology in Traditional Medicine and Complementary/Alternative Medicine, http://www.gfmer.ch/TMCAM/PGC_TMCAM_2004.htm
18. John Hammell, "'PharmaPrinting': The Medical Industrial Complex Wants Control of Your Herbs", http://www.iahf.com/pharma.html
19. ibid.
20. Robert Lusetich, "Condition Critical for US Healthcare", The Australian, 9 January 2004
21. ibid.

Other useful websites include:
• http://www.IAHF.com
• http://www.paradigm-changes.com
• http://www4.dr-rath-foundation.org/

[Kathryn Alexander is a local nutritional healing/ detoxification expert and is available for personal consultations and workshops. Her book, Get a Life: The Detoxification Diet Made Easy!, and her double audio CD, The Principles of Detoxification, are available at Maple Street Co-op or online via her website, http://www.getalife.net.au. She can be contacted on (07) 5435 8138 or 0414 702520. The full text of this article is available at http://www.getalife.net.au/mag/NHP_html].

[From "Maple Street Co-op News", June/July 2004; published by The Maple Street Co-operative Society Ltd, 37 Maple Street, Maleny, Qld 4552, Australia, tel (07) 5494 2088, email maplest.coop@serv.net.au,
website http://www.maplestreetco-op.com.au]