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Nutritional and Herbal News and Links
Natural Products & Complementary Medicine Industry in NZ Proposes Way Forward Following Failure of the Therapeutic Products BillCan Science Meet the Challenge of Complementary Medicine?The Australian Therapeutic Products Bill 2007Diminishing Right to Vitamins in the Land of the Free?Doctors discover malnutrition in the elderly.......again!Putting the Lid on Recurrent ShinglesSchool Students Better Watchdog than Public Health AuthoritiesAdverse Drug Reactions Hotline to CloseMedical discoveries made by accident - medical research based upon good luck!Dietary fat consumption has nothing to do with obesity.Adverse effects of new drugs not necessarily revealed by clinical trials.Health Links
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Following the rejection of the Therapeutic Products Bill and the proposed Trans Tasman agency by the New Zealand Parliament (Therapeutic Products Bill), widespread agreement about the best way forward has apparently been agreed by the natural products industry in NZ (1,2,3). According to a press release issued by NZ Health Trust (1,2) more than 150 businesses and organisations have signed the agreement which rejects the government promoted pharmaceutically based control system of complementary medicines which was intended to be administered by the Australia New Zealand Therapeutic Products Authority (ANZTPA) in Australia (3). The new agreement, which is yet to be accepted by government, exempts complementary medicines and natural products from the control of the joint agency and is therefore consistent with the widespread feelings demonstrated by the alternative health community in NZ (Therapeutic Products Bill). Exempting complementary medicines and natural products from the control of the proposed Trans Tasman Therapeutic Products Authority is not only popular amongst the alternative health community but should also prove very popular with the medical profession who were concerned about the complete failure of the Bill following the refusal of the Australian and New Zealand governments to proceed unless complementary medicines were included in the Bill (Misinformation About Pan, & Increased Regulatory Control of Alternative Medicines in Australia & NZ, Therapeutic Products Bill). Since it was felt by doctors that the failure of the Bill would make it more difficult to access new drugs (Misinformation About Pan, & Increased Regulatory Control of Alternative Medicines in Australia & NZ) the proposal to exempt complementary medicines from the Bill removes the only obstacle preventing passage of the Bill through NZ parliament, an outcome that clearly should be welcomed by doctors concerned about access to new drugs. Additionally, given the widespread community support base for such a proposal, it should also be popular amongst those who expressed a desire to see a more democratic outcome (Misinformation About Pan, & Increased Regulatory Control of Alternative Medicines in Australia & NZ). Notwithstanding the popularity of this proposal amongst the alternative medicine community however, there are still those who oppose such a seemingly democratic solution. Taking an opposite stance for instance, is Natural Products New Zealand (NPNZ), who have recently complained about advertisements opposing the Bill and supporting the complementary medicine industry in NZ (Misinformation About Pan, & Increased Regulatory Control of Alternative Medicines in Australia & NZ). NPNZ continues to support the control of complementary medicines by the proposed Trans Tasman Authority even in spite of the divisive nature of such a proposal amongst the alternative medicine community (Therapeutic Products Bill). NPNZ apparently feel the potentially unsafe or dangerous nature of complementary medicines (Misinformation About Pan, & Increased Regulatory Control of Alternative Medicines in Australia & NZ) justifies the control of such products by the Australian based ANZTPA although strangely, when I recently requested evidence of their claims about the dangers of such products they refused to comply with my request (Misinformation About Pan, & Increased Regulatory Control of Alternative Medicines in Australia & NZ). It seems that though many people claim alternative medicines are dangerous, when they are asked to provide scientific proof or cite placebo controlled randomised controlled trials they become extremely evasive. This is not too surprising given the fact that the TGA and medical experts in Australia have repeatedly drawn attention to the safety of such products (Pan Crisis, Alternative Medicine Takeover, Response to Government Inquiry, Therapeutic Products Bill, Misinformation About Pan, & Increased Regulatory Control of Alternative Medicines in Australia & NZ). As I have stated elsewhere (Misinformation About Pan, & Increased Regulatory Control of Alternative Medicines in Australia & NZ):
Recently, in a letter to members dated 13th August 2007 (4), Michelle Beckett of NPNZ outlines the position of the executive and refers again to the concerns of NPNZ about the safety of complementary medicines and the need for the proposed ANZTPA:
While scientific evidence of the dangers of any therapeutic product, drug or vitamin, is vitally important, it seems resort is given here to incidents which might happen in the future. Having said this however, Michelle Beckett is perhaps making a very good case here for restrictions upon international trade. Why should therapeutic products be imported when they can be manufactured under more closely supervised conditions in Australia or New Zealand? Surely there should be effective government incentives to ensure such therapeutic products are produced within Australia or NZ or countries which utilise effective safety standards. The suggestion that NZ may be importing dangerous products because of inadequate safety standards and production facilities in certain countries is an excellent point and one which NPNZ could take up with the NZ government. Meanwhile, the TGA in Australia has apparently decided to apply more pressure to NZ manufacturers by imposing tighter controls following the rejection of the Therapeutic Products Bill by NZ Parliament (5,6). It was expected that governments would apply further pressure to the industry following failure of the Bill, perhaps even resorting to the same type of scientifically unsubstantiated claims which were employed so successfully during the Pan drug debacle (Therapeutic Products Bill). The reader is reminded that the current legislative campaign in Australia and NZ is the result of the Pan drug debacle which demonstrated the safety of complementary medicines as compared to drugs (Pan Crisis, Alternative Medicine Takeover, Response to Government Inquiry, Therapeutic Products Bill, Misinformation About Pan, & Increased Regulatory Control of Alternative Medicines in Australia & NZ). New Zealanders have consistently demonstrated their opposition to regulation of complementary medicines by the proposed ANZTPA, a fact which has been confirmed by the results of the political enquiry and the rejection of the Bill by parliament (Therapeutic Products Bill). Surely it is time to move on now by adopting a more democratic and scientifically justifiable attitude by ceasing the divisive attempts to force complementary medicines to be regulated by the pharmaceutically based ANZTPA. The medical profession wants the Bill passed to enable access to new drugs but the NZ government stubbornly refuses to pass it unless complementary medicines are included (Misinformation About Pan, & Increased Regulatory Control of Alternative Medicines in Australia & NZ). A more conciliatory and scientifically justified approach by both Australian and New Zealand governments is desperately needed so that access to new drugs in NZ will not be impeded. References
1.http://www.nzhealthtrust.co.nz/pdf/Press%20Release%20Joint%20position%20statement%20Aug%2
Amy Adams, Natural Health sector agrees the way forward for
regulation, press release, NZ Health Trust, 13th August 2007. Can Science Meet the Challenge of Complementary Medicine?For the past few decades confusion has reigned in the world of mainstream medicine and nutrition as scientists struggled to explain the link between nutrition and chronic diseases (Nutrition and Megavitamins, B Vitamins, Nutrition Breakthroughs, Experts say dietary supplements may save $billions in health care costs!!). Although the epidemiological evidence of this link is indisputable (Nutrition and Megavitamins, B Vitamins, Nutrition Breakthroughs, Experts say dietary supplements may save $billions in health care costs!!), scientists are constantly frustrated by their inability to pinpoint the precise reasons for this link by simplistic clinical trials (When There is Evidence for Nutrition but Little Evidence for Evidence Based Medicine). In fact, scientists only recently discovered that there is no precise scientific means of diagnosing vitamin deficiencies or determining who will benefit from supplements of simple vitamins such as folic acid and therefore they have recommended supplements of this vitamin or the addition of this vitamin to staple foods (The Folic Acid Lesson, Nutrition Breakthroughs, Dietary Supplements or Functional Foods). To date, the principles of (When There is Evidence for Nutrition but Little Evidence for Evidence Based Medicine) evidence based medicine and (Holistic or Reductionist) reductionism have completely failed to meet the challenge of complementary medicine. The effects of the confusion resulting from the failure of scientific reductionism and evidence based medicine are clearly manifested by the continual disagreements and conflicts which are so prevalent in the medical world. Recently for instance, university courses in complementary medicine have been described in the U.K. as (1,2) "anti-science" and "scandalously unacademic". David Colquhoun, professor of pharmacology at University College London, described universities conducting courses in complementary medicine thus (1,2):
In further support of this view, Edzard Ernst, professor of complementary medicine research at the Peninsula College of Medicine and Dentistry (1,2), described most complementary medicine degrees as "scandalously unacademic". Supporters of such courses however, have branded critics as (1,2) "out of step with the times". Meanwhile, in Australia, governments are contributing millions of dollars (3,4) to the establishment of the National Institute for Complementary Medicine at the University of Western Sydney. The National Institute for Complementary Medicine is intended to (4) "broaden the scientific community's understanding of complementary therapies and alternate medicines". In New Zealand the appointment of a new Chief Advisor to assist in the integration of complementary medicine and conventional medicine has heralded a (5) "New era for complementary medicine" while the purpose of the National Center for Complementary and Alternative Medicine in the U.S. is to (6) "Explore complementary and alternative healing practices in the context of rigorous science". And in Malaysia complementary medicine is being integrated into public hospitals (9). But there are still those who seem to prefer to adhere to a simplistic and rigid reductionist view of reality where yesterdays scientific 'facts' are very quietly discarded like out of date fashions (Science Today, Quackery Tomorrow, Darwinian Medicine) and who still unscientifically generalise about alternative therapies which they describe as unscientific or quackery (7,8). Of course even such persons eventually accept the importance of vitamins like folic acid, even though scientists still have no means of determining precisely who will benefit from supplements of such vitamins. Perhaps they would suggest we need double blind trials of various levels of dietary folic acid intake to determine the precise intake needed to prevent birth deformities. To them it seems, folic acid is different to other vitamins, although they seem unable to supply scientific proof that this is so. Of course the problem for scientists and EBM advocates (When There is Evidence for Nutrition but Little Evidence for Evidence Based Medicine) is that reality or real life experiences always precedes scientific evidence. The full benefits of food and folic acid were not discovered by double blind trials so those who claim that EBM is the only way of knowing (When There is Evidence for Nutrition but Little Evidence for Evidence Based Medicine) will always be the last to learn the truth. Governments and public health authorities around the world are currently responding to increasing scientific evidence that the epidemic of chronic diseases, which are the main causes of morbidity and mortality today, are linked to nutrient poor diets and therefore diet or nutritional treatments offer considerably more therapeutic or preventative potential than any other treatment science has so far been able to offer. This is a simple fact. Sceptics or EBM advocates however, seem determined to maintain the status quo and usually have little or no positive suggestions to make regarding the current epidemic of chronic diseases (10). They seem to be motivated by an obsession with arbitrary and ever changing simplistic rules of evidence rather than the suffering caused by iatrogenic or chronic diseases (Health Trends). Should we turn a blind eye to the suffering caused by chronic diseases until EBM advocates are happy that nutritional supplements conform to their requirements for the rules of evidence? Should we deny real life experiences in the absence of randomised controlled trials? If the sceptics wish to avoid taking dangerous nutrients they should be permitted to do so - unless and until such actions forces the remainder of the community to pay because of further increases in the huge costs of chronic diseases! As the world moves forward there will always be those at the forefront of research and those who lag behind. References
1.http://www.dailymail.co.uk/pages/live/articles/news/news.html?in_article_id=471045&in_page_id=1770
Laura Clark, Row over surge in 'scandalously un-academic' university
courses, Daily Mail, 26th July 2007.
The Australian Therapeutic Products Bill
2007
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"There is a world of difference between potentially harmful nonbiological drugs and innocent - if sometimes misapplied - nutrients.........alien chemicals and natural nutrients should not be treated alike, and if medical education were on the ball, they never would be." Roger Williams, Nutrition Against Disease, Pitman Publishing Co., 1973. |
Bill Defeated in NZ Parliament but Australian Government Expects Legislation to be Passed this Year - Recent Developments.
The Australian government, like other governments around the world (see Misinformation About Pan, & Increased Regulatory Control of Alternative Medicines in Australia & NZ, Pan Crisis, TGA & Pan, Codex in Australia, Pan Crisis & Future of Alternative Medicines, Alternative Medicine Takeover, Response to Government Inquiry), continues to seek to impose restrictions on vitamins and supplements with the Therapeutic Products Bill 2007 which is intended to control the industry in New Zealand (1,2,3,4). According to Adams (5):
| "New Zealanders face losing their access to thousands
of safe and effective natural supplements if the Therapeutic
Products and Medicines Bill is passed. That is the
inescapable reality.
This bill would hand over all rights New Zealand has to control its own health-products laws to an Australian corporation which will apply the same style of rules that have seen the Australian natural-products industry crippled over the past 15 years." |
These changes are understandably causing considerable concern in New Zealand (5,6,7,8,9,10,11) as trends in Australia and around the world reflect a movement to restrict health freedoms by imposing increasingly draconian restrictions on the marketing of vitamins and dietary supplements (see Misinformation About Pan, & Increased Regulatory Control of Alternative Medicines in Australia & NZ, Pan Crisis, TGA & Pan, Codex in Australia, Pan Crisis & Future of Alternative Medicines, Alternative Medicine Takeover, Response to Government Inquiry). It is history now that the Pan crisis in Australia (Pan Crisis) was just a devious and scientifically baseless excuse to introduce draconian controls over the vitamin and supplement industry (Misinformation About Pan, & Increased Regulatory Control of Alternative Medicines in Australia & NZ, TGA & Pan, Codex in Australia, Pan Crisis & Future of Alternative Medicines, Alternative Medicine Takeover, Response to Government Inquiry).
After considerable opposition to the Australian government's moves to restrict health freedoms in New Zealand, on the 15th June the Committee established by the New Zealand government to look into the Therapeutic Products and Medicines Bill tabled their report in Parliament (12,13,14). After receiving 895 submissions the Committee found that they could not reach agreement on the Bill and therefore (13,14) "cannot recommend that the Bill be passed." The Committee noted that the alternative medicine industry was generally strongly opposed to the Bill with contributors questioning the need to apply prescription drug type regulations to dietary supplements (13):
| "Much of the opposition to the regulation of complementary healthcare products through the joint scheme centred on their comparative safety, the perceived high cost of the proposed regime, and the argument that it is thus inappropriate to impose a pharmaceutical model of regulation and licensing upon them." |
According to National Party members (13):
| "The level of search and seizure power in regard to complementary medicines seems to be well out of line with the potential risk. In other words the powers given are more commensurate with risks associated with dangerous high-level drugs than they are with herbal tea." |
The Committee also noted various other concerns of those opposed to the legislation (13):
| "Recurring concerns were that the costs and other consequences of complying with the new regulations could reduce choice for the consumer, that the products remaining on the market might become more expensive, the new Authority might undermine New Zealand’s sovereignty, and that small and innovative New Zealand-based businesses might be adversely affected." |
Especially since the government has provided no scientific justification for the proposed legislation it is hardly surprising that the Bill has been described as (14) "deeply divisive" as the Australian government seeks to impose its will upon the New Zealand people primarily for commercial purposes and in utter disregard of the health and freedom of New Zealanders.
In a major embarrassment for those promoting the erosion of health freedoms in New Zealand however, on 15th of July the New Zealand government accepted defeat of the controversial Therapeutic Products and Medicines Bill, reluctantly admitting they did not have the numbers to get it through parliament (50,51,52,53,54). Although the New Zealand government proposed a compromise involving the exemption of complementary medicines from the Bill, such was the attitude of the Australian government that apparently they preferred to see the entire Bill fail rather than exclude complementary medicines (54). According to New Zealand State Services Minister Annette King however (53,54,56,57), the Therapeutics Products and Medicines Bill would merely be "postponed" until there was more support in parliament for the scheme. The New Zealand government has refused to permanently bury the Bill (50,52,53,54,55,56,57). In a consideration of why the Bill was defeated Ms King claimed that the (56,57) "complementary health manufacturers" did not have sufficient influence. But the insufficient influence referred to by Ms King was the result of widespread community concern across NZ, a process often described as democracy.
This point was made by Marcus Blackmore who drew attention to the extent of community concern in New Zealand (58):
| "The New Zealand Bill did not pass through parliament due to a consumer protest in that country because there was the perception that it would create a regulatory environment that is not relative to the low risk nature of complementary medicines. There is always a risk of this when government categorises complementary medicines under the same banner as drugs." |
Following the failure of the Trans Tasman Bill, the New Zealand government have signaled their intention to pursue tighter national controls over supplements (54,55) and apparently warned that (54) "it will not be business as usual for the complementary medicines industry." According to Young (55): "the Government is set to look at using ministerial powers to create domestic regulations for complementary medicines after it conceded defeat yesterday on a transtasman regulatory agency. So while the New Zealand government are crossing their fingers and hoping for sufficient support to pass the Trans Tasman Bill they will pursue their own national crackdown on alternative medicines. And following defeat of the Bill, the Parliamentary Secretary for Health in Australia, Senator Brett Mason, stated that the Australian government (59) "will now proceed in a way that allows both countries to explore other options for harmonisation", although he avoided spelling out exactly what these new options may be. In view of the tactics utilised in the past, it would not surprise if there were further attempts to exploit community fear about the safety of therapeutic products by vague allegations about the 'dangers' of complementary medicines, not drugs (Misinformation About Pan, & Increased Regulatory Control of Alternative Medicines in Australia & NZ).
Amazingly, as I indicate below, all this recent legislative interest in complementary medicines apparently resulted from the Pan witch hunt which demonstrated the safety of complementary medicines as compared to pharmaceutical drugs! Strange that the toxicity of pharmaceutical drugs which was demonstrated again as a result of the Pan debacle resulted in so much subsequent DISINTEREST in strengthening drug safety regulations!
In spite of these developments however, the Australia New Zealand Therapeutic Products Authority (ANZTPA) has recently stated they expect legislation to be passed this year regardless of the divisive nature of the proposals and in spite of New Zealand opposition (15). According to Phil Davies, transitional director of ANZTPA (15), apparently the unpopular and divisive nature of the Bill was "not necessarily unexpected" and progress is continuing with the Bill now "in the hands of the New Zealand Government". According to Davies (15), both Australian and New Zealand governments "have announced that they are working to establish ANZTPA in 2007" and "the new regulatory scheme itself would then come into operation some time in 2008."
Apparently it seems, opposition to the Bill is irrelevant as authorities have already decided to implement their policies irrespective of the effects on freedom and public health.
Why the Public Needs Protecting from Vitamins - how to justify an industry takeover.
While government authorities pretend that the Therapeutic Products and Medicines Bill is necessary to protect the public from the safest therapeutic or preventative health promoting products on the market (Dietary Supplements, Holistic Medicine Sets the Standard for Safety), thousands of patients continue to suffer or die as a result of the toxicity of government supported pharmaceutical drugs. Yet the government seeks to apply these same safety standards, which result in thousands of deaths every year, to alternative medicines. Most conspicuous throughout this entire process is the fact that these changes, though consistent with profits and commercial considerations, are completely out of step with the available scientific evidence (Dietary Supplements, The Folic Acid Lesson, Holistic Medicine Sets the Standard for Safety). As is the case in Australia, in New Zealand too (43) the safety levels achieved by the alternative medicine industry absolutely dwarfs the achievements of the much more dangerous and highly regulated pharmaceutical drug system.
If concern about the safety of therapeutic substances is genuine of course, then safety requirements will be prioritised in direct accordance with scientific evidence of the toxicity or known health risk of each particular product. The persistent refusal to adopt a structured and scientifically based safety system where regulatory safeguards are focused especially upon those specific products that are known to pose the greatest risk (ie. drugs), is of course ample proof that their true concerns have nothing to do with their publicly stated concerns about safety.
The current global push to takeover the supplement industry (Alternative Medicine Takeover) correlates with several very important facts.
Firstly, the pharmaceutical industry is suffering as the toxicity and limitations of drug treatments are being exposed throughout the world (Holistic Medicine Sets the Standard for Safety, Science or Progress?, Dietary Supplements, Global Trends in Health Care). As adverse drug reactions continue to hit the headlines and the bank balance of drug companies (16,17), medical experts are increasingly realising that toxic pharmaceutical drugs have little to offer for the prevention of chronic degenerative diseases (Global Trends in Health Care), the most important causes of morbidity and mortality today (Health Trends). In fact, the proliferation of pharmaceutical drugs during last century correlated with a phenomenal increase in the incidence of heart disease, cancer, and other chronic diseases (Health Trends). The past 100 years of attempts to cure chronic diseases with drugs has not only been a catastrophic failure, but furthermore, this obsession with toxic drugs has created a whole range of new diseases called iatrogenic diseases (Holistic Medicine Sets the Standard for Safety) as doctors succumbed to the influence of the drug companies. It has also created a global dependence upon pharmaceutical drugs as drug companies reveled in their ever increasing profits (Integrated Medicine). Politicians and drug industry puppets have permitted this disgraceful situation to continue for the past century.
The ever increasing global incidence of drug induced iatrogenic diseases demonstrates indisputably the failed and hopelessly ineffective safety requirements used for the marketing of pharmaceutical drugs, yet the powers that be seek to apply this same failed system to the marketing of health promoting supplements. And drug companies have responded by criticizing public concerns about drug safety pointing out there is no such thing as a totally safe drug and consumers have "unrealistic expectations" (16).
Secondly, as concern spread regarding the proliferation of chronic diseases and the obvious failings of drug treatments (Health Trends), people around the world increasingly resorted to using vitamins and dietary supplements as doctors offered little assistance for their various chronic illnesses (Holistic or Reductionist?). This lead to a global boom in alternative therapies as people sought therapies which were safer and more effective, especially preventatively, than toxic pharmaceutical drugs (Holistic or Reductionist?). As a result of these trends, drug companies and health authorities have sought to cash in by increasingly researching natural supplements and alternative therapies while at the same time seeking to monopolise these treatments so that any effective natural treatments could ultimately only be dispensed by doctors (Pan Crisis, TGA & Pan, Codex in Australia, Pan Crisis & Future of Alternative Medicines, Alternative Medicine Takeover, Response to Government Inquiry). Pharmaceutical companies and health authorities have increasingly become aware of the enormous potential of vitamins and dietary supplements (The Folic Acid Lesson, Doctors Discover Malnutrition in the Elderly, Nutrition Breakthroughs). In fact, modern scientific medicine now predicts that individualised nutrition or megavitamin therapy will be one of medicine's main tools in the 21st century for the prevention of chronic degenerative diseases (Nutrition Breakthroughs). Additionally, governments and health funding organisations have been steadily accumulating evidence that billions of dollars in health care costs may be saved if everyone used dietary supplements (Experts say dietary supplements may save $billions in health care costs!!, The Folic Acid Lesson). In other words, medical science has done a complete about face and begun to endorse therapies which they callously dismissed as quackery only a few years ago (But isn't Holistic Medicine Quackery?, Science Today, Quackery Tomorrow, The Folic Acid Lesson). Such is this amazing revolution in health care, but yet it is still only in its early stages!
The direction in which modern medicine is progressing is very clear. There is an increasing recognition that toxic drugs will never prevent most chronic degenerative diseases. On the other hand, individualised nutritional therapy or megavitamin therapy (nutrigenomics) is considered to be a modern scientific breakthrough which has the potential to prevent chronic diseases, reduce the ever increasing global dependence upon drugs, and reverse the current epidemic of chronic diseases and drug caused iatrogenic diseases.
This is the modern scientific environment which has created the single minded determination of the pharmaceutical industry and health authorities to takeover the dietary supplement industry.
How to Simultaneously 'Pan' Dietary Supplements and Increase Confidence in the Industry - the public will believe anything.
Although evidence of a global push to control the alternative medicine industry is overwhelming, there are still those who dispute that current legislative changes are intended to enable a virtual takeover of alternative medicines and eventually restrict their availability in retail stores. The TGA for instance, claims that (18) "(18)the current Australian regulatory framework for complementary medicines under Therapeutic Goods Act 1989" which is "not subject to the standards and guidelines of the Codex Alimentarius Commission" ( notice the TGA strictly avoids any future or long term commitment). Especially since the Australian government has already warned that some alternative medicines will be withdrawn from sale or reformulated (26) the intention to reduce supplement availability is quite clear. The TGA describes the regulation of dietary supplements in Australia thus (18):
| "The regulation of vitamin and mineral
supplements in Australia The Australian Government acknowledges and supports the right of consumers to be able to make informed choices on matters related to health, and to expect that medicines available in Australia, including vitamin and mineral supplements, will be safe and of high quality. Australia has a risk-based system where the level of evaluation and regulatory control of a medicine is based on the relative risk of the product and the seriousness of the condition for which it is intended to be used. All therapeutic goods must be entered in the Australian Register of Therapeutic Goods before they can be supplied in, or exported from, Australia, and must be manufactured in accordance with the principles of Good Manufacturing Practice, which ensures they are of acceptable quality." |
So what has the Australian government done to support "the right of consumers to be able to make informed choices on matters related to health, and to expect that" (alternative?) "medicines" (will always be available in retail outlets) " in Australia." What has the Australian government done to protect the retail availability of dietary supplements and prevent a takeover by pharmaceutical companies? And have they demonstrated in practice that "Australia has a risk-based system where the level of evaluation and regulatory control of a medicine is based on the relative risk of the product and the seriousness of the condition for which it is intended to be used." Have they devoted most of their legislative attention to the most hazardous therapeutic products (ie drugs)?
Similarly, according to the ANZTPA fact sheet on the proposed regulatory scheme for complementary medicines (19):
| "Will consumers still be able to buy a range of
complementary medicines? Yes. Under the proposed joint regulatory scheme consumers will continue to have access to a wide range of complementary products, with the sort of products currently sold through retail outlets such as supermarkets and health food stores continuing to be available in this way. In Australia complementary medicines are already regulated by the Therapeutic Goods Administration (TGA) and Australian consumers have a choice of over 17,000 complementary medicines containing around 2,200 active ingredients Under the proposed joint regulatory scheme consumers would have an assurance of the quality and safety of complementary medicines and would be provided with truthful information about a product's therapeutic health benefits to help them make more informed choices." "Dietary supplements should not be regulated in the same way as over-the-counter medicines and prescription medicinesThe proposed joint regulatory scheme is a based on categories or scales of risk. In simple terms this means that a lighter level of regulation is being proposed for lower risk therapeutic products, which includes most complementary medicines. Tighter regulations are being proposed for higher risk therapeutic products such as prescription medicines and some medical devices such as pace makers and heart valves which would go through pre market evaluation by the Authority. It is also proposed that for lower risk complementary medicines, suppliers and manufacturers will be able to self assess or certify their products by entering information into an online web based data base to gain a product licence. The declarations made about a product would be subject to audit. There would be a separate office of complementary medicines within the joint Authority, which will have offices bases in Wellington and Canberra." "Consumers have rights to access natural health products and complementary medicinesConsumers will continue to have access to a wide range of complementary medicines, with the sort of products currently sold through retail outlets continuing to be available in this way. When purchasing these products, consumers have a right to expect they will be safe and of high quality, while maintaining choice. The main aim of the proposed joint regulatory scheme for therapeutic products is to safeguard public health and safety." |
ANZTPA has carefully avoided any suggestion that they will ensure the current range of retail complementary medicines, and in the currently available potencies, will continue to be available. So what protections has the government included in the proposed legislation to ensure that the potency and range of currently available retail dietary supplements will not be reduced? Do their actions back up their words? Where are the legislative protections ensuring the retail availability of the current range and potency of dietary supplements? Of course there are no such protections since the government has already stated their intention to withdraw or reformulate supplements and reduce consumer choice (26). Especially since the Australian government has repeatedly stated they wish to "restore confidence" in the alternative medicine industry (Misinformation About Pan, & Increased Regulatory Control of Alternative Medicines in Australia & NZ), how have they expressed this wish in proposed legislation? What legislative steps have they taken to ensure retail dietary supplements will not have their potency or availability reduced or restricted? Especially since it was the government's own false statements regarding Pan which had a negative impact on confidence (Misinformation About Pan, & Increased Regulatory Control of Alternative Medicines in Australia & NZ), do their actions confirm their honesty and sincerity?
Interestingly, this same type of refusal to guarantee the continued availability of the currently available range of dietary supplements is also occurring in New Zealand. When Annette King, the Minister for State Services in the New Zealand government and the Minister in charge of The Therapeutic Products and Medicines Bill, was asked in parliament whether there would be reduced availability of complementary medicines following implementation of the Therapeutic Products Bill she chose to completely avoid the question. The following question was put to her by Sue Kedgeley (20):
| "Can the Minister confirm that once the proposed agency is operational and the transitional period completed, an effective traditional remedy or dietary supplement that is not on the approved list will be illegal and not be able to be sold in New Zealand, even if it has been safely used for centuries and has had overseas regulatory authorities' approval, such as that of the American Food and Drug?" |
Ms King completely avoided the thrust of the question and responded thus (20):
| "One of the big issues in terms of this regulator is to ensure that we could have some mutual recognition with other countries. What we will not have now is an agency like the FDA agreeing to anything being safe in New Zealand, because there is nothing for it to be able to acknowledge. What we are trying to stop is that in the future we have a country like the United States and its regulator the FDA making decisions for us. What we want is a joint regulator between two friendly nations. We are looking at some countries having to make decisions for other countries because those countries are unable to have the quality assurance themselves." |
Similarly, Tony Ryall also sought an assurance from Ms King about the continued availability of the current range of complementary medicines (20):
| "Can the Minister understand why New Zealanders
are so strongly opposed to her plan to cover natural health
products when the Government's own papers state that 60
to 65 percent of the products that are currently on shop
shelves now will be wiped from those shelves under this
proposal* and when the advice of one of New Zealand's
leading natural health products companies is that the cost
of regulating a product will go from $2,700 to $64,000 under
her plan-a plan that she has mucked up completely?" * Emphasis added |
But once again the Minister gave a completely dismissive response (20):
| "I would much rather have had the opportunity to do something positive than to sit where that member has for 7 years doing absolutely nothing but whinge. To answer the member's question, he has totally misinterpreted the consultation document on fees and charges, and I am happy for officials to give him a personal briefing. But this is not the first time the Opposition has misinterpreted an official document. Another example of misinterpretation was that of the Australian regulatory impact statement. Those members opposite got that wrong as well, and they were shown to have got it wrong. The member got this wrong, as well." |
It is abundantly clear that government authorities and bureaucrats in both Australia and New Zealand are determined to completely avoid any discussion of, or commitment to, the continued retail availability of the currently available range of dietary supplements and alternative medicines. Amongst all the inconsistencies and contradictions this refusal to guarantee the future availability of supplements is conspicuously consistent. Of course this is also consistent with global trends and the requirements of Codex (Misinformation About Pan, & Increased Regulatory Control of Alternative Medicines in Australia & NZ).
It is imperative that we explore in more detail the true attitude of government authorities and the TGA towards alternative medicines and since the government's current legislative campaign to crack down on alternative medicines began with the Pan crisis (see Pan Crisis, Alternative Medicine Takeover, Response to Government Inquiry), this provides an appropriate starting point for examining the governments attitude and motivation. It should be realised of course, that if the government wishes to control alternative medicines on behalf of drug companies then the only way they could possibly achieve the drastic legal reforms they seek is on the basis of public health and safety. Put bluntly, the public must somehow be convinced that health promoting nutritional supplements are more dangerous than toxic pharmaceutical drugs which are listed on the poisons schedule. In this regard it should be noted that the government is simultaneously pursuing a policy aimed at adding these same dangerous dietary supplements to foods (Dietary Supplements or Functional Foods).
At the outset it should be made abundantly clear, given the stated aims of the TGA are to "restore confidence" in the industry and ensure the safety of alternative medicines ( Misinformation About Pan, & Increased Regulatory Control of Alternative Medicines in Australia & NZ, Pan Crisis, Alternative Medicine Takeover, Response to Government Inquiry), that the government must provide scientific evidence that the Pan crisis has proved the unsafe nature of all alternative medicines (since the governments legislation is not product specific there must be scientific evidence that all alternative medicines are unsafe - if one drug is found unsafe the TGA does not take action against all drugs) and a consequent loss of consumer confidence. These are the often stated requirements the government has used to justify a legislative "crackdown" on alternative medicines ( Misinformation About Pan, & Increased Regulatory Control of Alternative Medicines in Australia & NZ, Pan Crisis, Alternative Medicine Takeover, Response to Government Inquiry). When considering the comments of the TGA it should be realised that the only product reported to make anyone ill during the Pan crisis was in fact an over the counter drug containing the toxic chemical hyoscine hydrobromide ( Pan Crisis). The Pan crisis therefore proved once again the safety of complementary medicines as compared to drugs since not one person was made ill by complementary medicines during the Pan crisis even though both complementary medicines and drugs were produced under the same conditions ( Pan Crisis).
Comments made by the TGA or the Australian government in regard to the Pan crisis should also be considered in light of the fact that the government's legal action against Pan Pharmaceuticals has recently been dismissed by the Supreme Court of New South Wales (22,23).
Let us examine the recent actions of the Australian government and the TGA as a result of the Pan crisis.
Initial statements made by the TGA regarding the consequences of the Pan crisis and reported in the media on the 28th and 29th of April 2003 (39,40) claimed that Pan Pharmaceuticals was endangering the lives of consumers and therefore all "consumers should avoid taking herbal and vitamin preparations and complementary medicines". Notice that the TGA specifically targets complementary medicines here and not the withdrawn prescription drugs and over the counter drugs which precipitated the entire crisis and which caused serious adverse reactions (Pan Crisis, Alternative Medicine Takeover, Response to Government Inquiry). But Dr McEwen of the TGA also added that the main concern of the TGA was not safety but rather (39,40): "our great worry is that a product may not be true to label." The Health Minister also confirmed this stance saying (31) there may be nothing wrong with many of the health supplements withdrawn from sale". But on the 2nd of May the Health Minister made the following astounding false claim (24): "The recall affects only complementary preparations and not prescription medicines recommended by your doctor," she said. I would like to reassure everyone that all prescription medicines, including generic medicines, are safe and people should continue taking them." This is an absolutely astonishing claim since it was an over the counter drug, Travacalm (hyoscine hydrobromide), and not complementary medicines, which triggered the entire Pan crisis (Pan Crisis). This trend of resorting to false claims about the safety of complementary medicines is clearly a common theme for the TGA and the Australian government.
These untrue comments were followed up on 28th May by Trish Worth, the Parliamentary Secretary for Health (25): "the Pan Pharmaceuticals recall has highlighted the importance of preventing or deterring deliberate or reckless breaches of standards and conditions applicable to the manufacture of medicines in order to protect the health and safety of the Australian public" Trish Worth describes the committee set up by the government to examine alternative medicines as a result of the Pan crisis (25):"the establishment of this committee and amendments to the Therapeutic Goods Act go a long way towards giving the public and all health care practitioners confidence that the Government has taken the necessary steps to examine the role of complementary medicines in the health care system." So according to Trish Worth, "the role of complementary medicines in the health care system" must be examined because of the Pan crisis which revealed the toxicity of drugs and the safety of alternative medicines!! This is the reasoning which is consistently used by the Australian government and the TGA throughout their current push for legislative reforms of alternative medicines.
Amazingly, in New Zealand the same attitude was expressed by Annette King, the Minister for State Services, who stated (42), "it is because of the Pan Pharmaceuticals situation that this Government has decided to move, in conjunction with Australia, to regulate complementary and therapeutic dietary supplements." Once again, because the Pan debacle demonstrated the safety of complementary medicines as compared to drugs we are expected to believe, for some reason, that this justifies the need for increased regulatory control of all complementary medicines! Such statements seem to say more about politicians views of the collective intelligence of the community than about the safety of vitamins.
So the Australian government subsequently established a committee to allegedly examine the "safety" of alternative medicines and "restore confidence" in the industry because alternative medicines, unlike drugs, had been shown to be totally safe during the Pan crisis. As headlines such as (26) "Strict New Rules Curb Herbal Drug Sales" and (27) "Red Tape Forcing Up Medicine Prices", appeared in March - April 2005, all under the guise of "restoring confidence", the government responded to the Report of the Committee of enquiry (28) in a most predictable fashion by warning that alternative medicines may be withdrawn from sale (26): "many products would have to be reformulated or relabeled, and some may need to be removed from the market". The Parliamentary health secretary was apparently not aware of this however (26): "the parliamentary secretary responsible for complementary medicines, Christopher Pyne, said he had not been told about the possible withdrawal of products. 'Australia is very fortunate to have such a high-quality complementary medicines industry,' he said, adding that the Pan scandal had shown that the TGA was 'on top of the industry'."
Close examination of details surrounding the Pan crisis demonstrates quite clearly the desperation of authorities who were pushing for a takeover of the supplement industry with many authorities apparently feeling the need to resort to false or unscientific claims (Misinformation About Pan, & Increased Regulatory Control of Alternative Medicines in Australia & NZ, Pan Crisis, Alternative Medicine Takeover, Response to Government Inquiry). Some authorities were apparently so desperate that they even resorted to complete lies or wild exaggerations (Pan Crisis, Alternative Medicine Takeover, Response to Government Inquiry). Some even went so far as to suggest that a dangerous over the counter drug was an alternative medicine or supplement and therefore all supplements were dangerous. Even politicians made untrue statements claiming that only complementary medicines were withdrawn from sale and not prescription drugs when the truth is that both over the counter AND prescription drugs were withdrawn (Pan Crisis). As I have stated previously (Pan Crisis):
| "It is obvious from comments made by a range of health authorities during the Pan crisis that there is an extraordinary eagerness amongst members of both the medical profession and the pharmaceutical industry to establish a link between, on the one hand, poisoning caused by over the counter drugs, and on the other, regulatory controls for alternative medicines. This clearly represents a considerable degree of desperation about the progress of what is obviously an ongoing agenda to convince the public of the dangers of alternative therapies and thereby justify increased regulatory controls." |
This desperation to establish a link between adverse reactions to drugs like hyoscine hydrobromide and the need for increased regulatory control over complementary medicines is so extreme it seems, that some traditional opponents of complementary medicine have even sought to establish some vague kind of link between this drug and natural herbs, apparently because hyoscine hydrobromide was derived from a plant. Hyoscine hydrobromide is however, an S2 or S3 poison or drug (National Drugs and Poisons Schedule Committee, 2002) and not a complementary medicine which can be purchased from health food stores. Since the drug morphine is derived from the opium poppy, perhaps these critics would therefore conclude that morphine is a complementary medicine! It is sad to see so many people have abandoned the scientific facts in their apparent eagerness to justify increased regulatory control of alternative medicine.
As has recently been pointed out by McEwen and colleagues of the TGA (46), the "Travacalm Episode" was caused by "widespread hyoscine hydrobromide toxicity." In fact, the Travacalm incident is top of the TGA's list of (47) Australian reports contributing to the early global recognition of a drug-related problem." Strange indeed that the toxicity of this drug led the TGA to warn consumers to stop taking hundreds of complementary medicines for which there was no evidence of a safety threat (39,40): "consumers should avoid taking herbal and vitamin preparations and complementary medicines." Since the hyoscine hydrobromide containing Travacalm was a drug rather than a complementary medicine, why was the TGA so determined not to issue a general warning about the consumption of drugs which after all, they knew to be much more dangerous than complementary medicines? Why did they choose to warn the public about the least dangerous products? The fact that that so many health authorities, bureaucrats, and even politicians, joined forces in the intense campaign of misinformation about the Pan debacle is most disturbing.
In November 2006 the Australian government was continuing to destabilise and discredit the industry by announcing yet another study, this time to determine if alternative medicines "really work" (29,30), pretending of course that the vast scientific literature on the subject does not exist (Nutrition and Megavitamins, B Vitamins, Nutrition Breakthroughs, Holistic or Reductionist, Experts say dietary supplements may save $billions in health care costs!!). Additionally, this is in spite of the fact that according to the TGA alternative medicines are intended for (34) "health maintenance, health enhancement and risk reduction" and are (32) "often developed with an emphasis on health and wellness rather than disease". Just how the TGA proposes to test how effective alternative medicines are for "health maintenance, health enhancement and risk reduction" and restoring "health and wellness" will indeed be interesting to see. And in spite of claims by the government's own expert committee of enquiry that (33) "compared with other medicines, complementary medicines may offer lower risk and more cost-effective options for the prevention and treatment of some diseases, conditions and disorders," the TGA claims alternative medicines cannot be labeled as suitable for prevention or to treat any serious disease (34) even in spite of extensive scientific evidence indicating otherwise (Nutrition and Megavitamins, B Vitamins, Nutrition Breakthroughs, Holistic or Reductionist, Experts say dietary supplements may save $billions in health care costs!!). In other words, it seems it would be illegal to claim supplements are suitable for treating malnutrition or thiamine may be used to treat or prevent beri beri, or folic acid could be used to prevent neural tube defects or other birth defects (35). In many instances, according to the TGA, it will be illegal to state truthful (scientifically verifiable) claims (35). All this in the guise of restoring confidence.
Why do Australian authorities such as the TGA pretend that nutritional supplements do not "really work" and blatantly contradict leading world nutrition experts such as Professor Bruce Ames (45)?:
|
Why are statements by the Australian government and the TGA so irresponsible and inconsistent with the public health point of view demonstrated by world leaders in nutrition research like Professor Bruce Ames? Why is the Australian government lagging so far behind, still stumbling about in the dark ages of vitaminphobia? At a time when the benefits of nutrition are now known, why are Australian authorities still refusing to encourage the use of supplements as recommended by world experts?
Sadly, those who cannot embrace new discoveries continue to obstruct advances in human knowledge and health care. It seems they have learned nothing from past attempts to prevent the widespread use of vitamins such as folic acid and thereby sentence millions to unnecessary birth deformities. Scientific progress has always been impeded by such closed minded people who seek to impose their rigid draconian ideas upon others. Such persons are generally seen to oppose dramatic innovative new discoveries, irrespective of scientific evidence. They are the last people to accept breakthroughs in research. And they can be easily identified by the eagerness with which they seek to attack and insult, perhaps becoming exceedingly hostile and irrational with anyone who does not agree with their rigid view of reality. Their extreme reluctance to apologise is also most conspicuous. They usually seem almost totally preoccupied with a negative approach to life characterised by insults and criticisms. Most noteworthy is the fact that they seldom seem to offer positive suggestions on how to reduce human suffering from the current epidemic of chronic diseases or drug induced diseases. Their comments seem to reveal a desire to preserve the status quo rather than promote positive changes in health care. They seem to be prone to all sorts of misconceptions of reality which they seem to perceive as some kind of threat to their particular belief system. According to this type of belief system common sense does not exist until it can be demonstrated by a meta-analysis of randomised controlled trials!
As has recently been pointed out by Rosemary Stanton, the mistake littered record of nutritional research emphasises that (48) "we should have learnt that sometimes we don't even know what we don't know" and "we should be humbled by our lack of knowledge of food and human nutrition." However, like a mental straightjacket, arrogance is not conducive to the learning of new concepts let alone an accurate perception of one's own ignorance, since to the arrogant, it is most important that their views prevail, regardless of truth (Science Today, Quackery Tomorrow). Not surprisingly, the greatest scientists tend to be the most humble since they have a more accurate perception of the limitations of their own knowledge (49). In the words of Kothari (49):
| "some of the greatest people who are very learned, are almost painfully humble. You almost get irritated that this man knows so much and yet he pretends to be humble. But in the depths of his heart you see, he knows that he doesn't know! " |
I appeal to those who have traditionally been more interested in insults and opposing positive change to adopt a more positive caring attitude and join the effort to reduce human suffering by promoting positive change in our health care system (Integrated Medicine).
The TGA's determination to prevent claims about prevention or treatment of serious diseases flies in the face of all the available evidence (Nutrition and Megavitamins, B Vitamins, Nutrition Breakthroughs, Holistic or Reductionist, Experts say dietary supplements may save $billions in health care costs!!). Suggestions by the TGA that supplements can only be used for treating symptoms are in stark contrast with the scientific facts which reveal that nutrients frequently have a curative effect unlike most drugs which merely suppress symptoms ( Nutrition and Megavitamins, Nutrition is for the Birds, Symptom Suppression, Response to Government Inquiry). As I have indicated elsewhere (Response to Government Inquiry), if we are to go by the scientific facts then most drugs should carry the label "For Suppression of Symptoms Only" while nutritional supplements should be labeled "For Disease Prevention and Optimum Health". Although this would be consistent with the available scientific evidence the TGA has chosen to adopt a position which is completely at odds with the scientific facts. There is absolutely no evidence to show that all drugs have a curative effect and all nutrients have a symptomatic effect yet this is the amazing proposition being proposed by the TGA.
At every turn the government and the TGA have contradicted their own words. When a drug was found toxic during the Pan crisis they condemned alternative medicines - not drugs. When a drug was found toxic they said we need more stringent regulations to control alternative medicines - not drugs. After falsely condemning alternative medicines they then suggested they wanted to restore confidence in the alternative medicine industry. And after claiming they have a risk based approach to safety, they then targeted the safest therapeutic products on the market and ignored the most hazardous. All this when they repeatedly admitted that alternative medicines are "low risk"(18, 34). Obviously the Australian government and the TGA have their own agenda, an agenda which they are strenuously seeking to hide.
As I have summarised elsewhere (Alternative Medicine Takeover):
| "It is indeed interesting to note that the TGA
is also now attempting to dispel fears regarding the Codex
in Australia (20)*.
Yet the TGA has been responsible for the Pan witch hunt and
the unjustified condemnation of alternative medicines when a
DRUG was found to be toxic (3,4)*.
It is history now that this witch hunt was the first step in
the TGA's current campaign to dramatically reform the
alternative medicine industry in this country, including
proposed restrictions on factual information, guarantees of
market exclusivity, withdrawal or relabelling of products,
and increased power to cancel licences of manufacturers (4,6,8,9,13,19,23)*.
Amazing how these changes are so in line with changes being
promoted by Codex. The Australian government, the TGA, and other bureaucrats who were involved, have an extremely serious credibility problem. Why should anyone believe them now when they went to such incredible lengths to conceal the truth, and their long term agenda, during the Pan crisis and its sequel............................. When our national drug regulator seeks to abandon the available scientific evidence relating to public health and adopt a stance instead which is consistent with the commercial interests of multi-national drug companies then an urgent inquiry is obviously needed. If the TGA really wished to dispel fears about Codex in Australia they would obviously have called for the government to enshrine health freedoms pertaining to alternative medicines in legislation. Why was it decided to omit such vitally important matters from the terms of reference of the recent inquiry? When does the government intend to act to protect and preserve the current health freedoms of consumers? It is all very well to adopt an entirely negative position and state that Codex does NOT apply to Australia, how about a detailed picture of what DOES apply to Australia? What is the eventual aim of their current anti-alternative medicine campaign? What is the underlying agenda? Why have they gone to so much trouble to mislead the public about the consequences of Pan? What possible reasons could the government have for being so determined NOT to make any such assurances or adopt legislative reforms to protect the freedom of choice of alternative medicine consumers?" * For references see Alternative Medicine Takeover |
The determination with which government authorities have refused to provide legislative protections to protect and preserve the current freedom of choice which consumers of dietary supplements enjoy is most noteworthy and consistent in both Australia and New Zealand. The following concerns expressed by Sue Kedgley of the Greens Party in New Zealand regarding the proposed legislative changes remain unanswered (21):
|
Sue Kegley further documents the concerns of the Green Party regarding the proposed legislative changes (41):
| "We note that no justification is provided in the
legislation for the government's decision to include dietary
supplements in a trans-Tasman regulator. Nowhere in the bill
does the Government explain why it believes the natural
health products industry in New Zealand should be subjected
to this heavy-handed regulatory regime. We believe it is
crucial that this is clarified before Parliament begins to
consider the bill. Further concerns about the bill: • The proposed regulatory framework for therapeutic goods has failed in Australia. Far from being ‘international best practice’ as the government alleges, reputable Australian sources claim that the Australian regulatory system for complementary medicines (through the existing Australian Therapeutic Goods Authority) has done considerable harm to the Australian natural health industry in terms of increasing compliance costs for dietary supplements businesses and therefore the cost of natural health products, reducing innovation in the industry, the range of products available to consumers. • Val Johansen, a key player in the complementary medicines industry in Australia, says the Therapeutic Goods Authority’s excessive and bureaucratic regulatory system has hamstrung and hobbled the industry there. She says the excessively high compliance costs (which have been increasing by more than 15% a year) are driving many dietary supplements businesses offshore. • One of the problems the Australian natural health industry is experiencing is the high cost of getting a product or new ingredient licensed. According to Val Johansen and others, there have been very few new products coming into Australia and consumers there have access to a much restricted range of supplements which are mostly produced by multinational corporations who can afford the high compliance costs, rather than by small businesses. Increased compliance costs will inevitably be passed onto the consumer in terms of higher costs for supplements. • The proposed agency will undermine the sovereignty of our Parliament. If passed into law, control of dietary supplements, pharmaceuticals and medical devices industries in New Zealand will transfer to the Australia New Zealand Therapeutics Products Authority –an offshore entity that will be set up under Australian law, and will be headquartered in Canberra, with an office in Wellington. It will be the first time entire industries in New Zealand will be controlled by an off-shore entity headquartered in another country. Documents I have obtained under the Official Information Act indicate that about 93% of the staff of the agency will be Australians, and just 7% New Zealanders. This speaks volumes about how ‘equal’ this agency will be. • We acknowledge that there will be a Ministerial Council comprising the Ministers of Health of New Zealand and the Federal Government of Australia, who will oversee the agency. But the two Ministers will meet in private. While the agency is subject to the Official Information Act, it appears that the Ministerial Council may be exempt, which would mean that the public will have no way of knowing what the two Ministers discuss or approve in the Ministerial Council, beyond what they choose to make public. I note that the Minister has turned down repeated requests I have made under the Official Information Act for minutes of Ministerial Council meetings and other information relating to the establishment of the agency. The Minister has also refused requests to provide this information to the Health Select committee. • The two Ministers, meeting in private, not our Parliament, will review the agency. And while a report on the agency will be tabled in Parliament each year, there is no provision for the report to be considered by a select committee, or for other recourse or scrutiny in the event that MPs have concerns about aspects of the report. The agency is not subject to key legislation such as the Public Finances Act. And the main powers of the agency, to issue Orders on all manner of issues, will be delegated to an unelected and unofficial Managing Director who will have statutory powers of delegated legislation presently exercised by the Minister of Health, as well as powers to enforce and police regulations. • The agency will have unprecedented police powers of search and seizure. This means that inspectors or police from the off-shore entity will have the power to issue warrants and prosecute people and organisation here in New Zealand and close down dietary supplements companies they believe to be non-compliant. • The agency will also have the power to issue civil penalty and other offences, and to impose instant fines of up to $550,000 on a company. As well as instant fines, penalties for offences range up to $5.5 million for companies. • Rules and Orders issued by the proposed agency will have the force of law in New Zealand, but will not require the approval of our Parliament. The Managing Director of the proposed agency will have the power to enforce and police Rules and Orders in New Zealand, even though they will not have been voted on by our Parliament. • Technically the Rules and Orders could be challenged by a ‘disallowance motion’ in Parliament, but the committee should note that a disallowance motion has never passed in the 153 year history of our Parliament. This means that the power to challenge regulations in our Parliament is essentially illusory. • The definition of what is a ‘therapeutic product’ is vague and it would be left to the Managing Director to decide, on a case by case basis, what should constitute a therapeutic product. • Once the new agency was fully in place, in about five years time, any ingredients that had not been been approved and included on a so-called ‘positive list’ would become illegal. • The agency will circumvent the Treaty of Waitangi and reduce the access of Maori to their traditional medicines and herbs, guaranteed by the Treaty of Waitangi. Since traditional herbs are part of the ‘flora fauna’ guaranteed to Maori by the Treaty of Waitangi, requiring Maori who wish to commercialise their traditional herbs to apply to get it licensed to an off-shore entity, would seem to be a breach of this treaty commitment." |
As Kedgley points out (41), the risk based changes being thrust upon the people of New Zealand by the government completely ignores the known benefits of dietary supplements at a time when surveys have proven that nutritional deficiencies are commonplace amongst the New Zealand people. Why are governments so opposed to people experiencing the well known health benefits of health promoting dietary supplements?
Interestingly, at the same time as the Minister for State Services in New Zealand was pushing for the Australian government to control vitamins and supplements in New Zealand, supposedly because the toxicity of drugs during the Pan debacle demonstrated the dangerous nature of supplements, she was also supporting the mandatory fortification of bread with one of these dangerous supplements, folic acid (44). Of course doctors have refused to endorse the use of folic acid supplements for decades because, unlike drugs, it was considered too dangerous (The Folic Acid Lesson, Nutrition and Megavitamins, Nutrition Breakthroughs, Nutrition is For the Birds, Dispelling the Vitamin E Myths). While the public should apparently be protected from those substances that made no one ill during the Pan debacle, it is nevertheless acceptable to add one of these dangerous substances to bread where individual dosage levels are impossible to determine. In fact, the mandatory fortification of bread with folic acid is described by Ms King as (44) "a triumph for humanity and common sense." But just who was responsible for delaying or preventing this triumph was not mentioned by Ms King. Also not mentioned was whether this "common sense" applies to other nutrients and adulterated nutrient impoverished foods and the general nutritional state of New Zealanders or whether folic acid is absolutely unique amongst nutrients (The Folic Acid Lesson).
Meanwhile, in the real world, doctors are becoming increasingly aware of the very serious consequences of malnutrition and its increasing prevalence (Doctors discover malnutrition in the elderly.......again!), and scientists are discovering the enormous potential of individualised nutritional therapy or megavitamin therapy (Nutrition Breakthroughs) and the addition of dietary supplements to foods (Dietary Supplements or Functional Foods), which are expected to be at the forefront of medicine's fight against chronic diseases this century (Nutrition Breakthroughs, (Dietary Supplements or Functional Foods). And health authorities around the world now realise that billions of dollars in health care costs could be saved if everyone took vitamins (Experts say dietary supplements may save $billions in health care costs!!). While there is so much concern about cost savings let us not forget that this translates into a huge reduction in human suffering, something which governments traditionally express little concern about. As the Australian government pretends that these health promoting substances which could produce such enormous benefits to public health are in fact so dangerous urgent regulations are needed, so they simultaneously ignore human suffering. But this is normal. How many millions have suffered and are still suffering while governments and health authorities argued about the terrible dangers of folic acid and