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The Global Threat to Alternative Medicines

1. The Pan Crisis & Moves to Introduce Dramatic Regulatory Reform of the Alternative Medicine Industry in Australia

2. The Therapeutic Products Bill 2007

 3. Regulatory Changes in the 'Land of the Free'

4. Dietary Supplements Added to Functional Junk Foods

5. The Codex in Australia: Natural Health Products on Trial

6. Australian Alternative Doctor Deregistered & Drug Treatment Legally Enforced


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Natural Products & Complementary Medicine Industry in NZ Proposes Way Forward Following Failure of the Therapeutic Products Bill

Can Science Meet the Challenge of Complementary Medicine?

The Australian Therapeutic Products Bill 2007

Diminishing Right to Vitamins in the Land of the Free?

Doctors discover malnutrition in the elderly.......again!

Putting the Lid on Recurrent Shingles

School Students Better Watchdog than Public Health Authorities

Adverse Drug Reactions Hotline to Close

Medical 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

 

 


Natural Products & Complementary Medicine Industry in NZ Proposes Way Forward Following Failure of the Therapeutic Products Bill.

 

 

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):

"Usually experts consider that adverse reactions to pharmaceutical drugs outnumber adverse reactions to complementary medicines by around 99 to 1 or, at worst, 98 to 2 (Alternative Medicine Takeover, Response to Government Inquiry), a fact which clearly indicates, given the claimed risk based nature of legislative reforms, that safety legislation should be at least 49 times more strict for pharmaceutical drugs than for alternative products."

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:

"With the recent scandals of contamination of toys, toothpaste and other products from China, one must reflect on where else these contaminations may occur. When one then reflects that many of the vitamins, minerals, herbal extracts, excipients and processing aids are now manufactured and supplied from India, China and other third world or developing countries, it is clear that relying on documentation without actual test screening is possibly quite high risk behaviour. At the very least it would seem that some kind of identity test must be performed, and further testing undertaken on an at least rotational testing basis for other attributes and possible contaminants."

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.
2.http://www.scoop.co.nz/stories/BU0708/S00272.htm
3.http://www.nzhealthtrust.co.nz/pdf/position_statement_140807.pdf JOINT INDUSTRY POSITION STATEMENT REGULATION OF THERAPEUTIC PRODUCTS IN NEW ZEALAND, NZ Health Trust.
4.Michelle Beckett, Re: Regulation of New Zealand Therapeutic Products (letter circulated to members and interested parties), Natural Products New Zealand, 13th August 2007.
5.http://www.tga.gov.au/manuf/gmpsom.htm Guidance on the GMP clearance of overseas medicine manufacturers, TGA, August 2007, Canberra.
6.http://www.tga.gov.au/manuf/gmpsom.pdf Guidance on the GMP clearance of overseas medicine manufacturers, TGA, August 2007, Canberra.


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):

"Universities that run them should be ashamed of themselves. They are cashing in on people's wishful thinking when there is no evidence that complementary medicine works. They might as well offer degrees in astrology."

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.
2.http://www.dailymail.co.uk/pages/live/articles/news/news.html?in_article_id=471124&in_page_id=1770 Laura Clark, Dons in revolt over 'unacademic' degrees, Daily Mail, 26th July 2007.
3.http://www.bordermail.com.au/news/bm/national/853706.html Complementary medicine boost, The Border Mail, 7th July 2007.
4.http://www.theage.com.au/news/National/Alternative-medicines-get-funding-boost/2007/07/06/1183351 Alternative medicines get funding boost, The Age, 6th July 2007.
5.http://www.nzdoctor.co.nz/news?article=1d4afc1d-7a5a-48f9-bd3f-0c46dad5e781 New era for complementary medicine; Media release from health minister Pete Hodgson and Green Party health spokesperson Sue Kedgley, 4th July 2007.
6.http://nccam.nih.gov/about/ataglance/
7.http://www.quackwatch.org/01QuackeryRelatedTopics/nccam.html Wallace I. Sampson, Why the National Center for Complementary and Alternative Medicine (NCCAM) Should Be Defunded.
8.http://www.geocities.com/healthbase/camufo.html Paul Lee, Is Complementary & Alternative Medicine a UFO? Skeptic Report, July 2003.
9.http://thestar.com.my/news/story.asp?file=/2007/7/18/nation/18334698&sec=nation
Kepala Batas Hospital first to integrate traditional and modern medicine, The Star, 18th July, 2007.
10.http://skeptics.org.nz/SK:CAM:350524
Vicki Hyde, Complementary and Alternative Medicine -
Current Policies and Policy Issues in New Zealand and Selected Countries
,
Submission to the Ministerial Advisory Committee on Complementary and Alternative Health (MACCAH), New Zealand Committee for the Scientific Investigation of Claims of the Paranormal, NZ Skeptics.
 


The Australian Therapeutic Products Bill 2007
Update - 28th July 2007

Following on from the Pan crisis and Codex, the Australian government  expects to control vitamins and supplements in New Zealand in 2008.
(See below also to see similar changes in America.)

"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) "the proposed Codex Guidelines for Vitamin and Mineral Food Supplements will NOT apply in Australia and will have NO IMPACT on the way these types of products are regulated in Australia," although the TGA does point out it is only the (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 medicines

The 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 medicines

Consumers 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)?:

"It is inexcusable that anyone in the world should have an inadequate intake of a vitamin or mineral, at great cost to that person's health, when a year's supply of a daily multivitamin/mineral pill as insurance against deficiencies costs less than a few packs of cigarettes.......A metabolic tune-up is likely to have enormous health benefits, particularly for those with inadequate diets such as many of the poor and the elderly who need improvement the most, although it is currently not being addressed adequately by the medical community. The issues discussed here highlight the need to educate the public about the crucial importance of optimal nutrition and the potential health benefits of something as simple and affordable as a daily multivitamin/multimineral supplement. Tuning up metabolism to maximize the human health span will require scientists, clinicians and educators to abandon outdated paradigms of micronutrients merely preventing deficiency disease and explore more meaningful ways to prevent chronic disease and achieve optimal health through optimal nutrition."

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):

  • "it would impose an inappropriate, pharmaceutical model for low risk healthcare products, and would result in increasing pharmaceutical control of natural health products
     
  • natural health products would become more expensive and difficult to access
     
  • small New Zealand businesses would go to the wall as a result of excessive compliance costs
     
  • there would be reduced consumer choice as many ingredients would not be available in the future
     
  • some traditional remedies that have been safely used for centuries, such as Chinese herbs and Ayuvedic medicine, would become illegal in a few years time
     
  • our sovereignty and control over medicines and natural health products would be undermined, and Parliament would effectively hand over jurisdiction for these products to the Trans-Tasman regulator. "

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 other supplements (The Folic Acid Lesson)?   And have they apologised, offered compensation, or changed their ways? But in the world of multinational drug companies and their bureaucratic puppets and covert agendas, politicians and health authorities seek to convince the public that nutritional supplements are so dangerous they should not be so commonly available.

The current attitude of the Australian government is grossly irresponsible as they deliberately, for their own devious purposes, refuse to publicly endorse the widespread daily use of nutritional supplements as has been recommended by health experts around the world. Although they know the suffering caused by the past refusal to acknowledge evidence relating to the importance of folic acid, still they persist with this nutritional recklessness and indifference to human suffering. How else could the intense campaign of deceit and misinformation about Pan be explained other than by a desire to  camouflage what were known to be shameful and potentially extremely unpopular legislative reforms?

Strange as it may seem, science has provided a precedent for this ridiculous situation.

The twentieth century was the century during which all the vitamins were discovered and yet in this same century, following the discovery of the vitamins, scientists developed the food processing industry to remove these essential health promoting nutrients from foods more effectively than ever before in human history (Nutrition and Megavitamins). They called it scientific progress. Over time of course, as people became sick from nutritional deficiencies, even the scientists learned the foolishness of food processing. As a result, science came to the rescue again however, and developed ways of manufacturing synthetic vitamins and adding these back to the foods from which they had previously been removed. This was a great scientific breakthrough indeed and everyone was happy. Science had created two new highly profitable industries which could coexist quite happily together.

Meanwhile, health conscious consumers were forced to purchase "whole" grain or "natural" foods from health food stores to avoid the latest food processing discoveries of scientists. While science was busy destroying or "dismantling" natural nutrient rich whole foods, the astute consumer was forced to try and "reassemble" these foods by purchasing the separate constituents from health food stores. For instance, the wheat grain could be "reassembled" by purchasing the separate parts of the wheat such as the germ, the bran, and vitamins. In this way the health conscious consumer could overcome the advances of modern science and do his or her bit to prevent malnutrition. Sadly however, such consumers incurred the wrath of doctors who sought to prevent healthy eating and who therefore referred to such people by derogatory terms such as "food faddists" or "health nuts" who believed in "nutrition quackery" (Dietary Supplements or Functional Foods). As is now apparent to doctors however, the food faddists were decades ahead of medicine in their attempts to prevent malnutrition (Dietary Supplements or Functional Foods). The bran and whole foods favoured by food faddists and ridiculed as quackery by doctors are now recommended by doctors (11,36,37,38). If only they had listened to the food faddists all those years ago they could have prevented so much suffering! Sadly however, unlike the food faddists who seem to possess a degree of common sense and inherent wisdom, the scientists needed to experiment with the general public and observe malnutrition by double blind studies before they realised the foolishness of processing the nutrients out of foods.

This precedent demonstrates quite clearly that yes, politicians and health authorities could indeed be so stupid, callous, and uncaring as to reduce the availability of nutritional supplements at a time when malnutrition is becoming increasingly prevalent - but it also demonstrates that new highly profitable industries, such as the addition of dietary supplements to foods (Dietary Supplements or Functional Foods), are likely to develop as a direct result of this action!

But the Folic Acid Lesson teaches us that vitamins cannot be too freely available and should be subsidised by governments because of their fundamentally curative cause based nature, unlike modern symptom concealing drugs.

As far as Australia and  New Zealand are concerned, it would seem unlikely that the Australian government would seek to implement full control over alternative medicines before gaining legislative control over New Zealand. Once the necessary legislation is in place then it will be up to the Australian government to decide the nature and timing of the changes they wish to implement.

Since the campaign of misinformation about Pan has been so successful we can no doubt look forward to more exercises in mass deceit.

Those who put profits and personal gain ahead of health and caring will continue to resort to any means possible to enforce their will upon the majority. It is up to all of us to be vigilant and ensure that caring and compassion do not give way to greed. We owe it to the aged community, and we owe it to our children, and to every following generation. Do not let them down.

References

1. http://www.health.gov.au/internet/wcms/publishing.nsf/Content/7D33BF39495CAA19CA2572AE001C Therapeutic Products Bill 2007: Guide to the exposure draft, 2007, Department of Health and Ageing, Australian Government, Canberra.
2. http://www.health.gov.au/internet/wcms/publishing.nsf/Content/7D33BF39495CAA19CA2572AE001C Therapeutic Products Bill 2007: Guide to the exposure draft, 31st Jan 2007, HOUSE OF REPRESENTATIVES, The Parliament of the Commonwealth of Australia, Canberra.
3. http://www.aar.com.au/pubs/bio/fohapr07.htm, Przemek Kucharski, A review of the exposure draft of the Therapeutic Products Bill 2007 (Cth), Focus: Health – April 2007, Allens Arthur Robinson.
4. http://www.claytonutz.com.au/uploads/Therapeutics%20Product%20Bill_104168857_1.pdf Summary of key provisions in the exposure draft of the Therapeutic Products Bill 2007 ("the Bill"), Clayton UTZ, Australia.
5. http://www.stuff.co.nz/stuff/4055356a12935.html Amy Adams, Health products: the great Aussie takeover, The Press, Friday, 11 May 2007.
6.http://www.nzhealthtrust.co.nz/news.html NZ Health Trust
7. http://www.scoop.co.nz/stories/PO0705/S00230.htm ‘Anti-Vitamin Bill’ protest at Parliament Tomorrow, Health law threatens '1000 products' Trans-Tasman Medicines Regulator a ‘Trojan Horse’, Bitter pill to swallow, Western Leader, 28 April 2007.
11. http://www.nytimes.com/2007/05/15/health/nutrition/15nutr.html?_r=1&oref=slogin Eric Nagourney, Nutrition: A Cardiovascular Argument for Eating Whole Grains, The New York Times, 15 May 2007; See also Philip B. Mellen, Thomas F. Walsh, David M. Herrington Nutrition, Metabolism and Cardiovascular Diseases .
12.http://www.parliament.nz/en-NZ/SC/Reports/0/e/9/0e9c2505c5084f0fa20509afba8967ae.htm   Therapeutic Products and Medicines Bill 103—1, Report of the Government Administration Committee, New Zealand Parliament, 15th June 2007.
13.http://www.parliament.nz/NR/rdonlyres/B9BAD06B-FDF0-4A55-8F20-3E8E096A9BA6/56884/D Therapeutic Products and Medicines Bill 103—1, Report of the Government Administration Committee, New Zealand Parliament, 15th June 2007.
14.http://www.nzherald.co.nz/section/story.cfm?c_id=204&objectid=10445946&pnum=2 Sophie Hazelhurst, Committee fails to reach agreement on therapeutics bill, The New Zealand Herald, 15th June 2007.
15.http://www.anztpa.org/newsletters/2007/0707newsletter.pdf Philip Davies, Newsletter Number 3, The Australia New Zealand Therapeutic Products Authority Project, July 2007.
16.http://www.ahrp.org/infomail/05/11/14.php Vera Hassner Sharav, Loss of Trust: Big Drug Makers See Sales Decline With Their Image, Alliance for Human Research Protection, 14 Nov 2005; see also, Alex Berenson, Big Drug Makers See Sales Decline With Their Image, New York Times, 14 Nov 2005. 
17.http://www.businessweek.com/magazine/content/05_02/b3915433.htm Amy Barrett, John Carey, Michael Arndt, More Bitter Pills For Big Pharma, Business Week, Jan 10 2005.
18.http://www.tga.gov.au/cm/fs_codex.htm Fact sheet - Codex, TGA, Canberra,
19.http://www.anztpa.org/cm/fs-cm.htm The proposed joint regulatory scheme for complementary medicines, Fact Sheet, Australia New Zealand Therapeutic Products Authority, Jan 2007.
20.http://theyworkforyou.co.nz/portfolios/state_services/2007/mar/14/o01#23 Questions to Ministers, New Zealand Parliament, 14th March 2007; see also http://www.hansard.parliament.govt.nz/hansard/Final/FINAL_2007_03_14.htm#_Toc163464757 .
21.http://www.greens.org.nz/searchdocs/other10437.html Sue Kedgley MP, Green Party, Trans Tasman Shenanigans, Complementary Health Newsletter, 1st December 2006.
22.http://www.democrats.org.au/news/index.htm?press_id=5806  Senator Lyn Allison, Democrats Demand Howard Apologise for Pan Pharmaceuticals Witch Hunt, AUSTRALIAN DEMOCRATS PRESS RELEASES, 18th April 2007.
23.http://www.theaustralian.news.com.au/story/0,20867,21578443-2702,00.html Tracy Ong, Pan Pharmaceuticals boss acquitted, The Australian, 18th April 2007.
24.http://www.theage.com.au/articles/2003/05/02/1051382070157.html  See: Doctors' medicines all safe: govt, The Age, 2nd May 2003.
25.http://web.archive.org/web/20030622072144/ http://www.health.gov.au/mediarel/yr2003/tw/tw03023.  See: Trish Worth,  Final List of Members for Expert Committee on Complementary Medicines, Media Release, 27 May 2003.
26.http://www.smh.com.au/news/National/Strict-new-rules-curb-herbal-drug-sales/2005/03/09/11103160 Mark Metherell, Strict new rules curb herbal drug sales, Sydney Morning Herald, 10th March 2005.
27.http://www.theage.com.au/news/National/Red-tape-forcing-up-medicine-prices/2005/04/23/111415 Phillip Hudson, Red tape 'forcing up medicine prices', The Age, 24th April 2005.
28.http://www.tga.gov.au/cm/cmresponse.htm See: Australian Government response to the recommendations of the Expert Committee on Complementary Medicines in the Health System, Department of Health, Canberra, March 2005. 
29.http://www.theage.com.au/news/National/Govt-launches-alternative-medicine-study/2006/11/23/116387 Govt launches alternative medicine study, The Age, 23rd Nov 2006.
30.http://www.theaustralian.news.com.au/story/0,20867,20809394-29277,00.html Alternative medicine to be put to the test, The Australian, 23rd Nov 2006.
31.http://web.archive.org/web/20040426071749/http://www.abc.net.au/news/newsitems/s843371.htm  See: ABC News, Heads to Roll at Pan, 30th April.
32.http://www.tga.gov.au/docs/html/cmfact1.htm Complementary medicines reform package - an overview Complementary medicines information sheet, 20 April 1999, TGA, Canberra.
33.Bollen, M., Chairman,  Report of the Expert Committee on Complementary Medicines in the Health System, Canberra, September, 2003. http://www.tga.gov.au/docs/pdf/cmreport.pdf  
34.http://www.tga.gov.au/cm/cmreg-aust.htm The regulation of complementary medicines in Australia
An overview
, April 2006.
35.http://www.bmj.com/cgi/content/full/328/7433/180 MB Katan, (Edit) Health claims for functional foods, BMJ  2004;328:180-181 (24 January).
36.http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=15195181& Jacobs DR, et al, Consumption of whole grain foods and chronic disease, Tidsskr Nor Laegeforen. 2004 May 20;124(10):1399-401.
37.http://www.jacn.org/cgi/content/full/19/suppl_3/291S?maxtoshow=&HITS=10&hits=10&RESULTFO
James W. Anderson et al, Whole Grain Foods and Heart Disease Risk, J Amer Coll Nutr, 19, 291S, 2000.
38.http://www.jacn.org/cgi/reprint/19/suppl_3/289S.pdf Leonard Marquart et al, Whole Grains and Health: An Overview, J Amer Coll Nutr, 19, 289S, 2000.
39.
http://www.news.com.au/common/story_page/0,4057,6349938%5E2,00.  See: Judy Skatssoon, Safety breaches force recall, April 28, 2003.
40.
MaGuire, T., Largest Ever Drug Recall, Daily Telegraph, 29th April 2003.See : http://www.dailytelegraph.com.au
41.http://www.greens.org.nz/searchdocs/other10593.html Sue Kedgley MP, SUBMISSION: THE THERAPEUTIC PRODUCTS AND MEDICINES BILL, Parliament, 20th February 2007.
42.http://www.hansard.parliament.govt.nz/hansard/Final/FINAL_2003_12_04.htm Annette King, NZ Parliament, 4th Dec 2003.
43.http://www.naturopath.co.nz/assets/File/Natural%20Medicine%20The%20Safest%20Way%20to%20Avoid%20Death.pdf Natural medicines – the safest way to avoid death in NZ, The Naturopaths, New Zealand, 12th October 2006.
44.http://www.nzherald.co.nz/topic/story.cfm?c_id=294&objectid=10447345 Bread to be fortified with folic acid, New Zealand Herald, 22nd June 2007.
45.http://jn.nutrition.org/cgi/content/full/133/5/1544S Bruce Ames, The Metabolic Tune-Up: Metabolic Harmony and Disease Prevention, J. Nutr. 133:1544S-1548S, May 2003.
46.http://www.ingentaconnect.com/content/adis/dsf/2007/00000030/00000005/art00002?crawler=true  McEwen, John et al,  Widespread Hyoscine Hydrobromide Toxicity Due to Contract Manufacturer Malpractice: The Travacalm Episode, Drug Safety, Volume 30, Number 5, 2007 , pp. 375-378(4).
47.http://www.australianprescriber.com/magazine/28/6/140/2/ Kerri Mackay, Showing the blue card: reporting adverse reactions, Aust Prescr 2005;28:140-2.
48.http://www.natsoc.org.au/html/papers/stanton.pdf Rosemary Stanton, Who's Driving the Food Supply?, Food for Healthy People and Healthy Planet Conference ; see also Bryan Furnass (Ed), Good Grub - food for healthy people and a healthy planet, Nature and Society Forum Inc ABN 52 456 986 523 People and Nature (PAN) Perspectives book (267 pp), published by Nature and Society Forum and the Mulanggarri Foundation.
49.http://aidsmyth.addr.com/articles/medicalignorance.htm Manu Kothari, Medical Ignorance & The Democracy of Intellect, 12th June 2000.
50.http://en.epochtimes.com/news/7-7-23/57900.html Barry Mills, Relief over Natural Products Bill Defeat, The Epoch Times, 23rd July 2007.
51.http://www.nzdoctor.co.nz/news?article=8489bfc2-9080-4143-8e45-99c3df93fb6d Therapeutic Products and Medicines Bill Shelved and Sedated, Media release from the New Zealand Society of Anaethetists, 19th July 2007.
52.http://www.smh.com.au/news/World/Joint-therapeutic-agency-plans-on-hold/2007/07/16/118455967 Joint therapeutic agency plans shelved, Sydney Morning Herald, 16th July 2007.
53.http://www.theage.com.au/news/World/Joint-therapeutic-agency-plans-shelved/2007/07/16/11845596 Joint therapeutic agency plans shelved, The Age, 16th July 2007.
54.http://www.newswire.co.nz/main/viewstory.aspx?storyid=382883&catid=33 Time Runs Out For Joint Medicines Agency, Newswire NZ, 16th July 2007.
55.http://www.nzherald.co.nz/author/story.cfm?a_id=164&objectid=10451961 Audrey Young, Government defeat on medicines spurs 'lame-duck' jibes, New Zealand Herald, 17th July 2007.
56.http://www.parliament.nz/en-NZ/PB/Debates/Debates/Speeches/3/9/2/48HansS_20070717_00000 English, Bill: Questions for Oral Answer — Questions to Ministers, New Zealand Parliament, 17th July 2007.
57.http://www.scoop.co.nz/stories/PA0707/S00273.htm English, Bill: Questions for Oral Answer — Questions to Ministers, New Zealand Parliament, 17th July 2007.
58.http://www.blackmores.com.au/News/Detail.aspx?ArticleId=8979 Marcus Blackmore, Blackmores’ perspective: Trans-Tasman Harmonisation on hold, 24th July 2007.
59.http://www.theaustralian.news.com.au/story/0,25197,22141485-23289,00.html Adam Creswell, Drug regulator collapse dents patient hopes, The Australian, 28th July, 2007.
 


Diminishing Right to Vitamins in the Land of the Free?

The FDA in America, like the TGA in Australia (see above), moves to restrict health freedoms and tighten control over alternative medicines.

As Europe leads the way (1,2,3,4,5,6) in restricting health freedoms by imposing draconian restrictions upon the alternative medicine industry and  the marketing of dietary supplements, so the FDA in America (1,7,8,9,10,11,12,13) and the TGA in Australia (see above) are also moving in the same direction. Evidence reveals these changes are commercially based with the eventual intended goal of establishing a protected monopoly in alternative medicines for drug companies.

In spite of these trends there are many commentators who contradict current claims about impending vitamin restrictions and loss of health freedoms, however, it seems to me that most if not all of such persons prefer to avoid looking at the "big picture", preferring instead to confine their analysis to very specific legislative changes. This tunnel vision approach ignores global changes, general trends and the profit motive of drug companies and their puppets. I have always made it clear that my concern is with these general trends and with the end results as well as the credibility and track record of those proposing the changes (see Pan Crisis, TGA & Pan, Codex in Australia, Pan Crisis & Future of Alternative Medicines, Alternative Medicine Takeover, Response to Government Inquiry). For instance, if doctors who have traditionally regarded vitamins as useless, harmless, placebos suddenly want new legislation because vitamins are so dangerous, then there clearly is a massive credibility problem. This is also true when we see politicians and health authorities abandoning scientific evidence and resorting instead to lies and wild exaggerations in an obviously desperate attempt to justify proposed changes, as occurred during the Pan witch hunt. Let us not let the detail blind us to the truth. Greed is a huge motivator.

Currently there is much concern in America about the direction in which legislators are moving and the continuing erosion of health freedoms (1,7,8,9,10,11,12,13). Like Australia, America is moving in a direction which is consistent with global trends and the requirements of Codex and Big Pharma. While current legislative proposals may not necessarily be the "knockout punch" that so many are expecting, they are nevertheless causing widespread confusion and alarm (1). According to Adams however, the knockout punch is on the way, it just has not landed yet (11): "the FDA is about to deal a final, fatal blow to the alternative medicine industry, outlawing nutritional supplements, functional foods, homeopathy and natural therapies all at once." Adams lists the following possible consequences of this proposed legislation (11):
 

"Things that will be regulated out of existence

It is very clear that the FDA is intending to regulate and ultimately destroy the entire CAM industry (Complementary and Alternative Medicine). Based on the explanations in the FDA's own document, the following things are likely to occur:

  • All vitamins, nutritional supplements and functional foods will be stripped of their structure & function claims, reducing them to empty labels where virtually nothing at all is allowed to be stated.
     
  • Vegetable juice will be regulated as a drug. Raw juice retreats will be raided or shut down.
     
  • Growing and selling common garden herbs will get you arrested as a drug dealer.
     
  • Massage oils and handheld massagers will be regulated as "medical devices."
     
  • Yoga props, pilates machines and weight machines will be regulated as "medical devices" and require FDA approval before being sold or used.
     
  • Raw sprouts and other anti-cancer foods will be regulated as drugs.
     
  • Bottled water that "treats" dehydration will be regulated as a drug.
     
  • Massage therapists who use hot rocks as part of their therapy will have the ROCKS regulated as medical devices! (It's true. The FDA will actually look at a pile of rocks and declare, "Those are medical devices!")
     
  • Functional foods, supplements, vitamins and homeopathic remedies will disappear from store shelves, pending FDA "review." (The only things remaining will be processed junk foods and pharmaceuticals, which is exactly what Big Business wants.)
     
  • Therapeutic tea products, such as green tea, will be outlawed and confiscated.
     
  • Vitamin store owners will be arrested and prosecuted for "practicing medicine without a license."
     
  • Citizens owning personal inventories of "unapproved drugs" (vitamins and herbs) may have their homes raided at gunpoint and their inventories confiscated by armed law enforcement agents.
     
  • The importation of herbs and functional foods from all countries may be banned."

Adams continues (11):

"Keep in mind that the FDA is the same agency that:
  • Wants to label irradiated foods as "pasteurized."
     
  • Voted to put the deadly drug Vioxx back on the market after tens of thousands of deaths, even after its own manufacurer pulled it from pharmacies.
     
  • Raided a church at gunpoint, confiscating biofeedback machines and charging that they were "practicing medicine" by counseling church members on issues like depression.
     
  • Openly allows corrupt, "on the take" experts to vote on new drug approvals, even when those experts are taking money from the same companies impacted by their votes.
     
  • Refuses to legalize stevia, the safe, natural herbal sweetener that's used virtually everywhere else in the world. The agenda? Protect the profits of aspartame and other chemical sweeteners.
     
  • Openly allows the mass poisoning of the public with cancer-causing food additives such as sodium nitrite.
     
  • Refuses to enforce its own laws regarding unsafe chemical toxins in personal care products, allowing perfume and lotion companies to continue poisoning the public with cancer-causing chemicals that don't even have to be listed on the label, nor proven safe.
     
  • Ordered the destruction of recipe books that mentioned stevia. (A campaign to keep the public ignorant of the herb.)
     
  • Does everything in its power to protect drug company profits, including discrediting herbs, supplements and alternative medicine."

While authorities may disagree about the immediate significance of this legislation as far as the alternative medicine industry is concerned (1), there is little disagreement about the intended or eventual end results and the motivations behind this legislation (1,7,9,10,11,12,13). One of these concerns relates to the push to define alternative treatments as "drugs" so that even treatment with vegetable juices could be regarded as "drug" treatment (1,7,9,10,11,12) and suffer the same restrictions as toxic pharmaceutical drugs. Paradoxically however, there is a simultaneous global push to add dietary supplements to foods (Dietary Supplements or Functional Foods).

These proposed powers are consistent with powers already conferred upon the FDA by the Trilateral Cooperation Charter (TCC) to enable them to redefine the term "health fraud" so that (1) "any product that is both safe and gives rise to beneficial effects on health i.e. the vast majority of dietary supplements, become potential subjects of health fraud." According to the Alliance for Natural Health, ANH (1):
 

"The most worrying aspect of the TCC is the way in which the three counties have agreed to define ‘health fraud’. In essence, they have provided such a wide definition of health fraud that it potentially allows the regulators in each of the three countries to go after any company making therapeutic natural health products – even if they present no harm to consumers and contain no false or misleading information on their labels or associated marketing material. In fact the FDA claims over 730 prosecutions since the TCC’s inception in 2003 through to just October 2005.

The TCC defines health fraud as follows, but note in particular the second part of the definition we have bolded for emphasis:

“The false, deceptive, or misleading promotion, advertisement, distribution, sale, possession for sale, or offering for sale of products or provision of services, intended for human use, that are represented as being safe and/or effective to diagnose, prevent, cure, treat, or mitigate disease (or other conditions), to rehabilitate patients or to provide a beneficial effect on health."

Interestingly, the Natural Solutions Foundation in America recently reported that their web site supporting alternative medicine was recently blocked for mysterious reasons (29). These restrictions on free speech are very similar to changes in Europe (1) and in Australia where the Australian government also seeks to prevent truthful claims about vitamins or natural health products (Alternative Medicine Takeover). And in the UK opponents of alternative medicine are so vocal and organised that the national press has refused to publish an article supporting complementary medicine (14,15,16,17,18), while in Wales, a supplier of vitamins was made a criminal following a dawn raid of his premises by the British Medicine's Regulator (19,20).

Just as in Australia, the FDA in America is merely attempting to justify a complete takeover of alternative medicines on the basis of false or wildly exaggerated unscientific claims about safety (30,33,34,35,36), precisely the same tactics used by the TGA as a result of the Pan witch hunt. According to Byron Richards (30):
 

"The FDA has conveniently used the excuse of looking out for consumer safety to increase their perverse regulatory power, undermine free speech, disrupt commerce, and generally get in the way of helping people improve their health. The “half-truth” of the safety issue is used as a ploy to reduce the rights of Americans, one freedom at a time. Once again, the FDA is seeking more police power to intimidate supplement companies. This is one step in an overall FDA master plan to eliminate therapeutic nutritional supplements from the free market. Those who lose are the American public."

Richards continues (30):

"The PR spin suggesting a “need” for this legislation is to protect consumers and give consumers confidence in the supplement industry. The only reason for any lack of consumer confidence is due to a relentless and fraudulent persecution of supplements by the controlled media acting on behalf of the sickness industry. It is an attempt to divert public attention from the real safety issue of dangerous drugs that kill several thousand Americans per week."

Once again these tactics are exactly the same as those employed by the TGA in Australia, who, while destroying the supplement industry, pretended they were building consumer confidence in the industry (Pan Crisis, TGA & Pan, Codex in Australia, Pan Crisis & Future of Alternative Medicines, Alternative Medicine Takeover, Response to Government Inquiry). Richards draws attention to the fact that since evidence of serious adverse reactions to supplements is so rare the legislation has been deliberately structured so as to permit side effects of pharmaceutical drugs to be blamed on supplements (30):
 

"The bill says, “The term adverse event means any health-related event associated with the use of a dietary supplement that is adverse.” This is far different than a serious adverse event. In another words, any symptom a person associates with taking a vitamin that in their opinion is improper will need to be recorded as an adverse event. Such reports need to be open for FDA inspection at any time. This legislation is nothing more than an FDA harassment vehicle."........"The way the legislation is written a person could blame vitamins for almost anything, even if they are on multiple drugs or have pre-existing serious health problems."

Once again these identical trends are occurring in Australia where experts have also suggested, when it comes to alternative therapies, an adverse event is an adverse event (31,32) "whether or not it is confirmed to be related to the therapy," a fact I drew attention to in my article about the Pan witch hunt (Pan Crisis). If you are taking pharmaceutical drugs and vitamins at the same time the vitamins can therefore be blamed for any adverse reactions. Amazing how, like puppets, the ramblings of Australian authorities reflect so closely the words of the FDA. Is the FDA making Australian policy? Or is the policy in both countries determined by Big Pharma?

Richards continues (30):

"Adverse event reporting is addressing a non-existent problem. It is seeking to shift the legal burned of proof to supplement companies. It is targeted to harass small and truly helpful nutritional companies. It plays on the false need for improved safety as the excuse to gain further regulatory control of the supplement industry. It is a ploy by the FDA and various bought-off members of Congress to further harass supplement companies, setting the stage for Codex implementation and overturning U.S. law that gives consumers access to a wide variety of supplements."

Richards sums up the consequences of adverse event reporting (AER) legislation(36):

"Adverse Event Reporting legislation will enable doctors to viciously attack vitamin supplements based on Big Pharma propaganda, and with the help of the FDA have effective dietary supplements removed from the market..................AER legislation for dietary supplements is best understood in the context of Big Pharma and FDA efforts to brand dietary supplements as dangerous and categorize them as drugs.  This effort is taking place internationally, regionally, and within the United States.  Many FDA actions in this campaign are blatantly illegal and undermine American sovereignty........Big Pharma will pay for fraudulent science, as was done to attack vitamin E, and doctors across the country will tell their patients to report any symptom as an adverse event relating to vitamin E (or anything else), simply because the person is taking vitamin E.  Then, the FDA will apply drug-like risk analysis to the information they collect from vitamin companies, and slant statistics with a goon-like twisted “public health” perspective.  They will then rule numerous vitamins to be unsafe at various levels of intake." 

It seems that in America time is running out to prevent the takeover of the dietary supplement industry which is being sought by those who oppose health freedoms and the availability of dietary supplements, such as the FDA and Big Pharma (37,38). Step by step Big Pharma and its puppets are continuing their relentless march towards the global takeover of vitamins and supplements and their desire to deny citizens the right to rectify malnutrition and vitamin deficiencies with supplements. According to Richards (37):

"Your right to have free access to safe and highly effective dietary supplements is under an intense multi-pronged FDA attack. On May 14, 2007 the Supreme Court sided with the FDA by deciding not to hear the case of Nutraceutical v FDA, letting stand a federal appeals court ruling that permits the FDA to use drug-related risk/benefit analysis to determine if a nutrient is safe. This is the exact same point the FDA is trying to get put into law through Senate bill S.1082 and HR.1561, which consumers have flooded the Senate on over the past few weeks. And it is the same point the FDA is seeking to help implement on an international basis through Codex. The Supreme Court denial to hear this case is a dramatic turn of events that means there is very little time left to act to preserve free access to dietary supplements............................"

"You may find it hard to believe that the FDA would follow this path when so many people are in need of natural and safe health options. Yet, the FDA is already working with Codex on an international basis to help establish risk analysis (toxicology) for dietary supplements. FDA scientists are heavily involved with the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU). In the upcoming meeting in Germany in Nov 2007 an FDA-supported plan will be presented in an effort to help establish the application of risk analysis to guide CCNFSDU to set “Safe Upper Limits” for dietary supplements. Safe Upper Limits, as currently viewed by Codex, are a public health scam; they are a politically correct strategy for branding dietary supplements as drugs based on drug-related risk analysis technology. The FDA and Codex goal is to remove therapeutically useful dietary supplements from the free market so they don’t compete with drugs. Another goal is to make all useful nutrients into prescriptions to give Big Pharma a total monopoly on all health options."

Perhaps one of the most disappointing aspects of this whole matter is the fact that some supposed supporters of alternative medicines, and even some suppliers of alternative medicines, have been persuaded to 'change sides' and support the push to control alternative medicines. I have previously drawn attention to this occurrence in Australia (Alternative Medicine Takeover) and according to Richards (Big Pharma Trojan Horses Permeate Supplement Industry), it is also occurring in America (35,36). According to Richards (35), "Unfortunately, it is up to 'we the American people' to save the supplement industry from traitorous groups pretending to be on your side."

Although legislators have managed to confuse the debate about Codex and controls over marketing of vitamins, the general direction of, and motivation behind, these changes, should be abundantly clear to everyone. As I indicated elsewhere (Alternative Medicine Takeover, Alternative Medicine Enquiry) , it would be very easy for governments to adopt a scientifically based attitude, in response to proactive pressure from lobby groups, and move to strengthen health freedoms in current legislation in accord with the available scientific evidence which shows the safety and effectiveness of supplements (Dietary Supplements, Dietary Supplements or Functional Foods, Nutrition Breakthroughs). Legislative safety amendments clearly should reflect evidence of known toxicity and relative risk of therapeutic substances and therefore the more hazardous pharmaceutical drugs should be receiving the most legislative attention (Dietary Supplements). This is in accord with all the available scientific evidence. Proactive action would involve interest groups lobbying government to subsidise nutritional supplements and make them more available to all. The right to proper nutrition, using supplements if desired, should be enshrined in our constitutions. At the same time governments should be urged to introduce new labeling and grading for pharmaceutical drugs according to scientific evidence of known risk.  Additionally, unless a drug is known to have a "curative" effect it should be labeled accordingly as a symptomatic treatment (Alternative Medicine Enquiry):
 

"Regulations should formally acknowledge the different efficacy standards for alternative medicines and pharmaceutical drugs by requiring that the former, particularly nutritional supplements, are labeled "For Disease Prevention and Optimum Health" or similar, while drugs should be labeled "For Suppression of Symptoms" or similar. Exemptions could of course be granted in specific cases where this is warranted. Such a system would be totally consistent with all the available scientific evidence. This distinction must be formally acknowledged in the interests of public health."

The fact that governments are moving in the opposite direction, and the fact that interest groups are generally silent on such proposals, is most conspicuous and incriminating. I issue a challenge to those who say there is no threat to supplement availability intended by currently proposed legislative changes to publicly endorse the above suggestions and endorse and enact a risk and toxicity based approach to legislation of therapeutic products in accord with scientific evidence (Dietary Supplements).

While all these changes are occurring it is business as usual for the multinational drug companies. Even former editors of the New England Journal of Medicine draw attention to the corruption and fundamental profit motive of drug companies (21,22,23,24). Although the New England Journal of Medicine recently relaxed its guidelines to permit more potential conflict of interest amongst submitting authors (25) there is continuing unrest amongst doctors about the corrupt influence of Big Pharma upon the medical profession (26,27). And in America claims are being made that senators are being bought off by Big Pharma as the drug companies attempt to steamroll their opposition (27,28). At the same time the food industry is continuing its relentless campaign to add dietary supplements to foods (Dietary Supplements or Functional Foods).

But as the potential benefits of nutrition are becoming increasingly obvious, at the same time drug industry profits and the production of innovative "blockbuster drugs" are in significant decline as the drug industry is forced to depend increasingly upon production of "copycat" or so called "me-too drugs" which offer no clear therapeutic advantage (39,40,41,42,43,44). Additionally, according to Humer (45), who cites figures from the Pharmaceutical Research and Manufacturers Association of America , "USD100 million are wasted every year in the United States alone because patients take drugs that are ineffective or have serious side effects."

With the assistance of politicians, the medical profession, and even deserters in the alternative medicine industry, it is hardly surprising that Big Pharma is seeking to "cash in" on the current boom in alternative medicines. Politicians, bureaucrats, and doctors have joined forces, as we observed as a result of the Pan witch hunt, to try and convince consumers that health promoting nutrients are so dangerous nothing but complete government control will save the human race. They tell us that in order to protect us they need the same control over vitamins as has resulted in thousands of deaths from pharmaceutical drugs every year. And they tell us that as malnutrition becomes more prevalent vitamins are too dangerous to take. And as scientists discover the need for megavitamins vitamins should be restricted. And of course it should be against the law to say that nutritional supplements alleviate malnutrition. And anyone who suggests megadoses of nutrients could be used to treat genetic diseases - surely they should be arrested! But we will need extremely big gaols - but then again.......if we privatise the gaols......

References

1. http://www.alliance-natural-health.org/index.cfm?action=news&ID=278 ANH PRESS RELEASE: FDA Guidance for CAM, CAM THERAPIES IN THE USA IN TURMOIL FOLLOWING RELEASE OF FDA DRAFT GUIDANCE DOCUMENT, Alliance for Natural Health, 2nd May 2007.
2. http://www.alliance-natural-health.org/_docs/ANHwebsiteDoc_272.pdf ANH puts spotlight on EU procedures for food supplements following European Court judgment, Alliance for Natural Health, 16 March 2007, Dorking, United Kingdom.
3. http://www.alliance-natural-health.org/index.cfm?action=news&ID=275 ANH PRESS RELEASE: ANH responds to EFSA accusation of legal threat, Alliance for Natural Health, 27 March 2007, Dorking, United Kingdom.
4. http://www.alliance-natural-health.org/index.cfm?action=news&ID=274 ANH PRESS RELEASE: ANH puts spotlight on European Commission over food supplement procedures, Alliance for Natural Health, 16 March 2007, Dorking, United Kingdom.
5. http://www.staffnurse.com/nursing-news-articles/euro-court-backs-vitamin-restrictions-1348.html Euro-court backs vitamin restrictions, July 18th 2005.
6. http://www.theecologist.org/archive_detail.asp?content_id=202 Hidden Agenda, The Ecologist, 01/06/2003.
7. http://www.healthfreedom.net/index.php?option=com_content&task=view&id=217&Itemid=251 FDA CAM Regulation Guidance, Health Freedom Foundation.
8. http://www.healthfreedom.net/index.php?option=com_content&task=view&id=209&Itemid=244 Upcoming legislation that will severely affect your health choices, Health Freedom Foundation.
9. http://www.anxiety-and-depression-solutions.com/articles/news/FDA_alt_med_0407.php FDA Seeks Stricter Regulations for Alternative Medicines, Insight, Apr 24, 2007.
10.http://www.mediaisland.org/en/cam-practices-products-and-fda-regulation-updated-threat-assessment
Ralph Fucetola JD - www.vitaminlawyer.com CAM Practices, Products and FDA Regulation: Updated Threat Assessment, Media Island International, 04/24/07.
11.http://www.newstarget.com/021789.html Mike Adams, Health freedom action alert: FDA attempting to regulate supplements, herbs and juices as "drugs", News Target, April 11, 2007.
12.http://www.healthfreedomusa.org/index.php/?p=354 Comments on FDA Guidance to Regulate CAM, Natural Solutions Foundation, 04/06/07.
13.http://www.healthfreedom.net/storage/aahf/documents/HFF_dietary%20supplement.pdf $100 For a Single Vitamin C Tablet, Health Freedom Foundation.
14.http://www.alliance-natural-health.org/index.cfm?action=news&ID=266 Read and forward this - the press won't publish it!, Alliance for Natural Health, 14 Dec 2006, Dorking, United Kingdom.
15.http://www.alliance-natural-health.org/_docs/ANHwebsiteDoc_262.pdf Robert Verkerk, Who’s confused about alternative medicine?, Alliance for Natural Health, 14 Dec 2006, Dorking, United Kingdom.
16.http://www.alliance-natural-health.org/index.cfm?action=news&ID=265 UK anti-comp med campaign given another stab by Prof Ernst, Alliance for Natural Health, 12 Dec 2006, Dorking, United Kingdom; see also, http://www.dailymail.co.uk/pages/live/articles/health/healthmain.html?in_article_id=422017&in_page Barbara Rowlands, Complementary medicines are useless and dangerous, says Britain's foremost expert, Daily Mail, 12 Dec 2006.
17. http://www.alliance-natural-health.org/index.cfm?action=news&ID=262 Furious UK debate on comp med continues, Alliance for Natural Health, 01 Dec 2006, Dorking, United Kingdom.
18. http://www.alliance-natural-health.org/index.cfm?action=news&ID=259 Leading UK professor accuses alternative medicines industry of 'vile and cynical exploitation', Alliance for Natural Health, 24 Nov 2006, Dorking, United Kingdom; see also, http://press.psprings.co.uk/bmj/november/pv1129.pdf , Prof Jonathan Waxman, Personal View: Shark cartilage in the water, BMJ 2006; 333: 1129.
19.http://www.alliance-natural-health.org/index.cfm?action=news&ID=267 Vitamin seller made a criminal, Alliance for Natural Health, 15 Dec 2006, Dorking, United Kingdom.
20.http://www.alliance-natural-health.org/_docs/ANHwebsiteDoc_263.pdf Vitamin seller made a criminal, Alliance for Natural Health, 15 Dec 2006, Dorking, United Kingdom.
21.http://www.americanscientist.org/template/BookReviewTypeDetail/assetid/39097;jsessionid=baa9... Arthur L. Caplan,  Indicting Big Pharma, American Scientist Online, Jan-Feb 2005; see also, The Truth about the Drug Companies: How They Deceive Us and What To Do about It. Marcia Angell. xx + 305 pp. Random House, 2004, On the Take: How Medicine's Complicity with Big Business Can Endanger Your Health. Jerome P. Kassirer. xx + 251 pp. Oxford University Press, 2005, Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs. Jerry Avorn. viii + 448 pp. Alfred A. Knopf, 2004.
22.http://www.motherjones.com/news/qa/2004/09/09_401.htm Peter Meredith, The Truth About Drug Companies, September 7, 2004; see also, The Truth About Drug Companies: How They Deceive Us and What to Do About It.
23.http://www.newstarget.com/021795.htm Mike Adams, Americans fed up with drug industry influence, FDA corruption, reveals remarkable Consumer Reports survey, April 16, 2007.
24.http://www.truthout.org/cgi-bin/artman/exec/view.cgi/61/20823 Dean Baker, Prescription Drug Scams, 29 June 2006; see also http://www.nytimes.com/2006/06/28/business/28foundation.html?ex=1309147200&en Reed Abelson, Charities Tied to Doctors Get Drug Industry Gifts, NY Times, June 8 2006; http://www.washingtonpost.com/wp-dyn/content/article/2005/11/29/AR2005112901650.html Jonathan Weisman, Drugmakers Win Exemption in House Budget-Cutting Bill, Washington Post, November 30, 2005; http://www.nytimes.com/2005/11/28/business/28cheer.html?ex=1290834000&en=1f0e2dde86b6 Stephanie Saul, Gimme an Rx! Cheerleaders Pep Up Drug Sales, NY Times, Nov 28 2005.
25.http://www.freerepublic.com/focus/news/726423/posts Nathan Newman, Big Pharma, Bad Science; see also New Eng J Med, June 2002.
26.http://www.medicationsense.com/articles/jan_apr_06/conflict_of_interest_020306.html JS Cohen, THE MEDICAL PROFESSION'S CULTURE OF CORRUPTION, PART 1: MedicationSense E-Newsletter, www.MedicationSense.com, 2006; see also, Brennan TA et al, JAMA, Jan. 25, 2006;295(4):429-433.
27.http://www.medicationsense.com/articles/may_aug_06/conflict_of_interest_060306.html JS Cohen, THE MEDICAL PROFESSION'S CULTURE OF CORRUPTION, PART 2: MedicationSense E-Newsletter, www.MedicationSense.com, 2006.
28.http://www.americanchronicle.com/articles/viewArticle.asp?articleID=25995 Senators Bribed By Big Pharma vs. Senators Not Bought Off, Byron Richards.
29.http://www.healthfreedomusa.org/index.php/?p=349 FAQ RE: Site Blocked, Natural Solutions Foundation, March 16 2007.
30.http://www.newswithviews.com/Richards/byron1.htm Byron J. Richards, THE F.D.A. - A WOLF IN SHEEP'S CLOTHING, NewsWithViews, July 7, 2006.
31.
http://apsu.inopsu.com/cam2001.pdf  See: Dr Mike South, et al, Adverse Effects Associated with the use of Complementary or Alternative Medicine, Australian Paediatric Surveillance Unit, 2001.
32.http://apsu.inopsu.com/CAMprotocol.pdf  See: Dr Mike South, et al, Adverse Effects Associated with the use of Complementary or Alternative Medicine, Australian Paediatric Surveillance Unit, 2001.
33.http://www.thenhf.com/government_affairs_117.htm Scott C. Tips, A Night At The Opera -
The Debate Over Mandatory Adverse Event Reporting
, National Health Federation, October 19, 2006.
34.http://www.newswithviews.com/Richards/byron14.htm
Byron J. Richards, THE POLITICS AND PROFITS IN KEEPING AMERICANS SICK, NewsWithViews, November 12, 2006.
35.http://www.newswithviews.com/Richards/byron16.htm
Byron J. Richards, BIG PHARMA TROJAN HORSES PERMEATE SUPPLEMENT INDUSTRY, NewsWithViews, December 5, 2006.
36.http://www.truthinwellness.com/articles/health_freedom_reels_pt2.php
Byron J. Richards,  Big Pharma Juggernaut Rolls To Victory – Health Freedom Reels – Part 2, Truth in Wellness, 2006.
37.http://www.newswithviews.com/Richards/byron30.htm
Byron J. Richards, UNDERSTANDING THE THREAT TO DIETARY SUPPLEMENTS PART 1, NewsWithViews, May 15, 2007.
38.http://newswithviews.com/Richards/byron31.htm
Byron J. Richards, UNDERSTANDING THE THREAT TO DIETARY SUPPLEMENTS PART 2, NewsWithViews, May 16, 2007.
39.http://stanmed.stanford.edu/2005summer/drugs-metoo.html Rosanne Spector, Me-too drugs Sometimes they're just the same old, same old, Stanford Medicine Magazine, Summer 2005.
40.http://www.time.com/time/nation/article/0,8599,1572974,00.html Douglas Waller, Too Little Bang for the Buck in Drug Research?, Time, 27th Dec 2006.
41.http://www.gooznews.com/archives/000573.html Merrill Goozner, GAO: Drug Innovation Lags Despite High Drug Prices, Gooznews, 19th Dec 2006.
42.http://www.bmj.com/cgi/content/full/331/7520/0-b "Me-too" drugs drive the rise in drug expenditure,
BMJ  2005;331 (8 October).
43.http://www.motherjones.com/news/qa/2004/09/09_401.html
44.http://www.washingtonpost.com/ac2/wp-dyn/A43257-2003Nov14?language=printer Peter Lansbury, An Innovative Drug Industry? Well, No, Washington Post, 16th Nov 2003.
45.http://www.roche.com/fbh_zvg05_e.pdf Innovation in the Pharmaceutical Industry — Future Prospects, Talk by Dr Franz B. Humer, Chairman of the Board of Directors and CEO of F. Hoffmann-La Roche Ltd, to the Zürcher Volkswirtschaftliche Gesellschaft Zurich, 16 March 2005


Doctors discover malnutrition in the elderly.......again!

How many times must doctors discover malnutrition in the elderly before they discard their anti-nutrition bias (see Medical Bias) and take action to reverse the starvation of our elderly citizens rather than just filling them with drugs? Now doctors have made this same astonishing discovery yet again as a result of the recent study by Professor Bolin at Sydney's Prince of Wales Hospital (1,2,3,4) as well as studies in Britain (5,6), though they seem to pretend this is a new discovery. Of course this is the opposite of the truth, doctors having known for many years about the widespread prevalence of malnutrition, even in hospital or nursing home patients where nutrition is controlled (7,8,9,10,11,12,13,14,15,22,24: see also; Nutrition and Megavitamins, B Vitamins, Nutrition is for the Birds, Do Not Resuscitate). Malnutrition in hospitals or aged care facilities is so common in fact that it has been termed "iatrogenic malnutrition" or doctor caused malnutrition (15,16; Do Not Resuscitate). In spite of this it has been claimed that this most recent Australian study (3) "is believed to be the first randomised study of its kind examining malnutrition in a clinical setting with control and intervention groups", a disgraceful admission indeed given past evidence of the prevalence and importance of malnutrition (Do Not Resuscitate, Nutrition and Megavitamins). Although doctors have traditionally regarded malnutrition as being unimportant, accumulating evidence of the consequences of malnutrition (7,9,10,14,17,18,19,20,21,22) seems to be very slowly convincing doctors of the importance of adequate nutrition.

Particularly enlightening is the following report from The New York Times taken more than twenty years ago (10):

"MALNUTRITION may account for a substantially greater portion of illness among elderly Americans than has long been assumed, according to several medical experts on aging........Most recently, many gerontologists have been both alarmed and excited by evidence that malnourishment may cause much of the physiological decline in disease resistance seen in elderly patients, a weakening of immunological defenses that has commonly been blamed on the aging process.......In experiments that have captured the attention of many gerontologists, Dr. Chandra has shown that nutritional supplements can partly restore the immune systems of malnourished elderly patients and can also improve their responses to vaccines for influenza, tetanus and pneumonia. A lack of immunological reaction in the aged often undercuts the benefits of vaccines, which work by triggering the body's defenses."

But 7 years later, in 1992, the following report also appeared in The New York Times (9):

"Dr. Howard Fillit has come up with a low-cost way to fend off, and even reverse, what most people view simply as the inevitable ravages of age: He feeds people.........Up to 40 percent of the scores of very sick, elderly patients Dr. Fillit sees at Mount Sinai Medical Center are malnourished, he said, even though they -- and their families and nursing aides, when they are lucky enough to have either -- usually do not realize it. In many cases, he said, their bad diet has caused, or at least severely worsened, their pneumonia, their heart trouble or even their dementia...'If they were objective, they would see themselves as skeletons,' said Dr. Fillit, who runs Sinai's Geriatric Evaluation and Treatment Unit. 'But they just see themselves as old.'..................Hence the living skeletons that keep turning up on Dr. Fillit's doorstep. 'Every day they come in, and the primary diagnosis from a geriatrician's point of view is malnutrition and social impairment,' he said. 'What good is it going to do to give them the right antibiotic for pneumonia and send them back home?. 'It's All Reversible' ...People often have weakened their immune systems, already slipping as a natural consequence of age, by not eating properly. 'These people are dying from infections,' he said. 'That's how people in Somalia are dying.' Sometimes the old people he sees are confused, displaying what look like the symptoms of Alzheimer's Disease. But on closer examination, he has discovered that they were simply lacking adequate amounts of B12, a vitamin commonly found in meat, fish and milk. 'It's all reversible,' he said."

The fact that malnutrition continues to be so prevalent is due to the preference for drug treatments and the consequent low priority given to malnutrition by doctors. According to Professor Bolin in this regard (1,3): "Unfortunately, nutrition and malnutrition are not priorities for physicians and surgeons and only come to notice when a patient's recovery is not progressing. Often this is too late."  So even in 2007 nutrition is still not a priority for doctors, but perhaps this is not too surprising given the claim by Professor Dwyer that (23), "vitamin deficiency is rare in Australia since so many of the foods we consume contain vitamin supplements." In his article entitled (23) "Serving up nonsense in the form of pick-me-up pills", Professor Dwyer even contradicts nutrition research from around the world indicating the benefits of nutrition and vitamin supplements, especially in regard to chronic diseases like heart disease (see Nutrition and Megavitamins, B Vitamins, Nutrition is for the Birds, Dietary Supplements or Functional Foods?). According to Professor Dwyer (23):

"A consumer who takes the Nature's Own advertisement for vitamins at face value is likely to conclude that everyone should consume a daily multivitamin preparation to help avoid heart disease. The truth is different, and this again highlights the fact that self-imposed standards for advertisers, and the media outlets that present their information, are failing consumers."

As I indicated elsewhere (Do Not Resuscitate), such is medicine's disregard for malnutrition that doctors refused to give vitamin injections to my father even though he was dying from starvation. The traditional medical bias against nutrition is well known (Medical Bias) with some authorities even claiming that nutritional supplements are so useless they do no more than enrich our sewerage (Pan Crisis). Such is medicine's traditional contempt for nutrition that pregnant women have even been advised by doctors in the past to deliberately starve themselves in order to produce a smaller baby and have an easier delivery (Medical Rationing):

"One of the most tragic examples of iatrogenic diseases may well be the current epidemics of heart disease, syndrome X, diabetes, adrenal disorders, and respiratory diseases (see Health Trends) which may all share a common cause. According to increasing scientific evidence all these diseases may result from low birth weight caused by inadequate nutrition during pregnancy (96,97,98,99, 100,101,102,103, 104,105,106,107)*. But 50 years ago modern medical science was advising women to deliberately practice semi-starvation during pregnancy to ensure they would give birth to a smaller baby and hence have an easier delivery (108,109)*. And medical experts continue to wonder why there has been such an epidemic of chronic diseases in the latter half of the 20th century. And medical bioethicists, bureaucrats, and economists seek to withdraw treatment from the chronically ill because of costs.

There is no better example of the possible tragic consequences of medicine's short sighted symptomatic approach to "health care". The fact that deliberate iatrogenic foetal malnutrition may be a significant factor in the current epidemic of chronic diseases should be headline material, but yet it rarely receives any mention whatsoever. The "costs" of this irresponsible nutritional advice would be expected to be most prominent in those who are now 50 years of age or older. Unfortunately we must all pay the price for the disruption of the learning process which occurs when health authorities seek to deny or conceal the truth."

*See Medical Rationing for references.

Another suggestion made as a result of the Bolin study is the possibility that malnutrition may not be caused only by insufficient nutrient intake, but additionally, inefficient absorption or metabolism of nutrients may also play a key role, a possibility according to Bolin, that warrants further research (3):

"Malnutrition is not simply caused by lack of access to food – we believe other factors such as malabsorption play a key role"......."An extension of the study will look at malabsorption rates in the community by using a dual sugar absorption test ."

This is all very interesting but malabsorption and problems with nutrient utilisation have long been known to be a significant factor in nutritional status and malnutrition (Nutrition and Megavitamins, B Vitamins). In fact, according to the Genetotrophic Concept and Nutrigenomics (Nutrition Breakthroughs, Genetic Nutrition), common genetic deviations in people cause various inefficiencies in nutrient utilisation and the need for megadoses of nutrients if malnutrition is to be avoided. The Genetotrophic Concept was developed by Roger Williams more than 50 years ago as a result of his research which indicated that inefficiencies in nutrient utilisation were commonplace, a discovery which was rejected by the medical world which based its belief on the assumption that efficiency of nutrient utilisation is identical in nearly everyone (Nutrition Breakthroughs).

While progress in nutrition is to be welcomed, how about giving credit to past researchers who made these discoveries years ago. And instead of talking about the terrible prevalence of malnutrition, why not do something about it?

References

1. Clara Pirani,  Malnutrition widespread in elderly patients, The Australian, 9th May 2007.
2. Julie Robotham, Elderly patients risk malnutrition, Brisbane Times, 9th May 2007.
3. Kate McEvoy, New Study Reveals High Rates of Malnutrition in Elderly, WestEnder, 10th May 2007.
4. ABC News Online, Elderly patients need greater nutritional care: study, 9th May 2007.
5. We are eating ourselves ill: Treating malnutrition costs NHS more than obesity, The Independent (UK), 6th May 2007.
6. Junk Food Nation, The Independent (UK), 6th May 2007.
7. Chen CC, Schilling LS, Lyder CH., A concept analysis of malnutrition in the elderly, J Adv Nurs. 2001 Oct;36(1):131-42.
8. Peter Ellingsen, Scandal of the elderly who go hungry, The Age, 4th Dec 2005.
9. James Bennet, Hidden Malnutrition Worsens Health of Elderly, The New York Times, 9th may 2007.
10.Erik Eckholm, MALNUTRITION IN ELDERLY: WIDESPREAD HEALTH THREAT, The New York Times, 13th Aug 1985.
11.Elderly in British hospitals malnourished, 30th Aug 2006.
12.Seiler, WO,
Clinical pictures of malnutrition in ill elderly subjects, Nutrition, Volume 17, Issue 6, June 2001, Pages 496-498.
13.Azad, N. et al, Nutrition survey in an elderly population following admission to a tertiary care hospital, CMAJ • September 7, 1999; 161 (5).
14.Malnutrition in the elderly – a more significant global problem than obesity, Novartis press release, 13th Nov 2006.
15.Wendland BE, Malnutrition in institutionalized seniors: the iatrogenic component., J Am Geriatr Soc. 2003 Jan;51(1):85-90.
16.
http://webhost.sun.ac.za/nicus/Factsheets/updated2006/Hospital%20Malnutrition%20(2004)%20SC.doc. Hospital Malnutrition: European Union moves to address the "skeletons in the hospital cupboards, Nutrition Information Centre University of Stellenbosch.
17.
Raynaud-Simon A, Lesourd B., Malnutrition in the elderly. Clinical consequences, Presse Med. 2000 Dec 16;29(39):2183-90.
18.Lesourd B., Immune response during disease and recovery in the elderly, Proc Nutr Soc. 1999 Feb;58(1):85-98.
19.Harris CL, Fraser C,
Malnutrition in the institutionalized elderly: the effects on wound healing., Ostomy Wound Manage. 2004 Oct;50(10):54-63.
20.Zazzo JF., Physiopathology and consequences of malnutrition, Rev Prat. 2003 Feb 1;53(3):248-53.
21.Pamela Mason, Undernutrition in Hospitals - causes and consequences, Hospital Pharmacist, 13, 358, 2006.
22.Barry Jones, NHS Patients 'Risk Complications And Death' Because Of Poor Nutrition In Hospitals, British Society Of Gastroenterology, 23rd March 2006
23.http://www.smh.com.au/news/opinion/serving-up-nonsense-in-the-form-of-pickmeup-pills/2006/01/24/1 John Dwyer, Serving up nonsense in the form of pick-me-up pills, Sydney Morning Herald, January 25, 2006.
24.http://www.jacn.org/cgi/content/full/19/5/613 DL McKay et al, The Effects of a Multivitamin/Mineral Supplement on Micronutrient Status, Antioxidant Capacity and Cytokine Production in Healthy Older Adults Consuming a Fortified Diet, Journal of the American College of Nutrition, Vol. 19, No. 5, 613-621 (2000).


Putting the Lid on Recurrent Shingles

Four years ago, following a severe respiratory infection, I developed severe shingles in the ear. The initial outbreak was characterised by intense pain in the ear, neck, throat and scalp, high fever, copious discharge from the ear, serious loss of hearing in the affected ear, severe headache, and symptoms of encephalitis. I responded quickly to Zovirax (Acyclovir) but the course of treatment only lasted one week. When I finished this course of treatment the shingles returned (recurrent shingles) almost as severe as it had been a week earlier but the GP I was attending could not believe the shingles could return even though he saw it with his own eyes. When I emphasised my CFS and poor immunity to him and asked if perhaps I needed a longer course of the drug he replied most emphatically that it is impossible for shingles to come back and therefore I did not need any further doses of the drug. He said this even though he saw with his own eyes that the weeping blisters in my ear had returned and I was once again complaining of intense pain. He adopted a dismissive attitude and said it was best that I just try to forget about it although he referred me to a neurologist and an ear specialist..

In the meantime, while waiting to see the specialists, I was forced to continue enduring a continuing attack of shingles because the GP did not believe it was possible for it to return. While this attack continued more damage was being done to the affected nerves in my ear, around my scalp and face, and in my head.

When I saw the ear specialist he took one look at my ear and said he could not help me but said he would have to ring the infectious diseases specialist. Very promptly it was arranged for me to see the infectious diseases doctor who immediately told me the shingles had returned (this was no secret to me...in spite of what the GP said!) and prescribed Valtrex to treat it. He advised me that because of my CFS and immunity problems I would need to take this drug for a considerable time until my body was strong enough to stop the shingles. He was right. As it turned out I had to take the drug for 4 months. Unfortunately though, my recovery from this second attack of shingles was much slower than the first time because the nerves around my ear, face, scalp, and brain, had been more severely damaged because the GP refused to give me further treatment. Eventually however, the pain settled and I was was lucky enough to recover much of my lost hearing.

This year however, 4 years later, I contracted a gastric infection which was followed by the return of shingles again in the same ear although this time the attack was not as severe as previously. The doctor prescribed Zovirax which I responded to very quickly but once again I found if I stopped the drug the shingles returned. After about 6 weeks however I was temporarily able to stop the drug. It was not long however before I developed another viral respiratory illness which was very persistent although it did respond to astragalus (huang qi). The damage was done however and the shingles returned forcing me to take the Zovirax again.

A new problem emerged however, increasing intolerance of shingles drugs. Although the drugs often made me feel sick the biggest problem and a problem which became worse the longer I took the drugs, was severe heart palpitations. I could not tolerate this. I also found that Zovirax seemed to depress my immunity and make me susceptible to constant colds and viral infections. For months after commencing Zovirax I experienced constant colds, chills, and viral infections and the only way I could control these constant infections was to take astragalus. I could not stop astaragalus for more than one day without a return of these infections and this continued until 3 weeks after I ceased taking Zovirax.

I searched the internet for natural remedies for herpes or shingles and I tried many without success. Astragalus, although extremely effective for many viruses was no help for the shingles. Other well known treatments such as Lysine, Olive Leaf, Red Marine Algae, Lactoferrin, Echinacea, vitamin C, and other immune tonics, were all useless. The only herb which seemed to help was Camu Camu but I cannot be definite about this because the shingles may have been weakening when I took it. However, after taking 2.5g of Camu Camu for a short period the shingles has not returned

My message from this experience is twofold. Firstly I plead with doctors not to be so closed minded and to use more common sense and compassion in their diagnoses. Just because they did not read about it in a book does not mean it does not exist. How many times must this same lesson be learned by doctors? Medical science is always learning so why pretend otherwise? How can anyone learn with such a closed mind? The tragedy here is that shingles often causes chronic pain after the infection has gone and this leads closed minded doctors to suggest a reactivation of shingles must be nothing more than chronic shingles pain. Additionally, most doctors will not prescribe antiviral drugs for shingles if the symptoms have been present more than 48-72 hours, falsely believing that such drugs are ineffective beyond this time. This is a statistical decision, but when an attack continues for 4 months such statistics merely sentence a patient to continued suffering. Incidentally, apart from CFS, doctors have so far found no diagnosable reason for my poor immunity. I do not have AIDS or any other detectable immune disease.

Secondly, I merely wish to pass on my experience with various shingles treatments in the hope it may benefit others. I would be interested in hearing of others who have shared my experience.


School Students Better Watchdog than Public Health Authorities, Food Authorities & Consumer Organisations
School science tests more reliable than government authorities and drug company.

Recently, in an absolutely shameful demonstration of the ineffectiveness of normal public health watchdogs and the reliability of self testing by drug companies, two New Zealand schoolgirls discovered the inaccurate claims made by the drug company Glaxo Smith Kline (GSK) regarding the vitamin C content of their fruit drink, Ribena (1,2,3,4,5).  That the scientific testing carried out by school students has been shown in this instance to be more accurate and reliable than the combined resources of public health authorities, consumer organisations and one of the largest drug companies in the world, is absolutely disgraceful and cause for alarm. Most people would assume that scientific testing by drug companies and public health authorities would be more accurate and reliable than testing carried out in school laboratories but this is apparently not necessarily the case. In the words of Burke regarding the misleading claims made by GSK (6); "After 55 years of telling porkies, Ribena has finally sent itself to the naughty corner."

As a result of the school science experiments in New Zealand and the resultant impending legal action against GSK in that country (1,2,3,4,5,6), GSK assured Australian authorities it would also change product advertising in Australia so as not to mislead consumers with false or misleading advertisements ( 6,7,8,9). Apparently the impending legal action in New Zealand prompted GSK to approach the Australian Competition and Consumer Commission (ACCC) (6,9) who subsequently emphasised that since GSK had "self-reported the discrepancies" (9), the ACCC considered further legal action unnecessary, even in spite of actions occurring in New Zealand. Would GSK have taken this action if they were unsure of a favourable response from the ACCC?

Subsequent to events in New Zealand, GSK Australia issued this statement (10); "On the nutritional information panels on some Ribena Ready to Drink products, Ribena claimed an amount of Vitamin C that could not be substantiated by acceptable testing methods. As a result, Ribena Ready to Drink products no longer make any claims regarding the Vitamin C content and any claim made in the future about the Vitamin C content will be substantiated by validated testing methods."

Mr Graeme Samuel, Chairman of the ACCC, justified the refusal of the ACCC to take legal action in this case of misleading advertising by a major drug company by stating (9); "where a company cooperates with the ACCC, this is taken into account when determining what further action is appropriate." So in Australia it seems,  false advertising for a few years by large drug companies may not be considered sufficiently important to warrant legal action as long as 'mistakes' are eventually "self-reported" to the ACCC.  This situation needs urgent clarification. Is there any duty to abide by current advertising laws or has the act been structured in such a way as to minimise mandatory duties and maximise the discretionary powers of the ACCC?

In this instance we have two New Zealand students to thank for apparently testing this product more accurately than could be achieved by the combined resources of public health authorities, consumer organisations and one of the largest drug companies in the world. In fact, thanks to these students GSK has promised to develop new testing methods for vitamin C (11);

"Since the NZCC brought its concerns to our attention, GSK has already:
􀂾 Revised all advertising to ensure there were no claims in regard to Vitamin C that could potentially be misleading to consumers
􀂾 Modified Ribena labels on the RTD products so that the labels made no reference to Vitamin C
􀂾 Implemented a plan to reformulate RTD Ribena products with new methods for testing Vitamin C
GSK Consumer Healthcare in both New Zealand and Australia sincerely regret any confusion caused to customers in relation to these Ribena products.

Perhaps if GSK were to ask the two New Zealand schoolgirls for advice on accurate tests we may not see a repeat of this problem.

References

1. Ribena Vitamin C claims false and misleading, Media Release, Release no. 112, Issued 27 March 2007, NZ Commerce Commission.
2.
Jeevan Vasagar, Schoolgirls rumble Ribena vitamin claims, The Guardian, Tuesday March 27, 2007.
3.
Carolyn Churchill, School science test exposes false Ribena vitamin C claims, UK Herald, 27 March 2007.
4.
Schoolgirls find there's no C in Ribena, Sydney Morning Herald, 27 March 2007.
5.
NZ vitamin C row hits Ribena firm, BBC News, 27 March 2007.
6. Kelly Burke, Ribena to withdraw vitamin C claims, Sydney Morning Herald, 22 March 2007.
7.
Valarie Tan, AVA confirms Ribena drinks sold here are "rich in Vitamin C", Channel NewsAsia,  29 March 2007.
8.
Australian watchdog squashes Ribena health claims , Yahoo News, 21 March 2007.
9.
Ribena Vitamin C claims 'may have misled consumers', Media Release 075/07, Australian Competition and Consumer Commission, 21st March 2007 .
10. A correction from Ribena, Glaxo Smith Kline, Australia.
11. GSK Consumer Healthcare statement on Ribena, Glaxo Smith Kline, Australia, 28th March 2007.


Adverse Drug Reactions Hotline to Close as Government Withdraws Funding from Hotline to Spend More Money Controlling Alternative Medicines.

It seems there is no rush of funding support for Australia's Adverse Medicine Events Line which played such a vital part in the Stilnox story (1,2). Apparently the TGA, the Commonwealth government, and drug companies, just cannot find the money to support those who suffer adverse drug reactions. In spite of alleged increasing concerns about the safety of dietary supplements (Pan Crisis, Therapeutic Products Bill), the withdrawal of funds for the Adverse Medicine Events Line by the government seems destined to force closure of a valuable public health watchdog at a time when more and more people are suffering adverse drug reactions. In fact, in the Daily Telegraph on the 9th July 2007 (p10), appeared 2 articles side by side indicating the current attitude of the Australian government to public health. The first article, entitled "Cures Killing Hundreds - Anti-psychotics prove grim trip, described the tragedy of government supported modern drug therapies which continue to destroy so many lives. The second, but much smaller adjoining article entitled "Drug Hotline Out of Funds" underlined the priorities of the Australian government which is currently spending millions of dollars taking control of the alternative medicine industry.

References
1. http://choice.com.au/viewArticle.aspx?id=105298&catId=100386&tid=100008&p=1&title=Consumer Consumer reporting of adverse drug reactions, Choice Magazine Online, Australian Consumers Association, 6th June 2006.
2. http://www.news.com.au/couriermail/story/0,23739,21757617-953,00.html Janelle Miles, Drug hotline may close, Courier Mail, 19th May 2007.


Medical discoveries made by accident - medical research based upon good luck!

In his book Happy Accidents: Serendipity in Modern Medical Breakthroughs (1,2), Dr. Morton Meyers, Emeritus Professor of Radiology and Medicine, demonstrates that many medical discoveries have resulted from just plain old fashioned good luck or what he terms "serendipity". According to Meyers (1), "Many of the pivotal discoveries of the past century, which have saved or enhanced innumerable lives, came about as a result of happenstance. Scientists with open, creative minds stumbled across surprising results, and found what they were not looking for."

As is pointed out by Meyers (1), in stark contrast with the results of good luck in medical research, the results which have been achieved by deliberated directed research are very poor: "One approach to medical discovery is the centralized management of directed research. The experience of more than 3 decades with a War on Cancer directed and funded by the federal government has shown the futility of this approach. The better approach is based on independent, creative, curiosity-driven research that liberates serendipity. It is this approach that has brought us the bountiful results mentioned previously. We need to be sound in our judgment of the allocation of funding and resources.Fostering an openness to serendipity has the potential to accelerate medical discovery as never before."

Meyers recommends  individuality, open-mindedness, and freedom from bias in medical research and training (1): "students, particularly in science and medicine, must be taught about the role of serendipity and be prepared to recognize and exploit departures from expected results. Indeed, chance does favor the prepared mind...........The process of peer review should be modified to reduce the inherent bias toward prevailing concepts and to welcome mavericks and outsiders."

References
1. http://www.medscape.com/viewarticle/555061?src=mp Morton A. Meyers, Eureka! When Scientists Find What They're Not Looking For, Medscape, 05/07/2007; see Happy Accidents: Serendipity in Modern Medical Breakthroughs, Morton A. Meyers, Arcade Publishing; 1 edition (March 9, 2007).


Dietary fat consumption has nothing to do with obesity.

According to latest research the amount of fat in the diet has no effect on obesity. In fact, reducing dietary fat may even aggravate the obesity problem. In the U.S., two decades of significant reduction in dietary fat consumption has corresponded with "massive" increases in obesity. Willett, W.C., Obesity Reviews, 3, 59, 2002.

Adverse effects of new drugs not necessarily revealed by clinical trials.

It has long been known that the side effects of new drugs are only revealed by long term use by the general community. Short term clinical trials involving a few chosen participants do not necessarily reflect the long term effects in the wider community. The real clinical trials do not begin until new drugs are marketed in the general community, although patients may not be aware of this. Temple, R.J., Himmel, M.H., JAMA (editorial), Vol. 287, 1st May, 2002. See also Lasser, K.E. et al, JAMA, 2002;287:2215-2220.

 

 
 

Health Links

 
 

 

Alpha Lipoic acid
http://www.supplementwatch.com/supatoz/supplement.asp?supplementId=15
http://www.nutritionreporter.com/Alpha-Lipoic.html
http://www.healthy.net/asp/templates/interview.asp?PageType=Interview&

American Ginseng
Lowers blood sugar levels
http://www.healthwellexchange.com/nutritionsciencenews/NSN_backs/Feb_

Andrographis
For colds and flu
http://www.herbs.org/current/andrographis.htm

Anticortisol treatments for stress
http://qualitycounts.com/fpcortisol.html
See this great site for numerous links to info about anticortisol supplements.

Antioxidants
http://www.healthwellexchange.com/nutritionsciencenews/NSN_backs/Jan_01
For Parkinson's disease
http://www.healthwellexchange.com/nutritionsciencenews/NSN_backs/May

Arthritis
Glucosamine for,
http://www.healthwellexchange.com/nutritionsciencenews/nsn_backs/Mar_

Arterial disease and atherosclerosis
http://circ.ahajournals.org/cgi/content/abstract/103/14/1863
http://www.healthwellexchange.com/nutritionsciencenews/NSN_backs/Ja

Asthma
Resource site for everything to do with child asthma and allergy. 
http://childasthmaallergy.researcheasy.com

Astragalus
http://www.newhope.com/nutritionsciencenews/NSN_backs/Oct_00/astra

Australian Alternative Health Supplies
http://www.alternativehealth.com.au/

Beta-Glucan 
For immunity
http://www.healthwellexchange.com/nutritionsciencenews/NSN_backs/J

Blood sugar level - herbs to lower
http://www.healthwellexchange.com/nutritionsciencenews/NSN_backs/Feb

Brain - nutrients for,
http://www.healthwellexchange.com/nutritionsciencenews/NSN_backs/Feb_
http://www.healthwellexchange.com/nutritionsciencenews/nsn_backs/Mar_

L-carnitine
http://www.supplementwatch.com/supatoz/supplement.asp?supplementId=
For exercise tolerance
http://www.healthwellexchange.com/nutritionsciencenews/NSN_backs/Sep_0

Candida and Yeast Infections
http://www.candidablog.com/

Chromium
http://www.supplementwatch.com/supatoz/supplement.asp?supplement
For diabetes and heart disease
http://archfami.ama-assn.org/issues/v8n5/ffull/fdt7004.html

Depression herbs and supplements
http://www.healthwellexchange.com/nutritionsciencenews/NSN_backs/
http://www.herbs.org/current/sjwnointeraction.htm
St Johns Wort as effective as drugs
http://www.healthwellexchange.com/nutritionsciencenews/NSN_backs/Jun_

Devil's Claw as effective as drug for arthritis
http://www.herbs.org/current/devilsclawosta.htm

Diet Therapy Software for Practitioners
FoodPharmacy Diet Therapy™ Software allows you to instantly
integrate the power of nutritional therapy into your practice - regardless of your level of nutritional training.
http://www.foodpharmacy.com/

Dietary supplements, use of,
http://archinte.ama-assn.org/issues/v161n6/abs/isa00010.html

Exercise enhancers for increased stamina
http://www.healthwellexchange.com/nutritionsciencenews/nsn_backs/S

Eye herbs and supplements
http://www.healthwellexchange.com/nutritionsciencenews/NSN_backs/Jan_
http://www.healthwellexchange.com/nutritionsciencenews/NSN_backs/Ap
http://www.i-care.net/eyeresearch.html

Fatty acids
For bone growth and repair
http://www.healthwellexchange.com/nutritionsciencenews/nsn_backs/Ma 

Folic Acid
http://www.supplementwatch.com/supatoz/supplement.asp?supplementId=1
For heart disease
http://archinte.ama-assn.org/issues/v161n5/abs/ioi00333.html
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&l
http://www.ajcn.org/cgi/content/abstract/73/6/1027
For pancreatic cancer
http://aje.oupjournals.org/cgi/content/abstract/153/7/680?maxtoshow=&HIT

Glucosamine
http://www.healthwellexchange.com/nutritionsciencenews/nsn_backs/Mar_
http://www.supplementwatch.com/supatoz/supplement.asp?supplementId=145
Glucosamine web sites
 (http://www.arthritis-glucosamine.net)
The Arthritis & Glucosamine Resource Center. A very informative site about arthritis and glucosamine. Over 100 articles on treating arthritis, the science backing glucosamine, a review of glucosamine products, an arthritis newsletter, tips to beat arthritis pain, and much more.
http://www.glucosamine-arthritis.org/
At the Arthritis & Glucosamine Information Center you'll find top quality
information on arthritis and glucosamine, the latest research, details on
arthritis medications and treatments, and tips for effectively managing
your pain.

Heart disease herbs and supplements
http://www.healthwellexchange.com/nutritionsciencenews/NSN_backs
http://archinte.ama-assn.org/issues/v161n5/abs/ioi00333.html
http://www.healthwellexchange.com/nutritionsciencenews/NSN_backs/Sep
http://archfami.ama-assn.org/issues/v8n5/ffull/fdt7004.html
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&l
http://www.ajcn.org/cgi/content/abstract/73/6/1027
http://www.ajcn.org/cgi/content/abstract/73/6/1052

Herpes herbs and supplements
http://www.herbs.org/current/propolis.htm

Immune system herbs and supplements 
http://www.herbs.org/greenpapers/immune.html
http://www.newhope.com/nutritionsciencenews/NSN_backs/Oct_00/astra
http://www.herbs.org/current/andrographis.htm
http://www.healthwellexchange.com/nutritionsciencenews/NSN_backs/Jan_
Immune Power
http://www.immune-power.com/
Info about natural immune stimulants and plant sterols and sterolins

Liver herbs and supplements
http://www.healthwellexchange.com/nutritionsciencenews/NSN_backs/Jan_

Macular degeneration herbs and supplements
http://www.healthwellexchange.com/nutritionsciencenews/NSN_backs/Jan_01
http://www.healthwellexchange.com/nutritionsciencenews/NSN_backs/Apr_0

Methylcobalamin ( vitamin B12 )
Commercial supplements (Australian)
http://www.vitaminme.com.au/site/page.cfm?u=7&s=shopProductInfo&t=shopProductInfo&productId=
http://www.afan.com.au/index.php?main_page=product_info&cPath=34&products_id=256
http://www.mrvitamins.com.au/product_info.php?products_id=14755
http://www.custommedicine.com.au/shop/vitamin-methylcobalamin-lozenges-p-223.html

General Nutrition
See All About Nutrition for extensive nutrition info
http://aanutrition.com/

Parkinson's disease
http://www.healthwellexchange.com/nutritionsciencenews/NSN_backs/May_

Phosphatidylserine
For brain function
http://www.healthwellexchange.com/nutritionsciencenews/nsn_backs/Mar_

Promotional Products & Reusable Bags
See Promoter's Paradise for promotional merchandise & reusable bags.
http://www.promotersparadise.com/

Propolis
Propolis more effective for herpes than drug
http://www.herbs.org/current/propolis.htm

Prostate gland
Quercetin relieves pain
http://www.healthwellexchange.com/nutritionsciencenews/NSN_backs/Jul_01
Saw palmetto reduces size
http://www.herbs.org/current/sawshrink.html

Qigong
An ancient Chinese exercise that cultivates one's inner energy.
http://uniquehealingsolutions.com/

Recyclable and Reusable Bags
See Promoter's Paradise for all your reusable bags and shopping bags
http://www.promotersparadise.com/

St John's Wort
http://www.herbs.org/current/sjwnointeraction.htm
http://www.healthwellexchange.com/nutritionsciencenews/NSN_backs/Jun

Saw Palmetto 
Shrinks prostate gland
http://www.herbs.org/current/sawshrink.html

Schisandra
http://www.healthwellexchange.com/nutritionsciencenews/NSN_backs/Jan_

Steel Buildings and Garages
Go to Mid Coast Garages for all your garages or steel buildings.
http://www.steelbuilding.com.au/

Vitamin A
http://www.supplementwatch.com/supatoz/supplement.asp?supplementId=28

Vitamin B6
http://www.supplementwatch.com/supatoz/supplement.asp?supplementId=2
For lung cancer
http://aje.oupjournals.org/cgi/content/abstract/153/7/688?maxtoshow=&HIT

Vitamin C
http://www.supplementwatch.com/supatoz/supplement.asp?supplementI
Vitamin C levels low in arterial disease and atherosclerosis
http://circ.ahajournals.org/cgi/content/abstract/103/14/1863

Vitamin E
http://www.supplementwatch.com/supatoz/supplement.asp?supplementI
New evidence for heart disease
http://www.healthwellexchange.com/nutritionsciencenews/NSN_backs/Jan_
For heart disease in diabetics
http://www.ajcn.org/cgi/content/abstract/73/6/1052

 

 
  If you need a quality steel building, whether it be a small shed or garage, or an aircraft hangar, make sure you see Mid Coast Garages.  
     

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