Codex - The Sickness Indu$try's Last Stand - Part 1
An Overview in the Pacific Region
An Investigative full length feature Article
By Eve Hillary
Revised June 20, 2005 Sydney
Preamble
What is CODEX? (34) In short it is an annual World Health Organisation (WHO) sponsored gathering of delegates in Europe, many of them trans-national pharmaceutical corporations who are primarily focused on increasing their market share, by pushing their desired and arbitrary regulatory “standards” into a global standard and forcing it onto the smaller local supplement industry, all in the name of “international regulatory excellence”. The Codex Committee is also bound by the World Trade Organisation (WTO) treaties. The WTO is a global commercial police that ensures countries are required to purchase from trans-national corporations in favour of their own locally produced goods, in the name of “lowering trade barriers”. This WHO/WTO joint effort called CODEX is in the process of wiping out local supplement companies and natural health care practices, to bring in more drug based medicine, in what is euphemistically known as “creating a level playing field”, while primarily giving the public a misleading impression that someone in the World Health Organisation (WTO) is looking after its health and safety. CODEX recommendations are then adopted by regulators such as the Australian TGA or the US FDA by various direct or indirect means that end up as Acts and amendments that are passed into law by Parliaments or Congress, usually without public debate.
In 2002 I unveiled Codex to a Brisbane, Australia audience of 300 people. Only 3 knew anything about it - the same three I'd spoken with before the lecture. I then wrote a chapter on CODEX in my book “Health Betrayal”. Primary documents about CODEX is not easy to find. (34) And there remains deliberate misinformation emanating from government sources with close ties to trans-national corporations. Meanwhile, the Australian regulator, the TGA (Therapeutic Goods Administration) is deeply involved in the corporate agenda as this article will track. The Australian Health Minister, Mr. Abbott, has recently called a Sydney talkback radio program to “reassure” the presenter and listening audience that CODEX is not an issue in Australia. At the same time there has been no effort on the part of the government to publicly reveal the extraordinary events that have delivered Australia into corporate governance in health care. This includes the very real possibility that many cheap and effective natural remedies may no longer be available to the public after July 1 when drastic changes that have never been openly debated, are set to be implemented by Parliament anytime within the next 12 months.
It is my intention to reveal the fact that trans-national pharmaceutical corporations have already assumed the role of government at least where health care is concerned. I intend to highlight what steps have already been taken by corporate interests to move Australia and New Zealand toward CODEX and toward international corporate governance in the Asia Pacific region. This being true, it would alter the basic premise and agreement which Australian governance was founded upon – Democracy. This agreement cannot be altered except with the informed consent of the majority and only after public debate and referendum. It is my educated guess that most Australians want democracy for themselves and that they would want to preserve it for future generations. It is my guess that Australians do not want to be governed by trans-national corporations. It is my intention to allow these issues to be debated, understood and corrected by the electors, the only legitimate proprietors of government at this time.
Short History – Key Data
When debating regulatory matters I believe it is essential to bear in mind that the supplement industry and the drug industry are fundamentally different industries. The natural supplement industry and its related discipline, natural health care is thousands of years old with a proven tradition. For example, Nostradamus used compressed rose petal pastilles, rich in vitamin C to treat his patients suffering from bubonic plague. Many of his patients survived the dreaded disease, and Nostradamus himself, who took the pastilles never succumbed to the illness.
The modern supplement industry has been traditionally locally owned by private or family companies and evolved around its own proven quality and safety standards. Traditionally using cheap and naturally sourced raw ingredients, the supplement industry has an enviable product safety record. In addition an entire branch of natural and nutritional medicine has developed over the centuries with a long tradition of safety and a large body of scientific evidence in support of its efficacy. A little known fact is that literally thousands of peer-reviewed studies exist to support the success of natural and nutritional approaches to medicine. (36,37,38,39,40) There exist many conditions that can only be significantly remedied by nutritional medicine.
The pharmaceutical industry as we know it, on the other hand, only started in earnest about 60 years ago. Many drugs have been so recently synthesised that their side effects will not be known for some years to come. Pharmaceutical corporations rely on patented artificial chemical drugs to generate most of their profits. Aggressive drug company marketing and image management has created the impression that drugs are essential to health, when in fact deaths from adverse drug reactions make up the fourth highest cause of death in the US. Still stinging from the market share lost through consumers opting for natural supplements, the trans-national pharmaceutical corporations have influenced the regulators to regulate supplements as drugs when in fact vitamins and minerals are not drugs but essential to all humans on a daily basis.
There are many conditions caused when sufficient nutrients are not supplied to the body each day, but there is no such thing as a drug deficiency.
Getting Health Care into Perspective – Understanding CODEX
It's official. US research shows that inappropriate and dangerous medical treatments and adverse drug reactions are now the number one cause of death (4). To some it was no surprise. It seemed an inevitable outcome from the 1980's when health care was taken over by “health care” corporations and the pharmaceutical industry, when the bottom line in health care became profit instead of sending the patient home well and drug free, if possible. (13)
There are still no Parliamentary enquiries into the deaths of 18,000 Australians each year, killed by inappropriate doctoring and prescribed pharmaceutical drugs that are licensed by the TGA (the Australian regulator). The cause of these avoidable deaths has been known by the government for over ten years when Dr. Runciman made it known in a report he prepared to the government in 1995. And yet nothing has been done about it. This makes these unnecessary deaths a deliberate act on the part of the perpetrators, the medical and pharmaceutical corporations and the Australian government. This act is the equivalent of deliberately exterminating all living beings from an entire large sized Australian country town each year. (1,2,3). This killing for profit has knowingly continued for the past 10 years.
In addition to the death toll, 50,000 Australians are maimed and disabled, not by their diseases, but by the “health care system” which includes; bad doctoring and serious or permanent damage from drugs that were licensed by the TGA. Yet there are no outraged politicians giving undertakings on the Senate steps to find the culprits, to stop the criminality of it. This appears astonishing, since 187 Australians are unnecessarily killed and maimed each day – that's seven Australians killed or maimed per hour by conventional health care - more Australians than were ever killed in all the wars. By the time you have read this another Australian will die or be disabled by inappropriate medical treatment or an adverse reaction from a drug that was licensed and approved by the TGA. No memorials are erected to these victims. (1,2,3)
Where is Mainstream Media?
A few years ago the media conducted a feeding frenzy about an unfortunate person who died allegedly of an allergic reaction to royal jelly, a highly nutritious food that worker bees feed to the hive queen bee. (Unfortunately many more fatal allergic reactions occur annually than ever before, to both synthetic and to natural substances, due to the fact that general immunological health is declining through environmental degradation.) The person had ingested both the jelly and a meat sausage before the allergic reaction occurred, one that could equally have been caused by the preservative in the sausage. However, the TGA launched a lengthy investigation into the royal jelly, and required Royal Jelly to carry a health warning on the label. The sausage, of course was not investigated, nor allocated a health hazard label, one that the fatty, preserved product could arguably deserve, since the nitrite preservatives in sausages are responsible for many serious or fatal allergic reactions.
To salvage any remaining integrity the media would need to start presenting honest reports about the serious damage done to victims of the pharmaceutical and conventional health care corporations. Instead it runs the occasional unfounded vitamin scare about the purported dangers of vitamin C or Echinacea.
WHO is the TGA?
The TGA (therapeutic goods administration) is the Australian “regulator” of drugs, chemicals, medical devices and now nutritional supplements and herbs which it calls “complementary medicines”. The TGA is a statutory body, created by an act of Parliament over 20 years ago on behalf of the Australian community. Its motto is “to ensure the safety of all Australians”.
Despite hundreds of letters from concerned citizens and chemically injured persons, the TGA has continued to allow chemicals onto the market which are shown to have toxic effects on humans even when used as directed.
In addition the TGA has licensed pharmaceutical drugs such as Zyban, Vioxx and mercury laden vaccines among others, despite available data about the potentially serious and fatal effects these drugs have on humans. The TGA still allows the drugs that cause a large proportion of the 18,000 deaths and 50,000 serious injuries through adverse drug reactions while on the other hand it has compiled a large data base on its regulation of natural substances including vitamins, minerals, and even honey and olive oil, listing them as medicines.
The TGA has taken over the regulation of nutrients which have traditionally been produced by a separate and unique industry and are not part of the pharmaceutical industry (because nutrients are not drugs, they are essential to all humans). Most health conscious persons now take supplements because it is known that food produced by modern agriculture is depleted in essential nutrients. TGA now regulates nutrients as drugs requiring clinical trials. There is no point to conducting “clinical trials” to determine whether persons need calcium or any other essential nutrient since it has been a long established fact that humans need all essential nutrients daily. The sole advantage in regarding nutrients as drugs is that the drug industry then stands to have exclusive control of all supplement manufacturing, sales and distribution.
The TGA maintains close ties to the World Health Organisation (WHO) and to the Codex Commission. Domestically, it convenes various committees upon which sit well known representatives of pharmaceutical interests and pharmaceutical front organisations. (19,20,21) TGA regularly consults with and places on its committees representatives of pharmaceutical and food companies such as Proctor and Gamble, Unilever, Johnson & Johnson, Roche, Eli Lily, Glaxo, Pfizer, Wyeth and many other multination drug corporations. Without Australians' knowledge or consent, the TGA routinely places corporations in positions of power when making decisions about Australian's health. (23) It could be argued that any decision arising from this improper relationship could well be a legal nullity.
TGA Targets Pan
Globally there was one privately owned large supplier of ingredients for the manufacture of nutritional supplements that was big enough to be in direct competition with trans-national pharmaceutical corporations. The supply chain of nutritionals and drugs has been fiercely coveted by the multi-national pharmaceutical corporations such as Roche, Merck and Wyeth, to name just a few. But Sydney based Pan Pharmaceuticals was a privately owned company, and a relatively big player that supplied most of Australia and a portion of the world market with ingredients for the formulation of nutritional supplements and a large variety of natural supplement products.
In April 2003 the TGA raided Pan Pharmaceuticals, giving the grounds that the company's travel sickness product had included a faulty batch. The company had already voluntarily recalled it and was addressing the problem as was customary in the industry. However, TGA handled Pan far differently from the way it had dealt with any multi-national drug company. The regulator immediately forced Pan to shut down and within a few days recalled over 1600 natural supplement products with which nothing was found amiss on the routine testing that had occurred just previously. (5) The regulator created chaos among consumers and retailers alike as the TGA recall escalated into the largest recall of natural products in history, all the more extraordinary since there had been no complaints about the company's supplements prior to the recall.
Moreover, the vitamin and mineral supplements, which had caused no known ill effects, were classed by the TGA as necessitating a class 1 recall, meaning the regulator claimed the natural products would “cause death or permanent injury”. The TGA however, provided no evidence that any vitamin or mineral, and in particular Pan's had ever caused death or disability. This TGA mischief created wide spread anxiety about nutritional supplements in the public mind. A feat that would have cost the Pharmaceutical industry public relations machine millions of dollars, was thus done overnight by the TGA “regulator”. The ruse terrified scores of little old ladies who thought their calcium tablet would kill them and demanded a refund from their health food store, but it failed to impress those who already knew about the war on alternative and complementary health. And it particularly aroused suspicion in those who relied on logical data to come to their conclusions
What this deception did, however, was to reveal the TGA double standard in favour of drugs from drug giants and against natural products that were produced by Australian companies who were big enough to cut into multinational drug company market shares. Meanwhile, any evidence contained in the recalled vitamins and minerals, disappeared without a bubble when the regulator destroyed a vast mountain of natural supplements at an unknown location.
TGA bias was particularly evident by the manner in which the regulator conducted future recalls. Interestingly, the regulator conducted a class 2 recall on VIOXX; a drug manufactured by drug giant Merck - a drug which did cause 55,000 confirmed deaths and over 180,000 confirmed injuries to Americans alone. A Class 2 recall meant the TGA believed the “defects could cause illness...but are not class one” That meant that the regulator claimed the drug could not kill or disable anyone, which was an obvious and self evident falsehood that put the community at risk. (6).
If Pan was shut down after nobody complained about its supplement line or suffered a single problem, then it would be reasonable for trans-national Merck to be shut down for selling a drug that killed tens of thousands of Americans alone. This has not been the case and the TGA has not even conducted an investigation into how many Australians or New Zealanders might have been killed by the Drug Vioxx to which it issued a licence.
Within days of the raid, the hapless Pan company and its founder were embroiled in official red tape and TGA forced Pan to close its doors permanently. Shortly after the TGA raid, someone called in KPMG, the liquidator, so fast, that the owner, Jim Selim was removed from his own company with the velocity of a speeding bullet and the manufacturing plant and company was sold lock stock and barrel, in only six months for a pittance, (a likely world record for a liquidator). The Pan company that Mr. Selim had built up over 20 years, worth over 500 million dollars was sold for only 20 million within a few months of the TGA raid. (10) Interestingly, KPMG is a multinational power broker based in Switzerland that deals in accounting, mergers, liquidation and interestingly, also in chemicals and pharmaceuticals. KPMG's specialty however, is offering financial advice and other consultant “services” to the pharmaceutical industry. ( 8 ).
Over the ensuing 2 years the TGA has kept Mr. Selim busy in a gruelling round of court battles while the liquidator, KPMG continued to pick the carcass clean. Recently, KPMG filed a statement of claim against Mr. Selim for the amount of 300 million over the collapse of Pan brought about by the TGA. (10)
Since the Pan debacle, the beleaguered but apparently spirited former owner of Pan intended to start another business in Viet Nam as a manufacturer of health products there but TGA and now ASIC (the Australian company watchdog) is attempting to stop his manufacturing licence in Viet Nam, alleging irregularities in the paperwork. Interestingly, most of the big pharmaceutical companies such as Novartis, Pfizer and GlaxoSmithKline have now set up offices in Vietnam. (9, 10).
TGA on Post Pan Rampage
After the TGA disposed of Pan, it systematically ran through other small Australian vitamin and supplement manufacturers like a dose of Epsom salts in a frenzy of “inspections” and “regulatory activities”.
Small Australian-owned supplement manufacturers allege TGA used a variety of intimidatory methods against them including the halting of manufacturing operations and near impossible requirements that mainly cost over $500,000 to implement. NZ Health Trust reports “recent reports out of Australia....include comments such as compliance costs having increased by 800% for one firm, another has had to spend an extra $2 million in compliance costs, another still faces a $1.86 million bill to upgrade their computer systems as now required.” TGA officials allegedly demanded proprietors sign confidentiality agreements and other agreements demanding that the proprietor will not hold TGA liable for the loss of their business after such “regulating activities”. (11) Australian supplement companies remain silent after TGA's “inspections”. Many are bound by agreements and none wanted their names revealed for fear of a fresh round of “TGA regulatory activities”. Although a few are now considering legal action regardless, an enquiry into TGA corruption should get these witnesses testifying with considerable help from a subpoena.
The TGA had routinely inspected the Australian supplement industry in the 2 years before it sent Pan to the wall, and did not suspend a single manufacturer's license. But after Pan, dozens of manufacturers were driven out of business and over 12 Australian supplement companies “voluntarily” turned in their manufacturing licenses and went to the wall after TGA scoured through their business again. (All the manufacturers had already passed previous years' rigorous TGA inspections.) (18, 11) Those who could afford it just paid the money and did what was required of them to stay in business for the time being. Other manufacturers sold out for fire sale prices. Following this obvious witch hunt, many natural product lines remain out of stock in Australia and many nutritional supplements have been permanently discontinued as have the smaller Australian companies who made them.
TGA and Drug Corporations Set Up Committee
In May 2003, only a month after TGA gutted Pan, the regulator issued a public statement alleging that “concerns” had been raised about the quality of complementary medicines (supplements) and indeed even the competency of complementary practitioners (naturopaths). All this after:
- the defective travel sickness pill was a drug and not a supplement and had been removed.
- the company had been closed, and dismantled
- none of the 1600 Pan dietary supplements were found to have caused any problems
- no naturopath or alternative practitioner had killed or harmed anyone with supplements (However, in the time it takes to read this far another 4 Australians have been killed or seriously injured by dangerous medical procedures or pharmaceutical drugs licensed by the TGA.)
Ignoring all the evidence to the contrary, the TGA stated on its website; “In May 2003, to reassure the public and maintain confidence in Australia's reputation as a supplier of high quality and safe medicines, the Australian Government established the Expert Committee on Complementary Medicines in the Health System (the 'Expert Committee')”
The TGA “expert” committee designated to investigate supplements on behalf of the Australian public, includes pharmaceutically orientated individuals and several pharmaceutical front organsiations such as the Self Medication Industry (ASMI) which represents Bayer, Pfizer, Merck, Glaxo, Schering and Wyeth among other trans-national pharmaceutical corporations. (12) Brazenly, the expert committee also includes the Vice President of manufacturing operations in the Asia Pacific Region of Wyeth, a multinational that markets drugs, vaccines and also nutrient supplements including raw ingredients to supplements. (12) Incredibly, Wyeth, was in direct competition to the products and raw ingredients that Pan supplied in the Asia Pacific region, just before TGA raided Pan. Wyeth has a huge Asia Pacific base of operation and is aggressively expanding its corporate territory. (16) Interestingly, Wyeth's profits plunged a few months before the TGA shut down Pan and the drug giant was only saved a substantial loss that quarter by its small but profitable range of vitamin products. (17,14, 15).
The TGA “expert” committee, stacked with corporate representatives has been working on creating more TGA legislation governing the control and regulations of supplements. In a stunning display of corporate governance over Australians, it has recently released fifty more expert recommendations that have resulted in 107 pages of proposed amendments to the TGA Act which would increase the powers of the TGA to “regulate” even more stringently. This would give TGA police powers and the power to impose criminal charges and penalties on Australian supplement manufacturers. All this when there has never been a problem with supplements.
Since late 2004, the TGA Amendment Bill of 2005 has been floated around the Australian Parliament, but not yet tabled. The Bill has been thus far difficult to source because it has been the apparent intention of government to obscure this document from public view as it is noted in prominent type on front page the draft copy; “ DRAFT - IN -CONFIDENCE This draft is supplied in confidence and should be given appropriate protection. “ This Bill proposes stiff criminal charges including a half a million dollar fine against anyone who does not report even a purported mild adverse reaction to a natural remedy or a supplement. Since deaths from supplements are virtually unheard of, it is not difficult to imagine the official abuses, and persecutions against natural practitioners and products inherent in such legislation, when the pharmaceutical industry death tolls remain unchecked. The only beneficiaries of the proposed Bill appear to be the Pharmaceutical corporations, probably a broad indication of the identity of its originators. This Bill is intended to make it a potential criminal offence for anyone to order any supplements from overseas.
So far there has been no public debate about passing legislation that gives police powers to the TGA and by extension, the pharmaceutical corporations that have become a part of the regulator.
Fortunately all interested Australians can now access this proposed bill on the website listed below at reference nos. 41, 42.
Considering the improper methods used to originate and pass TGA legislation the Australian Public may wish to contact their Members of Parliament and demand they say NO to passing the Therapeutic Goods Amendment Bill of 2005.
