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Travacalm is a drug - an over-the-counter pharmacy-only medicine - not a complementary remedy YET THERE WAS A RECALL OF ALL COMPLEMENTARY REMEDIES.

 

TGA Targets Pan
http://www.energygrid.com/health/2005/04eh-codex.html

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 widespread 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 a secret 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)


20 pages of recall notices 

Recall notices of all Pan products recalled were placed in every newspaper in Australia by TGA regardless of circulation size. I counted 20 pages of recall notices over the period of two weeks in a newspaper that would have been described as semi-rural which covers a population of roughly 50,000 people. This same population is a subset of the Canberra region which is also serviced by a larger newspaper, The Canberra Times. 

This expense no doubt would have been born by Pan.


Massive Multinational Assault
on Alternative Medicines

Australians deliberately denied access to more than one thousand products ranging from vitamin pills to multi-mineral supplements

Copyright Joe Vialls, 2 May 2003
http://homepage.ntlworld.com/steveseymour/subliminalsuggestion/
vitamins.html

In less than seven days! " The ever-compliant media immediately started circulating rumors about 'that dangerous Travacalm', and hinted at mixing machines not being cleaned properly between blending batches of different products. One former employee was produced on television, to state that he was only allowed one hour to clean his mixing machine between batches instead of three hours, and that was that. The media fix was in, despite a total lack of evidence."

Under cover of the fake "SARS Crisis" currently saturating the western media, Australia's Therapeutic Goods Administration has suddenly moved to outlaw and remove from store shelves about 80% of all vitamin and other related alternative products. Although less than a week ago customers were happily buying everything from vitamin A to G, and enthusiastically chewing every conceivable mineral and trace element, these same customers today face empty shelves in more than 5,000 health food stores across the nation.

American and European readers who may be wondering "What has this Australian stuff got to do with me?" are urged to read on a little further. Australia is well known as a gullible and thus attractive proving ground for multinational scams, meaning that what happens in Oz this week, might well serve as a foretaste of what is yet to come in America and Europe next week, or next month, or even next year.

The extraordinary situation facing Australians today, started at the beginning of this week, when the Therapeutic Goods Administration [TGA] suddenly decided to cancel the manufacturing license of Pan Pharmaceuticals, a large Australian company which not only manufactures its own line of medicines, but also provides a manufacturing service for 80% of all alternative goods providers across Australia. Basically then, by shutting down Pan Pharmaceuticals without just cause, the TGA ensured that alternative health goods purveyors and customers would be critically disadvantaged across the entire nation.

To suggest [or even think] that the TGA action was deliberately designed to shut down natural health products in favor of the huge pharmaceutical multinationals and their coal-tar synthetic drugs, at first seems ill advised, perhaps even absurd. But unfortunately for the TGA, we can and will prove in a proper step-by-step investigation, that the shutdown process was premeditated and deliberate.

Members of the Therapeutic Goods Administration are Australia's medical goods "thought police", endowed by government with incredible powers. There are documented examples of these people shutting down retail health food businesses for daring to suggest that cheap apricot kernels might retard [not "cure"] cancer, while at the same time other members of the TGA were busy endorsing the massive use of highly-addictive and extremely profitable amphetamines on Australian children, with alleged but unproven "learning disorders".

Every scam needs a convincing trigger to start the desired chain of events. In the case of Pan Pharmaceuticals the trigger was an in-house medicine called "Travacalm", designed as its name suggests to combat motion sickness in its various manifestations. The TGA allegedly received complaints in late 2002 about this medicine, including claims of minor "hallucinations". In an apparent response to these uncorroborated claims, on 21 January 2003 Travacalm Original tablets AUST R 78192 were recalled, with the official reason given as "The product is being recalled following a number of reports of excess side effects related to the active ingredient."

Fine so far, and the TGA certainly seemed to be acting responsibly, but it was not. You see, there are actually three versions of Travacalm, but only the "Original" version was recalled. Travacalm Original is unique in its active ingredient dimenhydrinate, which is not contained in Travacalm H.O [hyoscine hydrobromide], or in Travacalm Natural, which contains only zingiber officinale [natural ginger].

So by banning Travacalm Original but not the other two Travacalm products, the TGA revealed to us all that it was really only banning the single ingredient dimenhydrinate, the active antihistamine not present in either the H.O. or Natural versions of Travacalm.

There is nothing unique or secret about the side effects of dimenhydrinate, which have been known for many years. Users can be subject to headache, blurred vision, palpitations, loss of coordination, dry mouth, low blood pressure causing dizziness and weakness, and ringing in the ears. What are less widely known, are the disturbing hallucinogenic side effects of dimenhydrinate experienced by many experimental users with access to the Internet. 

A good description is posted at http://www.angelfire.com/ca7/legalize/drugs/dimenhydrinate/ "It takes about an hour for the full effects of this drug to be reached, maybe even more. You know when it hits you though. The most screwed up thing is a complete loss of balance. Walking around without falling on your ass is quite the challenge. Small hallucinations are possible (your pen sprouts legs and begins a journey across your desk). And auditory hallucinations (hearing s…) come into the picture at higher doses. "Short-term memory is shot to f…. As soon as you finish a thought, you forget what it was you were thinking about. To the casual observer, you would look quite weird. Slack-jawed, red faced, dilated pupils, possibly a hunched posture, maybe even drooling. The feeling is like floating on a cloud during a hurricane (or something to that effect)."

Obviously then, all medications including dimenhydrinate are potentially very dangerous and capable of producing hallucinations, which leads us to question why it was that on 21 January 2003, the Australian Therapeutic Goods Administration recalled only Pan Pharmaceutical's Travacalm Original, while leaving other medicines with higher levels of dimenhydrinate on the open market.

These other dimenhydrinate medicines include [but are not limited to] Calm X, Dimetabs, Dinate, Dommanate, Dramamine, Dramanate, Dramocen, Dramoject, Dymenate, Hydrate, Marmine, Nico-Vert, Tega-Vert, Triptone, and Vertab. All without exception should also have been ordered off the shelves, but were not.

Predictably perhaps, all of the other dimenhydrinate medicines are manufactured by pharmaceutical multinationals "friendly" to members of the Therapeutic Goods Administration, and unconfirmed rumors still persist about certain senior TGA bureaucrats being discreetly provided with free "medical seminars" in Fiji or Bali, complete with all essential extras including unlimited alcohol and prostitutes.

Regardless of the fine detail of exactly how this situation was engineered, by February 2003 Australian Pan Pharmaceuticals had been artificially "dirtied", and was ripe for the picking. The scene had been set for the biggest recall of natural health products in Australia - perhaps in the world. The scam itself started on Monday 28 April, and a mere four days later on Thursday 1 May, the TGA had identified and ordered 1,363 complete product lines to be stripped from store shelves across Australia. Does anyone out there really believe that a bunch of lazy bureaucrats managed all that in four days, without considerable forward planning?

So by Thursday 1 May, one thousand three hundred and sixty-three complete product lines had been officially recalled, meaning hundreds of millions of alternative health pills and capsules had to be stripped from the shelves, leaving Australian consumers understandably anxious. To claim that this TGA action "undermined public confidence in alternative health", would be seriously understating the case.

Naturally the Therapeutic Goods Administration provided no details of why this was happening, though the ever-compliant media immediately started circulating rumors about "that dangerous Travacalm", and hinted at mixing machines not being cleaned properly between blending batches of different products. One former employee was produced on television, to state that he was only allowed one hour to clean his mixing machine between batches instead of three hours, and that was that. The media fix was in, despite a total lack of evidence.

Hundreds of thousands of Australians were suddenly deprived of the ability to buy their chosen alternative health products, and "doubt" had also been deliberately cast over the safety of the alternative health products already in their homes. Many Australians started to grumble that the alternative health manufacturers were no better than the hated drug companies: all of them obviously out to make a quick buck without the slightest regard for public safety. Lines of demarcation became blurred, and customers started to mill around like lost sheep.

Hard evidence to hand indicates that the undermining of public confidence, and the resulting confusion, were the prime object of the exercise, because there is no proof that any of these 1,363 product lines pose the slightest risk to human health. Ironically perhaps, in its headlong rush to shepherd Australians back towards out-of-fashion medical doctors and their wide range of synthetic coal-tar based drugs, the Therapeutic Goods Administration reinforced the reality of perfect safety with official statements.

Putting its foot firmly in its mouth, the TGA publicly announced three times in less than a week, "there are no problems with prescription drugs obtained from your doctor", and "prescription drugs are not affected". This was unquestionably reassuring news for potential patients being herded back towards the medical profession, and even greater news for the pharmaceutical multinationals, who up to this point in history have been losing A$2,000 million per year in Australia alone to alternative health products.

Unfortunately there was a fatal flaw in these glib and very convenient TGA statements. Though Pan Pharmaceuticals is best known for its own alternative health products, and as a contract manufacturer for 80% of all other alternative health products across Australia, it is also a significant producer of a wide range of in-house and contract "prescription drugs". Those prescription drugs manufactured by Pan are still in your doctor's surgery, and they are still on the shelves at the pharmacy, despite the startling fact that all were produced in the same allegedly "unclean" mixing machines as the 1,363 banned alternative health products.

In summary, the Australian Therapeutic Goods Administration recalled a Pan dimenhydrinate product in January 2003 but failed to recall its fifteen multinational equivalents at the same time. The TGA also failed to issue a public warning about the possible hallucinogenic side effects of dimenhydrinate. In late April the Therapeutic Goods Administration started a whispering campaign against Pan Pharmaceuticals, with the intent of severely undermining public confidence in alternative health products. This latter claim has now been proved by the selective TGA recall of all 1,363 Pan Pharmaceutical alternative health products, but without the recall of a single Pan Pharmaceutical "prescription medicine".

It is difficult to forecast the long-term outcome of this deliberate campaign, because no one yet knows what the multinational pharmaceutical corporations will instruct the Australian TGA to do next. Certainly the massed media campaign has already severely undermined Australian public confidence in alternative health products, and for a few weeks or months it will be very difficult [in some cases impossible], to even purchase fresh stocks of vitamins, minerals and so on. In turn, this forced lack of trade will send thousands of small alternative health retails outlets into bankruptcy.

Using these techniques, the multinational pharmaceuticals seek to "break the alternative consumer habit" if possible, and to an extent they will be successful. The "hard core" alternative crowd will not respond of course, and if necessary will import their own products, but it is not the "hard core" that the multinationals seek to undermine.

It is "middle" Australia [and America and Europe] that the multinationals are targeting. Millions of intelligent folk who used to go to medical doctors all the time, until they started to pick up the warning signs of the horrific side-effects of prescription medicines. These are the people who must be weaned off healthy products, and brought back under direct medical control.

The fake Australian Therapeutic Goods Administration scam will certainly help to do this, and if only 50% effective, should still return roughly one billion dollars per annum to multinational pharmaceutical investors. Not a bad return for the price of a few hookers in Fiji and Bali.

 


 

Restricting accessibility to alternative health products
http://friendsoffreedom.org

Inge's Comment: After reading Dr. Rath's report on halting the "artificially manufactured SARS hysteria", I would like you to consider the following COINCIDENCES with alarm.

Since Plan A (Shock and Awe – with weapons of mass destruction) and Plan B (creating an artificial medical emergency – the SARS hysteria) have both been sabotaged with the public injection of TRUTH by Dr. Rath,  Plan C is suddenly emerging.  The pharmaceutical/ military/ new-world-order syndicate has no intention of allowing simple and inexpensive PROVEN CURES to destroy their global control, power, or profits.

How can the pharmaceutical cartel eliminate this competitive threat – Simple!  
Plan C.  Restrict accessibility! 

Over the years, all the smaller supplement-manufacturing companies have been bought out or forced out of the marketplace by the giant multinational pharmaceuticals, and now there are a just few ‘pharmaceutical’ companies which manufacture the world's supply of Vitamin C, and most other supplements – and therefore, have the capacity to regulate – or eliminate – the supply. (Truly the fox owning and guarding the chicken coup.)

Can this all be coincidence?

Suddenly I read that Vitamin C is not available in Chili – because of a worldwide ‘manufacturing’ shortage.

Then I read today that because of "sudden and sweeping government intervention on justification of a necessary investigation into violations of Good Manufacturing Practice, "Pan Pharmaceuticals saw its complete line of supplements production recalled, practically ruining the natural products industry in Australia. I am waiting to see how many other such capers will appear in other countries, unless Dr. Rath can embarrass the syndicate by publicly exposing their tactics once again.

At the same time, The New York Times ran a series of articles last week, alerting the public to "the dangers of overdosing on supplements". (These articles naturally made no mention of the fact that pharmaceutical drugs are now the fourth leading cause of death in America - while death from supplements are as scare as hen's teeth.)

How convenient! Scare the hell out of the consuming public, and REMOVE the supply.

Do they really take us for complete idiots who cannot to see through their manipulative policies of deception?

But most of all, SHAME on all the governments and their regulatory agencies, which have allowed themselves to become infiltrated and controlled, and now shamefully demonstrate their willingness "to sell their own citizens down the drain - camouflaged under the pretense of protecting us from ourselves".  SHAME, SHAME,  SHAME!  

May I remind those in collusion with the pharmaceutical syndicate's agenda, or those who prefer to continue wearing blinkers, that their families also get sick, and that their health is also ruled by the "sickness industry", and that they may someday find themselves desperately praying to have access to the natural remedies that work – and there are MANY  that have been eliminated through persecution, prosecution, and conspiratorial regulations. 

(We destroyed the life-saving discoveries of geniuses like Dr. William Koch, or Dr. Royal Rife - both of whom gave us universal treatments for infectious diseases, and we ignored and maligned the clinical discoveries of Dr. Fred Klenner - who cured polio already in the 40-s and 50's.  Did we really need a polio vaccine (since we had 3 ignored cures) - while the vaccine resulted in contaminating entire populations with SV40 - which has been shown to cause specific new cancers?)

Your health is hanging in the balance. Your freedom is hanging in the balance. Indeed, your life is hanging in the balance!

Inge Hanle
mailto: hanle@axion.net

P.S.  Please help us to get the TRUTH out - and to remove the shackles of fear that has a suffocating stranglehold on people when they do not know nor suspect the deception.  The main media is embedded, or too scared to tackle this subject for fear of retribution.  So it is up to us, and individual citizens, to protect ourselves and our fellowman.
The TRUTH shall make us free again! 
Thank you for your help and participation.

Dr. Rath's website is http://www4.dr-rath-foundation.org/

_______________________________________________

How Dr. Rath brought the SARS epidemic "under control"
http://friendsoffreedom.org

How Dr. Rath and $30,000 in Public Health Advertising by the Dr. Rath Health Foundation brought the SARS epidemic "under control"

Throughout the Iraq war, Dr Rath has exposed the Rockefeller Group and the pharmaceutical/ petrochemical cartel as the largest benefactors of a war with weapons of mass destruction. This war would be abused to abolish civil rights worldwide, guarantee the survival of the pharmaceutical industry and establish the monopoly of the pharmaceutical cartel over global health. Unmasking the ‘war plan’ of these corporate interest groups behind the military war against Iraq and exposing these groups as even benefiting from a war led with weapons of mass destruction, made it impossible for them to do just that - to risk a war with weapons of mass destruction.

The very same week that Dr. Rath published his open letter exposing the "Rockefeller-financed Trilateral Commission" behind the Bush-Administration’s war, the plan for the use of weapons of mass destruction was dropped. That very same week the Pharma-Cartel launched their Plan B: the SARS epidemic.

By the middle of March, all of a sudden, the news were dominated with the buzz-word ‘SARS’ and a global scare campaign was launched. The SARS epidemic was a man made PR-stunt with the goal of creating the global psychological state that would allow the pharmaceutical cartel to create in people the state of mind enabling it to continue its rule – even with an Iraq war fought only with conventional weapons.

Dr. Rath and his team recognized this strategy and called their bluff. He knew the scientific fact that all viruses including the virus that causes SARS (corona virus) can be largely blocked by optimum use of ascorbic acid (vitamin C) and other essential nutrients. 

Dozens of studies with different viruses have all confirmed that there is no known virus that does not respond to vitamin C. In a study published in the Proceedings of the National Academy of Sciences USA, it was shown that vitamin C alone can block even the HIV/ AIDS-Virus by more than 99 % (Proceedings Natl. Acad. Sci. USA, 1990, 87, 7245-9).

Knowing these facts, Dr. Rath decided to publish full page Public Health Alerts in newspapers in Hong Kong, the Philippines and Singapore. The title was "Vitamin C against SARS". The subtitle read "What everyone should know – but the World Health Organization (WHO) does not tell you – about natural protection from the new epidemic."

Dr. Rath’s public health information informed people in the countries most affected, about the benefits of vitamin C and other essential nutrients to optimize the immune system and help prevent the spread of SARS. But this Public Health Alert, financed by the Dr. Rath Health Foundation, was also a harsh criticism of the World Health Organization (WHO). Dr. Rath criticized the WHO, founded half a century ago to promote human health, to be undermined and abused by pharmaceutical investment interests.

This investment industry is based on the patentability of drugs and continues to instrumental the WHO to serve primarily the promotion of patentable, profitable prescription drugs. In fact, there is no other reason why the World Health Organization would fail to fulfill its obligation and bring the life saving information about the health benefits of essential nutrients to the people of the world.

The text for the open letters was submitted to the newspapers on 9th April 2003 and under-went a meticulous review in the respective countries, including by one Ministry of Health. This review process alone made sure that the information about the effectiveness of a non-patentable natural substance, vitamin C, for the natural control of the SARS epidemic is available everywhere and can and must be used.

The publication date for Dr. Rath’s health information in these Asian countries was set for Saturday 12th of April 2003. The advent of the "Public Health Information Campaign by the Dr. Rath Health Foundation" and the public exposure of WHO as a puppet of the pharmaceutical cartel, rang alarm bells within the WHO. In fear of the loss of its credibility with the people of the world, this world body had to react. Disputing the scientific facts was no option. So the only way out was a withdrawal of the scare tactics. Their basic message: It’s not that bad.

Thus, on the very same day that millions of people in Asia woke up to the stunning news of fighting SARS with vitamin C they must have been even more stunned by the WHO making a 180 degree turn around. Referring to the WHO’s medical officer Mike Ryan, the New York Times reported for the world to know: "Virus Called Mostly Under Control".

What a remarkable day. After having launched one of the largest media stunts in the history of planet earth, the pharmaceutical cartel and its allies within the WHO had to withdraw it within hours of Dr. Rath calling their bluff.

Dr. Rath comments: "I have been fighting the pharmaceutical cartel for more than a decade now, but this success overshadows everything. The pharmaceutical interest groups - exposed as conducting an organized fraud business that risks the life of millions of people and drains the economies of this planet - are apparently extremely nervous. There can be no other reason why they reacted so fast following my exposure that the pharmaceutical cartel is the organizer and benefactor of this man made hysteria. This fact should open the eyes of every intelligent person: How scared must they be if $30,000 in public health advertising is all it takes to stop an epidemic that has been dominating the news around the world."

After having been denied the opportunity to escalate the war against Iraq into a war with weapons of mass destruction: after having been denied the possibility to abuse such an event to abandon civil rights around the world for its own survival, the pharmaceutical cartel has just suffered another blow.

The people of the world are one step further toward recognizing the true nature of the pharmaceutical cartel as an unscrupulous investment group around the Rockefeller group. The pharmaceutical investment industry has sacrificed more lives over the past decades for their unscrupulous "business with disease" than the number of people who died in all wars of mankind put together.

The people of planet earth are waking up to the fact that there is a special interest group among us that not only took control of the White House and controls news dissemination around the world through their ownership of Time Warner, CNN and other news channels, but also abuses these instruments to impose wars and epidemics on our planet.

It’s time for a change. We ask you to support the People’s Agenda for a new world of health, peace and social justice.


Script addicts loath to admit natural medicine is effective
http://www4.dr-rath-foundation.org/THE_FOUNDATION/News/2003/
natural_health_alternatives/2003-05-02.htm
  

Australian President of Complementary Healthcare Council defends vitamins and minerals following the TGA attack

(smh.com.au / May 2, 2003) -- It is the medical experts decrying alternative therapies who are ill informed, not the public, writes Ian Brighthope.

The recent medicine recall has flushed out the detractors of natural medicine who have hijacked the situation to criticise the efficacy of complementary medicine.

Reading some of the reports from ill-informed professors of medicine who are suddenly instant experts in complementary medicine, it would be easy to believe the Australian public is stupid.

Foolish, misguided and dim, millions of people are being misled, taking natural health products because they are "longing for a little bit of mysticism" and quite content to waste "millions of consumer dollars".

There is a wealth of scientific evidence to support the use of natural health products, including:

The mineral selenium: a randomised, controlled trial of this supplement had to be stopped because of "the apparent reductions in total cancer mortality and total cancer incidence" in the experimental group. The researchers could no longer ethically justify not giving this substance to the placebo group (Journal of the American Medical Association, 1996).

Lactobacillus bacteria: if pregnant women take Lactobacillus bacteria every day, the risk of their newborn babies having atopic eczema, a horrible, distressing and painful condition, halves (The Lancet, 2001).

The vitamins folic acid and B12: if everyone diagnosed with heart disease took these vitamins, we would save 310,000 lives over five years in the US alone (Journal of the American Medical Association, 2001).

St John's wort: this herb is commonly used for mild and moderate depression; a meta-analysis of trials in 1996, published in the British Medical Journal, showed that it was as effective as standard antidepressants, but with fewer side effects.

I could also quote research about vitamin C, zinc, the herb saw palmetto and dozens of other substances.

But it's not just about studies and research, although there are many of these to support the use of natural health products. As a practising GP, I don't think the Australian public is stupid. I have been a nutritional doctor for 25 years, and I have treated thousands of patients, frequently very sick people, with all manner of illnesses including cancers and psychiatric diseases. I rarely prescribe drugs - I write, on average, only four scripts a year. Consumers take natural health products for one simple reason: because they work. People feel better, and they get better.

The Pan recall is a terrible event, terrible for consumers who no longer have access to products they use and trust. It is also terrible for small businesses - the Complementary Healthcare Council of Australia estimates 500 small businesses will be forced to close, and 5000 Australians will be out of work.

The recall was caused by quality defects highlighted in the case of badly manufactured Travacalm. This involved serious side effects for the people affected, but this is not a natural health product. Travacalm is a drug - an over-the-counter pharmacy-only medicine that was poorly manufactured and quite rightly recalled.

Despite the attacks from those pushing their own agendas, the natural product industry will survive this, and be strengthened by it. The overriding message is that the system works.

The natural products industry continues to liaise closely with the Therapeutic Goods Administration to identify ways we can move forward and limit the potential damage for our industry, at the same time ensuring that the highest levels of safety for Australians are maintained.

 


Pharma-Cartel Runs Amok. 
The Global Deception campaign denying the health benefits of Vitamins can no longer prevent the collapse of the Pharmaceutical House of Cards

http://www4.dr-rath-foundation.org/THE_FOUNDATION/News/2003/
pharmaceutical_business/2003-05-06.htm

The following headlines appeared recently in newspapers and other news sources around the world:

Watchdog warning on vitamin pills
CNN / May 08, 2003
http://www4.dr-rath-foundation.org/THE_FOUNDATION/News/2003/pharmaceutical_business/2003-05-08-3.htm

Vitamins can damage your health, warns watchdog
The Times / May 08, 2003 by Valerie Elliott
http://www4.dr-rath-foundation.org/THE_FOUNDATION/News/2003/pharmaceutical_business/2003-05-08-1.htm

Too many vitamin pills can be bad for you
IOL, Reuters / May 08, 2003
http://www4.dr-rath-foundation.org/THE_FOUNDATION/News/2003/pharmaceutical_business/2003-05-08-2.htm

Warning over vitamin doses
BBC News / May 07, 2003
http://www4.dr-rath-foundation.org/THE_FOUNDATION/News/2003/pharmaceutical_business/2003-05-07-2.htm

Health Risk Warning Over High Doses Of Vitamin Pills
Sunday Times / May 04, 2003 by Jonathan Leake
http://www4.dr-rath-foundation.org/THE_FOUNDATION/News/2003/pharmaceutical_business/2003-05-06-2.htm

Vitamins: More May Be Too Many
New York Times / April 29, 2003 by Gina Kolata
http://www4.dr-rath-foundation.org/THE_FOUNDATION/News/2003/pharmaceutical_business/2003-05-06-1.htm

Don’t be fooled by this propaganda!

These pieces of irresponsible journalism have a single common purpose - to discredit safe and effective natural remedies. The comments made in these reports fly in the face of the huge volume of scientific evidence accumulated over the past sixty years or more, that attests to the health benefits of vitamins and other essential micronutrients.

The negative comments quoted in both the New York Times (April 29th) and The Sunday Times (May 4th) follow in a long line of positions taken by the organization referred to in these reports that include: Nothing Is Wrong With DDT and Diesel Exhaust Emissions Pose No Risk To School Children. The report of the Expert Committee on Vitamins and Minerals (EVM) referred to by the Sunday Times and in the later reports, was first published in August 2002. The EVM in fact failed in its brief, which was to set so-called safe upper limits for certain vitamins and minerals. Due to a lack of evidence of any adverse effects, the EVM managed to propose safe upper limits for only 9 out of the 34 micronutrients that it studied and the limits that it did propose are scientifically questionable.

As usual, the press are trying to blow this out of all proportion and start a scare story. No doubt we shall shortly see the absurd 'Vitamin C Causes Cancer' story making the headlines yet again. It seems that the pharma-cartel have decided that attack is their best form of defence and that creating panic (a la SARS) is a good tactic.

_____________________________________________

May 28, 2003

To: American Association for Health Freedom: Candace Campbell, Dr.Shari Leiberman

To: National Health Federation: c/o Wes- to Maureen Salaman, Mike Culbert, Scott Tips,JD

To: American Holistic Health Association: c/o Suzan Walter

EMERGENCY ALERT: PLEASE ACT IMMEDIATELY

Friends:

I am driving a 6 hour round trip from BC Canada today to Seattle for an emergency meeting with Jonathan Wright, MD in an effort to spur direly needed donations to the Alliance for Natural Health in the UK so that they can file an ALL IMPORTANT LAWSUIT no later than JULY to overturn the EU Food Supplement Directive.

I urgently need your assistence to spread the word about this: please see my article at http://www.iahf.com/anh_lawsuit.html it includes photos and a table. I made a trip to the UK in march to generate it, where I spoke at the Vitality Vitamin Trade Show in London before a large group of alternative medical practitioners, vitamin companies, health food stores and consumers pledging IAHF's support for ANH's legal effort due to its extreme global importance.

An edited version of my article will appear in the next issue of Life Extension Magazine. Unfortunately, it has been watered down and I fear that the urgency in my message was removed via the editing process which was overly fraught with "political correctness" stemming from an ignorant editor who has never worked in our industry before and doesn't understand the issues. (See their version at http://www.lef.org/magazine/mag2003/2003_preprint_eu_01.html

The EU is expanding by 10 new countries next year.

All will politically allign with Germany and France, because they politically dominate the EU- (proof is in my article.)

One year ago a draconian EU Food Supplements Directive was passed into EU law, and England and all other EU member states have a deadline of July to harmonize their domestic law to it. Alliance for Natural Health is a very solid organization established by all the alternative medical organizations in England as a last ditch effort there to defend consumer access to supplements, not only in England, but globally due to how events in the EU will impact Codex and WTO trade disputes in this area.

They have the best law firm in England working with them, one of the few firms that has ever succeeded in overturning an EU Directive, and we CAN win in court to monkeywrench the Cartel's global juggernaut, but NOT WITHOUT URGENT DONATIONS to ANH that can be made via credit card via their website at http://www.alliance-natural-health.org

My reason for going to Dr.Wright today is simple:

The FDA raid against his Tahoma Clinic in the early 90s helped catalyze the drive to pass DSHEA, and now we have no choice but to do our damndest to get the rest of the world to harmonize to DSHEA, or the consequence will be that WE will continue to be set up for harmonization to a grossly restrictive unfolding international standard.

I need Wright to help me reach out to vitamin companies which have been LIED TO on this issue by IADSA, a controlled opposition group which I have exposed at http://iadsa-exposed.tripod.com IADSA is "led" by Randy Dennin, an employee of Pfizer, the largest drug company in the world, and his goal is NOT to "protect" us, it is to DESTROY us, while only going through the MOTIONS of "protecting" us. The smoking gun is shown on the IADSA exposed site where you can see that IADSA kicked NNFA New Zealand out of their umbrella group for asking "too many questions" about gross conflicts of interest, and ESPECIALLY for calling IADSA to task for doing NOTHING to protect New Zealand's very liberal food based regulations from harmonization to Australia's overly stringent, pharmaceuticalized regs.

Since building the IADSA exposed site last fall, you should be aware that in Australia the TGA (their FDA) has just engaged in a fraudulent recall of over 1300 dietary supplement products which were yanked from the shelves without a SHRED OF EVIDENCE that they were in any way "contaminated."

Ron Law, former exec dir of NNFA New Zealand, the man who sent me the documentation used in the IADSA EXPOSED website had an article titled Natural Justice? published in The Independent, New Zealand's largest business newspaper to condemn and expose as fraudulent this TGA recall, and also to expose lies from New Zealand's health minister, Anette King, who wrongly extended the recall to Pan's dietary supplement products sold in New Zealand based strictly on HEARSAY EVIDENCE from TGA that the recall was "necessary." (See that article at http://www.iahf.com/asia/20030520.html

Canada is in the process right now of being harmonized to Australia, and IAHF ally Friends of Freedom in Ontario will attempt to get an injunction in court this month to stop the scheduled June 4th gazetting of new regulations that totally slam the Canadian industry, opening them up for exactly the same kind of attack via manufacturing site licenses (which can be pulled on a whim) by regulators as illustrated by the Pan recall in Austrlalia. FoF is also attempting to get Bill C-420 through the Canadian Parliament in a last ditch effort to protect consumer access to supplements north of the 49th parallel.

Canada is our northern flank. Efforts are already underway to form a carbon copy of the EU Dictatorship in our hemisphere to be called the "Free Trade Area of the Americas" and all of this is discussed in my article.

The Cartel's takeover of our industry is deliberately INCREMENTAL, long and drawn out, HOWEVER, if we fail to act at KEY MOMENTS to COUNTER their agenda of globalization and harmonization of the laws world wide, we WON'T BE ABLE to defend DSHEA.

Keep in mind that the FIX is ALREADY IN: On March 20, 2001, Congress WHITEWASHED an oversight hearing on the Codex vitamin issue, and the truth did not come out about how the FDA is setting us up for the harmonization of our laws to a grossly restrictive international standard.

NNFA's pharmaceutically dominated DC lobbying firm Parry, Romani, DeConcini and Symms (which has numerous multinational pharmaceutical clients including Pfizer) played a major role in the WHITEWASHING of that hearing, mostly via the instigation of Pfizer, the largest drug company in the world.

They wouldn't let me testify, or any of my witnesses including Richard Malter, PhD. Malter wrote a scholarly rebuttal to a paper which FDA had the pharmaceutically dominated National Academy of Science generate titled "A Risk Assessment Model for Establishing the Safety of Dietary Supplements" Malter's rebuttal was published in the Journal of Orthomolecular Medicine.

The FDA is setting us up to lose in a WTO trade dispute by generating a false definition of vitamin safety. The only legal means by which we can keep our domestic law from being harmonized to a highly draconian international standard is on a basis of safety, and FDA is setting us up so we won't be able to defend ourselves in a WTO Trade Dispute, which would be settled in an international court that does not follow US rules of evidence: the WTO's Dispute Settlement Body. The DSB is a mickey mouse court which rubber stamps the greed driven agendas of the multinational corporations. Every decision they have made has gone against the public health, against the environment, against human rights, against labor rights, against all the intangibles that go into the making of a nation's laws.

Please see my article at http://www.iahf.com/anh_lawsuit.html and help generate donations to ANH by the July deadline so they can file suit in the European Court of Justice to overturn the EU Food Supplement Directive. If this Directive is not overturned, there will be NO WAY TO STOP a grossly restrictive vitamin standard from being driven through at CODEX, and then EXPANDED at Codex to parallel the expansion of the EU Food Supplement Directive in a few years. This is one of those KEY MOMENTS during the Cartel's long drawn out takeover in which we MUST ACT. If they catch us napping now, we're done for down the road. This is our last chance to defend this industry from global destruction, the last chance to stop the unfolding of a slow motion train wreck. Please communicate with me about this. I need your active support to spread this alert rapidly.

John Hammell, President
International Advocates for Health Freedom
in BC Canada until June 7th at 604-597-7821, thereafter in VA at 800-333-2553

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http://www.iahf.com/asia/20030520.html

Ron Law from New Zealand comments below on the recent Australian recall of over 1300 dietary supplement products. His article Natural Justice? was published in the Independent, the largest business newspaper in New Zealand. He quite correctly questions the Australian TGA's actions, as well as New Zealand Health Minister Annette King's actions in ordering a mandatory recall on Pan's products in New Zealand, going strictly on a basis of TGA hearsay evidence.

Moreover, he catches King in a series of lies, discussed below, pertaining to her loud contention that New Zealand "must harmonize" its laws to Australia in order to "properly protect the public health." This summer the US FDA intends to violate the law (DSHEA), which requires them to draft FOOD BASED GMPs for dietary supplements, but the FDA is on the verge of coming out with GMPs even STRICTER than pharmaceutical GMPs, which will force attorney Jonathan Emord to file yet another lawsuit in order to reign them in. I predict right now what FDA and Congressional sycophants such as Senator Dick Durbin, and Congressman Henry Waxman will do, (with massive backing from the mainstream media): they will attempt to LIE about this TGA recall (EXACTLY AS New Zealand Health Minister Annette King has been) in an effort to "justify" FDA ignoring our current law, and Durbin and Waxman will attempt to ALSO LIE ABOUT THIS in an effort to get cosponsors on their bill (Waxman is drafting a House companion bill.)

As these events unfold in Australia, New Zealand, and the USA, in Canada, the HPB is busy harmonizing Canada to Australia by seeking to slam dunk the supplement industry via Gazette 2, while Friends of Freedom in Ontario attempts to fight back by reintroducing David Rowland's lawsuit charging the HPB with flagrant violations of Canadian's rights under the terms of the Charter of Rights and Freedoms. In attempting to screw the Canadian people via Gazette 2, the HPB is attempting to blatantly ignore the fervently expressed wishes of the Canadian people who voted with their feet against HPB oppression in 1997, but rather than secure the victory that they thought they had secured, all that really happened was that the large companies trying to knock off their smaller competition succeeded in pulling the wool over people's eyes, "led" by dubious "leadership" in the pharmaceutically dominated Canadian Health Food Association. Health Canada literature handed out to supplement industry role players under the guise of "soliciting public comments" (which HPB always ignores) flat out state that Canada is harmonizing to Australia.

The same exact pattern has been occurring in England, and America: where pharmaceutically dominated vitamin trade associations are leading their rank and file membership to the cliff, while keeping the consuming public in the dark about the onrushing genocide. "Leading the way" in this global scam is so called "International Alliance of Dietary Supplement Trade Associations" (IADSA) which has been exposed at http://iadsa-exposed.tripod.com The smoking gun which exposed IADSA as fraudulent is that they kicked NNFA New Zealand out of their umbrella group, refusing to do anything to help them fend off pressure from much larger Australia to harmonize their very liberal food based dietary supplement regs to Australia's highly onerous pharmaceutically based regs which are the strictest in the world. Here, Ron Law exposes the lie that there is any NEED for New Zealand (or ANY nation) to harmonize to Australia's regs.

The fraudulent TGA recall is timed to attempt to cast extreme doubt on the safety of dietary supplements in order to coincide with the passage of the EU's Food Supplement Directive, which is timed to spur completion of a draconian vitamin standard at Codex within the next couple of years which will be made possible by the EU expanding by 10 more nations next year (all of which will fall in line behind Germany and France, which politically dominate the EU. A carbon copy of the EU Dictatorship called the "Free Trade Area of the Americas" is intended for our hemisphere, whereby the intention is to harmonize the USA's dietary supplement laws to Australia (via Canada) and to the EU. The intention is to isolate us, and take us LAST, using the SAME MECHANISMS being seen right now in Australia and Europe.

The FDA has already set us up to lose in a WTO Trade Dispute via which our dietary supplement laws can be forcibly harmonized to a grossly restrictive international standard by falsely defining dietary supplement safety. This has been done via FDA's illegally introducing an unscientific, pharmaceutically funded paper at Codex in direct violation of current US law, titled "A Risk Assessment Model for Establishing Safe Upper Levels for Nutrients" Congress whitewashed an oversight hearing on March 20, 2001 where they truth regarding this unscientific paper and FDA's illegal action could have been exposed. The hearing was whitewashed due to the political influence of pharmaceutically dominated NNFA's lobbying firm on Capital Hill- Parry, Romani, DeConcini and Symms- which has numerous multinational pharmaceutical clients, including Pfizer, the world's largest drug company. I was not allowed to testify, and neither were any of my witnesses including Richard Malter, PhD, who authored a scholarly rebuttal to the NAS so called "Risk Assessment" paper. Malter's rebuttal was published in the Journal of Orthomolecular Medicine.

FDA continues to mount an attack on DSHEA by commissioning the NAS to generate totally unnecessary so called "safety monographs" against the best selling, most popular dietary supplements- with the intention of setting us up for harmonization to grossly draconian international standards. These monographs are being "developed" for melatonin, DHEA, saw palmetto extract, glucosamine, shark cartilage, chapparel, and chromium picolinate. Just 10 days after Congress whitewashed the Codex oversight hearing where NNFA's International Committee Co Chair Karl Reidel made the highly questionable statement under oath that the USA "is not in jeopardy" of having its dietary supplement laws harmonized to a grossly restrictive international standard, his co chair on the International Committee, Randy Dennin, employee of Pfizer, was Chairing a meeting of IADSA in South Africa titled "Toward a Global Regulatory Model". It is painfully clear through Dennin's kicking NNFA New Zealand out of IADSA and doing nothing to protect New Zealand from massive pressure to harmonize to Australia's excessive TGA "system" that IADSA is doing the diametric opposite of what they PRETEND to be doing ("protecting" the industry.)

When will people EVER learn ???? FDA will be coming out with illegal GMP regs this summer which violate DSHEA which only mandates them to come out with food based GMPs. FDA's new regs are even more stringent than pharmaceutical GMPs, and FDA will attempt to justify ignoring the law based on this TGA recall. Senator Durbin will attempt to use the TGA recall to get cosponsors for S.722, the Dietary Supplement Safety Act of 2003, and when Waxman drafts a companion bill he'll also try variations of New Zealand Health Minister King's lies in an effort to urge Congress to gut DSHEA by passing S.722.

These attacks aren't happening in a vacuum. The world's FDA's and legislators world wide are being coordinated via ICDRA International Conference of Drug Regulating Authorities, a UN umbrella group attempting to bring about global harmonization of the laws on behalf of pharmaceutical interests.

The most effective thing vitamin consumers and manufacturers can do in the face of this global attack on the natural products industry is to make an immediate contribution to the Alliance for Natural Health's lawsuit to overturn the EU Food Supplements Directive. See my article at http://www.iahf.com/anh_lawsuit.html and make a donation via http://www.alliance-natural-health.org Overturning the FSD and continued lobbying in the EU Parliament against the Traditional Herbal Medicines Directive and to amend the Pharmaceuticals Directive is the best way to monkeywrench the Cartel's dictatorial global takeover plan. We must get the rest of the world to harmonize to DSHEA. IADSA sure as hell isn't trying to bring about this outcome, they're pretending to, while Dennin is actually setting us up on behalf of Pfizer, his employer. His email address is randy.dennin@pfizer.com See http://iadsa-exposed.tripod.com for jpeg files of solid evidence of IADSA's agenda in the form of original correspondence to and from IADSA and NNFA New Zealand.

~~~~~~~~

 

published in The Independent- Largest Business Newspaper in New Zealand

Natural justice?

by Ron Law, New Zealand

Deficiencies in the Australian regulatory system will likely cost the Aussie/NZ natural healthcare product industry $300-$500 million, writes Ron Law

The largest regulatory failure of foods or medicines in the history of the planet happened in the self-proclaimed best-regulated country in the world Australia.

Blessed with watchdog the Therapeutic Goods Agency (TGA), extracting $NZ60 million from the pharmaceutical and natural healthcare product industries, Australians probably thought they had a guarantee against the shoddy practices behind this months extraordinary recalls of products manufactured by Pan Pharmaceuticals.

The New Zealand dietary supplements industry of which some players had been clients of the now-suspended Pan has come under grossly unfair and evidentially unwarranted attacks in the wake of the Aussie debacle.

A recent statement by Health Minister Annette King that the New Zealand industry does not want regulation is patently false.

Papers will today be tabled at Parliaments Health Select Committee inquiry into the proposed trans-Tasman joint TGA proving that not only does industry want appropriate regulation, it is fully united and had agreement with the Health Ministry on a proposed Healthcare and Therapeutic Products Bill in November 1998.

The papers will show the minister was, on taking office, advised of the proposed Bill and gave it her blessing, not realising her officials had already scuttled it via a secret letter by former minister Wyatt Creech to his counterpart in Australia in July 1999.

The case for New Zealand to join Australia in health product regulation is demolished by the TGAs recent extraordinary responses to the apparently errant Pan:

" December 2002-January 2003: Serious adverse reaction reports pour in to the TGA relating to a pharmaceutical product Travacalm Original. (Eventually, nearly 100 serious adverse reactions including 19 admissions to hospital will be reported.)

" 21 January 2003: Based on adverse reaction reports, TGA initiates a voluntary recall of Travacalm Original, a product containing dimenhydrinate 50mg, hyoscine hydrobromide 0.2mg and caffeine 20mg.

Over the next week TGA tests the other two Travacalm products. Travacalm H.O. (which contains hyoscine hydrobromide 0.3mg) is found to contain between 0% and 700% of the active ingredient in tablets within a single packet, indicating that the formula was not mixed properly prior to tabletising.

The third Travacalm product, Travacalm Natural, which contains 500mg of ginger, was assayed and found to be OK and not required to be withdrawn.

" 30 January 2003: TGA initiates voluntary recall of Travacalm HO.

All three Travacalm products were contract-manufactured by Pan Pharmaceuticals.

Then, for mysterious reasons, which we can only speculate about at present, three months later,

" 28 April 2003: shortly before close of business, and without any warning, the TGA holds a media conference to announce Pan Pharmaceutical product would be recalled, including export-only products, and many thousands of products made by Pan for other companies were under suspicion. TGA made the calculated statement that, consumers should stop taking ALL complementary medicines. As it turned out, less than 10% of products on the TGA database were eventually withdrawn, and perhaps less than 5% of New Zealand product was implicated.

Having thus placed all natural healthcare products under suspicion, whether made by Pan or not, the medical head of the TGA, bizarrely, reassured the public that pharmaceutical products were kosher.

However, the two products which had failed the TGAs laboratory analysis were pharmaceutical products. The natural healthcare product had been found to be of high quality.

What about the prescription medicines for export that had their licenses revoked were they faulty? How could it be that pharmaceutical products paid for by the Australian government were high quality, yet the same products being exported were not?

The TGA had discovered serious quality and safety breaches in the manufacture of products by that company [Pan Pharmaceuticals] since May 1, 2002,to quote the Honourable Annette King, New Zealand Minister of Food Safety as she issued the largest recall of food products in the world.

Kings recall came less than 24 hours after she publicly stated she couldn't recall these products because they were unregulated and that is why she needed new regulation.

MPs Lynda Scott and Sue Kedgley pointed out in Parliament question time on 1 May that s40 of the Food Act gave her such powers and the minister backtracked.

The recall in New Zealand was mandatory. The minister had no evidence any of the natural healthcare products recalled were unsound or unfit for human consumption or damaged or deteriorated or perished, or contaminated with any poisonous, deleterious, or injurious substance,the only basis s40 provides for a mandatory recall.

Kings only evidence was Australian TGA hearsay (it wont release evidence in case it decides to prosecute).

Our minister would appear to have acted illegally and this may well be considered by Parliaments Regulations Review Select Committee as an unusual or unexpected use of powers in the Act.

But back to the TGA. Having discovered a major public health problem with pharmaceutical products in January, during February, March and April all it did to protect the public from patently unsafe pharmaceutical products was:

" It cancelled Pan Pharmaceuticals license to manufacture microdose medicines including prescription medicines and products such as over-the-counter pharmaceutical folic acid medicines without telling the public or recalling the relevant medicines. The TGA did not appear to care that many women rely on high-dose pharmaceutical folic acid medicines to protect their babies from severe deformities.

" Having established there were major quality assurance problems with at least two pharmaceutical products, it tested every pharmaceutical product made by Pan.

" According to inside sources, the TGA decided against testing the natural healthcare products because that would cost too much. (So much for the natural healthcare industry's paid-up fees.)

Much media comment had suggested New Zealand needed a system such as Australia's to ensure this sort of disaster didn't happen and that products were easily traced and recalled.

We were told New Zealand needed Good Manufacturing Practice (GMP) and a register of products. Yet nearly all the New Zealand companies involved in this Australian scam already operate under GMP (voluntarily). They all have proper recall procedures in place.

And, even with the most burdensome regulatory system in the world, requiring GMP and consisting of a government-controlled central register of products and regular audits, Australia could not guarantee quality.

The TGA had audited Pan Pharmaceuticals and given it the big tick. Companies had contracted Pan because the regulator gave them the big tick.

Why did it take the TGA a week to come up with a full list of products? New Zealand, with its so-called unregulated industry under the New Zealand Food Safety Authority was only ever half a working day behind Australia in recalling products.

This sorry saga demolishes the argument that New Zealand needs a regulatory system such as Australia's to facilitate recalls. In catastrophic situations such as, this no amount of planning or regulation can work. Not when the regulator ambushes an industry sector with zero warning and sends the media and medico-centric politicians into a feeding frenzy preventing industry responding in a measured way.

The TGA has failed society and industry miserably. The TGA system was not even capable of differentiating pharmaceutical and natural healthcare products and could not differentiate registered (Aust-R high risk) and listed (Aust-L low risk) products.

The TGA had to resort to a manual, paper-based system to identify product. Every supplier had to provide via email or fax a separate document relating details of every product affected.

Many Australian companies which used Pan will be driven out of business. They cannot quickly bring to market a product from another manufacturer: regulatory approval will take a minimum of six weeks for a listed product and six months for a registered one. Each entry will cost in the region of $500 plus an equivalent consultant fee and many companies have 300-500 products.

The natural healthcare product industry pays the TGA $6 million in protection money per year, money supposedly to help guarantee the credibility of the therapeutic goods industry. Why did the TGA protect the interests of the pharmaceutical industry and not afford the natural healthcare product industry the courtesy of a phone call?

There is no evidence to show the TGA has analysed a single natural healthcare product involved in this recall and found it wanting. There was no evidence of adverse reactions to natural products. Recalling things like charcoal tablets and vitamin C tablets and suggesting that they are unsafe is absurd in the extreme.

For a problem that surfaced as a result of serious adverse reactions to pharmaceutical medicines, it is a mystery that the Australian regulators have turned that around to hammer innocent parties.

If the TGA had planned to inflict severe wounds on innocent parties it could not have planned it better.

The negative impact on the natural healthcare product industry in Australia and New Zealand is likely to be $300 million-$500 million a figure orders of magnitude more than the maximum fine a court can impose on a guilty party.

It is staggering the TGA has exercised unbridled power without notice, without affording the right to consult a lawyer, without a formal charge, a trial, right of defense or right of appeal.

Not just the alleged sinner, but an industry that is an innocent bystander is punished because it used a manufacturer approved by the regulator itself.

Even those industry players who could be regarded as friends of the TGA have opposed the notion that it dominate the proposed trans-Tasman joint regulatory agency the government and health officials are seeking. Large companies such as Blackmores, Mayne, Healtheries and Nutralife variously described TGA as restrictive, oppressive, overly prescriptive, inflexible, lacking transparency, burdensome, overly-bureaucratic, costly, excessive, and cumbersome in their submissions to New Zealand's Health Select Committee.

Few within the natural healthcare industry would disagree with the above adjectives. To this list could be added vindictive, uncontrolled, vile, despicable and even corporate terrorist.

The Australian system was supposed to guarantee the quality of product but has failed to do so. It seems that the only thing that the Australian TGA system protects Australian citizens from is the good quality imports that we enjoy in New Zealand.

Now is the time to establish an independent commission of inquiry into the wider issue of regulation of health. This would expose how the natural healthcare industry remains in bondage to regulators with motives not driven by good regulatory practice.

Industry should now pool resources, employ the best team of litigation lawyers it can find, initiate a war on corporate terrorism and run the Australian TGA out of town.

Compared with its style of democracy, totalitarianism is a cakewalk.

Ron Law, a former biochemist, advises natural healthcare product associations on industry issues and lectures in business management. He was appointed by the Director General of Health to the Sentinel Event Project working group that advised the Ministry of Health on the reporting and management of medical injury in the public health system.

_________________________________________________________

 

Pan Pharmaceuticals statement

ASX announcement

Statement made to the media by Colin Henson, April 30, 2003
http://www.panpharma.com.au/html/announcements/attach/PPH%20030430%20
Statement%20by%20Colin%20Henson.pdf

Good afternoon ladies and gentlemen. My name is Colin Henson. I am a non-executive director of Pan and chairman of the Audit Committee and I’ve been asked to speak to you today in relation to the current situation.

Mr Jim Selim is the Managing Director of Pan and is currently working with our trade partners on facilitating the TGA recall and developing the recovery plan for Pan Pharmaceuticals.

Our chairman and another director are in Canberra meeting with the TGA this afternoon. There are a few key points that I want to make:

The recall

Pan was surprised by the speed of the TGA’s actions, which have caused difficulties for our wholesalers, customers, retailers and consumers.

We need to bear in mind that Pan does not market branded products. We manufacture for wholesalers, under contract, who brand the product as their own.

Under TGA rules, there are two separate recall processes.

Firstly, Pan has been asked to recall 219 products previously test marketed as Pan’s branded products. To Pan’s knowledge, none of these products remain on retail shelves and as far as I’m aware, they are not actively marketed.

Secondly, the TGA has requested the wholesalers who market branded products to recall products identified by the TGA.

Pan is currently developing its plan to handle recalled goods and to support wholesaler reclal processes. Pan is doing everything it can to facilitate this process. And I must say, ladies and gentlemen, that Pan stands behind its products and its customers to the extreme.

Customer Safety

From a consumers’ perspective, it is important to note that no specific health risk had been identified by the TGA with the recalled products.

The TGA has identified issues with Pan’s manufacturing processes but the company is confident that there is no threat to human health from these products. And it is worth noting that apart from the Travacalm product the TGA has not identified any specific incidents.

Any mention of allergic reactions and other possible health risks are pure speculation and please note both the Parliamentary Secretary and the TGA talk about ‘could’, rather than ‘have’, caused health problems.

The product Travacalm which the TGA had identified as causing problems for some consumers, had been dealt with previously in a recall in February 2003.

The current recall predominately affects products listed as AUST L, or low risk products, with the TGA.

Pan and its predecessors have been a manufacturer of complementary medicines for 29 years. Prior to the latest audit, the company’s manufacturing processes have been regularly audited by the TGA and have consistently been found to meet TGA standards.

The cause of the problem

The TGA has identified a number of issues with Pan’s quality control procedures. Some of these are a result of human error, others may be the result of quality system breakdown.

One staff member has been dismissed as a result of the Travacalm incident and another senior staff member is assisting the company with its investigations.

The TGA report is substantial, Pan is working through each of the issues raised by the TGA and I should add there, that the reason why we are standing here today rather than yesterday or the day before to speak to you in relation to this matter is because of the volume of information provided to us by the TGA on Monday afternoon which requires a careful review and verification.

The future of Pan

Pan will be presenting a plan to the TGA to address the issues identified in its audit and demonstrate how quality assured manufacturing can recommence at the earliest possible opportunity.

The TGA has advised Pan that satisfaction of TGA requirements could lead to the suspension being lifted at any time.

We are doing our best to hold onto our staff. Casual staff have been asked to take leave but our permanent staff are busy working on the recovery plan. And once again, as I’ve said in other places that Pan is conscious of the loyalty that the staff have given to the company over many, many years and the assurance to the staff is that that loyalty will be reciprocated.

Ladies and gentlemen I’ll close there with one final statement and that is that the Board and senior management believe that there is a future for Pan.

Thankyou.


 

TGA Skeletons, WHO Privatised the Regulator?
A three Part Feature Article on who was behind the world’s largest recall. 

May 12, 2003 
by Eve Hillary
http://www.evehillary.org/who.privatised.tga.htm