The TGA (Therapeutic Goods Administration) is the Australian “regulator” of drugs, chemicals, medical devices and nutritional supplements and herbs which it calls “complementary medicines”. The TGA is a statutory body, created by an act of Parliament over 27 years ago. Its motto is “to ensure the safety of all Australians”.
A new study, which focused on the secrecy surrounding regulatory authorities throughout the world, has found that Australia’s TGA, unlike the US Food and Drug Administration, does not release any information arising from the evaluation of new drugs for market. Click here for the full story. The regulator has a reputation for being the most hard-line in the world and in fact, as the facts below will demonstrate, it is a rogue regulator that accepts no responsibility or accountability for its actions.
Skeletons in the Closet of the TGA
1: Hiding Public Information: Most recently the TGA is developing new rules for weight-loss products, many of which are natural products. Many submissions have been made from professional and consumer groups on this issue. Despite demands to release the information for public viewing the TGA is withholding information that other regulators would make available. This is in keeping with TGA's culture of secrecy and arrogance that it has no accountability to anyone, not even the public it purports to be protecting.
One has to ask, what is it they are hiding and or protecting by not allowing public scrutiny? The other serious question for Australians is do they really want a regulator that behaves in such and mistrustful manner?
2: Illegal Recall of Natural Products: No single event in the history of the TGA can best demonstrate its rogue behaviour and flagrant disregard for the natural health industry, than what has been called the "Pan Debacle".
Pan Pharmaceuticals was a privately owned company, and a relatively big player that manufactured most of Australian, and a portion of the world market, natural supplement products.
In 2003 the TGA withdrew Pan Pharmaceuticals license to manufacture on the grounds that the company’s travel sickness product had a faulty batch. Pan had already voluntarily recalled Travacalm and was addressing the problem as was customary in the industry. However, the TGA immediately forced Pan to shut down and within a few days instigated a class 1 recall “can cause death or permanent injury” of all vitamin supplements produced by Pan even though it was the pharmaceutical drug, Travelcalm that they had issue with. NOT ONE OF THE NATURAL PRODUCTS WAS EVER TESTED BY THE TGA FOR PROBLEMS INVOLVING PUBLIC SAFETY.
After the TGA disposed of Pan, it systematically ran through other small Australian vitamin and supplement manufacturers in a frenzy of “inspections” and “regulatory activities” provoking a tremendous amount of fear in the industry.
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 - which the businesses have to pay for.) 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.
In April 2007 the NSW Supreme Court found Jim Selim innocent of charges laid against him stating the TGA raid was illegal. Mr Selim filed a civil law suite and subsequently was awarded $55m in damages and legal fees in 2008. A Class Action Suite has now been filed against them to the tune of a quarter of a billion dollars. Details of this story can be found at this link.
During the process of the court case it was revealed that the TGA had destroyed key documents and evidence of their misdeeds. Clearly a government agency with a lot to hide.
Strangely enough, there is to be no inquiry into the TGA's illegal actions or why the taxpayer is now having to bail the rogue regulator out with such a large pay out. There is no outcry by the Australian people and natural health practitioners and manufactures remain terrified of speaking out about what is happening to them. NOT ONE TGA OFFICIAL HAS BEEN HELD ACCOUNTABLE. NOT ONE INQUIRY HAS BEEN MADE INTO THE TGA AND ITS SUBSEQUENT ACTIONS.
Health Freedom New Zealand are relieved we were able to stop our Government from going into partnership with this criminally negligent organisation whose officials would have made up the majority of the trans-Tasman agency ANZTPA.
3: Changing the Rules Frequently: Small Australian-owned supplement manufacturers allege the TGA use a variety of intimidating methods against them including the halting of manufacturing operations and near impossible requirements that can cost over $500,000 to implement. Ingredients allowed to be used in products are swapped from one list to another with no real scientific validity behind it. It seems the TGA can get a way with whatever it wants, and so it does.
The 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”.
Australian supplement companies remain silent after TGA’s “inspections”. Many are bound by agreements and none want their names revealed for fear of a fresh round of “TGA regulatory activities”.
Few questions are being asked in Australia about the role of the Therapeutic Goods Administration, which is now entirely funded by fees from drug companies.
One wonders what these type of terror tactics have to do with ensuring the safety of Australians?
4: The Vioxx Scandal: In contrast the TGA never conducted any trails on adverse reactions to Merk & Co's drug Vioxx when it was known that the medication could increase the risk of heart attacks and strokes. The link to cardiovascular problems first appeared in a study conducted in 2000.
However, for four years the TGA and FDA in the United States did nothing to limit its use, instead accepting its American manufacturer's suggestion that the increased risk could be due to something other than Vioxx. Vioxx has now killed an estimated 60,000 people worldwide and injured over 150,000. The manufacturer has now had 100 and more civil lawsuits against it with a payout of over five billion dollars in damages to families affected by the scandal. The full story can be read at this link.
The TGA have responded to all these deaths by drugs with TGA Amendment Bill 303150, 2005. This will allow for a 5 year jail sentence for anyone in Australia caught using (or importing from overseas) a vitamin, mineral, protein or supplement that the TGA does not approve of.
This Bill further restricts and tightens access to supplements while allowing free and clear passage of killer drugs to enter the market. The new penalties will be so prohibitive that it will be almost impossible to bring to market any herbal remedy or supplement unless it is backed by million dollar trials, and even then it will be swept under the carpet.
Possessing a pound of marijuana or being convicted of armed robbery, gets a lighter prison sentence than being caught selling a pound of prohibited Laetrile (vitamin B17) or Red Yeast Rice extract, just to name a few of the natural therapies banned to protect the drug companies monopoly on the disease market.
Merk & Co, on the other hand, unlike Pan, have not been shut down, it took 4 years to withdraw the product from the Market which they did themselves without prompting from any regulator, after profiting billions of dollars. Now they are selling their cervical cancer vaccine Gardasil with little evidence it prevents cervical cancer, but much evidence that it could kill you. In the first four months of it going to market 18 deaths have been attributed to the vaccine and hundreds of adverse side effects.
5: More Concern for Profit than Safety: The TGA approved Gardisil for 12 and 13 year olds in the first year of secondary school, along with a catch-up program for women up to 26. Since then more than 17 girls a week have been experiencing adverse reactions (in Australia alone) such as seizures and numbness after taking the vaccine. The Daily Telegraph revealed that as of November 30 2008 there had been 496 adverse reaction reports filed to the TGA.
About a month after 13-year-old Jenny Tetlock missed the lowest hurdle in gym class, the first hint of the degenerative muscle disease that, 15 months later, has left the previously healthy teenager nearly completely paralyzed. Her father, Philip Tetlock, a psychology professor at UC-Berkeley's Haas School of Business, has embarked on an odyssey to find out whether the vaccine or random coincidence is to blame.
When Gardasil was released inventor, former Australian of the Year Professor Ian Frazer, urged parents to vaccinate their daughters to prevent them getting cervical cancer. He later was quoted as saying "It would be a pity if that opportunity was lost because of fainting".
Dr Rohan Hammett, TGA acting national manager said the safety of Gardasil was being monitored by bodies in Australia and overseas with more than 10 million doses distributed worldwide to date. He added the rate of adverse reactions was consistent with those expected with any vaccine.
So no cause for alarm then. These adverse side-effects were nothing the drug companies and the TGA didn't expect, however failed to warn the general public about it. Apparently some peoples lives are expendable as long as others are saved, a paradigm of thinking prevalent in orthodox medicine but abhorrent to this organisation.
6: Blatant Discrimination: Finally if you're not convinced there is a conflict of interest of monumental proportions occurring in the dual roles of the TGA regulating pharmaceutical drugs and complimentary medicines (what we in NZ call natural products). We'll leave you with this final, simple point:
The TGA requires warning labels on natural iron supplements to say “Warning: not for the use of iron deficiency” but does not require the same warning for Ferrogradumet, the pharmaceutical iron tablet.
Why is it that pharmaceutical drugs are the third biggest killer of Australians but in the interest of public safety, natural health supplements are more rigorously policed by the TGA?
Australia's drug evaluation and approval process is now wholly reliant on the drug industry for its funding.
Whoever pays the piper plays the tune. It's difficult to understand how the process can be totally open and transparent if the pharmaceutical industry are paying the salaries of those who regulate them?
What is the Australian Government Doing About the TGA's Criminal Behaviour?
The Australian Government does not seem interested in inquiring into the systemic discrimination of the TGA. They are withdrawing funding for the Adverse Drug Reactions Hotline. Apparently the TGA, the Commonwealth government, and drug companies, just cannot find the money to support those who suffer adverse drug reactions. Closure of a valuable public health watchdog comes at a time when more and more people are suffering adverse drug reactions.
The Daily Telegraph on the 9th July 2007 had an article entitled "Drug Hotline Out of Funds" which underlined the priorities of the Australian government, currently spending millions of dollars taking control of the natural products industry. The amount of money they have spent on the trans-Tasman agency ANZTPA so far is $11million dollars.
Thousands of people die every year in Australia from the TGA's legally approved drugs. It is now the third leading cause of death in Australia. There is no proposed legislation to tighten regulations on the pharmaceutical companies that make them. However, there is grave concern for the public safety of people taking Glucosamine and there are plans to tighten regulations on natural products.
The TGA in Summary
The TGA is like a relentless locomotive train that storms certainty down its track steamrolling any and all opposition in its way advancing the pharmaceutical agenda to wipe out it's competition and dominate the health industry with monocromatic solutions to any and all diseases, including ones it invents.
It is the opinion of this organisation that Health Freedom will never prevail in Australia until the TGA is completely dismantled and two new and separate agencies replace it. One for the sensible regulation of natural products that represent the true nature of risk associated with such products, and one that stringently regulates the pharmaceutical drug industry. It has never made sense to Health Freedom NZ that one regulator gets to regulate two competing industries under the same roof. Conflict of interest is obviously going to occur as has so clearly been demonstrated by Australia's TGA.
More on TGA Skeletons - Who Privatised the Regulator by Eve Hillary.