Wednesday, January 21, 2009

Arrogant Therapeutic Goods Administration still refusing to cough up for its wrongful actions

The TGA is Australia's version of the FDA. They think that they can get away with destroying hundreds of businesses and creating huge financial losses on the basis of mere speculation. One of the grosser examples of bureaucratic irresponsibility and abuse of power. They are all the more hateful because they have settled with the "big" guy whom they hurt but now seem to think they can stiff all the the little guys by insisting on long drawn out and expensive court action. I have commented on the scum previously. Note that I am no fan of "alternative" medicine. As you can see here I think that there is too much quackery even in conventional medicine. But my attachment to the importance of evidence is obviously not shared by the TGA and the bitches who seem to run it -- depite scrutiny of evidence being their brief

PHIL Alexander has turned to the law for help five years after it was used against his naturopath business in the country's biggest medicines recall. He has become part of a $120 million class action against the commonwealth over its role in the collapse of Pan Pharmaceuticals, which once supplied his multivitamin business. "It was an incredibly harrowing experience," Mr Alexander said, recalling the 12,000 items of stock he was forced to destroy in the recall.

He even received death threats as frightened customers turned against him and bad publicity swamped his sales. "The odd father rang up and said 'If you kill my baby, I'll kill you'," Mr Alexander said.

In 2003, the Therapeutic Goods Administration suspended Pan's licence and progressively recalled 1600 of its products. The TGA accused Australia's then largest complementary medicine maker of substituting ingredients, manipulating test results and running sub-standard production lines after a Pan travel sickness drug was linked to 19 admissions to hospital.

But the decisions the authority made at the time were brought into serious question last year after the commonwealth settled with Pan founder Jim Selim for $55 million over the TGA's handling of the affair.

Now Mr Alexander wants redress, saying his once-thriving Sydney business has never recovered from the TGA's actions. "They pulled all the vitamins and minerals off the shelves, without cause," he said. "After 14 weeks, we were able to get stock made and get it back on the shelves, but of course over 30 per cent of our customers wouldn't come back."

Mr Alexander said the TGA had acted on an "ideological and regulatory whim" in ordering such a massive recall. He said Pan had passed a TGA audit not long before, and no complaints were made or illnesses recorded from the recalled products.

Mr Alexander said he first learned of his business's fate on the 6pm news one Monday in April 2003. "All hell broke loose, and the next day the phones went absolutely mad for 14 days. We spent months returning all the calls. It was bedlam, it was just insane," he said. The TGA refused to even test his multivitamins for contamination, despite ordering the destruction of his stock, Mr Alexander said.

A Health Department spokeswoman said yesterday the TGA was unable to comment because the case was before the courts. But the regulator has publicly refused to concede any of the allegations made in Mr Selim's lawsuit.

Susanna Khouri, investment manager with IMF Australia, which is funding the lawsuit, said Mr Alexander's story of lost revenue and emotional harm was repeated many times over.


Court challenge to NICE over osteoporosis treatment

Typical NHS short-sightedness. They pennypinch on drugs and as a result spend thousands dealing with avoidable fractures

The medicine regulator faces a legal challenge this week over its ruling that thousands of women with thinning bones should be denied effective treatment on the NHS. Draft guidance from the National Institute for Health and Clinical Excellence (NICE) states that doctors should prescribe the cheapest drug available to women with the early signs of osteoporosis, even though up to one in five patients cannot take it. The National Osteoporosis Society and the drug manufacturer Servier say that this is unethical and will do nothing to prevent fragility fractures that contribute to 13,000 premature deaths a year, as well as causing widespread disability and pain.

They will contest the NICE guidance in the High Court, as part of a full judicial review, claiming that the watchdog has not been transparent about its processes and is infringing the human rights of patients by denying them alternative medication on the ground of disability. NICE denies that it has acted illegally. But in a letter to The Times last September, 40 experts called on the watchdog to reconsider its decision, calling it "unethical and short-sighted".

Half of women and one in five men over the age of 50 will develop osteoporosis, in which the spine, wrist and hips become thin and fracture easily. While bone-strengthening drugs are available, the side-effects of alendronate, which costs 50 pounds a year, include crippling stomach pains and indigestion, while the medication is difficult to take - requiring patients to stand or sit for 30 minutes while it is absorbed. The guidelines mean that a woman in her early seventies who cannot tolerate alendronate would have to get up to 60 per cent worse - using a clinical scoring system - to qualify for strontium ranelate, an alternative medication that costs 17 pounds a month.

Nick Rijke, a spokesman for the National Osteoporosis Society, said: "Already there are more than 70,000 hip fractures a year which result in 13,000 deaths and cost the public purse 2.3 billion. "Yet with effective treatment, many of these fractures could be prevented, not only saving lives, but saving the taxpayer money at the same time."

Andrew Dillon, the chief executive of NICE, said that the recommendations on osteoporosis had been "a complex set of guidance to produce", but added that he was confident that NICE had acted lawfully and that the claim would be dismissed.


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