Friday, August 15, 2008

Vengeful Australian drugs regulator costs taxpayers $55 million

The TGA does not like alternative medicines generally and they were particularly cheesed with this guy because they had lost previous legal battles with him. So they used faults in a few of his products as an excuse to shut down his entire business -- even though there was no evidence of problems with over 200 other products. The fact that they had been too lazy to do any inspections in response to earlier complaints would also have counted against the TGA. The big damages payout is clear evidence that the TGA is a typical bureaucracy: At once lazy and irresponsible in the use of its powers. Since they control all access to drugs in Australia, new and less capricious management for them would seem urgent

The former chief executive of Pan Pharmaceuticals will get $55 million in compensation from the Commonwealth government, after the Federal Court found a government agency had been negligent. Jim Selim was the chief executive of Pan Pharmaceuticals, which went into liquidation in 2005, owing some $180 million after faulty batches of its travel sickness remedy Travacalm resulted in at least 87 adverse reactions and 19 hospitalisations. Symptoms included psychotic episodes, hallucinations and blackouts.

The Therapeutic Goods Administration (TGA) suspended Pan's licence and ordered the immediate withdrawal of 219 of its products. After Pan pleaded guilty to 24 charges relating to defective medication, Mr Selim launched legal action, claiming the TGA had pursued a vendetta against him and Pan.

Today, Justice Arthur Emmett congratulated legal counsel for reaching a settlement in a case he said could have continued for several more weeks. "I see no reason why the court shouldn't act in accordance with the wishes of the parties,'' Judge Emmett said. He made an order confirming the settlement, which will see $50 million compensation paid by the Commonwealth to Mr Selim and an extra $5 million for legal costs, to be paid within 28 days.

Outside the court, Mr Selim said he was thankful for the result but he was still waiting for a public apology from the TGA for its actions, which he said had come at great personal cost to himself.

Source. More background here

The Pill may put you off smell of your man and ruin your relationship. An update

To millions of women it has been the great liberator over the past four decades, allowing them the freedom to control their fertility and their relationships. But the contraceptive Pill could also be responsible for skewing their hormones and attracting them to the "wrong" partner. A study by British scientists suggests that taking the Pill can change a woman's taste in men - to those who are genetically less compatible.

The research found that the Pill can alter the type of male scent that women find most attractive, which may in turn affect the kind of men they choose as partners. It suggests that the popular form of contraception - used by a quarter of British women aged between 16 and 50 - could have implications for fertility and relationship breakdowns.

The findings, from a team at the University of Liverpool, add to growing evidence that the hormones in the Pill influence the way that women assess male sexual attractiveness. The Pill is thought to disrupt an instinctive mechanism that brings together people with complementary genes and immune systems. Such a couple, by passing on a wide-ranging set of immune system genes, increase their chances of having a healthy child that is not vulnerable to infection. Couples with different genes are also less likely to experience fertility problems or miscarriages. Experts believe that women are naturally attracted to men with immune system genes different to their own because of their smell.

Commenting on the latest study, the researchers said that it could indicate that the Pill disrupts women's ability to judge the genetic compatibility of men by means of their smell. They said that this might not only impact on fertility and miscarriage risk, but could even contribute to the end of relationships as women who stop or start taking the Pill no longer find their boyfriend or husband so attractive.

Several previous studies have suggested that women tend to prefer the smell of men who are different from them in a cluster of genes called the major histocompatibility complex (MHC), which governs the immune system. Some of these studies have also found that this effect is not seen among Pill users.

The latest study, published in the journal Proceedings of the Royal Society, has now assessed the impact of Pill use in the same women, both before and after they began using oral contraception. A group of 97 women was tested, some of whom started taking the Pill during the course of the research. All had their MHC genes tested and were asked to sniff T-shirts worn in bed by men with different patterns of MHC genes.

Unlike some previous studies, the research did not find any preference for dissimilar MHC genes. However, when the women started taking the Pill their preferences shifted towards the scent of men with more similar genes to their own. This suggests that Pill use has an effect on perceptions of scent attractiveness, even if there is no underlying female preference for similar or dissimilar MHC genes.

Craig Roberts, who led the study, said: "The results showed that the preferences of women who began using the Pill shifted towards men with genetically similar odours. Not only could MHC-similarity in couples lead to fertility problems, but it could ultimately lead to the breakdown of relationships when women stop using the Pill, as odour perception plays a significant role in maintaining attraction to partners."

The research also found differences between women in relationships, who tended to prefer odours of men with different MHC genes, and single women, who tended to prefer the smell of MHC-similar men. This could potentially indicate that if women are tempted to have an affair, they are more likely to choose a man with very different genes, to maximise the diversity of any offspring that they might have.

The scientists said that more work was needed to explain the way various studies have obtained different results on whether women naturally prefer men with different or similar MHC genes. They also cautioned that the importance of scent in human mating preferences remains uncertain.

The research backs up an earlier study of how women's perceptions of partners can alter when taking the Pill. Psychologists from St Andrews and Stirling universities found that women on the Pill tend to prefer macho types with strong jaw lines and prominent cheekbones. However, women who are not taking that form of contraception seem to be more likely to go for more sensitive types of men without traditionally masculine features.


Improved IVF process

A couple have become the first in Britain to have a baby using a new fertility technique, after seven years of trying to become parents. Evie Bloomer was conceived using vitrification - a method of embryo storage that has a higher success rate than the standard slow-freezing process. Her parents, Ian and Rebecca, from Cwmbran, South Wales, have been trying for a baby since marrying in 2001. Mrs Bloomer, 28, suffers endometriosis, a condition in which womb tissue grows elsewhere in the abdomen.

Evie's birth is a landmark because vitrification could deliver substantial improvements in fertility treatment. Embryo freezing allows parents to store surplus embryos should the first cycle fail, or to try for further children later on. The first such baby was born in the United States in 1984 and thousands have since been born in Britain.

But only 50-80 per cent of frozen embryos survive the thawing process because of ice crystals, which can cause fatal damage. Vitrification is an improved method by which embryos are flash-frozen in liquid nitrogen, together with an antifreeze. Around 98 per cent of embryos frozen this way survive thawing. Lyndon Miles, head of embryology and andrology at IVF Wales, who treated the Bloomers, said that a vitrification programme started in August last year was already delivering very promising results. Of 39 couples treated so far, 17 have had a pregnancy and the success rate of 43.5 per cent is more than double the 21 per cent that the clinic has achieved with slow-frozen embryos.

Dr Miles said wider use of vitrification could help the Human Fertilisation and Embryology Authority to persuade more couples to use just one embryo in IVF treatment, potentially cutting the multiple birthrate from one in four to one in ten. "If you are going to have single embryo transfer, your embryo freezing programme has to be very good so you have embryos available as a back-up," he said.

"Though this is a new technique for the UK, early results and publications in Japan and the USA have been extremely encouraging. The first published study on babies born from vitrification shows no adverse effects and there are no implications to Evie's health as a result of the process."


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