Monday, July 06, 2009

Slimming pill is investigated over 'links to liver damage'

This is pretty absurd. If you have got a million people taking something, of course some of them will get ill -- from other causes. And only ONE of the deaths involved liver damage. Drawing any conclusion from that is a statistical absurdity

A slimming pill that triggered massive sales when it was launched earlier this year is being investigated amid fears it is linked to liver damage. Alli, which blocks the absorption of fat in the gut, is the first diet pill of its kind to be available without prescription. Its main ingredient is the drug orlistat. But now the US medicine watchdog, the Food and Drug Administration (FDA), is investigating a series of alerts from patients who developed problems while taking orlistat.

The UK drugs regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has also received 31 reports of side effects linked to orlistat since Alli was launched in April. But it was not able to say if those were from patients taking Alli or the stronger pill Xenical – which also contains orlistat but is available only on prescription.

Since Xenical became available in 2001, 24 patients taking it have died, one of liver failure and the others from heart attacks, gall bladder inflammation, multi-organ failure and lung clots. There were also five cases of sudden death where the cause was unclear. In total, the MHRA has received 1,252 reports from patients of potential side effects from Xenical, including heart problems, gastrointestinal issues and skin complaints. Nearly 100 were connected with liver problems.

On the day Alli was launched in the UK, £1million worth of pills were sold. But it has already provoked controversy. Manufacturer GlaxoSmithKline (GSK) claims it can boost weight loss by up to 50 per cent, helping dieters lose an extra 1lb for every 2lb shed. The treatment is supposed to be taken by people with a body mass index of more than 28, but there have been claims that pharmacists are flouting the rules and giving it to women who are much slimmer. The FDA can ban the sale of drugs and can also order changes to labelling or prescription guidance. While any of its rulings are not automatically adopted in the UK, the European Medicines Agency, which licenses orlistat in the UK, works closely with the FDA.

A spokesman for the FDA said: ‘We have received rare reports of hepatitis and other liver-related laboratory abnormalities in people taking orlistat. The FDA is closely monitoring this issue to determine the need for any regulatory action.’

GSK said the safety of consumers was of ‘utmost importance’ to the company and that it supplied all information about adverse effects to Government drugs bodies. A spokeswoman said: ‘Alli has been used by millions of consumers in the US. The safety and efficacy profile of orlistat is well documented and has been established through data from more than 100 clinical studies involving more than 30,000 patients worldwide.’

A spokeswoman for Roche, which manufactures Xenical, said the company took patient safety issues very seriously. She added: ‘There is no evidence of a link between Xenical and liver toxicity.’


Men rejoice as research suggests beer bellies caused by genetics - not by the booze

Beer lovers across Britain will be raising a glass to the latest research on drinking. For scientists have discovered that the so-called 'beer belly' is not caused by consuming alcohol – but more to do with genetics. A study of thousands of beer drinkers found that although people who drink regularly are more likely to put on weight, they do not necessarily accumulate fat around the abdomen.

Researchers monitored more than 20,000 people – 7,876 men and 12,749 women – over an average of eight-and-a-half years. Men who were classed as the heaviest drinkers – regularly consuming two pints of beer a day – put on the most weight. But when the researchers then measured hip-to-waist ratios to establish which drinkers developed a pot belly, the results were randomly spread across all drinking groups.

The scientists concluded that genetic factors dictating how people put on weight were more significant than drinking beer. However, they insist that their findings do not mean that drinking should be encouraged, and recommend giving up alcohol completely to avoid gaining weight.

In the study they measured participants' weight, waist and hip circumference at the start and then asked them to document their measurements regularly themselves. The results were adjusted for variables including illness, the menopause, dieting and smoking. The men most likely to put on weight were those who drank the most and also those who drank no beer at all.

Light drinkers saw the least variation in their waist size. For women, drinking more beer was more directly associated with piling on the pounds. But for all the categories, drinking beer led to overall weight gain on both the waist and the hips, and did not necessarily lead to a beer belly. The study stated: 'This analysis showed the empirical basis for the common belief of a beer belly, as we found that beer drinking and waist circumference were positively associated. 'However, our data provided only limited evidence for a site-specific effect of beer drinking on waist circumference, and beer consumption seems to be rather associated with an increase in overall body fatness.

'In terms of public health relevance, it may be therefore important to focus on beer abstention to maintain body weight. 'In terms of the beer belly belief, an explanation could be that all the observed beer bellies in the population result from the natural variation in fat patterning and not from the fact of drinking beer.'

The study, which was carried out by German and Swedish researchers, was published in the European Journal of Clinical Nutrition. Beer contains no fat and, measure for measure, has fewer calories than wine. A pint of beer contains about 200 calories, whereas the same volume of wine contains nearly 400.


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