Lots more nasty side-effects of statins now acknowledged

New health warnings are to be issued over popular cholesterol-lowering drugs after evidence that thousands of users suffer side effects such as depression and sexual problems. More than six million adults who are prescribed statins by their GPs will be told about five new 'undesirable effects' in leaflets issued with packets of the drugs. These are sleep disturbances, memory loss, sexual dysfunction, depression and a rare lung disease that can kill if left untreated.

But some doctors have criticised delays by the Government's drug safety watchdog, the Medicines and Healthcare products Regulatory Agency. The MHRA signalled the need for updated warnings in February last year but disagreements about the wording have held up the changes.

Dr Ike Iheanacho, editor of the Drug and Therapeutics Bulletin which conducts independent reviews of evidence on drugs, said most patients and doctors were unaware of the newly identified problems. But he stressed that patients should not stop taking statins, which are credited with saving 10,000 lives a year by the British Heart Foundation. Dr Iheanacho said: 'Statins are of unquestioned value in the prevention of cardiovascular events and are used by increasing numbers of people. 'However, when new data emerges on their unwanted effects, it is crucial that they are incorporated into the product information.'

A review of studies by the MHRA in February 2008 concluded there was enough evidence from clinical trials and patient reports to identify the new problems as a 'class effect'. This means all statins may trigger the problems. It found up to 12 per cent of patients taking part in one clinical trial suffered sleep disturbances such as insomnia, while 11 per cent of users in the same trial had depression and three per cent some level of memory loss.

Another study suggested 12 per cent of statin patients had erectile dysfunction. Overall, there was a much lower rate of side effects but, given the huge number of users, this would add up to thousands of patients being affected. Very rarely statins may lead to interstital lung disease, which can cause respiratory failure if untreated.

Dr Iheanacho, in the latest issue of the Drug and Therapeutics Bulletin, said his inquiries showed the delay in updating leaflets was caused by one of the drug companies disagreeing with the proposed wording. 'This situation is unacceptable,' he added.

A spokesman for the MHRA said the time frame for the new leaflets would depend on 'movement in the supply chain' for the drugs. She said: 'Once the MHRA approves a new leaflet the company has three months to print and use it.'

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Are date rape spiked drinks an urban myth?

Last week, academics concluded that women who claim they've been drugged and raped were usually just drunk...

When she recalls the night she went off with a stranger, Daniella swears blind someone slipped something into her drink. How else could a man she never met before have managed to get the 29-year-old legal secretary from the nightclub in Bradford where they met, into his car? How to explain the memories that still haunt her - shameful images of herself, partially clothed, writhing around on the back seat? 'I'm pretty certain we didn't have sex. I think I'd have known,' she says, 'But it's all a bit blurred. I'm also not sure what did happen.'

But she is certain that she would not have consented to whatever happened. And she blames her inability to say no, or to struggle, on whatever it was the man put in her drink. 'I've been drunk before and it didn't feel anything like this,' she says. 'I felt really nauseous and confused. He bought me a couple of drinks from the bar while I was dancing, so he had plenty of opportunity to put something in them.' Heaven forbid that it could have been the drink itself.

The truth of what really happened will never be known. Daniella never reported the incident and was never tested for signs of the Rohypnol she believes she was given. And despite the sickening events she recounts, the cold scientific reality is that while fear of drink spiking is still rife among women, experts claim it hardly ever happens in practice.

A toxicology expert from the Forensic Science Service, which analyses evidence for the police, told the Mail he had come across only one sample of blood or urine containing Rohypnol - the most commonly talked about 'date-rape' drug - in the past decade. 'The reality is drink spiking is very, very rare', said senior forensic scientist Michael Scott-Ham. 'Alcohol itself is the problem.'

A controversial study, published last week, claimed drink spiking is an 'urban myth', a modern scapegoat for a generation of women who cannot face the fact that the vast amounts of alcohol many are imbibing could be in any way responsible for a loss of control, which can have devastating consequences.

'Something very curious is going on,' says Dr Adam Burgess, who spent a year researching the issue at the University of Kent's school of social policy for a project funded by the British Academy. 'How can you account for this great big gap between lack of any evidence for drink spiking and what so many women believe is going on? 'There's a displacement exercise going on here. Why, despite all the evidence, do women so readily blame the spiker rather than the amount of alcohol they are drinking? That is the real issue here.' ...

Could it be that women instinctively feel that if they admit to themselves how much they had drunk they would also be admitting they were somehow to blame for putting themselves at risk? Believing your drink was spiked transfers the blame to a malevolent, external force, something which women have no control over. It shifts responsibility.

Alcohol expert Robin Touquet, Professor of Emergency Medicine at Imperial College, London, points out: 'Women are demonising so- called drink spiking rather than facing up to the fact that drinking too much alcohol can put them in a highly dangerous situation. 'Most of the time, drink spiking does not happen. It always comes down to booze. 'Alcohol is a drug and in excess it adversely affects every system in the body. The message to women is: "Don't make yourself vulnerable."'

Forensic scientist Michael Scott-Ham agrees: 'The biggest problem is that a lot of people get very drunk very quickly and sometimes they are taken advantage of in this situation...

Another pivotal study offers further evidence that alcohol is the drug to be guarded against. The study, conducted by the Forensic Science Service in 2005, examined 1,014 cases of 'drug facilitated sexual assault' by analysing blood and urine samples from victims gathered by police forces in England and Wales. In only 21 - about 2 per cent - were traces of drugs found that the women had not taken voluntarily.

These included Ecstasy, gammahydroxybutyrate (GHB) and tranquillisers. Alcohol was picked up in 46 per cent of cases. Illegal drugs such as cannabis and cocaine were in 34 per cent of cases....

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