Wednesday, April 11, 2012

Why don't GPS warn you that statins can harm your memory?

This would appear to be part of a slowly-growing general awareness of the toxicity of statins.  The cure may be worse than the disease if all effects are taken into account

The side effects probably show up rarely in clinical trials because of therapeutic non-compliance.  People made ill by the drugs discontinue or cut down taking them but out of embarrassment don't admit it as they know that getting into a clinical trial is a big deal

John Holliday had been on a higher 40mg dose of cholesterol pills for only a few weeks when he started to lose his concentration.  ‘I’d be watching TV and suddenly find myself unable to follow the plot of a drama,’ says John, 52, a telecoms project manager who lives in Southend-on-Sea, Essex, with his wife Jill, 51, and their two children Adam, 20, and Emma, 16.  ‘I’d have to read the same page of a book over and over because I couldn’t take any information in.

‘I’d always been known for my amazing memory — I was great on trivia and had total recall of events that happened 20 years ago, but suddenly I couldn’t remember things and my brain felt fuzzy.’

Just like up to seven million other people in Britain, John had been prescribed a statin to lower his blood cholesterol levels.     The drugs are credited by the British Heart Foundation as contributing towards the dramatic 50 per cent fall in deaths from heart attacks in the past ten years.

But while there is consensus that statins are lifesavers for people who have previously had a heart attack, concern is growing over their debilitating side-effects.  They include muscle weakness, depression, sleep disturbance, sexual dysfunction, muscle pain and damage, gastro-intestinal problems, headaches, joint pains and nausea.

Now, official bodies here and in the U.S. have ordered that the drugs must carry warnings for cognitive problems, too. Worryingly, it’s claimed GPs are failing to warn patients of the effect statins can have on the mind — meaning they may mistake them for signs of ageing or Alzheimer’s.

‘When I went back to my doctor after six weeks for a blood test, I told him how dreadful I was feeling,’ says John.  ‘But he just said all drugs had side-effects and didn’t mention reducing the dose.’

Things came to a head when a friend showed John an electrical circuit he’d built for his car. ‘I’d worked with circuits since I was 16 but it made no sense,’ he says.

So John insisted on seeing his doctor again and repeated his concerns about his rapidly declining memory. This time the GP told him he could start on another type of statin when he felt well enough, and so John stopped taking the drugs immediately.

‘It took a few months, but gradually my memory returned and I’ve got my concentration back. I can’t say for sure statins caused these problems, but it seems like too much of a coincidence.’

Earlier this year, the Food and Drug Administration (FDA) in the U.S. ordered statins must carry warnings that some users have reported cognitive problems including memory loss, forgetfulness and confusion.  This followed a decision by the UK’s Medicines Healthcare Regulatory Agency (MHRA) to add memory problems to the list of  possible statin side-effects in late 2009.

The FDA said reports about the symptoms were from across all statin products and age groups. Those affected reported feeling fuzzy or unfocused in their thought process — though these were found to be rare and reversible.  The FDA also warned, following U.S. research, that patients on statins had a small excess risk of developing Type 2 diabetes — but stressed that the benefits of taking a statin still outweigh this.

The MHRA had 2,675 reports for adverse drug reactions connected with statins between 2007 and 2011.

Officially, side-effects are rare —affecting only 1 per cent of people on the pills — but some doctors say they are under-reported.  Dr Malcolm Kendrick, a GP and author of The Great Cholesterol Con, says he frequently sees patients suffering from mental confusion in his job in hospital intermediary care for the elderly.  ‘Many of the patients I see will have been admitted to hospital after a fall or similar crisis,’ he says.

‘If they appear confused I’ll often advise taking them off statins to see if it has any effect — in my experience, about 10 to 15 per cent of people who appeared to have memory problems experienced an improvement in their memory symptoms after being taken off the drug.  ‘I had one dramatic case where a lady was admitted to hospital on 40mg a day of simvastatin with such poor memory function her family asked me about power of attorney.

'I suggested taking her off statins and within a week her memory had returned to normal. She went home a fit and independent 83-year-old.’

Dr Kendrick says cholesterol is the main constituent of synapses (structures that allow signals to pass between brain cells and to create new memories) and is essential for brain function.

‘It is still not proven that statins have a significant effect on mortality — it has been calculated that a man who has had a heart attack who took a statin for five years would extend his life by only 14 days.

'Too many statins are being given to people at low risk.  ‘Even in the highest risk group you need to treat 200 people a year with statins to delay just one death.  'One day the harm these drugs are doing is going to be obvious — the benefits are being over-hyped and the risks swept under the carpet.’

While Dr Kendrick’s controversial view is in the minority, one large review of 14 studies by the London School of Hygiene and Tropical Medicine, published by the highly respected Cochrane Library last year, concluded there was ‘little evidence’ cholesterol-lowering drugs protect people who are not at risk of heart disease.

This review has been criticised by other doctors who say side-effects are rare and that there are still benefits even for people at lower risk who do not have established heart disease.

These defenders of statins include Professor Colin Baigent of the Clinical Trial Service at Oxford University, who published research in 2010 showing statins reduced deaths from all causes by 10 per cent over five years.

‘There is relatively little evidence of cognitive impairment — what evidence there is all comes from observational studies.  ‘People read about side-effects and then put two and two together and blame the statins for their muscle pain or other health problems — it’s just not reliable evidence.

‘If you look at the best-quality randomised controlled trial where patients don’t know if they are taking a statin or placebo, there is no evidence of memory problems.  'Even the FDA says the risks of cognitive problems are very small and go away when statins are discontinued.  ‘We’re in danger of forgetting just how effective these drugs are.’

Dr Dermot Neely of the charity Heart UK, and lead consultant at the Lipid and Metabolic Clinic at the Royal Victoria Infirmary in Newcastle, agrees side-effects with statins are rare.  ‘I’ve been dealing with patients on statins since 1987 and I can count on the fingers of one hand the number whose memory symptoms turned out to be caused by statins.’

However, he said he often saw patients who had not been told about side-effects.  ‘It’s important GPs are clear about the drugs statins can interact with, such as certain antibiotics, as this can get overlooked.  ‘If a patient notices an adverse effect after starting statins, they should discuss this with their GP —but not stop their drugs suddenly because this can be dangerous.’

Sonya Porter, 73, decided to stop taking statins after her memory problems became so bad that she walked away from a cashpoint leaving her money behind.  ‘I was permanently fuzzy-headed and just couldn’t seem to concentrate,’ says Sonya, a retired PA from Woking, Surrey.

Then I started to get scared I might have Alzheimer’s. After reading about memory problems associated with statins, I thought it was at least a possibility. I decided to come off the pills to see if it made any difference.  ‘I didn’t ask my GP, I just did it — I’d rather die of a heart attack than Alzheimer’s disease. Within a month I felt normal again and didn’t have any problems with memory.  ‘I’m terrified that I could have been misdiagnosed with Alzheimer’s.’

John Holliday is also reluctant to go back on statins.  ‘I wouldn’t rule it out completely — my latest test showed my cholesterol levels have gone up,’ he says.  ‘But on balance, I’d rather take my chances with heart disease than feel as confused as that again. It’s all very well living slightly longer — but it’s about quality of life, too.’


Stem cell jab that repairs liver without need for transplant to be trialled on sick British children

Hopeful and at a stage where is could soon be in use

Doctors have developed a pioneering treatment for liver disease that could save hundreds of lives a year and avoid the need for transplant surgery.  Liver specialists desperately need new approaches to the epidemic of liver diseases that is leading to huge demand for donor livers.

Eighteen British children suffering from rare and life threatening liver conditions are to receive infusions of specially treated liver cells removed from the organs of dead donors.  Doctors believe they will make vital stem cells - the building blocks of life - and repair the damaged organ.

The worlds first trial using liver stem cells is to take place at London's King's College Hospital and will be headed by paediatric liver consultant Professor Anil Dhawan.  He described the use of stem cells to treat liver disease as an 'exciting breakthrough'.

He said: 'We have many very sick children and babies who need transplants. If we can cure them without a transplant that will a fantastic development.  'We have tried using ordinary liver cells with limited success, but is the first time a treatment has been developed that gets the liver to re-grow using stem cells.'

It comes after they successfully treated on baby Iyaad Syed last year.  Iyaad was born healthy in February 2011 but his liver had started to fail after he caught the herpes-simplex virus. Professor Dhawan injected donor liver cells into the boy's abdomen when he was just two weeks old. In November, doctors announced that Iyaad had recovered well and his own liver was functioning normally.

Liver specialist, Professor Etienne Sokal, who developed the technique at the Catholic University of Louvain in Belgium said: 'Some patients with liver disease are unable to produce appropriate stem cells to repair the liver.

'We have been able to show the cells we infuse into the liver last and continue to supply the liver with new stem cells, which are able to correct the missing functions of the liver in these children.  'Our early trials in the laboratory were successful enough for us to get the go ahead to start human trials.'

If the trials in children are successful it is hoped the treatment can be extended to patients who have livers damaged by alcohol abuse, viral diseases like hepatitis or the growing numbers of patients who going into liver failure due to obesity.

At present large numbers of liver patients die each year waiting for an organ transplant - while some don't even make the transplant list due to organ shortages.  For those lucky to get an organ there is the risk of the liver rejecting putting them back on the transplant list.

The UK - along with many countries - is facing an epidemic of serious liver disease much of it due to alcohol abuse and obesity which is dramatically increasing the need for donor livers.

Latest figures show that around one fifth - or around 150 - of 700 organs transplanted each year go to recovering alcoholics.

The death toll due to liver disease has risen by a quarter in the last decade and many of the victims are only middle-aged. Just over 11,500 men and women now die of liver disease every year -up from 9,200 in 2001.

It is estimated that just under 80 per cent of these deaths are caused by alcohol, and obesity and the remaining 20 per cent by hepatitis and inherited conditions.

A culture of overeating is also putting the lives of more than 500,000 obese young people at risk of serious liver disease according to a recent report by the Department of Health.

While alcohol is a major contributor to liver damage, many people are unaware of non-alcoholic fatty liver disease, which is linked to being overweight.  It can progresses to a life-threatening condition called cirrhosis of the liver and is now almost prevalent as alcohol abuse as a cause of liver disease.

The new treatment developed by Professor Sokal offers the hope of an alternative to liver transplants for the growing numbers of people who face death due to liver failure.  The stem cells are better tolerated than a organ transplant and require less immuno- suppression drugs- reducing risks of rejection.

From a small number of cells gathered from one liver, experts have been able to grow millions of special liver cells capable of making stem cells when infused into a patient's liver.

Trying to treat liver disease by infusing donor liver cells is not new. But until now only adult liver cells have been used - with limited success as the cells die off after a period of time.

By using specially treated liver cells that are capable of becoming stem cells, scientists believe they may have found a permanent cure for patients who would normally need a transplant.

Doctors will trial the stem cell treatment on children with an inherited metabolic disorder that affect the liver called Crigler-Najjar syndrome.  Children with this condition are unable to eliminate toxins from their bodies and therefore must undergo daily 12-hour exposure to special blue lights, just to survive.  Without daily treatments, a child would suffer brain damage, muscle and nerve damage and death.

The treatment will also be tried on children with urea cycle disorders who are unable to process liver toxins because of a genetic defect. This condition can lead to brain damage and death without a special diet.  Experts believe that up to 20 per cent of cot deaths may be due to undiagnosed urea cycle disorders.

Professor Dhawan, said: 'If all goes well the children we are treating with the cells will show an improvement within a couple of months. We would expect those children to come off their medicines and therapy. It will mean the liver cells have done their job and corrected the defects that made them ill.

'Then we will have to see how long the effect lasts and whether we have to top up these children with further infusions. I am optimistic the treatment will work.'

Professor Max Malago, a liver transplant surgeon at London's Royal Free Hospital, said: 'There is enormous demand for donor livers at present which is impossible to meet. There patients who are desperate to transplant but unfortunately not everyone can get an organ.  'If there was an alternative treatment to transplant where you could save the liver it would offer hope to patients who are at present dying waiting for an organ.'


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