By
Jerome Burne
21:12 EST, 17 March 2014
|
21:12 EST, 17 March 2014
Just because aches appear after you’ve started on a statin prescription doesn’t mean the drug caused it
He’d been a GP for a quarter of a century and had written ‘tens of thousands of statin prescriptions’.
Then two years ago, Dr Kailash Chand, too, started taking the cholesterol-lowering pills to protect his heart.
As Dr Chand, who is the deputy chairman of the British Medical Association — the doctors’ union — explains: ‘I was in my late 50s and I’m Asian, so I ticked various boxes for being at raised risk of heart disease. It seemed the sensible thing to do.’
Within two weeks, however, Dr Chand,
who is now 60, began experiencing pains in his back and legs unlike
anything he’d suffered before.
‘Mostly it was a dull ache,’ he says, ‘but for a couple of days a week the pain was crippling and I had to take painkillers.’
This went on for two years and — bad news for his heart — forced Dr Chand to give up badminton, his favourite form of exercise.
Initially, Dr Chand had assumed the pain was something that would pass.
In fact, it worsened, and the bouts became more frequent. He also began to have problems sleeping and started to wonder about possible causes.
‘I didn’t even consider statins,’ he says. ‘I was wondering instead about things like too much travelling or bad posture when sitting.
‘I did various checks, like a liver function test, X-rays and an MRI scan. All came back clear.
‘So last year I thought it was worth seeing what would happen if I stopped taking the drug.
‘Within two to three weeks my back and legs began to feel a lot better and my sleep improved.
‘For me that was the litmus test that showed that the statin was the cause of the problem.’
Dr Chand is certainly not alone. Muscle pain is the most frequently reported statin side-effect and while estimates of the numbers affected adversely by statins vary, according to one eminent U.S. cardiologist, 20 per cent of healthy men on the drugs say they have significant side-effects.
With seven million Britons taking statins, that could mean up to 1.5?million are being affected.
Yet according to a study published last week, Dr Chand and all the others are almost certainly mistaken.
A major analysis of 29 trials of statins by researchers at the National Heart and Lung Institute at Imperial College, London, concluded that the drugs are practically free from side-effects.
When people say they are suffering symptoms such as muscle pains, insomnia, fatigue or gut problems caused by statins, claim the scientists, they are making a false link.
Just because twinges and aches appear shortly after you’ve started on a statin prescription doesn’t mean the drug caused it. (Other known side-effects of statins, such as memory problems, blurred vision, ringing in the ears and skin problems, were not included in this review.)
Dr Chand, for one, is far from convinced by these new findings: ‘I know the difference between twinges and a new sensation that is quite specific and doesn’t go away.’
MANY GPs WON’T TAKE STATINS
There is no doubt that for people who are at risk of a second heart attack, statins do make a difference
The latest claims come at a time of considerable controversy over statins.
There is no doubt that for people who are at risk of a second heart attack, statins do make a difference.
Yet last month the National Institute for Health and Care Excellence (NICE) suggested a change to its guidelines that would lower the threshold for prescribing them, so that many otherwise healthy people would end up on them.
At the moment statins are recommended for healthy patients when their risk of heart disease is greater than 20 per cent over ten years.
The proposal is to drop that to 10 per cent. According to the GPs’ magazine Pulse this could increase the number of healthy Britons on statins to 12 million.
Yet when Pulse asked doctors for their views on the change, more than half said that they wouldn’t follow it themselves or apply it to their family and friends.
Their reasons included it being ‘a step too far’, or that they were ‘worried about increasing side-effects’, ‘sceptical about the claims of benefit’, or feared it ‘would increase GPs’ workloads’.
‘Statins are useful drugs if you have had a heart attack,’ says Dr Chand, ‘but the only ones to benefit from giving them to millions more healthy people at low risk will be the drug companies.’
Timothy Noakes, professor of exercise and sports science at the University of Cape Town, South Africa, has gone further: ‘Focusing on an elevated blood cholesterol concentration as the exclusive cause of coronary heart disease is unquestionably the worst medical error of our time.
‘After reviewing all the scientific evidence, I draw just one conclusion: never prescribe a statin drug for a loved one.’
So how can we explain this big gap between the views of people who have personal experience of using these drugs — doctors and patients — and official bodies such as NICE?
An investigation by Good Health has found that the claim that statins are beneficial for almost everyone — and the latest claim that they have zero side-effects — is based on evidence provided by the drug manufacturers themselves.
And as we shall see, there are major question marks over this evidence.
WHAT IS THE TRUTH ABOUT SIDE-EFFECTS?
Muscle pain is the most frequently reported statin side-effect (file picture)
It’s now widely accepted that pharmaceutical companies have, in the past, tweaked drug trials to make them appear more favourable.
Sometimes this means simply not publishing unsuccessful trials, or setting up ones in such a way that they are more likely to yield positive results.
So are the drug company trials that found virtually no difference between side-effects from a placebo and a statin trustworthy?
Three years ago the respected Cochrane Collaboration, a research body that analyses the benefits of treatments by looking at lots of trials, published a report on the risks and benefits of taking statins.
This is what it said about relying on studies done by drug companies testing their own products:
‘It is now established that published pharmaceutical-industry-sponsored trials are more likely than non-industry-sponsored trials to report results and conclusions that favour a drug.’
The review also complained that the trials of statins don’t give nearly enough information about side-effects, pointing out that more than half the trials hadn’t reported on adverse events at all.
In fact, the lead author of recent Cochrane reviews of statins is unable to take them himself because of the side-effects.
‘I’ve always had high blood pressure so as I got older I thought I should go on statins,’ says Professor Shah Ebrahim. ‘But I found I had really bad muscle pains with them.’
He investigated by stopping the drugs, which stopped the pain — but it came back when he started them again.
‘That convinced me the effect was real,’ he says. ‘But I’m still not sure there isn’t a reverse placebo effect [when you expect to suffer certain bad side-effects and you do] going on, so I may go back on them.’
Last year Dr John Abramson, of the Department of Health Care Policy at Harvard Medical School, picked up on the worrying lack of good data on side?effects.
He warned about only relying on commercial trials of statins to find out how common side-effects were.
Writing in the British Medical Journal, he said that the big gap between the number of side-effects reported by company trials and the number found by independent trials ‘shows that the determination of harms cannot be left to industry alone’.
There are various ways trials are conducted that effectively ‘hide’ the side-effects. One way is to weed out the people who have stronger reaction to drugs in the early stages of the trial.
Most trials have a ‘run-in’ period, officially a chance for the researchers to exclude people who don’t follow instructions about taking the medicine.
However it’s also an opportunity to spot anyone who shows signs of suffering from statin side-effects.
THE HIDDEN EVIDENCE
NICE is now proposing that more of us, even those with a low risk of heart disease, can benefit from statins. So how reliable is the evidence on which this is based?
The crucial study that has influenced NICE’s proposal was done by the Cholesterol Treatment Trialists (CTT) Collaboration and published in The Lancet in 2012.
The CTT is a prestigious research centre in Oxford staffed by top epidemiologists and statisticians.
What makes it special is that it is the only place in the world to hold the detailed records of what happened to individual patients from all the 29 commercially run trials on statins.
But what worries the world’s top statin experts is that none of them has been able to get access to that drug company data.
As Professor Rita Redberg, a U.S. cardiologist and editor of the authoritative journal JAMA Internal Medicine, told the Mail: ‘CTT will not make their data available to any colleagues and other researchers who wish to study risks and benefits of statins.
‘The CTT data is not accessible publicly.’
In response to this, Professor Collin Baigent, a senior researcher at CTT and the lead author on the Lancet trial, explained to us that the deal with the drugs companies was that they would hand over their data for analysis so long as the CTT agreed not to release it to third parties.
Professor Baigent also cleared up something else that had been puzzling other investigators.
The CTT’s reports always claimed that the rate of side-effects from statins was very low. Professor Baigent said that in fact, the CTT database did not have any information about non?fatal statin side-effects.
He explained that this was because when it was set up in 1994 it was only investigating the risk of death from statins, so that was the only side-effect data that had been asked about.
The result was that when the CTT studies said the risk of any other side?effects was low, it relied on the published results of statin trials by individual pharmaceutical companies.
Exactly the same data relied on by the latest study claiming the drugs were virtually side-effect free.
WHAT THE PATIENTS THINK
So what about the many patient reports of problems such as muscle pain or cataracts or depression?
‘These claims are based on unreliable studies,’ replied Professor Baigent. ‘They are just hypotheses at this point. They haven’t been tested in randomised clinical trials.’
Yet relying on commercial trials gives a distorted picture of what is going on in real life, as Dr Chand knows only too well.
The problem is that this distorted picture leaves people such as 67-year-old Eva Kelly feeling abandoned when they do develop side-effects.
Eva, a retired council worker from Harringay, North-East London, says she ‘went through hell on those drugs — how can anyone suggest I somehow made it all up?’
She was put on statins in 2006 and all was fine for three years, but then she began to get the occasional bad cramp and pains in her left leg.
Her GP said it was probably a coincidence, but switched brands of statins. But then, last August, the cramps set in 24/7.
‘I couldn’t leave home,’ she says. ‘It was unbearable, like someone was taking a hammer to my leg.
‘I cried buckets in the surgery, begging the doctors to take me seriously. I’m not a hypochondriac, I said. I’m not a time-waster. But I was scared to stop taking the drugs.
‘One of the doctors asked if I wanted to die prematurely from heart disease.
‘Eventually I persuaded one to send me for an MRI scan; that showed I had a neurological problem.
‘The consultant said it was probably caused by medical treatment.
‘I was sent for physiotherapy because my leg muscles were so weak, but no one told me what to do about the statin.
‘This January I decided to stop it anyway. My cramps are 50 per cent better and I can walk a bit. You don’t make that kind of thing up.’
Muddying the waters is the fact that eight out of the 12 members of the NICE panel that recommended the increased use have declared ties to the manufacturers, including Pfizer, Sanofi-aventis and AstraZeneca.
Meanwhile, although the Imperial College study — which concluded that the drugs are practically free from side-effects — did not receive any drug company funding, the National Heart and Lung Institute lists these same drug companies among their sponsors.
Once again, it must be stressed that statins have clear benefits for those who are at risk of a second heart attack; and, for others, NICE maintains the potential benefits outweigh any risks.
Nevertheless, the decision to take them may not be as straightforward as we’re told.
or comment on this article
-
Moment Playboy model is whacked in the butt with golf club
-
Three-year-old boy makes powerful plea for cupcakes
-
Porn star Belle Knox interviewed in her first adult film
-
Man with 132lb scrotum has it removed. WARNING Graphic…
-
L’Wren Scott launching her Banana Republic line in 2013
-
Savannah Guthrie announces she’s married AND pregnant
-
Duke student feels ‘empowered’ by X-rated career
-
Scenes outside designer L’Wren Scott’s NY apartment
-
Released for the first time, footage of 9/11 from space
-
Happy St.Patrick’s day! Green dye put in the Chicago river
-
CCTV of pilot Zaharie Shah and co pilot Fariq Ab Hamid
-
Deep blue danger – Diver repeatedly fends off shark attack
-
Designer L’Wren Scott was ‘embarrassed and millions in debt’…
-
The moment Mick heard L’Wren was dead: Jagger’s face is…
-
Boeing 777 hijackers plunged to 5,000ft and used low…
-
How a gangly Mormon girl called Luann transformed herself…
-
Was Malaysian co-pilot’s last message to base a secret…
-
North Korea is as bad as the Nazis, says UN report – but…
-
Picture Exclusive: The elite Scientology recruitment school…
-
Duke student porn star reveals she has watched adult films…
-
‘I was a paid hypocrite’: Bearded former Two and a Half Men…
-
Amazing video of man singing Let It Go from Frozen as 21…
-
Today show host Savannah Guthrie, 42, announces that not…
-
New York hotel heir found dead at 28 of suspected drug…
Comments (11)
what you think
-
Newest -
Oldest -
Best rated -
Worst rated
The comments below have not been moderated.
Minka,
London, United Kingdom,
moments ago
Perhaps some doctors are able to control their health better with lifestyle changes?
Statins are a frought issue. Yes, they have side-effects and are not without risk. However, they can also save lives; if they didn’t decrease serious illness and mortality they would not be prescribed because the NHS would rather save the money. There are plenty of patients who do take control of their diets and exercise, but it’s clearly not an option for everybody; for those who are very unlikely to change their diet, or who have hereditary cholesterol problems, statins can be a life saver.
Peter,
Knutsford, United Kingdom,
13 minutes ago
Five years back, I was prescribed statins. Six weeks into the course, I started to have great pain in my back and legs. I stopped taking the pills, but it was six months before I could get out of bed. Do what you want, but I will never take statins again.
Jay,
Swindon,
18 minutes ago
My Doctor was a Statins maniac – the cure for everything – it gave me very painful leg joints, unable to lift a foot or leg and bad joint pain – but HE would not give up and made me try every variety – no luck – I have now been taking Ezetimibe tablets ‘Ezetrol’ for about 10 years – wonderful, one a day, no pain and keeps my Cholesterol down to level 6 – never varies, no pain – Doctors don’t like it as they don’t get their bonus payments!!
Lucas Sebastian,
Santa Monica, United States,
24 minutes ago
Yes, statins have been proven to help prevent further cardiovascular events (MI, stroke), but the numbers aren’t necessarily as solid as many of the drug companies have made them out to be. For example, in secondary prevention of a stroke (i.e. patient has already had a stroke, and we’re working to prevent a second one), as per the SPARCL trial (touting atorvastatin/Lipitor 80mg daily), we would need to treat 53 patients for an average of 4.9 years in order to prevent a second stroke from occurring in ONE patient, but that there was NO overall reduction in mortality when compared with placebo. For that one patient who has had a second stroke prevented, it obviously means well done, but for the other 52, where does that leave them? Each patient to their own, for some, the possibility that they could be the benefactor may be enough to propel them to take the statin, but for others, the risk of side effects (the incidence of hemorrhagic stroke actually increased) is too high.
Lucas Sebastian,
Santa Monica, United States,
30 minutes ago
Yes, statins have been proven to help prevent further cardiovascular events (MI, stroke), but the numbers aren’t necessarily as solid as many of the drug companies have made them out to be. For example, in secondary prevention of a stroke (i.e. patient has already had a stroke, and we’re working to prevent a second one), as per the SPARCL trial (touting atorvastatin/Lipitor 80mg daily), we would need to treat 53 patients for an average of 4.9 years in order to prevent a second stroke from occurring in ONE patient, but that there was NO overall reduction in mortality when compared with placebo. For that one patient who has had a second stroke prevented, it obviously means well done, but for the other 52, where does that leave them? Each patient to their own, for some, the possibility that they could be the benefactor may be enough to propel them to take the statin, but for others, the risk of side effects (the incidence of hemorrhagic stroke actually increased) is too high.
Johnb1,
Sandgate, Australia,
43 minutes ago
I have been on Statins for 14 years, I stopped taking them 4 months ago, I had forgotten about leg pains, real bad cramp at night, I don,t get them anymore. Then I read further about side effects, like cateracts ,guess who has cateracts, maybe now that I have stopped taking statins the eyes won,t get any worse.
mailman99,
Eastbourne, United Kingdom,
1 hour ago
Every drug can have different side effects for different patients. When I told my consultant that I had muscle pain from statins he sadly shook his head at my foolishness. I then developed joint pains from warfarin and switched back to aspirin. Another medical procedure caused my atrial fibrillation to return and I had to take warfarin again to thin my blood before they would do a cardioversion, After a few weeks my joint pains returned.
What do I do? Risk having a stroke or stop walking due to joint pain?
dumbanddumber,
auckland, New Zealand,
11 minutes ago
cynical,
plymouth, United Kingdom,
1 hour ago
QUOTE: “Muddying the waters is the fact that eight out of the 12 members of the NICE panel that recommended the increased use have declared ties to the manufacturers, including Pfizer, Sanofi-aventis and AstraZeneca. †………………. says it all to me really – i won’t take the things either – made my depression much worse – but do the doctors care ?? nah
murphy,
suffolk, United Kingdom,
1 hour ago
Because Doctors who having used them have suffered the same side affects as everybody else. Statins are worth billions to the big pharmaceuticals. This is one of the reasons the NHS is costing so much. Statins are dangerous and effect peoples quality of life.
Minka,
London, United Kingdom,
moments ago
andycabs,
Mora, Sweden,
1 hour ago
7 million people in Britain take statins? The whole country is a stepford wife.
The views expressed in the contents above are those of our users and do not necessarily reflect the views of MailOnline.
Find out now