A bitter pill: the dispute over statins
Caroline Fisher could only look on helplessly as Mustafa Gunaydin, her partner of 20 years, went from energetic middle age to helpless disability.
As he lost weight and his hair fell out, doctors tried the accepted medical treatments, but in vain. Gunaydin shrivelled and his muscles became useless. He became too weak to speak and, eventually, to breathe. Aged 59, he suffered a three-day heart attack and died.
Fisher is convinced that Gunaydin’s death was linked to statins, the world’s most commonly prescribed drugs, which are designed to lower cholesterol, the fatty substance found in every cell of the human body and in varying levels in the blood. Cholesterol has long been held up as a cause of heart disease – but that cause-and-effect relationship is increasingly under question.
“I think statins are poisonous for some people, and that they damaged Mustafa,” says Fisher. “My heart sinks when people tell me they have been prescribed them. I think they are being medicated unnecessarily and are at risk of premature ageing, and debilitating pain and fatigue. We don’t yet know what further damaging side-effects will come to light. Cholesterol is needed for all muscle function, including the heart.”
Before his death, and against medical advice, Gunaydin stopped taking statins. Within a month his health was so transformed that he was able to go on an energetic holiday walking in Turkey.
On his return, a blood test showed that his cholesterol had risen and revealed high levels of creatine kinase, a breakdown product of muscle tissue. It should have served as a warning that the statins were causing damage; however, Gunaydin’s symptoms were diagnosed as motor neurone disease.
“The doctor said if Mustafa didn’t go back on statins, he would die,” says Fisher.
Since statin drugs were introduced in the Seventies, cholesterol reduction has been an unchallenged goal of all public health policy. The latest official guidelines, issued last year by the National Institute for Clinical Excellence, say anyone with a 10 per cent raised risk of heart disease – measured by elevated cholesterol level, blood pressure, fitness and family history of heart disease – should be offered statins, in most cases a treatment that continues for life. It is a guideline that could draw in 17.5 million patients, or around 40 per cent of all adults in the country.
But critics argue too little is known about whether the risks of the drugs could outweigh the benefit. (Potential side-effects are known to include life-threatening muscle weakness, diabetes, kidney or liver dysfunction, and memory loss.)
“There has to be a proper investigation into the use of these drugs,” says David Purkiss, 71, a former carpenter, who lives with his wife, Sheila, 67, in Titchfield, Hampshire. “Doctors are covering up the side-effects. I started talking about what statins had done to me to someone in a hospital waiting room, and I quickly had about nine people comparing notes. A doctor came out and told me to shut up.”
Purkiss suffered such a dramatic decline in strength on statins that he ended up in a wheelchair. However, since he stopped taking the drugs eight years ago, he has enjoyed a reign as a champion geriatric weightlifter.
His problems began in 1999 when, aged 44, he went into hospital for a routine operation on his hereditary varicose veins, a condition that had afflicted both his parents.
Purkiss was told he needed to take statins because he might be at risk of heart disease. “I started having really terrible muscle pains, my strength started to go – and then I developed diabetes,” he said.
“I was given all sorts of heavy-duty painkillers, but it just got worse. It was so bad I can remember hanging on to the kitchen work surface and weeping while I tried to stay upright.”
Purkiss began researching his symptoms on the internet. “It was fairly obvious to me that the drugs were causing the problem, but no one would admit it,” he said. “The GP said he wouldn’t be responsible for my health if I stopped taking them.”
He was then referred to an orthopaedic surgeon for the separate problem of arthritis in his spine caused by heavy lifting on the building sites. It was this consultant who suggested Purkiss stop taking the drug.
“I went to see him, depressed, desperate and in a wheelchair,” he says. “He asked me what I thought was wrong with me, and I said statins. He said I could stop taking them to see what would happen.
“Six months later, I went back for a check-up. I marched into his office, spun around in a pirouette, and said: ‘What do you think about that, then?’ He couldn’t believe the change.”
There are many similar stories. Barry Jones, 57, from Chapel-en-le-Frith, Derbyshire, was diagnosed with diabetes three years ago and was told the illness raised his statistical risk of heart disease. Jones, an occupational safety manager for the county council, says he rapidly became too weak to climb the six flights of stairs to his office. His doctor suggested physiotherapy.
When Jones went on a cruise with his wife to try to forget about his declining health, he found himself sitting next to a pharmacist at dinner. “He started talking about statins, saying they caused such severe muscle problems they shouldn’t be prescribed. Without telling my doctor, I stopped taking them. It made an almost immediate difference, and the pain ceased within a fortnight, When I went back for my next check, I told the doctor I wasn’t going to take statins anymore. He agreed the drugs could cause these side-effects in some people, but he wanted me to go on taking them. He said he didn’t want me to have a stroke or heart attack.
“I said I would rather risk a slightly higher percentage chance of dying than live my life in unbearable pain.”
Others say they fear the consequences of ignoring medical guidance.
Kathy Clark, 64, an insurance claims assessor from Weston-super-Mare, Somerset, was diagnosed with raised cholesterol and prescribed statins two years ago. She was also advised to reduce fat as much as possible in her diet. “I gave up butter completely for about a year and tried not to use fat in cooking, but I thought to myself, what’s the point of living if you have to monitor everything you’re eating?”
The diet had no appreciable impact on her cholesterol level. But, while taking the statins, she suffered two strokes in rapid succession, and eight months later was diagnosed with diabetes. “I am in a Catch-22,” she says. “Because of having had the strokes, the doctor says I can’t now stop taking the statins. It doesn’t make much sense, but I don’t want to go against the advice.”
Growing numbers of doctors are outraged that so many people are being exposed to what they see as statin damage.
“Besides the apparent benefit of statins, they appear to have a number of other effects,” says Uffe Ravnskov , a Danish physician who runs the International Network of Cholesterol Sceptics, a global network for doctors and scientists. “Most commonly, statins can cause muscular weakness, or dystrophy, as well as diabetes and cancer. They can also cause nerve damage, and memory loss, because they reduce cholesterol, which is actually vital to brain function.
“These symptoms affect large numbers of patients, but people go on taking them because they’re too frightened of doctors to stop.”
Aseem Malhotra, a London consultant cardiologist and leading critic of the cholesterol hypothesis, says that the full side-effects suffered by thousands of patients in statin trials funded by the drug manufacturers have never been made public by the Oxford University Clinical Trials Service Unit, which coordinates the project. “Biased funding of research and commercial conflicts of interest are contributing to an epidemic of misinformed doctors and patients,” he says. “The information we are using to support the use of statins is biased and that is unethical.”
Meanwhile, a study of 26,000 people by Ishak Mansi, of the University of Texas Southwestern in Dallas, published last year, showed statin users had almost double the risk of developing diabetes. This year, a study from Japan suggested side-effects from statins might also be contributing to heart failure, while another from Michel de Lorgeril, of Grenoble University, analysing all published statin studies since 2006, said statins showed “no benefit” in heart disease prevention and caused “potentially fatal” muscle weakness.
Equally, among the millions of statin users are many people who have been taking the drugs long-term without problems. James Hayman, 56, from Loughton, Essex, a sales manager in a paper firm, is a smoker who was diagnosed with diabetes in 2010, and found to have a cholesterol level of 10 (six is considered high). He has been taking statins ever since. “I feel absolutely fine,” he says. “I have absolutely no side-effects, and if I had heart disease I would know about it by now.”
The statin supporters have also accused their critics of causing avoidable deaths. A study published in June blamed media coverage of the doubts over statins for encouraging 200,000 people to stop taking their prescribed medicine, leading to 2,000 extra heart attacks and strokes, with a statistical likelihood of 500 fatalities.
Most recently, however, Fiona Godlee, editor of the British Medical Journal, has added her voice to the statin critics and called on the chief medical officer to demand full disclosure of the statin side-effect data. “Not only are the risks greater than have been stated,” she says, “but how strong are the benefits? We just don’t know.”