Could statins be the health catastrophe of a generation?
As two major new studies appear to differ over whether the drugs do more harm than good, Justin Smith weighs up the evidence
When they began to be prescribed in earnest in the mid-Nineties, statins were regarded by many as miracle drugs. The cholesterol-lowering pills, intended to combat heart disease, marked a turning point in medicine from cure to prevention; it was presumed they would be an overwhelming force for good, saving millions of lives.
On Friday, a major study of 30,000 patients by Imperial College London (published in JAMA Network Open, an American Medical Association journal) ostensibly confirmed this narrative, showing that doubling the dosage of statins for those who have already had a cardiovascular event could prevent an extra 12,000 heart attacks and strokes a year.
Yet what is also beginning to become ever more apparent is what some in the medical community – and myself, as a researcher and filmmaker on the subject – have been arguing for years. That overuse of statins in those without a cardiovascular condition could in fact become the biggest health catastrophe of a generation.
Another authoritative study published last week is the latest in a growing body of evidence to suggest not just that statins may have been significantly overprescribed, but also that, for many, the risks of taking them as a preventive measure could outweigh their benefits.
The analysis, published in Annals of Internal Medicine, an American journal, examined the four most commonly prescribed statins using data from 40 previously published randomised clinical trials.
Researchers found that statins were likely to provide benefits at a substantially higher health risk than expected, suggesting that the 10-year risk thresholds used in the current guidelines are set at a level that could be doing more harm than good.
Prominent voices who have questioned the current widespread use of statins include Sir Richard Thompson, the Queen’s former personal physician and past president of the Royal College of Physicians. In addition, the British Medical Journal has in recent years taken a position against the widespread use of statins.
But in spite of this mounting controversy, statins remain among the most commonly prescribed drugs in the world – and the UK is no exception.
In 2013 it was estimated seven million people were being prescribed the drugs in Britain (although the NHS claimed in 2017 that figure was actually four million). In any case, according to the National Institute for Health and Care Excellence guidelines, 12million Brits would be eligible for statins.
The rise in so-called “health MoTs” for adults over 40 in Britain has further increased the numbers being offered statins as primary means of prevention against heart disease. For many, it has become a choice we feel pressured into.
Heart disease is the leading cause of death worldwide, so it’s understandable that health authorities have allocated huge resources over the last few decades to fight it. Much of this effort has been based on the idea that one of the main causes of heart disease is cholesterol. As a result, cholesterollowering medications – statins in particular – have become, by far, the most widely used intervention.
The first set of cholesterol treatment guidelines were developed in the United States in 1988 and have been updated every few years since, leading to notable increases in the number of people deemed eligible.
In 2013 the American College of Cardiology and the American Heart Association published recommendations that, if followed, would lead to a doubling of the number of people who take statins in the UK and US. In fact, according to Prof John Ioannidis at Stanford University School of Medicine, those recommendations meant that well over one billion of the world’s population became eligible.
This advice was controversial not just because of the large increase in the number of potential patients, but also because the calculator used to assess an individual person’s risk for cardiovascular disease was found to overestimate the risk – placing some people into the statin eligibility group that were unlikely to need them.
At the time, the British Medical Journal also published an article questioning potential conflicts of interest – half of the panelists responsible for the recommendations had disclosed current or recent ties to drugs companies, raising concerns over perceived, though unproven bias.
True enough, statins are big business. In 2017 the London-based research firm Visiongain said the global cholesterol-lowering industry is worth $19.2billion (£15billion) and is forecast to grow 4.9per cent each year during the next five years.
One statin, Lipitor, generated more than $13billion in 2006 for the pharmaceutical giant Pfizer before it went off patent in 2011.
The analysis published this week makes an attempt to factor into the equation that statins may do us harm.
Studies have shown that they can cause a range of health problems including muscle damage and weakness, memory issues, type-2 diabetes and erectile dysfunction. A study published in the journal Nature earlier this year also found that they inhibit the growth of some potentially useful bacteria in the gut, allowing other bacteria to flourish and become superbugs resistant to antibiotics.
There is, however, a long way to go before the full extent of statin side effects can be quantified properly.
Statin supporters often say the rate of side effects is very low, and that muscle pain, the most commonly reported side effect, is imaginary. They refer to the nocebo effect (the opposite of a placebo): the idea that health problems from other causes are blamed on a prescribed medication because of a preconceived idea that the medication will cause them harm.
During the nine years I have been closely following this debate, I have received hundreds of messages and emails from people who have been harmed by the drugs; many of whom are unfortunately still recovering years after stopping taking them.
What I have seen during the last few years in particular is that patients have lost respect for their doctor. They have often been ignored when they tried to voice their concerns, and I have received a number of accounts where people feel they have been bullied into taking statins. People have told me of their doctors being dismissive of the side effects, and blaming symptoms on simply getting old.
Other medical professionals seem blinkered by links between heart disease and cholesterol, ignoring other significant causes such as stress, nutritional imbalances and environmental factors such as pollution. There are also a number of studies suggesting that statins, paradoxically, could be bad for the heart. It is already known that they block the production of a substance called coenzyme Q10; a critical component in the production of cellular energy and something the heart, in particular, has high requirements for.
So, are statins overprescribed? Those in favour of their mass use often suggest that opponents are on the fringe of medical opinion.
However, Prof Sherif Sultan, president of the International Society for Vascular Surgery, takes part in a debate about statins at the VEITH symposium in New York, each year. He strongly believes that statins should not be given to people who do not have a diagnosed heart problem – reducing their prescription by around 75 per cent.
Dr Rita Redberg, a cardiologist and professor of clinical medicine at the University of California in San Francisco, and editor-in-chief of JAMA Internal Medicine, has also questioned the use of statins for those of low risk, believing the harm may outweigh the risk for millions.
Debate rages on, as prescriptions for statins continue to be doled out. The one thing we can conclude for certain is that evidence is stacking up for an urgent independent review.
‘People have felt bullied into statins – and ignored when they voiced concerns’