Friday, September 05, 2008

Cholesterol lowering drug 'increases risk of cancer by 50 per cent'

LOL! Conventional "wisdom" again. How often have I repeated the old saw that the medical miracle of today is the iatrogenic disaster of the future! The solons are spinning like tops, of course -- even though the evidence for harm is similar to the evidence for benefit -- weak in both cases

A cholesterol-lowering drug may increase the risk of cancer by half, according to new findings. Researchers found there were 105 cases of cancer in people taking Inegy compared to 70 in those on a dummy drug over a four year period. The study also suggested that Inegy, which combines a statin called simvastatin and another drug called ezetimibe, has little effect in reducing the risk of heart attacks and strokes

Prof Heinz Drexel, of the University of Innsbruck in Austria and spokesman for the European Society of Cardiology, said: "I am not sure that the efficacy is proven and I am not sure that the safety is proven. I wouldn't take the drug myself. "In patients with an urgent need to reduce cholesterol I would give them the drug but that is they are the exception and that is not consistent with how it is being used currently. "It is being more widely used than I think it should be. We can use something else in patients whose cholesterol is not sky high."

In the last two years 300,000 prescriptions for Inegy were dispensed in England and Wales and between four and five million people are thought to be taking standard statins. The National Institute for health and Clinical Excellence (Nice) has approved ezetimibe for use in people with an inherited high cholesterol disorder who cannot take normal statins. Doctors have not been told to stop prescribing the drug but the British Heart Foundation said any patients with concerns should speak to their GP.

The lead author of the new study, Prof Terje Pedersen, of Ulleval University Hospital in Oslo, called for caution, saying the findings could be down to "chance". An analysis carried out by a team at Oxford University also said two other trials had not found the same link and the findings probably were due to chance. But Prof Drexel said there were 50 per cent more cases of cancer among patients taking the drug, which suggested it was unlikely to be a statistical fluke. He agreed that the findings, presented at the European Society of Cardiology congress in Munich, do not prove the drug causes cancer and said a longer follow up will be needed to know for sure.

The research involving 1,873 people with a mild to moderate aortic stenosis - which causes partially blocked heart valve - also showed that although the drug did lower cholesterol, it appeared to have little effect on the number of cardiovascular events such as heart attacks and strokes. There was also a higher proportion of deaths from cancer with 39 deaths in the Inegy group and 23 deaths in those on the placebo. The cancers in both groups were across all major areas of the body including the skin and lungs, according to the findings, which were also published in the New England Journal of Medicine.

An editorial in the journal said it should not be assumed that the cancer finding is down to chance until more data is available. It said ezetimibe interfered with the absorption of cholesterol but also affected the absorption of other molecules which could affect the growth of cancer cells. The editorial states: "Physicians and patients are unfortunately left for now with uncertainty about the efficacy and safety of the drug." British and American drugs regulators are investigating the findings but doctors have not been advised to stop prescribing the drug.

Dr Mike Knapton, Director of Prevention and Care at the British Heart Foundation (BHF) said: "People should be reassured that drug regulators will act quickly if robust evidence of risk to patient health appears. "If you have been prescribed ezetimibe you should continue to take it. If you have concerns about side effects of this or other medication, you should talk to your doctor to weigh up the risks and benefits."

A spokesman for Merck and Schering-Plough, makers of Inegy, said: "We do believe that the cancer findings in the study are likely to be an anomaly and that in light of all the available data does not support an association with Inegy. "We are working with regulatory agencies to further evaluate the data. However, we do not believe that changes in the clinical use of Inegy are warranted."


We need a change of heart on statins

They say love is blind, and if there is one thing that doctors can be accused of, it is being in love with statins. Over the past few years, prescribing figures at my practice have constantly been topped by these drugs.

They also say love endures and our love affair with statins is likely to survive yesterday's report of a link between a combination statin and an increased risk of cancer (especially as this link has not been seen when patients have been on statins alone).

Love has its basis in attraction, and statins are extremely alluring - between four and five million of us are being prescribed the standard version. Their prescription, in combination with other powerfully effective medicines, makes a real difference to those with diabetes or existing cardiovascular disease (the so-called secondary prevention). The inexorable decline of the "heart patient" can often be arrested and, following a heart attack, or the development of angina or diabetes, patients are able to maintain a level of health unimaginable a decade or two ago. No wonder GPs are so enthused.

Love, though, can go to your head. And while no one would dispute the use of statins in secondary prevention, there is increasing pressure to prescribe them to people who are fit and well - but who may be worried about their cholesterol levels, or their risk of cardiovascular disease (this is primary prevention). Here the drug's power is not so great, and so doctors and patients should listen to their heads as well as their hearts when embracing statins.

What the drug cannot do is turn vice into virtue. No drug can yet do this. Patients may be half joking when they ask me for something to lower their cholesterol so they can continue eating their high-dairy, high-fat diet, but their request reflects the increasingly prevalent perception that the magic of modern medication can overcome the need for lifestyle changes. Stopping smoking, taking exercise, modifying diet, paying rigorous attention to blood pressure - in many instances these changes can be more effective in warding off cardiovascular disease than taking a statin.

But the power that has been handed to doctors by medical advances often leads patients to believe that science can conquer all, no matter what the ravages of our lifestyle or our age. Why bother going to the gym or eating five a day when you can take one of those new-fangled anti-obesity drugs? Why use sunblock and sit in the shade when Botox will get rid of those wrinkles? And from there, we move on to: I don't have one of those affluent happy lifestyles I see all about me, I must be depressed. Can I please have a happy pill?

We have irrational expectations about our health and wellbeing, which are, ironically, often fuelled by a medication culture. Preventative medicine makes us miserable - reportedly, the higher a population's exposure to medication, the lower its people rate their health. That's the trouble with prescribing biologically active chemicals to those who aren't necessarily high-risk cases: once you're on the tablet, you are medicalised. You have entered the world of checks and monitoring and have replaced the assumption of health with the fear of illness.

I see it in the reactions of patients when I discuss the necessity of medication to lower their blood pressure, replace their deficient thyroid or other long-term treatments. It is a step out of the fearlessness of youth to the multiple medications of old age. So if the love of statins has spun heads, including mine, it is only because they are so wonderful at improving the longevity and function of those already at risk. Those who aren't, however, must resist the siren call of medication which so easily blinds us to the other preventative measures that very often lie within our own grasp. Even if the lure of a magic pill seems like an easier alternative.


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