Friday, February 14, 2014

The great statins divide: As go-ahead's given for one in four adults to be offered heart drug, one doctor says this mass pill-popping is folly...

Dr Malhotra

The man in my consulting room was in his mid-50s and had arrived complaining of severe chest pain. ‘I’ve had it for a while now, doctor,’ he said, grimacing, ‘it won’t go away.’

I glanced at his notes — an angiogram had showed that his heart was fine, while an endoscopy had revealed there was nothing untoward going on in his oesophagus or stomach. Then I asked what drugs he was taking regularly. ‘Well, nothing really . . . just statins.’

That was almost certainly the culprit. I asked him to stop taking them for a fortnight, which, despite protests from his GP, he did and, lo and behold, two weeks later the patient was pain-free.

I recommended he embrace the so-called Mediterranean diet and exercise a little more, and he went away a happy and healthy middle-aged man.

If NICE (the National Institute for Clinical Excellence) gets its way, that scenario could be needlessly played out in GP surgeries and hospital consulting rooms hundreds of thousands of times a year. It would mean 12 million of us taking a little pill before bed, five million more than take statins today.

That’s five million more patients for the NHS to keep an eye on, five million more people who, despite the fact many will be in good health, have been well and truly ‘medicalised’ and face the prospect of spending the rest of their lives on daily medication.

In making its recommendation, NICE seems to be siding firmly with the drug companies and relying on industry- sponsored statistics which consistently under-report — some would even say hide — the risk of side-effects.

These statistics will tell you that perhaps one in 10,000 patients taking statins will suffer severe muscular pain as a side-effect.

In contrast, reliable data from the real world, published recently in the British Medical Journal and backed up by anecdotal evidence from my experience as a cardiac physician, suggests that the real figure for serious side-effects associated with statin use is closer to one in five.

In other words, if NICE succeeds in turning five million middle-aged and predominantly healthy men and women into statin-popping patients, then one million of them will be back — just like my fiftysomething patient — in surgeries and consulting rooms, complaining of side-effects that, as well as muscle pain, include digestive problems, short-term memory loss, erectile dysfunction, sleep disorders, cataracts (mainly in women) and even type 2 diabetes.

The drug companies will tell you how cheap statins are — just 10p a day — but that completely ignores the costs of the follow-up appointments and hospital investigations that patients suffering from such side-effects will require.

With even NICE admitting that 140 people will have to take statins to prevent just one of them having a heart attack or stroke, that’s 139 people taking them for no good reason, running the risk of unpleasant side-effects in the process while all the time taxpayers pick up the ever-growing bill for looking after them.

But NICE also seems to be ignoring serious doubts about how effective statins are.

Yes, they can lower cholesterol levels (they work by inhibiting an enzyme that produces cholesterol in the liver), but real-world data show they have absolutely no effect on either overall death rates or rates of serious illness.

The advocates of statins will point to falling death rates from heart attacks and strokes in recent years but many clinicians — myself included — believe that death rates are falling not because of the increased use of statins, but because of the decrease in smoking (a smoker is 50 per cent more likely to die from a heart attack than a non-smoker who’s had a heart attack) and more effective intervention in Accident and Emergency.

Good medicine involves the right treatment being given to the right patient at the right time, and I’m the first to admit that statins have an important role to play when it comes to the care of patients who have either had heart attacks or have been diagnosed with heart disease.

But giving them to millions of reasonably healthy people is not only medically dubious, it also risks sending out entirely the wrong message to those who, as they approach middle-age, ought to be giving very serious thought to their own diet and lifestyle.

The next big decrease in deaths from heart attacks won’t be brought about by doling out statins but by doing battle with the biggest — and still growing — health problem that we, in common with other Western nations, face: obesity.

Being overweight and having a poor diet causes more serious health problems than alcohol and smoking put together, with obesity associated with such serious conditions as type 2 diabetes, high blood pressure, cancer and cardiovascular disease.

My biggest worry about statins is that people will see them as a magic pill that allows them to tuck into three pizzas a night and umpteen hamburgers with impunity. But they aren’t. People who want to take care of  their health, need to make changes themselves.

It’s not that difficult. The Mediterranean diet simply involves more olive oil, more nuts, two to three portions of oily fish a week and lots of fruit and vegetables, while cutting out refined sugars and carbohydrates (so no white bread, rice or pasta) and processed foods laden with fats and salt.

As for exercise, I’m not talking about training for a marathon — a brisk 20-minute daily walk will do great things for your cardiac health.

Make those sort of lifestyle changes and — whatever NICE says — you won’t need those statins at all. 


£1-a-month drug could HALVE risk of prostate cancer: Heart failure medication 'stops cancer cells growing'

A drug that costs little more than £1 a month could reduce a man's chances of developing prostate cancer by half, new research shows.

The drug, called digoxin, is already widely used to treat thousands of patients with heart failure and abnormal heart rhythms.  It is made from chemicals originally derived from foxgloves, one of Britain's best-known flowering plants.

The latest breakthrough, by scientists in the U.S., suggests men who take the drug every day may be much less likely to develop a prostate tumour.

It's thought that digoxin stops prostate cancer cells from growing by lowering levels of a protein called HIF-1.  This protein is vital for malignant cells to flourish because it controls the growth of new blood vessels that feed the tumour with the oxygen and nutrients it needs to survive.

The findings, published in the journal The Prostate, are in line with a 2011 study which found the same drug appeared to have a powerful effect on breast cancer - also by blocking the effects of the HIF-1 protein.

It could mean the drug, for which nearly five million NHS prescriptions are issued every year, could one day be used alongside other treatments in the early stages of cancer.

Nearly 40,000 cases of prostate cancer are diagnosed every year in the UK and 10,000 men die from it - the equivalent of more than one an hour.  The risks increase with age, with men over 50 more likely to develop a tumour, and there is a strong genetic element to it.

In a bid to find new ways of beating the disease, scientists have been exploring the powers of existing drugs - such as digoxin - that are already used for other diseases and are therefore cheap and readily available.

In 1785, country doctor William Withering noticed a remarkable improvement in a patient with congestive heart failure after they took a traditional herbal remedy made from foxglove.

He identified that the active ingredient was a substance called digitalis and wrote about his findings more than 200 years ago in a book entitled 'An account of the foxglove and some of its medical uses'.

Drug company giants like GlaxoSmithKline eventually turned it into a tablet called digoxin, used for heart failure as well as atrial fibrillation, an abnormal heart rhythm that increases the risk of stroke.  It has been used for decades on the NHS and has been taken by millions of patients with heart defects -costing around £1.30 for a 28-day supply.

Now the hope is it could tackle cancer too.  However, the drug can have side effects such as nausea, headaches and breast enlargement in men and has even been linked with an increased risk of death from cardiac conditions in some people.

It's unlikely to be given to healthy men to prevent tumours but could be used alongside other treatments when cancer has first been diagnosed.

Researchers at the University of Washington School of Medicine and the Fred Hutchinson Cancer Research Centre, both in Seattle, looked at just over 1,000 men diagnosed with prostate cancer between 2002 and 2005.

They studied health records to see how many had been taking digoxin for heart conditions before they fell ill with cancer and compared the results with a similar-sized group of cancer-free men from the area.

The results showed that men on the drug were between 42 per cent and 56 per cent less likely to develop a prostate tumour, even when researchers allowed for other factors that might increase the risks - such as having a family history of the disease.

Their results also match those from a team at Johns Hopkins University in Baltimore, who in 2011 found digoxin appeared to stop the growth of prostate cancer in nearly one in four men.

In a report on the latest data researchers said: 'These findings support the growing evidence that digoxin has potential anti-tumour activity. Larger studies are warranted to evaluate the potential role of the drug in relation to prostate cancer development and progression.'

Cancer Research UK said it was too early to say if the drug could be used to prevent prostate cancer and stressed the numbers involved in the study were small.

Health information officer Dr Indi Ghangrekar said: 'If men are worried about their risk of prostate cancer, or notice any unusual or persistent bodily changes, like difficulty passing urine or needing to urinate more often, they should talk to a doctor.'


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