Are statins safe? Only you and your doctor can decide

The controversy raging over the safety and effectiveness of statins is creating uncertainty among people taking them or who might need to consider doing so. Are statins as controversial as stories suggest?

Statins lower the amount of bad (low-density lipoprotein) cholesterol in your blood, and the higher your cholesterol, the greater the riskof a heart attack. If you have a gene defect that causes a very high cholesterol level – a condition called familial hypercholesterolaemia (FH) – then you are at very high risk of a heart attack. Before statins, doctors were virtually powerless to prevent such heart attacks because there were no drugs that were effective at reducing cholesterol without causing intolerable side effects. Statins changed all that.

Now people with FH can take a statin and expect to live a normal lifespan. Similarly, if you have suffered a heart attack, regardless of your cholesterol level, there is abundant uncontested evidence that taking a statin will reduce your risk of a further heart attack or stroke. So where is the problem?

The problem arises when we consider giving a statin to healthy people, who have no apparent cholesterol gene defect or evidence of heart disease, in the hope it will prevent a future heart attack. This is when doctors start to worry about the risk-to-benefit ratio. If a doctor is going to prescribe a statin for a healthy individual to protect against future heart disease, he or she wants to be pretty certain the drug won’t do more harm than good because, unfortunately, all drugs have side effects.

Statins reduce the risk of a heart attack or stroke even in those with relatively low cholesterol levels

So you and your doctor need to know three things – what are your chances of having a heart attack or stroke in the next few years without any treatment? How much would that risk be reduced if you took a statin? And what is the likelihood of a serious side effect?

By noting down some simple facts such as your age, gender, whether you smoke, your blood pressure, your cholesterol level and family history, your doctor can calculate your risk of suffering a heart attack or stroke in the next 10 years. Evidence on benefits and side effects comes from clinical trials designed to impartially quantify the benefits and risks of taking a statin.

The combined evidence from many such trials shows that statins reduce the risk of a heart attack or stroke even in those with relatively low cholesterol levels. But, because most people with low cholesterol levels are at relatively low risk of a heart attack, many people would need to be treated to prevent one of them from having a heart attack. This would not be a problem if there were no risks associated with taking a statin.

So what are the risks? Studies have identified three potentially serious but very rare risks. People taking statins are at slightly increased risk of developing type 2 diabetes. This seems to occur in people on the verge of developing it anyway, and despite the onset of diabetes those people are still at lower risk of heart attack or stroke in the future than they would be without a statin.

There is also a small increased risk of a haemorrhagic stroke – a bleed into the brain – but this risk is more than offset by the reduced risk of a stroke – caused by a blocked artery – if you take a statin, so your overall risk of a stroke is reduced.

The third risk is that statins can definitely cause a condition called myopathy which is characterised by muscle pain and evidence of muscle damage on blood tests. Very rarely, if the treatment is not stopped, this can progress to a potentially fatal condition called rhabdomyolysis. But if the treatment is stopped, the symptoms stop too. Patients are warned to watch out for muscle pains when they start taking a statin and, not surprisingly, many do complain of muscle pains. But few of them have actual myopathy. Placebo-controlled trials have shown that when patients are told to watch out for muscle pains, almost as many taking a placebo report experiencing them as do those taking the active drug. It is this phenomenon that has led to the perception that statin side-effects are common, which they are, but it does not mean they are unsafe.

So what should you do? If you are at high risk, take a statin. The risks of not taking one – a heart attack or a stroke – far outweigh risks associated with the drug. If you are not in this category, ask your GP to assess your risk then discuss the best way to reduce it. For many this will mean a change in lifestyle and diet, not a statin. If your doctor recommends a statin and you experience a side-effect, they can usually be resolved by reducing the dose or swapping to another brand.

Clinical trials tells us that, at a population level, statins are safe and effective. But only you and your doctor can decide if they are right for your needs. Be guided by your doctor rather than by what you might read or hear elsewhere.

Are statins safe? Only you and your doctor can decide

Statins: Patients are allowed to make poor choices but the media shouldn’t help them | Ranjana Srivastava

It’s clear that her symptoms are advancing and that she was right on the futility of further chemotherapy. She is having trouble staying awake, her appetite is deteriorating, and she is weaker by the day. This may well be our last appointment.

“We can get rid of a number of your medications,” I say, frowning at the long list that her daughter says is proving increasingly difficult to administer.

“Let’s do that,” she says joyfully.

So in one of my favourite acts, I slash half her list, explaining why as I go along.

But she stops me at the statin, an anti-cholesterol drug she was prescribed 20 years ago for a barely elevated cholesterol detected on an insurance test.

“I need that so I don’t die from a heart attack.”

“Not quite,” I say soothingly. “Statins exert their benefit over many years and we agree that now, it’s more important to maintain comfort.”

“I can’t imagine my day without my statin,” she declares, leaving me to wonder somewhat enviously how her cardiologist managed to evince such devout compliance for a questionable cause.

Just then her husband pipes up. He is a sprightly 74, still working, and unlike his wife, detests medications, including the statin he was prescribed after a serious heart attack some years ago.

“Well, I’ve decided that at 75, I am swapping the statin for sausages. From what I hear, the two are as bad as each other.”

She has heard this before because the wife adds with a smile, “At 75 or when I die, whichever happens sooner.”

I urge the husband to discuss his decision with his doctor before stopping treatment, I tell my patient to stop her statin and I bid them both a fond goodbye.

As they leave, I find myself thinking about many recent conversations I have had with patients about statins. With cancer patients who have a limited life expectancy, stopping the statin is both safe and right. But during my stints in general medicine, where we treat heart attacks, strokes and dementia, the answer is more nuanced.

Does everyone need a high-dose statin? How many will experience side effects? Is lifestyle modification a reasonable starting point or should every patient be commenced on a statin? The reality of most hospital management is that a drug is prescribed and the patient finds out as an afterthought. But if a statin, once started, is likely to become a lifelong drug, what considerations are important beforehand?

Many patients have heard of statins but awareness does not mean familiarity and it certainly does not mean being informed. For every person who trusts a doctor’s recommendation to take a statin, someone else suspects a conspiracy theory fuelling the prescription of the world’s highest-selling drug.

For the patient who wants to know more, things can get complicated. A cursory internet search warns that statins make women (but not men) more aggressive, accelerate ageing, damage stem cells, worsen heart disease, cause dementia and are “unhealthy and unethical” to prescribe.

Alongside are studies asserting that statins significantly reduce the incidence of heart attacks and strokes and improve mortality. Their benefits are evident within the first year of intake and accumulate over time, making them among the few drugs to have a dramatic impact on health outcomes. Considering that heart disease is the number one killer in many parts of the world, this is no ambit claim. But pity the hapless patient trying to make an informed choice – it’s hard to know which “expert” advice to heed because everyone sounds knowledgeable.

Very few patients needed to stop statins due to adverse effects.

When I recently prescribed a statin to a young woman with a heart attack and a host of coronary risk factors, she expressed concern. I explained that no drug was without side effects but a new, rigorous, non-industry funded, meta-analysis by the clinical trial service unit of Oxford University, shows that the benefits of statins have been underestimated and harms exaggerated. The results were published in the Lancet medical journal.

Treating 10,000 high-risk patients with a low-cost, generic statin for five years prevented 1,000 strokes and heart attacks and treating 10,000 lower-risk patients prevented 500. Of 10,000 patients, five might suffer muscle aches, up to 100 may develop diabetes and five to 10 may suffer a brain haemorrhage but these side-effects have been included in the estimate of the absolute benefit.

Very few patients needed to stop statins due to adverse effects. It may not be the absolute final word but the meta-analysis concludes that many problems have been misattributed to statins, therefore planting fear in the minds of those at high cardiovascular risk and dissuading them from taking a potentially life-saving drug.

But how did these rare toxicities garner so much attention in the first place?

In October 2013, the British Medical Journal, as part of its mission to promote rational prescribing, published a paper quoting the incidence of statin-related side effects being as high as 18% and thus concluding that statins did not provide an overall health benefit to those patients deemed at low risk. But the 18% figure was based on flawed research and it was apparent that even in the quoted research, the figure was closer to 9%, but without the inclusion of a placebo-controlled group, which meant even the 9% could not be genuinely attributed to statins. (The meta-analysis says that statins are “no less well-tolerated than placebo”).

Seven months later the BMJ corrected the erroneous statements but did not retract the entire paper. Sir Rory Collins, the lead author of the Oxford meta-analysis, warned at the time that without full retraction, doctors and patients would continue to be misinformed. It turns out he was prescient.

Medical journal editors … owe it to society to publish papers that “first do no harm”.

Misleading media reports followed and led to increased reticence among doctors to prescribe or even discuss statins and increased unwillingness among patients to take them. Statins were already being under-used but a new wave of adverse media meant a further reduction in use.

In the UK, 200,000 patients stopped taking statins. 60,000 fewer statin prescriptions were dispensed in Australia following a now-withdrawn television program. If those patients avoided statins for the next five years, researchers estimated that a few thousand would suffer a fatal heart attack or stroke. For a disease that kills 17 million people around the world each year, an ounce of prevention is not to be sniffed at.

So what does the statin saga teach us? For one, it underlines the power of the media and in turn, the responsibility of health reporters and newspaper editors to think twice before exploiting health news to suit their audience.

“Beloved grandma loses mind to cholesterol drug” and “How statins ruined my life” might be guaranteed click-bait but responsible reporting might instead discuss the dreadful statistic of one Australian dying of cardiovascular disease every 12 minutes and how to prevent it. Statins are no panacea but combined with diet, exercise and curbing cigarettes and alcohol, they have a role.

Second, it reminds medical journal editors that they owe it to society to publish papers that “first do no harm”. If Big Pharma can’t be trusted to provide unbiased data and to base advice on sensational tabloid fare makes a mockery of medicine, doctors must put their faith in someone to provide credible information.

There is an old joke that the majority of academic papers are read only by the author and the editor – this may be a little harsh but busy clinicians mostly flick through abstracts and note key points rather than read even a fraction of the million scientific papers published annually with an interrogating mind. It is up to journal editors to simplify the task and spell out the difference between interesting research and findings that transform patient care.

Finally, better health arises from better health literacy. In a free society, patients are allowed to make poor choices but the media shouldn’t facilitate it. Just this week an acquaintance asked me what I thought of her daughter’s “courageous” bid to not vaccinate her child for fear of “giving her autism”. I reminded her that the fraudulent data had long been exposed and retracted but she said she had seen it on the net and that was that. Dashing my hopes, she next took on statins.

“What do you make of the controversy?”

“There is no controversy,” I replied. “Read the report.”

“You would say that, wouldn’t you?”

Then, after a pause, “But seriously, did you see the story about the old lady who went mad on her statin?”

No, I didn’t. But newspaper editors, please take note!

Statins: Patients are allowed to make poor choices but the media shouldn’t help them | Ranjana Srivastava

Statins prevent 80,000 heart attacks and strokes a year in UK, study finds

Statins to lower cholesterol prevent 80,000 heart attacks and strokes every year in the UK, far outweighing the harm from rare side-effects, according to a review of the evidence which aims to put a heated controversy to rest and reassure the public that statins are safe.

The review is published by the Lancet medical journal, whose editor, Richard Horton, likened the harm done to public confidence by the critics of statins to that caused by the paper his journal published on the MMR (measles, mumps and rubella) vaccine in 1998.

“Controversy over the safety and efficacy of statins has harmed the health of potentially thousands of people in the UK,” he wrote in a comment published with the review. In six months after the publication of “disputed research and tendentious opinion” on the side-effects of statins in 2013, a study estimated that over 200,000 patients stopped taking a statin. It predicted there would be 2,000 extra heart attacks and strokes over the next decade as a result.

The Lancet was taking a stand, he said, “because of our experience of MMR. We saw in a very painful way the consequences of publishing a paper which had a huge impact on confidence in a safe and effective vaccine.

“We learned lessons from that episode and those lessons need to be widely promulgated. They are lessons for all journals and all scientists.”

The furore over statins broke out after Nice, the UK’s National Institute for Health and Clinical Excellence, advised doctors in 2013 to prescribe statins for patients with a low, 10% risk of heart disease in the next 10 years, which was half the previous level of a 20% risk. It made 4.5 million more people, who were fundamentally healthy, eligible for statins, which Nice said could prevent up to 28,000 heart attacks and 16,000 strokes each year.

The guidance, which was based on evidence from the group led by Prof Rory Collins at the clinical trials service unit at Oxford University, was questioned by the British Medical Journal, which is campaigning against the over-use of medicines and medical treatment. The BMJ ran two papers claiming statins did not reduce deaths and that the risk of side-effects outweighed the benefits.

Collins severely criticised the papers and the BMJ, arguing in the Guardian that they could harm more people than Wakefield did with his MMR paper. Wakefield suggested a link between the jab and autism, deterring some parents from having their children vaccinated.

In the light of the loss of confidence in the pills, the new review of the evidence on the benefits and side-effects, led by Collins, was intended to help doctors, patients and the public make an informed decision about statin therapy, it said.

About a third of those who have already had a heart attack or stroke and would be eligible for statins are not taking them, and that rises to a half among those in the low-risk group. Many do not want to take pills because they do not consider themselves ill, while others worry about side-effects.

The authors say the benefits of taking statins have been under-estimated while the harms have been exaggerated. Treating 10,000 high-risk patients prevents 1,000 heart attacks or strokes and treating 10,000 low-risk patients prevents 500, they say. In the UK, about 2 million people at high risk – because they have suffered a heart attack or stroke – and about 4 million at low risk take statins.

About 40,000 people in each group – a total of 80,000 – avoid potentially fatal heart attacks and strokes as a result, said Collins.

He and his fellow authors stressed that their findings were from randomised controlled trials, which have compared large groups of similar people, some on statins while others were not.

The statins critics generally cite findings from observational studies, Collins said – that is data from people who have been taking statins in the real world, but without a carefully selected comparison group who have not been on the pills. That makes it hard to tell whether any problems are actually caused by the drugs.

There are side-effects, says the review. There is a real risk of myopathy, a neuromuscular disorder which causes muscle damage. One in 10,000 people per year will develop myopathy as a result of this. Another five to 10 people will have a haemorrhagic stroke, which involves bleeding into the brain and 10 to 20 people on statins are diagnosed with diabetes.

There have been claims that as many as 20% of patients have “statin intolerance”, with claims of muscle weakness and pain. At most 10 to 20 in every 10,000 have an increase in such symptoms on the drugs, says the review.

Some GPs have been among the sceptics over statins, but Dr Maureen Baker, chair of the Royal College of GPs, said the study cut through the controversy. “It recognises the benefits that these drugs have for many patients, but also the potential side-effects that any prescribing healthcare professional should be aware of.”

GPs would never take a decision to prescribe statins lightly and should only do it after a discussion with the patient and the medication should be regularly reviewed, she said.

“We hope this research reassures patients who are on statins that in the majority of cases statins are safe and effective drugs – but in most cases where adverse side-effects are seen, these are reversible by stopping taking statins.”

Consultants spoke of struggling to persuade patients that the drugs would help them. “I often meet people who don’t want to take statins yet are happy to take other drugs with greater risks of side-effects, or take supplements with no benefit at all,” said Dr Tim Chico, a consultant cardiologist in Sheffield. “Statins have been unfairly demonised, and this prevents a sensible discussion of the risks and benefits of their use. Statins can cause side-effects, but the chance of developing these is low, while the effects of suffering the heart attack that a statin might have prevented can be fatal or life-long.”

Prof David Webb, president of the British Pharmacological Society, said: “In recent years, those of us who manage the large number of patients at excess risk of heart disease and strokes have been fighting an uphill battle to persuade them to take statins, a class of medicines that have been repeatedly shown to save lives.

“The problem has largely related to concerns about muscle aches and potentially more serious side-effects (muscle damage, diabetes and haemorrhagic stroke) that have been very well publicised on the internet.

“Many patients who have much to benefit from statins, and many of those at more modest risk, have been persuaded not to take them because of exaggerated claims of harm, and some research suggesting that the benefits have been overestimated. It is likely that many lives have been lost, based on a received view that statins are dangerous and ineffective.”

Statins prevent 80,000 heart attacks and strokes a year in UK, study finds

Statins For Cancer Treatment

Statins For Cancer Treatment

Mediterranean diet better than statins for tackling heart disease – study

Heart disease is better treated with a Mediterranean-style diet than cholesterol-lowering drugs, it has been claimed.

A study found those who had a diet rich in vegetables, nuts, fish and oils were a third less likely to die early, compared with those who ate larger quantities of red meat, such as beef, and butter.

Speaking at a global conference on heart disease in Rome, Italy, leading heart disease expert professor Giovanni de Gaetano said: “So far research has focused on the general population, which is mainly composed of healthy people.

“What happens to people who have already suffered from cardiovascular disease?

“Is the Mediterranean diet optimal for them too?”

The study followed 1,200 people with a history of heart attacks, strokes and blocked arteries over seven years. During that time, 208 patients died but the closer people were to an ideal Mediterranean diet the less likely they were to be among the fatalities.

The conference was told those who ate mainly along Mediterranean lines were 37% less likely to die during the study than those who were furthest from this dietary pattern, after adjusting for age, sex, class, exercise and other habits.

Previously, cholesterol-lowering drugs such as statins were believed to be the most effective method of combating heart disease, the leading cause of death in the UK.

Statins, which are among the world’s best-selling prescription drugs, are said to help reduce major heart problems by around 24%.

They are the most widely-prescribed drugs in the UK, with at least seven million users costing the NHS £285m a year.

According to the latest figures from the British Heart Foundation, cardiovascular disease causes more than a quarter (27%) of all deaths in the UK – around 155,000 deaths each year – an average of 425 people each day or one death every three minutes.

Sir David Nicholson, former chief executive of the NHS, entered the debate over statins in July when he said he had stopped taking them as part of his medication for diabetes. “If a lifestyle change works then why would you take the statin? The trouble is that they give you a statin straightaway, so you don’t know what is working,” he said.

Mediterranean diet better than statins for tackling heart disease – study

The Dangers of Statins – The Flipside of Cholesterol-Lowering Medications

Statistics show that about a quarter of Americans from age 45 and above are taking statin drugs. This is also the estimated number of Americans who should start asking themselves whether it is still worth it to continue taking the drugs or not.

Muscle Pain and Heart Failure

Muscle pain, along with feeling weak, is the most common side effect associated with statins. In fact, reports state that about 75% of patients using statins suffer from muscle pain. Particularly those who are physically active. Experts assume that this may be due to the decreased energy production in muscles caused by the deteriorating levels of Q10 proteins.

Heart failure also has a direct link to muscle pain. The incidence of heart failure has increased in the past few years. The increase has been related to the affected production of Co-Q₁₀ caused by statin drugs.

The lack of Co-Q₁₀ inhibits the cell’s mitochondria to produce energy, which in turn leads to muscle pain and weakness. Hence, these also make the heart more susceptible to illnesses due to the level of energy it uses to function.

Neuropathy

Statin patients are at risk of nerve damage after taking the drugs for a long time. In most cases, the damage is often irreversible even after the patient stopped taking the drugs.

Polyneuropathy is another neurological problem that patients often complain about. People who develop polyneuropathy experience tingling as well as pain in the hands and feet, weakness, and difficulty walking.

The worst part is that the likelihood of the illness getting worse increases to 9% after a year of using the drug and up to 15% following a two-year intake.

Cancer

A significant number of studies with statins and rodents always resulted in cancer. The problem is, such possibility was not linked to humans because statin trials only go on for up to three years. Even with the fact that cancer takes some time to develop.

However, manufacturers do recognize that statin drugs weaken the immune system, which unfortunately may result in infectious disease and cancer. Still, they recommend its use for transplant patients to act as an immune suppressor, and for inflammatory arthritis.

Type II Diabetes

Statins were made and introduced as an attempt to help protect and improve heart health. However, case studies show that the only thing these drugs do is worsen the patient’s condition.

One good example of that is obesity, which users tend to develop after they begin a statin treatment due to the drugs’ gluttony effect.

Second to that, statin users become highly at risk of developing Type II diabetes. Studies showed that statin users become prone to developing long-term complications related to Type II diabetes. Some of which are eye disease, peripheral nerve disease, and kidney disease.

All these dangers of statins only prove that these drugs may help patients at some point, but it does not take long before something goes wrong.

Science has long explained that cholesterol is not the reason behind the development of heart disease. In fact, cholesterol is essential to human health while lack of exercise, poor eating habits, and obesity are more likely the direct causes of such illness.

To conclude, intake of cholesterol-lowering drugs will not help if you do not support it with lifestyle and dietary changes. If you want to regulate your cholesterol and keep your heart in the best condition, you only need to include a few simple things in your lifestyle.

Perform brisk walking or aerobic exercise at least 30 minutes a day five times a week. Add lecithin-rich foods and herbs in your diet, and eat plenty of heart-healthy foods, like omega-3 fats.

Remember, you can always consult with a healthcare practitioner to improve your heart health naturally if you want to avoid the dangers of statins.

Sources: Dr Hyman, Care2, The Alternative Daily, and The Weston A Price Foundation.

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The Dangers of Statins – The Flipside of Cholesterol-Lowering Medications

The Shocking Truth About Statins Drug

The truth about prescription drugs – Are you aware of them?

As reports show a quarter of Americans are taking potentially harmful prescription drugs, we ask – is there another way?

You may think that the medical industry’s primary concern is to aid you to improve your overall health but sadly, this is not necessarily the truth. The medical establishment is, in fact, much better at treating disease than they are at getting you healthy, as this is where they make colossal amounts of money. Improving your health is sometimes the last thing that medical establishments want, as they much prefer making you pay for pharmaceutical drugs and therapies that treat only the symptoms of disease rather than the cause.

Heart disease and statins

One of the leading causes of death in America is heart disease; killing around 610,000 people every year in the US. The medical industries believe that cholesterol is the primary factor in the development of heart disease and this has led to the pharmaceutical industry developing drugs called statins, which were designed to lower cholesterol and reduce the risk of heart disease. Accompanied by a large marketing campaign, these drugs have turned into huge money makers for the pharmaceutical companies that create them. In 2013 alone, statins created around $ 29 billion of sales for the pharmaceutical industry. This is the kind of return you can expect from convincing 1 in 4 Americans over the age of 45 that they need to take statins – but does everyone really NEED them?

Are statins all they’re cracked up to be?

There is a wide range of detrimental health effects that have been linked to statin drugs, but, as a regular Joe Public, you are likely not to have heard of many of the below:

Interference with the production of coenzyme Q10, which supports the body’s immune and nervous systems, boosts heart and other muscle health, maintains normal blood pressure, and much more.

Weakening the immune system and increase the production of cytokines, which trigger and sustain inflammation.

They make some patients unable to concentrate or remember words, and are linked to muscle and neurological problems.

Reduction of the beneficial effects of omega-3 fatty acids by promoting the metabolism of omega-6 fatty acids, which increases insulin resistance and the risk of developing diabetes.

Reduction in the benefits of exercise. Exercise increases the activity and numbers of mitochondria, cells’ “power plants” that process sugars and fat. The study found that with statin use, mitochondrial activity actually decreases with exercise.

Reduction of the body’s ability to produce cholesterol, which is essential to brain health—the brain is 2% of the body’s weight, but contains 25% of the entire body’s cholesterol.

Higher incidence of nerve degeneration and pain, memory loss, confusion,depression, and a higher risk of ALS and Parkinson’s.

An increase in likelihood of overeating.

An animal study linked statin use to muscle damage. Animals that exercised on statins had 226% more muscle damage than those not given statins.

They affect the quality of sleep.

Increased risk of prostate and breast cancer.

Result in liver damage by increasing the liver’s production of digestive enzymes.

Speed aging and lower sex drive.

Linked to aggressive and violent behavior in women.

Statins, the media and the AHA

It is very rare that the media actually question or critically analyze the press releases they receive from medical establishments, and this is why you very rarely hear about any negative side effects of statins. When you do, they are closely followed by the published opinion that the risks are greatly outweighed by the benefits of the drugs.

However, this is not necessarily true.

Even those at the forefront of heart disease prevention sometimes get it wrong. The American Heart Association (AHA) published a study based on the over-simplified and out-dated notion that there are just 2 types of cholesterol – “good” (HD) and “bad” (LDL). The AHA also centered their dietary recommendations on the debunked theory that “bad” cholesterol causes heart disease and that saturated fats raise LDL and should therefore be avoided.

What the AHA and other medical establishments don’t seem to realize is that cholesterol is actually vital to human health. It is too simplistic to think that “bad” cholesterol is the route of all heart disease evil. It can be harmful to health if the is an excess of cholesterol but we should also be worried if there isn’t enough cholesterol in our bodies as we age; even “bad” cholesterol is essential.

Numerous studies have linked an insufficient amount of cholesterol to deaths caused by heart attacks and gastrointestinal and respiratory diseases. A study of over 15,000 patients over 18 years found that those with a higher LDL count and overall cholesterol level had a reduced chance of developing atrial fibrillation, an irregular heart rate which reduces blood flow to the body.

Government agencies are finally realizing that cholesterol isn’t the time bomb it has been made out to be. The Dietary Guidelines Advisory Committee is about to withdraw its longstanding advice to avoid all high cholesterol foods.

How to really live a healthy life

It is perfectly clear that all the independent science and studies, not those paid for by the pharmaceutical and medical industries, show that the way to a healthy and longer life is a simple balance of eating well, exercising regularly and taking natural and healthy supplements instead of pharmaceutical drugs.

Poor eating habits, lack of exercise and obesity are direct causes of most metabolic diseases and these problems can all be addressed in a natural and simple way without the intervention of pharmaceutical drugs. Regular exercise and a good balanced diet, such as the ketogenic diet, can help you to live a long and healthy life without handing over your hard earned cash to pharmaceutical giants.

Remember, the way you manage your own health is your decision and no doctor can force you to take any drugs that you don’t want to. Don’t always assume that the medical industry has your best interests at heart, as they are more than likely more concerned with the state of your wallet than of your health.

Given the pharmaceuticals’ influence over the mainstream media, it is not surprising that the media is full of misinformation. To make sure you are fully informed about ways to improve your health you should always do your own research into the real side effects of drug therapies and the many benefits of more holistic natural approaches to healthcare.

Do you want to know how I cured my own prostate disease naturally without any harmful pharmaceutical drugs or invasive surgery? Click Here to find out. 

I Wish You Good Health,

Ben

References

Ong, Ben. All About The Prostate. USA: bensprostate.com, 2016. Print.

The Shocking Truth About Statins Drug

Guideline Critics Shift Attacks From Beta Blockers To Statins

With the release today of updated European and US guidelines the ongoing controversy regarding beta-blockers appears to be resolved. But that doesn’t necessarily mean there will be an outbreak of guideline peace and harmony. The critics who helped ignite the controversy over beta blockers now say new statin recommendations contained in the guidelines are based on deeply flawed evidence.

The previous incarnation of the European guideline on perioperative evaluation and treatment of people undergoing noncardiac surgery was the subject of intense criticism due to the scandal discrediting Don Poldermans, a Dutch researcher widely published in the field. To address the current uncertainty US and European medical societies earlier today released updated versions of these guidelines.

“Given the recent publication of several large-scale trials, including POISE-II, and new risk calculators, as well as the controversy regarding the use of beta blockers related to the DECREASE trials, the writing committee felt it was necessary to reevaluate all of the data on cardiovascular care for the patient undergoing noncardiac surgery,” said US Writing Committee Chair Lee Fleisher, in a press release.

Regarding beta-blockers the US and European guidelines now do not recommend routine use in patients who undergo non-cardiac surgery, though people who are already taking beta-blockers should continue taking them. (Previously the European guideline but not the US guideline did support routine use of beta-blockers.) Both guidelines state that beta blocker therapy may be initiated prior to surgery in carefully selected higher risk patients.

Statin Recommendation Comes Under Fire

Both the new European and US guidelines say that preoperative initiation of statin therapy may be considered in patients undergoing vascular surgery and that people already taking statins should continue taking them. Now some of the same critics who attacked the reliability of the beta blocker guideline say that this recommendation is not supported by the evidence.

The new recommendation is based on several observational studies and one randomized controlled trial. (Two other randomized trials were not considered because they were performed by Poldermans’ group and have been discredited.) The  critics, UK cardiologists and researchers Darrel Francis and Graham Cole, say that the one  trial by Durazzo et al has fatal flaws that make it completely unreliable. (Durazzo, it may be worth noting, had been a frequent co-author of Polderman’s and had been a co-author of several of the controversial or retracted studies.)

In an analysis published earlier this year, Cole, Francis, and co-authors wrote that the Durazzo study

…was a double-blind randomised trial of 100 patients undergoing vascular surgery, with a 45-day course of atorvastatin or placebo. It sought reduced perioperative events in the atorvastatin arm, which indeed was what was found: 8% versus 26% (p = 0.031) at 6 months [22].

This study has serious failings, which make it an unsound basis for recommending therapy. First, its sample size calculation is stated to have been based on a 22% event rate at 6 months in a previous paper [23]. In reality, the source article states that the rate was 12% at 6 months. Such a transcription error would cause a study to be approximately 4-fold undersized.

Second, the authors indicate that they designed their study to detect a relative risk reduction of 95%. This study design is not credible as no therapy has ever been so effective in preventing myocardial infarction. If the true effect size was, for example, half of this, this overestimate would have contributed a further ~ 4-fold undersizing of the study.

Third, the survival data published cannot be correct. The paper reports that of the 50 patients in each arm, none were lost to follow-up. Therefore, every patient surviving to each displayed time point should be exactly 2%. With this in mind, in the Kaplan–Meier graphs, almost all the numerical values in the survival follow-up figure contradict the graphical values shown.

Finally, for 50-patient groups with no loss to follow-up, event-free survival rates must again be multiples of 2%. They are quoted as 91.4% and 73.5%, values that are not possible.

Francis and Cole sent the following comment about the new guidelines:

We are very sad that over 100 world authorities were forced to sign the European guideline without all having had time to read the papers on which their recommendations were based, and without being able to openly voice dissent.

Their awful predicament is easiest to see for a therapeutic idea whose road has been very “bumpy” indeed: the perioperative course of statins. The outcome data of the key trial by Durazzo et al has for over 6 months been publically known to be impossible. This is buttressed by Don Poldermans’ now notorious DECREASE III and IV trials, whose own university’s investigation revealed extensive fictionalisation, and by meta-analyses whose events arose mostly or entirely amongst these extraordinary pieces of science.

There are important lessons to learn. First, guidelines must in future have the right to say that all the major trials have now been discredited, so there is no longer a recommendation. If we fail to recognise this, we have truly failed our patients.

Second, never again should we pretend that all the experts have agreed on recommendations. It was always unlikely, and in this case clearly ridiculous.

In an interview, Fleisher, the chair of the US guideline, defended the committee’s recommendation of statins. He said that the committee was aware of the limitations of the Durazzo study and that the recommendation was based on the totality of the evidence, including the observational studies. He agreed that there was a significant need for more high quality studies.

Guideline Critics Shift Attacks From Beta Blockers To Statins

Statins advice to GPs is a victory for vested interests more than evidence | Kailash Chand

Statins could be prescribed to more men and women, with a smaller sized risk of heart condition, right after the NHS medicines watchdog lowered the bar for prescriptions.

Good (the National Institute for Overall health and Care Excellence) has issued advice that proposes lowering the cardiovascular primary prevention chance threshold – the degree of danger at which statins can be prescribed – from 20% to 10%.

Several believe that such advice would not have the self-confidence of the pros charged with its implementation. In Could a nationwide conference of general practitioners passed a unanimous movement calling for Good to recommend such adjustments only on the basis of a complete disclosure of trial information. This was followed in June by an unprecedented open letter to Wonderful from a variety of senior medical doctors and academics expressing four major areas of concern: medicating wholesome folks non-disclosed side-result information relying on market-funded statins trials and conflicts of curiosity within Good.

Nice is basing this advice on an examination of market-sponsored trials that might have exaggerated benefits whilst under-reporting harm. Most statins data is presented employing relative chance, which inflates benefit. For example, the heart safety review claimed a forty% reduction in mortality from cardiovascular disease, but the reduction in overall mortality was .3% per yr.

Concomitantly, the side-result information has been declared commercially out of bounds, leaving medics and individuals unable to evaluate the cost-advantage of these drugs.

I have been a GP for more than thirty years and prescribed statins with little concern, right up until I took statins myself for in excess of two years. I developed side-results like myalgia, backache and rest disturbance. I stopped taking statins and my signs and symptoms largely disappeared.

An intervention trial evaluating rosuvastatin unveiled that one particular in one hundred females taking a statin risked building type 2 diabetes at one.9 years. For these individuals the chance of contracting diabetes is roughly the same as the likelihood of keeping away from a non-fatal heart attack. For individuals with a minimal danger of cardiovascular illness, 130 men and women require to get statins for a 12 months to avoid just one undesired overall health outcome.

Wonderful describes itself as follows: “We offer independent, authoritative and proof-based advice on the most successful methods to avoid, diagnose and deal with ailment and unwell health …”

The health care occupation should hence assume Great to base its findings on full data disclosure and independently evaluated cost-benefit of statins. Nevertheless, it transpires that eight out of twelve people on the Wonderful guideline improvement group have ties to the drug organizations, and Wonderful is recommending this guideline on the basis of the Cholesterol Therapy Trialists Collaboration drug-business-funded trials. Nice simply asserting that is independent seems unconvincing.

At existing, it is estimated that about 7 million individuals in the United kingdom consider statins. If Great guidance is followed the number could enhance by numerous million. The evidence for the benefit in major prevention – ie preventing cardiovascular condition in men and women who do not have any diagnosed cardiovascular ailment – is weak.

Three-quarters of people having a 1st heart assault, for instance, have standard cholesterol amounts. According to the Planet Well being Organisation, 80% of cardiovascular illness is caused by smoking, inactivity, an unhealthy diet regime, and other way of life variables. Statins give the illusion of protection to numerous individuals who would be significantly much better served by merely strolling more and staying away from processed food.

Excellent medicine ought to usually be proof based and offered to the correct patient at the proper time. Statins have an important position in patients who have an current heart illness or have had a heart assault. Sufferers should be wary of these guidelines, and engage in meaningful dialogue with their medical doctor, just before deciding regardless of whether or not to medicate. If growing numbers of folks without having heart condition consider statins it will be a victory for vested interests more than proof.

Statins advice to GPs is a victory for vested interests more than evidence | Kailash Chand

NHS medicines watchdog lowers bar for statins prescriptions

Statin tablets. Photograph: Alamy

About 40% of the grownup population could be supplied cholesterol-busting statins medication by their medical doctors, below official advice from the NHS medicines watchdog.

The National Institute for Health and Clinical Excellence (Good) confirmed the draft recommendation it produced in February, which sparked a row among doctors in excess of alleged above-prescribing. Some critics accused Nice’s guideline group of shut ties with the pharmaceutical business.

Prof Mark Baker, director of the centre for clinical practice at Good, strongly defended both the choice to provide the medicines to people with a lower danger of heart condition than previously suggested and the independence of people doing work on the guideline. They had carried out their operate “in the face of some entirely unjustified attacks on their integrity,” he explained.

“I have to remind you that no one will get into our tips group if they have any considerable vested interest, particularly a financial interest,” he explained at the launch of the guideline on tackling the threat of heart attacks and strokes. All the interests of the group members were declared, not like people of some of the critics, he explained. Appointees to the group are essential to have had no economic involvement with pharmaceutical businesses for at least the prior year.

Great says GPs should first talk about life-style measures – a better diet program and much more exercise – with men and women who have a ten% risk of a heart attack or stroke in the subsequent ten years. They can then supply a statin if they believe it appropriate. Previously, GPs have been suggested to intervene when their patient had a twenty% risk.

An estimated four.five million much more individuals will be eligible for statins, in addition to the 13 million presently eligible. Great says half these patients will possibly not be presented them or will refuse. Somewhere amongst 5 and 10 million are believed to be taking the drugs at present.

The medication are now off-patent and for that reason cheap. Great says if 80% of the 4.five million newly eligible take them, the cost to the NHS will be £52m, which is tiny in the context of the cost savings from heart assault and stroke treatment method.

If two million – significantly less than half – of the decrease-threat group accept statins, Nice estimates that an additional four,000 deaths from heart attacks will be saved, and eight,000 strokes and 14,000 non-fatal heart attacks prevented.

Critics of statins have contested their rewards in individuals at reduced risk and raised considerations about side-results. Baker rejected these arguments. The evidence from randomised, managed trials of the medication “demonstrate the very same frequency and severity of signs in the statins and the placebo group,” he explained.

“Most of the side-results attributed to the medication but not always brought on by them are very typical. The occurrence of issues like muscle ache has minor or nothing to do with whether folks consider statins.”

A single extreme sort of muscle pain had been reported, but it was very unusual, he explained. He believed that some sufferers and GPs had wrongly assumed the significant response was as common as the mild one particular.

Opposition to statins for the decrease-threat group surfaced in the British Health-related Journal last year. The journal has retracted statements in two papers it published. Independent professionals have been asked by the BMJ’s editor, Dr Fiona Godlee, to advise on whether the papers ought to be retracted, in response to a contact from Professor Rory Collins, joint head of the clinical trials support unit at Oxford University.

Nice’s guidance was welcomed by numerous senior scientists, but some pointed out the importance of attempting to modify people’s life style in preference to handing out medicines. “We must not basically use pharmaceuticals to treat the benefits of unhealthy conditions,” mentioned Sir Michael Marmot, director of the Institute of Health Equity at UCL. “Choosing healthier lifestyles is a lot more challenging simply because our society promotes low cost unhealthy meals, lower alcohol costs, and vehicle use rather of walking or cycling.”

NHS medicines watchdog lowers bar for statins prescriptions

Statins could assist reduce women"s chance of breast cancer

Analysing a mammogram. Substantial ranges of cholesterol have been linked to an elevated chance of breast cancer. Photograph: Rui Vieira/PA

Decreasing cholesterol with statin medication could aid prevent breast cancer, analysis suggests.

A examine of a lot more than 600,000 British girls located that the threat of breast cancer was nearly doubled in these with abnormally substantial ranges of blood fats.

The research is nevertheless at an early stage and the findings do not show that cholesterol aids trigger breast cancer.

But if future function demonstrates a causal link it opens up the probability of utilizing low cost cholesterol-lowering statins to decrease women’s danger of the ailment.

Cardiologist Rahul Potluri, from the University of Aston, mentioned: “We discovered that ladies with higher cholesterol had a considerably better opportunity of establishing breast cancer.

“This was an observational study so we can not conclude that large cholesterol causes breast cancer, but the power of this association warrants more investigation.

“A prospective examine that monitors the chance of breast cancer in ladies with and without having large cholesterol is required to verify what we observed. If the connection amongst high cholesterol and breast cancer is validated, the next stage would be to see if reducing cholesterol with statins can minimize the risk of developing cancer.”

A total of 664,159 females from across the Uk whose wellness information had been stored on a big database took part in the examine.

Almost 23,000 (three.4%) had hyperlipidaemia, that means their blood contained abnormally large amounts of lipid fats – cholesterol and triglycerides.

Some 530 ladies with the situation had been amid the 9,312 who created breast cancer.

Statistical analysis showed they have been one.64 instances much more most likely to have the condition than girls with out hyperlipidaemia.

Earlier analysis has shown a clear association amongst weight problems and breast cancer in submit-menopausal women.

A US examine last year identified that a cholesterol solution named 27HC fuelled human breast tumours in genetically engineered laboratory mice.

Scientists also identified higher levels of 27HC in each wholesome breast tissue and tumour cells in girls with breast cancer.

“We have a standard principle that weight problems is linked to breast cancer and a research in mice suggested that this may possibly be because of cholesterol,” stated Dr Potluri, who presented his findings at a European Society of Cardiology meeting in Barcelona.

“We made a decision to investigate whether or not there was any association among hyperlipidaemia, which is substantial cholesterol primarily, and breast cancer.”

He added: “While our study was preliminary, our benefits are promising. We discovered a considerable association in between having high cholesterol and creating breast cancer that demands to be explored in much more depth.

“Caution is required when interpreting our results because even though we had a large examine population, our analysis was retrospective and observational with inherent limitations. That explained, the findings are interesting and additional analysis in this discipline could have a big affect on patients numerous many years down the line.

“Statins are low-cost, widely offered and fairly risk-free. We are probably heading in direction of a clinical trial in 10 to 15 years to check the impact of statins on the incidence of breast cancer. If this kind of a trial is productive, statins may have a function in the prevention of breast cancer, specifically in substantial threat groups, this kind of as women with higher cholesterol.”

Baroness Delyth Morgan, chief executive of the Breast Cancer Campaign charity, mentioned: “These are interesting results that report a website link between increased unwanted fat in the blood and an increased chance of breast cancer.

“Nevertheless, this is just the 1st phase in comprehending much more about how cholesterol relates to the risk of breast cancer, and far more study is required to figure out whether statins could help avert breast cancer.

“We do know that getting overweight, notably soon after menopause, can enhance a woman’s risk of building breast cancer. We would inspire women to sustain a healthful excess weight and to go over any considerations, such as their breast cancer threat, bodyweight or cholesterol levels with their GP.”

Statins could assist reduce women"s chance of breast cancer

Statins could decrease the chance of breast cancer

In excess of the previous few many years, research have recommended an association between obesity and breast cancer. Final 12 months a research in mice concluded that lowering circulating cholesterol or interfering with its metabolic process might be utilized to prevent or deal with breast cancer.

Dr Potluri explained: “We have a common principle that weight problems is linked to breast cancer and a study in mice advised that this may be since of cholesterol.

“We determined to investigate regardless of whether there was any association among hyperlipidaemia, which is high cholesterol basically, and breast cancer.”

The researchers performed a retrospective evaluation of much more than one particular million sufferers across the United kingdom between 2000 and 2013 from the Algorithm for Comorbidities, Associations, Length of stay and Mortality (ACALM) clinical database. There had been 664,159 girls and of these, 22,938 had hyperlipidaemia and 9,312 had breast cancer. Some 530 girls with hyperlipidaemia developed breast cancer.

The researchers used a statistical model to study the association in between hyperlipidaemia and breast cancer. They located that obtaining hyperlipidaemia enhanced the chance of breast cancer by one.64 occasions.

Dr Potluri said: “We located that females with high cholesterol had a substantially higher possibility of creating breast cancer. This was an observational study so we can’t conclude that substantial cholesterol causes breast cancer but the power of this association warrants further investigation.”

He additional: “A potential examine that monitors the threat of breast cancer in girls with and with no substantial cholesterol is essential to confirm what we observed.

“If the connection in between high cholesterol and breast cancer is validated, the following stage would be to see if lowering cholesterol with statins can decrease the chance of creating cancer.”

Dr Potluri additional: “Statins are cheap, extensively available and relatively risk-free.

“We are possibly heading in the direction of a clinical trial in 10 to 15 many years to test the result of statins on the incidence of breast cancer.

“If this kind of a trial is profitable, statins might have a position in the prevention of breast cancer specially in higher chance groups, such as females with large cholesterol.”

He extra: “Although our study was preliminary, our final results are promising.

“We found a considerable association amongst getting higher cholesterol and building breast cancer that demands to be explored in much more depth.

“Caution is needed when interpreting our outcomes simply because even though we had a big study population, our evaluation was retrospective and observational with inherent limitations. That explained, the findings are interesting and further research in this discipline could have a big influence on patients a number of many years down the line.’

The investigation is due to be presented these days at Frontiers in CardioVascular Biology in Barcelona, Spain. The meeting is organised by the Council on Fundamental Cardiovascular Science of the European Society of Cardiology (ESC) in collaboration with 13 European cardiovascular science societies.

Statins could decrease the chance of breast cancer

Fears that attacks on statins could place lives at risk

The Nationwide Institute of Overall health and Care Excellence is due to publish ultimate suggestions on prescribing of statins later in July.

Draft proposals recommend cutting the “risk threshold” in half, meaning the vast bulk of men aged over 50 and most females more than the age of 60 would be recommended to get the medication to guard against strokes and heart condition.

Cardiologists and scientists stated the weight of evidence – like 27 clinical trials – demonstrated obviously that the advantages of the tablets outweigh any side-effects, even amongst individuals with a lower possibility of heart assault.

Significantly less than one per cent of patients would suffer side-effects, they explained, although those who took the drugs would normally lessen their threat of heart attack and stroke by 40 per cent.

Prof Adam Timmis, professor of clinical cardiology, Barts and the London NHS believe in, mentioned: “Even in very low-chance groups, the benefits of statins tremendously exceed any identified hazards.”

The group expressed concern that the public had been misled by claims – now withdrawn, after their publication in the BMJ – that 1 in five sufferers on the medicines suffers ill-results.

Prof Rory Collins, head of the Nuffield Department of Population Wellness at Oxford University explained it was frequent for older folks taking statins to suffer aches and pains, but trials had proven these had been just as typical in individuals not taking the drugs.

He said he felt “anxious” that individuals at higher chance of heart assault and stroke may well cease taking the drugs since they believed side-effects have been far higher than is the situation.

Prof Peter Weissberg, healthcare director of the British Heart Basis, stated: “The most significant threat to very good medication is prejudice, belief and anecdote.

“As human beings we are all influenced by our personalized experience. That’s why in medication we need aim proof to guide our prescribing and that comes from the randomised controlled trials.”

He mentioned the principle behind mass use of the drugs was related to that of immunisation, in that numerous individuals have to take medicine for some to be spared a stroke or heart attack.

“What we are dealing with with statins is the balance between visible harms and invisible positive aspects,” he mentioned. “Patients can always inform you about an effect which is down to the drug which they really do not like but they will not be ready to inform you whether or not they are nonetheless alive due to the fact of that drug or not.”

He stated folks could lessen their chance of heart ailment by adopting a healthful life style, and not see statins as a “soft option” to counteract a lifetime of eating burgers.

Prof George Davey Smith, professor of clinical epidemiology at the University of Bristol, said 25 years of analysis had offered definitive and clear evidence to assistance the use of statins.

He said: “The jury is no longer out on the price/benefit ratio for taking these tablets. This is not forcing the tablets down people’s throats .. it is about offering them the evidence on which to make a choice.”

The twists and turns of statins:

1980s: Statins very first licensed in the Uk

2000: New NHS standards for heart illness care advocate that statins must be given to patients assed to have a 30 per cent danger of a heart assault or stroke within a decade

2005: Nationwide Institute for Health and Clinical Excellence (Wonderful) lowers the threshold to twenty per cent

November 2013: United States healthcare guidelines which suggest the drugs for individuals with a 15 per cent threat of heart attacks, halve their thresholds to seven.five per cent. Wonderful confirms it is thinking about the identical proof which brought about the alter in US policy.

February 2014: Wonderful publishes draft proposals which lessen the threshold to 10 per cent – which means one particular in four adults would be recommended to consider statins. The amounts mean the vast bulk of guys aged over 50 and girls aged over 60 will be advisable to get the pills.

March 2014: British Health-related Journal publishes articles or blog posts which recommend that one in 5 men and women on statins will suffer side-results this kind of as liver illness and kidney problems

Might 2014: BMJ withdraws the statements and launches an investigation into whether or not the complete posts must be retracted

June 2014: 9 doctors and academics compose to Jeremy Hunt, the Well being Secretary, criticising suggestions which they say will lead to the “medicaliasation of five million healthy people.” The doctors like the head of the Royal College of Physicians say Great should not enable medical doctors with financial ties with statins to assist to draw up suggestions

1 July 2014: Panel of six top cardiologists say the attacks on statins fly in the face of proof exhibiting their rewards outweigh any dangers

18 July 2014: Great ultimate guidance is due

Fears that attacks on statins could place lives at risk

Statins, the ethics of preventive medicine, and the nocebo response | @guardianletters

The standard medical doctor-patient partnership. The GP contract can shell out physicians to encourage wholesome lifestyles, but is not that morally dubious? Photograph: Popperfoto/Popperfoto/Getty Photos

The Royal Colleges of Physicians and GPs are opposed to Good proposals for population-level prescription of statins (Medical doctors call for rethink on prescribing statins, eleven June). As 1 of the designers of the Newcastle University simulation on healthier ageing, it is gratifying to see this scenario currently being played in the true world. Coming in the very same week that we hear that one-third of the population is at high danger of kind two diabetes, probably we can consider an even far more fascinating situation: tagging obese patients with stepometers? If this is combined with rewards and penalties, the question is also ethical and philosophical, not health care: by what moral authority should medical doctors handle behaviour? A scenario today, but actuality tomorrow?

Prevention of avoidable diseases is starting up to look like the only way to save the NHS from bankruptcy, but this calls for the NHS to become a behavioural-adjust organisation that promotes specific lifestyles. The energy is there to do this. The GP contract can pay physicians to fill this new part, but is not that morally dubious? Well being follows an income gradient: the reduce the cash flow, the a lot more unhealthy the “lifestyle”. Unhealthy lifestyles of folks on lower incomes are not freely chosen. Minimal pay, unemployment, and minimal social and financial standing funnel by means of to lower self-esteem. Stress and depression improve the threat of self-treatment by way of tobacco, alcohol, sugar and fat. Lower earnings also increases your likelihood of living in poor housing, and not getting capable to afford healthful meals or exercise appropriately.

Doctors can intervene by filling individuals up with statins or forcing patients to dress in new technological innovation to monitor activity, blood sugar and cholesterol. Delivered at the population level, these measures will perform by skating in excess of the biggest trigger of poor wellness, which is low earnings. Are medical doctors prepared to do this dirty work? They have a choice. Physicians and GPs are firmly camped in the leading one% of income. As inequality is turning out to be a hot topic and we are heading towards an era when unequal incomes may possibly be addressed, may possibly the schools set an instance by voluntarily limiting doctors’ shell out to a a number of of typical earnings? Taking a hit in your own wallet is a potent stage, as befits the hallowed standing of medicine.
Kenneth Charman
Going to fellow, Changing Age Network, faculty of health-related sciences, Newcastle University

• I was interested in Sarah Boseley’s mention of the “nocebo result” (Professor at centre of statins row says public becoming misinformed, 14 June), although it didn’t quite describe the nature of this phenomenon, which truly has small if anything to do with middle age, and maybe far more to do, as she says, with people just not wanting to be on capsules. My late father, Dr Walter Kennedy, very first coined the term “nocebo response” in a health-related paper back in 1961. He utilized the Latin nocebo (“I shall injure”) as the opposite of placebo (“I shall please”) to indicate any unpleasant response to real or dummy remedy, this being a response within the patient themselves, and not due to the pharmacological action of a medication.

In other words, there is not a “nocebo effect”, only a “nocebo response”. Unfortunately, the term nocebo is occasionally utilized incorrectly for an lively drug’s unwanted pharmacologically induced unfavorable side-effects. Kennedy plainly stated that nocebo responses ought to in no way be baffled with real pharmaceutical side-results.
Dr Peter Kennedy
Wivenhoe, Essex

Statins, the ethics of preventive medicine, and the nocebo response | @guardianletters

Proof for NHS statins guidance "wholly inadequate", says specialist

He has now stopped taking them and mentioned: “I am not going back on statins unless I have the evidence”.

Great will publish its final suggestions on statins following month, after a public consultation. Its draft guidance suggests cutting the “risk threshold” for statins in half — meaning that the vast bulk of men aged in excess of 50 and most girls above the age of 60 are most likely to be recommended to consider the medication to guard towards strokes and heart condition.

Experts said the adjustments would indicate that the amount of individuals recommended to get cholesterol-lowering medication was very likely to rise from 7 million to twelve million, leaving a single in 4 grownups on the medicine.

Last week the tips was criticised by a group of nine major medical doctors and academics who said the medication could do much more harm than great.

In a letter they accused Good of an “overdependence” on research funded by the pharmaceutical business, which are kept “hidden” due to business confidentiality agreements.

The group cited research, independent of the drug sector, displaying that statins have been connected with a 48 per cent boost in the threat of diabetes in middle-aged females.

Other likely side effects could incorporate depression, fatigue and erectile dysfunction, they warned.

Prof Mark Baker, director of NICE’s centre for clinical practice, admitted the expert panel which drew up the advice had partly relied on summaries of data from the Clinical Trial Support Unit at Oxford University, which is run by Sir Rory.

Prof Baker said the total data could not be launched to Nice or independent researchers simply because the trials have been “commercially funded” and the details was owned by drugs companies.

The unit receives tens of hundreds of thousands of pounds in funding from this kind of companies, though Sir Rory has insisted its outcomes “bear no relation to our funders.”

On Saturday Sir Rory explained the group which criticised the guidance need to be “ashamed of themselves”. Such considerations in excess of statins could “cause really massive numbers of pointless deaths from heart attacks and strokes”, he advised the Guardian.

Even so Prof McPherson, who chairs the Uk Health Forum, said he supported the points raised in the letter. He known as on Sir Rory, a fellow epidemiologist, to let the data on statins trials to be scrutinised by “independent reviewers”.

Prof McPherson told The Telegraph: “It is outrageous that Great is producing these pronouncements with no seeing the information and with out the data becoming witnessed by independent reviewers.”

He added: “My interpretation of the proof base currently being utilized is that it is wholly inadequate to make this kind of a prescription.

“As far as I can inform the trials had been not correctly accomplished in the sense that there was not systematic, routine periodic double blind evaluation of high quality of existence in between therapy of handle in all these trials, which you need.

“Also, in so far as there was, none of these information are offered for public scrutiny.

“I feel Great creating these slightly draconian guidelines on the basis of such an inadequate proof basis is foolhardly.”

He added: “I have just stopped taking statins and I am significantly more agile than I was when I was on them. I want to know why, what is the proof for it. I am not going back on statins except if I have the evidence.

“You envision all this creaking an aching is a matter of aging, and it may not be.”

On Saturday Sir Rory intervened in a row more than two current academic papers in the British Health-related Journal which questioned the widespread use of statins.

The authors have both withdrawn statements right after some figures they cited had been discovered to be incorrect, and the posts are getting reviewed by the journal. Sir Rory mentioned a third party, such as the Standard Medical Council or Division of Wellness, should carry out its personal evaluation of the articles.

Proof for NHS statins guidance "wholly inadequate", says specialist

Professor who sparked statins row says government should intervene

The Oxford professor who triggered a public row over statins says the Department of Wellness and other authorities must intervene to guarantee the public will get precise details on the hazards and rewards of the possibly daily life-saving medicines.

Prof Sir Rory Collins says he has small self-confidence in an inquiry convened by the British Health-related Journal (BMJ) to determine whether or not two papers it published that made an error on the extent of side-effects need to be completely withdrawn.

The authors have retracted these statements, but Collins says as long as the papers are in circulation, they will even now wrongly undermine confidence in the drugs and he does not think the inquiry is truly independent.

Collins explained: “I never believe it is acceptable for the British Health care Journal to investigate itself,” and named on the General Medial Council, the Academy of Medical Sciences or the Department of Well being to investigate.

He additional that when the BMJ “will get things wrong, it isn’t going to correct them effectively when it truly is shown it will get factors incorrect, it doesn’t make that clear – for illustration blaming the peer reviewers when it wasn’t the peer reviewers’ fault – and they should not be in a position where they are investigating themselves. That wouldn’t be taking place in any other sphere.”

Cholesterol-reducing statins are lifestyle-savers, helping to avoid heart attacks and strokes in men and women who have already experienced 1 and are therefore at higher danger of another. But the battle now raging is above the use of the medication in healthy individuals at minimal risk.

Draft guidance from the Nationwide Institute of Well being and Care Excellence (Nice) has advisable that everybody with a risk as reduced as ten% more than 10 years (rather than 20% as now) should be eligible for statins from their GP. About seven million middle-aged men and women are now taking a everyday statin and the regulator’s proposed advice could lengthen that to 5 million much more.

This week, a single of the two BMJ authors and 7 other medical professionals, which includes the president of the Royal School of Physicians, Sir Richard Thompson, and former chair of the Royal University of GPs, Dr Clare Gerada, wrote to Good and the wellness secretary, Jeremy Hunt, asking for the guidance to be delayed. The letter questioned the rewards and side-effects in low-threat people and claimed the correct picture was distorted simply because drug companies have not place trial information into the public domain.

Thompson has declined to comment, but the British Cardiovascular Society, which represents physicians treating heart ailment, mentioned the letter he signed “does not signify the views” of its members.

Nice rejected the phone for delay. “Cardiovascular disease maims and kills people by way of coronary heart ailment, peripheral arterial disease and stroke. With each other, these kill 1 in three of us. Our proposals are intended to prevent a lot of lives becoming destroyed,” said Prof Mark Baker, director of its centre for clinical practice.

At the heart of the furore is a deep-seated concern on the element of some grassroots GPs and the public about placing men and women on pills when they are not ill. Although childhood vaccination has been really extensively accepted, the concept of a everyday drug dose to ward off illness in adulthood disturbs numerous men and women.

The two papers published by the BMJ last yr are component of a extended-operating campaign towards this “medicalisation” of lifestyle by the journal. Men and women who flip up in GP surgeries with raised cholesterol are often unfit rather than unwell. They have life-style troubles, like overweight and inactivity. Nice’s guidance says physicians should help patients in modifying their life style initial and offer statins only if they and the patient believe it proper, but some GPs concern there will be strain to put a lot more individuals on pills.

Gerada has mentioned this was the major cause she signed the letter and not any suspicion of the drug organizations. The statins story, she mentioned, “is a metaphor for what is going on today – the medicalisation of humans”.

We have, she mentioned, “paradoxical and conflicting agendas. One is patient empowerment, placing the public and patients in charge of their wellness, striving to get them to self-manage, attempting to get them to attempt to recognize the consequences of what they do and attempting to get them to self-care.” But on the other side is a distinct agenda, committed to “if it can be measured, it shall be and this concept that fit, healthful men and women who are middle-aged and elderly shouldn’t be congratulated for that. As an alternative we need to pull them in and give them medicines, just in situation.”

A middle-aged girl, for instance, could be on a statin, aspirin, HRT and perhaps vitamin D. “A complete bucket-load of medicines are currently being promoted to men and women and yet this is juxtaposed towards the self-care agenda. And at the exact same time we have the fattest individuals, the most unhealthy men and women, who are taking significantly less workout and consuming far more. So are we then getting hoodwinked into considering if we take this pill, we can abdicate accountability for all our well being requirements because we’ve taken a pill?”

Collins says he is in favour of debate, but that it is essential that folks have the facts. “I feel it is flawlessly realistic that people choose not to consider a statin or a doctor decides not to advise it, but I believe men and women ought to be ready to make an informed option.

“I am concerned that the public as a entire and physicians as a complete are being misinformed. The affect is probably to be greatest in the people in best need. I know people do not like the comparison with MMR vaccine, but the actuality of this is far worse. This has the prospective to result in very big numbers of unnecessary deaths from heart attacks and strokes and the men and women who place their names to that letter ought to be ashamed of themselves. But in my view this goes to the failure of the BMJ to deal promptly with the difficulty when it was recognized [by withdrawing the two papers].”

Fiona Godlee, editor of the BMJ, believes it has behaved totally properly. Collins criticises her appointment of Dr Iona Heath, chair of the BMJ’s ethics board but also author of a paper vital of statins some many years ago, to head the inquiry. “I required to make a choice swiftly and Iona is somebody of huge integrity who is aware of how the BMJ functions,” she said. The selection will be produced by the other folks on the panel and “will have to be really firmly justified”, she stated. All the proof will be place in the public domain. The journal will carry on to check out the concerns about medicalisation, she has mentioned.

Collins and his group at the Clinical Trials Support Unit of Oxford University are the only investigators who have witnessed the full patient-degree data for some – but not all – of the statins trials. They formed the Cholesterol Treatment Trialists Collaboration in purchase to monitor and analyse the information on statins more than the many years. His critics level out that drug firms have assisted fund his work.

Shah Ebrahim, even so, who heads the independent Cochrane collaboration crew whose overview of the rewards and side-effects of the medication led to the Wonderful recommendation, also thinks the papers ought to be withdrawn. “I have not taken money from the pharmaceutical firms. I never get aeroplane tickets paid for by pharmaceutical companies to speak at meetings. I am coming at it untarnished of influence,” he mentioned.

“I was a statins sceptic 3 many years in the past. Our second Cochrane evaluation reflected that in our cautious interpretation of what must be completed.” But over the previous couple of many years, he has altered his mind and is dismayed at the selective use of data and single studies to discredit the drugs.

“An awful good deal of loose statistics have been bandied about,” he said. The paper by Abramson and colleagues in the BMJ, he explained, “was a pitch to discredit Rory Collins’s examination and the Cochrane assessment. We wrote and mentioned they have got the sums wrong and the side-results data was spurious. They have now withdrawn that.”

Ebrahim has just lately published a key assessment not only of the side-effects information in the published trials, but also of 90 “observational scientific studies” – the side-results reviews from real people taking statins more than the years – which is not data owned by secretive drug businesses. The paper, in Biomed Central, identified that the absolute risk of dangerous unintended occasions of statins is “extremely little” in contrast to the advantages. The most significant was “weak proof” of an enhance in kind two diabetes in a modest proportion of folks on statins. “That does appear to be genuine, but it looks to be a attribute of folks who have danger elements for diabetes,” he said. It was attainable that the statins brought on the diabetes to produce earlier – but the drug would still support stop a heart attack which may well destroy them, he stated.

A lot of the controversy worries reduced ranges of side-results. Some men and women on statins complain of tiredness or muscle soreness. But in the drug trials, so did approximately equal numbers of folks unwittingly taking placebos – dummy drugs. “Potentially 17% of men and women give up taking a statin and 17% give up taking a placebo. That is the nature of tablet taking,” stated Ebrahim. At times there may be a “nocebo result” – people knowledge aches and pains in middle age that they could attribute to a drug they are taking. But occasionally, they just don’t want to be on tablets. And curiously, that is exactly the argument of the anti-medicalisation lobby.

Professor who sparked statins row says government should intervene

Jeremy Hunt need to investigate statins tips panel, says Labour

On Wednesday Prof Mark Baker, a senior Nice official, described the considerations as “completely unjustified” . None of the panel members stood to acquire financially from the guidance, he additional.

All of the back links, such as payments for sitting on advisory boards for drug companies and acquiring funding for investigation, have been formally declared to Nice and published on-line.

Nonetheless, Sarah Wollaston, a Conservative member of the Commons wellness decide on committee and a former GP, said: “This ought to lead to an examination by Good. It is a concern as this panel’s choice has this kind of widespread implications for prescribing and expense to the NHS.”

“I feel there are various levels. Sometimes the conflict of interests can be extremely small. It is about the degree of the conflict.

“I feel it is very critical that the public can clearly see what degree of conflict they have and can be confident they have the proper stability of Good specialists.

“Doctors require to have a register much like MPs do, of outdoors interests, so men and women can swiftly and simply see what their interests are. ”

She continued: “A broadly trusted independent physique demands to be in a position to examine the information as well.

“The concern is that we will end up medicating healthier people.”

Andrew Gwynne, the shadow wellness minister, extra: “Patients want to come to feel the suggestions they get can be trusted – but the lack of transparency in this method will be concerned them additional.

“Neither large firms nor individuals should stand to personally profit from choices about our care. Jeremy Hunt must launch an investigation without delay.”

Great will publish its last recommendations subsequent month, following a public consultation.

In February it announced its ideas to reduce the “risk threshold” for statins in half — meaning that the huge vast majority of guys aged over 50 and most females in excess of the age of 60 are likely to be advised to consider the medication to guard against strokes and heart disease.

Nice says the advice will prevent a lot of men and women from turning into unwell and dying prematurely.

Even so, in a letter to Mr Hunt and Great, the group of 9 doctors, which includes Sir Richard Thompson, the president of the Royal College of Doctors, cited analysis, independent of the drug industry, showing that statins have been connected with a 48 per cent boost in the chance of diabetes in middle-aged girls.

Other likely side results could contain depression, fatigue and erectile dysfunction, they warned.

Jeremy Hunt need to investigate statins tips panel, says Labour

Statins for folks at low threat of heart condition requirements rethink, say top physicians

Anybody with a ten% or higher danger of establishing cardiovascular illness in the following ten years must be eligible for treatment method with the cholesterol-busting drug statins, says the Wonderful draft proposal. Photograph: Alamy

A group of physicians, like the head of a single royal school and the former head of one more, is calling for a rethink on an NHS proposal that people at low risk of heart illness should be prescribed statins.

Sir Richard Thompson, president of the Royal School of Physicians, and Clare Gerada, a past chair of the Royal College of GPs, are two of the eight signatories of a letter to the Nationwide Institute for Health and Care Excellence (Good) and the wellness secretary, Jeremy Hunt.

The signatories are concerned that up to 5 million healthy men and women will be “medicalised”. The Wonderful suggestions, which are nonetheless in draft kind, propose that anyone with a ten% or better chance of establishing cardiovascular ailment in the subsequent ten many years need to be eligible for treatment method with the cholesterol-busting medicines.

But the appeal was firmly rejected by Great. “Cardiovascular ailment [CVD] maims and kills men and women by way of coronary heart disease, peripheral arterial disease and stroke. With each other, these kill one particular in three of us. Our proposals are meant to stop numerous lives currently being destroyed,” explained Prof Mark Baker, director of the centre for clinical practice at Wonderful.

The eight physicians say they do not think the advantages of statins outweigh the side-effects. The doctors point out that all the trial data comes from pharmaceutical organization trials, which have not been place in the public domain. “The overdependence on industry information raises considerations about achievable biases. Comprehensive evidence shows that market-funded trials systematically generate more favourable outcomes than non-business sponsored ones,” they create.

Wonderful says the draft guideline does not propose that GPs immediately prescribe tablets. Baker says doctors and individuals need to investigate the alternatives for stopping smoking, dropping excess weight, eating much more healthily, consuming less alcohol and turning out to be much more energetic.

“The independent committee of authorities found that if a patient and their physician measure the chance and determine statins are the proper decision, the evidence clearly exhibits there is no credible argument towards their safety and clinical effectiveness for use in men and women with a 10% risk of CVD more than 10 years,” Baker mentioned.

“Simply because the price tag of statins has fallen, it is also cost-effective to use them to minimize the chance of cardiovascular illness at a reduced threshold than Wonderful has previously recommended.

“This advice does not medicalise hundreds of thousands of healthier individuals. On the contrary, it will aid prevent many from turning into ill and dying prematurely. We recognise that powerful views are held by some on the two sides of the argument about the best way to use statins, but our task is to reach a balanced judgement. Worries about hidden information and the bias that the pharmaceutical industry may or may not have are important problems and need to be resolved. Wonderful is element of the energy to do that but just as the signatories to the letter will have completed in their expert careers, we need to have to act in the best interests of sufferers on the basis of what we know now.

“Last but not least, it really is really worth noting that other countries, most notably the US, have looked at the same evidence and reached similar conclusions about the prescription of statins.”

The other signatories of the letter are Prof Simon Capewell, clinical epidemiologist at the University of Liverpool, Prof David Haslam, chair of the National Weight problems Forum, GP Dr Malcolm Kendrick, cardiologist Dr Aseem Malhotra, Dr JS Bamrah, health care director of Manchester Psychological Wellness and Social Care Trust, and Prof David Newham, director of clinical investigation at the Mount Sinai School of Medicine in New York.

They say they are also concerned that GPs have misplaced self confidence in the medicines for low-risk sufferers, citing a survey by Pulse magazine and a resolution of the common practitioners committee of the British Health-related Association, which known as on Good to refrain from recommending statins for this group “unless this is supported by evidence derived from complete public disclosure of all clinical trials’ information”.

The letter is published as the British Medical Journal convenes an inquiry into the publication of two papers – one of them written by Malhotra – on statins, which manufactured claims for the scale of side-effects which have been later publicly retracted.

Statins for folks at low threat of heart condition requirements rethink, say top physicians