99. What on Earth is Going on in Australia?

In February 2013 the official advisory body on nutrition In Australia issued its latest version of the Australian Dietary Guidelines. The report produced by the National Health and Medical Research Council (NHMRC) includes new stringent advice on the consumption of sugar (1). The public is recommended to:

“Limit intake of foods and drinks containing added sugars such as confectionary [sic], sugar-sweetened soft drinks and cordials, fruit drinks, vitamin waters, energy and sports drinks”

Compare this with the advice 10 years earlier in 2003:

Consume only moderate amounts of sugars and foods containing added sugars”

The advice on alcohol is:

If you choose to drink alcohol, limit intake”

So in effect the Australians have decided that sugar should be regarded in the same way as alcoholic beverages.

In reaching this position the Council recognized that the case for limiting sugar intake had become much stronger in the last few years. Consequently there is now convincing evidence that the consumption of sugar sweetened soft drinks (SSBs) is a key factor leading to excessive weight gain in children.

In the period leading up to the preparation of this report there was a serious attempt to cast doubt on the evidence relating to the damaging effects to health of excessive sugar consumption.

A research group in the University of Sydney published a paper which claimed that as the incidence of obesity continued to increase there was actually a decrease of 23% in the total amount of sugar being consumed in Australia between 1980 and 2003. As a result it was concluded that sugar could not possibly be responsible for the growing incidence of obesity, a phenomenon referred to as the Australian Paradox (2).

In an article in “The Australian” Bill Shrapnel, a dietitian and deputy chairman of University of Sydney Nutrition Research Foundation claimed that there was no evidence to justify the recommendation to restrict the intake of sugar (3). In fact he challenged the Council to produce the relevant information. His colleague Professor Jennie Brand-Miller focusing on sugar, distracts attention from saturated fat, salt and alcohol. They both contend that policy is based on myth and that there is no science to support the advice on sugar.

Following these public statement an independent economist, Rory Robertson decided to take an interest. Prior to this he had successfully lost 10 kg simply by restricting his intake of sugar. His experience helped to convince him that sugar (and fructose in particular) is the key to solving the obesity issue. In his view the conclusions of the University of Sydney researchers just did not ring true and so he studied the Australian Paradox paper.

In his opinion the conclusion is demonstrably false for the following reasons:

  • Some of the data presented shows clearly that over the period under consideration the trend is up not down
  • The primary source of their preferred indicator was abandoned as unreliable by the Australia Bureau of Statistics 10 years previously because it was decided that it was impossible to measure how much sugar was imported as it was already present in many thousands of manufactured products
  • The authors failed to mention official information on “sugar availability” which gives a reasonably good estimate of sugar consumption and is relatively high in recent years
  • National dietary surveys, coupled with on data food imports and industry information on soft drink consumption all indicate a high level of sugar consumption.

Robertson concluded:

All in all, we are left with a clear sense that there is no “Australian Paradox”, just an idiosyncratic and unreasonable assessment – and avoidance – of the available sugar data by those who coined the phrase” (4).

Details of the Robertson objections were published in “Business Day” and as a result the journalist Michael Pascoe received a communication from Jennie Brand-Miller (5). In this she claimed that the recent high values of “sugar availability” were caused by the fact that sugar required as a feedstock for the manufacture of ethanol, which is used as a fuel. She wrote that:

“Sugar availability takes no account of food wastage, use in animal food, beer and alcohol fermentation, or in non-food industrial use, and we cannot assume that a steady portion is lost in this way. Globally, raw sugar is an important ingredient for ethanol production. In Australia, ABARE data show that ethanol production as a biofuel for transport rose from 42 million litres to 209 million litres (almost four-fold) from 2005 to 2009.”

It was stated that the increase in ethanol production would require about 14 kg per head if 100% of raw sugar was used to make it. The reply continued:

Although there are no firm figures for how much raw sugar is presently being used for ethanol production, supplies of C-molasses alone are not adequate, and the absolute amounts are likely to be increasing”

Michael Pascoe commented:

“There’s a good reason why there are “no firm figures” – sugar is not used for ethanol production in Australia, as the most cursory of Google searches on Australian biofuels would show.”

In Australia fuel ethanol is produced from red sorghum and waste products from sugar and starch production.

Pascoe then informed the Professor of his findings and she accepted that he was correct.

At this point he assumed that the authors would correct or retract the original paper but instead published the same misrepresentations of the key facts in “Australian Paradox Revisited.”

More recently a group of academics at the University of Western Australia has conducted a detailed examination of the available data on sugar supply and consumption over the last 20-30 years(6). In particular they set out determine if there is sufficiently robust data to support the existence of an Australian Paradox.

They considered that it was essential to find out how much sugar was contained in manufactured products, especially those which had been imported. It was found that if all forms of sugar in the diet are taken into account, which includes sugar contained in processed foods and drinks as well as refined sugar, there was a steady increase in imports between 1988 and 2010. Although there were also exports these were small when compared with the imports. In 2010 there was an estimated

6 g of sugar per capita per day in highly processed food products exported from Australia compared with 30 g of sugar per capita per day imported into the country via similar products.

The FAO data used in the Australian Paradox paper did not include information on sugar present in imported products. The paper concluded when the data on imported food is included that the consumption of sugar was increasing in parallel with the increasing incidence of obesity. This clearly undermines any claim for the existence of an Australian Paradox.

The University of Sydney has conducted an investigation into allegations by Rory Robertson. The report has just been published and I will go through it and report on it shortly.

REFERENCES

  1. http://www.eatforhealth.gov.au/sites/default/files/files/the_guidelines/n55_australian_dietary_guidelines.pdf
  2. http://www.australianparadox.com/pdf/OriginalAustralianParadoxPaper.pdf
  3. http://www.theaustralian.com.au/news/health-science/a-spoonful-of-sugar-is-not-so-bad/story-e6frg8y6-1226090126776
  4. http://www.australianparadox.com/pdf/DitchingSugar27032012.pdf
  5. http://www.smh.com.au/business/pesky-economist-wont-let-big-sugar-lie-20120725-22pru.html
  6. W Rikkers et al (2013) http://www.biomedcentral.com/content/pdf/1471-2458-13-668.pdf

 

98.The High-Cholesterol Paradox

This is a repost by Glyn Wainwright which originally appeared on

bit.ly/1fkGYgb

I am very grateful  to Glyn for permission to post here. He can be contacted at
@Cholesterol_OK

Based upon a presentation to the European Conference WAPF London 2014

Glyn Wainwright MSc MBCS CITP CEng

Independent Researcher, Leeds UK

The Paradox

Being told you have ‘high cholesterol’ is commonly taken as a sign of an unhealthy destiny. Research suggests that for many elderly people the news that they have ‘high cholesterol’ is more often associated with good health and longevity (1).

 

For over 50 years this has been a paradox, the ‘High-Cholesterol Paradox’. What is really going on?

Hypothesis becomes Dogma

In the 1950s the prestigious American MD, Dr Ancel Keys (2), supported a popular theory that heart disease was caused by dietary Fats and Cholesterol (Lipids) circulating in the blood. In 1972 a British Professor, Dr John Yudkin (3), published a book called ‘Pure, White and Deadly’ which proposed over-consumption of refined sugar as the leading cause of diabetes and heart disease. The science was contested by ‘interested parties’, and the matter was resolved by ‘government decree’ in a US Senate report. On Friday January 14th 1977, Senator George McGovern’s Senate Select Committee on Nutrition and Human Needs published ‘Dietary Goals for the United States’.

This document sided heavily with Dr Keys’ lipid theory. Thus ‘hypothesis became dogma’, without the benefit of scientific proof. The McGovern report recommended that we consume more carbohydrates (sugar generating foods) with more limited amounts of fats, meat and dairy. Since the 1970s there has been a rise in the use of High-Fructose Corn Syrups in processed food, and the introduction of low-fat foods which tend to have added sugar to make them attractive to eat.

Until the 1970s there had been a small but consistent percentage of overweight and obese people in the population. By the 1980s obesity rates had begun to climb significantly. This sudden acceleration of obesity is very closely associated with the adoption of new high-sugar, low-fat formulations in processed foods – the consequences of the McGovern report recommendations being adopted around the world.

Advice to reduce our intake of saturated fats, obtained from meat and dairy, caused a rise in the use of plant based oils and so-called ‘vegetable fats’. This was misleadingly promoted as healthy. The biochemical destiny of dietary ‘Saturated Fat’ is not the same as that of excess ‘Carbohydrates and Sugars’.

Fats do not cause obesity or disease. It is the excess sugars (glucose and fructose – High Fructose Corn Syrup HFCS) which create abdominal obesity (4).

The erroneous idea, and fear, of artery blocking fats was exploited to market fat substitutes. Invite anyone talking about ‘artery blocking fats’ to hold a pat of butter in a closed fist. As the butter melts and runs out between their fingers, ask ‘How do fats, which are evolved to be fluids at body temperature, block the vascular ‘pipes’ in our bodies?’

Plant oils are not the natural lipids for maintaining healthy human or animal cell membranes. Animal sourced fats, and essential fatty acids (EFA), are identical to those we require for the maintenance of the healthy human body.

Let us explore some more big anomalies in the last 40 years of dietary health guidance.

Good Cholesterol? Bad Cholesterol? Spot the Difference?

All biochemists can confirm that all cholesterol molecules throughout the known universe are identical in every respect. So how can there be ‘good’ or ‘bad’ cholesterol. It is now possible to frighten people with unscientific descriptions like ‘Good’ and ‘Bad’ when talking about cholesterol.

This single misleading description may have prevented a whole generation from knowing the true causes of the very real disturbance in the levels of fatty nutrients (Lipids) circulating in our blood (4).

Healthy Lipids

If the total blood serum cholesterol (TBSC) is high and the organs are getting enough lipids, the blood lipid circulation is healthy. The large parcels of fatty nutrients (LDL lipids) sent by the liver are consumed by our organs (receptor-mediated endocytosis) and the smaller fatty wrappers and left-over lipids (HDL Lipids) return to the liver. The Fatty Nutrients (LDL) and the recycled lipids (HDL) are in balance. Such a healthy-lipid ‘High-Cholesterol’ person is well nourished and likely to have a long and healthy life.

Damaged Lipids

If the total blood serum cholesterol is high but the fatty nutrient droplets (LDLs) have sugar-damaged labels, the organs are unable to recognise and feed on them. The supply of fatty nutrients to organs is broken.

The liver continues to supply fatty nutrients (albeit with damaged LDL labels), but the organs’ receptors are unable to recognise them. The organs thus become starved of their fatty nutrients. Like badly labelled parcels in a postal service, the sugar-damaged lipids build up in the blood (raised LDL) and fewer empty wrappers are returned to the liver (low HDL).

LDL (erroneously called ‘bad’ cholesterol) is raised in the blood, awaiting clearance by the liver. There is less HDL (erroneously called ‘good’ cholesterol) being returned by the organs.

High Cholesterol (high levels of total blood serum cholesterol TBSC) when caused by damage to the LDL lipid parcels is a sign that lipid circulation is broken. These fats (LDL) will be scavenged to become visceral fats, deposited around the abdomen. This type of damage is associated with poor health

So it really doesn’t matter how high your total blood serum cholesterol (TBSC) is. What really counts is the damaged condition of the blood’s fatty nutrient parcels (LDL lipids). In our research review of metabolic syndromes (4) (e.g. diabetes, heart disease, obesity, arthritis and dementia) we explained that the major cause of lipid damage was sugar-related.

Sugar Damage (AGEs)

The abbreviation AGE (Advanced Glycation End-product) is used to describe any sugar-damaged protein. As we age, excessive amounts of free sugars in the blood (5)may eventually cause damage quicker than the body can repair it. The sugars attach by a chemical reaction and the sugar called fructose is known to be 10 times more reactive, and therefore more dangerous than our normal blood sugar (glucose). Since the 1970s we have been using increasing quantities of refined fructose (from high-fructose corn syrup). Its appealing sweetness, and ability to suppress the ‘no longer hungry’ receptor (6)(ghrelin receptor) is driving excessive food intake. Its ability to damage our fatty nutrients and lipid circulation is also driving waist-line obesity and its associated health problems (4,7).

Checking for Damage in our Lipids

There is a ‘simple to administer’ commonly available blood test used to check for sugar-damage. It is used to check the proteins in the blood of people who are diabetic or at risk of becoming diabetic. It tests for Glycated Haemoglobin (HbA1c) by counting the proportion of damaged molecules (per 1000) of Haemoglobin protein in the blood (mmol/mol). Researchers looking at ways of testing for damage to lipids, have found that sugar-damaged blood protein test (HbA1c), presents a very reasonable approximation of the state of sugar-damage in the blood lipids. Until there is a good general test for sugar-damage in blood lipids, this test (HbA1c) could be a sensible surrogate. This is a better way of assessing health than a simple cholesterol test (TBSC).

Improved sugar-damaged blood protein (HbA1c) scores in diabetic patients is accompanied by improvements in their lipid profiles. This could be very useful to anyone wanting to improve health outcomes by managing lifestyle and nutrition.

Clinical Consequences of Lowering Cholesterol

In 2008 Dr Luca Mascitelli asked me to examine a paper by Xia et al (8). It was very interesting to note that lowering cholesterol by as little as 10% (molecular in cell walls) in the pancreas (pancreatic beta-cells) prevented the release of insulin (cholesterol-mediated exocytosis). This paper described a mechanism by which ‘cholesterol lowering drugs’ directly cause diabetes. It was known that in statin drug trials which looked at glucose (blood sugar) control there was poor blood-sugar control in the statin user groups. Since 2011 the USA government (FDA) required statins to carry a warning about the risk of causing diabetes (9).

Memories are made of this – Cholesterol

The healthy human brain may only be 5% of body weight but it requires over 25% of the body’s cholesterol. The nervous system uses huge quantities of cholesterol for insulation, protection and structure (myelin). F W Pfrieger et al. (10) have shown that the formation of the memory (synapses) is dependent on good supplies of cholesterol.

Post-mortem studies show that depleted cholesterol levels in the cerebrospinal fluids are a key feature of dementias. It was also reported that behavioural changes and personality changes are associated with low levels of cerebrospinal cholesterol.

In another review paper on Dementia we commented extensively on the damage done by fructose and the depletion of cholesterol availability. Low cholesterol levels in the nervous system are not conducive to good mental health.

Consequences of Lowering Cholesterol

Drug treatments which lower cholesterol are acknowledged to cause adverse side-effects (ADRs) in at least 10% of Statin users (11). This figure may be as high as 30%. Conservative estimates indicate that in at least 1% of patients the side-effects are serious enough to be life threatening (e.g. Rhabdomyelitis, Dementia, Behavioural Disorders and Violence).

Our review (12) found that cholesterol lowering therapies were implicated in:

? Damage to muscles (including the heart) and exercise intolerance (13)

? Increased risk of Dementias (Impaired Synaptogenesis and Neuro-transmission) (14)

? Failure of Myelin Maintenance (Multiple Sclerosis Risks) (15)

? Neuro-muscular problems, aches and pains (Amyotrophic Lateral Sclerosis) (16)

? Diabetes (Insulin release inhibited) (8)

? Poor Maintenance of Bones and Joints

? Suppression of protective skin secretions (Apo-B) and increased MRSA infection (17)

Why would anyone want to lower cholesterol

What is needed is a lowering of damage to lipids – caused by sugar.

REFERENCES

1. Weiss, A., Beloosesky, Y., Schmilovitz-Weiss, H., Grossman, E. & Boaz, M. Serum total cholesterol: A mortality predictor in elderly hospitalized patients.

Clin. Nutr. Edinb. Scotl. 32, 533–537 (2013).

2. Mancini, M. & Stamler, J. Diet for preventing cardiovascular diseases: light from Ancel Keys, distinguished centenarian scientist.

Nutr Metab Cardiovasc Dis 14, 52–7 (2004).

3. Yudkin, J.

Pure, white and deadly: how sugar is killing us and what we can do to stop it. (2012).

4. Seneff, S., Wainwright, G. & Mascitelli, L. Is the metabolic syndrome caused by a high fructose, and relatively low fat, low cholesterol diet?

Arch. Med. Sci. AMS 7, (2011).

5. Bierhaus, A., Hofmann, M. A., Ziegler, R. & Nawroth, P. P. AGEs and their interaction with AGE-receptors in vascular disease and diabetes mellitus. I. The AGE concept.

Cardiovasc Res 37, 586–600 (1998).

6. Lindqvist, A., Baelemans, A. & Erlanson-Albertsson, C. Effects of sucrose, glucose and fructose on peripheral and central appetite signals.

Regul. Pept. 150, (2008).

7. Seneff, S., Wainwright, G. & Mascitelli, L. Nutrition and Alzheimer’s disease: the detrimental role of a high carbohydrate diet.

Eur. J. Intern. Med. 22, 134–140 (2011).

8. Xia, F.et al. Inhibition of cholesterol biosynthesis impairs insulin secretion and voltage-gated calcium channel function in pancreatic beta-cells.

Endocrinology 149, 5136–45 (2008).

9. FDA publication. FDA Expands Advice on STATIN RISKS. (2014). at http://www.fda.gov/downloads/ForConsumers/ConsumerUpdates/UCM293705.pdf

10. Pfrieger, F. W. Role of cholesterol in synapse formation and function.

Biochim Biophys Acta 1610, 271–80 (2003).

11. Roger Vadon (Producer). BBC File on 4 Statins. (2008).

12. G Wainwright, L Mascitelli & M Goldstein. Cholesterol-lowering therapy and cell membranes. Stable plaque at the expense of unstable membranes?

Arch. Med. Sci. 5, 289–295 (2009).

13. Hall, J. B.Principles of Critical Care – Rhabdomyolysis and Myoglobinuria. (McGraw Hill 1992, 1992).

14. Mauch, D. H.et al. CNS synaptogenesis promoted by glia-derived cholesterol.

Science 294, 1354–7 (2001).

15. Klopfleisch, S.et al. Negative impact of statins on oligodendrocytes and myelin formation in vitro and in vivo.

J Neurosci 28, 13609–14 (2008).

16. Goldstein, M. R., Mascitelli, L. & Pezzetta, F. Dyslipidemia is a protective factor in amyotrophic lateral sclerosis.

Neurology 71, 956; author reply 956–7 (2008).

17. Goldstein, M. R., Mascitelli, L. & Pezzetta, F. Methicillin-resistant Staphylococcus aureus: a link to statin therapy?

Cleve Clin J Med 75, 328–9; author reply 329 (2008).

 

Continuing Professional Development (CPD) WAPF talk accredited by:

The Naturopathic Nutrition Association

Federation of Nutritional Practitioners (FNTP)

British Association of Applied Nutrition (BAAN)

British Association of Nutritional Therapy (BANT

 

 

 

 

97. NICE but Naughty

So NICE has decided to go ahead with its proposal to recommend that those with a 10% risk of developing heart disease should be considered for treatment with statins. In an article in the BMJ, Professor Mark Baker, the director of the Centre for Clinical Practice at the NICE, stated that 77 people would need to take statins for 3 years for one to benefit (1). He justified this on the grounds that with blood pressure lowering drugs, 104 patients would have to be treated for one to benefit.

My initial reaction is to suggest that it is about time Mark Baker started living in the real world. In my experience, the vast majority of patients agree to take drugs on the strict understanding that it almost certainly will have an impact, which applies to them personally. If patients were actually told that there was only a one in 50 or even a one in a 100 chance that the drug would work in their case, how many would be prepared to undergo the treatment? Furthermore when the possibility of side-effects is factored into the equation, a person would have to absolutely desperate to have the treatment when the possibility of benefit is so small.

Baker’s response reminds me of the good old days in Belfast when somehow or other certain individuals had more than one vote in elections. One person was most indignant when he was accused of having 13 votes, because in reality he only had 9!!!

Surely it is time for legislation to be introduced, which will make it a mandatory requirement for the chances of success as well as the risks of side-effects to be presented to patients before agreeing to any form of drug therapy. After all it is standard practice to spell out the risks and chances of success before a person agrees to an operation so why should treatment with drugs be any different?

So to get back to the statins, let us consider what Baker does not tell us. The figures quoted only apply to those who have heart disease in the past. However when statins are used for primary prevention, which effectively is what is being proposed, there is no benefit in terms of improvement in life expectancy. Although there may be a very small benefit with respect to heart disease and strokes, this is more than outweighed by increased risks of developing diabetes and muscle damage (2). Baker also fails to mention that there is not a shred of reliable evidence to demonstrate that statins have any benefit whatsoever in women. In fact a comprehensive study conducted in Norway has found that for women from about age 60, when most deaths occur, the higher the cholesterol level the greater the life expectancy(3). The justification for using stains is primarily that they will lower cholesterol, which certainly does not make sense in the light of this information.

On side-effects Baker was incredibly complacent. He dismissed claims that GPs had reported seeing far more side effects from statins than were reported in the published trials. In his view:

The best evidence comes from placebo controlled trials, which show similar levels of side effects in statins and in placebos”.

He went on to say:

“Muscle pain has little or nothing to do with statins, and serious complications are extremely rare.” Furthermore the claims of a multitude of side effects:

“simply aren’t true”(1).

These statements beggar belief. As Dr David Newman points out, it often takes years of post-marketing surveillance (i.e., observational) studies and case reports for dangerous side effects to emerge. It is evident that these will not be picked up during trials, which usually focus on benefits and in any case are not specifically designed to get an accurate assessment of the adverse side-effects. A particular example is the Heart Protection Study, which was conducted in 2002 with Professor Rory Collins, director of the CTT project at Oxford University, as one of the leading investigators. This study commenced with 32,000 potential participants, who appeared to meet the criteria for treatment with statins. However about 12,000 of them were removed from the study because they had difficulty tolerating or taking a statin. In the publication of the results, information was limited to 20,000 who actually took part in the trial. What this means is that those with significant side-effects were eliminated before the trial commenced (4).

In the Women’s Health Initiative, data were collected from 153,840 postmenopausal women who were clear of diabetes at the start of the investigation. During the study, 10,242 participants developed diabetes. It was found that those who were on statins were 48% more likely to contract the disease. The results applied to all types of statin medication (5). This is undoubtedly a real effect. During the past 15 years here in the UK the incidence of diabetes has approximately doubled. There must be a strong possibility that the increased usage of statins has contributed to this increase. It is a particularly serious form of ill-health, which is not usually cured by medication.

Other adverse side-effects that have been reported include depression, memory loss, confusion and erectile dysfunction (6).

The reality is that the NICE position on statins is fundamentally flawed in the sense that it totally ignores relevant information which would have a critical influence on the final recommendation. In the past I have acted as external examiner for many Ph.Ds and I have no hesitation in concluding that this report is not up to standard.

It really is time that that Jeremy Hunt and his ministerial colleagues got a grip on things. This latest NICE recommendation will cost about £50 million to implement. Any marginal benefits will undoubtedly be more than counter-balanced by the adverse side-effects. In fact the net effect may well be a further deterioration in public health. There is simply no way that this expenditure can be justified. If this is true of statins, how many other drugs are currently being prescribed regularly for which the benefits are minimal or maybe even damaging to health?

Politicians seem to be cowed into submission by the specialists in the medical world. Yet the reality is that many of the issues are relatively straight forward. People like Mark Baker must not be allowed to get away with sweeping generalizations but should be required to present a proper logical case for the decisions they reach. If the Minister is unable or unwilling to demand answers to the crucial issues then he would be well advised to initiate an independent inquiry, which should be led by a person outside the medical profession and the pharmaceutical industries. A barrister or judge might be the most suitable person for such a task.

Alternatively this could be an ideal opportunity for the Parliamentary Committee on Health to pick up the baton.

The fact is that the current situation is an absolute disgrace and until it is addressed the NHS will continue to spend money on drugs with very little benefit to patients.

REFERENCES

  1. http://www.bmj.com/content/349/bmj.g4694
  2. http://www.thennt.com/nnt/statins-for-heart-disease-prevention-without-prior-heart-disease/
  3. http://vernerwheelock.com/?p=105
  4. http://www.huffingtonpost.com/david-h-newman-md/assault-on-science_b_5423957.html
  5. http://archinte.jamanetwork.com/article.aspx?articleid=1108676
  6. http://drmalcolmkendrick.org/2014/06/27/another-backlash-begins/

 

 

96.Has Evidence Based Medicine lost its mind?

NICE has just announced that the proposal for all those with a 10% risk of developing heart disease should be offered statins has been confirmed. Effectively this means virtually everyone because even with the healthiest, fittest person there must be at least a 10% chance heart disease will cause their death. Perhaps “the great and the good” in NICE might care to reflect on what this means in practice. This is neatly illustrated in the story below by Pam Olver. I am very grateful to her for permission to publish it.

She can be contacted via her website at http://thismissionispossible.wordpress.com/enter-here/

And on Twitter @kiwikaidoc

This is Pam

Image

 

 

Posted on Thursday 17 July 2014 by thegintree

Have I lost my Mind? Or has Evidence based medicine failed itself?

Last night was a pretty ordinary night at the accident and urgent medical centre where I was doing an evening rostered shift. There was nothing extraordinary about Ted* (not his real name). In fact there was nothing extraordinary about his presentation either. Just another octogenarian. He could have been your dad or grandad, your brother or uncle. A person, an individual. Someone who is dear to you. Evidence based medicine has turned him into ‘just another octogenarian’. But he is Ted. He is a person, not a number. He is not actually quite the same as any other octogenarian even if they have the same clinical diagnoses. But evidence based medicine has turned everyone like Ted into generic Ted.

Let me tell you more. You can decide what to make of the story. You can decide what you would do.

Ted arrived at the after hours medical centre with his daughter. That’s what they had been told to do. “Arrive after 5 and someone will see you”. He was from out of town and staying with his daughter to recuperate from his foot infection. He had been staying with another daughter who lived a 45 minute drive from his usual place of residence. You see, Ted at the age of 81 was till living independently at his own house, near to his own GP. But he had an infected foot and was staying with his daughter. He then travelled here to stay with another daughter. She wasn’t sure how long it would be for. But he was going to run out of his medication. But the locum GP at his regular practice would not do a repeat prescription for him as he/she hadn’t seen him before. So now he was in my waiting room. He needed more pills and his foot was still painful. Oh, and he was constipated and just wanted a ‘good shit’. He didn’t need to be in an urgent care facility where there are 2 doctors and a full waiting room. He did need care. But this story is not about that kind of care (important nonetheless).

He had the requisite medipac of drugs. I right cocktail. At least he brought them along because he didn’t have a clue what the pills were or what they were for other than he’d had a ‘heart attack’ in January. Prior to this he had been on no medication at all. Nada. Nothing. And he had got to 81. Pretty good in my eyes.

The medicine list:

Aspirin 100mg daily

Metoprolol 23.5 mg daily

Enalipril 2.5 mg bd

Atorvastain 80mg daily (I kid you not!)

Ticagrelor

That’s exactly what happens when Evidence Based Guidelines are used for generic Teds. Except that Ted is Ted, not generic Ted.

But Ted came in also for review and dressings on his sore foot. It looked rather like a diabetic foot to me. He had a lovely macerated digital space between is 4th and 5th toes. But he is not diabetic. His finger prick glucose was 11. Pretty high considering he ate last at lunchtime.

The elephant in the room: are these drugs of any benefit at all for Ted? He has no idea of any benefits. He takes them because the doctor at the hospital discharged him on these because he ‘had a heart attack’. Because that’s everyone who has a heart attack gets. Ted is not everyone. Ted is Ted. What actual benefits will Ted get from this cornucopia of drugs.In all likelihood none at all. And about the side effects and drug interactions?

We know that there is a correlation between statin use and diabetes. And 80mg? Better than poison. We know that beta blockers aren’t that good if you have diabetes. And aspirin in the elderly – quite a high risk of bleeding. And ticagralor? Is there any safety data for use in the elderly? So here is Ted with his muscles very likely affected by his high dose statin, and a sore foot. That increases his risk of falling. So does blood pressure medication. Falls in the elderly have a high morbidity and mortality – broken hips, brain bleeds – and he is on two drugs that can make bleeding worse.

So is it possible then that drug side effects have contributed to his sore foot and increased his morbidity (and mortality) risk? If so, it means that the medicines he has been prescribed ‘because he had a heart attack’ may not be doing anything useful for Ted at all, but may indeed reduce his quality of life. Did anybody bother to ask Ted what he might want for himself. It’s called informed consent.

Ah, well at least Ted might not die from a heart attack. But will he live longer or better?

 

95. Mainstream Nutrition Myths (Debunked by Science)

This is a repost with permission which has been written by Kris Gunnars. I am very grateful to him for his agreement to publish here. This is an up-to-date commentary, which accurately summarises the deficiencies and problems of the current official advice promoted in many different countries.

He can be contacted via his web site which is at http://authoritynutrition.com/about/

Mainstream nutrition is full of nonsense.

Despite clear advancements in nutrition science, the old myths don’t seem to be going anywhere.

Here are 20 mainstream nutrition myths that have been debunked by scientific research.

Myth 1: The Healthiest Diet is a Low-Fat, High-Carb Diet With Lots of Grains

Several decades ago, the entire population was advised to eat a low-fat, high-carb diet (1).

At the time, not a single study had demonstrated that this diet could actually prevent disease.

Since then, many high quality studies have been done, including the Women’s Health Initiative, which is the largest nutrition study in history.

The results were clear… this diet does not cause weight loss, prevent cancer OR reduce the risk of heart disease (2345).

Bottom Line: Numerous studies have been done on the low-fat, high-carb diet. It has virtually no effect on body weight or disease risk over the long term.

Myth 2: Salt Should be Restricted in Order to Lower Blood Pressure and Reduce Heart Attacks and Strokes

 

The salt myth is still alive and kicking, even though there has never been any good scientific support for it.

Although lowering salt can reduce blood pressure by 1-5 mm/Hg on average, it doesn’t have any effect on heart attacks, strokes or death (67).

Of course, if you have a medical condition like salt-sensitive hypertension then you may be an exception (8).

But the public health advice that everyone should lower their salt intake (and have to eat boring, tasteless food) is not based on evidence.

Bottom Line: Despite modestly lowering blood pressure, reducing salt/sodium does not reduce the risk of heart attacks, strokes or death.

Myth 3: It is Best to Eat Many, Small Meals Throughout The Day to “Stoke The Metabolic Flame”

 

It is often claimed that people should eat many, small meals throughout the day to keep the metabolism high.

But the studies clearly disagree with this. Eating 2-3 meals per day has the exact same effect on total calories burned as eating 5-6 (or more) smaller meals (910).

Eating frequently may have benefits for some people (like preventing excessive hunger), but it is incorrect that this affects the amount of calories we burn.

There are even studies showing that eating too often can be harmful… a new study came out recently showing that more frequent meals dramatically increased liver and abdominal fat on a high calorie diet (11).

Bottom Line: It is not true that eating many, smaller meals leads to an increase in the amount of calories burned throughout the day. Frequent meals may even increase the accumulation of unhealthy belly and liver fat.

Myth 4: Egg Yolks Should be Avoided Because They Are High in Cholesterol, Which Drives Heart Disease

 

We’ve been advised to cut back on whole eggs because the yolks are high in cholesterol.

However, cholesterol in the diet has remarkably little effect on cholesterol in the blood, at least for the majority of people (1213).

Studies have shown that eggs raise the “good” choleserol and don’t raise risk of heart disease (14).

One review of 17 studies with a total of 263,938 participants showed that eating eggs had no effect on the risk of heart disease or stroke in non-diabetic individuals (15).

However… keep in mind that some studies have found an increased heart attack risk in diabetics who eat eggs (16).

Whole eggs really are among the most nutritious foods on the planet and almost allthe nutrients are found in the yolks.

Telling people to throw the yolks away may just be the most ridiculous advice in the history of nutrition.

Bottom Line: Despite eggs being high in cholesterol, they do not raise blood cholesterol or increase heart disease risk for the majority of people.

Myth 5: Whole Wheat is a Health Food and an Essential Part of a “Balanced” Diet

 

Wheat has been a part of the diet for a very long time, but itchanged due to genetic tampering in the 1960s.

The “new” wheat is significantly less nutritious than the older varieties (17).

Preliminary studies have shown that, compared to older wheat, modern wheat may increase cholesterol levels and inflammatory markers (1819).

It also causes symptoms like pain, bloating, tiredness and reduced quality of life in patients with irritable bowel syndrome (20).

Whereas some of the older varieties like Einkorn and Kamut may be relatively healthy, modern wheat is not.

Also, let’s not forget that the “whole grain” label is a joke… these grains have usually been pulverized into very fine flour, so they have similar metabolic effects as refined grains.

Bottom Line: The wheat most people are eating today is unhealthy. It is less nutritious and may increase cholesterol levels and inflammatory markers.

Myth 6: Saturated Fat Raises LDL Cholesterol in The Blood, Increasing Risk of Heart Attacks

 

For decades, we’ve been told that saturated fatraises cholesterol and causes heart disease.

In fact, this belief is the cornerstone of modern dietary guidelines.

However… several massive review studies have recently shown that saturated fat is NOT linked to an increased risk of death from heart disease or stroke (212223).

The truth is that saturated fats raise HDL (the “good”) cholesterol and change theLDL particles from small to Large LDL, which is linked to reduced risk (242526).

For most people, eating reasonable amounts of saturated fat is perfectly safe and downright healthy.

Bottom Line: Several recent studies have shown that saturated fat consumption does not increase the risk of death from heart disease or stroke.

Myth 7: Coffee is Unhealthy and Should be Avoided

Coffee has long been considered unhealthy, mainly because of the caffeine. However, most of the studies actually show that coffee has powerful health benefits.

 

This may be due to the fact that coffee is the biggest source of antioxidants in the Western diet, outranking both fruits and vegetables… combined (272829).

Coffee drinkers have a much lower risk of depression, type 2 diabetes, Alzheimer’s, Parkinson’s… and some studies even show that they live longer than people who don’t drink coffee (3031323334).

Bottom Line: Despite being perceived as unhealthy, coffee is actually loaded with antioxidants. Numerous studies show that coffee drinkers live longer and have a lower risk of many serious diseases.

Myth 8: Eating Fat Makes You Fat… so if You Want to Lose Weight, You Need to Eat Less Fat

 

Fat is the stuff that is under our skin, making us look soft and puffy.

Therefore it seems logical that eating fat would give us even more of it.

However, this depends entirely on the context. Diets that are high in fat AND carbs can make you fat, but it’s not because of the fat.

In fact, diets that are high in fat (but low in carbs) consistently lead to more weight loss than low-fat diets… even when the low-fat groups restrict calories (353637).

Bottom Line: The fattening effects of dietary fat depend entirely on the context. A diet that is high in fat but low in carbs leads to more weight loss than a low-fat diet.

Myth 9: A High-Protein Diet Increases Strain on The Kidneys and Raises Your Risk of Kidney Disease

 

It is often said that dietary protein increases strain on the kidneys and raises the risk of kidney failure.

Although it is true that people with established kidney disease should cut back on protein, this is absolutely not true of otherwise healthy people.

Numerous studies, even in athletes that eat large amounts of protein, show that a high protein intake is perfectly safe (383940).

In fact, a higher protein intake lowers blood pressure and helps fight type 2 diabetes… which are two of the main risk factors for kidney failure (4142).

Also let’s not forget that protein reduces appetite and supports weight loss, but obesity is another strong risk factor for kidney failure (4344).

Bottom Line: Eating a lot of protein has no adverse effects on kidney function in otherwise healthy people and improves numerous risk factors.

Myth 10: Full-Fat Dairy Products Are High in Saturated Fat and Calories… Raising The Risk of Heart Disease and Obesity

 

High-fat dairy products are among the richest sources of saturated fat in the diet and very high in calories.

For this reason, we’ve been told to eat low-fat dairyproducts instead.

However, the studies do not support this. Eating full-fat dairy product is not linked to increased heart disease and is even associated with a lower risk of obesity (45).

In countries where cows are grass-fed, eating full-fat dairy is actually associated with up to a 69% lower risk of heart disease (4647).

If anything, the main benefits of dairy are due to the fatty components. Therefore, choosing low-fat dairy products is a terrible idea.

Of course… this does not mean that you should go overboard and pour massive amounts of butter in your coffee, but it does imply that reasonable amounts of full-fat dairy from grass-fed cows are both safe and healthy.

Bottom Line: Despite being high in saturated fat and calories, studies show that full-fat dairy is linked to a reduced risk of obesity. In countries where cows are grass-fed, full-fat dairy is linked to reduced heart disease.

Myth 11: All Calories Are Created Equal, It Doesn’t Matter Which Types of Foods They Are Coming From

 

It is simply false that “all calories are created equal.”

Different foods go through different metabolic pathways and have direct effects on fat burning and the hormones and brain centers that regulate appetite (484950).

A high protein diet, for example, can increase the metabolic rate by 80 to 100 caloriesper day and significantly reduce appetite (515253).

In one study, such a diet made people automatically eat 441 fewer calories per day. They also lost 11 pounds in 12 weeks, just by adding protein to their diet (54).

There are many more examples of different foods having vastly different effects on hunger, hormones and health. Because a calorie is not a calorie.

Bottom Line: Not all calories are created equal, because different foods and macronutrients go through different metabolic pathways. They have varying effects on hunger, hormones and health.

Myth 12: Low-Fat Foods Are Healthy Because They Are Lower in Calories and Saturated Fat

 

When the low-fat guidelines first came out, the food manufacturers responded with all sorts of low-fat “health foods.”

The problem is… these foods taste horrible when the fat is removed, so the food manufacturers added a whole bunch of sugar instead.

The truth is, excess sugar is incredibly harmful, while the fat naturally present in food is not (5556).

Bottom Line: Processed low-fat foods tend to be very high in sugar, which is very unhealthy compared to the fat that is naturally present in foods.

Myth 13: Red Meat Consumption Raises The Risk of All Sorts of Diseases… Including Heart Disease, Type 2 Diabetes and Cancer

 

We are constantly warned about the “dangers” of eating red meat.

It is true that some studies have shown negative effects, but they were usually lumping processed and unprocessed meat together.

The largest studies (one with over 1 million people, the other with over 400 thousand) show that unprocessed red meat is not linked to increased heart disease or type 2 diabetes (5758).

Two review studies have also shown that the link to cancer is not as strong as some people would have you believe. The association is weak in men and nonexistent in women (5960).

So… don’t be afraid of eating meat. Just make sure to eat unprocessed meat and don’t overcook it, because eating too much burnt meat may be harmful.

Bottom Line: It is a myth that eating unprocessed red meat raises the risk of heart disease and diabetes. The cancer link is also exaggerated, the largest studies find only a weak effect in men and no effect in women.

Myth 14: The Only People Who Should go Gluten-Free Are Patients With Celiac Disease, About 1% of The Population

 

It is often claimed that no one benefits from a gluten-free diet except patients with celiac disease. This is the most severe form of gluten intolerance, affecting under 1% of people (6162).

But another condition called gluten sensitivity is much more common and may affect about 6-8% of people, although there are no good statistics available yet (6364).

Studies have also shown that gluten-free diets can reduce symptoms of irritable bowel syndrome, schizophrenia, autism and epilepsy (65666768).

However… people should eat foods that are naturally gluten free (like plants and animals), not gluten-free “products.” Gluten-free junk food is still junk food.

But keep in mind that the gluten situation is actually quite complicated and there are no clear answers yet. Some new studies suggest that it may be other compounds in wheat that cause some of the digestive problems, not the gluten itself.

Bottom Line: Studies have shown that many people can benefit from a gluten-free diet, not just patients with celiac disease.

Myth 15: Losing Weight is All About Willpower and Eating Less, Exercising More

 

Weight loss (and gain) is often assumed to be all about willpower and “calories in vs calories out.”

But this is completely inaccurate.

The human body is a highly complex biological system with many hormones and brain centers that regulate when, what and how much we eat.

It is well known that genetics, hormones and various external factors have a huge impact on body weight (69).

Junk food can also be downright addictive, making people quite literally lose control over their consumption (7071).

Although it is still the individual’s responsiblity to do something about their weight problem, blaming obesity on some sort of moral failure is unhelpful and inaccurate.

Bottom Line: It is a myth that weight gain is caused by some sort of moral failure. Genetics, hormones and all sorts of external factors have a huge effect.

Myth 16: Saturated Fats and Trans Fats are Similar… They’re The “Bad” Fats That we Need to Avoid

 

The mainstream health organizations often lump saturated and artificial trans fats in the same category… calling them the “bad” fats.

It is true that trans fats are harmful. They are linked to insulin resistance and metabolic problems, drastically raising the risk of heart disease (727374).

However, saturated fat is harmless, so it makes absolutely no sense to group the two together.

Interestingly, these same organizations also advise us to eat vegetable oils like soybean and canola oils.

But these oils are actually loaded with unhealthy fats… one study found that 0.56-4.2% of the fatty acids in them are toxic trans fats (75)!

Bottom Line: Many mainstream health organizations lump trans fats and saturated fats together, which makes no sense. Trans fats are harmful, saturated fats are not.

Myth 17: Protein Leaches Calcium From The Bones and Raises The Risk of Osteoporosis

 

It is commonly believed that eating protein raises the acidity of the blood and leachescalcium from the bones, leading to osteoporosis.

Although it is true that a high protein intake increases calcium excretion in the short-term, this effect does not persist in the long-term.

The truth is that a high protein intake is linked to a massively reduced risk of osteoporosis and fractures in old age (767778).

This is one example of where blindly following the conventional nutritional wisdom will have the exact opposite effect of what was intended!

Bottom Line: Numerous studies have shown that eating more (not less) protein is linked to a reduced risk of osteoporosis and fractures.

Myth 18: Low-Carb Diets Are Dangerous and Increase Your Risk of Heart Disease

Low-carb diets have been popular for many decades now.

 

Mainstream nutrition professionals have constantly warned us that these diets will end up clogging our arteries.

However, since the year 2002, over 20 studies have been conducted on the low-carb diet.

Low-carb diets actually cause more weight loss and improve most risk factors for heart disease more than the low-fat diet (7980).

Although the tide is slowly turning, many “experts” still claim that such diets are dangerous, then continue to promote the failed low-fat dogma that science has shown to be utterly useless.

Of course, low-carb diets are not for everyone, but it is very clear that they can havemajor benefits for people with obesity, type 2 diabetes and metabolic syndrome… some of the biggest health problems in the world (81828384).

Bottom Line: Despite having been demonized in the past, many new studies have shown that low-carb diets are much healthier than the low-fat diet still recommended by the mainstream.

Myth 19: Sugar is Mainly Harmful Because it Supplies “Empty” Calories

 

Pretty much everyone agrees that sugar is unhealthy when consumed in excess.

But many people still believe that it is only bad because it supplies empty calories.

Well… nothing could be farther from the truth.

When consumed in excess, sugar can cause severe metabolic problems (8586).

Many experts now believe that sugar may be driving of some of the world’s biggest killers… including obesity, heart disease, diabetes and even cancer (87888990).

Although sugar is fine in small amounts (especially for those who are physically active and metabolically healthy), it can be a complete disaster when consumed in excess.

Myth 20: Refined Seed- and Vegetable Oils Like Soybean and Corn Oils Lower Cholesterol and Are Super Healthy

Vegetable oils like soybean and corn oils are high in Omega-6 polyunsaturated fats, which have been shown to lower cholesterol levels.

But it’s important to remember that cholesterol is a risk factor for heart disease, not a disease in itself.

Just because something improves a risk factor, it doesn’t mean that it will affect hard end points like heart attacks or death… which is what really counts.

The truth is that several studies have shown that these oils increase the risk of death, from both heart disease and cancer (919293).

Even though these oils have been shown to cause heart disease and kill people, the mainstream health organizations are still telling us to eat them.

They just don’t get it… when we replace real foods with processed fake foods, we become fat and sick.

How many decades of “research” does it take to figure that out?

94. Growing doubt on statin drugs — the problem of drug-lifestyle interaction

This is a repost with permission which has been written by Dr John Mandrola. I am very grateful to him for his agreement to publish here.

He can be contacted via his web site which is at http://www.drjohnm.org/

Introduction

My mind is changing about statins. I’m growing increasingly worried about the irrational exuberance over these drugs, especially when used for prevention of heart disease that is yet to happen.

An elderly patient called my office last week to tell me thank you…not for a successful procedure or surgery, but rather, for helping with a problem that had dogged her for a decade. How did an electrophysiologist help a patient without doing a procedure?

I stopped her statin.

A few weeks later, the patient said, her muscle and joint pain were gone. “I thought it was arthritis. I’m walking now. I haven’t felt this good in years. I’ve even lost 5 pounds.”

So why was this elderly patient on a statin?

It was being used to lower cholesterol in the hopes that it would lower the risk of a future heart attack or stroke. This is called primary prevention. The patient had no vascular disease but had a high cholesterol level.

The problem of course is that statins have not been well-studied in elderly women. Her doctor, and the medical establishment writ large, have extrapolated findings of clinical trials on younger mostly male patients to all patients with high cholesterol levels. This is a striking jump to make given that low cholesterol levels in the elderly associate with higher death rates.

Anecdotes are not evidence but this one moved me to review some of the statin evidence. And to think (again) about treating people versus disease.

As always, let’s start with the truth–absolute not relative values. Then I will move on to some new revelations about statins, and then an interesting theory of why potent cholesterol-lowering drugs have such painfully small effects on overall cardiovascular outcomes.

The Truths:

When statins are used in low-risk patients without heart disease (primary prevention) there is no mortality benefit. That’s right. Your chance of dying are the same on or off the drug, regardless of how much the statin lowers the cholesterol level.

When statins are used for primary prevention there is a small lowering of future vascular events (stroke/heart attack) over 5-10 years. The absolute risk reduction is in the range of 7 per 1000. That means you have to treat 140 patients with a statin (for five years) to prevent one event. Or this: for 99.3% of statin-treated patients, there is no benefit. I like to call this the PSR or percent same result.

There is also general agreement that statins increase the risk of developing diabetes, especially in women, and that risk is about the same as preventing a stroke or heart attack, approximately 1%.

Another fact is that patient-level (raw) data from the industry-sponsored cholesterol trials have not been independently analyzed. Systematic reviews from the Cochrane group have analyzed only published data rather than the raw data. There is likely a difference.

There is great debate about the incidence of statin side effects, such as muscle pain, cognitive issues, decreased energy, sexual problems, kidney and liver injury, among others. In the industry-sponsored randomized controlled clinical trials, discontinuation of statins was not significantly different from placebo. Observational data, and the observations of any clinician, provide a different picture.

No statin drug has ever been compared to lifestyle interventions for the prevention of cardiovascular disease.

New Revelations:

A study presented in April 2014 at the Society of General Internal Medicine Meeting in San Diego showed that individuals prescribed statin therapy for high cholesterol consumed more calories and more fat than non-statin users. And, not surprisingly, this increase in calories paralleled an increase in BMI (Body Mass Index) in statin users.

An analysis of a prospective cohort study of men (published in JAMA-IM) revealed that physical-activity levels were “modestly” lower among statin users compared with nonusers independent of other cardiac medications and of medical history.

Possible Connecting Theory: Drug-Lifestyle Interaction

These two recent studies are troublesome. As pointed out in the excellent coverage from heartwire journalist Michael O’Riordan, there may be an interaction between medication and lifestyle. Namely, if statin users consume more calories, gain weight and exercise less it becomes easy to see why cardiovascular benefits are so small.

It’s been really hard to explain why the striking reductions in bad cholesterol (LDL)–up to 30-50%–from statins hasn’t translated into significant future benefit.

One possibility is that cholesterol levels are a lousy surrogate for outcomes. That surely seems true in the elderly, but what about in younger patients and those with familial high cholesterol? These patients are definitely at increased cardio-vascular (CV) risk. So cholesterol levels are surely not unimportant. There is convincing data, for instance, that higher HDL (good cholesterol) levels associate with lower CV risk.

Another possibility for lack of statin benefit is analogous to AF rhythm-control and high blood pressure issues. As in, yes, it’s better to be in regular sinus rhythm and have normal blood pressure, but getting to those goals with pills isn’t the same as being there naturally. With rhythm-control and blood pressure drugs the achievement of the desired outcome is muted by side effects from the drugs. Perhaps it’s the same with statin drugs?

You don’t have to posit malfeasance on the part of big pharma here. All you have to do is think past the disease-specific mindset of modern-day medicine. We are much more than our cholesterol level. A statin drug, like so many drugs which block enzyme pathways far upstream in major cellular pathways, is going to have much more biologic action than just moving an easily measured cholesterol level.

When you step back and look at medications as chemical modifiers of cellular processes in complex biologic systems like our body it’s easy to understand that health comes not from pills. Not even statins.

JMM

REFERENCES

  1. Should people at low risk of cardiovascular disease take a statin? BMJ 2013;347:f6123
  2. The above authors reply to criticism: http://www.bmj.com/content/347/bmj.f6123/rr/678736
  3. The Cholesterol Myth | YouTube video of Australian TV investigative journalism piece: http://youtu.be/F0kIC-dbW2gMore commentary on statin drugs…
  4. CW: Really good news about the safety of statin drugs
  5. Statins are so misunderstood…
  6. Statin drugs are much more than cholesterol lowering agents…
 
 

93. Latest: Statins may Prevent Breast Cancer

The pharmaceutical industry is desperate to find ways of justifying the use of statins and the most recent attempt relates to breast cancer. According to press reports, a cardiologist, Rahul Potluri, at Aston University has discovered that women with a high level of cholesterol in their blood also have an increased risk of developing breast cancer. This was based on an analysis of data collected from over 600,000 women in the UK. Dr Potluri suggests that this may lead to a clinical trial to see if treatment with statins over a period of 10 to 15 years would reduce the incidence of breast cancer, especially in those with high levels of cholesterol.

While it maybe true that women with breast cancer have higher levels of cholesterol than those who do not, this certainly does not mean that the high cholesterol is the cause of the breast cancer. It is possible that the cancer is causing the high cholesterol or maybe there is some other common factor which has an effect on both the incidence of the breast cancer and the blood cholesterol. There may be no link whatsoever and it is purely coincidence that explains the findings.

Secondly, even if there is some type of relationship, reducing the cholesterol level does not necessarily prevent breast cancer developing. Although it is claimed that statins are beneficial to patients with heart disease because they lower the blood cholesterol, some researchers argue that the effect is due to a reduction in inflammation and that the cholesterol lowering is irrelevant.

Thirdly, it has been established that in women, those with the highest cholesterol values have the greatest life expectancy (1). This means that there is absolutely no reason why any woman with a high cholesterol value would wish to lower it. If we assume that the level of cholesterol is a critical factor which influences the incidence of various diseases and ultimately a person’s life expectancy then there can be no possible justification for any procedure which would effectively increase the risk of dying. I can only speculate that those who continue to push the case for the use of statins in women are unaware of this crucial information or perhaps they just choose to ignore it. It is also worth pointing out that there is absolutely no credible evidence which confirms that statins are beneficial for women, even in those who suffer from heart disease.

Although this story has had substantial coverage in the press it is quite fascinating to note some of the comments from readers. Here are some examples:

  • Another ploy to sell statins. Do the drug companies pay these scientists to issue such B/S., I bet they do. Statins are dangerous, the evidence is overwhelming.
  • Good grief, they really are desperate to sell these things aren’t they? All they are doing is revealing how much political power that pharmaceutical companies now wield
  • Statins are becoming these wonder drugs that will cure your every illness, that now includes breast cancer. Total hogwash. The only thing that statins are good for is making huge profits for the pharmaceutical companies
  • The creation and research of statins has cost hundreds of millions. The pharma companies are now trying to maximise profits by “proving” that they are good and do help. Remember a few months back the article about how statins don’t help that much? It was shut down in days as the pharma companies have too much to lose. In fact there were hundreds of studies showing statins do nothing other than harm yet the handful of studies that were anomalous got through and are touted as the truth.
  •  Gave up on Statins 4 years ago, best thing I’ve ever done.

SOURCE: Daily Mail

  • Doling out statins to all and sundry is irresponsible medicine. Statins are a very dangerous medication that should be avoided if at all possible, and it usually is. Do yourself a favour: Tell your doctor to shove them where the monkey shoves its nuts, i.e. where the sun don’t shine
  • You have to hand it to the pharma industry and the government: statins simply must be taken by as many people as possible!So now it’s breast cancer, something half the population is scared off. Perhaps next month they’ll tell us it prevents Alzheimers?The study hasn’t even got any results yet, but I bet millions of women will now ask their GP to give them statins – result!
  • Its breast cancer now, but what about the diabetes the knackered liver and the knackered kidneys that they cause
  • These drugs have the effect of rendering one stupid, brain function is dependent upon cholesterol
    Reduce people to simpletons, then sell them the drugs to offset the dementia that the statins bring on, nice work if you can get it.
    In summary, the only motive here is money, the effects are irrelevant to the producers.

SOURCE: Daily Telegraph

  • This is not about our health just the massive profits of Big Pharma. They don’t really care if we end up with muscle weakness, leg cramps and depression. Been there, done that and threw the ruddy pills on the fire
  • Blah, blah, blah. Good grief! Guardian are you so desperate to fill space that you must keep encouraging this kind of pseudo-scientific nonsense drip-fed by big pharma and their tame “scientists”?
  • Why is the Guardian littering its website with press releases that promote the use of an already over-prescribed drug? Word’s like ‘could’ and ‘suggest’ smack of PR

SOURCE: The Guardian

So it seems there are plenty of individuals who have an appreciation of the way in which the drug companies continue to push their products. While it is certainly helpful to have these comments, it is regrettable that the journalists who write the articles accept the information at face value. In doing so they are playing into the hands of the drug companies which must be to the detriment of their readers. It really is time for those reporting on issues of this type to adopt a much more critical and sceptical approach than is evident at present.

REFERENCE

  1. http://vernerwheelock.com/?p=105

 

92. Is Vitamin D the Answer to Diabetes?

Compared with the population as a whole, those with a high Vitamin D status have almost 90% less diabetes. This is the remarkable result obtained in a study initiated by Grassroots Health, which is dedicated to understanding the role of Vitamin D and promoting its benefits (1). It is responsible for D*action, which is an international public health project to solve the vitamin D deficiency epidemic. It was founded by Carole Baggerley, who had successfully conquered breast cancer, which she largely attributed to Vitamin D.

This particular study was conducted by Dr Cedric Garland of the University of California at San Diego. Dr Garland is a respected academic who along with his brother Frank (now deceased) discovered the link between exposure to sunshine and the incidence of bowel cancer by collecting and analysing data from the various states in the USA. This then focused attention on the role of Vitamin D and stimulated the recent research conducted over the past 30 years or so, which has demonstrated that most people do not have sufficient and would greatly improve their health by raising the level of Vitamin D in their bodies.

The results are shown in Table 1. NHANES, is the National Health and Nutrition Examination Survey, which is genuinely representative of the US population. It is evident that the much higher level of Vitamin in the Grassroots participants is more than double that of the NHANES participants.

Table 1. Incidence of diabetes and serum levels of Vitamin D in US and in Grassroots populations (2)

  NHANES Grassroots
Diabetes incidence, per 1000 person years 8.5 0.9
Average Vitamin D serum levels, ng/ml (nmol/l) 22(55) 53(130)

 

There is a discussion between Carole Baggerley and Cedric Garland on You Tube which is well worth watching (3).

http://www.youtube.com/watch?v=Cakw11ufk9A&feature=youtu.be

While these are preliminary results they are nevertheless extremely significant and their importance cannot be underestimated. In particular, the relatively high levels in the serum of those with a low incidence of diabetes must be recognised. Dr Garland emphasised that if the serum level can be pushed up about 60 ng/ml (150 nmol/L) that diabetes would be virtually eliminated and that this could be achieved very quickly, possibly within a year. Furthermore it applies to both Type 1 and Type 2 diabetes. There is absolutely no danger associated with daily doses of up to 10,000 IU.

Although the Scientific Advisory Committee on Nutrition(SACN) is currently considering Vitamin D, an update was published in 2007 (4). At that time an adequate serum concentration was considered to be 25 nmol/l. This is much lower than the average NHANES value. However it also recognised that some researchers advocated values higher than 75 nmol/l, SACN did not make any recommendation. The results of the Grassroots study demonstrate that even higher values must be reached if the maximum benefits are to be achieved.

Vitamin D can be produced in the body as a result of exposure to sunlight. But this will only happen if people spend time outside during the summer months and allow the sunlight to contact the skin. However in the typical climate of the British Isles, we do not always have enough sunshine at the height of the summer and certainly not during the rest of the year. The quantities present in foods are not capable of supplying what is actually needed. Hence supplements must be taken.

The update confirmed the Dietary Reference Value for pregnant and breast feeding women as 400 International Units (IU). This is just far too low. Much higher intakes of the order of 5,000 IU or even more must be taken to achieve the levels in the blood to control diabetes.

This investigation by Grassroots is just another one of many studies which confirms the crucial importance of Vitamin D as a critical and essential nutrient. In addition it is now evident that the previous thinking on the requirements was based primarily on the prevention of rickets. The recent improvement in our understanding makes it very clear that Vitamin D has a key role in many different organs and that the requirement to satisfy these functions fully is considerably higher than originally envisaged.

Other examples of the benefits to health of Vitamin D are:

  • Participants in trial with a supplement of 1100 IU Vitamin D plus calcium achieved a reduction of 77% in the incidence of breast cancer as compared with those taking a placebo (5)
  • In a study in south west Germany involving over 3,000 men and women who were high risk for heart disease it was found that those with a blood serum level of >75 nmol/L had one quarter the death rate of those whose level was  <25 nmol/L. It was noteworthy that despite the very different death rates the cholesterol values and the BMIs were virtually the same (6)
  • In pregnant women carrying twins it was found that those with serum Vitamin D of >75 nmol/L had a 60% reduction in the odds of pre-term birth compared those whose serum Vitamin D was <75 nmol/L (7).

For those interested in a comprehensive account of the Vitamin D story, I can recommend “The Vitamin D Solution” by Michael Holick (8).

From a public health perspective, there is no question that diabetes is the big issue. The fact that the incidence has doubled in the last 15 years and is continuing to rise shows very clearly it is a major threat. Many people are condemned to a miserable existence possibly having to lose limbs by amputation.  Those with diabetes have a much increased risk of developing various cancers, heart disease and Alzheimer’s Disease. Despite all the efforts and expenditure, progress in controlling the diabetes has been disappointing (9). The existing strategies are obviously not working.

The information here provides convincing evidence that most people do not have anything like enough Vitamin D in their system. I realize that there will still be calls for more research before policies can be devised. However the position is absolutely dire and if not addressed immediately will undoubtedly continue to get even worse. Encouraging everyone to take a supplement of Vitamin D would pay rapid dividends. For a start, a daily intake of 1000 IU would make a huge difference. Even if this is done on a pilot scale initially, almost certainly benefits would be observed within a relatively short time-frame. Ideally a programme of monitoring is needed but if necessary could be introduced at a later stage. The benefits would be huge, the costs relatively small and the risks of harm negligible. If this approach is combined with the recent SACN proposal to reduce sugar then we really could crack the diabetes problem. As this is just the tip of the iceberg, we might also expect progress with respect to heart disease, cancers and Alzheimer’s. A “no-brainer” if ever there was one.

I would not be surprised if such an initiative gets the “thumbs down” from the “great and the good” in the medical and public health professions. Nevertheless the time bomb is ticking away and we have the means to address it. It remains to be seen if there is any politician with the confidence and determination to take on the vested interests and the dinosaurs. I wish I could be more hopeful!!!

REFERENCES

  1. http://www.grassrootshealth.net/
  2. http://grassrootshealth.net/index.php?option=com_content&view=article&id=193
  3. http://www.youtube.com/watch?v=Cakw11ufk9A&feature=youtu.be
  4. http://www.sacn.gov.uk/pdfs/sacn_position_vitamin_d_2007_05_07.pdf
  5. http://ajcn.nutrition.org/content/85/6/1586.full.pdf
  6. G N Thomas et al (2012) Diabetes Care 35 (5) pp1158-1164
  7. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3706065/
  8. M F Holick (2010) “The Vitamin D Solution: A 3-Step Strategy to Cure Our Most Common Health Problems” Plume (Penguin) New York
  9. Remy Boussageon et al (2011) http://www.bmj.com/content/343/bmj.d4169.pdf%2Bhtml

91. Science Media Centre Briefing on Statins

The Science Media Centre describes itself as:

“an independent press office helping to ensure that the public have access to the best scientific evidence and expertise through the news media when science hits the headlines”(1).

A recent briefing by the Centre covered the proposal by NICE to extend the use of statins to a much greater number of patients. According to a report in the BMJ, six leading professors of cardiology and epidemiology stated their conviction that the evidence from trials amply justified their confidence that the benefits of statins outweighed any risks (2). It was somewhat surprising that the briefing was so heavily weighted on the pro-statin side of the argument. Fiona Fox, director of the centre defended this position on the grounds that:

“The “vast majority” of cardiac and statin experts believed that the evidence was overwhelming, she said, and it was not the centre’s job to provide a platform to a minority who did not and thereby project a false image that the debate was in equipoise when it was not…”

This stance really does beggar belief. It would appear that Ms Fox is not well informed about this topic and that as far as this issue is concerned the Centre has not provided a balanced perspective. A more accurate picture has been painted by Ben Goldacre in the BMJ when he wrote:

On the one hand, we have clinicians and researchers insisting that no sane patient would refuse a safe simple treatment that reduces their chances of a heart attack by one in 200; on the other, we have clinicians and researchers insisting that one in 200 is a laughable and trivial benefit, which no sensible patient could ever care about(3).

Here are a few extracts from the responses in the BMJ which show that there is definitely not universal support for the NICE proposal on statins:

  • “Medicalisation of five million healthy individuals. We believe that the benefits in a low risk population do not justify putting approximately five million more people on drugs that will then have to be taken lifelong, without knowing enough about the side effects……… It is a concern that 8 members of NICE’s panel of 12 experts have had direct financial ties to the pharmaceutical companies that manufacture statins” (4).

Sir Richard Thompson, President of the Royal College of Physicians and 7 others

  • “I am in no doubt, both personally and from the reported experience of my patients, that statin side-effects are consistently under-reported. This occurs two ways; firstly, doctors airily dismiss symptoms reported by patients (“statins could not possibly cause that!”), and secondly it is unusual for well-recognised side-effects such as rhabdomyolysis or even non-specific muscle pains to be yellow-carded. In my view the potential severity of muscle symptoms justifies extreme caution” (5).

Andrew N Bamji Retired Consultant Rheumatologist

  • “Putting approximately five million more people in the UK on drugs, that will then have to be taken lifelong, for primary prevention of CVD without knowing enough about the side effects is foolhardy. The data on side effects needs to be made public and scrutinised by well qualified independent assessors. My own epidemiological experience of published results from industry funded studies comes from 3rd generation OCs and HRT. In each case there was strong evidence for industry bias in the published results“ (6).

Klim McPhersonVisiting Professor of Public Health Epidemiology, New College Oxford

One wonders why the Science Media Centre has allowed such a one-sided briefing. Could it be that there has been a failure to research the subject properly (eg by reading the BMJ and other reputable journals) or it has allowed itself to be unduly influenced by the pharmaceutical industry?. Whatever the reason, any reputation the Centre has established will have suffered.

If the Centre wishes to limit the damage then it must immediately have another briefing on statins which accurately reflects the current state of reliable information (not opinions!) on the benefits as a preventive measure, coupled with the genuine concerns about adverse side-effects.

REFERENCES

  1. http://www.sciencemediacentre.org/
  2. http://www.bmj.com/content/348/bmj.g3306
  3. http://www.bmj.com/content/348/bmj.g3306/rr/759401
  4. http://www.bmj.com/node/759197
  5. http://www.bmj.com/node/758202
  6. http://www.bmj.com/node/759198

 

 

 

90. Why is Nutrition in such a Mess?

I well remember all the hype surrounding the publication of the NACNE (National Advisory Committee on Nutrition Education) report in the early 1980s (1). The main thrust of this was that the national diet had deteriorated to such an extent that it was responsible for the relatively high level of chronic diseases, especially heart disease and certain cancers. Particular interest was generated because of allegations that the government of the day had attempted to suppress the document. Eventually The Lancet published the report. It presented quantitative recommendations for reductions in the consumption of fat, saturated fat, sugar and salt. It also recommended an increase in the intake of dietary fibre.

Despite the reluctance on the part of government, the official COMA (Committee on Medical Aspects of Food Policy) was instructed to review the evidence and effectively confirmed the NACNE recommendations. This was then endorsed as government policy. Subsequently the main emphasis was on the fat and the saturated fat in terms of the health promotion strategies and the response by the food industries.

COMA recommended that the saturated fat intake should be reduced from 20% of food energy to 15% as part of a strategy to reduce cardiovascular disease (2). This target was reached by 2000(3). In fact the National Food Survey shows that the intake of saturated fat has fallen from 56.7 g/day in 1969 to 29.2 g/day in 2000(4). What is very clear is that the predicted improvements in public health certainly have not materialised. The incidence of obesity has continued to increase. In men it has doubled since 1993, which is when detailed information was first collected (5). Even more worrying is that since 1994 the incidence of diabetes has more than doubled for both men and women (6).

The position in the UK is mirrored in the USA. In an article in the New York Times, published earlier this year , Gary Taubes provides valuable insight into the failing of nutrition which help to explain why there are fundamental flaws in the current approach to public health nutrition(7).

Taubes points out that over 600,000 scientific papers and articles have been published on these topics in the last 50 years. So why have we made so little progress? In his assessment , which I fully support, the conventional explanation is that:

“Type 2 diabetes is caused or exacerbated by obesity, and obesity is a complex, intractable disorder. The more we learn, the more we need to know.”

He goes on to suggest another possibility, which seems eminently sensible:

“The 600,000 articles — along with several tens of thousands of diet books — are the noise generated by a dysfunctional research establishment. Because the nutrition research community has failed to establish reliable, unambiguous knowledge about the environmental triggers of obesity and diabetes, it has opened the door to a diversity of opinions on the subject, of hypotheses about cause, cure and prevention, many of which cannot be refuted by the existing evidence. Everyone has a theory. The evidence doesn’t exist to say unequivocally who’s wrong.”

The necessary high quality research into human nutrition is expensive because it is so complex and investigations have to continue for a long time, if the results are to be valid. In the real world this is usually just not feasible even in countries such as the USA, which is relatively well off. The inevitable consequence is that the vast majority of researchers have adjusted their sights by accepting a lower standard of evidence than is required to reach conclusions that are genuinely worthwhile.

This means adopting various approaches include the following:

  • Using laboratory animals to do experiments and then hoping the results can be extrapolated to humans which may or may not be true
  • Conducting experiments for a relatively short period (in terms of the human lifespan) on a specific group of humans and then assuming they applicable for the entire lifetime. It is also very common for results obtained with middle-aged men to be applied to men and women of all ages.
  • Making observational studies to find out the relationships between a particular disease and the consumption of selected foods. Once an association is established it is often assumed to demonstrate cause and effect even though there is no direct evidence that this is actually the case. Other possibilities which include another separate cause which affects both factors may be totally ignored

This situation is completely unacceptable but it seems to be the way things are done. While it is blindingly obvious to anyone who makes an objective analysis that present policies are not working. Indeed this is part of the problem and the fact remains that they continue to be implemented. Here in the UK the government persists with its Responsibility Deal which requires that the food industry takes steps to reduce even further the amount of saturated fat which is present in the typical British diet. The fact that substantial reductions have already been achieved while public health continues to deteriorate is shrugged off because it would mean that the politicians and the leading lights in the medical and public health professions would have to admit that that the original advice was wrong.

The reality is that although researchers would justify their approaches on the grounds that this is the best they can d. This simply is not good enough. Rigorous standards are essential if research dealing with human nutrition is to have any meaning. Hopefully ways can be found to obtain the requisite funding…… perhaps a small levy on the sales of food. If not, surely it is preferable to admit that we just do not know rather than effectively guessing what policies to adopt thereby running the risk of doing more harm than good!!

REFERENCES

  1. Ad hoc working party of National Advisory Committee on Nutrition Education(1983) . Proposals for nutritional guidelines for health education in Britain. . London: Health Education Council.
  2. Department of Health and Social Security (1984) “Diet and Cardiovascular Disease” London: HMSO
  3. http://webarchive.nationalarchives.gov.uk/20130103014432/http://www.defra.gov.uk/statistics/files/defra-stats-family-food-nfs-nfsexcan.xls
  4. http://webarchive.nationalarchives.gov.uk/20130103014432/http://www.defra.gov.uk/statistics/files/defra-stats-family-food-nfs-nutshist.xls
  5. Health Survey of England 2010 Adult Trend Tables
  6. Health Survey for England 2009
  7. Gary Taubes (2014). http://www.nytimes.com/2014/02/09/opinion/sunday/why-nutrition-is-so-confusing.html?_r=0