114. Potential Breakthrough in South Africa

There is now overwhelming evidence that the decision to advise consumers to reduce the amount of fat and saturated fat (SFA) in the diet has turned out to be one of the most disastrous mistakes in the history of public health policy. As people implemented the recommendations it was inevitable that there was a corresponding increase in the intake of sugar and carbohydrates. This was driven by the promotion of “low fat” products, many of which were formulated by replacing the fat with sugar. In addition, there has been a phenomenal growth in the sales of soft drinks, which usually have a very high content of sugar. The changes in food consumption patterns have been accompanied by increases in the incidence of obesity, although this has tailed off a bit recently in the UK. Even more seriously, diabetes is now a major problem. Here in the UK the incidence has doubled in the past 15 years and it is expected to continue increasing. Diabetes is especially worrying because it is associate with increased risk of heart disease, cancer and Alzheimer’s Disease. The NHS in England currently spends almost £1Billion on drugs to treat diabetics, while the cost of all treatment is about £10 Billion. It is reaching the point where it is becoming unsustainable.

The solution is blindingly obvious. The cause has to be removed. Diabetes is caused by excessive levels of glucose in the blood. If the amount of sugar and starch, which is broken down to glucose, is restricted in the diet then it follows that there will be less available for absorption from the gut into the blood. The logic is irrefutable. This is fully supported by reliable scientific research and a huge number of personal case histories from individuals who have reduced their intake of sugar and refined carbohydrates. It should also be appreciated that most of this can be replaced by fats, especially the SFAs, which are valuable nutrients in their own right (1). For more details of current thinking on nutrition I can recommend “the Diet Delusion” (2) by Gary Taubes and “Big Fat Surprise” by Nina Teicholz (3).

The big hurdle is that the majority of those in the medical and public health professions are not prepared to accept this relatively “new” understanding and interpretation. The fundamental issue is that most of those in a position to initiate a U-turn have been active proponents of the existing policies which have failed so miserably. There are probably several reasons for this.

  • They have closed minds and simply cannot adjust their thinking. As a result they perform all sorts of contortions in rather pathetic attempts to justify the status quo
  • They choose to ignore the new information and the consequences
  • They just cannot face up to the fact that they have been wrong in the past and therefore presented patients and governments with advice that was faulty.

There are also very powerful business interests, including food, pharmaceuticals and weight loss which would be adversely affected if there was a big shift in policy.

At present there is little doubt that the reactionary forces hold the upper hand simply because virtually all politicians are not prepared to challenge the relevant “experts”. This may seem bizarre but it does appear they lack the ability and the confidence to do so.

However the hard reality is that we are largely dependent on the politicians to initiate action. This is why we need to watch developments in South Africa very carefully indeed.

The story starts with Professor Tim Noakes, Professor of Sports Medicine at the University of Cape Town (UCT). For most of his life he had followed the conventional dietary guidelines. He was also very active as he went running most days and had competed in over 70 marathons and ultramarathons. About 4 years ago he started to question the rationale behind the dietary he was following and promulgating to others. As a consequence he decided that the advice was fundamentally flawed and so he went through the painful process of changing his mind. His current position is explained in an interview (4). He explains the rationale in a lecture given in 2012 (5).

Within the last few weeks Tim Noakes was invited to address members of the South African Parliament , where he obviously made a significant impact(6). As a result there is already an initiative to implement some of the proposals suggested. This really is a very big step forward and it is to be hoped that sooner rather than later, there will be moves to re-formulate the public health policies in order to alter the national patterns of food consumption.

However it will not be plain sailing because there has been a backlash from other academics in UCT, who wrote a letter which condemning the stance taken by Noakes. It was signed by Prof Wim de Villiers Dean of Faculty of Health Sciences, Prof Bongani Mayosi, Head of Department of Medicine, and emeritus professor, cardiologist Dr Lionel Opie, and Dr Marjanne Senekal, associate professor and Head of Division of Human Nutrition.

Here is the letter in full:

“The apparent endorsement by Members of Parliament of South Africa of the latest fashionable diet, ‘Banting’ (‘SA’s Ticking Time-bomb’, Cape Times, 19 August 2014) and the message it sends out to the public about healthy eating, is cause for deep concern – not only regarding Parliament’s support for it as an evidenced-based ‘diet revolution’, but sadly, the long-term impact this may have on the health of the very people they have been elected to serve.

“Any diet for weight loss and maintenance should be safe and promote health in the long-term. Currently the long term safety and health benefits of low carbohydrate, high fat diets – such as Atkins, Paleo and South Beach, and in which Banting falls – are unproven, and in particular whether it is safe in pregnancy and childhood.

“Importantly, while the consumption of a low carbohydrate, high fat diet may lead to initial weight loss and associated health benefits – as indeed would a balanced weight loss diet – there is good reason for concern that this diet may rather result in nutritional deficiencies, increased risk for heart disease, diabetes mellitus, kidney problems, constipation, certain cancers and excessive iron stores in some individuals in the long term. Research leaves no doubt that healthy balanced eating is very important in reducing disease risk (see web page below dedicated to this debate).

“It is therefore a serious concern that Professor Timothy Noakes, a colleague respected for his research in sports science, is aggressively promoting this diet as a ‘revolution’, making outrageous unproven claims about disease prevention, and maligning the integrity and credibility of peers who criticise his diet for being evidence-deficient and not conforming to the tenets of good and responsible science. This goes against the University of Cape Town’s commitment to academic freedom as the prerequisite to fostering responsible and respectful intellectual debate and free enquiry.

” This is not the forum to debate details of diets, but to draw attention to the need for us to be pragmatic. Research in this field has proven time and again that the quest for lean and healthy bodies cannot be a quick-fix , ‘one- size-fits-all’ solution. The major challenge lies in establishing sustainable and healthy dietary and physical activity patterns to promote long term weight maintenance and health after weight loss, and includes addressing psychosocial, environmental and physiological factors.

“Our bodies need a range of nutrients sourced from a variety of food groups to survive. Diets like the Banting are, however, typically ‘one dimensional’ in focus. They promote increased intake of protein and fat containing foods at the expense of healthy carbohydrate containing foods, and focus on adherence to a limited food plan. Ignored are the other important factors impacting on health – like physical activity (the important of which we cannot emphasise enough), environmental factors, and individual health profiles.

“UCT’s Faculty of Health Sciences, a leading research institution in Africa, has a reputation for research excellence to uphold. Above all, our research must be socially responsible. We have therefore taken the unusual step of distancing ourselves from the proponents of this diet. To foster informed engagement of the issues related to the Diet debate, the Faculty has established a (page on its website) with material on this.”

And this is the reply:

For whatever reasons, the Faculty of Health Sciences of the University of Cape Town manages consistently to misrepresent my public message which is simply the following: a high carbohydrate diet is detrimental to the health of persons with insulin resistance whereas carbohydrate restriction in this group can be profoundly beneficial as it can reverse obesity and in some cases Type 2 diabetes mellitus, the two conditions that will ultimately bankrupt South African medical services unless we take appropriate preventive actions. This message first presented publicly in my book Challenging Beliefs in 2011, has never changed.

“It is also the message I presented to members of staff at Parliament a week ago.

“If that message is without scientific support, then the Faculty of Health Sciences has every right to cross the civil divide as it has now chosen; an action which, I suspect, is unprecedented in the history of the Faculty of Health Sciences and perhaps the history of the University of Cape Town. But if there is evidence for my position, then the Faculty is guilty of failing fully to inform its past and present science, medical and dietetics graduates in a manner appropriate for a Faculty that considers itself to be a world-leader.

” An outline of the scientific evidence for my position is presented in about 20 000 words in our book Real Meal Revolution. That work includes references to the most important scientific works (of an abundant literature) supporting my interpretation. For the Faculty of Health Sciences of the University of Cape Town consistently to deny that peer-reviewed evidence is a classic example of cognitive dissonance.”

CONCLUSION

In my opinion, the letter from the academics is totally unacceptable. To claim that that the ideas advocated by Noakes may:

“result in nutritional deficiencies, increased risk for heart disease, diabetes mellitus, kidney problems, constipation, certain cancers”

simply beggars belief. There is not a shred of evidence to support the statement. Similarly it is totally unjustified to accuse Noakes of

“outrageous unproven claims about disease prevention”.

If the authors of the report had bothered to examine the evidence, there is plenty. Wild unsubstantiated statements are the hallmarks of desperation.

There is a very little doubt that obesity, diabetes and related diseases have been caused by precisely the type of diet which the UCT academics support. The writers of the letter appear to be so committed to theories which have been totally discredited that are not prepared to consider any alternative. The fact is that they are advocating strategies which have been largely responsible for the current disaster in public health. They would do well to note the conclusion of Albert Einstein who defined insanity as doing the same thing over and over again and expecting a different result!

It is to be hoped that the South African politicians stick to their guns and adopt the Noakes approach to construct a completely new public health policy. This would undoubtedly produce enormous benefits for the country with huge improvements in the health of the population, which must pay off in the economy. There would also be savings in health expenditure.

Finally South Africa would establish itself as the world leader in health policy innovation, which ought to trigger similar initiatives in many other countries.

REFERENCES

  1. http://vernerwheelock.com/?p=155
  2. Gary Taubes (2007) “The Diet Delusion” Vermillion: London
  3. Nina Teicholz (2014) “The Big Fat Surprise: Why Butter, Meat and Cheese Belong in a Healthy Diet” Simon & Shuster New York
  4. http://www.biznews.com/health-biznews-com/2014/07/tim-noakes-makes-real-meal-critics-say-diet-dangerous/
  5. https://www.youtube.com/watch?v=5IYVIdztWWs#t=31
  6. http://www.iol.co.za/news/politics/sa-s-ticking-time-bomb-1.1737511

 

 

113. Can We Trust the Drug Companies?

The banking industry quite rightly suffers from public opprobrium because of its role in the financial crisis, manipulation of the bank rate and mis-selling of various products. By contrast the pharmaceutical industry is somewhat more highly regarded. Nevertheless recent examples of unethical behaviour indicate that the approach to business in this sector does not exactly embrace the highest principles of corporate social responsibility.

I have just discovered a website which provides reliable evidence on how this industry operates (1). In this blog I will refer to a number of issues which have arisen in recent years.

  • In an undercover investigation, initiated by a tip-off from a whistleblower, The Daily Telegraph discovered that pharmaceutical firms appear to have rigged the market in so-called “specials”. These are prescription drugs that are largely not covered by national NHS price regulations. Secret recordings by Telegraph reporters showed that sales representatives for drug firms offered to provide apparently falsified invoices allowing chemists to bill the NHS for sums far greater than they would spend. Hence the retailers would be able to send inflated invoices to the NHS, allowing them to pocket the difference. As a consequence it was estimated that hundreds of millions of pounds of public money has probably been wasted in recent years due to the practice (2).
  • In a Newsweek investigation, reporter Sharon Begley concludes that the framework of medical research is fundamentally flawed so that the wrong answers are being produced time and time again (3). According to John Ioannidis, who is in charge of the Prevention Research Center at Stanford University people are being hurt and dying because of false medical claims which are based faulty research.
  • In a recent blog I have described in detail how pressure was applied to the respected Cochrane Collaboration to influence the conclusions of an evaluation of statins (4). Two professors from the University of Oxford persuaded the compilers of the report to reach a conclusion favourable to statins, based on data produced by pharmaceutical companies, which was not open to independent scrutiny. Other evaluations have concluded that there is no net benefit from statins when used for primary prevention. Despite this NICE has made recommendations which effectively mean that everyone over 50 will be offered statins. Even NICE accepts that 77 people will have to treated in order that one will benefit! In the USA alone the expenditure on statins is more than $20 billion per year, much of which is probably unnecessary.
  • There are many examples of “breakthroughs” which turn out to worthless when subjected to further examination. Various studies which concluded that popular antidepressants work by altering brain chemistry have now been contradicted. A study done in 1996 which concluded that estrogen therapy reduces older women’s risk of Alzheimer’s was overturned in 2004.
  • Richard Smith, a former editor of the British Medical Journal (BMJ) is convinced that fraudulent research regularly appears in the 30,000 scientific journals currently published throughout the world. Furthermore even when fabricated or falsified research is discovered, journals rarely publish a retraction. Dr Smith is critical of the failure of scientific institutions, including universities, to discipline dodgy researchers even when alerted to problems by journals. Most cases are not publicised. Few countries have measures in place to ensure research is carried out ethically. In practice such incidents are simply not recognised, covered up altogether or the guilty researcher is urged to retrain, move to another institution or retire from research (5).
  • Ben Goldacre trained as a medical doctor and is the author of the “Bad Science” column in The Guardian. In his book “Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients,” he describes how he ended up prescribing the antidepressant reboxetine to his patients based on insufficient data. Despite the fact that there is overwhelming research which shows that the drug is ineffective, it was still approved in the U.K. In order to get approval of the drug in Europe, the manufacturer had simply kept quiet about its negative data. Seven trials had been conducted comparing reboxetine against a placebo. Only one, conducted in 254 patients, had shown a positive result, and that one was published in an academic journal, for doctors and researchers to read. But six more trials were conducted, in almost 10 times as many patients. All of them showed that reboxetine was no better than a dummy sugar pill. None of these trials was published. Goldacre had no idea they existed. It got worse. The trials comparing reboxetine against other drugs showed exactly the same picture: three small studies, 507 patients in total, showed that reboxetine was just as good as any other drug. They were all published. But 1,657 patients’ worth of data was left unpublished, and this showed that patients on reboxetine did worse than those on other drugs. He goes on to describe how drug companies hide data about medication risks that affect children, how they attempt to intimidate the employers of researchers who produce results they don’t like, and how they routinely withhold safety data in various other ways that do harm to patients (5).The fundamental problem is that the regulatory bodies, which we would reasonably expect to stamp out such practices have failed us. Drugs are tested by the people who manufacture them, in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients, and analysed using techniques that are flawed by design, in such a way that they exaggerate the benefits of treatments. There is good evidence to demonstrate that the results of research funded by drug companies are highly likely to favour the manufacturer. On the other hand if the results are not favourable then there is absolutely no obligation to make these public. Consequently doctors and patients, only ever see a distorted picture of true effects of any particular drug. In view of the fact that the drug companies are the main source of information to the medical profession this is the picture which becomes widely disseminated. This is reinforced by the fact that the same messages are promulgated through the scientific journals. Although these are usually regarded as objective the reality is that are often covertly planned and written by people who work directly for the companies, without disclosure. Sometimes whole academic journals are owned outright by a single drug company (6).

REFERENCES

  1. http://www.wanttoknow.info/pharmaceuticalcorruptionmediaarticles-0-20
  2. http://www.telegraph.co.uk/health/healthnews/10133557/Pharmaceutical-scandal
  3. http://www.thedailybeast.com/newsweek/2011/01/23/why-almost-everything-you-hear-about-medicine-is-wrong.html
  4. http://vernerwheelock.com/?p=545
  5. http://www.theguardian.com/society/2006/may/03/health.medicineandhealth
  6. http://healthland.time.com/2012/09/24/a-doctors-dilemma-when-crucial-new-drug-data-is-hidden/

 

 

 

112. Diabetes can be Cured: Change the Diet and Ditch the Drugs

As a society we seem to have been conditioned to expect that treatment with drugs and other medical procedures are the answer to every form of ill-health. Many of us feel short-changed if we come away from a visit to the GP without a subscription for one or more medicines. However the hard reality is that the NHS expenditure on drugs continues to increase. During 2013-2014 there were 45.1 million items prescribed for diabetes, with a net ingredient cost of £803.1million (1). This represents an increase of 66.5% in the number of items and 56.3% in the net ingredient cost since 2005-2006. In England it is estimated that 6% of the population has diabetes and the total cost is currently about £10billion, which is 10% of the NHS budget (2). It is estimated that by 2025 there will be 5 million people with diabetes in England (3). Those with diabetes have a reduced life expectancy and an increased risk of retinopathy, stroke, kidney failure, heart disease and amputation of limbs.

A man diagnosed with diabetes at age 40 will lose almost 12 years of life and 19 Quality Adjusted Life Years (QALYs) compared with a person without diabetes. A woman of the same age will lose about 14 years of life and 22 QALYs (4).

Unfortunately at present there is little success in controlling the disease. In the light of the current projections, it would seem that there is little confidence that there will be any improvement in the immediate future. Screening for diabetes does not seem to be effective. In a large study conducted in the East of England it was found that screening of patients with increased risk of diabetes was not associated with any reduction in all-cause, cardiovascular, or diabetes-related mortality over a 10-year period (5). There are also serious questions about the effectiveness of treatments of diabetes to lower the blood glucose. In a meta-analysis of data from 13 randomized controlled trials there was no benefit from intensive glucose lowering in terms of all-cause mortality or deaths from cardiovascular disease. in adults with diabetes (6). Furthermore, an increase in all-cause mortality of 19% cannot be ruled out. Only one study showed a protective effect on myocardial infarction but this was counterbalanced by an increase in total mortality. The authors pointed out that drugs for the treatment of diabetes are being approved on the basis of their effectiveness in lowering blood glucose, despite the fact that there is no evidence based on clinically relevant criteria.

The fundamental problem is that the key to overcoming any disease is to identify the root cause and take appropriate steps to eliminate it. In practice, this is rarely done and most of us blithely accept that even though we continue doing whatever caused the disease, it can be overcome by treatment with drugs. The reality is that the best that be achieved with drugs is some alleviation of the symptoms. Even if a “cure” is achieved, the likelihood is that the disease will recur unless the cause is removed. This is very aptly illustrated by the experience of David Servan-Schreiber, who was clinical professor of psychiatry at the University of Pittsburgh School of Medicine (7,8). At the age of 31 he was diagnosed with a brain cancer. A tumour was successfully removed by surgery. He persistently asked the cancer specialists what advice they could give him to prevent the development of another tumour. Much to his surprise they had absolutely no suggestions to offer and even worse they seemed to have no interest. This encouraged him to do his own investigations and in his book (7) he describes what he found out. Much of this related to his lifestyle. As a consequence he made a series of changes, including a complete transformation to his diet. With brain cancer the life expectancy is 2-3 years but Servan-Schreiber managed to survive for another 20 years. Had he just accepted the advice of the medical profession, it is highly unlikely he would have lived for so long.

I cannot over-emphasise the crucial importance of this episode. There must be literally millions of people here in the UK who would benefit from advice on how to avoid diseases and how cures could be achieved by making changes to lifestyle.

Type 2 diabetes (T2D) is responsible for the increased incidence referred to above. There is ample evidence that it can be controlled, possibly even cured completely by making changes to the diet. The condition is directly due to the increased level of glucose in the blood. As a result the pancreas has to produce insulin to keep prevent excess glucose in the body. Excess insulin damages many of the organs, which can eventually lead to a range of diseases. If there is excessive glucose over a prolonged period the pancreas is unable to cope and the glucose becomes rampant, causing all sorts of damage. The solution is obvious. Reduce the amount of glucose which enters the body by altering the diet. Sugar is one of the main culprits, so it should be avoided like the plague. In addition starch is broken down to produce glucose. This means that foods such as refined flour, rice or pasta should be limited because the starch is released quickly giving rise to big increases in the blood glucose.

Essentially this means a diet which is low in carbohydrates (LC). The big problem is that the official advice is to increase carbohydrates. There is a strong possibility that those diagnosed with T2D will be advised to replace fat with carbohydrates. This is fundamentally wrong! The recommendation to reduce fat and especially saturated fat (SFA) does not stand up to rigorous examination. In fact, many of the individual SFAs are important nutrients (9). So what we should be doing is limiting the carbohydrates and consuming plenty of fats. Obviously avoid the trans fats which may be present in manufactured products and are being eliminated by the industry anyway. Despite the marketing claims that polyunsaturates (PUFAs) are good for you because they ”lower cholesterol” I certainly do not recommend them (see 9).

There is now a very convincing case that diets which are low in carbohydrates and high in fat (LCHF) can overcome many of the common chronic diseases. With respect to T2D, there is growing body of scientific research showing that this type of diet is extremely effective in lowering blood glucose and effectively curing T2D provided the LC intake is maintained (10). There are also numerous case studies of individuals who have successfully overcome T2D by making these changes to their diets 11,12).

CONCLUSION

First of all it is essential that all those diagnosed with T2D should be advised to make changes to their diets so that they are LCHF. It is an absolute disgrace that at present they will probably advised to eat more carbohydrates. In any event, the use of drugs should only be used as a last resort or better still not used at all, as there is a lack of evidence that they will be effective.

Even more important is that the official dietary guidelines must be revamped. It is a matter of great concern that we are still being advised to reduce the fat/SFA.

It just does not make sense to carry on as we are at present. The incidence of the disease is getting worse and the costs are increasing. It is becoming unsustainable. We have the answers, all that is needed is that we apply our existing knowledge and the benefits would be enormous.

REFERENCES

  1. http://www.hscic.gov.uk/catalogue/PUB14681/pres-diab-eng-200506-201314-rep.pdf
  2. http://www.diabetes.org.uk/Documents/About%20Us/Statistics/Diabetes-key-stats-guidelines-April2014.pdf
  3. http://www.diabetes.org.uk/Documents/Reports/State-of-the-Nation-2012.pdf      
  4. http://jama.jamanetwork.com/article.aspx?articleid=197439
  5. Rebecca K Simmons et al (2012) http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(12)61422-6/fulltext
  6. Remy Boussageon et al (2011) http://www.bmj.com/content/343/bmj.d4169.pdf%2Bhtml
  7. D Servan-Schreiber(2011) “Anticancer: a new way of life” Penguin Health ISBN 978-0-718-15684-8
  8.  http://vernerwheelock.com/?p=279
  9. http://vernerwheelock.com/?p=153
  10.    http://vernerwheelock.com/?p=226
  11.  http://vernerwheelock.com/?p=229
  12.   http://vernerwheelock.com/?p=405

 

 

 

111. The Institute of Economic Affairs (IEA) Report on Obesity

The IEA has just published a report which concludes that:

“The rise in obesity has been primarily caused by a decline in physical activity at home and in the workplace, not an increase in sugar, fat or calorie consumption” (1).

The report relies mainly on official statistics but is also heavily dependent on the conventional view that obesity is the result of consuming more calories than are expended. Despite the fact that this concept is the basis of official policies in the UK and in many other countries and organisations there are compelling reasons why it is fundamentally flawed. In this blog I will explain why it is not calories per se but sugar/refined carbohydrates, which is the fundamental cause of obesity. In addition I will assess the quality of the information presented on how the consumption of sugar has changed over the past 30-40 years.

The author Christopher Snowdon concludes that the evidence shows that in Britain the per capita consumption of sugar, salt, fat and calories has been falling for decades. In particular, sugar consumption has fallen by 16 per cent since 1992 while calorie consumption has fallen by 21 per cent since 1974.

QUALITY OF THE DATA

The main sources of information are the National Food Survey (NFS) up to 2000, when it was replaced by the Family Food survey. Because these 2 surveys each have different basis, it is not possible to obtain a continuous tracking of the changes. It was not until 1993 that obesity statistics were commenced. Although there has been a steady increase in the incidence of obesity in adults since then the pattern in children is rather different. The information was first collected in 1995 and then there was a peak about 2004 and the decline in recent years has reduced the incidence in 2012 to almost the same level as in 1993.

Although the NFS has limitations it is probably fair to conclude that it does provide a reasonably reliable indicator of trends. This certainly applies to total calories which declined from 2210 in 1980 to 1750 in 2000. The NFS also showed declines in total fat from 106g in1980 to74 in 2000. The corresponding values for total carbohydrate, which of course includes sugar were 264 and 218. The author of the IEA report presents a graph which shows that “sugar” has declined between 1992 and 2012. Presumably the data for the period up to 2000 is from the NFS. I have gone back to the original, which makes it clear that the calculations for the intake of nutrients does not include information on soft drinks and alcoholic drinks and confectionery. All of these contain sugar and if an accurate assessment of the trend is to be determined it is essential that allowance is made for the contribution from these sources. I have also been in touch with the team which is responsible for the food statistics, which has confirmed that there is no reliable information available on the intake of sugars prior to 2000

The difficulties of estimating the intake of sugar are exacerbated by the fact that it is present as an ingredient of many different processed foods, because it is inexpensive and makes foods attractive to the palate. Many of the “low fat” variations of foods are actually formulated by removing the fat and replacing it with sugar. Yoghurts are a typical example. In order to calculate the total intake for the population it is necessary to know the volume of sales and the exact nutrient composition of each particular food. It is a huge and difficult task to do this properly. In Australia the bureau of Statistics simply decided to abandon attempts to produce a reliable value because it was too difficult (and expensive!). Although the UK attempts to deal with this problem, the complexity of the food market and the rapid rate of change mean that it is virtually impossible to obtain reliable information

To sum up, in all probability there has been a substantial drop in the consumption of calories and possibly also in fat. However when it comes to sugar, reliable information is hard to obtain but we can be confident that there is absolutely no credible evidence that there has been a decline in the consumption of sugar. In the light of the substantial increase in the amounts of soft drinks sold, coupled with the growth of sugar-containing processed foods, there are strong indications that total sugar consumption has increased steadily in the period up to 2000.

In recent years, some people are actively cutting down on their sugar consumption, which could mean that for a sector of the population sugar consumption could continue to increase even though the amount for the population as a whole remained constant.

Finally we have to place this in the context of what we know about nutrition. Although many still hold to the view that obesity is caused by consuming more calories than are expended, this has been subject to severe criticism. An excellent example is the work of Zoe Harcombe in her book  “The Oesity Epidemic”(2). For example it has been shown that weight loss by calorie reduction simply does not work (3).Invariably this involves a reduction in fat, which can actually result in an increase in the amount of carbohydrates consumed. Furthermore there is convincing evidence that it is sugar and the refined carbohydrates which are the fundamental cause of obesity (4).In particular, there are compelling studies showing that it is the composition of the diet, which is crucial for obesity to occur. Specifically diets which are high in sugar/refined carbohydrates predispose not only to obesity but also to diabetes, heart disease, various cancers and Alzheimer’s Disease. Conversely, there is now a body of knowledge which demonstrates that diets which are low in carbohydrates and high in fat (LCHF) can be beneficial with respect to a range of diseases/conditions(5). These include heart disease, blood pressure, cancers, body weight and overcoming Type 2 Diabetes.

It follows from this that the crucial issue is the intake of sugar and refined carbohydrates. As I have explained above the Information on sugar is not reliable. The case presented by Christopher Snowdon does not stand up to scrutiny. There is no “English Paradox”. In any event, it is not obesity per se that should be a matter of concern with respect to public health. Much more critical is the growing incidence of diabetes, which has doubled in the past 15 years or so (4). There is absolutely no doubt that this is caused by excessive consumption of sugar and refined carbohydrates.

This report has rather uncanny parallels with what has been happening in Australia, where 2 academics from the University of Sydney have claimed that there is an “Australian Paradox “(6). This was based on a conclusion that the consumption of sugar had declined over the same period that obesity had been increasing. This was disputed by an economist Rory Robertson, who showed convincingly that there was no credible data to demonstrate how the consumption of sugar had changed over the relevant period. He concluded that:

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” (7).

Because of this he forced the university to set up an inquiry into the activities of the academics with respect to manipulation of the data. The results of the inquiry have recently been announced. Although Christopher Snowdon has claimed that the academics were exonerated, the reality is that the findings were somewhat unequivocal.

Although the adjudicator dismissed the allegations about “research misconduct” it was clear that he was not impressed by the quality of the original “Australian Paradox” paper. He concluded that the paper was not tightly written and contained a number of arithmetic errors. He expressed the view that important new findings would usually be published in a high-impact, rigorously peer-reviewed journal. Subsequently the results would be considered in special edition publications of conference journal format. Clearly this had not been done as the original was published in what was regarded as a ‘soft’ journal, where the quality controls are less stringent. As a consequence it was recommended that a new one be prepared which specifically addresses the key factual issues raised in the inquiry. Furthermore this paper should be written in a constructive manner which respects the issues relating to the quality and reliability of data, raised by Rory Robertson (8).

However, from a close reading of the report it is obvious that there really has been no attempt to deal with many of the serious allegations made by Rory and that effectively it is a rather poor attempt at a “whitewash” (9). A further detailed submission has been prepared by Rory and it is to be hoped that ultimately the issue will be addressed properly (10).

CONCLUSION

So it is evident that this report by IEA does not make any useful contribution to our understanding of the causes of obesity and should be ignored. The fact remains that sugar and refined carbohydrates lie at the root of many of the public health problems not only in the UK but right across the globe.

REFERENCES

  1. http://www.iea.org.uk/sites/default/files/in-the-media/files/Briefing_The%20Fat%20Lie.pdf
  2. Zoe Harcombe (2010) “The Obesity Epidemic” Columbus
  3. http://vernerwheelock.com/?p=221
  4. http://vernerwheelock.com/?p=158
  5. http://www.nutritionjrnl.com/article/S0899-9007(14)00332-3/fulltext
  6. http://vernerwheelock.com/?p=510
  7. http://www.australianparadox.com/pdf/DitchingSugar27032012.pdf
  8. http://vernerwheelock.com/?p=513
  9. http://vernerwheelock.com/?p=517
  10. http://www.australianparadox.com/pdf/RR-response-to-inquiry-report.pdf

 

 

 

 

110. The Tragedy of the Advice to Reduce Fat

There is now very convincing evidence that the recommendations to reduce the intake of fat and especially of saturated fat (SFA) have turned out to be one of the most notable failures in the field of public health policy.

As Nina Teicholz (1) and others have shown, the recommendations can be traced back to Ancel Keys, a researcher at Missouri, who was the lead investigator in the Seven Countries Study.This concluded that that there was a direct correlation between the amount of fat/SFA in the diet of different populations, the level of cholesterol in the blood (TC) and the death rate due to heart disease. It is crucial to emphasise that a correlation does not demonstrate “cause and effect”. This is a fundamental error which has been repeated time and time again in the area of human nutrition. Let me explain with a simple example. If there are numerous police cars observed in a location which has high crime, this does not mean that the crime is caused by the police cars. Reducing the number of police cars will certainly not reduce the crime level. Unfortunately there are many conclusions about nutrition which are reached using this kind of irrational logic. However Keys was even worse than this because he manipulated his data. He actually had data from 22 countries but he used information from just 6 countries, which allowed him to demonstrate that the more fat (and SFA) consumed in a country, the higher the death rate attributed to heart disease. He conveniently omitted:

  • Countries where people eat a lot of fat but have little heart disease, such as Holland and Norway
  • Countries where fat consumption is low but the rate of heart disease is high, such as Chile.

If he had included all his data, then any semblance of a correlation disappeared….the points were all over the place.

For a comprehensive critique of the Seven Countries Study, I can recommend “The Obesity Epidemic” by Zoe Harcombe (2).

Clearly Keys was a very influential in the USA in the sixties and seventies. As a result his views prevailed with the politicians and anyone else who mattered. It is important to appreciate that many distinguished scientists who were opposed to Keys were subjected to a campaign of vilification. John Yudkin, the British nutritionist argued that sugar not fat was the critical factor and was portrayed as a figure of ridicule (3). Keys described Yudkin’s arguments in heart disease “tendentious” and his evidence “flimsy indeed”. Once the policy was in place, it became virtually impossible to criticise it. For example the outstanding nutritionist, David Kritchevsky encountered hysterical opposition which he described to Nina Teicholz as follows:

 

“People would spit on us! It’s hard to imagine now, the heat of the passion. It was just like we had desecrated the American flag. They were so angry that we were going against the suggestions of the American Heart Association and the National Institutes of Health.”

So for the past 30 years or so the advice to lower the fat/SFA has been promoted very powerfully by the public health authorities, supported by the food and pharmaceutical industries. As a result there has been a shift in food consumption with some of the fat being replaced by sugar and other carbohydrates. Although the driving force for the new recommendations was in the USA, the impact has been felt across the globe, primarily because the position adopted by the World Health Organisation (WHO) which was determined largely by the Americans. Unfortunately many other countries took the lead in formulating nutrition policies from the WHO. There is now widespread acceptance that the increase in the consumption of carbohydrate-foods, especially sugar, is the main factor contributing to the so-called “obesity crisis” (4).

It is absolutely essential that we learn from this episode and try to avoid making the same mistakes again. Regrettably we seem to be incapable of doing so as I will demonstrate by considering another current issue, namely salt.

SALT

The official recommendations in the UK are that the population average for adults should be 6g salt per day which translates into 7g/day for men and 5g/day for women (5). The justification is that it will help to lower blood pressure (BP). However it important to note that the reductions which can be achieved by lowering the salt intake are relatively small compared with the levels which are recorded for those suffering from hypertension. It is also assumed that any reduction in BP will result in a corresponding reduction in the risk of heart disease. Furthermore the approach taken by the UK advisory committee has been subject to serious criticism by the Institute of Medicine in the USA (6). On the other hand there are some concerns that there may be dangers in reducing the salt intake to levels that many constitute a danger to health. A recent paper (the PURE study) in the New England Journal of Medicine (6) has collected data on sodium and potassium excretion (to assess the amount consumed) for over 100,000 people in 17 different countries. It was found that those consuming between 7.5 and 15 g salt/day had the lowest risk of death and cardiovascular events. Those with less and those with more had higher values. Clearly we have to be careful about the interpretation of these results. But this study certainly flags up potential dangers. In particular, there is a real possibility that people in the UK who attempt to follow the official advice may finish up with an inadequate intake of salt. If the results of the above study apply to the UK it would mean that current intakes are about right.

Despite this there are some individuals who take a very strong line about salt reduction. At a recent conference Norm Campbell and Graham MacGregor are reported to have stated that:

“Any “controversy” over whether dietary salt is a cause of heart disease and stroke is the result of weak research methodology or commercial interference…”

According to Dr Malcolm Kendrick this can be translated to:

“If you do not believe that excess salt consumption is a cause of heart disease and stroke you are a flawed and misdirected scientist (weak research methodology), or you are corrupt (commercial interference). No other explanation is, of course, possible. You are either an idiot, or corrupt, and therefore – by definition – should be ignored. Or perhaps stoned to death for being an unbeliever.” (8).

The fact that Campbell and MacGregor are also beneficiaries of financial support from various commercial concerns is conveniently not mentioned.

When asked to comment on the PURE study referred to above this is the reaction from Campbell and MacGregor:

“When a member of the audience pointed to the PURE analysis showing that most of the world eats much higher levels of sodium than those recommended by most international organizations, MacGregor and Campbell leaped on this as an example of a study that had radically failed to measure salt in an appropriate fashion, even devising a new “formula” to estimate salt intake because even spot urine testing had been inadequate. “Please let [PURE principal investigator Dr] Salim Yusuf [McMaster University, Hamilton, ON] know that he should stop using spot urine analysis,” MacGregor said curtly.”(9).

Malcolm Kendrick sums it up very nicely

“.. the main point here is the fact that we have more bully boy tactics going on. Two ‘grand fromages’ take the stage to beat the opposition into pulp”.

We know that salt (sodium) is an essential nutrient and that a certain amount must be included in the diet. Very large amounts may be damaging to health. We simply do not know accurately the optimum range of intakes. It may well be that for a substantial proportion of the population, there is no need to alter the intake. Under these circumstances, in my view, it is totally irresponsible to advocate a change. Before any official advice is recommended we have to be certain that there will be an improvement in health as a result. Even more important there must be no possibility that of harm to those who follow the advice.

The parallels with Ancel Keys are much too close for comfort. There is a total failure to try to deal with the actual evidence and the name of the game is to use anything to win your case and denigrate those with the temerity to have a contrary view. It is obvious that there is not a cast iron case for reducing salt. There is a distinct possibility that lowering current intakes may well have a damaging effect. Rather ironically those most at risk would be the people who take the advice seriously and try to comply with the recommendations. We really must learn from the mistakes of the past. The lesson is that we have to have a very convincing rationale before advising how the diet should be changed.

REFERENCES

  1. Nina Teicholz. (2014)“The Big Fat Surprise: Why Butter, Meat and Cheese Belong in a Healthy Diet” Simon & Shuster New York
  2. Zoe Harcombe (2010) “The Obesity Epidemic” Columbus p 87
  3. Gary Taubes (2007) “The Diet Delusion” Vermillion: London p120
  4. http://vernerwheelock.com/?p=158
  5. http://www.sacn.gov.uk/pdfs/sacn_salt_final.pdf
  6. http://vernerwheelock.com/?p=293
  7. http://www.nejm.org/doi/full/10.1056/NEJMoa1311889
  8. http://drmalcolmkendrick.org/2014/06/22/calling-all-physicians-the-salt-debate-must-stop/
  9. 9.       http://www.medscape.com/viewarticle/826970?src=emailthis

 

 

 

109. Cochrane Collaboration Evaluates Statins for Primary Prevention of Heart Disease

The Cochrane Collaboration has established a unique reputation for the publication of reports on a variety of topics in the medical field. This is an area where there are very powerful vested interests and the quality of much of the research is questionable. Therefore the contribution of the Collaboration has proved to be extremely valuable with respect to decisions on treatment and policy formulation.

In recent years the Collaboration has produced two reports which focus on the use of statins for the primary prevention of heart disease. In the first one it was concluded that caution should be taken in prescribing statins for primary prevention among people at low cardiovascular risk (1). However in the second on e published 2 years later, the conclusion was that the totality of evidence now supports the benefits of statins for primary prevention(2). In this blog I will attempt to discover why and how there has been such a radical shift in position.

At the outset I should emphasise, that I consider the critical information to assess the value of these drugs is all-cause mortality. First of all, there can be no argument about the validity of the “diagnosis”. Secondly, this is what most patients will wish to know. It not much comfort if a reduction in the risks of death from heart disease is counterbalanced by an increased risk of dying from another disease. It is also important to have reliable information on adverse side-effects. Many patients are likely to question the value of an extra few months on this earth if the quality of life is made miserable by the drugs.

The first report which was released in January 2013 included research up to September 2007. This was based on 14 trials (with 16 trial arms) involving 34,272 participants. The mean age of the participants was 57 years (age range 28-50), 65.0% were male. However data on all-cause mortality was only provided in 8 trials. Furthermore in 2 trials which accounted for over one quarter of the participants were stopped prematurely.

The report noted that all but one of the trials had some form of pharmaceutical industry sponsorship. Research has shown that the results of trials sponsored by the pharmaceutical industry- are more likely than non-industry-sponsored trials to report results and conclusions that favour drug over placebo because of biased reporting and/or interpretation of trial results (3). As a consequence:

“In primary prevention where world-wide the numbers of patients eligible for treatment are massive, there might be motivations to use composite outcomes and early stopping to get results that clearly support intervention.”

The authors concluded that the review:

highlights the shortcomings in the published trials of statins for primary prevention. Selective reporting and inclusion of people with cardiovascular disease in many of the trials included in previous reviews of their role in primary prevention make the evidence impossible to disentangle without individual patient data. In people at high risk of cardiovascular events due to their risk factor profile (i.e. 20+% 10-year risk), it is likely that the benefits of statins are greater than potential short term harms although long-term effects (over decades) remain unknown. Caution should be taken in prescribing statins for primary prevention among people at low cardiovascular risk.”

As soon as the report was published, there was an objection from Rory Collins and Colin Baigent of the Cholesterol Treatment Trialists’ (CTT) Collaboration at the University of Oxford. Their concern was the report had stated that the CTT collaborators had not published information about the proportional and absolute benefits of statin therapy among people with no prior history of vascular disease. They referred specifically to a paper published in The Lancet in 2010.They also objected to a statement in the press release announcing the release of the report which was as follows:

Given that low cholesterol has been shown to increase the risk of death from other causes, statins may do more harm than good in some patients”.

In reply the lead author Shah Ebrahim pointed out that the CTT Lancet paper of 2010 was not available at the time the review was completed. However he insisted that the estimate of the effects of lowering LDL cholesterol with respect to major vascular events, contained in the review, was similar to that of the CTT. He also re-iterated his surprise that the CTT did not provide more information on other outcomes among participants taking statins for primary prevention. He drew attention that others have raised the issue of all-cause mortality in primary prevention trials (4) and that there are particular concerns about increased risk of diabetes in people who take statins (5).

With respect to the press release, the point was accepted and a correction was issued.

Now we come to the second report which was published in January 2013 (2). This included research which was published up to the beginning of January 2012 and was based on 18 trials (with 19 trail arms) with 56,934 participants. The mean age was 57 years and 60.3% were men.

Thirteen trials with 48,060 participants recruited reported on total mortality. In the statin group 1077 out of 24,408 people died (4.4%) whereas in the control group there were 1223 deaths out of 23,652 (5.1%). This translates into an Numbers Needed to Treat (NNT) of 96 which means that 96 people have to be treated for 5 years for one to benefit. Furthermore it is crucial to appreciate that this means 96 people have to be treated for 5 years for one to benefit.

There was a reduction in various end-points related to cardiovascular disease (CVD) which were associated with falls in total cholesterol (TC) and LDL cholesterol in trials which reported these outcomes. The review concluded that adverse side-effects were not excessive although not all trials reported these fully. . Patients’ perception of quality of life was reported in only one trial and this showed limited benefit.

It is also interesting to note that in this report it was stated that:

“there was low risk of bias ….though all trials were either fully or partially funded by pharmaceutical companies”

What is especially noteworthy is that this review makes detailed reference to the work of the CTT.

In particular:

  • The CTT Collaboration has published analyses focusing on the comparison between high and low doses of statins which demonstrate that more intensive treatment lowers LDL cholesterol more, resulting in greater benefits with no excess risk of non-vascular mortality (6).
  • Strong evidence of the absence of any adverse effects on cancer risk is also confirmed by a further CTT Collaboration report (7).
  • The Cochrane estimates of the effects on all-cause mortality are in agreement with those of the CTT (8). Although it does accept that there is an increased risk of myopathy and rhabdomyolysis in those treated with statins especially in those treated with high (9). These benefits equate to an NNT of 167 for people with a <5% five year risk for heart disease and 67 for those with a 5-10% risk. This means that for those with the lower risk 167 people have to be treated for 5 years for one to benefit and 67 for those with the higher risk

The final conclusion is that benefits of statins outweigh any serious adverse effects. Hence earlier claims that statins provide no overall benefit in primary prevention in terms of all-cause mortality can no longer be substantiated.

This represents an about turn in the space of 2 years. Here are a few comments which I believe are worth addressing if you are mystified by this complete reversal in the position reached by the Cochrane authors.

It is evident that the research from the CTT has been highly influential with the authors when coming to their final conclusion. I just wonder if they were aware of the criticisms of the work of the CTT by Dr David Newman (10). He points out that the CTT does not compare those who were on statins with the corresponding controls. Instead they selected those individuals in which the statin treatment reduced the LDL Cholesterol 1 mmol/L or 40 points in US terms. As Dr Newman describes it:

“…they shifted the data so that their numbers corresponded precisely to patients whose cholesterol responded perfectly.”

He continues:

 “Patients whose cholesterol drops 40 points are different than others, and not just because their body had an ideal response to the drug. They may also be taking the drug more regularly, and more motivated. Or they may be exercising more, or eating right, and more health conscious than other patients. So it should be no surprise that this analysis comes up with different numbers than a simple comparison of statins versus placebo pills. Ultimately, then, this new information tells us little or nothing about the benefits someone might expect if they take a statin. Instead it tells us the average benefits among those who had a 40-point drop in LDL.”

Furthermore the LDL Cholesterol drop cannot be predicted because the effect of the statins is unknown. This means that the conclusions of this analysis have absolutely no relevance to patients and doctors who have to decide if statins should be prescribed.

Here is a final quote from Dr Newman:

“Perhaps never has a statistical deception been so cleverly buried, in plain sight. The study answers this question: how much did the people who responded well to the drug benefit? This is, by definition, a circular and retrospective question: revisiting old data and re-tailoring the question to arrive at a conclusion. And to be fair they may have answered an interesting, and in some ways contributory, question. However the authors’ conclusions imply that they answered a different, much bigger question. And that is not a true story.”

It seems to me that this is a very valid criticism because the CTT studies do not include those who were on statins but failed to lower their LDL Cholesterol. I am not aware that anyone has answered Dr Newman’s critique. Incidentally this would explain why the CTT does not agree with other analyses which find that the use of statins as a preventive measure does not reduce all-cause mortality.

The CTT data on side- effects are entirely dependent on the results which were obtained from trials. Serious doubts have been raised. Rather ironically the second Cochrane report accepted that the reporting of adverse events in these trials is generally poor, with failure to provide details of severity and type of adverse events or to report on health-related quality of life. It then went on to conclude rather complacently:

“However, it seems unlikely that any major life-threatening hazards associated with statin use exist”.

Recently Sir Richard Thompson , President of the Royal College of Physicians and colleagues wrote to NICE expressing concern about the proposal to extend the use of statins to those with a low risk of developing CVD (11). The letter commented specifically on side-effects as follows:

“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”

The argument was supported by information on the number of adverse side-effects in various stain trials, which is shown here in Table 1.

Table 1 Adverse side-effects reported in various statin trial

Trial, Name of statin Side-effects, statin treatment,% Side-effects,control,%
AFCAPS/TEXCAPS Losartan 13.6 13.8
4S simvastatin 6.0 6.0
CARDS atorvastatin 25.0 24.0
METEOR rosuvastatin 83.3 80.4
LIPID Pravastatin 3.2 2.7
JUPITER Rosuvastatin 25.0,discontinuation,

15.0,serious side-effects

25.0, discontinuation,

!5.5, serious side-effects

WOSCOPS Pravastatin 7.8 7.0

Note: The values shown refer to “total adverse effects” unless otherwise indicated

What is quite remarkable about these figures is the similarity between those for the group treated and those for the controls. Furthermore the variation is huge. In one the values are as low as 3% but in another it is over 80%. The reality is that the companies have little interest in collecting data on side-effects. The information shown above clearly demonstrates the information on side-effects obtained in clinical trials simply lack credibility.

The letter also referred to the fact that independent researchers do not have access to raw data and noted that:

“…the data driving NICE guidance on statins comes almost entirely from pharmaceutical company funded studies. Furthermore, these data are not available for review by independent researchers, only those who work for the Oxford Cholesterol Treatment Trialists Collaboration (CTT).

The CTT has commercial agreements with pharmaceutical companies which apparently means that they cannot release data to any other researchers who request to see it. Which, in turn, means that the latest reviews of the data by NICE and also by the Cochrane group are totally reliant on the CTT 20121 meta-analysis analysis of this concealed data?”

It is highly relevant that in the recent BMJ controversy it has emerged that the CTT at Oxford University has had funding from drug companies of about £268million as Zoe Harcombe has revealed (12).

There have to be very strong suspicions that the Cochrane authors have allowed themselves to be bullied into submission by the actions of Rory Collins and Colin Baigent. It is evident from the information I have presented here that they have ignored key considerations, which ought to have had an impact in reaching their conclusions. Perhaps they should have studied another Cochrane publication entitled “Eminence v Evidence” (13) which makes some extremely pertinent comments.

This is a great pity because if ever there was a need for a body which can conduct an authoritative evaluation of the evidence it is now. It is to be hoped that the powers that be in Cochrane will take these points on board. Above all its contributors must stand up to bully boy tactics of the very powerful vested interests. Many will be familiar with the fact that Rory Collins tried the same tactic with the BMJ. To her great credit Fiona Godlee , the editor-in-chief was not intimidated by Collins and effectively took appropriate action which put him in his place. Cochrane could well to learn some lessons from this.

Finally, even if the conclusions of the second Cochrane report are genuine, let us consider this from the perspective of those who will be prescribed statins in accordance with the latest NICE guidelines. These mean that those with a 10% risk of developing CVD will be advised to go on statins. Effectively this means everyone over 50, because no matter how fit and healthy a person is, when the time comes there must be at least a 1 in 10 chance that the cause of death will be heart disease. Cochrane states that 67 people will have to be treated for 5 years for one person to benefit. Although according to Mark Baker of NICE, 77 will have to be treated for 3 years. Whatever the figure the chances are very small. Cochrane comments:

These NNTs are well within the range considered worthwhile in primary prevention

Well I have got news for the authors and for the medical professions as a whole if this is statement is an accurate reflection of its opinion. It is certainly not acceptable to me and I strongly suspect to the vast majority of patients. In my experience most people believe that if they are prescribed a drug it will effective for them personally. They might be prepared to accept that there may be less that 100% certainty, possibly as low as 20%, which is an NNT of 5! It is crucial that we are concerned here with prevention. I recognize that it is rather different for a person with a serious illness, who will clutch at anything that may be effective. But prevention is a new ball game and in my opinion, there would be very few who would agree to statins if they were aware that there was only a 1 in 67 chance that it would do them any good.

For anyone who is concerned that their risk of CVD is high and they wish to lower them, what should they do? Here are some suggestions:

  • If you smoke cigarettes, stop immediately
  • Take regular exercise, If you can walk at least 1 mile per day, this will certainly imlrove your life expectancy
  • Make adjustments to your diet. There is now very convincing evidence that restricting the intake of sugar and refined carbohydrates will reduce the risks not only of CVD but also of diabetes, cancer, Alzheimer’s Disease as well as lowering blood pressure and achieving weight loss

There is absolutely no doubt any benefits derived from statin treatment will be insignificant when compared those which can be achieved by implementing the measures outlined above. Furthermore, any side-effects will be minimal compared to those experienced by people on statins.

So whatever way you look at it, the case for statins just does not stack up. The truth is that the fundamental objective is the profitability of the drug companies and improving public health simply does not feature. In fact, if statins were only used to treat patients suffering from CVD, this could be a critical step towards good health. It would definitely release funds which could be better in spent in other ways, such as employing more nurses.

It is a matter of great regret that this particular Cochrane team did not follow the example of the one led by Tom Jefferson, which considered neuraminida inhibitors including Tamiflu (14). The background has been explained in an article in The Guardian by Ben Goldacre (15). An earlier Cochrane report had concluded that these ‘flu drugs do reduce the rate of complications of conditions such as pneumonia. However a paediatrician in Japan pointed out that the Cochrane report was based on the results of 2 published trials of which only one showed a positive response. In fact there were another 8 trials, for which the results had never seen the light of day and all of these had been negative!! As a direct result of this Tom Jefferson realised that in the 2008 report they had made a mistake in relying on the published data. So he decided to see if he could get hold of the information. There was a long battle with Roche, which by this time controlled the data, before the company eventually sent documents containing excerpts, which did not provide adequate information to assess the benefits and the adverse side-effects. It was also not possible to consider the details of the trial procedures, which is essential if the quality of the data is to be evaluated.

Consideration of the work of various regulatory agencies such as the FDA in the USA and EMEA in the EU indicated that there were serious flaws in the procedures. As Cochrane had not been provided with the detailed information it needed to do its review properly, it decide to exclude all this data from the analysis. Effectively it was unable to reach a conclusion and explained the position in a further review published in December 2009. This was followed by a long period of prevarication by Roche, including claims that some of the Cochrane researchers had made untrue statements about the drug and the company and allegations questioning their independence. Finally under pressure from the BMJ which supported the Cochrane investigators, Roche agreed to release all the data but it had taken 5 years for this to happen.

When this information was evaluated, the review was finally published in April 2014. Because the team now had the clinical study reports (CSRs) from the manufacturers it was able to compare the information with that which had been submitted to the regulatory authorities. Rather significantly it was decided not to use results which appeared in scientific journals because in previous versions of this review unresolved discrepancies in the data presented were identified in published trial reports. Substantial publication bias was also uncovered.

Based on these assessments of the regulatory documents (in excess of 160,000 pages), it was concluded that there were substantial problems with the design, conduct, reporting and availability of information from many of the trials. As a consequence, there were doubts about the reliability of the results. The review was based on 20 trials with zanamir (Relenza, from GSK) and 26 trials with oseltamir (Tamiflu fom Roche). It was found that:

both drugs shorten the duration of symptoms of influenza-like illness (unconfirmed influenza or ‘the flu’) by less than a day. Oseltamivir did not affect the number of hospitalisations, based on the data from all the people enrolled in treatment trials of oseltamivir. Zanamivir trials did not record this outcome. The effects on pneumonia and other complications of influenza, such as bronchitis, middle ear infection (otitis media) and sinusitis, were unreliably reported, as shown by the case report form in the trial documents. Some forms showed limitations in the diagnostic criteria for pneumonia. Regulatory comments noted problems with missing follow-up diary cards from participants. In children with asthma there was no clear effect on the time to first alleviation of symptoms.

Prophylaxis trials showed that oseltamivir and zanamivir reduced the risk of symptomatic influenza in individuals and households. There was no evidence of an effect on asymptomatic influenza or on non-influenza, influenza-like illness, but trial conduct problems prevent any definitive conclusion.

Oseltamivir use was associated with nausea, vomiting, headaches, renal and psychiatric events; these last three were when it was used to prevent influenza (prophylaxis). Its effect on the heart is unclear: it may reduce cardiac symptoms, but may induce serious heart rhythm problems. In adult treatment trials of zanamivir there was no increased risk of reported adverse events. The evidence on the possible harms associated with the treatment of children with zanamivir was sparse.”

This is not exactly impressive. Roche put out a press release contesting these findings but did not provide any reasons. When the benefits are balanced against the side-effects, it is difficult to justify their use. It was certainly a huge waste of money by the government to spend £500 million to stockpile supplies of this drug. But that is what happens when all the relevant data to make an informed decision is not available.

When this episode is compared with the performance of the team dealing with statins, a sad state of affairs emerges. In contrast to Tom Jefferson, the statin team seems to have just submitted to the power and influence of the industry and its supporters. There has been a total failure to insist on getting access to the primary data. As the Tamiflu review clearly demonstrates  when the original reports become available for assessment, the perspective is completely different. In the light of this, there have to be very strong suspicions that if and when the relevant statin data is released generally, we will find that the benefit/adverse side-effects ratio is very much worse than we have been led to believe.

Commenting on the Tamiflu review, Dr David Tovey, Editor-in-Chief of The Cochrane Library said:

“We now have the most robust, comprehensive review on neuraminidase inhibitors that exists. Initially thought to reduce hospitalisations and serious complications from influenza, the review highlights that [NIs are] not proven to do this, and it also seems to lead to harmful effects that were not fully reported in the original publications. This shows the importance of ensuring that trial data are transparent and accessible” (17).

Let’s hope that one day he will be able to say the same about statins.

REFERENCES

  1.  http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD004816.pub4/full
  2. http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD004816.pub5/full
  3. http://jama.jamanetwork.com/article.aspx?articleid=197132
  4. http://archinte.jamanetwork.com/article.aspx?articleid=416105
  5. http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(09)61965-6/abstract
  6. http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(10)61350-5/fulltext
  7. http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0029849
  8. Lancet 2012;378:doi:10.1016/S0140-6736(12)60367-5
  9. http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(07)60716-8/fulltext
  10. http://cardiobrief.org/2012/05/27/guest-post-data-drugs-and-deception-a-true-story/
  11. http://drmalcolmkendrick.org/2014/06/27/another-backlash-begins/
  12. http://www.zoeharcombe.com/2014/08/ctsu-funding-from-drug-companies/
  13. http://www.cochrane.org/news/blog/eminence-vs-evidence
  14. http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD008965.pub4/full
  15. http://www.theguardian.com/business/2014/apr/10/tamiflu-saga-drug-trials-big-pharma
  16. http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD008965.pub4/abstract;jsessionid=D0952B85723A29FF11B3087DB5F71938.f03t02
  17. http://www.cochrane.org/features/tamiflu-and-relenza-getting-full-evidence-picture

 

 

 

108. Swedish Expert Committee: A Low-Carb Diet Most Effective for Weight Loss

In September last year, the Swedish Council on Health Technology Assessment released a report entitled “Dietary Treatment for Obesity” (1) which has accepted much of the revised thinking on the relationship between diet and health.

This blog is by the Diet Doctor, Andreas Eenfeldt, who has an excellent website at http://www.dietdoctor.com/

I am very grateful to Andreas for permission to post this article here.

The original can be sourced at

http://www.dietdoctor.com/swedish-expert-committee-low-carb-diet-effective-weight-loss

Which diet is the most effective for weight loss?

This could be a historic day in Sweden (23 September 2013). Today it became official. After over two years of work, a Swedish expert committee published their expert inquiry Dietary Treatment for Obesity (Google translated from Swedish).

This report from SBU (Swedish Council on Health Technology Assessment) is likely to be the basis for future dietary guidelines for obesity treatment within the Swedish health care system.

The health care system has for a long time given general advice to avoid fat and calories. A low-carbohydrate diet such as LCHF (2) has often been dismissed as a fad diet lacking scientific foundation. The time has now come to update knowledge in this area.

According to SBU, the only clear difference among different dietary recommendations is seen during the first six months. Here a low-carbohydrate diet, such as LCHF, is clearly more effective than today’s conventional advice.

From fad diet to best in test.

Here are some more highlights from the report:

Health Markers

In addition, health markers will improve on a low-carbohydrate diet, according to SBU. You’ll get:

…a greater increase in HDL cholesterol (“the good cholesterol”) without having any adverse affects on LDL cholesterol (“the bad cholesterol”). This applies to both the moderate low-carbohydrate intake of less than 40 percent of the total energy intake, as well as to the stricter low-carbohydrate diet, where carbohydrate intake is less than 20 percent of the total energy intake. In addition, the stricter low-carbohydrate diet will lead to improved glucose levels for individuals with obesity and diabetes, and to marginally decreased levels of triglycerides.

So, all important health markers improved or unchanged on a stricter low-carbohydrate diet. Just like an international review of all research in the area showed last year (3).

Long-term Uncertainty

Long term, studies show no statistically significant differences among different diets, and the differences decrease with time. The SBU suggests that this is because of decreasing compliance with time. People simply tend to fall back to old habits.

The more studies we add, the better we can see the clear advantage of low-carbohydrate diets. Unfortunately SBU has excluded all studies examining both obese and overweight people. If you include studies on weight loss where overweight people are included – to get a greater scientific basis – a clear advantage for the low-carbohydrate diet was seen even after a year (4)

A well-designed study, which for the same reason as above, was dropped from the SBU report’s analysis, still showed a persistent advantage for the LCHF-like diet (Atkins) after two years, despite the difficulty with such long-term diet studies.

For the long-term effect, if you keep to a strict low-carbohydrate diet, there are only anecdotal reports on weight and cholesterol levels (5).

Physical Activity

SBU also kills the idea that exercise plays an important roll in weight loss. Exercise may be very good for health, but:

Systematic reviews of the literature show that the addition of physical activity to a dietary intervention for individuals with obesity have, if any, a marginal effect on weight loss at the group level.

The effect of exercise on weight in studies is in other words marginal or non-existent (6).

Warnings Against LCHF Dismissed

There’s a great lack of knowledge today on what dietary guidelines are best for long-term health. We simply don’t know.

Recent cautions on low-carbohydrate diets are at best based on statistical associations derived from food questionnaires from people who didn’t (!) eat a low-carbohydrate diet. The SBU also dismisses these warnings:

Most of these studies suffer from major shortcomings, which make them difficult to interpret. The foremost shortcoming in these studies is that it’s often impossible to determine whether those with the lowest intake are knowingly eating a moderate low-carbohydrate diet for health reasons, or if they are high consumers of fast-food.

The breakdown of carbohydrates, fat and protein, which in such studies are imaginatively labeled “a low-carbohydrate diet” is usually very similar to the macronutrient distribution in a hamburger with fries and soda…

Towards the Future

What will be the consequences of today’s report?

Advice on a low-carbohydrate diet is however very rare, if we look at the practice survey. It’s not clear how common it is to actively discourage patients from the strict low-carbohydrate diet. A low-carbohydrate diet, even the stricter form, will lead to a greater weight loss in the short term than the low-fat diet, and studies have indicated no adverse effects on blood lipids, provided that the weight stays low. One possible consequence of this report will therefore be an increased use of a strict low-carbohydrate diet for short-term weight reduction.

SBU will always express itself very carefully. But it can’t be said much clearer: It’s high time for the health care system to take seriously advice on LCHF for weight loss!

This is also interesting:

…it’s not possible to draw any conclusions about the relationship between a low-carbohydrate diet – regardless of fat content – and cardiovascular disease. Here we could apply the precautionary principle, and advise some restraint on saturated fat intake, as long as the documentation of the long-term effects are inadequate.

Many health care workers will no doubt (without any better reasons than preconceptions) be wary of dietary advice on more saturated fat. I was once scared of saturated fat myself.

I think that SBU is keeping a reasonable attitude here, as it isn’t even necessary to give advice on a lot of saturated fat for a low-carbohydrate diet. You can eat even a strict low-carbohydrate diet (such as LCHF) emphasizing unsaturated fats (3). This has been shown to be effective in several studies (7,8,9)

It would be wonderful if the health care system started to apply the benefits of a low-carbohydrate diet, even before the outdated fear of butter has melted away everywhere.

The SBU-report Dietary Treatment for Obesity is a gigantic step towards more effective dietary guidelines within the health care system. This is a historic day in Sweden.

REFERENCES

  1. http://www.sbu.se/upload/Publikationer/Content1/1/Diets_among_obese_individuals.pdf
  2. http://www.dietdoctor.com/lchf
  3. http://onlinelibrary.wiley.com/doi/10.1111/j.1467-789X.2012.01021.x/abstract;jsessionid=7396D07C42DB2B84642D35158B132AF9.d04t04
  4. http://www.dietdoctor.com/new-analysis-lchf-best-for-long-term-weight-and-health
  5. http://www.dietdoctor.com/will-lchf-work-long-term-say-four-years
  6. http://www.dietdoctor.com/how-to-lose-weight#13
  7. http://www.nutritionj.com/content/7/1/30
  8. http://www.nytimes.com/2009/06/09/health/09diet.html?ref=health&_r=1&
  9. http://www.sciencedaily.com/releases/2009/06/090608162426.htm

 

 

107. Support for Diets High in Fat and Low in Carbohydrates Gathers Momentum

There is a growing body of scientific evidence and personal experience which demonstrates that the high content of sugar and refined carbohydrate foods is one of the main factors responsible for the rapidly increasing levels of obesity and diabetes. This in turn increases the risks of conditions such as heart disease, cancers and Alzheimer’s Disease. Conversely those who make adjustments to their diet in order to reduce the carbohydrates and increase the fat consistently find that they can achieve significant improvements in their health.

A recent paper has pulled together much of the relevant information and provides a valuable summary of the current state of knowledge (1).

There are 12 key points which are as follows:

  1. Hyperglycaemia is the most salient feature of diabetes. Dietary carbohydrate restriction has the greatest effect on decreasing blood glucose levels.It is universally accepted that dietary carbohydrate is the main dietary determinant of blood glucose and restriction shows the greatest reduction in blood glucose concentrations as well as HbA1c(Glycylated haemoglobin, which gives the average blood sugar level over the previous few months)
  2. During the epidemics of obesity and type 2 diabetes, caloric increases have been due almost entirely to increased carbohydrate. In the USA, there were increases in the carbohydrate content of the diet of about 7% of calories with concomitant reductions in the intake of fat between 1970 and 2000. Similar changes have been recorded for Great Britain
  3. Benefits of dietary carbohydrate restriction do not require weight loss. This is crucial because many diabetics are not overweight and many who are overweight are not diabetic. In fact the obsession with weight per se has not been particularly helpful because most people have great difficulty in losing weight by the conventional calorie control approach. Paradoxically the switch to a diet which is low in carbohydrates is often accompanied by weight loss even when this has not been a specific objective
  4. Although weight loss is not required for benefit, no dietary intervention is better than carbohydrate restriction for weight loss. In a British study it was found that those on a low carbohydrate diet were more successful in losing weight than a comparable group who followed a conventional Healthy Eating diet. On the other hand low fat diets have produced very poor results. In the Women’s Health Initiative (WHI) the low fat intervention group was encouraged to consume a diet with 20% fat, which was rich in fruits, vegetables and grains (2). Although they lost 2.2 kg in the first year, this was regained by the end of the 7-year study.
  5. Adherence to low-carbohydrate diets in people with type 2 diabetes is at least as good as adherence to any other dietary interventions and is frequently significantly better. In a study of The Active Low-Carber Forum, an on-line discussion group with over 150,000 members, a common assertion was that a low-carbohydrate regimen provides the greatest degree of satisfaction. Provided the carbohydrate reduction is maintained, there is no need to restrict total food intake, which is necessary on a low fat diet.
  6. Replacement of carbohydrate with protein is generally beneficial. Although it is generally recommended that carbohydrate is replaced by fat, a number of systematic studies have found that high-protein-low carbohydrate diets have a more favourable effect on weight loss and cardiovascular risk factors than fat reduced diets.
  7. Dietary total and saturated fat (SFA)  do not correlate with risk of cardiovascular disease (CVD). Despite massive investigations it has not been possible to demonstrate that SFA is a risk factor for heart disease. One meta-analysis of prospective epidemiologic studies showed that there is no significant evidence for concluding that dietary saturated fat is associated with an increased risk of CHD or CVD (3,4). Although recommendations to lower SFA are an integral part of many national nutrition policies, the lack of evidence is now so compelling governments will eventually have make fundamental changes to official strategies.
  8. Plasma SFAs are controlled by dietary carbohydrate more than by dietary lipids. It is now becoming clear that the concentration of SFA in the blood is determined by the amount of carbohydrates rather than the SFA in the food. A diet low in carbohydrates is more effective in reducing the blood triglycerides than one which is low in fat.
  9. The best predictor of microvascular and, to a lesser extent, macro-vascular complications in patients with type 2 diabetes, is glycaemic control. In the United Kingdom Prospective Diabetes Study (UKPDS) it was found that the key controlling variable was HbA1c. As HbA1c increased, there was a corresponding increase in fatal and non-fatal myocardial infarction events. By contrast, there was a 14% decrease in myocardial infarction for every 1% reduction in HbA1c.
  10. Dietary carbohydrate restriction is the most effective method (other than starvation) of reducing serum triglycerides and increasing high-density lipoprotein (HDL). Compared with other diets, a low-carbohydrate diet achieved the greatest decrease in triglyceride, as well as decrease in weight, HbA1c and glucose and a greater increase in HDL.
  11. Patients with type 2 diabetes on carbohydrate-restricted diets reduce and frequently eliminate medication. People with type 1 usually require lower insulin. Dietary carbohydrate restriction, because of its increased effectiveness in glycaemic control, frequently leads to reduction and often complete elimination of medication in type 2 diabetes. Similarly, patients with type 1 typically require lower medication on low-carbohydrate diets.
  12. Intensive glucose lowering by dietary carbohydrate restriction has no side effects comparable to the effects of intensive pharmacologic treatment. It has been established that not only is the use of drugs to treat diabetes ineffective but there are also proven hazards. By contrast the change of diet definitely works and there are no known dangers.

CONCLUSION

When all the information is collated there is a very convincing case for choosing diets which are low in carbohydrates. It is becoming more and more obvious that the decision to advise a reduction in fat (and an increase in carbohydrates) was totally misguided. As a consequence huge numbers of people have developed chronic diseases. Unfortunately the wrong advice is still being promulgated in most countries. We have now reached the point where the evidence is overwhelming and that policies must be changed radically and without delay. The single exception is Sweden, where a recent official report clearly recognised the extensive benefits of a diet which is low in carbohydrates and high in fat. This topic will be covered in the next blog (5).

REFERENCES

  1. http://www.nutritionjrnl.com/article/S0899-9007(14)00332-3/fulltext
  2. http://jama.jamanetwork.com/article.aspx?articleid=202138
  3. http://ajcn.nutrition.org/content/91/3/535
  4. http://ajcn.nutrition.org/content/91/3/502
  5. http://vernerwheelock.com/?p=542

106. Bad Science and Big Business Responsible for Obesity Epidemic

Dr David Diamond is a neuroscientist who was overweight with high values for his blood cholesterol (TC) and triglycerides, which indicated that he was a prime candidate for heart disease. He was therefore typical of those who are recommended to be prescribed statins on the grounds that this treatment will lower the TC and therefore reduce the risks that they will suffer a heart attack. In this case Dr Diamond decided against statins but elected to change his diet and follow the official recommendations which were supposed to reduce his TC and triglycerides. Essentially he cut down on animal products such as meat, butter, cheese and eggs in order to reduce his intake of saturated fat (SFA). His diet consisted of skinless chicken, low fat foods (cheese, yogurt), olive oil, bread,vegetables, fruit, nuts, cereal and potatoes In addition he increased the amount of regular exercise.

After a couple of years, he found out that this regime not only failed to reduce his risk for heart disease, it actually increased it. His triglycerides and the ratio of TC/HDL Cholesterol got even worse. His cardiologist told him he needed to go on statin drugs immediately and that he was deluding himself by believing diet could change anything.

Instead Dr Diamond decided that he would do his own research into the scientific literature and become an expert in heart disease. This meant that during the day he was a neuroscientist, but in the evenings and weekends he was studying about heart disease. He tells his own story in a public lecture given at the University of South Florida where he is employed (1). It is available on You Tube and although it lasts for about an hour it is well worth watching. Here is a summary of some of the key points he makes.

He begins by recalling the experience of William Banting, a London undertaker, who in 1862 at age 66 years weighed 200 pounds even though he was only 5 foot 5 inches high. Although he tried cutting down on his calorie intake coupled with vigorous exercise, he was unable to lose weight. A surgeon named William Harvey recommended a diet rich in animal foods and vegetables but limited in sugar and starch. So he ate 3 meals a day consisting mainly of meat, fish or game. As far as possible he avoided bread, milk, beer, sweets and potatoes. Between August 1862 and May 1863 he had lost 35 pounds which increased to 50 pounds by the beginning of 1864.He wrote a pamphlet describing his experience which was widely disseminated. He lived well into his eighties.

More recently in the 1940s and 1950s Alfred Pennington in the USA found that those who consumed fresh meat with no restriction on fat but avoiding bread flour, sugar and sweets had no difficulty in controlling their weight.

In 1963, it was reported that weight loss could be achieved satisfactorily by a diet which was low in carbohydrates (2). The patients felt no hunger. They could eat as much meat, butter and fat as they wished, provided they restricted their consumption of foods containing carbohydrates. More recently the Atkins’ Diet has been the subject of much controversy but effectively there is no major difference between this diet and the one which Banting had adopted over 100 years earlier.

Despite all the claims that a diet low in carbohydrates can have all kinds of effects which are deleterious to health, these have proved to be totally unfounded. Research reported in 2006 confirmed that a diet low in carbohydrates not only facilitated weight loss but also moved other indicators of risk towards the normal/healthy levels (3). This included triglycerides and the TC/HDL ratio. Furthermore the blood glucose levels, which indicate diabetes were reduced considerably.

As a result of his investigations, Dr Diamond altered his own diet to one with eggs, butter, beef, chicken (with the skin), full fat cheese, coconut, dark chocolate, nuts and vegetables (especially broccoli), small quantities of fruit, bread, potatoes and sugar. This certainly worked and all the usual indicators reverted to the values consistent with low risks for various disease and general good health, not to mention the fact that he lost weight.

So what has gone wrong? Dr Diamond recounts the role of Ancel Keys, who was a very influential character from the 1950s when Americans were obsessed with the fact that they had one of the highest rates of heart disease in the world. Keys claimed that the higher the fat (and SFA ) intake in a country the greater the death rate from heart disease. However a relationship like this certainly does not demonstrate that the fat/SFA is the cause of the heart disease. In reality, the truth reveals that Keys was selective in his use of data, because other researchers pointed out that he had only used data from 6 countries, whereas if he had used all the data at his disposal (from 22 countries) it was evident that there was no relationship whatsoever. In fact Keyes was a fraud. Despite opposition from many experts, he managed to prevail. He was effectively supported by Senator George McGovern, who chaired a Senate Committee which devised dietary guidelines for the USA. These endorsed the advice to limit the intake of meat/meat products, partly because they were regarded as a source of SFA but also because they were a source of cholesterol. There was never any justification for either of these concerns (4, 5). However the Senate Committee report provided the rationale for the official US dietary recommendations which advised that the most of the diet should consist of carbohydrates, but that animal foods especially those which contain fat should be restricted.

Dr Diamond is just one of a long list of individuals who have evaluated the evidence objectively and come to the same conclusion. There is convincing evidence that the increased intake of sugar and refined carbohydrates is the fundamental cause of obesity, heart disease, diabetes, Alzheimer’s Disease and various cancers. Because the official advice is wrong, we have the paradox that those who follow it carefully are damaging their own health. As Dr Diamond found out, when he discovered that his risks of developing heart disease had increased, the treatments/advice offered were completely ineffective and actually exacerbated his condition. There is absolutely no doubt that this scenario is all too common. It is not just confined to the US because the guidelines devised there have been adopted by the WHO. Consequently the official policies on nutrition are essentially the same in most countries. This is a scandal of immense proportions, which is made worse by the fact that there is huge reluctance by the mainstream public health professionals to admit that there is a need for a profound change in national policies.

REFERENCES

  1. http://healthimpactnews.com/2014/how-bad-science-and-the-pharmaceutical-industry-created-most-modern-diseases/
  2. E S Gordon et al (1963) http://jama.jamanetwork.com/article.aspx?articleid=666850
  3. http://link.springer.com/article/10.1007/s11010-005-9001-x
  4. http://vernerwheelock.com/?p=270
  5. http://vernerwheelock.com/?p=105

 

 

105. Statin critics cleared. Top statin advocate knuckles’ rapped

Recently I have devoted several posts to the topic of statins (1,2,3). It is obvious that there are many serious doubts about the official/conventional approach to the use of these drugs which have been highlighted by the recent controversy in the BMJ. The results of the special inquiry established by Fiona Godlee, the editor-in-chief of the BMJ, have just been announced.  So I am delighted to post this article by the medical journalist Jerome Burne. I am very grateful to Jerome for permission to publish here. The original can be sourced at:

http://jeromeburne.com/2014/08/02/statin-critics-cleared-top-statin-advocate-knuckles-rapped/?relatedposts_hit=1&relatedposts_origin=1165&relatedposts_position=0

The long running spat between senior statin advocate Professor Sir Rory Collins and the British Medical Journal has come to a very satisfactory conclusion. His demand – that two papers challenging his claims about the safety and effectiveness of statins – be withdrawn, has been rejected by a committee specially set up to consider it.

Instead the report, just out, makes several low key but sharp criticism of the way Sir Rory has been dealing with his data. (For more background details on what has been going on see here – Eminence medicine defends status quo and here – Statin debate the ultimate two minute guide)

Sir Rory had been particularly incensed that both the BMJ articles had challenged his claim that statins were effective in healthy patients and caused very few side effects. His specific complaint concerned a minor error in reporting the percentage of side effects contained in another article. This was rapidly corrected

The two authors he was attacking – Dr Aseem Malhotra and Dr John Abramson – had their own concerns about Sir Rory’s work. Notably that his conclusions were based on placebo controlled trials of the drugs run by the drugs companies that kept the data they had collected hidden.

The secret statin data

Since the published results of drug company trials are notoriously unreliable, it’s now widely agreed that independent researchers should be able to look over the data that had been collected on each patient.

The research centre that Sir Rory heads – the Cholesterol Treatment Trialists (CTT) in Oxford – holds the biggest collection of statin data in the world, but no one outside the organisation has been able to study it for 20 years – CTT the house of statin secrets. The committee’s report made it clear that this was no longer acceptable.

‘It is very clear,’ it said ‘that statin trial data is not available for assessment,’ going on to note that this ‘may contribute to uncertainty about the risks and benefits’ of the drugs. That was a damming point since the basis for Sir Rory’s demand for a retraction was that questioning his results from randomised controlled trials was killing people by stopping them taking the drugs. In the committee’s view the issue was still uncertain.

The report picked up on another example of Sir Rory’s eccentric approach to evidence and to normal scientific debate. It noted that despite being asked to write an article rebutting Malhotra and Abramson’s claims and to participate in the rapid responses to the articles, all his correspondence arrived marked ‘not for publication’. ‘This was unlikely’ the report drily observed ‘to promote open scientific dialogue.’

Evidence based medicine not delivering

But there is a much bigger issue here than Sir Rory’s ‘grand old man’ style. While he behaved as if the RCT was an unimpeachable source of information, what has emerged from this battle is that the evidence based medicine project is in intensive care if not already expired. Statins are the most widely prescribed drugs ever and quite possibly the subject of more RCTs than any other.

Yet here we are 20 years on and there is widespread agreement that we still don’t really know how effective they are at preventing heart attacks in healthy people – the group who get by far the most statin prescriptions – or what the true side-effect rate is. Part of the problem is the drug companies’ well-known habit of fiddling of statistics, hiding of unfavourable results, selecting trial subjects most likely to produce favourable results and so on.

The unreliability of RCT’s has recently been acknowledged by one of evidence based medicine’s most enthusiastic supporters – Dr Ben Goldacre. “…We lack reliable information from randomised controlled trial on common symptomatic side effects of statins,’ he wrote in a BMJ editorial last month.

This is something of a volte-face for Dr Goldacre since it was only a few months earlier that a research paper with his name on it concluded that statins didn’t really have any side effects at all; reports saying they did were largely due to a sort of reverse placebo effect – people expected pains and other problems so sure enough they felt them.

A tarnished gold standard

In fact Dr Goldacre has become something of a flip-flopper. It was only a year ago that he wrote a good book (4) – Bad Pharma – that explained in great and forensic detail why results of commercial drug trials couldn’t be trusted because of drug company fiddling.

Yet his statin side effect trial was based on entirely on results from commercial trials. So Dr Goldacre who spent years jeering at any and all non-drug treatments for their lack of RCTs, now admits that even several dozen RCTs can’t decide on the effectiveness or safety of a single drug. It’s a gold standard that is looking fatally tarnished. The debate over how best to fix it wil be covered in another post.

RCT’s unreliablity is particularly unfortunate for patients on statins since waiting in the wings is a new generation of super statins that lower cholesterol even more powerfully and are expected to cost around 20.000 dollars a year – Beware new cholesterol drugs coming. How are we going to decide if they are worth it?

Meanwhile we may be on the verge of having a firm decision about one of statins’ long terms effects – type 2 diabetes. Nearly a thousand women have so far begun legal proceedings against the pharmaceutical giant Pfizer, claiming that their best-selling cholesterol lowering statin Lipitor caused them to develop diabetes – Thousand woman lipitor lawsuit

If they win, and there is considerable evidence to suggest there is a link, then NICE’s decision to recommend the drugs for another four million people or so, along with Sir Rory’s iron clad confidence that there are no side-effects worth worrying about, will look careless, arrogant and dangerous.

REFERENCES

  1. http://vernerwheelock.com/?p=385
  2. http://vernerwheelock.com/?p=432
  3. http://vernerwheelock.com/?p=481
  4. Ben Goldacre (2013) “Bad Pharma: How Medicine is Broken, and How We Can Fix It”. Fourth Estate: London