143. Drugged up to the Eyeballs!!!

The latest issue of the Health Survey for England provides data on the use of prescribed medicines by people living in the community, which therefore relate to the general population and not just those within the healthcare system. The results are based on information supplied by the individuals themselves rather than the agencies responsible for prescribing or dispensing.

It was found that:

  • 43% of men and 50% of women surveyed reported that they had taken at least one prescribed medicine in the last week.
  • 22% of men and 24% of women reported that they had taken at least three prescribed medicines in the last week. . This proportion increased with age but did not vary by sex.
  • The proportion of participants who reported that they had taken at least one prescribed medicine in the last week increased with decreasing income, increasing area deprivation (measured by Index of Multiple Deprivation), and body mass index (BMI).
  • Almost all participants aged 65 and over who needed help with activities of daily living (social care) were taking at least one prescribed medicine and most of them were

taking at least three.

In England, the total costs of medicines during 2013 was over £15B. There were over one billion prescription items dispensed which is equivalent to 2.7 million per day. 307 million (30%) were for cardiovascular disease of which 65 million were for hypertension, heart failure and lipid lowering. On average 18.7 prescription items were dispensed per head of population in England in 2013. The largest single category was for the treatment of diabetes which accounted for almost 10% of the total cost.

This information, which is being made available for the first time, raises a number of issues and questions.

Can this enormous usage of prescription drugs be justified? Although we have the information on the costs incurred, what exactly are the benefits? It is also vital to have an appreciation of the possible adverse side-effects which may be caused by the use of these drugs.

Despite the widespread belief that all drugs are beneficial to everyone who is treated, the reality is very different. A very useful piece of information is the Number Needed to Treat (NNT). This is the number which have to be treated for one person to benefit. The NNT website provides the figures for a number of commonly used medicines. Here are some examples:

  • For anti-hypertensive treatment for the primary prevention of cardiovascular events in mild hypertension it was concluded that no patients derived any benefit but 1 in12 were actually harmed (2). It is somewhat alarming to learn that in one of the trials used in this evaluation more women died amongst those being treated than in the group on the placebo.
  • When beta blockers are used to treat an acute heart attack (myocardial infarction) it was found that none were helped but 1 in 91 suffered from cardiogenic shock (3).
  • The use of aspirin to treat for a heart attack found that 1 in 42 derived a benefit (life saved) but 1 in 167 were harmed by non-dangerous bleeding (4).
  • Neuraminidase inhibitors are used to prevent influenza. However the evidence shows that none were helped in the sense that an influenza-like illness was prevented. But it was noted that if the drug is used as a treatment for acute influenza there is an average of about 1 day of symptom relief. Unfortunately this only applies to those with proven influenza infection who take the drug within 48 hours of the first symptom. On the other hand 1 in 7 experienced nausea and 1 in 37 were harmed by vomiting (5).
  • When insulin is used to control blood glucose in acute ischaemic stroke it was found that none were helped and 1 in 7 were harmed (6).

In view of all the controversy it is interesting to look at the information on statins:

  • Using statins to treat for acute coronary syndrome it was found that no-one derived any benefit (life saved; heart attack, stroke, or heart failure prevented) but an unknown number were harmed (medication side effects/adverse reactions) (7).
  • When statins were given for 5 years in order to prevent heart disease in those who already suffer from it the evaluation showed that 1 in 83 were helped (life saved), 1 in 39 were helped (preventing non-fatal heart attack) and 1 in 125 were helped (preventing stroke). However 1 in 50 were harmed by developing diabetes and 1 in 10 experienced muscle damage (8).
  • When statins were given for 5 years to prevent in heart disease in those did not have a history of heart disease, there were no lives saved although 1 in 60 were helped by preventing a heart attack and 1 in 268 would have avoided a stroke. On the other hand the adverse effects were same as above with 1 in 50 likely to have diabetes and 1 in 10 muscle damage (9).

And so it goes on. It is blindingly obvious that the effectiveness of drugs is much less than most people actually perceive and certainly does not comply with the image presented by their promotion and marketing. The reality is that when a drug is recommended or prescribed the patient involved expects quite reasonably that there is a strong possibility that he/she personally will benefit. The hard reality is that if a person has a life threatening illness, even a very low chance of success would be seized. But I wonder how many are aware just how poor the success rate is for many drugs? What is even worse is that the NNT shows that for lots of drugs “none were helped”! With prevention we have a totally different scene where people generally are being treated with little chance of any benefit. In addition they are also required to accept the possibility of experiencing side-effects which may be quite nasty. Multiple prescriptions mean that many of the drugs are used in combinations. The harsh reality is that our knowledge of such interactions is minimal and therefore we have little idea of any dangers to health which might arise.

In the light of this information, there can be little doubt that most of the drugs which are being prescribed have little beneficial effects for the vast majority of people who are treated with them. I find it absolutely astounding that for many of the drugs in use today the NNT reviewers concluded that none of those treated had any improvement in health. There can be no justification for continuing the use of such drugs. When the likelihood of adverse side-effects is taken into consideration, it is quite unbelievable that people are still being treated with them. To cap it all, a substantial proportion of the total health care expenditure is on drugs. It is obvious that much of this cannot be justified and is effectively a waste of resources, which could otherwise be used to employ additional staff who would actually care for patients.

This latest information is extremely revealing and worrying. A huge amounts of money is being spent on drugs that make little contribution to improving health and are probably doing more harm than good.

It beggars belief that although many parts of the NHS are being squeezed financially the expenditure on drugs appears to escape scrutiny, even though there is solid evidence that there is considerable scope for saving resources by ceasing to buy those which do little to improve health.

REFERENCES

  1. http://www.hscic.gov.uk/catalogue/PUB16076/HSE2013-Ch5-pres-meds.pdf
  2. http://www.thennt.com/nnt/anti-hypertensives-for-cardiovascular-prevention-in-mild-hypertension/
  3. http://www.thennt.com/nnt/beta-blockers-for-heart-attack/
  4. http://www.thennt.com/nnt/aspirin-for-major-heart-attack/
  5. http://www.thennt.com/nnt/neuraminidase-inhibitors-for-influenza/
  6. http://www.thennt.com/nnt/insulin-for-glucose-control-in-ischemic-stroke/
  7. http://www.thennt.com/nnt/statins-for-acute-coronary-syndrome/
  8. http://www.thennt.com/nnt/statins-for-heart-disease-prevention-with-known-heart-disease/
  9. http://www.thennt.com/nnt/statins-for-heart-disease-prevention-without-prior-heart-disease/

 

 

142. Treatment of Epilepsy: A Fascinating Case History

Fasting has been used as a therapy for seizures since the earliest times and in the Bible, Mark describes how Jesus cured a boy with epilepsy (1). In 1911, 2 physicians in Paris used starvation to treat 20 children and adults for epilepsy and reported that seizures were less severe. In 1921 Dr Rawle Geylin presented a paper to the American Medical Association Convention in which he described how cognitive improvement was achieved by the use of fasting as a treatment for epilepsy. This stimulated a research study at Harvard where it was discovered that when starvation was used to treat epilepsy there was usually an improvement in seizure control within 2-3 days. It was suggested that this was due to a change in metabolism because the absence of food or just a shortage of carbohydrates forced the body to utilise fat.

In 1921, there 2 important observations were made:

  1. When a person starves or consumes a diet with a low proportion of carbohydrates and a high proportion of fat, acetone and beta-hydroxybutyric acid (both of these are ketones) build up in the blood
  2. Research at the Mayo Clinic led to the suggestion that that the benefits of fasting could be obtained if the presence of ketones could be achieved by other means.

This led to the development of the “ketogenic diet” (KD) which consisted of 1 g of protein per kg of body weight in children, 10-15 g of carbohydrates per day and all the rest of the diet was fat. When this diet was used to treat children with epilepsy there were definite improvements in behaviour and in cognitive ability. Initial reports of success were soon confirmed and the use of the KD became established practice and was widely used during the 1920s and 1930s. Most of the standard text books which appeared between 1941 and 1980 had texts with full chapters describing the diet, telling how to initiate it, and how to calculate meal plans. A text book published in 1972 (2) described results for over 1000 children who had followed the KD. Complete control was achieved in 52% while there was improved control in 27%.

In 1938, new drugs which claimed to be suitable for the treatment of epilepsy started to appear on the market and the emphasis began to shift so that use the KD went into decline. Paediatric neurologists came to regard the drugs as the way forward. So the KD was used less and less. As a consequence fewer dietitians were trained in the use of the diet, which meant that it was often implemented incorrectly. As a result it was perceived to be ineffective and therefore fell out of favour.

There was little use until the early 1990s when a television programme in the USA described the story of a young boy, named Charlie who failed conventional therapies for his infantile-onset epilepsy, including numerous anticonvulsant medications and one surgical intervention (3). However when he was introduced to the KD, he achieved seizure freedom and remarkable neurodevelopmental recovery. At an international conference in 2008, Charlie, then aged 17 years, made a huge impact when he described his experience and expressed his thanks to all the dietitians, physicians, nurse and others who looked after him while being treated with the KD. He explained how the diet had controlled his seizures to such an extent that he was able to discontinue his use of antiepileptic drugs (AEDs) and, in essence, gave him his life back

He made the critical point as follows:

 “I was one of the few lucky ones. Since the diet was invented there have been millions of kids all over the world just like me, who were as sick as I was, but whose families either never heard about the diet or were talked out of it.”

What is particularly important is that the television programme generated considerable interest in the KD so that it was once again it became accepted as a recognised treatment and many research projects were initiated. In one study, at the outset there were 150 children who averaged 410 seizures per month being treated with a mean of 6.2 antiepileptic medications (4). After 3 months, 83% were still complying with the KD and 34% had >90% decrease in seizures. At 6 months, 71% still remained on the diet and 32% had a >90% decrease in seizures. At 1 year, 55% remained on the diet and 27% had a >90% decrease in seizure frequency. Most of those discontinuing the diet did so because it was either insufficiently effective or too restrictive. It was concluded that the KD was more effective than many of the new anticonvulsant medications and was well tolerated by children and families when it was effective.

A more recent study, using a questionnaire, was designed to find out if the improvement was maintained after the treatment with the KD was discontinued at least 6 months earlier (5). At the time of documented KD discontinuation, 31 (31%) were seizure free, 16 (16%) had a 90–99% seizure reduction, 12 (12%) had 50–90% seizure reduction, and 42 (42%) had <50% seizure control compared to before starting the KD. At the time of the survey the level of >50% control was higher than when the KD was stopped, 79% versus 52%. This clearly demonstrates that the effectiveness of the treatment had been maintained. There was no indication of long term serious adverse effects. There was overwhelming support for this approach to treatment with 96% of respondents willing to recommend it to other families.

There is no doubt that the KD does work for some patients. Clearly this would be unrealistic. There are many different forms of the condition and the scope for success may well depend on treating as early as possible. Certainly the success rates compare very favourably with those which have been reported for a number of drugs used to treat epilepsy. In fact most drugs which are available do not have anything like the efficacy reported for KD. Further research should provide greater understanding of how the KD works that might well enable improvements to be made in its effectiveness. Although this discussion is confined to epilepsy, there is now growing understanding and awareness that the impact of the KD is much broader. There is convincing evidence that reducing sugar and other carbohydrates coupled with an increase in certain fats is a means of overcoming diabetes, heart disease, cancer and Alzheimer’s Disease. Hence the case for adopting a KD type diet as a strategy for improving public health generally is extremely compelling.

On the other hand, there appears to be little concern about adverse side-effects with the KD and since it simply involves some alteration in the composition of the diet, these would not be expected.

It is relevant to speculate why drug therapy was allowed to replace the KD as a treatment for epilepsy. There must be a very strong suspicion that the activities of the drug companies in pushing their products were based on exaggerating the benefits and playing down any associated adverse effects. There is plenty of evidence that this is typical of how these companies operate (7,8). By contrast, resources to support the use of the KD were probably very limited and therefore no match for the deep pockets of the pharmaceutical industry. Charlie commented on the huge numbers of people who missed out on a potentially successful treatment because of the neglect of the KD and it was fortunate that his father was in a position to make the TV programme which had such an impact.

It is especially ironic that the KD would be enormously helpful to those millions who are suffering from diabetes (both Type 1 and Type 2) and other chronic diseases but are not being given the information by the main stream health professionals. Perhaps we can learn some lessons from the above which might help get the KD promoted to the general public.

This is already happening in South Africa so maybe other countries will be watching carefully. Next February there will be a major international Summit in Cape Town which could turn out to be of enormous significance. Already many of those who are actively promoting and campaigning for a re-think on nutrition policies have signified their intention to be present. It is to be hoped that there will be a critical mass which will have an enormous impact right across the globe.

The first event which will be for two days is aimed primarily at medical practitioners. The content will focus on scientific data, studies and facts relating to a lifestyle based on a KD type diet.  This will be followed by a one-day event which will be geared to the needs of the general public.

Further details are available on the official website at http://www.lowcarbhighfatexperts.com/

REFERENCES

  1. J W Wheless (2008) http://onlinelibrary.wiley.com/enhanced/doi/10.1111/j.1528-1167.2008.01821.x/
  2. Livingston S. (1972) Comprehensive management of epilepsy in infancy, childhood and adolescence. Charles C. Thomas, Springfield , IL , pp. 378–405.
  3. C E Stafstrom et al (2008) http://onlinelibrary.wiley.com/enhanced/doi/10.1111/j.1528-1167.2008.01820.x/
  4. J M Freeman et al (1998) http://pediatrics.aappublications.org/content/102/6/1358.abstract
  5. A Patel et al (2010) http://onlinelibrary.wiley.com/enhanced/doi/10.1111/j.1528-1167.2009.02488.x/
  6. http://www.medicine.ox.ac.uk/bandolier/band54/b54-4.html
  7. http://vernerwheelock.com/?p=644
  8. http://vernerwheelock.com/?p=581
  9. http://vernerwheelock.com/?p=658

 

141. Adjusting to a Low Carb High Fat Diet

You have done all the research and been convinced that it makes good sense to be consuming a diet which is low in carbohydrates and high in fat (LCHF) but also described as ketogenic. Then you have to decide how to put it into practice. It can all be quite a minefield because different people have different ideas about what exactly is meant by a ketogenic diet and how it can be implemented. In this blog I will make some suggestions based on my own experience and that of friends who are travelling on the same road.

I will begin with some basic principles:

  • There is no “one fits all” strategy because everyone is different so what works for one does not necessarily work for others
  • It follows therefore that you have to determine what is the most effective approach  for you
  • Make a start by doing an evaluation of your current diet and identify the changes you think would be needed
  • Do not be over ambitious. I recommend an evolutionary approach rather than a revolutionary one.
  • It is important to understand that the object is to make permanent changes to your regular pattern of food consumption
  • Introduce one change at a time. If you find that you simply cannot adjust then forget about it. Meal times should be enjoyable occasions not something to endured. However do not give up easily because the taste buds can adapt so give each you attempt a fair chance to be successful
  • Continue to introduce changes to suit yourself. Regard it as journey with many different turns and twists
  • The best way to judge if progress is being achieved is how you feel in yourself. If things are going well you should certainly feel more lively and energetic. You will probably lose weight. In my own case I lost about 5kg even though my BMI at the start was about 24. If you have an opportunity for blood analyses to be done, then the glycosylated haemoglobin (HBAc1) is probably the best one. The gives a good indication of the average blood glucose over the past 3 months.
  • Some advocate targets such as a specific amount of carbohydrates per day. This just does not appeal to me. You will definitely know yourself if there are improvements in your physical and mental health. So hopefully you reach a point where you are satisfied that significant progress has been achieved. But you can still keep trying out new ideas.

Now let us consider some practicalities. The top priority has to focus on eliminating as much sugar as possible from the diet. Sugar is “empty calories” which means it is just a source of energy and does not contain any other nutrients such as fats. proteins, minerals or vitamins. By contrast, there is a large body of evidence which demonstrates that excessive intake of sugar contributes to the development of a range of chronic diseases including Type 2 diabetes (T2D), heart disease and various cancers. The use of sugar in beverages and baking is obvious but the big problem is the widespread use of sugar in processed foods. It is not easy to identify because so many different terms can be used. The ingredients on chocolate biscuits include sugar, glucose syrup, invert sugar syrup, fructose, molasses all of which are forms of sugar. When sugar is digested, glucose and fructose are released. Fructose is likely to particularly damaging because it can only be utilised in the liver and so if present in excess will result in the condition of fatty liver. Sugars can interact with proteins thereby preventing them functioning properly. Because fructose has much greater affinity for the proteins than glucose this means sugar and High Fructose Corn Syrup (HFCS) are likely to be more dangerous than other foods which do not contain it. This is also a reason to limit the consumption of fruit juices because of the high content of fruit sugar which is fructose. It is absolutely vital to avoid all the “low fat” versions of all foods. Invariably the good fats have been removed and replaced with sugar and sweeteners. Although these are promoted as “Healthy” the reality is that they are anything but!

The next step is to consider the other sources of carbohydrates which are primarily those containing grain products such as bread as well as potatoes, pasta and rice. These contain starch which breaks down to glucose. Try to limit those which are refined, as for example white bread. This is because the glucose is released quickly resulting in rapid increase in the level of the blood so that insulin has to produced. It is the excess insulin that does so much of the damage leading to various types of ill-health. On the other hand, those foods which have not been refined release the glucose slowly. Porridge made from whole grain oats should not be a matter of concern.

According to the official dietary guidelines in most countries, the advice is to reduce the fat especially the saturated fat (SFA) and to replace it with complex carbohydrates. As many diabetics have found to their cost, this strategy is likely to result in raised blood glucose levels (1).

It is of course necessary to replace the carbohydrates with other foods. The main emphasis should be trying to increase the amount of vegetables. Onions, mushrooms, broccoli, cabbage, cauliflower, tomatoes are all very good sources of a range of nutrients.  Green leafy vegetables and salads are all good news. Although avocadoes have a high fat content, the fats are all good. It is important to recognise that the most of the SFAs from animal or vegetable sources are really valuable nutrients. Eggs, meat and dairy products are absolutely fine, especially the full fat versions but be careful with meat products unless you know exactly what ingredients are present. Where fats/oils are needed for preparation or cooking then choose butter or coconut oil. Olive oil should be used but preferably not for high temperature cooking. Fish and fish oils are predominantly omega-3s but vegetable oils and those polyunsaturates which “lower cholesterol” are mainly omega-6s. As the omega-6:omega-3 ratio in typical diets is far too high then cut out the omega-6s but boost the omega-3s.

Berries, nuts and seeds offer great potential because they contain lots of valuable nutrients and can be used for breakfast and salads as well as being key ingredients for baking.

I have only been able to provide an introduction here and hope to return to this topic in the near future. Further ideas and insight can be found in these references (2,3).

REFERENCES

  1. http://vernerwheelock.com/?p=422
  2. http://realmealrevolution.com/
  3. http://www.canceractive.com/cancer-active-page-link.aspx?n=531

 

 

140. “Our Diabetes Clinic Wouldn’t Listen, But Reported Me to the Authorities”

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/diabetes-clinic-wouldnt-listen-reported-authorities

A 9-year-old is firmly advised to eat a pound of root vegetables per meal for the brain to work

Diabetics are routinely exposed to neglect, because of old ingrained dogmas on how they need to eat. Diabetics are getting sicker unnecessarily, and often often their attempts to improve their health are met by opposition from health-care professionals.

The following example is one of the worst I’ve encountered. A mother managed to help her 9-year-old son with type 1 diabetes to become healthier and feel better by eating fewer  carbohydrates. The result of the mother helping her child? The diabetes clinic reported her to the authorities!

However, the report was soon abandoned – because everyone involved, including school health professionals, noticed that the child was doing much better than before – but the diabetes clinic continues to put up resistance.

Recently, the diabetes clinic sent a letter to the school, stating that the child needs to eat at least a pound of root vegetables per meal in order to “ensure that enough glucose reaches the brain”. The fact that the child was already feeling better than ever before doesn’t seem to matter. Here’s the full translation of the letter, signed by a dietitian at the clinic:

“The recommended intake of carbohydrates at lunch is no less than 30 g (1 oz).

In order to ensure that enough glucose reaches brain cells and other body tissues, a minimum of 30 g of carbohydrates is required at lunch.

If carbohydrate intake has to be in the form of root vegetables, then 300–700 g (about a pound) is required to get the carbohydrate intake up to 30 g (1 oz).”

This is a story from Sweden in the year 2014. A story that an appropriate investigative TV show should dig in to:

The Email Translated from Swedish

My son is 9 ½ years old and was diagnosed with type 1 diabetes three years ago. Early on, our diabetes clinic prescribed eating large amounts of carbohydrates, such as rice, pasta and potatoes. As I was raised in a different country and environment I didn’t have any knowledge about how to treat diabetes and I did as the diabetes clinic recommended.

My son got an insulin pump early on, as injections worked poorly and his blood sugar was very unstable. He also has a very sensitive digestive system, which led to constipation lasting for days, due to all the potatoes, rice and pasta, and the blood sugar roller coaster continued. After about 1 ½ years with diabetes I contacted the National Board of Health and Welfare and read up on various guidelines used in both Sweden and elsewhere about alternative diets and then decided to remove all carbohydrate-rich foods and limit him to 10 % carbohydrates. I also started to cook all meals at home from scratch.

I quickly realized that he was feeling very much better on a slightly higher dose of basal insulin (about 15 IE), no mealtime insulin and a moderate low-carbohydrate diet. With time, his digestive problems improved a lot and he hasn’t had constipation since the diet change. His blood sugar rarely goes high, over 230 mg/dl (13 mmol/l), and it’s even rarer that it goes too low.

When I told the diabetes clinic how I’d changed his diet they reacted as if I’d committed a crime. I tried to explain that he eats an appropriate amount of complex carbohydrates, low impact on both his digestive system and blood sugar. After the diet change he’s now feeling a lot better, both body and soul, but the diabetes clinic didn’t want to listen but instead reported me to the authorities because of my choice of diet for my son. I felt like a criminal. The filed report was dropped after a very short investigation where the authorities soon realized that my son ate a good and well-considered diet, was doing great and was in good hands.

The school physician and nurse supported me in my opinion on diet and saw nothing wrong with his diet. The school sent a letter to the diabetes clinic where they advocated my diet choice because they could clearly see that his blood sugar control had improved, his numbers improved and he felt great. My son’s assistant also says that this is the first time that she meets a diabetic with such a stable blood sugar. She finds it very easy as his blood sugar is not on a roller coaster.

However, the diabetes clinic at Karolinska won’t give up the idea that my son has to eat more carbohydrates and they are doing everything in their power to influence me and the school. Recently, the dietitian sent a recommendation to the school stating that my son should eat at least 30 g of carbohydrates for lunch in order to “ensure enough glucose to the brain cells” (see picture). The claim lacks scientific basis, and I think it nearly constitutes child abuse to suggest that a 9-year-old eat a pound of carrots for lunch every day, and moreover, this would worsen his blood sugar levels.

What frightens me the most is the diabetes clinic’s attitude and how I, who finally think that I’ve managed to get my son’s diabetes under control just fine, have been treated. I’ve really experienced that I don’t have this right, but should obey the diabetes clinic’s health professionals, who assume that they are the ones to decide. I asked the dietitian for a reference to support her recommendation, but the only source she gave was the agency that issues the official dietary guidelines.

After 1 ½ years on a low-carbohydrate diet my son now feels confident in his diabetes and thinks it’s very easy to manage. I’m currently writing a book about children with diabetes and diet, hoping that others may benefit from our experiences.

Sincerely, Katrin, mother of a 9-year old with type 1 diabetes

139. Vitamin D is Absolutely Critical

In an article in the Yorkshire Post (1) the National Institute for Health and Clinical Excellence (NICE) has released guidance which advocates that Vitamin D supplements should be given out free to people who are at risk of a deficiency (2). NICE claims that about 10 million people in England have low Vitamin D status. This means that a person can be at risk of rickets and weak bones. However Professor Hilary Powers of Sheffield University who chairs the Public Health England Vitamin D working group does not agree. She states that NICE has “jumped the gun” in advising on supplement intake. The current position is that those who are over 65 years old should have 400 International Units (IU) per day, while there is no recommendation for those between the ages of 4 but under 65 years. This is because it is assumed that all of these people will obtain sufficient from their food plus exposure to sunshine.

There is no doubt that we do need to pay much more attention to Vitamin D and its role in public health. Unfortunately the article misses a number of very important issues.

First the official position with respect to lack of any specific recommendation for those between 4 and 65 is completely unrealistic. Many people just do not get out in the sunshine or if they do remain covered up. The widespread use of sun blocs, because of concern about the risks of developing skin cancers, means that the action of the sunlight to produce Vitamin D is inhibited. Even if we get enough sunshine here in countries such as the UK, the stores built up during the summer months will be used up quickly so that for several months there will inevitably be a deficiency. The amounts present in foods are simply too low to provide an adequate supply. On top of this, because Vitamin D is only present in fat, the current emphasis on reducing fat makes it even more difficult to achieve an adequate intake from food sources.

What is of even greater significance is that the current recommendation for very young children is based on the prevention of rickets. However we now know Vitamin D is involved in many other functions in addition to its role in bone formation. It has been established that low levels are associated with increased risks of a range of diseases, including cancer, heart disease, diabetes and Multiple Sclerosis (MS).

Results from the Ludwigshafen Risk and Cardiovascular Health (LURIC) study illustrate the importance of the Vitamin D status with respect to general health and life expectancy(3). Between July 1997 and January 2000, 3316 men and women were recruited in Ludwigshafen in south west Germany who had been referred for coronary angiography. Of these 1801 were found to have Metabolic Syndrome (a cluster of conditions including obesity, diabetes, high blood pressure, raised triglycerides and low HDL Cholesterol). In other words they were high risk for heart disease and related problems. Information was collected and collated on the health and lifestyle. The Vitamin D status was determined by the level in the blood. The participants were followed for almost 8 years, during which time there 462 deaths. The results shown in Table 1 are absolutely fascinating. First of all, there is a progressive fall in the death rate as the level of Vitamin D in the blood increases. Those in the group with the highest Vitamin D have a death rate which is only one quarter that of those with the lowest level. Although this does not conclusively demonstrate that the Vitamin D is the cause of the improved chances of survival it is certainly consistent with that explanation. Furthermore this result does lend support to other findings that ensuring a high level of Vitamin D in the blood is a critical factor in maintaining good health. It is interesting to note that those with a high level of Vitamin D are also much more physically active than those with low values. Perhaps those who take exercise by activities such as walking, jogging or gardening spend more time outdoors. As a result they benefit from exposure to sunshine and build up substantial stores of Vitamin D.

TABLE 1 SELECTED CHARACTERISTICS, VITAMIN D STATUS AND DEATH RATES IN THE LURIC STUDY

                                    Vitamin D content in the blood
  <25 nmol/L 25-50 nmol/L 50-75 nmol/L >75 nmol/L
Age, years 66.0 63.6 62.2 61.7
BMI 28.9 29.0 28.7 28.8
Total Cholesterol, mmol/L 4.8 4.9 5.0 5.0
LDL Cholesterol.Mmol/L 2.7 2.8 2.9 2.9
C reactive protein, mg/L 70.2 37.7 34.8 28.7
Above average physical activity, % 12.8 27.8 37.1 52.9
Adjusted death rate Model 1(All causes) 1.00 0.56 0.48 0.18
Adjusted death rate Model 2(All causes) 1.00 0.62 0.56 0.25
Adjusted death rate Model 3(All causes) 1.00 0.63 0.61 0.25
Adjusted death rate Model 1(CVD) 1.00 0.55 0.36 0.25
Adjusted death rate Model 1(CVD) 1.00 0.60 0.45 0.34
Adjusted death rate Model 1(CVD) 1.00 0.61 0.49 0.36

 

Note: The crude death rates have to be adjusted to allow for differences in age and the relative proportions of men and women in each group. The reason for the 3 different values is that the assumptions in each model vary slightly.

Incidentally the values for Total Cholesterol and LDL Cholesterol are virtually identical despite the 4-fold difference in death rate! Another piece of evidence which undermines the cholesterol theory of heart disease.

While these investigations suggest that many people would benefit from supplementation with Vitamin D the only way to confirm that is the case is to conduct an experiment. Joan Lappe and colleagues at Creighton University in Nebraska have done just this (4). A total of 1179 post-menopausal women aged over 55 years were selected for participation in a double-blind randomized trial, which lasted for 4 years. There were 3 different treatments:

  • Placebo
  • 1500 mg calcium/day
  • Calcium plus Vitamin D (1100      International Units (IU)/day)

Almost 87% of the participants completed the study which is an excellent result.

When any cancers diagnosed in the first year were excluded (to eliminate any which might have been initiated before the study commenced) it was found that those who were taking Vitamin D plus calcium had a relative risk of death due to cancer which was 0.23. In other words their risk of cancer was just one quarter that of those taking the placebo. Those taking calcium only had the same risk as those on the placebo. This reduction in the risk of developing cancer is absolutely huge! It is certainly much greater than could be achieved by the use of drugs. It is especially significant that it fits in with and provides support for the epidemiological results. In this investigation it is not possible to be definitive about the role of the calcium as there was no treatment which was confined to Vitamin D on its own. It is also worth noting that some researchers advocate an even higher dose than 1100 IU/day so it is possible that even more favourable results can be achieved.

It really is time that the official bodies caught up with the latest insight and understanding which has been emerging in recent years and recognized the serious limitations in the current recommendations. In the meantime individuals can decide for themselves to take supplements,   especially in the wintertime. Any amount per day of up to 4000 IU will certainly not cause any harm. There are different forms of the vitamin and the preferred one for supplementation is D3. It is also important to ensure there is adequate Vitamin K2 in the diet (see 5).

REFERENCES

  1. http://www.yorkshirepost.co.uk/news/main-topics/general-news/call-for-free-vitamin-d-supplements-for-those-at-risk-of-deficiency-1-6971918
  2. http://www.nice.org.uk/guidance/ph56
  3. G N Thomas et al (2012) Diabetes Care 35 (5) pp1158-1164
  4. J M Lappe et al American Journal of Clinical Nutrition 85 (6) pp 1586-1591
  5. http://vernerwheelock.com/?p=173

 

 

138. Canadian Physician Tackles His Own Diabetes Successfully

Dr Jay Wortman is an MD based in Canada. At the age of 50 years it suddenly woke up to the fact that he had all the typical signs and symptoms of Type 2 Diabetes (T2D). He tested his blood glucose and found that it was far too high. At this point he decided the only way forward was to eliminate as much sugar and starchy foods as possible from his diet in order to lower his blood glucose even though this was not a recognized from of treatment for T2D. He describes the response in his own words:

“The first thing that happened was that my blood sugar normalized. This was almost instant and was followed by a dramatic and steady loss of weight. I started dropping about a pound a day. My other symptoms swiftly vanished, too. I started seeing clearly, the excessive urination and thirst disappeared, my energy level went up and I began to feel immensely better.” (1)

At the time Dr Wortman was working with the Aborigines. He was extremely conscious of the high rates of T2D in the Canadian Aboriginal population which were between 3 to 5 times higher than in the population as a whole. Obesity and metabolic syndrome were also major problems with the result that the Aboriginal communities were being devastated and the costs for treatment and care were huge. In addition to the usual costs in the community for drugs and personal care, people had to be transported from remote communities for treatment of complications such as kidney failure and amputations. Despite the fact that money was being spent on education and prevention the incidence of the disease continued to rise and there seemed to be no way that the trend could be reversed.

In the light of his own experience, Dr Wortman began to consider the diet of the Aboriginal population and discovered that the traditional diet which consisted of foods such as salmon, halibut and shellfish in coastal areas while Inland, it would include moose, deer and elk. There would also be berries and other seasonal wild plants. In reality there was little carbohydrate, in contrast to the contemporary diet which includes lots of carbohydrates such as bannock bread, consumed in large quantities as well as soft drinks and juices.

As a consequence he decided to see if he could set up a research project to study the role of dietary carbohydrates in the development of T2D and to clarify the impact of reducing their intake. He made contact with Dr Eric Westman, professor of medicine at Duke University in North Carolina who had just published a paper which showed how a number of young men had lost weight by consuming an Atkins diet over a 6-month period. What was especially significant was that the cholesterol levels had actually fallen. At the time the conventional view was that the high fat content in the Atkins diet would push up the cholesterol levels. Dr Westman helped formulate a proposal to conduct a dietary trial with Aborigines living in a coastal community which was submitted to the Canadian Institute of Health. The proposal was rejected and was the first hint to Dr Wortman of the deeply ingrained institutional opposition to low-carb diets. He soon became aware that the dietary changes which had been so successful for him personally were viewed with intense fear and suspicion by those who are supposed to be the authorities in the field. He was openly attacked by dietitians when he suggested that a low-carb diet could be an effective way of losing weight and treating T2D. As he put it himself he was

“…surprised to find that a debate that should be dispassionate and grounded in evidence would often become so emotional and irrational.”

Further evidence of the validity of the low-carb approach was shown by a case study of James Wilson, who was suffering from T2D.He had been on insulin for 17 years, but had been unable to get his blood sugars down to the normal range. He was also on medication for hypertension, was overweight and had high cholesterol. By simply cutting out sugars and starch within 2 weeks he had achieved normal levels for his blood glucose and had been able to stop the insulin treatment. He had also lost about 7 kg.

Two weeks later, he had lost another 5 kg and had discontinued his medication for blood pressure. After 18 weeks he had lost a total 23 kg, all the readings were normal and he required no medication. Interestingly he had not increased his physical activity.

It just so happened that Dr Wortman shared a flight with Dr Carolyn Bennett, who at the time was the Minister of Public Health and was working to develop what was to become the Public Health Agency of Canada. He was able to share information on the importance of the low-carb approach with her and clearly she took this on board. Subsequently she agreed to host a symposium which Dr Wortman had organized in February 2003. The purpose was to debate the issues around diabetes in the Aboriginal population, traditional diet and low-carb diet.

Those who agreed to participate were Dr Westman, Dr Steve Phinney, who had done work on the relationship between a high-fat low-carb diet on stamina in athletes and Dr Mary Vernon, who had been treating T2D patients successfully with a low-carb diet for years at her family medicine clinic in Kansas. Much to Dr Wortman’s delight, he persuaded Dr Walter Willett, the distinguished nutrition researcher at Harvard to attend. Dr Willett has recently argued that the USDA Food Pyramid had got it wrong because the advice on fats and oils was misguided and that the recommendations on refined carbohydrates should be much lower.

The object of the symposium was to address the following questions:

  1. Does the extent of the epidemic of diabetes in Aboriginal populations constitute a public health emergency?
  2.  Is there enough evidence that traditional diets and low-carb diets are similar to support further research in this area?
  3.  Is there enough evidence to warrant immediate program activity in this area?

To all of these the answer was a resounding “Yes”.

As a consequence, Dr Wortman eventually managed to obtain the funds to support a trial in which volunteers from the Aboriginal community were encouraging to revert to their traditional diet. The results were a great success and it was found that most lost weight, overcame T2D and generally improved their health. Unfortunately I have not been able to find the detailed results so if anyone can point me to them I would be grateful. A TV programme was made which featured a number of individuals who improved their health significantly when they changed their diet, but this does not appear to be easily accessible. However Dr Wortman describes his results in this interview on You Tube (2).

Dr Wortman, Dr Phinney and Dr Westman will all be speaking at the Low Carb Summit which is being held in Cape Town next February (3). We have come a long way since Dr Wortman first discovered how to deal with his T2D. It is uncanny that Professor Tim Noakes encountered similar rather irrational opposition to that experienced by Dr Wortman when he started to promote low carb diets in South Africa (4). Judging by what is happening in the social media coupled with the coverage in the media there is certainly a growing acceptance of the effectiveness of low-carb diets as a means of avoiding a range of common chronic diseases and achieving good health. The big problem is that national nutrition policies are still dominated by concepts which have absolutely no credibility but are still defended by the reactionaries. By providing a forum which brings together most of the advocates of the low-carb strategy, this event could well be the stimulus which will start to see changes in official national policies.

REFERENCES

  1. http://www.drjaywortman.com/blog/wordpress/about/
  2. https://www.youtube.com/watch?v=zjUdtK6ukqY
  3. http://www.lowcarbhighfatexperts.com/
  4. http://vernerwheelock.com/?p=565

 

 

 

137. Corruption of the Scientific Literature: Ghost Writing

Anyone reading a scientific paper in a reputable journal which uses a peer-review system expects the information to be reliable and objective. Unfortunately this is not necessarily the case because there is now convincing evidence that the pharmaceutical industry devotes huge resources to influencing the way in which the material is presented with particular reference to the conclusions. Following court cases in the USA drug companies have been required to disclose documents which reveal that ghost writing and guest authorship is now common practice.

Ghost writing exists when someone has made substantial contributions to writing a manuscript and this role is not mentioned in the manuscript itself. It often occurs simultaneously with guest authorship (sometimes called honorary or gift authorship), where the contributions of the named authors are very limited, or non-existent (1). The prime purpose of these strategies is to ensure that the benefits of any drug involved in the research are presented in the best possible light and that any undesirable side-effects are minimized. Most of the hard work preparing the manuscripts is done by professional writers whose name may not even be included as an author. Those listed officially as authors are usually well-known in the field and are used primarily to lend credibility to the paper. According to Jerome Kassirer, a former chief editor of the New England Journal of Medicine:

“Ghost writing debases fundamental tenets of the medical profession. It violates authors’ personal integrity, responsibility, and accountability. More importantly, ghost writing threatens the very fabric of science and thus the validity of our medical knowledge, and in doing so it jeopardizes patient care.”(1)

He refers to one specific example in which the marketing department of a pharmaceutical company promoted one of its products by carefully selecting positive reports and playing down any risks. It then made an agreement with a reputable academic to be paid a fee to submit the paper to a journal under his own name (2).

Richard Smith, a former editor of the British Medical Journal, and a colleague concluded that:

The way medical journals publish the results of clinical trials has become a serious threat to public health” (3).

In their opinion, clinical investigators have become adept at selecting results favourable to their paymasters, very often pharmaceutical companies, which are used by them to promote their products. As a consequence the researchers profit financially and advance their careers. The editors are provided with material to publish and the companies/organisations which own the journals are profitable. The losers are the trial participants whose contribution to research is wasted, the patients who must swallow the drugs despite the distorted evidence, and the public who must pay for the drugs.

As an example of what is happening is that unfavourable results may be excluded or removed from the paper that is subsequently published. By contrast, favourable results may be published many times (cloning) and then subject to intensive marketing to ensure that they get noticed.

CASE STUDY

As a result of litigation about Hormone Replacement Therapy (HRT) the Wyeth pharmaceutical company had to release 1500 documents which have been analyzed to provide valuable insight into these issues (4).

HRT was approved in 1995 and promoted on the grounds that the treatment would prevent cardiovascular disease (CVD), osteoporosis, Alzheimer’s Disease, colon cancer, tooth loss, and macular degeneration. However in 2002 the Women’s Health Initiative (WHI) demonstrated conclusively that HRT failed to prevent CVD. It was also discovered that it increased the risk of breast cancer and stroke. Further analyses showed that HRT increased the risk of dementia and incontinence.

The documentation revealed that companies devote considerable resources to the preparation and publication of articles in the medical journals as well as posters for display at meetings in order to establish key marketing messages. It is common practice to employ specialist companies in education and communications to create the papers and get them placed in journals and magazines that will be read by those in the medical professions.

With respect to HRT, Wyeth engaged DesignWrite, whose role was to help the company decide what data to present, recruit “authors”, choose journals, create abstracts for meetings with the object of positioning the product appropriately to influence those responsible for prescribing. Between 1997 and 2003 DesignWrite produced over 50 peer-reviewed papers and more than 50 scientific abstracts and posters, journal supplements, internal white papers, slide kits and symposia.

The analysis of the disclosed papers came to the conclusion that DesignWrite helped Wyeth create ghostwritten reviews and commentaries which were to:

  • Mitigate perceived risks of hormone-associated breast cancer
  • Promote unproven, off-label uses, including prevention of dementia, Parkinson’s Disease and visual impairment
  • Raise questions about the safety and efficacy of competing therapies
  • Defend cardiovascular benefits, despite lack of reliable evidence to support this position
  • Position low-dose hormone therapy

Despite the fact that the WHI had established that HRT did not prevent CVD, stroke or Alzheimer’s Disease, other benefits were devised and promulgated. It was suggested that HRT treatment was repeatedly shown to increase collagen content, dermal thickness and elasticity. Many ghost written articles questioned the link between HRT and breast cancer or falsely implied that breast cancers associated with HRT are less aggressive.

The insight gained from these studies is truly alarming and demonstrates the extent to which information is being manipulated in order to promote the sales of drugs of doubtful efficacy. There is a total failure to apply any kind of ethical or socially responsible standards. Essentially it means that not only are members of the public being defrauded but that they may also experience serious damage to their health.

It is highly significant that when this case study was published in 2010 many doctors were still prescribing HRT to menopausal patients even though there was sound evidence of its danger. The author concluded that:

This non-evidence–based perception may be the result of decades of carefully orchestrated corporate influence on medical literature.”

 

REFERENCES

  1. P C Gøtzsche, J P Kassirer, K L Woolley, E Wager, A Jacobs, A Gertel, C Hamilton (2009)
    http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000023
  2. J S Ross et al (2008) Journal of the American Medical Association 229 (15) pp-1812-1800
  3. R Smith and I Roberts (2006)   http://www.plosclinicaltrials.org/article/info%3Adoi%2F10.1371%2Fjournal.pctr.0010006
  4. A J Fugh-Berman  (2010) http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000335

 

136. Stroke Association. Digging beneath the Surface

I have just received a mail shot from the Stroke Association which points out that research into stroke is currently woefully underfunded. In order to maintain its current commitment to stroke research and support further ground-breaking research projects in the future I am asked to donate £100. It continues:

“Tragically, approximately 50,000 people in the UK die from stroke each year. The known risk factors-such as high blood pressure, smoking, high salt intake and lack of regular exercise-increase the chances of having a stroke, but the truth remains that anyone, at any age, is potentially at risk of stroke.

Furthermore:

“..this is a particularly exciting time for stroke research as the ongoing development of technologies such as advanced Magnetic Resonance Imaging (MRI) scans and new drug treatments have the potential to vastly increase our understanding of how to effectively prevent and treat stroke. Money invested in stroke research is an investment in a healthier, more active and independent future for thousands of people across the UK”.

The letter includes a separate document describing research which is aimed at assessing the effectiveness of clot removing devices. This is being conducted by Professor K Muir who is SINAPSE Chair of Clinical Imaging at the University of Glasgow. It is hoped that this approach may prove to especially valuable for patients who do not respond well to the clot busting treatment with thrombolytic drugs.

The results of this project may ultimately benefit some patients. However the difficulty I have is that unless there is a genuine effort to identify the fundamental causes and take steps to eliminate them, it is highly likely that the person will suffer another stroke. The information provided in the letter states that there are more than one million people living with the after-effects of stroke and that half of all stroke survivors are left with disabilities. It is obvious that the main thrust of the Association’s work is to support research to find a “cure”. However the reality is that this approach can never overcome the disease effectively.

If we are to make genuine progress with strokes then it is essential to place the main emphasis on prevention. It is preferable to help people avoid having strokes in the first place rather than having to try to “cure” them after the event.

I have looked at the Association’s website (1) and it is clear that the prime objective is raise money to fund research to help people affected by stroke. The emphasis on providing advice on how to prevent strokes is somewhat limited. I was particularly interested to find out what information was given about a healthy diet. Here is what we are told about cholesterol:

Cholesterol is a type of fat produced by your liver. It is also found in foods like meat and dairy products.  Your body needs small amounts of it, but too much is unhealthy. Extra cholesterol can travel around the arteries in your body, narrowing them and increasing your risk of stroke.  You can lower your cholesterol by making sure your diet is healthy and low in saturated fats[i]. Your doctor may advise you to take medication, too.

If you are over 40, you should have your cholesterol checked regularlyIt should be under 5mmol/L. “

It is somewhat bizarre that one of the references cited in the above quotation is the NHS Choices website, which is not exactly a reliable fount of knowledge as I have shown recently (3). Apart from that, it is just re-gurgitating all the old rubbish about cholesterol and saturated fat (SFA), which has been totally discredited as explained in this blog (4). To say that cholesterol travels around the arteries causing them to narrow is a weird statement which has absolutely no basis. Cholesterol is a substance which is essential to life. In fact there is convincing evidence that too little cholesterol rather than excessive amounts may be dangerous to health (5). Similarly lowering cholesterol may cause undesirable side-effects. By contrast, the higher the level of cholesterol levels in the blood the greater the life expectancy especially in women (6).

The case for lowering SFA is based on the belief that it raises blood cholesterol and therefore increases the risks of developing heart disease. As the “cholesterol theory” no longer has any justification the advice to reduce SFA cannot be sustained. Furthermore it is ludicrous to attribute similar characteristics to a family of fatty acids which vary in size from 4 carbon atoms to over 20. It is now widely recognised that many of the individual fatty acids are important nutrients in their own right and if the body lacks an adequate supply it may not be able to function effectively.

In recent years, it has become very clear that it is sugar and refined carbohydrates rather than the SFA which is the primary cause of many of the common chronic diseases, including heart disease, Type 2 diabetes (T2D), cancer and possibly even Alzheimer’s Disease. For example, many individuals with T2D have been able to overcome the condition effectively by reducing the amount of sugar and refined carbohydrates in their habitual diet (7). Therefore it is significant that the chances of developing a stroke are increased the higher the level of triglycerides (fat) in the blood, which in turn is largely determined by the amount of carbohydrates consumed (8).

Confirmation is demonstrated in an article by Laura Schoenfeld which recommends the following advice on healthy eating, which will help to avoid raised blood pressure that is a critical risk factor for stroke (9). These are as follows:

  • Reduce excessive carbohydrate intake, especially refined carbs and sugars
  • Increase intake of beneficial minerals like potassium, magnesium, and calcium
  • Eat grass-fed dairy products like ghee, butter, and cheese
  • Eat at least one pound of fatty fish per week
  • Drink tea
  • Eat more beets.

These are eminently sensible and if followed will help to reduce the risks of wide range of common diseases. The Stroke Association would do well to take note of this information and completely revamp the advice it provides on diet.

CONCLUSION

Despite the impression which people may have about the Stroke Association, the work that it does will certainly not help to reduce the incidence of strokes in the short term. According to its own publicity one its objectives is:

Life-saving research: working towards a world with fewer strokes”.

While I accept that the results of the research may help those who suffer a stroke to improve their chances of survival, it is difficult to understand how it will lead to fewer strokes. As the Association appreciates, many of those who survive will be seriously incapacitated. The only way to reduce the number is by prevention. There is a considerable body of knowledge on how to achieve this. In particular, by evaluating diet and if necessary making changes.  The Association could make a very significant contribution by disseminating what is currently known. As I have already explained the information about healthy eating shown on the Association’s website cannot be supported by reliable research and it is highly likely that those who follow the advice will experience a deterioration in their health. Recommendations to consume sources of carbohydrates such as bread, potatoes, rice and pasta will result in high levels of blood glucose, which will stimulate excessive insulin production and cause damage to many organs by insulin resistance.

In my opinion the work of the Stroke Association while appearing very laudable, will have little impact on the incidence of strokes. The approach adopted in most of the research projects is to try to find a cure. As I have explained this is largely a forlorn hope. The key question is “Who actually benefits?” The answer of course is the research community plus the manufacturers of the drugs and the devices which may possibly alleviate (not cure) the condition. The website lists many pharmaceutical companies among the sponsors! What do the stroke sufferers and the fundraisers gain? The harsh reality is “not a lot”!

So I will not be donating to this particular charity and I would respectfully suggest that anyone else who is considering making a donation asks some penetrating questions before parting with hard-earned cash.

REFERENCES

  1. http://www.stroke.org.uk/
  2. http://www.stroke.org.uk/referenced/how-prevent-stroke
  3. http://vernerwheelock.com/?p=614
  4. http://vernerwheelock.com/?p=554
  5. http://vernerwheelock.com/?p=505
  6. http://vernerwheelock.com/?p=105
  7. http://vernerwheelock.com/?p=558
  8. http://onlinelibrary.wiley.com/doi/10.1002/ana.22384/abstract
  9. http://chriskresser.com/6-ways-to-lower-blood-pressure-by-changing-your-diet


 

135. Spin and Bias in Reporting Trials on Pharmaceuticals

There is now convincing evidence that the manufacturers of drugs are absolutely unscrupulous in the way in which their products are marketed. Invariably the benefits are emphasised and overplayed while any side-effects are minimized. However all drugs have to be thoroughly tested and evaluated before they can be granted approval by the authorities. But questions have been raised about the objectivity and reliability of the information submitted by the companies as part of the approval process and how this is communicated to the medical/scientific community.

Turner and colleagues examined the data submitted by drug companies to the US Food and Drugs Administration (FDA) in support of applications for approval for 12 different anti-depressants. This information was then compared with what was published in the scientific literature, which is how the medical community learns about the drugs (1). The authors had access to the official reviews conducted by the FDA and used this to classify the anti-depressants as positive, negative or questionable (neither positive nor negative). In total there were 74 studies submitted to the FDA, of which 38 were judged to be positive and 37 of these were subsequently published as scientific papers. This left 36, of which 24 were considered negative and 12 questionable. Three of these were published as not positive and 22 were not published. However the remaining 11 were published but in the opinion of Turner et al were presented as positive, despite the fact that this was in direct conflict to the FDA decision!

It was noted that in all these journal articles the methods reported appeared to depart from the pre-specified method submitted to the FDA.  Although for each of these studies the finding with respect to the protocol-specified primary outcome was non-significant, invariably the authors were able to identify a different outcome that was positive which was then highlighted as if it were the primary outcome. The non-significant results for the pre-specified primary outcomes were either subordinated to non-primary positive results or omitted.

Essentially what is happening is that the positive results were made available which is perfectly reasonable. Some of the negative results probably never see the light of day but would certainly be of value to the medical profession. The twisting of results to give a favourable impression, which is in direct conflict with the results of the trial, is totally unacceptable.

A similar but more comprehensive approach has been adopted in 2 reports published by the Public Library of Science (PLoS). This is a non-profit scientific publishing project aimed at creating a library of open access journals and other scientific literature under an open content licence (2,3).

In the first one, all New Drug Applications (NDAs) submitted to the FDA between January 1998 and December 2000 were analysed (2). This consisted of 909 trials with 90 different drugs. Of the trials, 394 of them were matched to publications in the medical literature. A total of 340 trials were judged to be pivotal and 76% of these were published. There was strong evidence of publication bias in the sense that trials with statistically significant results were more likely to be published than those which were non-significant.

In the second study, Kristin Rising and colleagues analysed NDAs which were submitted in the years 2001 and 2002 (2). These were then compared with the relevant scientific publications. This study reached conclusions that were effectively the same as those studies described above. There was evidence of failure to publish and selective reporting of data. Once again the results of trials which were favourable to a specific drug were highly likely to be published. However where this was not the case it was found that there could be quite critical differences between the trials as they were described in the FDA reviews and their corresponding publications. There were 43 outcomes that did not favour the drug. Of these just under half of them (20) were not mentioned in the papers. In the remaining 23, the statistical significance changed between the NDA and the paper in 5 of them and in another 4 a positive outcome was given in the paper even though this was in conflict with the FDA review. In other words the favourable impression presented for these drugs could not possibly be justified.

It is clear that in the immediate period after approval by the FDA, which is the most relevant to public health, there is incomplete and selective publication of the results of the investigations which underpin the approval. As a consequence clinicians are likely to make inappropriate treatment decisions. The failure to provide complete and accurate information must be a severe impediment to any scientist wishing to improve the efficacy and safety of these drugs. In fact it has been advocated that publication bias should be regarded as a form of scientific misconduct (4).

A review by the Cochrane Collaboration identified 5 separate papers on publication bias which were published between 1992 and 1998 (5). These studies showed that trials with positive findings (defined either as those that were statistically significant, or those findings perceived to be important or striking, or those indicating a positive direction of treatment effect), had nearly four times the odds of being published compared to findings that were not statistically significant, or perceived as unimportant, or showing a negative or null direction of treatment effect. It was recommended that clinical trials are registered before recruiting participants so that review authors know about all potentially eligible studies, regardless of their findings.

In 2007 new legislation was introduced in Europe and in the US which has attempted to overcome these abuses. Nevertheless any meta-analysis which includes results obtained before that date must be regarded as suspect unless the authors were successful in obtaining all the relevant information on trials which produced negative outcomes that were not published.

REFERENCES

  1. E H Turner et el (2008) New England Journal of Medicine 358 (3) pp252-260
  2. K Lee et al (2008) PLoS Med 5 (9) e191
  3. K Rising et al (2008) PLoS Med 5 (11) e217
  4. I Chalmers (1990) Journal of the American Medical Association 263 (10) pp1405-1408
  5. S Hopewell et al (2009) The Cochrane Library, Issue 1: John Wiley & Sons

134. It is all happening in South Africa

We have now reached a position where it is absolutely obvious that the conventional recommendations on Healthy Eating which advise reducing saturated fat (SFA) and increasing complex carbohydrates are fundamentally wrong! In fact they are a key factor responsible for the deteriorating standards of public health in many countries as illustrated, for example, by the increasing incidence of Type 2 Diabetes (T2D). Despite the overwhelming evidence the official government policies, reinforced by the attitudes of the public health professions and institutions, continue to promote policies which are untenable. There can be little doubt that this is responsible for immense suffering and premature deaths. Ultimately these policies will have to be completely revamped although it would be a mistake to underestimate the reluctance of the establishment to admit its errors.

The shining light on the world stage is current developments in South Africa. Four years ago Tim Noakes, who is Professor of Sports Science at Cape Town University and a keen marathon runner, realised that his poor health was related to his habitual diet, even though he was complying with the official recommendations. He decided to evaluate the scientific literature which underpins the conventional advice and to his surprise discovered that the rationale just did not stand up to rigorous scrutiny. As so many others have recognised, the formulation of the recommendations which was undertaken by a US Senate Committee, was characterised by incompetence and influenced by leading academics more interested in pushing a dogma than trying to get at the truth.

As a consequence, he made changes to his own personal diet and within a very short period he lost weight and his risk factors for various diseases soon showed significant improvement. This was convincing proof to him that the key to a healthy diet is low not high carbohydrates and high fat not low fat.

Eventually he decided that he had to go public with this information and together with some colleagues produce a book entitled “The Real Meal Revolution”. The initial print run was for 3,000 copies. However it proved to be so popular that it was the Number One on sale of books in South Africa, where it has remained for over 20 weeks. Total sales are over 120,000. It really has struck a chord for the simple reason that it works. What is more the benefits, especially weight loss, are evident within a matter of weeks. Contrast this with the conventional approach to losing weight by calorie reduction, which rarely is effective. Furthermore the few who are successful invariably regain the weight lost within a relatively short period. There are uncanny parallels between the reception of “The Real Meal Revolution” and that of the pamphlet distributed by William Banting, a London undertaker 150 years ago (1). This explains why the term “Banting Diet” has been coined to describe a diet which is in line with the advice currently promulgated by Tim Noakes. There are Banting restaurants being established and members of the South African Parliament are taking a positive interest. It is possible that this may lead to a radical change in public health policy. If so, this could be a major breakthrough.

With this background, the fact that Tim and his colleagues have decided to organise an international Summit in Cape Town next February could turn out to be of enormous significance. Already many of those who are actively promoting and campaigning for a re-think on nutrition policies have signified their intention to be present. It is to be hoped that there will be a critical mass which will have an enormous impact right across the globe.

The first event which will be for two days is aimed primarily at medical practitioners. The content will focus on scientific data, studies and facts relating to a lifestyle based on a  Banting type diet.  This will be followed by a one-day event which will be geared to the needs of the general public.

Further details are available on the official website at http://www.lowcarbhighfatexperts.com/

This Summit will be a unique occasion, which I expect will have ramifications way beyond Cape Town and South Africa. I am confident that bringing together most of those who have been researching and disseminating the relevant information about the benefits to health of a diet low in carbohydrates and high in fat will convey a very powerful message, which will be felt around the world.

When dietary guidelines, which deal with the major constituents in the diet of fat, protein and carbohydrates, were first introduced the changes in eating habits were stimulated by the signals sent out by governments, professional institutions and bodies such as the World Health Organisation. These were then amplified by health promotion agencies, consumer organisations and the food industries. The food manufacturers and retailers had a particularly strong influence because of the resources available for marketing purposes. The big problem we have now is that these policies and strategies have become so firmly embedded that there is very powerful resistance to make any fundamental change to the messages that are being pushed out. As things stand at present certain foods which are perceived as “healthy” under current official guidelines will suddenly be regarded as “unhealthy” if the validity of the low carb approach becomes accepted as the norm. So companies providing such foods are unlikely adopt the new concepts without a fight. But perhaps what is of greater significance is those academics, civil servants and public health professionals who will have to admit that they have been wrong. Tim Noakes has already experienced the wrath of his academic colleagues (2).

As a consequence of the firmly entrenched establishment positions, it is highly unlikely that change will be achieved by a top down approach. I believe that the pressure for change will probably be generated from the bottom up that. In other words it will be dependent on people power. This is why I am convinced this Summit in South Africa could be the turning point. However it will only happen if the key messages are presented clearly and concisely so that there is no doubt about the way food consumption patterns have to be changed and how this can be achieved. “The Real Meal Revolution” certainly meets these objectives and so the big challenge is to replicate this in other countries. It is striking how many people have found that it is easy to adopt the principles and to get quick results with respect to weight loss. Even more significant is the number who have been able to improve their personal health. An excellent example is shown by the numerous case studies of individuals who have overcome T2D to such an extent that it has been possible to cease all treatment with drugs (3).

If all goes well I can envisage the Summit having an impact in a number of different ways, including the following:

  • Those who attend will gain new insight and understanding of how to achieve change and go home full of ideas and inspiration to make waves
  • It will provide knowledge and information and so provide a boost to those who promulgating these concepts via the social media
  • Already, there is coverage in some of the mainstream media and with luck this may well become much more extensive.

It really is very exciting. I plan to be there and I anticipate that it will a fascinating and stimulating experience.

REFERENCES

  1. http://vernerwheelock.com/?p=630
  2. http://vernerwheelock.com/?p=565
  3. http://vernerwheelock.com/?p=422