126. What Every Woman Should Know about Mammography

Mammography is a procedure in which the breast is examined using a special X-ray machine to detect signs of cancer. The rationale is that early detection enables treatment to be started before symptoms become evident thereby increasing the chances of curing or controlling the disease. This approach is utilised in many countries and in the UK is being actively promoted by the NHS.

As long ago as 1978 the Office of Technology Assessment (OTA) in the USA reported that questions were being raised about the safety of the procedure (1). In a report the OTA noted that many in the medical profession believed that it was efficacious and safe for all women, but there is no scientific information derived through controlled studies to support such a view. It was concluded that the technology had been introduced on an extensive scale before doubts about its safety raised questions about its effectiveness.

These fears were confirmed by the results of a study based on data collected in the Norwegian Breast Cancer Screening Program. The incidence of breast cancer in one group consisting of 119,472 women aged 50-69 at the outset who were screened using mammography on 3 separate occasions was assessed. This was then compared with the results for a similar control group of 109,784 women who were only screened on one occasion which was at the end of the 6-year period. It was found that the cancer incidence in those who had been screened 3 times was 22% higher than in those who were screened once. As expected the incidence of breast cancer was considerably higher in those who were screened at the beginning of the 6-year period because many cancers were only detected due to the screening. The authors were surprised to find that there was still a higher incidence in the group which had multiple screenings at the end of the period. If the screenings were performing as expected then this group should have had less cancer because the rationale is that the detection should enable the cancer to be treated. The explanation suggested was that many cases of breast cancer recover spontaneously. This means that the treatment for these particular cases is totally unnecessary and may actually be counter-productive (2).

A more recent evaluation was conducted by the Nordic Cochrane Collaboration which concluded that if 2000 women are regularly screened for 10 years one will benefit from the screening, as she will avoid dying from breast cancer. At the same time, 10 healthy women will, as a consequence, become cancer patients and will be treated unnecessarily. These women will have either a part of their breast or the whole breast removed, and they will often receive radiotherapy, and sometimes chemotherapy. These numbers were derived from the randomised trials of mammography screening. However, since the trials were performed, treatment of breast cancer has improved considerably. More recent studies suggest that mammography screening may no longer be effective in reducing the risk of dying from breast cancer. Screening produces patients with breast cancer from among healthy women who would never have developed symptoms of breast cancer. Treatment of these healthy women increases their risk of dying, e.g. from heart disease and cancer. It therefore no longer seems beneficial to attend for breast cancer screening. In fact, by avoiding going to screening, a woman will lower her risk of getting a breast cancer diagnosis (3).

Nevertheless here in the UK the NHS continues to claim that mammography screening will save 1400 lives per year. However a paper by Peter C Gøtzsche and Karsten Juhl Jørgensen of the Nordic Cochrane Centre published in the Journal of the Royal Society of Medicine entitled “The Breast Screening Programme and Misinforming the Public” challenges this position (4). They argue that the harm has been “downplayed” and that the information provided for the public has remained largely unaffected by “repeated criticism and pivotal research” which has questioned the benefits of screening and documented substantial over-diagnosis.

The paper states that information regarding lives saved through the screening programme is much exaggerated. “The claim that death rates have fallen ‘in part from earlier diagnosis associated with screening’ is astonishingly misleading,” says Peter Gøtzsche, who is the Director of the Nordic Cochrane Centre. “Deaths from breast cancer are falling because treatment is improving. There’s been a similar fall in the age-groups not invited to screening. In this respect, and many others, the Programme persists in misinforming the public. It was forced to revise its leaflet inviting women for mammography but the new leaflet and their latest Annual Review continue to repeat incorrect mortality estimates.”

According to the NHS Programme, screening will prevent one death from breast cancer for every 400 women screened regularly over ten years. Gøtzsche and Jørgensen were unable to find any evidence for this estimate in reports from the Programme or elsewhere. Based on studies in Sweden a more realistic estimate would be one death prevented for every 2000 women screened, which means the NHS figure is 5 times too high.

The authors also point out that the NHS publicity is ambiguous with respect to the over-diagnosis, which means that those considering screening do not appreciate the risks involved. Information from Denmark shows that the incidence of mastectomies is increased substantially as a direct result of over-diagnosis. However the impression presented by the NHS is that screening will reduce the chances of a woman requiring a mastectomy and is therefore seriously misleading.

This is another example of how the hierarchy in the medical profession persists in pushing a strategy which quite simply flies in the face of the latest evidence. The fact that more and more people can do their own investigations using the internet will ultimately undermine the official policy. In the meantime many people will suffer unnecessarily and public money will be wasted on a procedure that is clearly “not fit for purpose”.

Further insight into this topic can be found on the Canceractive website (5).

REFERENCES

  1. http://www.princeton.edu/~ota/disk3/1978/7805/780501.PDF
  2. P-H Zahl et al (2008) JAMA Internal Medicine 168 (21) pp 2311-2316
  3. http://www.cochrane.dk/screening/index-en.htm
  4. http://www.rsm.ac.uk/media/pr295.php
  5. http://www.canceractive.com/cancer-active-page-link.aspx?n=1420

 

BLOG 2014 125. Rubbish on NHS Choices Website

I have just been looking at a section of the NHS Choices website entitled “The Truth about Carbs” (1). I just cannot believe the utter rubbish that is presented here about carbohydrates.

Here are some extracts:

  • “Carbs” has become a dirty word in recent times, especially in the weight loss world, due in no small part to the popularity of low-carb diets such as the Atkins, Dukan and South Beach. The “carbs are bad” mantra from Dr Atkins and co has left many people confused about carbohydrates and their importance for your health, including maintaining a healthy weight.
  • Carbohydrates are a source of energy. When eaten, the body converts most carbohydrates into glucose (sugar), which is used to fuel cells such as those of the brain and muscles.
  • Carbs are important to your health for a number of reasons. In a healthy balanced diet they are the body’s main source of energy. High fibre, starchy carbs release sugar into the blood more slowly than sugary foods and drinks.
  • Carbs should be the body’s main source of energy in a healthy balanced diet, providing about 4kcal (17kJ) per gram. Carbs are broken down into glucose (sugar) before being absorbed into the bloodstream. From there, the glucose enters the body’s cells with the help of insulin. Glucose is used by your body for energy, fuelling all of your activities, whether going for a run or breathing. Unused glucose can be converted to glycogen found in the liver and muscles. If unused, glucose can be converted to fat, for long-term storage of energy.
  • Vegetables, pulses, wholegrain varieties of starchy foods, and potatoes eaten with their skins on are good sources of fibre. Fibre is an important part of a healthy balanced diet. It can promote good bowel health, reduce the risk of constipation, and some forms of fibre have been shown to reduce cholesterol levels. Many people don’t get enough fibre. On average, most people in the UK get about 14g of fibre a day. We are advised to eat an average of 18g a day.
  • Carbohydrate contains fewer calories gram for gram than fat, and starchy foods can be a good source of fibre, which means they can be a useful part of a weight loss plan. By replacing fatty, sugary foods and drinks with high-fibre starchy foods, it is more likely you will reduce the number of calories in your diet. Also high fibre foods add bulk to your meal helping you feel full. “You still need to watch your portion sizes to avoid overeating,” says Sian. “Also watch out for the added fats used when you cook and serve them: this is what increases the calorie content.”
  • While we can most certainly survive without sugar, it would be quite difficult to eliminate carbs entirely from your diet. Carbohydrates are the body’s main source of energy. In the absence of carbohydrate, your body will use protein and fat for energy.
  • However, cutting out starchy foods from your diet could put you at increased risk of a deficiency in certain nutrients, leading to health problems …, unless you’re able to make up for the nutritional shortfall with healthy substitutes.
  • It may also be hard to get enough fibre, which is important for a healthy digestive system and to prevent constipation. Healthy sources of carbs such as starchy foods, vegetables, fruits, legumes and dairy products are an important source of nutrients such as calcium, iron and B vitamins.
  • Cutting out carbohydrates and replacing those calories with fats and higher fat sources of protein could increase your intake of saturated fat, which can raise the amount of cholesterol in your blood – a risk factor for heart disease.
  • When you are low on glucose, the body breaks down stored fat to convert it into energy. This process causes a buildup of ketones in the blood, resulting in ketosis. Ketosis as a result of a low carbohydrate diet can be accompanied by headaches, weakness, nausea, dehydration, dizziness and irritability particularly in the short term.
  • Try to limit the amount of sugary foods you eat and instead include healthier sources of carbohydrate in your diet such as wholegrains, potatoes, vegetables, fruits, legumes and lower fat dairy products.

 

Many of the statements above cannot be substantiated. There simply is not the evidence to support them. I could spend a long time explaining why this is so but what I find particularly fascinating is the comments posted by people who have also been appalled by what is presented as official policy. Let them speak for themselves with some of their views:

  • since switching to a low carb (not no carb) diet my endurance training has improved dramatically. I never feel tired or lethargic, so carbs don’t have to be your main source of energy. By the way, I have also lost nearly 2 stones in weight and my blood pressure has fallen into the “ideal” zone. I eat loads of butter and cream, lots of green veg and eggs, and about the same amount of meat as before (but with the fat left on, which I used to trim off after years of ‘brain washing’!).
  •  The article still contains rubbish like :-”Can we survive without carbs?

    While we can most certainly survive without sugar, it would be quite difficult to eliminate carbs entirely from your diet. Carbs are the body’s main source of energy. In the absence of carbs, your body will use protein and fat for energy.”

    An unbiased article would point out that calories can be obtained from any of the three macronutrients and that your body has the largest energy store in the form of fats, not carbs.

    Bacon and egg is a carb free breakfast, steak with two green veg has a few grams. Nobody advocates zero carb diets but restricting to <100 grams per day gives many people benefits to health.

    If you want to lose weight reduce calories and make sure the ones you reduce are all carbohydrate – the optional macro nutrient.

  • There are essential Amino and Fatty acids but I have never heard of essential carbs. Carbs especially refined sort are the cause for obesity and excessive insulin which both combined are disastrous to the biological function and yet the NHS prescribe this diet (high insulin diet) which I find a real irony. NHS how much did you get paid by our sugar industry for this article
  • I hold the NHS very highly, therefore I am acutely embarrassed by the bad science in this article.
    Due to my recent diagnosis of diabetes I’ve been reading a lot of peer reviewed modern studies, and I’m becoming more and more mystified and frustrated by the nutritional advice by the NHS.
    Frankly, your recommended low-fat high-carbs regime is almost the last thing diabetic people should eat, which is bad news as correct nutrition is the first line of defence against diabetes.I’m going with Sweden and their sensible LCHF approach, instead. They’re at the forefront of research on obesity and diabetes, whereas you’re still using 40 years old fallacious and financially biased science from the United States.

VW note:

Apparently the article which I have cited was updated in the light of comments about the previous version. Here are extracts made in December 2013 and January 2014 in response to that:

  • Have the NHS been infiltrated by certain members of the food lobby or are they really this ignorant?
    No wonder this country has an obesity crisis!
  • Dreadful article. Old 70′s health myths dressed up as common sense advice.
    I do not understand how this is allowed to be put out as public information from the NHS.
  • Hello Sian, I am concerned that you are pushing the low fat dogma despite the relentless science and research that shows that the dogma is nonsense. The NHS has a public duty to admit low fat calorie obsession is a dead end. You do not deal with hormones, metabolism and gut health. Food quality and healthy metabolism are key to health, not carbs. Please stop defending the mistakes of the past. (Sian is the author of the article).
  • This is a very unbalanced article. It’s fine as a “pro carbohydrate” item but needs to be balanced by an article stating the opposing case based on the insulin hypothesis of obesity and the problems of carbohydrates in diabetes etc.There is a problem with the “science” above in that the article http://www.nejm.org/doi/full/10.1056/NEJMoa022207 does in fact demonstrate a statistically significant improvement in weight loss at both months 3 and 6 of around 4% of weight loss. Most of us would take an extra weight loss of 3 to 4 kg in 6 months and say “thank you very much, Dr Atkins”. That could be an extra half stone to some of us.

    At 12 months with a high dropout rate and the use of “baseline data carried forward” for the dropouts the weight loss difference is reduced to a mere 2% of body weight with P=0.26 so there is still an 80% probability of getting a better weight loss on the low carb arm of this one study.

    This article should be withdrawn and re-written.

  •  Perfectly sufficient fibre and associated food factors such as vitamins can be gained from a diet based on leafy greens and raw coloured vegetables.
  • This commentary is full of inaccuracy, fallacy, opinion, and error. Point wise:1. Fibre is a carb. strictly, but it is not digested or metabolised, so should not be described nutritionally as a carb.
    2. We do not need carbs at all – none.
    3. Starchy foods when cooked do not release energy slowly, they dump glucose into the blood quickly. This is contraindicated – utterly.
    4. There is no requirement, and no reason why grains need to be in the human diet at all.
    5. Carbs are the main source of energy when they make up the largest portion of intakes, sure – but there is no reason why this needs to be so. Fats and protein also contain energy.
    6. So what if fats contain 2.25 x the energy per g than carbs? If carbs cause you to eat 3 to 4 times as much total energy per day (which they do, due to insulin response).
    7. Glycogen shortage is not a problem during exercise in properly fat adapted individuals.
    8. This author has provided no supporting literature at all, it is an opinion piece, its full of ridiculous errors and fallacies, and its plain ignorant. NHS choices, really; come on.
  • I have been low carb for over a year. Result ; lower triglycerides, ldl static, hdl increased, fasting blood sugar lowered, energy levels increased. Oh and not to mention two and a half stone lighter. I eat lots of saturated fat and enjoy it. Am i constipated? No.You need to examine the huge and growing scientific evidence on low carb high fat diets.

CONCLUSIONS

I think there is no need for me to add anything further. The comments from the different contributors have addressed most of the issues which would be of concern to me. Although the article has been revised it looks to me that most of the earlier comments are still applicable, which means that there has been little improvement. It seems that the NHS has got into such a pickle that it is having to defend the indefensible. The tragedy is that while some individuals have been able to work things out for themselves, the vast majority are still at the mercy of people like the author of this article. The inevitable consequence is that many are suffering unnecessarily and dying prematurely. It is obvious that the current policies are not working and a complete re-think is required. The knowledge and information is readily available. It is an absolute scandal that it has not been incorporated into the NHS strategy.

If one wants inspiration then take a look at what is happening in South Africa, starting with a link to The Real Meal Revolution website (2).

REFERENCES

  1. http://www.nhs.uk/livewell/loseweight/pages/the-truth-about-carbs.aspx
  2. http://realmealrevolution.com/

 

 

124. Cancer: Evidence Points to Carbohydrates not Fat

INTRODUCTION

When the dietary recommendations were being devised initially a high intake of fat was considered to be a risk factor for certain types of cancer and in particular breast cancer in women. This conclusion was based largely on international comparisons and the results of animal studies.

RESULTS OF VARIOUS STUDIES

However the results of the Nurses’ Health Study which were published in 1999 completely undermined the conventional wisdom at the time. This major project commenced in 1976 when 88,795 female registered nurses aged 30 to 55 years free of cancer were recruited. The participants were followed up for 14 years. In 1980 they completed a food frequency questionnaire and this exercise was replicated in 1984, 1986 and 1990. A total of 2,956 women were diagnosed with breast cancer.  When the cancer incidence was related to diet there was absolutely no evidence of increased risk of breast cancer with increased intake of animal fat, polyunsaturated fat, saturated fat or even trans unsaturated fat. In fact it was found that the risk of breast cancer tended to be highest among those with the lowest fat intake. Certainly there was no suggestion that lower intake of total fat or of any particular types of fat over the 14 years of the study was associated with a decreased risk of breast cancer. So it was concluded that a reduction of total fat in mid-life was unlikely to prevent breast cancer.

This study included more cases, longer follow-ups and more person-years than any previously published prospective study on diet and breast cancer. The quality and the reliability of this work are enhanced by the fact that the diet of the participants was assessed on 4 different occasions (1).

In Korea 829,770 men and 468,615 women aged between 30 and 95 were given a medical check in the years 1992-1995. They had a follow-up examination after 10 years during which time there had been 20,566 cancer deaths in the men and 5,907 in the women. The results (Tables 1 and 2) show that the deaths from all causes and from several cancers increased progressively with the concentration of blood glucose. When the results for the first 5 years were excluded the same trends were evident which eliminates the possibility that the increase in blood glucose is actually caused by the cancer (2).

TABLE 1. RELATIVE MORTALITY RATES FOR SELECTED CANCERS AND BLOOD GLUCOSE LEVELS IN KOREAN MEN

Cause of deaths                                        Fasting Blood Glucose levels, mg/100ml
<90 90-109 110-125 126-139 >140 Diabetes
All causes 1.00 1.04 1.28 1.50 2.09 1.83
All cancers 1.00 1.04 1.17 1.28 1.29 1.27
Colorectum cancer 1.00 1.07 1.27 1.23 1.31 1.28
Pancreatic cancer 1.00 1.08 1.28 1.45 1.91 1.71

 

TABLE 2. RELATIVE MORTALITY RATES FOR SELECTED CANCERS AND BLOOD GLUCOSE LEVELS IN KOREAN WOMEN 

Cause of deaths                                   Fasting Blood Glucose levels, mg/100ml
<90 90-109 110-125 126-139 >140 Diabetes
All causes 1.00 1.01 1.24 1.42 2.35 1.99
All cancers 1.00 1.00 1.01 1.12 1.23 1.31
Colorectum cancer 1.00 0.96 1.05                  0.85 1.11
Pancreatic cancer 1.00 1.45 1.70                  2.05 1.71
Breast 1.00 1.15 0.89                  1.24 2.23

 

In an Austrian study, 63,585 men and 77,228 women whose mean age at baseline was 43 years were followed up for an average of 8.4 years. Over 5,000 cases of cancer were diagnosed. The average age of diagnosis was 64 years. Those who developed cancer in the first year were excluded.

Table 3 shows that with cancers of the liver, gallbladder and bile duct, thyroid and multiple myeloma the tendency is for the mortality rate to increase as the level of fasting blood glucose increases based on results for men and women. It should also be noted that with some of these cancers there is an increased rate at relatively low levels of blood glucose. For leukaemia, there is no consistent trend. For breast cancer in women (Table 4) a relatively high death rate is only apparent in those over 65 at the highest blood glucose level (3).

TABLE 3 FASTING BLOOD GLUCOSE CONCENTRATIONS AND THE INCIDENCE OF VARIOUS CANCERS IN MEN AND WOMEN

                                 Fasting blood glucose at enrolment, mmol/L
  2.2-4.1 4.2-5.2 5.3-6.0 6.1-6.9 >7.0
Liver cancer 1.37 1.00 1.89 2.45 3.56
Gallbladder and bile duct 0.92 1.00 1.90 3.74 3.36
Thyroid cancer 1.24 1.00 2.22 2.34 -
Multiple myeloma 1.54 1.00 2.26 2.42 -
Leukaemia 0.78 1.00 1.47 1.00 -

TABLE 4. FASTING BLOOD GLUCOSE AND THE INCIDENCE OF BREAST CANCER IN WOMEN AT DIFFERENT AGES

                                 Fasting blood glucose at enrolment, mmol/L
Breast cancer 2.2-4.1 4.2-5.2 5.3-6.0 6.1-6.9 >7.0
All 0.96 1.00 0.99 0.91 1.38
<50 years 0.99 1.00 0.61 0.67 -
50-65 years 1.05 1.00 1.08 0.80 1.12
>65 years 0.80 1.00 1.09 1.03 1.63

 

Breast cancer patients with diabetes are more likely to die prematurely from breast cancer than patients without diabetes (RR 1.76) which suggests that besides affecting the incidence rate diabetes also promotes breast cancer mortality (4).

A recent systematic review confirmed that patients with breast cancer and pre-existing diabetes suffer all-cause mortality that is increased by about 50%. This finding was consistent across different populations and was generally independent of possible confounding variables. The main implication of this study is that diabetes is associated with adverse outcomes in breast cancer throughout its full course, from initial presentation, during treatment (which influences the choice of therapy), and, ultimately, to mortality (5).

In a Canadian investigation 512 women treated for breast cancer were followed for an average period of just over 4 years. Women with diabetes were excluded. The breast cancer recurred in 76 of the women and there were 43 deaths. The relationship with the blood insulin (Table 5) show that those with the highest levels were more likely to experience a recurrence (by a factor of 2) and to die (by a factor of 3.1) when compared with those with the lowest levels (6).

TABLE 5. BLOOD INSULIN LEVELS AND RISK OF BREAST CANCER AND DEATH

Insulin level, Pmol/L 8.1-27.0 27.0-35.3 35.3-51.9 51.9-339.8
RR, breast cancer 1.0 1.3 1.5 2.0
RR, death 1.0 1.5 2.0 3.1

 

Insulin has been shown to stimulate cell proliferation in normal breast tissue and in human breast cancer cell lines. It has also been established that the administration of insulin promotes breast tumour growth in animal models. In the Women’s Health Initiative (WHI) 93,676 post-menopausal women aged between 50 and 79 years were followed for over 6 years commencing between 1993 and 1998. Fasting insulin levels were measured and the results (Table 5) showed that the incidence of breast cancer was more than doubled at the higher levels when compared with the lowest level. It should be noted that any women with diabetes were excluded from the study and all those involved were not on hormone therapy (7).

TABLE 6 FASTING INSULIN LEVELS AND BREAST CANCER INCIDENCE

Insulin level, µIU/ml <3.9 3.9-5.6 5.6-8.8 >8.8
Hazard Ratio 1.00 1.00 1.59 2.65

 

Because of the potential role of insulin in the development of cancer there is considerable interest in studying the effect of various therapies for diabetes. An investigation in Saskatchewan with 10,309 participants (55% men) who had used anti-diabetic drugs for less than a year resulted in 245 deaths. However there were marked differences in death rates depending on the drug used. It was found (Table 7) that people exposed to sulfonylurea or exogenous insulin (agents that increase circulating insulin levels) were significantly more likely to have a cancer-related death than people exposed to

metformin (which does not increase insulin levels). When adjustment were made to the death rates to allow for other factors such as the age of the patients it was found that the risk of cancer-related mortality was even greater for insulin exposure (90% relative increase) than for sulfonylurea exposure (30% relative increase) (8).

TABLE 7. CANCER THERAPY AND MORTALITY

Therapy Cancer mortality   rate, per 1,000 person-years
Metformin 6.3
Sulphonyl urea 9.7
No insulin 6.8
Insulin 9.9

 

STUDIES WITH MICE

In an investigation with mice the development of tumours was compared for different diets. The control contained 55% carbohydrate which is roughly the same as the national diets in the UK or the USA. The experimental diets contained 8, 10 and 15% CHO. With mice that were particularly susceptible to tumour growth it was found that at 1 year old almost half of those on the 55% carbohydrate diet had developed tumours but none were detected in those on the 15% carbohydrate diet. In total 70% of the mice on the high CHO diet developed tumours and only one reached the normal life span. Less than 30% of those on the low CHO diet developed tumours while more than half reached or exceeded the normal life span. The low CHO diet reduced the plasma insulin levels which in results in a reduced glucose uptake by the tumour cells. There was a positive correlation between plasma insulin levels and tumour size which confirms that the glucose supply is related to tumour growth (9).

CONCLUSION

There is little doubt that excessive amounts of sugar and refined carbohydrates in the diet is the primary cause of Type 2 Diabetes (T2D). Confirmation is shown by the fact that T2D can be effectively cured by a diet which is low in carbohydrates and high in fat (10). It is now becoming clear that the rationale to reduce fat and especially the saturated fats (SFAs) was fundamentally flawed (11). The evidence presented here flags up the dangers of consuming excessive carbohydrate with respect to many different cancers. The fact that the risks increase as the concentration of glucose in the blood increases is particularly relevant. The case for limiting the intake of sugar and refined carbohydrates has now reached the point where it is extremely convincing. Unfortunately this is in direct conflict with the official dietary recommendations in many countries. Although there is growing awareness of the risks associated with sugar consumption, many people have difficulty in adapting their diets because they are still convinced the SFAs are dangerous. In reality, there was never any justification recommending a reduction in these fats. On the contrary they should be considered as valuable nutrients (12).

REFERENCES

  1. Michelle Holmes et al (1999) JAMA 281 (10) pp.914-920
  2. S H Jee et al (2005) Journal of the American Medical Association 293 (2) pp194-202
  3. K Rapp et al (2006) Diabetologica  49 (5) pp 945-952
  4. F Xue & K B Michels (2007) American Journal of Clinical Nutrition 86 (3) pp S823-S835
  5. K S Peairs et al (2011) Journal of Clinical Oncology 29 (1) pp 40-46
  6. P J Goodwin et al (2002) Journal of Clinical Oncology 20 (1) pp 42-51
  7. M J Gunter et al (2009) Journal of the National Cancer Institute 101 (1) pp 48-60
  8. S L Bowker et al (2006) Diabetes Care 29 (2) pp254-258
  9. V W Ho et al (2011) Cancer Research 71 (13) pp 4484-4493
  10. http://vernerwheelock.com/?p=558
  11. Nina Teicholz. (2014)“The Big Fat Surprise: Why Butter, Meat and Cheese Belong in a Healthy Diet” Simon & Shuster New York
  12. http://vernerwheelock.com/?p=155

 

123. Changing Patterns of Food Consumption

Epidemiological studies into changing patterns of food consumption and disease statistics can provide valuable insights into the relationships between diet and health. In Great Britain data from national statistics show that amount of fat consumed has fallen from 120gm/day in 1969 to 74gm/day in 2000. When expressed as a proportion of energy consumed the fat intake has decreased from 42.6% in 1980 to 37.7% Calories in 2010.At the same time there has been an increase in the energy as carbohydrate from 44.4 t0 47.4%. Consideration of the different types of fats shows that between 1969 and 2000 that the intake of saturated fat (SFA) has fallen from 56.7 to 29.2 g/day. In other words it has been reduced by almost half!

Healthy Eating has now been actively promoted in the UK for at least a quarter of a century. There is no question that one of the driving forces for these changes was the official UK Committee on Medical Aspects of Food Policy (COMA) in 1984 which recommended:

  • Total fat as a percentage of total daily energy should be reduced from 42 to 31-35% calories
  • Saturated fat should be reduced from 20 to 15% calories
  • Polyunsaturated fat could be increased.

It is evident that the national diet has changed in accordance with these recommendations. The response from the food industry and from consumers has been very positive as demonstrated by the development of extensive ranges of low fat products. A good example of the success of these strategies is the growth in sales of semi-skimmed milk which is now the predominant liquid milk product. However it should also be noted that the reduction in total fat has been largely replaced by an increase in carbohydrates much of which consists of sugar.

Table 1 Changes in the intakes of fat in Great Britain

Year Total fat, g/day Saturated fat , g/day Monounsaturated fat, g/day Polyunsaturated fat, g/day
1969 120 56.7 46.5 11.0
1972 112 52.0 42.9 11.5
1975 107 51.7 39.8 10.1
1980 106 46.8 39.6 11.3
1985  96 40.6 34.7 13.1
1990  86 34.6 34.8 13.9
1995  78 30.8 28.7 13.4
2000  74 29.2 26.3 13.4

 

Source: National Food Survey.

Note: The National Food Survey was replaced by Family Food in 2000 so that data collected since then is not comparable.

. The justification for recommending a reduction in total fat was that as a concentrated source of calories it was a major contributor to obesity. As SFA were considered to raise the level of blood cholesterol (TC) it was concluded that reducing SFA would lower the TC with a consequential reduction in the risk of heart disease. Therefore it is highly relevant to see what has actually happened to some of the key indicators of public health.

The Health Survey for England is a valuable source of information on the state of public health and this has been used to prepare the following tables (1).

Table 2 shows that there have been large increases in the prevalence of obesity. The value for men has almost doubled since 1993.

TABLE 2 PREVALENCE OF OBESITY (BASED ON BMI>30)

YEAR ALL MEN ,% ALL WOMEN,%
1993 13.2 16.4
1998 17.3 21.2
2003 22.2 23.0
2008 24.1 24.9
2010 26.2 26.1

 

In Great Britain the life-time risk of developing bowel cancer in men has increased from 3.5% in 1975 to 6.9% in 2008. In women there has been an increase from 3.9% to 5.4% over the same period. For females aged between 40 and 59 years the breast cancer rates have increased from 134/100,000 in 1979 to 215/100,000 in 2008 (2).

Table 3 shows that between 1994 and 2010 the incidence of diabetes has more than doubled for both men and women (1). The importance of these results cannot be underestimated.  According to Diabetes UK there are 145,000 new cases of diabetes every year which means that the total number in the UK is about 2.6 million. In addition it is estimated that there are about 1 million people who have diabetes which has not been diagnosed and that 7 million people have pre-diabetes which means that they are up to 16 times more likely to develop diabetes than those who do not have the condition.

TABLE 3 PREVALENCE OF DIABETES

YEAR ALL MEN, % ALL WOMEN,%
1994 2.9 1.9
1998 3.3 2.5
2003 4.3 3.4
2006 5.6 4.2
2009 6.5 4.5
2010 6.3 5.3

 

However diabetes is in many ways just the tip of the iceberg because those who suffer from it are likely to experience further complications. These can include damage to small blood vessels which in turn leads to blindness, kidney failure and nerve damage.  Deterioration of the larger arteries can contribute stroke and heart disease as well as difficulties in pregnancy and infection. The American Heart Association has concluded that adults with diabetes are two to four times more likely to have heart disease or a stroke than adults without diabetes.

EXPERIENCE OF OTHER COUNTRIES

The changes in food consumption patterns which have occurred in the UK over the past 25-30 years are in direct contrast with what happened in Spain between 1964 and 1991(3). Over this period the consumption of the main sources of carbohydrate in the diet: bread, pulses, pasta and rice declined from 43.8 to 20.4% of the total food intake. At the same time one of the main sources of fat, dairy products increased from 13.3 to 22.8% of food intake. Other important sources of fat including meat, fish and eggs increased from 10 to 19.7% (Table 4).

TABLE 4 CHANGES IN FOOD CONSUMPTION PATTERNS IN SPAIN BETWEEN 1964-65 AND 1990-1991

                1964-1965              1990-1991
FOOD                                           Gm/person/day
Bread 361.7 164.1
Pasta 12.7 11.7
Rice 27.6 17.9
Potatoes 292.2 137.5
Vegetables 155.8 165.3
Pulses 41.4 22.5
Total fruits 164.8 326.7
Total meat 73.3 229.3
Fish 62.2 87.6
Eggs 43.8 27.9
Milk 219.5 380.0
Cheese 4.4 15.5
Sugar 38.7 25.2
Wine 131.4 68.8
Total fats/oils 76.0 58.8

 

Between 1976 and 1990 the mortality rates from CHD declined from 126/100,000 to 110/100,000 in men and from 59/100,000 to 49/100,000 in women. The decline in deaths due to strokes was even more impressive. It fell from 171/100,000 to 104/100,000 in men and from 147/100,000 to 86/100,000 in women (Table 5).

The reduction in carbohydrates and the increase in fats would be expected to be accompanied by an increase in the death rate from heart disease if the rationale which underpins the dietary recommendations for the UK. In fact the reverse has actually happened with a decline in these death rates.

TABLE 5 CHANGES IN MORTALITY

                                           Mortality/100,000
  1976 1990
Coronary heart disease    
                    Men 126 110
                    Women 60 49
Stroke    
                    Men 171 105
                    Women 147 86

 

Essentially similar results have been reported for Japan.  Between  1958 and 1995 the fat intake in the national diet increased by a factor of 4 due to the increased consumption of meat, eggs and dairy products(4).  Inevitably much of the increased fat was saturated. Despite this change in the pattern of consumption there was no change in the incidence of heart disease. By contrast, the incidence of stroke fell by 85%.

REFERENCES

  1. Health Survey of England 2010 Adult Trend Tables
  2. Cancer Research UK
  3. L. Serra-Majem et al (1995) American Journal of Clinical Nutrition 61 (supplement) pp. 1351S-1359S
  4. A. Okayama (1993) Journal of International Epidemiology 22 (6) pp 1038-104

 

 

122. Disclosure of the Results of Clinical Trials: Case Study of Tamiflu and Implications for Statins

One of the key issues to emerge from the recent spat between Sir Rory Collins and the BMJ about statins (1) has been the refusal of the Cholesterol Treatments Trialists’ Collaboration (CTT) at Oxford University to allow open access to the original clinical trial data. The independent panel set up by the editor of the BMJ concluded that it:

“strongly believes that the current debates on the appropriate use of statins would be

elevated and usefully informed by making available the individual patient-level data

that underpin the relevant studies” (2).

There have been suggestions that the information which is released for publication and to the regulatory bodies is not a true representation of the primary data obtained in the clinical trials (3).

Recently the original data on ‘flu vaccines have been released and it is especially pertinent to discover the insight this example provides.

Tamiflu is one of the medicines used to treat or prevent many different types of flu including bird flu and swine flu. It is recommended by the World health Organisation (WHO) and has been approved by the Food and Drugs Administration (FDA) in the US and by the European Medicines Agency (EMA). In the UK the government has spent £424m in recent years but much of this has had to be discarded because it was never used according to a critical report by the National Audit Office (4).

It is claimed that it will reduce the duration and severity of the flu but questions have been raised about the evidence on which this is based.

The House of Commons Select Committee on Science and Technology has been conducting an Inquiry into “Clinical Trials and Disclosure of Data”. In particular the inquiry focused on the need for transparency of the results of clinical trials, which are primarily concerned with the evaluation of drugs prior to approval (5).

Specific information relating to Tamiflu was presented in a submission from the Cochrane Collaboration which is an international network of volunteer scientists who carry out reviews of evidence on interventions in health care using highly structured and reproducible methods. Cochrane reviews are considered as the gold standard in evidence-based decision making for interventions and are used by many governments in the formulation of public health policies. It is independent of the pharmaceutical companies and any other potential conflicting interests. A group of their researchers had been reviewing 2 vaccines used for ‘flu, namely zanamivir (Relenza, GW now GSK) and oseltamir (Tamiflu, Roche). In their submission they explained the problems encountered in their attempts to obtain the information which was required for their evaluations. In 2009 the team was doing an update of an earlier review which had been published in 2005, when it received a query from a Japanese paediatrician. Dr Keiji Hayashi wanted to know how it was possible that in our 2005 update we had included 8 unpublished Tamiflu trials contained in extreme summary form within another review funded by Roche and carried out by Roche staff and consultants. How could we possibly have done that as we had not seen the original studies? As a consequence Roche was approached but only agreed to release the original raw data if the reviewers would sign a confidentiality clause. Obviously this was not possible because it would compromise the independence, transparency and reproducibility of the report. However as result of coverage on Channel 4 News and in the British Medical Journal Roche publicly promised full study reports. Despite only 4-5 parts of the 10 trials were handed over as Roche claimed that would all that was needed. Subsequently the documents were released and much to their surprise the researchers discovered that there is a clinical study report for each drug trial conducted. This is a complex document containing hundreds or thousands of pages of information with minute details about trials, their planning and execution. Up to that point the Cochrane reviewers were totally dependent on a journal article of a few pages.

At the outset they were aware of 26 trials but it subsequently emerged that there were 123 trials on Tamiflu. The fact that so many were kept under wraps may have had damaging effects on public and clinician confidence in the rigour of how medications are assessed in the UK for safety and effectiveness. There is also a risk that NHS funds have not been used for interventions which offer the best value for money.

  • Nevertheless the Cochrane team did succeed in gaining access to the material which Roche had submitted to the EMA as well as comments made by the FDA on Tamiflu. As a result the team was able to compare the more detailed information with relatively few publications which had been available previously. They found that there were discrepancies in reporting harms and some important aspects of study design between publications and regulatory reports. There were also suggestions that the drug interferes with the natural antibody production. If this is the case it would mean that the use of Tamiflu weakens natural host defences and may weaken response to any antigen stimulating interventions such as vaccines. The regulatory evidence released from EMA and FDA indicates that the positive effects of the drug are not as marked as those claimed by the manufacturer and its consultants in industry-sponsored publications. In agreement with the FDA there was no reliable evidence to conclude that Tamiflu is effective against influenza complications (e.g. pneumonia) and person-to-person transmission.

CONCLUSIONS

In the light of the evidence which has come to light the authors question whether the government would have agreed to stockpile Tamiflu if the complete picture was available when the decision was made. They also note that the WHO and the Centers for Disease Control (CDC) in the US apparently disregard this information and continue to recommend Tamiflu.

This particular case study is confirmation that information has been manipulated by one company in order to improve the chances of approval being granted by the regulatory authorities. There is also no doubt that this type of action is used to advantage in the market place.

Clearly this revelation has major implications for statins. It would not be in the least surprising that a similar approach is being used by the manufacturers of statins. It would certainly explain why Rory Collins and his colleagues at the CTT are so reluctant to allow any outsiders to have access to the clinical trial data which they have. There are already serious doubts about the value of statins, especially when used as a preventive measure in people who have not had problems with heart disease (6). The Department of Health and other bodies such as NICE must insist that the statin data at the CTT and elsewhere is open to scrutiny as a matter of urgency.

NOTE: It is extremely unfortunate that the Cochrane team which recently review statins did not show anything like the same determination as the one investigating Tamiflu. Had it done so it might well have reached a conclusion which was much less favourably disposed towards the use of statins (7). It is rather ironic that relied so heavily on the information provided by the CTT and apparently did not have access to the original trial data. As a consequence, the reputation of the Cochrane Collaboration has become somewhat tarnished, which is a great pity!

REFERENCES

  1. http://vernerwheelock.com/?p=528
  2. http://journals.bmj.com/site/bmj/statins/Final%20report%20of%20the%20independent%20panel%20310714.pdf
  3. http://vernerwheelock.com/?p=575
  4. http://www.nao.org.uk/report/access-to-clinical-trial-information-and-the-stockpiling-of-tamiflu-2/
  5. http://www.publications.parliament.uk/pa/cm201314/cmselect/cmsctech/104/104vw05.htm
  6. http://vernerwheelock.com/?p=432
  7. http://vernerwheelock.com/?p=545

 

 

121. Time for a Reality Check on the NHS

According to a report in The Guardian:

The NHS is generally acknowledged to be facing a growing funding crisis after four years of tight settlements, deepening demographic pressure and an inefficient system that splits health and social care. The Nuffield Trust has suggested there will be a financial shortfall of £2bn in 2015-16” (1).

The politicians are desperately trying to overcome the problems by finding more money.

The critical feature is that there is an almost total failure to conduct any kind of hard-nosed analysis to identify the fundamental issues and devise suitable objectives for the NHS. We have to face the reality that health is deteriorating as shown, for example, by the doubling of diabetes, primarily Type 2(T2D) in the past 15 years. The number of people who require care and nursing is growing steadily. It is therefore no surprise that the costs continue to increase. Clearly this is not sustainable in the long term. If we carry on in this way we will finish up like the USA which spends more than twice the amount on health care per capita as other developed nations, but ranks 49th in life expectancy worldwide.

Instead of accepting that there is a need for additional funds the politicians should be trying to determine what should be done to prevent standards of public health getting worse and working out how to reverse current trends so that a steady improvement can be achieved. Conceptually this is not difficult. The current approach is primarily “curative”. Unfortunately a cure is impossible in the vast majority of cases and the best that can be done is to “manage” the condition or disease. The obvious answer therefore is to place much more emphasis on preventing the disease in the first place.

So why have we come so far down the wrong road? To understand this we have to consider the role of the drug companies. Most of us have been conditioned or “brain washed” into believing that there should be a “cure” for every possible form of ill-health we experience. Even if one is not available at present all we have to do is pour money into research and eventually the scientists will come up with a remedy. While this may work for a number of diseases (eg antibiotics and certain infections) it is definitely not the answer for all diseases. With many of them the damage is permanent. For others, a “cure” may be possible in the short term but if the primary cause (eg exposure to toxins or poor diet) is not removed then the likelihood is that disease will re-cur.

Any analysis of the current difficulties of the NHS must examine the role of the
drug companies. The expenditure on drugs by the NHS is about £14B, which is almost 10% of the total budget (2). It is vital to appreciate that for many of the drugs being prescribed, there is no reliable evidence to demonstrate that they are effective. Quite the contrary, many of them are ineffective. One way of assessing this is to determine the NNT (Number Needed to Treat), which is the number of people who have to be treated in order that one will benefit. This may come as a surprise to many who quite naturally assume that if they have treatment with a drug it will almost certainly help them to recover. However if the NNT is 10 it mean there is a 10% chance of benefit and with an NNT of 100, then there is only a1% chance. Some examples from the NNT website, which only uses high quality studies in its analyses, are shown in Table 1(3). I believe most people would be absolutely astounded to see these results. The normal expectation is that any treatment will have a positive effect for the individual involved. This is certainly true of antibiotics so it somewhat disconcerting to learn that there is only a 1 in 4 chance that the treatment will prevent a respiratory tract infection. However for other treatments the odds of success are even smaller. With thrombolytics for a major heart attack, only 1 in 43 benefits and even then that is dependent on the treatment being applied within 6 hours. The results are even worse if treatment is delayed. Furthermore there were some risks that serious harm could also occur. Despite all the hype it turns out that the NNT team only find benefits for statin treatment in those with known heart disease even then it only applies to 1 patient out of 83. However the risks of developing diabetes are 1 in 50 while 1 in 10 may expect muscle damage. It seems highly likely that perceptions of the benefits of drug treatments are very much greater than the reality. It would be fascinating to discover how many people would agree to these treatments if they were informed of the chances of personal benefit beforehand. Even more astounding is the revelation that although some drugs have limited benefits for some conditions, when used for others there is no benefit whatsoever and in many cases those treated suffer adverse side-effects. This is appalling. It is quite obvious that the benefits of drug use have been grossly exaggerated. Hence it follows that most of the money spent by the NHS and any other body/individual on drugs is wasted. Effectively the pharmaceutical industry is sucking resources out of the system which could be spent in other ways that would facilitate patients. From a policy perspective, reducing expenditure on drugs by the NHS should be a top priority. Unfortunately there is no indication that any politician is aware of this information let alone prepared to tackle this issue head on.

TABLE 1. The Benefits and Harm Associated with Various Medical Treatments

Treatment Benefits Harm
Beta Blockers for Acute Heart Attack (Myocardial Infarction). None were helped 1 in 91 were harmed by cardiogenic shock
Early Invasive Management for Acute Coronary Syndromes None were helped (preventing death)1 in 9 were helped by feeling less pain in chest1 in 59 were helped by avoiding a heart attack in the next year 1 in 33 were harmed by suffering a heart attack.1 in 33 were harmed by suffered major bleeding
Anti-Hypertensive Treatment for the Primary Prevention of Cardiovascular   Events In Mild Hypertension None   were helped (preventing death, stroke, heart disease, or   cardiovascular events 1 in 12   were harmed (medication side effects and stopped the   drug)
Statins Given for 5 Years   for Heart Disease Prevention (With Known Heart Disease) 1 in 83 were helped (life saved)1 in 39 were helped (preventing non-fatal   heart attack)1 in 125 were helped (preventing stroke) 1 in 50 were harmed (develop diabetes)1 in 10 were harmed (muscle damage)
Statins for Acute Coronary Syndrome None   were helped (life saved; heart attack, stroke, or heart   failure prevented) An unknown number were harmed (medication side   effects/adverse reactions)
Statin Drugs Given for 5 Years for Heart Disease   Prevention (Without Known Heart Disease) None were helped (life saved)1 in 60 were helped (preventing heart attack)1 in 268 were helped (preventing stroke) 1 in 50 were harmed (develop diabetes)1 in 10 were harmed (muscle damage)
Blood Pressure Medicines for Five Years to Prevent   Death, Heart Attacks, and Strokes 1 in 125 were helped (prevented death)1 in 67 were helped (prevented stroke)1 in 100 were helped (prevented heart attack)  1 in 10   were harmed (medication side effects, stopping the drug)
Thrombolytics Given for Major Heart Attack 1 in 43 were helped (life saved, given within   6 hours)1 in 63 were helped (life saved, given between   6-12 hours)1 in 200 were helped (life saved, given   between 12-24 hours) 1 in 143 were harmed (major bleeding episode)1 in 250 were harmed (hemorrhagic stroke)
Thrombolytics   for Acute Ischemic Stroke None   were helped (stroke symptoms improved) 1 in 20   were harmed (symptomatic intracranial hemorrhage)
Prophylactic   Antibiotics for Reducing ICU Respiratory Tract Infections and Mortality in   Adults 1 in 18 were helped (life saved)1 in 4 were helped (prevented one respiratory   tract infection) An unknown number were harmed (medication side effects/adverse   reactions)

 

Once the limitations of drugs are appreciated it follows that we have to accept that many diseases cannot be cured. Whilst some alleviation may be possible, the reality is that if these diseases are to be overcome, the only effective strategy is prevention. Essentially this means lifestyle. In this blog I will focus primarily on diet because there is now overwhelming evidence that it does play a critical role in determining an individual’s personal health. This brings us up against another fundamental difficulty which is that much of the official advice is fundamentally wrong and has therefore been a crucial factor contributing to many of our common health problems.

There are convincing reasons why T2D, not obesity, should be regarded as the indicator of public health status. During 2013-2014 there were 45.1 million items prescribed for diabetes, with a net ingredient cost of £803.1million (4). 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 (5). It is estimated that by 2025 there will be 5 million people with diabetes in England (6). 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 T2D 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 (7). Despite the huge expenditure on drugs, there are serious questions about the effectiveness of treatments of T2D to lower the blood glucose. In a meta-analysis of data from 13 randomized controlled trials there was no benefit, in adults with T2D, from intensive glucose lowering in terms of all-cause mortality or deaths from cardiovascular disease (8). 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. It all adds up to more evidence about the misplaced confidence in the use of drugs to cure many diseases.

There is ample evidence that T2D can be controlled, possibly even cured completely by making changes to the diet (9). The condition is directly due to the increased level of glucose in the blood. As a result the pancreas has to produce insulin to prevent excess glucose in the body. Excessive insulin damages many of the organs, which can eventually lead to a range of diseases. If there is too much 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 (10). So what we should be doing is limiting the carbohydrates and consuming plenty of fats

In order to make progress it is essential to alter the dietary advice. However this will not be easy. Although there is growing appreciation to limit sugar intake, the official advice from government and the NHS is to reduce fat. This means that those people who are genuinely attempting to consume a healthy diet will opt for low fat versions of dairy, meat and other types of food. Unfortunately this are usually formulated by removing the fat and replacing it with sugar and/or sweeteners. So the consumers are missing out on valuable nutrients and pushing up their intake of sugar. The official advice is to replace the fat with complex carbohydrates, such as wholemeal bread, potatoes, rice and pasta. All of these contain starch which is broken down to glucose, which inevitably raises the level of glucose in the blood. This approach is fully supported and promulgated by the vast majority of professional dietitians and nutritionists, who in any event feel compelled to comply with the official doctrine.

While recognizing the difficulties, it is the responsibility of the politicians to set the agenda and formulate policy objectives accordingly. Clearly it will mean that they have to take on very powerful vested interests, who will fight tooth and nail to maintain the status quo because they are doing very nicely. Politicians must be prepared to tackle bodies such as NICE which is “not fit for purpose” (11).

The current strategy is not working. Vast sums of public money are being wasted. Many people are suffering unnecessarily and dying prematurely. This is a huge challenge for the politicians. Are there any out there with the intellectual ability, determination and astuteness to address this issue?

REFERENCES

  1. http://www.theguardian.com/politics/2014/sep/22/ed-miliband-speech-tax-tobacco-nhs-labour-conference
  2. http://www.theguardian.com/society/2013/nov/06/drug-industry-nhs-cap
  3. http://www.thennt.com/
  4. http://www.hscic.gov.uk/catalogue/PUB14681/pres-diab-eng-200506-201314-rep.pdf
  5. http://www.diabetes.org.uk/Documents/About%20Us/Statistics/Diabetes-key-stats-guidelines-April2014.pdf
  6. http://www.diabetes.org.uk/Documents/Reports/State-of-the-Nation-2012.pdf      
  7. http://jama.jamanetwork.com/article.aspx?articleid=197439
  8. Remy Boussageon et al (2011) http://www.bmj.com/content/343/bmj.d4169.pdf%2Bhtml
  9. http://vernerwheelock.com/?p=422
  10. http://vernerwheelock.com/?p=153
  11. http://vernerwheelock.com/?p=569

 

 

120. Revelations about Aspartame

Aspartame is a low-calorie sweetener which is produced by G D Searle a company owned by Monsanto. It is approximately 200 times sweeter than sucrose. According to the official website the benefits include:

  • Aspartame Tastes Like Sugar
  • Aspartame Enhances and Extends Flavors
  • Aspartame Does Not Promote Tooth Decay
  • Aspartame is Helpful for Individuals with Diabetes
  • Scientific Studies Show Aspartame is Beneficial in Weight Control
  • Aspartame Can Be Part of a Healthful Diet (1).

The Food Standards Agency (FSA) takes the view that aspartame is perfectly OK as shown by this extract from the website:

Aspartame was first approved in the UK in 1982 following the review of its safety by the UK’s Committee on Toxicity, Consumer Products and the Environment (COT), a committee of independent experts that advises the Government on the safety of food chemicals. This was reaffirmed in 1988 by the European Commission’s former Scientific Committee on Food (SCF).

Following the publication of a number of anecdotal reports, which cast doubt on the safety of this sweetener, the SCF reviewed more than 500 papers published in the scientific literature between 1988 and 2001 on the safety of aspartame, including studies supporting the safety of aspartame and others pointing to potential adverse effects, which concluded, in 2002, that there was no evidence to suggest a need to revise the outcome of their earlier risk assessment or the Acceptable Daily Intake (ADI) previously established for aspartame of 40 milligrams per kilogram of body weight per day (40 mg/kg bw/day).

A study published by the Ramazzini Foundation in Bologna, Italy, in July 2005 claimed to have shown that rats given dosages of aspartame equivalent to the Acceptable Daily Intake (ADI) may develop tumours. EFSA assessed the study and raised a number of concerns regarding it. They concluded, that ‘there is no need to further review the safety of aspartame nor to revise the previously established ADI’.

The FSA supported the conclusions of EFSA’s review but reiterated that all approvals of food additives should be kept under review as and when new scientific information becomes available. Indeed, as part of its systematic re-evaluation of all food additives, EFSA has re-evaluated the safety of aspartame ………As a result, it concluded in December 2013 that ‘aspartame and its breakdown products are safe for human consumption at current levels of exposure’ ” (2).

However not everyone would agree with this position. In particular, Devra Davis has delved into the background and she would certainly dispute the rather complacent line taken by the FSA (3). Devra  has impeccable credentials. She is an epidemiologist who spent 10 years employed by the National Academy of Sciences. During her time as Senior Advisor to the Assistant Secretary for Health in the Department of Health and Human Services, she advised leading officials in the United States, United Nations, European Environment Agency, Pan American Health Organization, World Health Organization, and World Bank. Between 1983 and 1986 she served as a member of the Board of Scientific Counsellors of the U.S. National Toxicology Program. She founded the Center for Environmental Oncology of the University of Pittsburgh Cancer Institute where she was director from 2004 to 2010.

In an interview in the late 1990s, the author discovered some interesting history about aspartame from James Olney, a research neurologist and psychiatrist at Washington University in St Louis. In 1969 a study conducted by researcher Harry Waisman with 7 infant monkeys found that after drinking milk flavoured with aspartame for a year, one was dead and 5 had suffered epileptic seizures. In 1971 Waisman died and the work was never completed. However Olney’s own studies showed that aspartame paired with MSG to produce brain tumours in rats. Two years later, FDA scientist Martha Freeman decided the information submitted by the manufacturers on safety was inadequate.

In July 1976, the FDA decided to investigate the 15 key aspartame studies submitted by G D Searle and set up a Task Force under the chairmanship of Jerome Bressler. The sequence of events following the publication of the report is described in a document prepared by the Aspartame Toxicity Information Center (4). This provides a mine of information which should be consulted by anyone who is interested in the background to the approval of aspartame by the FDA. The references have been removed but many relate to official US Government documents. In August 1977, the Bressler report was released and it contained major criticisms of the procedures relating to the material presented by Searle, namely:

  • “In one study, 98 of the 196 animals died but were not autopsied until as much as one year later. Because of the delay, much of the animal tissue could not be used and at least 20 animals had to be excluded from postmortem examinations
  • The original pathology sheets and the pathology sheets submitted to the FDA showed differences for 30 animals
  • One animal was reported alive at week 88, dead from week 92 through week 104, alive at week 108, and finally dead at week 112
  • An outbreak of an infectious disease was not reported to the FDA
  • Tissue from some animals were noted to be unavailable for analysis on the pathology sheets, yet results from an analysis of this “unavailable” tissue was submitted to the FDA
  • There was evidence that the diet mix was not homogeneous allowing the animals to eat around the test substance. This evidence included a picture and statements by a lab technician
  • Fifteen foetuses from animals in one experiment were missing
  • Sections from the animals were too thick for examination
  • There was no documentation on the age or source of the test animals
  • There was no protocol until one of the studies was well underway
  • Animals were not permanently tagged to prevent mix ups
  • Some laboratory methods were changed during the study, but not documented.”

A G.D. Searle pathologist referring one of the studies was quoted by investigators as saying:

You should have seen things when this study was run — there were five studies being run at one time — things were a mess!”

Bressler himself commented:

The question you have got to ask yourself is: Because of the importance of this study, why wasn’t greater care taken? The study is highly questionable because of our findings. Why didn’t Searle, with their scientists, closely evaluate this, knowing fully well that the whole society, from the youngest to the elderly, from the sick to the unsick . . . will have access to this product.”

At this point it should be noted that Donald Rumsfeld who had just left office as Defense Secretary had been appointed as the CEO of Searle. It was evident that he had been hired early in 1977 because of his connections with government and with the Republican Party, although at that time the Democrat Jimmy Carter was president.

In September 1997, the Director of the FDA’s Bureau of Foods received a report from another Task Force which claimed that the Searle studies appeared to be authentic (meaning that they hadactually been conducted).

For each of the major discrepancies found by the Bressler-led Task Force — those listed above and many others – there was a comment in the FDA Bureau of Foods Report minimizing the problem. It seemed that no matter how serious the mistakes were, the FDA Bureau of Foods was determined toaccept the studies by G.D. Searle.

The experimental errors as described above were so bad that it proved difficult to minimize all of the major errors in these key studies. In some cases, the best that they could do was to say that “The Task Force could find no evidence that this was a deliberate attempt to influence the study.” or “It could not be determined if the results would have been altered….”

In other words it was evident that moves were being made to downplay the serious criticisms in order to pave the way for approval. This was confirmed by Jacqueline Verrett, a senior investigator at the FDA, who earlier had conducted an examination of the procedures and protocols which applied to the Searle studies. After she left the Agency, she was interviewed by a journalist who reported as follows:

Jacqueline Verrett, the senior scientist on the review team, said members were barred from stating opinions about the research quality. ‘It seemed pretty obvious that somewhere along that line they(bureau officials) were working up to a  whitewash,’ she said. ‘I seriously thought of just walking off of that task force.’ Verrett, now a private consultant, said that she and other members wanted to ‘just come out and say that this whole experiment was a disaster and should be disregarded.”

In her testimony before the U.S. Senate during 1987, Dr. Verrett stated the following:

This authentication was hence intended to verify that the submitted data had not been altered;that it reflected the actual outcome of the study and that it did not change substantially, particularly in a statistical sense, the various parameters from which the conclusion of safety had been derived.Our analysis of the data in this manner reveal that in these three studies, there were really no substantial changes that resulted, although in numerous instances, a definitive answer could not be arrived at because of the basic inadequacies and improper procedures used in the execution of these studies.

I would like to emphasize the point that we were specifically instructed not to be concerned with, or to comment upon, the overall validity of the study. This was to be done in a subsequent review, carried out at a higher level.

It would appear that the safety of aspartame and its breakdown products has still not been satisfactorily determined, since many of the flaws cited in these three studies were also present inall of the other studies submitted by Searle.

 Well, they told us in no uncertain terms that we were not to comment on the validity of it. And I hoped, although having been there at that point for 19 years, I should have known better, that there really would be an objective evaluation o this beyond the evaluation that we did. I do not feel that that was done, based on what I have read in the GAO report that I have looked at and so forth. They definitely did not objectively evaluate these studies, and I really think it should have been thrown out from day one.”

 “We were looking at a lot of little details and easy parameters in this study, when the foundationof the study, the diet and all of these other things, were worthless. We were talking about the jockey when we should have been talking about the horse, that he had weak legs. It is built on foundation of sand.”

Here are some comments about the approval process by the FDA:

  • “In March of 1979, the FDA somehow concluded that G.D.Searle’s aspartame studies could be accepted. They decide to convene the Public Board of Inquiry (PBOI).”
  • “The PBOI voted unanimously to reject the use of aspartame until additional studies on aspartame’s potential to cause brain tumours could be done. The PBOI was particularly concerned about experiment E33/34 where 320 rats received aspartame and a much higher percentage of animals in the aspartame group developed tumours than in the control group (Brannigan 1983, page 196). In addition, the PBOI was concerned about experiment E70 where 80 rats received aspartame. Both the aspartame group and the control group had an unusually high number of tumours, leading one to suspect that both groups were actually given aspartame.”
  • “On January 21, 1981, the day after Ronald Reagan takes office as U.S. President, G.D. Searle reapplied for the approval of aspartame. G.D. Searle submits several new studies along with their application. It was believed that Reagan would certainly replace Jere Goyan, the FDA Comissioner. G.D. Searle president, Donald Rumsfeld’s connections to the Republican party were also thought to play a part in Searle’s decision to reapply for aspartame’s approval on the day after Ronald Reagan was inaugurated.”
  • “In March of 1981, a 5-member panel of scientists was established by the FDA Commissioner Jere Goyan to review the issues raised by the PBOI.”
  • “In April 1981, Arthur Hull Hayes, Jr. was appointed FDA Commissioner by Ronald Reagan.”
  • “On July 18, 1981 aspartame was approved for use in dry foods by FDA Commissioner Arthur Hull Hayes, Jr. overruling the Public Board of Inquiry and ignoring the law, Section 409(c)(3) of the Food Drug and Cosmetic Act (21 U.S.C. 348), which says that a food additive should not be approved if tests are inconclusive (Federal Register 1981, Farber 1989,page 38). In an article in Common Cause Magazine, Florence Graves states that two FDA officials said that Arthur Hull Hayes, Jr. wanted to push aspartame approval through in order to signal reforms of the Reagan Administration.”
  • “On October 1, 1982 an amendment was attached to the Orphan Drug Act (an act which encourages the development of drugs for rare diseases) which modified the U.S. Patent law.
    The amendment extended the patent on only one product — aspartame — by 5 years, 10 months and 17 days.”
  • “On October 15, 1982, G.D. Searle petitioned the FDA for approval to use aspartame in soft drinks and children’s vitamins.”
  • “In 1983 acting FDA Commissioner, Mark Novitch approved aspartame for use in carbonated beverages and carbonated beverage syrupbases . FDA Commissioner, Arthur Hull Hayes was out of town the day that the approval was signed, but he worked closely with Mark Novitch on this issue. Ignoring the FDA’s own safety standards, they more than doubled the Acceptable Daily Intake (ADI) of aspartame from 20 mg/kg to 50 mg/kg.”
  • “Shortly after the FDA approval for aspartame in carbonated beverages, FDA Commissioner, Arthur Hull Hayes left the FDA under charges of improprieties, took a position as the Dean of New York Medical College and was hired as an a consultant ($1,000 per day) with G.D. Searle’s public relations firm, Burston Marsteller.”

CONCLUSION

There really is no need for much comment. The information speaks for itself. There is a lot more for anyone who wishes to follow the link to reference (4). The case for approving aspartame is built on a foundation of sand. With this background it is difficult to understand how and why the FSA and other regulatory bodies appear to be so complacent. One wonders if they have even bothered to review the information presented here. No doubt further testing has been done but how much can this be trusted in view of the appalling record of the company? If this information could be disseminated widely, then consumers could make up their own minds. As aspartame is extensively used in low calorie products, those especially at risk will be people who are attempting the follow the official dietary guidelines.

REFERENCES

  1. http://www.aspartame.org/
  2. http://www.food.gov.uk/science/additives/aspartame
  3. Devra Davis (2009) “The Secret History of the War on Cancer” pp 419-426. Basic Books New York ISBN 978-0-465-01568-9
  4. http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012203/02P-0317_emc-000202.txt

 

119. The Medical-Industrial Complex

As long ago as 1960, President Eisenhower warned about the dangers of the Military-Industrial Complex. Here is a quote from the famous speech:

“In the councils of government, we must guard against the acquisition of unwarranted influence, whether sought or unsought, by the militaryindustrial complex. The potential for the disastrous rise of misplaced power exists and will persist.

We must never let the weight of this combination endanger our liberties or democratic processes. We should take nothing for granted. Only an alert and knowledgeable citizenry can compel the proper meshing of the huge industrial and military machinery of defense with our peaceful methods and goals, so that security and liberty may prosper together” (1).

There are compelling reasons for concluding that these features are characteristic of the current relationships between the pharmaceutical industry, the medical profession and governments. In other words we now have a Medical-Industrial Complex. My thoughts have been triggered by my recent blog (2) which highlighted evidence showing that there are serious deficiencies in the regulation of drugs leading to suggestions that the process has been corrupted.

It is essential to face up to the fact that the standards of public health are deteriorating as demonstrated by the increased incidence of diabetes, which has doubled in the past 15 years. While it is true life expectancy has been extended it is highly doubtful if the quality of life has shown a corresponding improvement. The increased incidence of dementia and related conditions such as Alzheimer’s Disease means that many people are unable to care for themselves in later years. On the other hand, expenditure by the NHS in the UK continues to increase. Much of this is to meet the extra costs incurred by expenditure on the latest development in drugs and other tests/procedures.

A detailed analysis has been conducted at the Safra Institute in Harvard University entitled:

“Institutional Corruption of Pharmaceuticals and the Myth of safe and Effective Drugs” (3)

The authors contend that institutional corruption has occurred at three levels. First, large-scale lobbying and political contributions by the pharmaceu­tical industry has influenced Congress to such an extent that legis­lation has been passed which compromised the role of the Food and Drug Administration (FDA). Second, because of industry pressure, Congress has underfunded FDA enforcement capacities since 1906 so that it is incapable of thoroughly evaluating drugs submitted to it for approval. Since 1992 it has had to depend on industry-paid “user fees” which has effectively limited the FDA’s ability to protect the public from serious adverse reactions to drugs that have few offsetting advantages. Finally, industry has commer­cialized the role of physicians and undermined their position as independent, trusted advisers to patients.

Many of the drugs submitted in recent years have few if any advantages over those already on the market. In fact the FDA can actually approve drugs even if they are inferior to those which have previously approved. An evaluation conducted in France concluded that of all the new drugs approved between 1981 and 2001, about 12% offered therapeutic advantages. However between 2002 and 2011, only 8% were assessed as genuinely better than existing ones. However almost 16% were judged to be more harmful than beneficial. As few as 1.6% were considered to be substantially better. Assessments by the Canadian advisory panel to the Patented Medicine Prices Review Board and by a Dutch general practice drug bulletin have come to similar conclusions.

The reality is that most of the expenditure on research and development (R&D) is focused on developing drugs which differ slightly in chemical make-up but have a therapeutic function similar to existing drugs. This approach is adopted because it has a high chance of success and therefore less risk commercially.

Despite the failure to develop many drugs that will make a valuable contribution towards improving health, sales and profits have soared. This is because the marketing arms of the drug companies have successfully persuaded physicians to prescribe the much more costly new products that are at best therapeuti­cally equivalent to established drugs.

Two studies have found that 80% of the increase in drug expenditures was to pay for these minor-variation new drugs, rather than for important advances.  Companies claim that R&D costs are “unsustainable.” But the reality is that revenues have increased six times faster than has investment in R&D over the past 15 years.

Between 1964 and 1995, a systematic review of patients who were hospitalised in the US because of adverse drug reactions (ADR) or experienced an ADR while in hospital found some disturbing results. In all 6.8% had serious ADRs which means that 2.7 million people were affected. Of those 0.32 died, which represents 128,000 deaths every year. On this basis, ADRs are the 4th leading cause of death. These figures do not include ADRs which occurred outside hospitals.

1. Because politicians are dependent on drug companies for financial support to get elected as public representative, there has been a reluctance on their part to ensure that the regulatory process is completely thorough and effective. This can be demonstrated as follows:

  • New drugs are often tested against placebos rather than against established effec­tive treatments.
  • Surrogate or substi­tute end-points instead of the actual effects on patients’ health are often used to assess the effectiveness of new drugs.
  • Noninferiority trials which show that the product is not worse than another drug used to treat the same condition by more than a specified margin are accepted. Ideally there should be a requirement to show that the new drug is significantly better than one already on the market. These criteria do not conform to international ethical standards because they provide no useful information for prescribing.

2.  Companies are allowed to test their own products. Hence the trials are designed in such ways that they minimise the detection and reporting of harms and maximise evidence of benefits. They are permitted to exclude patients who are most likely to have ADRs, while including those most likely to experience benefit. Therefore drugs can be marketed as safer and more effective than they are in the real world.

3. In a submission to the House of Commons Health Committee, Richard Horton, editor of the Lancet, spelled out the problems which have arisen as a result of the heavy involvement of the drug companies in medical research as follows:

the extent of the commercial sponsorship of medical research and its intrusion into the academic sphere is one of the gravest threats to the independent evaluation of new medicines—indeed to the notion of an independent science base. Without greater scrutiny of the interaction between private and public sectors, the health of our population will continue to be put at risk by biased, over-interpreted, and misreported research findings. At present, our population is part of a largely unregulated experiment involving poorly investigated new medicines that have been licensed on the basis of insufficient data” (4).

He went on to describe how the entire process of publication of scientific research has been debased by the activities of the drug companies, whose over-riding consideration is the promotion of their products to the exclusion of all other factors. Examples include:

  • Manipulation of research findings. A drug which had “no effect” according to the researchers but the marketing actually claimed “primary endpoints significant in hypertensive patients”, which was a total distortion of the actual result.
  • Bias in sponsored studies: research has demonstrated clearly that sponsored studies are more likely to produce a positive result for a company than an independent study of their product.
  • Hiding negative data: the classic recent example concerned Paxil (GlaxoSmithKline). The results of trials which were not disclosed showed a pattern suggesting limited efficacy of the drug and risks of potentially fatal adverse effects. The available published evidence indicated a very different story. Under pressure, GSK was forced to reveal these hidden results—leading to a $2.5 million US legal settlement and an unequivocal FDA warning about the risks of the drug.
  • Undisclosed conflicts of interest: the escalating problem of industry payments to scientists—stock options, consultancy fees, research grants, staff costs, entertainment, conference fees, hospitality—has been recognised for several years.
  • Editorial kick-backs: The Lancet has been offered substantial sums of money in exchange for publishing certain research studies.

This is all sordid, unethical and totally unacceptable. A Medical-Industrial Complex definitely does exist. There is absolutely no doubt that industry, governments and the professionals interact and collaborate to exploit people when they are most vulnerable. Because all the players are very powerful, it will not be easy to achieve reform in order to ensure that the drug companies are subject to stringent regulatory control. Probably the best hope is transparency with the assistance of the internet. The recent incident involving Rory Collins and the BMJ is at least an encouraging sign that the drug companies and their acolytes are no longer getting their own way (5,6). The one thing we can all do is to be very, very careful before agreeing to take any drug.

REFERENCES

  1. http://coursesa.matrix.msu.edu/~hst306/documents/indust.html
  2. http://vernerwheelock.com/?p=575
  3. D W Light, J Lexchin & J J Darrow (2013) Journal of Law, Medicine and Ethics 14 (3) pp590-610
  4. http://www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/42/4121604.htm
  5. http://vernerwheelock.com/?p=432
  6. http://vernerwheelock.com/?p=528

 

118. Crony Capitalism. The Pharmaceutical Industry.

The use of drugs is an integral component of the conventional approach to modern medicine. Invariably a visit to your GP results in a prescription for at least one pill or potion. A similar treatment is often associated with a stay in hospital. The fundamental principle which underpins this strategy is that these medicines will be beneficial to the patient’s health. Furthermore while it is accepted that there may be side-effects, these can be tolerated if the benefits are genuinely worthwhile. The entire basis of the approach is dependent on regulatory processes that are rigorous in their assessments of the effects the drugs have on people who are treated.

Unfortunately a huge amount of evidence has emerged in recent years, which shows that there are serious deficiencies in the regulation of drugs and there are even suggestions that the process has been corrupted.

A recent book published in the US entitled “Crony Capitalism in America 2008-2012” (1) has a whole chapter devoted to the relationship between the pharmaceutical industry and the Food and drugs Administration (FDA). This has been reproduced on the Alliance for Natural Health website (2). This blog will focus on some of the key points. Although the book refers to the US many of the companies operate in the UK and it would not be in the least surprising if the relationship between the companies and the UK/EU regulatory authorities is essentially the same. Here are some of the hard realities of this business:

  1. Drug companies do not usually use natural compounds because it is impossible to patent them. As it costs somewhere around $billion to obtain approval, patenting is essential in order to recoup the costs involved.
  2. To facilitate approval process, the companies regularly hire staff with experience of working for the FDA. Many of the experts in the field who may be employed by universities and research organisations act as both advisers to the FDA and consultants to the industry.
  3. This engenders a cosy relationship between the both sides who participate in the regulation of the drugs
  4. According to a quote from the “Economist”:

Pharmaceutical companies bury clinical trials which show bad results for a drug and publish only those that show a benefit. The trials are often run on small numbers of unrepresentative patients, and the statistical analyses are massaged to give as rosy a picture as possible. Entire clinical trials are run not as trials at all, but as under-the-counter advertising campaigns designed to persuade doctors to prescribe a company’s drug.”

The “Economist” continues:

“Medical journals frequently fail to perform basic checks on the papers they print, so all sorts of sharp practice goes uncorrected. Many published studies are not written by the academics whose names they bear, but by commercial ghostwriters paid by drug firms. Doctors are bombarded with advertising encouraging them to prescribe certain drugs.”

5.       Knowledge of what is happening with respect to the progress of individual applications for approval can have major financial implications. An FDA chemist charged with criminal offences has pleaded guilty to leaking information about drug approvals or company mergers. Over a 5-year period the chemist had been involved with 25 companies and benefited to the tune of almost $4 million dollars.

6.       Once a drug has been approved it may be prescribed on a large scale, especially by official bodies such as the US government’s Medicare. Annual treatment costs for these approved drugs may be as high as $500,000 per patient. On the other hand, drugs which have not been approved are effectively banned in the US and doctors who prescribe them risk being stuck off and may even be prosecuted

7.       Although there may be compelling anecdotal evidence, including numerous case studies which indicate that naturally-occurring substances can be used successfully to treat a variety of diseases and conditions, the FDA insists that they can only be approved if the complete testing programme is implemented. Since there is no organization or company prepared to spend the money needed, there is no way that these substances will ever be approved. The position is re-inforced by the stance of the American Medical Association (AMA) which as a general rule is opposed to the use Complementary therapy but is also dependent on the pharmaceutical industry for much of its funding

8.       The use of generic drugs ought to be an effective means of reducing the costs of many drugs but this approach is to some extent stymied because the FDA insists that bioequivalence is demonstrated which adds to the costs. More significantly the FDA has a huge backlog of about 1900 applications for generics and the average time for a decision on approval is 26 months,

9.       In the US the government is very careful to avoid charging any leading pharmaceutical company with criminal misconduct. This is because conviction under the current law would mean that the government would no longer be able to purchase any products from that company. The government is too closely integrated with the drug/vaccine industry to allow that to happen. Thus, when Merck was found to have misled about its painkiller Vioxx, alleged to have caused at least 55,000 deaths (some estimates are much higher), the settlement with plaintiffs reached $4.9 billion. But Merck continued partnering with and selling to government without any interruption or even question.

This is just one example of crony capitalism in which government and industry become so interdependent on each other that there is really no effective control and the only beneficiaries are those individuals who have their “snout in the trough”. In essence the normal rules of competition are suspended and inefficiencies are rampant. It is of course the ordinary citizens who suffer because it is their taxes which are used to fund these excesses. They also miss out from the continued improvement in the quality of products coupled with a steady reduction in prices. As an example, compare the pharmaceutical industry with the mobile phone industry which advances in leaps and bounds. By contrast there is reliable evidence that there are very few new drugs which actually perform significantly better than those already on the market and some which are worse, but no doubt are promoted as “wonderful”.

REFERENCES

  1. Hunter Lewis (2013) “Crony Capitalism in America 2008-2012” ISBN 978-09887627-2-7
  2. http://www.anh-usa.org/big-pharma-and-fda-a-marriage-not-made-in-heaven/

 

 

117. Statins: Email to Julian Smith MP

Good Morning Julian,

I have just posted this article on my blog at

http://vernerwheelock.com/?p=569   More details of the damaging effects of statins will be found at http://www.spacedoc.com/statin_side_effects

My primary concern is the fact that such a large number of perfectly healthy people are suffering serious ill-health even though NICE accepts that it will not improve their health in any way. I contend that this is totally unjustified and unacceptable.

The reality is that 100s of thousands (maybe even millions) of people are being damaged by statins when the vast majority  of them do not benefit in any way. There is no doubt that there is manipulation of the results conducted by the drug companies to play up the advantages and play down the undesirable side-effects of statins. (See http://vernerwheelock.com/?p=545  and http://vernerwheelock.com/?p=528)

This issue has all the hallmarks of other scandals which have come to light recently such as Rotherham, Stafford Hospital or Hillsborough. The only difference is that much larger numbers of people are involved. There is no doubt that NICE is a major part of the problem. I believe that for a start some of the parliamentary committees should conduct a detailed investigation into the role of NICE and its relationship with the drug companies. This email is a formal request to you to place this information with the Parliamentary Committees for Public Accounts, Science and Technology and Health in the hope that they will take appropriate action. Please take any other measure you think would be effective.

All the factual information is based on thoroughly reliable sources and I believe that this issue must be addressed sooner rather than later. Let us hope that this will not be another scandal that drags on and on for years because nobody in a position to act would listen !!!

A copy of this email is being sent to the Craven Herald and I will also be placing the information on my blog at http://vernerwheelock.com/

I look forward to hearing your response.

Very Best Wishes

Verner