Feb 172016
 

MyPlate

You would imagine from its title that the US Department of Agriculture’s Nutrition Evidence Library would be a comprehensive database of all scientific research on nutrition.

Unfortunately, it isn’t. Here is its methodology:

  • Step 1: Develop systematic review questions and analytic frameworks
  • Step 2: Search, screen, and select studies to review
  • Step 3: Extract data and assess the risk of bias of the research
  • Step 4: Describe and synthesize the evidence
  • Step 5: Develop conclusion statements and grade the evidence
  • Step 6: Identify research recommendations.

All this seems very thorough doesn’t it? Well, when our friend Nina Teicholz, author of The Big Fat Surprise started looking for some of the recent nutrition trials, she noticed something strange.

“What I’ve found is that the Nutrition Evidence Library omits all the major Randomised Controlled Trials (RCTs) on saturated fats, nearly all the major RCTs testing the diet-heart hypothesis and its offspring, the low-fat diet, and nearly all the low-carb studies. That would be, in sum, pretty much all the research on nutrition, most of it NIH funded, since the birth of the diet-heart hypothesis.”

Or in other words, the selective inclusion of studies in steps 1 and 2 just happens to exclude the major trials and focuses instead on epidemiological studies, which are a weaker kind of evidence that cannot demonstrate cause and effect.

Why does this matter? Well, the US Dietary Guidelines for Americans are the most influential nutrition policy in the world. They are followed by governments all over the world.

These guidelines are underpinned by an expert report, which draws its evidence from the (incomplete) Nutrition Evidence Library. Can it be a surprise that the dietary guidance hasn’t changed for decades?

Nina is giving testimony on Friday (19 February) to the US Department of Agriculture, which publishes the US Dietary Guidelines. It is holding “listening sessions” because the US Congress mandated a review of the Guidelines by the National Academy of Medicine to find out what’s gone wrong.

She has started to compile a list of the nutrition research missing from the Nutrition Evidence Library which she would like to present on Friday. Could you help to complete the list? … in the next 24 hours!?

What to do to help complete the list:

  • find a nutrition study (clinical trial, observational study or review paper) on the low-fat diet, saturated fats or the low carbohydrate diet
  • check that it isn’t already in the list
  • enter the surname of the first author in the search on the top right of the Nutrition Evidence Library home page
  • if the study does not appear in the search results, add it to the list in the appropriate group in chronological order

UPDATE: 12 HOURS TO GO!!

Thanks to everyone who has helped to expand the list considerably so far. Here is the list as it stands now.

As you may realise from the list, most of the recent trials are missing from it. Of course, it could be a complete coincidence that the missing trials seem to be the ones which concluded positively about a low carbohydrate diet.

On the other hand, … take a look at the pages on Carbohydrates on the NEL website:

– Systematic review questions listed under the 2015 Methodology: http://www.nel.gov/topic.cfm?cat=3295 (all questions and answers appear to be from the 2010 dietary guidelines)

– the Carbohydrates section from the DGAC 2010 methodology: http://www.nel.gov/topic.cfm?cat=2854

All study designs were originally included in the searches, but cross-sectional studies were later excluded from the review if there was sufficient evidence from studies with stronger study designs. The Committee excluded studies that only included participants diagnosed with chronic disease, hyperlipidemia, hypertension (HTN) and related health conditions.”

“… The Committee only considered studies that directly assessed the relationship between the intake of food groups and health outcomes; studies examining the intake of food groups as a part of a larger dietary pattern were not considered in the review. “

For the topics considered by the 2005 DGAC, the Conclusions expressed in the 2010 DGAC report are informed by the evidence compiled for the 2005 DGAC report, but are based primarily on the NEL evidence gathered and reviewed since 2004. As discussed in the associated review, for some questions, the search was extended back further to capture a larger body of evidence. Studies of carbohydrates and health outcomes on a macronutrient level are often inconsistent or ambiguous due to inaccurate measures and varying food categorizations and definitions. The science cannot progress without further advances in both methodology and theory.”

Perhaps that last sentence should have said that the dietary guidelines cannot progress without further advances in both methodology and theory of reading the available scientific research?

Apr 012015
 
Poster image for You must be nuts!
Drugs and Pharmacies in Russia

Drugs – Photo courtesy World Health Organisation

After standing firm against criticism from the food industry of its recent guidance to reduce sugar intake among adults and children to 5%, and from Monsanto for its re-evaluation of glyphosate as probably carcinogenic, the World Health Organisation (WHO) seems set to attract criticism again, this time from the pharmaceutical industry. The latest edition of its two-yearly Model List of Essential Medicines is due to be published this month may contain a subtle but significant to change the WHO guidance concerning statin medication.

Since at least 2002, statins have been included in the list under the heading ‘Lipid-lowering drugs’ as follows:

“The WHO Expert Committee on the Selection and Use of Essential Medicines recognizes the value of lipid- lowering drugs in treating patients with hyperlipidaemia. HMG-CoA reductase inhibitors, often referred to as “statins”, are a family of potent and effective lipid-lowering drugs with a good tolerability profile. Several of these drugs have been shown to reduce the incidence of fatal and non-fatal myocardial infarction, stroke and mortality (all causes), as well as the need for coronary by-pass surgery. All remain very costly but may be cost effective for secondary prevention of cardiovascular disease as well as for primary prevention in some very high-risk patients.”

However, since the 2007 edition, this entry has been amended to specify Simvastatin (and other equivalent medication) as being “For use in high-risk patients.”

A source close to the preparation of the 2015 edition has revealed that this entry may now say “For use in high-risk patients with prior cardiovascular disease“. This follows recent research suggesting that the risks of patients taking statins long-term without prior heart disease outweigh the benefits. However, a spokesman for the WHO declined to comment ahead of publication.

In her interview for You must be nuts!, Dr Stephanie Seneff explained (see interview clip below) that she believed that statins are extremely dangerous and that she is very worried about the widespread disability we are likely to see from the mass prescription of statins. In 2009, she had written a paper explaining why a low fat diet and statins may cause Alzheimer’s. Here is her detailed paper explaining how statins really work, which explains why they do not really work. Dr Seneff recently co-authored a paper in Surgical Neurology International linking glyphosate to neurological diseases.

As you will know from a previous post, the UK guidance body NICE decided last year to expand the scope of people who should be prescribed statins. It has been criticised by senior doctors for over-medication and for failing to take into account the risk of adverse effects. Recent research has shown that statins may increase the risk of diabetes by 46% and Parkinson’s disease by 230%. However, NICE has been unable to provide the data on which its guidance is based and it has also emerged that no analysis of the adverse effects had been carried out. NICE was unavailable for comment on the revision of the WHO statin guidance.

Meanwhile the Statin Nation II DVD became available today.

1 April 2015 could be a historical day for critics of statin medications.

 

Evening update: Although the underlying references above are real, this was, sadly, only an April Fool joke. Unfortunately, there are no signs (yet) that any regulatory body has grasped how unreliably volatile ‘relative risk’ statistics are. Such statistics have been the basis for their passion for the mass prescription of statins for decades. Of course, no-one can know what the basis for NICE’s passion is since they seem unable to produce any data to back up their guidance.

Meanwhile, more and more evidence is emerging that the adverse effects of statins are more significant than any benefits, especially in primary prevention. Vascular Surgeon Professor Sherif Sultan, who attended the premiere of Statin Nation II, drew attention to two papers published in the Expert Review of Clinical Pharmacology last month:

1) How statistical deception created the appearance that statins are safe and effective in primary and secondary prevention of cardiovascular disease; and

2) Statins stimulate atherosclerosis and heart failure: pharmacological mechanisms.

Both should encourage regulators to stop recommending the mass prescription of statins to healthy people (ie for primary prevention of cardiovascular disease). Doctors too should be aware of the adverse effects of statins and report adverse drug reactions to the relevant regulatory body for all statin side effects which patients are reporting to them. In the UK, the ‘Yellow Card’ feedback mechanism was set up after the Thalidomide scandal in the 1960s. However, in the case of statins, it seems to have been stifled by the NICE targets for doctors to prescribe more statins to more older people.

At least here is a petition by statin victim Joan Wade who has been trying unsuccessfully for years to extract data about the clinical trials behind the statin guidance. She describes how, after taking Lipitor for 2 years, she “almost died from polyneuropathy and heart failure due to muscle wasting caused by the toxic/chemical poisoning. All the GPs involved in my case closed ranks and failed to report the incident under the Yellow Card Scheme to the regulatory body – the Medicines and Healthcare products Regulatory Agency (MHRA) – to conceal the truth about what happened.” Others who have signed her petition have also stated in the comments that their adverse effects were not reported.

We have also seen how respected researchers like Dr Stephanie Seneff have been unable to get their papers published unless they delete all negative references to statins. This is not science. It is suppression of evidence.

After 2 months, our call for a formal investigation by the Commons Health Select Committee remains unanswered. So, over 50 years on from the Thalidomide scandal, the run up to the General Election on 7 May 2015 in the UK would seem to be a good moment to highlight the statin scandal. Between now and 7 May, we will be publishing the remaining excerpts from the full interviews for You must be nuts!

Feb 182015
 

Sunday Express: Health chief slams statins (15 February 2015)

Two weeks ago, Obhi wrote to the Rt Hon Dr Sarah Wollaston MP, the Chair of the Commons Health Select Committee, to:

“… urge the Committee to investigate what I consider to be the chronic regulatory
failure which has led to the current dietary advice, the medical guidance to doctors and the
near-exclusive allocation of public research funding to commercial medical research,
without any obligation to publish the results.”

On Sunday, an article in the Sunday Express reported that Dr Wollaston had called for drug companies to release all their trial data on statin medications, saying “I’m concerned there may be side effects that have not been reported. Drug manufacturers should release all their trial data on statins so they are available for scrutiny.” Dr Fiona Godlee, the editor-in-chief of the BMJ, has to be commended for having led the calls for transparency of the research results.

As you may have seen from the You must be nuts! Twitter feed, there have been several other interesting developments over the past two weeks. Over in the US, the draft US Dietary Advice 2015 guidelines are poised to withdraw longstanding warnings about cholesterol. Meanwhile, researchers led by Zoë Harcombe concluded that “Evidence from randomised controlled trials did not support the introduction of dietary fat guidelines in 1977 and 1983“.

Unsurprisingly, NHS Choices, which continues to advise against eating cholesterol and saturated fat, quickly denied that this study was important, adding another web page to those recommended for deletion in Annex 1 of Obhi’s letter. Not even everyone at the NHS is convinced by the NHS Choices guidance, it seems. As part of its 100 days of change campaign, leading to NHS Change Day on 11 March 2015, story 32 revealed that:

“the Community Diabetes Team (Dietitians and Diabetes Specialist Nurses) launched a pilot programme of Low Carb Diet Groups, offering education and support for people with Type 2 Diabetes who wished to follow a healthy low carb diet and have the necessary support with their medication changes.”

Perhaps a clue to the reluctance to change the dietary advice comes from the news last week that researchers guiding the UK Government’s anti-obesity campaign had received hundreds of thousands of pounds of funding from the junk food industry. The BMJ published an editorial asking ‘Big food, big pharma: is science for sale?’. The editorial accompanied a 3-part investigation into Sugar’s web of influence (Part 1, Part 2 & Part 3).

It echoes a 2013 article by the previous editor of the BMJ, Dr Richard Smith: Is the pharmaceutical industry like the mafia? The article was based on his foreword to the book Deadly Medicines and Organised Crime: How Big Pharma Has Corrupted Healthcare by Peter Gøtzsche, the head of the Nordic Cochrane Centre.

The BMJ provided an interactive infographic to illustrate the connections between food industry companies/lobbies and members of the Scientific Advisory Committee on Nutrition and the Medical Research Council’s Human Nutrition Research Unit.

This brings us back to the astonishing revelation from Sir Rory Collins that his team would [future tense!] ‘carry out a “challenging” reassessment of the evidence which will include studying all reported side effects. Although the original research looked at the effect of statins on the heart and considered cancer risks it did not examine other side effects.’ Dr Malcolm Kendrick has called for an apology from Sir Rory Collins, who had called on the BMJ to retract two articles critical of statins last year because he claimed they over-stated the adverse effects of statins.

Last year, NICE had recommended extending the scope of statin prescriptions apparently primarily on the basis of assurances from Sir Rory Collins’ team that statins were safe. As mentioned in Obhi’s letter, NICE’s methodology is to carry out a cost-benefit analysis (to “assess whether treatments and ways of managing a condition are good value for money for the NHS“). However, by relying on the recommendations from Sir Rory Collins’ team, NICE’s analysis could not have taken account of the adverse effects of statins.

A more transparent analysis is provided by the NNT (the number needed to treat before 1 patient benefits). Two recent articles in the New York Times highlighted its usefulness: Can this treatment help me? There’s a statistic for thatHow to measure a medical treatment’s potential for harm.

For statins, the NNT for patients who do not have heart disease suggests that the harms outweigh the benefits.

We believe the adverse effects of long-term statin medication contributed to the frontotemporal dementia, muscle pains and cataracts of Obhi’s father over at least the past six years. In the light of the news that Sir Rory Collins’ team has yet to explore the adverse effects of statins, it would seem appropriate for NICE to retract all its guidance to doctors recommending statins in primary prevention. Evidently, it has no data to support its positive analysis of statin use.

Thanks to the transparency spotlight of social media, we look forward to a time in the near future when the dietary and medical advice, as well as medical research funding, will be guided exclusively by scientific evidence, rather than by money from commercial interests. We hope You must be nuts! – the business of dementia and Obhi’s letter will contribute to this call.

Meanwhile, we look forward to the world premiere of Statin Nation II in London on 28 February 2015.

Dec 212014
 
Poster image for You must be nuts!

It has taken much longer to complete the film than we had intended when we published the 3-minute prequel on New Year’s Day 2014!

The prequel shows the puppets Alph and Chah-Lee in bed on a Saturday evening – the eve of the start of the film.

Now (at last!) everyone has the chance to see what Alph shows Chah-Lee ‘the next day’. After making a few technical adjustments following its unlisted test publication on Vimeo in November, the film is now on YouTube.

Many thanks to everyone for the very positive feedback so far. We have started to add closed captions to the film in English so that the film will be subtitled automatically in the 163 languages now supported by YouTube. If you want to help refine the subtitles in any language, please let us know via the comments to this post.

Even though it was unlisted on Vimeo, over 700 people have watched the film so far in 37 countries. Thanks particularly to Deborah Walker and the Natural Health Radio team for helping to promote the film to their listeners. Deborah interviewed Obhi about how he has been applying his research to treat his father’s dementia and about the film. You can catch up with the interview here.

If you are looking for more details about the treatment given to Obhi’s father, Obhi wrote a guest post on the HealthInsightUK blog about it in August. The film’s Twitter feed (@youmustbenuts) highlights the latest developments on dementia, and the food, drugs and chemicals which may cause it.

Jul 212014
 
The Trouble with Medical Journals by Dr Richard Smith
The Trouble with Medical Journals by Dr Richard Smith

The Trouble with Medical Journals by Dr Richard Smith

In recent posts, we have seen that Dr Stephanie Seneff, Senior Research Scientist at MIT, was unable to get her paper published about whether the low fat diet and statins could cause Alzheimer’s until she deleted all references to statins. We have also seen that the financial reliance of medical journals on pharmaceutical companies exposes them to a potential conflict of interest – as revealed by Dr Richard Smith, former editor of the British Medical Journal, in his book The Trouble with Medical Journals.

On Saturday, Kailash Chand, the deputy chair of the British Medical Association, described the guidance from UK National Institute for Health and Care Excellence (NICE) recommending that doctors “offer atorvastatin 20 mg for the primary prevention of [cardiovascular disease] to people who have a 10% or greater 10‑year risk of developing [cardiovascular disease].” as “a victory for vested interests over evidence“. The consequence of the NICE guidance would be that “millions more” would be given statin drugs.

Back in February, Zoë Harcombe had identified the potential conflicts of interests of the members of the NICE panel. In June, a group of doctors and academics wrote an open letter to NICE and to the UK Health Secretary about their concerns about the latest NICE draft guidance on statins. The Department of Health thought it was up to NICE to manage any conflicts of interest and NICE saw no problems with conflicts of interest in the guidance.

No doubt it’s entirely coincidental that the patents for statin drugs were due to expire in 2013, when similar new guidance vastly expanding the number of candidates for statin drugs was issued by the American College of Cardiology and the American Heart Association. After all, as the graph below shows, by 2013 even though some 64 million prescriptions for statin drugs were issued by UK doctors, the cost to the NHS (and hence the revenue of pharmaceutical companies) had dropped to just £150 million, compared to the peak of £740 million in 2004.

Statin use and cost in England 2002-2013

A similar issue of conflicts of interest has emerged with the publication of draft guidance from NICE recommending free bariatric surgery for diabetes patients.

As Dr Malcom McKendrick found, the tool to assess the risk of cardiovascular disease recommends statins for extremely healthy men over 58 and extremely healthy women over 63. This morning, cardiologist Dr Aseem Malhotra pointed out that, in 2008, an analysis of published statin trials had identified an increased risk of cancer caused by statin drugs for certain populations.

“Close inspection of statin trials reveal the specific populations at risk for the development of incident cancer with statin treatment. These include the elderly and people with a history of breast or prostate cancer. Furthermore, statin-treated individuals undergoing immunotherapy for cancer may be at increased risk for worsening cancer.”

Even the patient information leaflet for Lipitor, the bestselling statin drug, suggests that it may not be suitable “if you are older than 70”.

Meanwhile, as revealed by investigative journalist Nina Teicholz in her excellent, bestselling book The Big Fat Surprise, the dietary advice recommending a low fat diet since 1961 has been based on faulty science. The book traces the disaster trail of evidence against saturated fat, which it summarises as follows: “the early trials condemning saturated fat were unsound; the epidemiological data showed no negative association; saturated fat’s effect on LDL-cholesterol (when properly measured in subfractions) is neutral; and a significant body of clinical trials over the past decade has demonstrated the absence of any negative effect of saturated fat on heart disease, obesity or diabetes. … It seems now that what sustains it is not so much science as generations of bias and habit … .”

The same appears to be true of the medical recommendations of statins, whose rationale is based on the same faulty hypothesis as the low fat diet. Should we, as Dr Seneff suggests, look forward to millions of people suffering disabilities through long-term statin use? Even before the latest NICE guidance, the OECD concluded in December that the UK had become the ‘statin capital of Europe‘.

Instead of spreading enthusiasm for mass bariatric surgery to deal with diabetes, perhaps NICE ought to read this paper in Nutrition advocating “Dietary Carbohydrate restriction as the first approach in diabetes management“. That means recommending a low carbohydrate, high fat diet, which was also found to be the best for weight loss in one of the few clinical trials in this field. This is already the official dietary advice in Sweden.

More than ever before, public authorities offering medical and dietary guidance must be not only free of bias but also be seen to be free of bias. They must also base themselves on rigorous science, in full knowledge of any negative effects. At present, this does not seem to be the case. In particular, the data underpinning the NICE guidance is unavailable, due to an agreement with a manufacturer of statin drugs. A wider problem is that, according to Dr Ben Goldacre and All Trials, some 50% of trial results are never published.

In spite of the scientific evidence to the contrary, most official dietary advice continues to recommend avoiding saturated fats, pushing people towards genuinely unhealthy trans fats and their substitutes, and a high carbohydrate diet – all of which have negative effects on health. A similar approach for statins could turn out to be yet another “very large, human-scale, uncontrolled, unmonitored … experiment” on the entire population, with a similar negative, long-term impact on our health – particularly that of our older relatives. Some doctors even see a risk that people in Western nations are suffering from a culture of over-intervention and over-medication. But then, as we will see, statins are not the only medication prescribed routinely to older patients which have serious adverse effects, particularly on their brains.

Mar 152014
 
Justin Smith, producer/director of Statin Nation

Last week, the UK’s Daily Telegraph published the article Low fat foods stuffed with ‘harmful’ levels of sugar. It analysed the sugar content of a range of food and drinks marketed as ‘low fat’.

In the sixth part of his interview for You must be nuts!, Justin Smith, the Producer/Director of the documentary Statin Nation, considers whether a low fat diet could lead to a high carbohydrate diet. Apart from sugar, he talks about the effect on blood sugar levels of eating grains.

In September 2012, a study by the Mayo Clinic found that a high carbohydrate diet raised the risk of dementia in older people by a factor of almost 4, compared to a low carbohydrate, high fat diet. “When total fat and protein intake were taken into account, people with the highest carbohydrate intake were 3.6 times likelier to develop mild cognitive impairment.”

Neurologist Dr David Perlmutter’s bestselling book Grain Brain: the surprising truth about wheat, carbs and sugar – your brain’s silent killers highlights the connection between eating grains and dementia.

Jan 082014
 
Justin Smith, Producer/Director of Statin Nation

This is the first part of our interview with Justin Smith, Producer/Director of the investigative documentary Statin Nation. In it, he explains the background to his decision to make Statin Nation.

Since we filmed the interview, with the backing of a crowd-funding campaign which reached its initial target in record time, Justin has started to make Statin Nation II.

A few days ago, he published the first intro clip from Statin Nation II, which looks at the new cholesterol guidelines introduced in the US last month.

Apparently, these new guidelines are set to double the number of people taking statin medications.

The crowd-funding campaign to finance Statin Nation II is now close to its second target. If you want to see the rewards on offer and contribute to the crowd-funding campaign, visit the Statin Nation II web page.

Coming soon: Part 2 of our interview with Justin Smith, in which he explains why he thinks that there has been ‘consistent misinformation about what constitutes healthy eating’.