Mar 132016
 

The Health section of this morning’s Sunday Express in the UK carries an article with the headline: ‘We are very worried’ Former Royal doctor demands statins inquiry.

Statin drugs are prescribed to around 12 million people in the UK to lower cholesterol, according to doctors’ guidelines issued by NICE and reinforced by the NHS with targets for prescribing statins to older patients. Statin drugs are supposed to prevent heart disease but, as we highlighted in our film You must be nuts! – the business of dementia, they have many side effects, including possibly dementia.

However, as Dr Stephanie Seneff revealed in the interview above, she was unable to publish her 2009 analysis that statins could cause Alzheimer’s until all references to statins had been deleted from her paper. It would seem likely that she is not the only researcher to have found negative effects of statins which have remained unpublished.

Sir Richard Thompson, former president of the Royal College of Physicians and personal doctor to the Queen for 21 years, has called for an inquiry to scrutinise the data on which this mass prescription is based. His comments follow the publication of the paper Beyond Confusion and Controversy, Can We Evaluate the Real Efficacy and Safety of Cholesterol-Lowering with Statins? by Dr Michel de Lorgeril and Dr Mikael Rabaeus in the Journal of Controversies in Biomedical Research.

The paper begins by drawing attention to the “increasing signs of altered validity of numerous company-sponsored trials”. As an example, it cites the neuraminidase inhibitors for treating influenza.

“The 5-year battle needed to access the raw trial data led to a reversed picture of the drugs: benefits had been overestimated and harms under-reported in the company-sponsored trial reports. Ultimately, the benefit/harm balance was not in favor of the drugs; this is a critical issue for physicians, in particular when they are in charge of fragile patients. One probable cause of the failure is that none of the trials was independent of the drug’s manufacturers. Several experts conclude that the “Tamiflu story” may suggest that the entire ecosystem of drug evaluation and regulation could be flawed.”

The paper concludes that “contrary to what has been claimed for decades, statins do not have a significant effect in primary and secondary prevention of cardiovascular disease.” It also recommends that “medical doctors should not prescribe statins in diabetics and in patients with metabolic syndromes.”

In essence, the paper points out that the main studies on which the enthusiasm for statins has been based would have been disqualified under the 2005/2006 EC regulations in the conduct and publication of randomised controlled trials. Even so, it suggests that “investigators and industrials can still succeed in finding a way around them.”

“This has led to the dogmas about statin efficacy and safety, based on unrealistic clinical reports and flawed meta-analyses, resulting in biased recommendations about statin use and ultimately extravagant situations and claims.”

After the failure of the UK Parliament’s Commons Health Select Committee to even reply to Obhi’s call for a formal investigation into this area (let alone taking any action), we hope that Sir Richard Thompson’s call will lead to a change in the current policy of prescribing drugs based on dogma, rather than science.

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 262014
 
Interview with Dr Stephanie Seneff (Senior Research Associate, MIT)

In the ninth part of her interview for You must be nuts, Dr Stephanie Seneff, Senior Research Scientist at MIT, reveals what happened when she tried to get a paper published which demonstrated a causal link between statins and Alzheimer’s.

In December 2009, Dr Seneff wrote a paper entitled APOE-4: The Clue to Why Low Fat Diet and Statins may Cause Alzheimer’s . A revised version of the paper, co-authored with Dr Glyn Wainwright and Dr Luca Masatelli, was published in the European Journal of Internal Medicine in December 2010 with the title Nutrition and Alzheimer’s disease: The detrimental role of a high carbohydrate diet.

Dr Richard Smith, a former editor of the British Medical Journal, highlighted the potential conflict of interest faced by medical journals and the problems of the peer review process in his book The trouble with medical journals. An edited version of its introduction was published in the Journal of the Royal Society of Medicine in 2006.

Mar 062014
 
Justin Smith, producer/director of Statin Nation

In the seventh part of his interview for You must be nuts!, Justin Smith, Producer/Director of the documentary Statin Nation considers whether a low fat diet and statin drugs could cause Alzheimer’s/dementia.

Mar 052014
 
Interview with Dr Stephanie Seneff (Senior Research Associate, MIT)

Dr Stephanie Seneff, Senior Research Scientist at MIT, talks about the connection between statin drugs and dementia.

In December 2009, Dr Seneff wrote a paper entitled APOE-4: The Clue to Why Low Fat Diet and Statins may Cause Alzheimer’s . A revised version of the paper, co-authored with Dr Glyn Wainwright and Dr Luca Masatelli, was published in the European Journal of Internal Medicine in December 2010 with the title Nutrition and Alzheimer’s disease: The detrimental role of a high carbohydrate diet.

Jan 012014
 
Poster image for You must be nuts!

Poster image for You must be nuts!

I should introduce you to my friends Alph, Beel and Chah-Lee. They are puppets. You must be nuts! tells the story of how their exploration of the film’s interviews changes their lives.

Here’s the prequel:

The puppet family

Alph and Chah-Lee are husband and wife. They live in the UK.

Chah-Lee is the more health-conscious of the two. Every time a new diet becomes popular, she has been following it in the hope of returning to her once-slim figure.

Alph is the one I know best and through whom I met Chah-Lee and Beel. He is fascinated by current affairs and science. His iPad is his window on the world and we came to know each other through an online science discussion forum.

Beel is Chah-Lee’s Spanish father. He has travelled extensively and has lived in Spain, the UK, Latin America, the US and France. He met and married Chah-Lee’s mother while he was living in the UK.

Chah-Lee’s keen interest in health developed partly in reaction to seeing her mother gradually put on weight. As Chah-Lee was growing up, her mother started suffering health problems related to her obesity and diabetes.

As a result, after Beel had worked for many years as a senior executive, he and his wife decided to live in Spain. They set up ‘Beel’s Beach Bar’ together on its Mediterranean coast. Although Chah-Lee’s mother passed away a couple of years ago, Beel continues to run the bar.

The background to the puppets

Needless to say, Alph, Beel and Chah-Lee are fictitious characters. Any resemblance to real persons, living or dead, is purely coincidental.

Of course, Alph, Beel and Chah-Lee could be anyone – A, B and C – and they could be living anywhere in the world. Their dialogue is derived from various informal conversations with friends and colleagues over the past year about dementia, dietary advice, prescription drugs and/or what constitutes a healthy diet. It aims to cover all the typical questions which arise in any such discussion.

The puppets were kindly created for the film by Enrique Nicanor. His past credits include creating and animating the original puppets for the children’s TV series The Magic Roundabout and producing and directing the Spanish version of Sesame Street for its first three years.

Elisabeth Christ provided the voice of Chah-Lee, Enrique provided the voice of Beel and I provided the voice of Alph. Kaberi was the puppeteer behind Chah-Lee while Enrique was the puppeteer for Alph and Beel.

Amid the increasingly grim findings of my research and the challenges of caring for someone with dementia, Alph, Beel & Chah-Lee provided a welcome source of light relief. The two days of filming the puppet sequences were strenuous but fun. My father was our fascinated and patient live audience while we filmed the breakfast scenes over several hours on Saturday.

Wishing you a dementia-free 2014 … and beyond.