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!

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’.