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.

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’.