Questioning the Status of Statins
In his weekly diary in the Daily Telegraph Dr James Le Fanu tells us what we already know:
The assertion last week by researchers at London’s Imperial College that statins have virtually no side effects is so contrary to the experience of legions of Daily Telegraph readers over the past few years, it is only reasonable to inquire how they came to this conclusion.
Dr Judith Finegold and her colleagues trawled through the published findings of the 29 drug company-sponsored statin trials and discovered that the number of “serious adverse events” to be similar among those taking the drug as among those on placebo.
I have not discussed Dr Finegold’s findings with her or her team. I do, however, take general issue with the findings of drug companies’ statin trials for various reasons.
First, the companies have a repertoire of strategies for ensuring the participants in their trials have a reduced risk of side effects. This includes excluding those more likely to experience them (such as the elderly) and those unable to tolerate statins, and “under-ascertainment” – that is, not inquiring too closely for the side effects they might cause.
Next, their findings are contradicted by independent surveys that find that muscular aches and pains are a hundred times more frequent than those reported in the clinical trials, while a series of further problems are not even mentioned – decreased energy, exertional fatigue, depression, memory loss, insomnia, reduced libido, etc, etc. It is only to be expected that the drug companies should be reticent about such matters. And it is certainly of interest, as I read via the HealthInsightUK.org, that the arrangements between Big Pharma and academic institutions specifically exclude access to the original data on which the claims for the safety of statins are based.
Dr Le Fanu concludes: “This latest study does not make me a convert to their wider use.”
Dr Ben Goldacre Retracts on Side-Effects
But the man who likes to point the finger, Dr Ben Goldacre the science policeman, had to backtrack reveals Le Fanu in his Telegraph article:
The controversy over the “statins have no side effects” report, discussed in this column a fortnight ago, has prompted some backsliding, with one of the authors, Dr Ben Goldacre of London University, conceding the data on which they based their conclusion was “flawed”.
The drug companies that sponsor the relevant clinical trials, he observed, “may not be motivated to search exhaustively for potential side effects”, while a substantial proportion of side-effects are omitted from the published version of the studies as they appear in academic journals. He adds:
Meanwhile, a reader who plays chess competitively — to club standard — noted that he could “see things over the board more clearly” whenever he had forgotten to take his Atorvastatin. He decided to stop taking the drug completely, and over a couple of months his official grading as a chess player shot up nearly 30 points (“some way above the average of club players in Britain”) and he “swept the board” in three successive tournaments.
It is likely that a formal study of statin-taking chess players would provide a rather more accurate assessment of the drug’s adverse effects on cognitive ability than can be found in drug company-sponsored clinical trials.
By Dec. 2014, Dr Le Fanu’s scepticism of statin “experts” comes to bear, it seems. Quoted below, his comment can be viewed here:
Readers may recall the highly improbable claim from ‘leading experts’ earlier this year that the cholesterol lowering statins have ‘virtually no side effects’ and thus can safely be prescribed to everyone over the age of 60 – or one in four of the adult population. It might thus appear rather puzzling that several speakers at last month’s annual conference of the American Heart Association asserted, on the contrary, that far from being ‘safe’ nearly half of patients are ‘statin intolerant’. I am grateful to the informative website healthinsightuk.org for clarifying the reasons behind this dramatic volte face.
Statins have recently come off patent and so are no longer generating the prodigious revenues of £15 billion a year for their manufacturers. The drug companies have anticipated this eventuality by developing a new type of cholesterol lowering drug (known as PSCK9 blockers) to be launched next year. This will inevitably be vastly more costly than the now off-patent statin and it would certainly be difficult to persuade doctors to prescribe them were the statins as ‘safe and effective’ as has routinely been claimed. Hence the belated ‘discovery’ they are not. Shocking, but sadly true.
11 April 2016 Dr Le Fanu takes umbridge with a shameless GP who pushes statins on a patient…
Finally, my thanks to a Bradford lady for passing on a shameful letter from her family doctor. It opens solicitously, “We would like you to stay healthy and well.” The practice has recently reviewed her medical records and (in bold) “you have been identified as being at significant (underlined but not specified) risk of developing heart disease.” Hence the enclosed prescription for Atorvastatin that (in bold again) “can reduce the risk of stroke and heart attack by a third and is best taken long term.”
That “by a third” sounds impressive but is the usual statistical sophistry. Her family doctor could perhaps more usefully have expressed the merits of Atorvastatin in a rather different way: that taking it would not prolong her life, and over a five-year period will prevent a heart attack in just 1.6% of those taking it and a stroke in 0.37% (i.e. 98% do not benefit).
The letter omits to mention the possibility of side effects, which, as reported last week, affect 43% of those on Atorvastatin. “Oh, for my old family doctor,” my correspondent laments. Quite so.
Other doctors take issue with statins also. One, Dr Malcolm McKendrick, has written a book debunking statins. The book’s description claims:
In this ground-breaking work, GP Malcolm Kendrick exposes the truth behind the hype, revealing: high cholesterol levels don’t cause heart disease; a high-fat diet – saturated or otherwise – does not affect blood cholesterol levels; and, the protection provided by statins is so small as to be not worth bothering about for most men and all women.
Statins have many more side effects than has been admitted and their advocates should be treated with scepticism due to their links with the drugs’ manufacturers. Kendrick lambastes a powerful pharmaceutical industry and unquestioning medical profession…
Dr Margaret McCartney, the Glasgow GP and author, read McKendrick’s The Great Cholesterol Con and immediately said, “I recommend it.” Writing in the Financial Times (https://www.ft.com/content/3657855a-ffbf-11db-8c98-000b5df10621), she said, regarding the taking of statins, we are all part of an experiment but it is social dislocation and poverty that have the biggest effect on health in the UK, not cholesterol. Her only real advice is the imperative to “think very carefully before you get your cholesterol checked.”!
There will always be those who promote statins but diet and lifestyle are essential to health. As of April 2016 this has at least some sound basis; it’s become increasingly clear that fruit is at least as effective as statins and without the side-effects. (See also An Apple a Day Keeps Doctor Away)
But surely one meta-analysis of 600 research papers should be heeded which concluded that statins are of no benefit to women at all and are of no benefit to men except those with a history of heart disease.
Statins; a wonder drug or bad news?
• Read more here at Healthsightuk
• A regular critic of statins, the anti-cholesterol drugs, Dr Le Fanu now has medical research on his side. Read his article in the Daily Telegraph wherein he outlines the history of statins: Statins for all and Billions for Drug Firms
• Statins – no end to the bad news. It seems muscle pain is the least side-effect to worry about when taking statins: High dose statins raise risk of serious kidney problems
• The Great Cholestrol Con is available via Dr Malcolm Kendrick’s website
• Vascular surgeon explains why he gave up statins: Link
• Statins ‘needlessly doled out to millions’ simply because of their age, the Royal College of GPs has warned: British Journal of General Practice