Jerome Burne writes:
"The blog has been suspended for several months while I wrote a book called the Hybrid Diet – out in mid-March; more details soon. I can’t help noticing that my silence has encouraged the forces of medical and nutritional counter-revolution to go on the offensive – low-carb diet is a killer, veganism is the only way to save the planet and, most recently, 8,000 lives will be saved if we give statins to all people in the UK over-75. This, as you’ll see below, is evidence-free.
Even though the statin claim gave me a Groundhog moment – I’ve written a lot, as you may know, about why the relentless and ongoing program to get the entire nation on statins practically from birth is a really bad idea – and here were the old familiar claims that have long looked dodgy – clear benefits, virtually no side-effects, publicising statin doubts kills people – all being taken for an outing once more.
Two indefatigable campaigners for medicine that is actually evidence-based – nutritionist Dr Zoe Harcombe and GP Dr Malcolm Kendrick – have already gone through the Lancet paper – and found the familiar failings once more, but I think I can add something. I’m assuming not everybody reading this has read their blogs so I’m summarising them and adding some other details. This is for ageing-friends who are increasingly being pushed down the stain path and deserve to know what’s involved.
Claim of 8000 lives saved – a falsehood
As Zoe’s response to the article make clear, there is a strong reason to be deeply suspicious about this research anyway. It is the work of the CTT Cholesterol Treatment Trialists’ Collaboration, a unit in Oxford which has been publishing the results of analyses of statin trials for over 20 years – mostly in the Lancet –that almost invariably claim that lives could be saved if more people took statins. The effect has been to get more and more people on the drugs as each new claim makes more people eligible, never fewer. This latest one was done by an off-shoot in Australia.
But the most devastating element of Zoe’s critique was showing that the claim of 8,000 lives saved was quite simply a ‘falsehood’. She points out that in the text of the article, as opposed to the abstract, the difference between those getting statins and those who didn’t was said to be ‘not statistically significant’.
In other words, any difference between the two groups could have happened by chance. The CTT attempted to improve the result by omitting four of the trials they were analysing, which had not found statin therapy to be effective. Even then the results were not significant.
Hand-in-hand with the promise that more is better, CTT publications also routinely assert that statins have virtually no side-effects. This is strongly disputed by statin critics.
Benefits of statins equals risk of diabetes
The debate spilt into the newspapers in 2014 when the most aggressive statin promoter, Professor Sir Rory Collins of the CTT, demanded two articles about the risk of side effects published in the BMJ be retracted on the grounds that percentage of people said to be suffering side effects was wrong by a couple of points.
I wrote about it here . It’s a topic that is complex enough to form part of a PhD thesis but the basic issue is straightforward. The more serious the side effects and the more of them there are, the less it makes sense to take the drug.
A simple but effective way of showing the benefits vs risks of a drug is to use a calculation known as NNT (Numbers Needed to Treat) vs. NNH (Numbers Needed to Harm). A website called www.thennt.com calculates these using results from lots of trials. These are the results if you’re taking statins when your chance of having a heart attack isn’t high:
- There is no ‘statistically significant mortality benefit’ in other words no one is going to avoid dying from a heart attack. (Pause for thought about the prediction of lives saved)
- 1 in 217 would avoid a nonfatal heart attack
- 1 in 313 would avoid a nonfatal stroke
Balanced against those are the risks.
- 1 in 21 would experience pain from muscle damage
- 1 in 204 would develop diabetes mellitus
So, your chances of avoiding a non-fatal heart attack (worthwhile) are very slightly worse than the risk of developing diabetes. The exact numbers depend on the group of patients being looked at. Zoe’s figures were different but just as unfavourable. If you haven’t had a heart problem – the great majority of people on statins haven’t – there is a 1:10 chance of being harmed by muscle damage and a 1 in 50 chance of developing diabetes.
Drug company major funder of studies of benefit
There are other reasons for not taking the CTT research at face value, which has been regularly pointed out in the past but have been consistently ignored by the unit. In 2014, at the time of the dispute with the BMJ, it emerged for the first time that the unit had received payments of over 250 million pounds from the major statin manufacturer Merck. That total is now almost certainly more.
All the RCT’s funded by statin companies, on which the unit bases all its many positive studies, are held by the CTT and are not available for any independent researchers to analyse. This is contrary to the standards of transparency over data, widely agreed to be essential if research is to be considered reliable.
Another reason to query the claims of this study is that other perfectly good ones have found that having higher cholesterol levels when you are older makes disease less likely. One study , which Dr Harcombe worked on together with the senior stain researcher Dr Uffe Ravnskov, found that high LDL was associated with a lower rate of deaths in most people over 60.
A detailed review of the effects of raised cholesterol in the elderly by Japanese researchers found that high levels of low-density lipoprotein (LDL) cholesterol were linked with ‘low all-cause mortality’. It was published in the Annals of Nutrition and Metabolism in 2015 (DOI: 10.1159/000381654). It also found a link between high total cholesterol and a ‘lower incidence and mortality rates from cancer, infection, and liver disease.’
Ignorant statin critics putting lives at risk
I first wrote about Dr Malcolm Kendrick and his investigations into cholesterol and statins for the Guardian in 2004 and he’d started long before that. He’s now a world expert and lectures doctors on it. A series running in his blog is entitled ‘What causes heart disease?’ has just reached part 61. In a sane, evidence-based medical system, he would be heading a research division helping the NHS to improve treatment.
Instead, as he points out in his blog on the Lancet article, its publication has been accompanied by a coordinated attack in two dozen cardiac journals around the world on ‘bad information’ about the safety and benefits of statins. ‘It puts human lives at risk,’ they all warn, ‘and often comes from politicians, celebrities and others who lack medical expertise.’ This is not science, this is black corporate PR that harms patients.
Malcolm illustrates the close connection between the research and the industry with the full ‘conflict of interests’ list included with the Lancet article. Out of 23 authors, five have nothing to disclose, the rest have all received payments from at least one drug company; two each have financial links with 14.
He also picks up basic flaws in the study that seriously undermine its conclusions. It is described as a ‘meta-analysis of twenty-eight RCTs’ but Malcolm shows that half of them can’t possibly tell you if statins save the lives of 75-year-olds or not.
Wrong trials used to prove statin benefit
Five of them were designed to compare the benefit of high vs low dose statins -not those getting a dose vs placebo. Even worse, nine of the RCTs didn’t actually include anyone who was over 75. So only 14 of this big, 28-trial analysis are actually relevant to claims about 8,000 lives saved. And what difference will removing half the studies have on the conclusion which already looks unbelievable? On past performance, it is unlikely the authors will be doing this calculation.
Malcolm, like Zoe, also spotted that the text – rather than the title – didn’t actually say that statins stopped elderly subjects dying. He points out that what was actually reported was that statin therapy ‘produced a 21% reduction in major vascular events.’
We can be certain that there wasn’t any reduction in fatal cardiovascular events – what you need to be able to claim you are saving lives – because ‘it would have been trumpeted from the rooftops.’
In one of his earlier blogs, Malcolm makes that point that strictly you can’t claim a treatment ‘saves lives’ at all because you can’t actually prevent death. What you can do is to enable some people to live longer, which immediately raises the question: How long? Malcolm, although probably no one else, has done the statistics to find the answer for statins. If you take the drug for five years, and you benefit, it will on average be for a few days.
The final point Malcolm makes about the Lancet analysis is a sophisticated one about how you do clinical trials. If there actually was a reduction in serious vascular events (after removing the irrelevant trials) was it balanced by an increase in other serious events that might be the result of statin therapy, making treatment worthless? The paper didn’t, of course, say anything about this but other studies have found this does happen.
However healthy you are you need a statin
These criticisms of the latest extravagant claim for statins are not the work of medically ignorant celebrities and politicians, they are the work of well-informed scientists who understand biomedical statistics and deserves serious consideration, not aggressive denigration.
But it is important to appreciate that the Lancet paper can be seen as part of the wider statin project, designed solely to get as many people on the drugs as possible by replacing science with marketing. Malcolm has described another example in his blog: ‘What causes heart disease part XIV’. It’s so blatant. it’s funny.
It involves an online test called QRISK that your GP may advise you to take to discover your cardiovascular risk over the next five or ten years. You tick various boxes – age, gender, total cholesterol, HDL, blood pressure – and if you have more than a 10% chance of a cardiovascular event, you need statins right away. What’s wrong with that?
When Malcolm played with QRISK, he found that if a man puts his age in as 67 or over, even if all his risk factors are perfect – cholesterol right down, blood pressure healthy etc, – he will still be diagnosed as needing a statin. Women are automatically recommended one a few years later.
True this reflects the fact that age, along with gender, are the two most powerful risk factor for CVD, but why are they? If you have no risk factors, what is pushing your risk up? Malcolm wrote that he was baffled by the fact that experts in cardiology seemed utterly unconcerned that they couldn’t explain how the two major risk factors for the disease they were treating had their effect.
But from the perspective of project statin, there’s no need for an explanation, all that’s needed is sales.
Both Zoe and Malcolm have recently brought out excellent books challenging health myths that have proved stubbornly resistant. ‘The Diet Fix’ from Zoe lucidly summarises research that shows where weight-loss advice is wrong and how to eat in a way that will keep you healthier and slimmer long-term. After you’ve read Malcolm’s ‘A Statin Nation’ you will be in no doubt about both how unreliable this latest research is and what a castle built on scientific and the cholesterol-heart hypothesis is. "
Post above taken from original here
All the best Jan