QUICKLINKS AND VIEW OPITONS
Thank God He Didn’t Die Of Heart Disease Doctor Dr. Malcolm Kendrick
Posted by .(JavaScript must be enabled to view this email address)
Tuesday, January 19, 2010 12:55 pm Email this article
There are those of us, poor misguided fools, who believe that the main point of taking drugs is to prevent an early death. We are clearly wrong. The important thing is that you must not die of heart disease. For dying of heart disease is clearly much worse than dying of something else.
(This article was written by Malcolm Kendrick, MD, author of the wonderful, eye-opening, paradigm-shifting book The Great Cholesterol Con: The Truth About What Really Causes Heart Disease and How to Avoid It .)
I don’t know, for myself, I think a major unexpected heart attack is not a bad way to go. A sudden sharp crushing pain, then it all goes dark, then – well who knows actually. Not that pleasant, but this is a better way to go, surely, than a slow agonising death from cancer. Or maybe not, maybe we should all have a chance to prepare for death, get used to the idea….. discuss.
Statin Study Finds No Decrease In Total MortalityTNT statin study found no decrease in total risk of death
These idle thoughts were prompted by (Yet Another Damned study YADs) demonstrating that if you give a very high dose of statins, you can reduce the chance of dying of CHD – a bit – compared to a standard dose of statins. However, the overall mortality rate is unchanged.
Study Authors Come to A Ridiculous Conclusion
TNT statin study authors state we should be lower cholesterol more aggresively
My first response to this study, the TNT trial, was “quelle surprise!” My second response was “I bet this results in yet more demands for ever greater cholesterol lowering.” I was not to be disappointed.
“In summary, our findings demonstrate that the use of an 80-mg dose of atorvastatin to reduce LDL cholesterol levels to 77 mg/dL provides additional clinical benefit in patients with stable CHD….” write Dr John C LaRosa (State University of New York Health Science Center, Brooklyn) and colleagues. “These data confirm and extend the growing body of evidence indicating that lowering LDL cholesterol levels well below currently recommended levels can have clinical benefit.”
A stance fully supported by Eric (rent a quote) Topol. “There isn’t any question left at this point that we should be more aggressive,” The Washington Post reports.
Eric Topol Runs Site Supported by Drug Company
Eric Topol who says to lower cholesterol further, but is paid by AstraZeneca
Oh Eric, Eric, Eric. You are just so predictable. Still, I suppose that you own, and run, a major cardiology website http://www.theheart.org which is almost completely supported by ‘unrestricted educational grants’ from AstraZeneca. AstraZeneca makes Crestor, and their marketing strategy is to push for greater and greater cholesterol/LDL lowering. So it would be a bit much to expect Eric to err on the side of caution. ‘Statinate and be damned’ would be his family motto. That mad tilter at the windmills of conventional thought.
And why does Eric, sorry AstraZeneca, promote aggressive LDL lowering? Because Crestor is the most potent statin of all. How do we know this? Because AstraZeneca keeps having to send out warnings to doctors about toxic side-effects. Good old Crestor, or as I call it, ‘Drug on the Green Mile.’ Anyway, I think we should all just take the things that Eric Topol says with a little pinch of salt – just to keep the blood pressure up.
Statins Do Not Reduce Total Risk Of Death
Statins Reduce Risk Of Dying From Cardiovascular Disease, But Not Total Risk Of Death
But still, to return to the main point. Does the TNT trial (Treating to New Targets), really support the use of high dose statins? Well, if you want to create liver problems and reduce the chances of dying of heart disease – yes.
If you want to prevent death…. Not really. And don’t just take my word for it.
Editorial Recognizes Statins Don’t Reduce Risk of Total Death
Dr. Bertram Pitt (University of Michigan School of Medicine) recognizes statins don’t reduce risk of total death
In an editorial accompanying the TFT study in the NEJM Dr Bertram Pitt (University of Michigan School of Medicine, Ann Arbor) thought that clinicians will need to look critically at the TNT data to determine whether the results are sufficient to alter clinical practice.
Pitt managed to spot that there were no differences in overall mortality between the two therapies and even an increase (my italics) in the number of deaths from noncardiovascular causes in those treated with atorvastatin 80.
Well, Bertram, if there were fewer deaths from cardiovascular disease, and no differences in overall mortality, it doesn’t take Albert Einstein to work out that there may have been an increase in deaths from other causes. No need to fire up the super-computer to figure that sum.
He notes (the clever chap that he is) that while the number of deaths from CHD was reduced by 26 among patients assigned to high-dose atorvastatin, the number of deaths from noncardiovascular causes increased by 31. ‘While this increase in noncardiovascular events may be due to chance, it is still a matter of concern.’ he noted (wisely).
Editorial Recognizes Statins Don’t Reduce Risk of Total Death
Dr. Bertram Pitt (University of Michigan School of Medicine) recognizes statins don’t reduce risk of total death
But the best bit is yet to come. This next commentary is quoted directly from theheart.org
Specifically, Pitt takes issue with the lack of observed differences in overall mortality, although he concedes that the study was not adequately powered to observe differences in this end point. For differences in mortality to be observed, investigators would have needed to enrol approximately 34 000 patients, something TNT investigators say would have been very difficult.
“We need to make the assumption that mortality has been proven, that LDL lowering does in fact lower total mortality rates,” said LaRosa.
Stains Have NEVER Been Shown to Lower Total Mortality
Stains have NEVER been shown to lower total mortality… None… Ever
We need to make the assumption that mortality has been proven…….. Why, exactly, do we need to make this assumption? No study, ever, on primary prevention of heart disease with statins has ever shown a reduction in overall mortality. None, ever. And there have been many. And assuming something so absolutely vital, based on a huge amount of contradictory evidence seems just a tad premature.
Stains Have NO Effect on Total Mortality
’... it can be stated categorically that statins have no effect on overall mortality’
I think I shall make an observation, rather than an assumption. As no clinical trial on cholesterol lowering in primary prevention of heart disease using statins (or any other drug actually) has ever demonstrated a reduction in overall mortality, it can be stated categorically that statins have no effect on overall mortality.
But now to talk statistics……run for cover, save the children.
‘Pitt concedes that the study was not adequately powered to observe differences in this end point (overall mortality).’
Now I am not a statistician – my brain fuses when confronted with mathematical formulae. But I do clearly understand the overall concepts. And I shall try to explain why the comment that the study was ‘not adequately powered to observe differences in this end-point,’ is bonkers. And can only be accepted if you are the sort of person who thinks that the Bill Clinton defence ‘But what is, is?’ sounds reasonable.
Almost all clinical trials need to enrol a sufficient number of people, over a sufficient time period, to show a significant difference between the ‘intervention’ group, and the ‘standard’ group. The greater the difference you expect to see, the less people you need to enrol. For example, if you expect that everyone who takes the drug will live, and everyone who doesn’t, will die, then it doesn’t take that many people to demonstrate a significant difference.
In my own mind I liken this to throwing a die to find out if it is ‘weighted’ or not. If the die is heavily weighted it will come up with a six almost every time, and it doesn’t take long to work out that you have a biased die on your hands. However, if the die is only very slightly weighted, it may take hundreds of throws before you can be sure that it is coming up six more times than is possible by chance.
Statisticians basically try to work out – before the trial starts – how many people you need to treat, for how long, to see if the die is weighted. Or if it is not. Or by how much the die is weighted. So you need to estimate, before the trial starts, what difference you think you are likely to find, then you can work backwards from this to establish how many patients you need for the trial to be properly ‘powered’ (with a bit of a buffer built in).
If the trial is insufficiently ‘powered’ i.e. doesn’t have enough people in it, you may see a difference, but it will not be statistically significant i.e. the difference could have been a ‘chance’ finding.
Still awake? Good.
TNT Statin Study Designed To Avoid Conclusion that Statins Do NOT Lower Total Mortality
TNT statin study designed to avoid the conclusion that statins do not lower total mortality or claim that it was due to random chance
Here is where we hit the ultimate Catch 22. The almost perfectly bonkers loop of self-referential logic in the TNT trial.
Step One – of mad logic:
Statins have been shown to reduce cardiovascular mortality in primary prevention studies (that is, in people who have not already got established heart disease). So a statistician, knowing this can say we need to look at (in the case of the TNT study) ten thousand people, with five thousand in one ‘arm’ of the study and five thousand in the other ‘arm’ over about five years or so. That is, if we expect to see around a 20% relative reduction in deaths from cardiovascular disease.
Step Two – of mad logic:
Because statins have not been shown to reduce overall mortality by much, if at all, we need a far greater number of patients in the trial to ‘power’ it, in order to see a significant reduction in overall mortality. In the case of TNT, at least 34,000 patients - apparently.
Step three – of mad logic:
When the study shows a reduction in cardiovascular mortality this is claimed to be statistically significant.
Step four – of mad logic:
When the study shows no difference in overall mortality, it can be confidently stated (without being struck down by a bolt of lightening from above) that the study was not powered to look at overall mortality, and therefore the finding could have been ‘chance’ and is not significant.
TNT Statin Study Claims Increase In Total Deaths is Insignificant
TNT statin study claims increase in total deaths is insignificant, but a decrease in cardiovascular deaths is significant
This is despite the fact that, in the TNT study, more people died of non-cardiovascular disease than cardiovascular disease, and that more people, total, died in the statin ‘treatment’ arm. This, we are told, is chance. Whereas the much smaller overall reduction in cardiovascular mortality is statistically significant.
And lo, the greater number of deaths is insignificant. Whilst the lesser number of deaths is significant. And the statistician looked upon his work and he was pleased. And because no one understands statistics, and they are terrified of making a statement that may make them seem foolish, we accept this complete rubbish without question.
Rubbish
Rubbish From Statin Supporters
Of course, accepting this rubbish does allow various doctors to make statements such as the ones that follow:
‘This study provides direct evidence of benefit of intensive treatment in stable coronary heart disease patients, a population that numbers about 30 million in the US. That’s huge.’ Dr Christopher Cannon (Brigham and Women’s Hospital, Boston, MA)
He went on to add: ‘To be able to prevent major cardiovascular events on this scale will have a huge public-health implication.’
Or how about a little more from John La Rosa (State University of New York Health Science Center, Brooklyn).
‘The results of the TNT study indicate that the linear relationship between reduced LDL and reduced CHD risk demonstrated in prior secondary-prevention trials holds true even at very low LDL cholesterol levels. These data extend the growing body of evidence that lower LDL cholesterol levels well below the currently recommended targets can further reduce the healthcare burden associated with cardiovascular and cerebrovascular disability.’
And they can still sleep in their beds at night. Cor blimey – as we say in the UK.
—————
Article Previous Published on THINCS.org
This article was previously published on THINCS.org
This article was previously published on THINCS.org (The International Network of Cholesterol Skeptics).
I republished the article here with Dr. Kendrick’s permission.
Malcolm Kendrick’s Contact Info
Malcolm Kendrick’s Email Address—.(JavaScript must be enabled to view this email address)
Dr. Malcolm Kendrick can be reached at .(JavaScript must be enabled to view this email address).
Malcolm Kendrick, MD is the author of the wonderful, eye-opening, paradigm-shifting book book The Great Cholesterol Con: The Truth About What Really Causes Heart Disease and How to Avoid It .)
.)
Articles on the same subject can be found here:
COMMENTS
Please feel free to share your comments about this article.
© Copyright 2003-2012 - Larry Hobbs - All Rights Reserved.