Conflicting views have again emerged about statin medications in two leading British Medical Journals. Statins are used to lower cholesterol and have been the best selling drugs of the past 25 years with sales in the tens of billions of dollars.
The Lancet published a review claiming that the medication is safe, that side effects have been over stated and that the benefits outweigh the risks. The BMJ has taken an opposite view claiming side effects are more common than admitted to and that the benefits are overstated.
This is confusing enough for doctors, let alone the public.
The confusion comes from three issues. The results of medical trials reflect the population involved in the trial. They may not be the same as those who end up being prescribed the medication. This is a very vital point. The value of statins in primary prevention (those with no established heart disease) is very different to secondary prevention (those with heart disease). Secondly trials have different “end points” that are measured. Many assess “proxy” end points, which do not always translate that well into the real world where living longer or feeling better is what people value.
Cholesterol, weight and even blood pressure are proxy measures. Nobody dies of them. They are risk factors for heart disease and stroke. But treating risk factors is not treating illness. We hope we are preventing illness, but this is not necessarily the case.
Most critically though is how the trial data is interpreted.
Cholesterol is a component of each and every cell in the human body. The rationale for lowering cholesterol levels is that this will reduce rates of heart disease and increase life expectancy.
Last year a review was published which the authors noted was the “first study ever to systematically evaluate statin trials using average postponement of death as the primary outcome”.
In primary prevention death was postponed 3.2 days and in secondary prevention death was postponed by 4.1 days.
This study was remarkable for two reasons. Firstly, that in 25 years of widespread use, at considerable expense to health systems, such an evaluation had never been done. And secondly, that the benefit in terms of life expectancy is non-existent!
How can this be?
It comes from the confusion of proxy health outcomes with actual health outcomes. Dates of birth and death are recorded and are difficult to fudge. Someone is either dead or alive. Thus life expectancy (or postponement of death) is a “hard” measure. So is whether someone has had a heart attack or not.
Nobody can argue that these medications do not lower cholesterol. One can argue what difference does a lower level make?
Previous work has shown that lowering cholesterol and blood pressure had little effect on the progress of atherosclerosis (artery narrowing).
Another “hard” way of evaluating medications is the number needed to treat. This measures how many people need to take a medication, and for how long, to get benefit. In primary prevention, if 100 people take a statin medication for five years 98.5% will get no benefit. Not one single life will be saved. Less than 1% will avoid a heart attack and a smaller number will avoid a stroke.
Some 10% will have muscle damage as a side effect and 1% will develop diabetes as a side effect.
In secondary prevention the numbers are better. Some 2.6% will avoid a heart attack and 1.2% of lives will be saved over five years. Yet 96% get no benefit. The side effect percentages are the same.
All trials can be criticized. The review on life extension covered only a six-year period (the length of the trials it examined). But if we treble it to 20 years this would at best lead to a postponement of death by 12 days or less as the longer you live the more likely you eventually die of some other cause.
The Lancet review has been criticized for doing nothing more than rehashing previous data. The authors have refused to allow independent review of their data and the lead author, Sir Rory Collins, has received considerable funding from statin manufacturers. You can form your own view on the significance of this.
What is the bottom line?
It has become too easy to reclassify healthy people as having a condition needing treatment, generally medications with costs and side effects. The role of cholesterol (a minor risk factor for heart disease) has been overstated, as has the value of lowering it, which is not an end in itself.
We have all been sold the dangers of fats! Damming evidence from the USA has revealed the role of the sugar industry in funding doctors to write reviews blaming fat rather than sugar in the diet as a health problem! Low fat diets are not and never were never healthy.
There are only two reasons to treat any condition in medicine. That is to improve the quality of life or extend life. Treatments, which do neither, in my opinion, are difficult to justify.
Lowering cholesterol does not make people feel better. If it does not increase life expectancy their widespread use needs to be seriously questioned.
You need to consider your unique situation and balance the risks and benefits. There is no one size fits all. Be questioning of what you are told about fats, cholesterol and statins and do your own research.
This article first appeared here.
Medical Doctor, author, speaker, media presenter and health industry consultant, Dr Joe Kosterich wants you to be healthy and get the most out of life.
Joe writes for numerous medical and mainstream publications, is clinical editor at Medical Forum Magazine, and is also a regular on radio and television.
Joe is Medical Advisor to Medicinal Cannabis Company Little Green Pharma, Chairman of Australian Tobacco Harm Reduction Association and sits on the board of Arthritis and Osteoporosis WA. He is often called to give opinions in medico legal cases.