In part one of ‘why I refused a statin drug’ I said I would explain how the issue of side effects can be downplayed in clinical studies.
Statin studies say what the designers of them want
Before I address this, just a quick recap on the key issue in the last episode. I highlighted how the interpretation of data which can make results seem much better than they really are in real life.
I showed how the published benefits of a 36% reduction in risk is actually only 1.1%. This is because the relative risk is promoted not the absolute rate. The absolute rate is the only one that counts. You must always look at absolute risk when assessing if you should agree to a particular medication.
You must also always look at the risk of side effects when assessing the benefits.
Statins are (not) for everyone
Unfortunately, the push for wider use of statins even in the healthy population has increased over recent years. Some “experts” have:
- suggested that everyone over the age of 50 should be on a statin.
- suggesting that they should even be given to children (Pfizer’s even developed a grape tasting statin for kids) fortunately that didn’t get much traction.
- suggested putting them in the water supply.
All of this is being done without knowing the true impact of negative side effects.
Clinical trials help
A reasonable question would be “aren’t the side effects are known from the clinical trials?” Indeed they are, but no one other than the pharmaceutical companies can access them.
Under an arrangement with the statin manufacturers, a cardiologist named Prof Rory Collins was instrumental in setting up an organization called the Cholesterol Treatment Trialists Collaboration (CTT Collaboration). Under an arrangement with the pharmaceutical companies this organization collects the raw data from clinical trials for further assessment.
So far, so good, but:
But data isn’t always transparent
Instead of making the data available for independent researchers to examine, they keep that information more secure than the gold at Fort Knox. They will not release any of the data, citing confidentiality with the Pharmaceutical companies.
Quite a weird situation given that ten’s of millions of people throughout the world are taking this drug. They are experiencing side effects, but they and their Doctors are being denied access to information that could help them…because of confidentiality!
It seems that patient’s lives are not important.
The “independents” aren’t so independent
In the meantime the CTT Collaboration publishes meta-analyses advocating the more wide spread use of statins. They claim independence even though it was revealed in the British Medical Journal that they have received in excess of US$300M from the manufacturers of Cholesterol Lowering medications.
To learn more about this organization and how they influence the medical fraternity to prescribe more statins you can do your own research. There is a lot of information about them on the internet.
Minimising the side effects – by study design
Let me give you an example of how the side effects of a drug can be minimized in a clinical trial.
I will refer to a study called the Heart Protection Study. (HPS).
In this trial all participants took a statin drug for 6 weeks called the ‘run in period’. As a result, 36% of the participants were excluded from the trial before it even begun.
What does that tell you?
If someone was experiencing negative side effects they wouldn’t want to continue, would they?
This is very likely the reason why the results of that trial showed few side effects whereas many Doctor’s claim that 20 – 30% of their patients experience negative side effects.
In the next part of this series I will address how the statin drugs work and some other things about cholesterol that you should be aware of.