Recently, most of the British media ran a story suggesting statins should be taken by millions of people in their 20s and 30s. The articles made statements such as:
Several of the reports made reference to a "new trial", running for 20 years and being the longest of its kind. In fact, the study they are referring to is WOSCOPS and this study was completed in 1995!
The WOSCOPS study included 6,595 men in the West of Scotland, with high cholesterol levels. During this five year study, 1.7% of people who were given the placebo died of heart disease, compared with 1.2% of those who were given the statin. And overall, the use of the statin increased the chances of still being alive after 5 years, from a 96% chance to a 97% chance.
An interesting feature of the WOSCOPS study is that around 80% of the people included were current smokers or ex-smokers. It is well known that smoking drastically increases the risk for heart disease. In fact, the heart disease death rate is 80% higher in heavy smokers than in non-smokers. We also know that smoking causes inflammation and this inflammation can take 5 years to return to normal levels after smoking has been stopped. Heart disease is an inflammatory condition and statins reduce inflammation. Therefore, the slight benefits that were achieved in the WOSCOPS trial back in 1995 could be due to the effect the statin had on inflammation, and it is possible that this had nothing to do with cholesterol at all.
Further evidence for any benefits found in the WOSCOPS study having nothing to do with cholesterol lowering can be seen in the fact that the people in the higher band of total cholesterol level benefited less than those in the lower band. This was also the case for LDL ‘cholesterol’.
The WOSCOPS Follow Up
In 2007, a follow-up study of WOSCOPS was published in the New England Journal of Medicine. For this, researchers undertook a 10 year follow up of the trial participants. There are a number of problems with this follow-up. After the original WOSCOPS trial had ended some of the people who were in the placebo group started taking a statin, and some of those who were in the statin group stopped taking the drug. The researchers did not take account of this in the WOSCOPS follow up study. This means that any results obtained 10 years on are meaningless. The original groups were now mixed with some taking a statin and others not taking one.
To make matters worse, the researchers did not know how many people were taking statins after 5 years – the follow up period was 10 years but they only had data on this aspect for the first 5 years.
Another point is related to the fact that more people got cancer in the group who were originally given the statin. The authors of the study dismissed this as a chance finding.
The data from the WOSCOPS follow up period actually shows that with increasing time, people who were in the original statin group had a higher incidence of cancer than those who were not given the drug.
An accompanying editorial to this study was also published in the New England Journal of Medicine at the time. The author stated that “there should no longer be any doubt that the reduction of LDL cholesterol levels has a role in the prevention and treatment of coronary heart disease”. The Times newspaper also featured this study in an article that took up the whole of the front page. The Times article suggested that “statins have benefits after dosage is stopped” and that statins should be used for even more people, “including younger people in whom heart disease has yet to get a start”.
The 'new study' more recently being reported is a follow-up of the follow-up and has further exaggerated all of the problems associated with the previous follow-up and original study. This kind of post hoc analysis is also unreliable because it is very easy to find data to support what you are looking for, retrospectively, long after the trial was done.
People should be aware that the motivation for this study was to deceive more people into becoming patients for profit and the media reports describing it are lazy and grossly inaccurate.
Shepherd, J et al. “Prevention of Coronary Heart Disease with Pravastatin in Men with Hypercholesterolemia” New England Journal of Medicine 1995; 333:1301-1308
Ford, I et al. “Long-Term Follow-Up of the West of Scotland Coronary Prevention Study” New England Journal of Medicine 2007; 357:1477-1486