WHAT WE CAN LEARN FROM A RETROSPECTIVE REVIEW OF STATIN USE
The safety and efficacy of statins have been predicted from the results of clinical trials most of which were carried out between ten and twenty years ago. Being specifically organised by or on behalf of the pharmaceutical companies who produce statins they have been shown by many independent medical scientists to be unreliable, in addition to which, they reflect the evidence of safety and efficiency as measured over a historic period of time. If the general parameters of the population change over a period of time, the old trials have no opportunity to reflect the impact which those changes may have on their outdated predictions.
The most important limitation of clinical trials is their inability to detect long term effects which occur over many years of use over a period much longer than the trials on the basis of which they are approved by the regulatory authorities. All of these deficiencies can be overcome by a retrospective comparison of the health and longevity of statin users as compared with non-users who had the same characteristics as a matched statin user had, at the point when the statin user began taking the drugs. Below is a list of benefits and harms which have actually occurred, rather than been predicted, over a lengthy period of time in the real world.
Actual number of cardiovascular deaths and major vascular events which have occurred in statin users who have been taking statins for at least ten years as compared with number of events which have occurred in matched individuals who have not taken statins.
Actual number of deaths from all causes for both statin users and non-users.
Number of statin takers who have stopped taking statins at some point and the percentage of statin takers who have abandoned statins each year.
Number of statin users who have stopped taking the drugs and have subsequently resumed statin treatment.
Number frequency and severity of other illness which have been suffered by statin users and non-statin users to see if there is any positive or negative effect of statins in relation to any such ilnesses.
Frequency, number and severity of recognised and unrecognised side effects of statin usersas compared with non-statin users.
In addition to the above findings the statistical analysis of data may reveal benefits or harms which have not been anticipated. As stated in The Statin Controversy booklet, “in a matter of months we would learn more about the effects of statins on the public than the clinical trials comprising the Lancet statin trial have provided in the previous 15 years of trials and 20 years of analysis.”