Monthly Archives: November 2016

RCT’s and 2005

Reading the book ‘Fat and Cholesterol don’t cause heart attacks’ found here

It becomes clear that 2005 is a pretty important date in the debate about heart disease and in particular Statins. Most doctors will swear that Statins are beneficial in primary and secondary care (meaning you have not had a heart attack and you have had a heart attack). Of the remaining doctors most will swear that they are beneficial in secondary care. Even Doctor Kendrick has raised his hand to this question. A few will be brave enough to doubt that they are of use to anybody. This latter small group may well be correct when we look at the data from a different viewpoint.

In 2005 the regulations regarding randomised control trials, that’s the kind of trials that doctors like to label as ‘gold standard’ and the kind of trials they bring up when trashing epidemiological studies (studying populations without controls in place). It seems that there was plenty to get worried about pre 2005 when it came to the quality of RCT’s, and there’s me thinking that all RCT’s run by big pharma were clean and above board :). The FDA decided that the way trials were run needed tightening up, I cannot quite remember which medical disaster took place that forced their hand but it must have been compelling to get the FDA to squeeze Pharma. The net result is that when you are told that Statins are good for secondary prevention it is invariably based on meta analysis done on numerous studies both pre and post 2005. In some cases its just pre 2005. If on the other hand you focus on just post 2005 when RCT’s presumably became more reliable the benefits of Statins disappear for secondary prevention. The section in the book on this also highlights some of the dodgy practices that go on with trials and big pharma. For example they usually run numerous identical trials in different locations so that they can bin the ones that do not turn out as they would like and simply quote the one that does. This has been tightened up post 2005. There has even been an example where a trial going well for Pharma was pulled early which is quite puzzling, only to find on deeper examination that the incidence of diabetes amongst Statin users was becoming a thorn in the side of Pharma at the time and they probably pulled the study while the results looked OK for the reason that to take it to completion would have meant running the risk of uncovering type II diabetes rates increasing amongst the users of Statins in the trial.

I can strongly recommend the book, its a little more technical in parts than your average book on Cholesterol but do not let that put you off. There are plenty of excellent readable chapters.