If statins are so safe, why won’t some researchers let us see their data?

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A couple of weeks ago one of my blog posts focused on a news story regarding the safety of statins. We were informed that ‘new evidence’  had found, except in rare circumstances, statins are no more hazardous than placebos. Yet, when one pays to get access to the actual paper on which these ‘conclusions’ were based (as I did), one realises that the authors of this paper list 6 separate reasons why statin safety data is not to be relied upon. In particular, there are several reasons why the true risk of side effects may be higher than the (inadequate) data would suggest. In this context, what compelled the lead author of the study to issue such strenuous reassurances about the safety of statins remains a mystery to me.

I got a feeling of déjà vu this week, on reading this story. Professor Rory Collins tells us that concerns about the potential hazards of statins is misguided and is putting lives at risk. The underlying message seems to be that people should just shut up, take their statins, and be grateful for this wonder drug.

The research group to which Professor Collins belongs (the Cholesterol Treatment Trialists or ‘CTT’) is tasked with conducting research on statin drugs. Mainly, it pools together the results of industry-funded statin studies, and then occasionally makes pronouncements on this class of drugs. I don’t think I would be mischaracterising the CTT to say that it is a staunchly pro-statin body (or lobby group).

However, if you wanted to see for yourself the data on which the CTT researchers base their edicts, you’d be sorely disappointed. That’s because despite repeatedly being asked for it, the CTT researchers have steadfastly refused to cough it up. Why this should be is anyone’s guess, but the CTT researchers’ stance appears to be that we’ll just have to trust them.

This strategy may have worked like a charm 20 years ago, when people really had no choice but to take what ‘key opinion leaders’ said at face value. These days, though, things are a bit different. The advent of the internet means that almost anyone can find reports of statin side effects as well as information on why the evidence base in this area is incomplete and/or hidden. I think a couple of decades back, the general reaction to Professor Collins’ comments would likely have been ‘well, he must know what he’s talking about – he is a professor, after all.’ While some may have this reaction today, my suspicion is that these will be outnumbered by people who think that Professor Collins dost protest too much.

Of course, it might be that Professor Collins truly believes what he says. He may, for instance, be utterly unaware of the reasons why the evidence base may not accurately reflect what goes on in the real world. Here are just four such reasons:

1. the evidence is taken from short studies or studies that have been terminated early (things that tend to lead give a falsely low impression of risks and also an exaggerated impression of benefits)

2. the screening out those susceptible to side effects before the study begins

3. the logging of side effects only if there’s been an extreme deviation from normal biochemistry (some studies only log side effects once biochemical markers are several times the upper limit of normal)

4. not looking for and logging  side effects in the first place

For someone who is an expert in statins and research, though, ignorance of the issues is unlikely here (though not utterly implausible). Given his position, I’d say if Professor Collins is ignorant of the issues, then he is failing in his duty to keep abreast of the area, in order that he can give balanced and impartial advice about statins.

Assuming, for a moment, that Professor Collins actually understands the deficiencies of the evidence base, what logical conclusions might drawn?

Some may get the distinct impression that Professor Collins is hopelessly biased. Perhaps he has some reason for bigging up statins at every opportunity, while downplaying the risks. Certainly, Professor Collins has conflicts of interest. Here you will see that he has been “engaged in research activities for Merck, Bristol-Myers Squibb, Sanofi, and AstraZeneca.” This does not mean his judgement is ‘clouded’, but it’s reasonable to wonder if it might have been.

And what of the claim that concerns about the side-effects of statins are putting lives as risk? The recent furore around statins appears to have been sparked by a proposed move here in the UK for doctors to consider people as candidates for statins if their risk of developing cardiovascular disease over the next decade is 10 per cent of more (as opposed to the current cut-off of 20 per cent for more over the next decade). However, we already know that in people without a history of cardiovascular disease, statins do not save lives. Extendingtreatment to those at even lower risk will not save lives either. If these people come to conclude that the risks of statins outweigh the benefit for them as an individual, they are simply not risking their lives at all.

If I had a personal message for Professor Rory Collins it would be perhaps to point out that the world has moved on since the CTT group was set up, and that the public has grown increasingly well informed and sophisticated. No longer can ‘experts’ make pronouncements without fear of being questioned or challenged.

Most importantly, though, not giving people the full facts does not allow them to make informed decisions, and actually can risk the health and wellbeing large swathes of the population. The CTT’s refusal to give up their data so that it can be independently analysed simply cannot be in the interests of patients, and may lead to some putting their health needlessly at risk of one or more of the recognised adverse effects of statins including fatigue, pain, liver damage, kidney damage and mental symptoms.

Maybe Professor Collins is unaware of the potential damage his comments may do in this respect. If so, he should at least be aware of the damage he may be doing to his own reputation by statements which, some might say, appear institutionally biased and are demonstrably misleading.

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