Some Salt with Your Statin, Professor?

Malcolm Macleod

doi:10.1371/journal.pbio.1001768

Abstract

We know that clinical trials sponsored by the pharmaceutical industry are likely to exaggerate benefit and minimise harms. But do these biases extend to their sponsorship of non-human animal research? Using systematic review and meta-analysis Bero and colleagues show that, in the case of statins, things are a little more complicated. While the conclusions of industry-sponsored studies were indeed more enthusiastic than warranted by their data, the data themselves painted a picture more conservative than was seen in non-industry-sponsored studies. This behaviour is consistent with maximising the return on investment, seeking robust data before embarking on a clinical trial, and, once that investment has been made, making every effort to "prove" that the drug is safe and effective if this is at all credible. The findings suggest that there is something different about industry-sponsored non-human animal research, perhaps reflecting higher standards than is the case elsewhere. Perhaps the academic community can learn something from our colleagues in the commercial sector.

Highlights

We know that clinical trials sponsored by the pharmaceutical industry are likely to exaggerate benefit and minimise harms
There are many examples where industry has been shown to seek to subvert rational interpretation of trial data to influence guideline development and prescribing behaviour [2,3,4]. These examples lead to the reasonable conclusion that findings from trials sponsored by the pharmaceutical industry need to taken with more salt than is probably good for you
Since clinical trials sponsored by the pharmaceutical industry seem to be at greater risk of bias than others, a lazy assumption might be that their non-human animal research is confounded, as they seek to rush compounds to market to maximise profitability

Summary

Introduction

We know that clinical trials sponsored by the pharmaceutical industry are likely to exaggerate benefit and minimise harms. In the same way that it would be difficult to conduct a randomised controlled trial of the effect of living in Scotland on your chance of having a stroke, it is difficult to do an experiment to test whether the funding source for a study influences the outcome.

Results

Conclusion