Drug Industry: Open Data and Clinical Trials

Yesterday I was writing about open access and open data in the context of the EU's Horizon 2020 initiative. Closer to home, I came across a wonderful real-life example of how open data can almost certainly save not just money, but lives.

The data in question concerns clinical trials. These are the indispensable tests that are carried out on drugs before they are approved and dispensed. Obviously, that data has to be as good as it can be, otherwise useless or even dangerous pharmaceutical products may be approved. And as anyone who has read Ben Goldacre's new book "Bad Pharma" well knows, that's precisely what has happened multiple times in the past. Which means that many thousands of people have suffered and probably died as a result.

This has occurred because the clinical data obtained by drug companies in the course of testing is not made fully available for others to inspect and check. Sadly, this is not simply a problem of the bad old days. As a recent editorial from the BMJ (British Medical Journal) makes clear, there are still issues today:

The drug industry does many good things. It produces medicines that can improve health and save lives. It creates jobs and stimulates economic growth. Sadly it does bad things too. Persistently and systematically over decades it has withheld and misreported data from clinical trials. As a result, a whole range of widely used drugs across all fields of medicine have been represented as safer and more effective than they are, endangering people’s lives and wasting public money...