How Open Data Can Save Money - and Lives - Open Enterprise 2012-11-21


"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 ... More specifically, the BMJ would like to see data about Roche's Tamiflu:  The BMJ is also intensifying its efforts to help resolve a three year battle to gain access to the full data on oseltamivir (Tamiflu). In 2009 the Cochrane respiratory group, led by Tom Jefferson, was commissioned by the UK government to update its systematic review of neuraminidase inhibitors. Despite a public promise to release 'full study reports' (internal company reports) for each trial, each of which can run to thousands of pages, Roche has stonewalled, variously pleading patient or commercial confidentiality, or claiming that sufficient data have already been provided.  In fact the Cochrane group has told the BMJ that about 60% of Roche’s data from phase III trials of oseltamivir have never been published. And although the European Medicines Agency (EMA) could have requested these data from Roche, it did not do so. This means that tax payers in the United Kingdom and around the world have spent billions of dollars stockpiling a drug for which no one except the manufacturer has seen the complete evidence base ..."


From feeds:

Open Access Tracking Project (OATP) »


oa.medicine oa.comment oa.advocacy oa.europe oa.lay oa.biomedicine oa.clinical_trials oa.ema oa.bmj oa.pharma

Date tagged:

11/21/2012, 13:55

Date published:

11/21/2012, 08:55