No More Secrets: Medtronic Shows How Open Science Might Work In The Real World - Forbes

Monday night, two groups of researchers released independent reviews of a back surgery device made by Medtronic, the $16 billion (sales) medical device giant. They found the product, Infuse, was no more effective than the older technique it was meant to replace and it carried added risks.  Medtronic had commissioned the analyses itself. And their release is a landmark moment not just because of what they mean for a single product but because Medtronic gave outside researchers unprecedented access to its internal data, launching a new experiment in corporate transparency. If open science is to take flight in the traditionally secretive worlds of drug and medical device manufacturing, it may well look something like this, with small but independent groups being given access to deep dives into data.  Calls for drug and medical device makers to share their data often stop far short of what Medtronic did here. The AllTrials.net effort being publicized by Ben Goldacre, the British author and medical researcher, only asks companies to share final data from their clinical trials. They often don’t even do that. The European Medicines Agency is discussing releasing more data for drugs it approves. But Medtronic, working with a group at Yale University, gave researchers the data for each individual patient, with identifying information removed, and gave up any control of the results. And Medtronic will allow Yale to give this same raw data to any group of researchers who have a legitimate reason to want it.  Harlan Krumholz, director of the Yale Center For Outcome Research & Evalution, who spearheaded the effort, says the project speaks toMedtronic’s values and very identity of the company.  'This is declaring a whole different day where they are not hiding anything on this drug when every other company is hiding their data,' says Krumholz, a frequent Forbes contributor.  In a YouTube video, Medtronic Chief Executive Omar Ishrak said: 'We recognize that our products and therapies must have the public and medical community’s trust.' That statement is all the more impressive given that the results of the reviews are anything but favorable to Infuse, or to Medtronic. The company did badly when it came to studying this product and getting accurate results to doctors and patients ..."