Medtronic and Yale open data project

19th June 2013

US company Medtronic has just heard the results from its groundbreaking project on clinical trial transparency. Two years ago Medtronic gave all the clinical trial data it has for one of its back surgery products to researchers at Yale University. The Yale experts commissioned two groups of researchers at Oregon Health & Science University in the US and the University of York in the UK to conduct separate systematic analyses of the data. The groups have just reported the results which show that Medtronic’s product is no more effective than the older technique it was meant to replace and it increased the occurrence of some side effects.

Harlan Krumholz, the director of the Yale Centre for Outcome Research and Evaluation, devised the Yale Open Data Access Project, or Yoda. He describes Medtronic in this Forbes story as “declaring a whole different day where they are not hiding anything on this drug when every other company is hiding their data.”

CEO of Medtronic Omar Ishrak explains the decision to release all the data to researchers at Yale and to allow the Yale group to make the data available to any other researchers who want to analyse it, in a YouTube video. He said: “We recognize that our products and therapies must have the public and medical community’s trust.”

Ben Goldacre, co-founder of AllTrials said: “This is a fantastic and inspiring story. Medtronic and GSK are showing clear leadership, moving forward by example, and making clear that the simple ask of AllTrials is eminently achievable. There is an inevitable policy trajectory towards greater transparency. CEOs of companies who have not moved towards transparency are inflicting enormous and unnecessary reputational harm on their companies, by pretending they can wish this away. We need industry to do the right thing, show clear leadership, and regain the reputation they deserve, as the industry that makes lifesaving products. They can start by signing up to AllTrials, drawing a line, and moving forwards.”

Carl Heneghan, Director, Centre for Evidence-based Medicine and co-founder of AllTrials said: “Only a few years ago, it would have been inconceivable that a company’s CEO would find it helpful to provide data to an independent group of scientists, who would go on to find their intervention doesn’t work. Yet, this is the situation we now find ourselves in: with Medtronic’s move to provide access to their trial data on Infuse. Medtronic and GSK are trying to restore confidence in the current system, which has received substantial setbacks due to the withholding of data. This is to be welcomed: restoring trust by access to data for independent review means effective treatments can be made available for patients quicker, and as in this case, ineffective treatments removed before they cause harms. In the interest of patients, the time is right for manufacturers to follow Medtronic’s lead, and sign up to AllTrials.”

More on this story from Yale University, in Forbes magazine, at the Wall Street Journal.