Gerrit Niezen

I watched the documentary The Bleeding Edge last night, and I cannot stop thinking about it. It deals with the regulation of medical devices in the USA, and how the FDA is failing in some instances because of big pharma. It sounds like it may have a bit of a conspiracy theory vibe, but a lot of the people they speak to used to work for the FDA themselves. I do believe the FDA is a force for good and that it has a lot of people there doing good work, but I can't stop the nagging feeling that something is not right with the whole system. Not that I think the European system is any better. But it does make me wonder if there is a better, more decentralised way of ensuring that medical devices are safe and effective.