What happened next provides a glimpse into the sometimes contentious world of medical testing and the federal rules that allow device makers to market new products with little or no data about their long-term effectiveness or safety.Good for Dr. Fourney.
Unlike prescription drugs, many medical devices are cleared for sale by the Food and Drug Administration without extensive studies in patients. In recent years, some of those devices, which seemed effective at first, have gone on to fail catastrophically.
Last year, when Dr. Fourney told the device maker, Vertos Medical, that his report would describe the problems that patients experienced after the six-month trial, the company filed a complaint with the University of Saskatchewan, where he is a professor. In that complaint, Vertos accused Dr. Fourney of scientific misconduct and violating “research ethics” by failing, among other things, to follow the study’s original protocol and by independently deciding to follow his patients for added time without seeking agreement from Vertos.
Read the whole thing: A Clash Over Vertos Medical’s Promising Procedure.
Given that humans have a 80+ year lifespan, the testing they do on humans for prescription drugs isn't long term, either, until it's released to the general public.
Don't be a guinea pig. If you participate in these experiments, you should be an informed participant.