All of us in the industry have heard the mantra many times: pharmaceuticals are not widgets. Now we have a tragic reminder of how true this is. Recently five healthy volunteers in France were injured after participating in a Phase I trial testing a new painkilling compound. Apparently, all five are facing permanent brain damage.
It is a tragic reminder of that testing new drugs is not without risk. As eloquently put by Dr. Ben Whalley, a neuropharmacology professor at the University of Reading in the U.K., while standardized regulations for clinical trials are “largely the same” across Europe “like any safeguard, these minimize risk rather than abolish it. There is an inherent risk in exposing people to any new compound.”
For those of us in the industry, we need to take this to heart and remember that we have the highest moral and ethical duty to those individuals willing to help us bring new products to market. We need to do everything we can to minimize those risks. People’s lives are at stake.