By now you have probably heard the terrible story out out of the United Kingdom regarding six human volunteers in a Phase I study who became seriously ill almost immediately after taking a study medication. An analysis of the situation is covered very thoughtfully in Derek Lowe’s excellent blog In the Pipeline.
If you haven’t heard, the story is roughly this. Study subjects took their first dose of the investigational compound being researched for the treatment of leukemia and had severe adverse reactions, leaving two in such serious condition that there is a degree of concern that they may not survive.
I feel terribly for these volunteers.
However, the FDA must be breathing a huge sigh of relief that this incident didn’t happen in the United States. With so many on Capitol Hill with a political ax to grind when it comes to the FDA, had this sorry episode occurred here, the agency would be facing an even blacker eye than it had over the flu vaccine fiasco and the COX-2 situation combined. I’m surprised that Senator Grassley hasn’t announced an investigation of the British medical authorities.
That said, there is no doubt that this incident will still have an impact here. First, it may chill the willingness of study subjects to participate in clinical trials. That may mean that companies conducting clinical trials need to put less resources into advertising and more into public relations efforts aimed at recruiting.
But secondly, and perhaps far more important, it stands to further throw risk/benefit assessment skills out of whack. Post COX-2′s we have been experiencing an environment where the focus is much more on risk than on benefit. That may be well and good – we all want to be protected. However, when the emphasis goes too far on the risk side, we may enter an environment that chills the development of new innovations, and in that sense, we would all suffer harm.