This is just the latest iteration of politicians and media jumping on the â€œFDA as tool of industryâ€ bandwagon. And itâ€™s neither true nor accurate. It seems odd that one day the media is writing, pundits and pronouncing and politicians are orating about a parched pipeline and over-zealous regulators while in the next breath about the need for the agency to "raise the bar." Consistency? We don't need no stinking consistency.
And then thereâ€™s the bit about proxy markers.
Hereâ€™s what the Journal story has to say about that:
â€œ â€¦ proxy markers can be misleading. Sometimes a drug works on a proxy but doesn't deliver the promised benefit for the primary health problem. Or a drug can have side effects that don't surface during initial proxy-marker studies but end up outweighing its benefit.â€
What? You mean using markers doesnâ€™t guarantee 100% accuracy! Shocking, just shocking. Hereâ€™s the bad news folks â€“ there is no perfect predictor of either risk or benefit. And if we allow ourselves to poo-poo the significant advances that biomarkers deliver than we are heading down the slippery slope of the Precautionary Principle that warns us to â€œdo nothing until we know everything.â€ Markers aren't magic, nor are they a "perfect" solution. Risk/benefit analysis is an inexact science and safety is a relative concept.
Hereâ€™s a link to the complete WSJ story:
The best way to help the FDA to â€œraise the barâ€ is to accelerate 21st century regulatory science. And that means funding the Reagan/Udall Center. Everything else is just rhetoric.