Here’s how the Wall Street Journal story, “FDA Procedures Draw Scrutiny†begins, “Controversies about cholesterol drug Vytorin and diabetes drug Avandia are reigniting debate over what evidence the Food and Drug Administration requires to approve drugs -- and may generate pressure on the agency to raise its bar.â€
This is just the latest iteration of politicians and media jumping on the “FDA as tool of industry†bandwagon. And it’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 there’s the bit about proxy markers.
Here’s what the Journal story has to say about that:
“ … 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 doesn’t guarantee 100% accuracy! Shocking, just shocking. Here’s the bad news folks – 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 “do nothing until we know everything.†Markers aren't magic, nor are they a "perfect" solution. Risk/benefit analysis is an inexact science and safety is a relative concept.
Here’s a link to the complete WSJ story:
http://online.wsj.com/article/SB120122452254515507.html
The best way to help the FDA to “raise the bar†is to accelerate 21st century regulatory science. And that means funding the Reagan/Udall Center. Everything else is just rhetoric.
This is just the latest iteration of politicians and media jumping on the “FDA as tool of industry†bandwagon. And it’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 there’s the bit about proxy markers.
Here’s what the Journal story has to say about that:
“ … 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 doesn’t guarantee 100% accuracy! Shocking, just shocking. Here’s the bad news folks – 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 “do nothing until we know everything.†Markers aren't magic, nor are they a "perfect" solution. Risk/benefit analysis is an inexact science and safety is a relative concept.
Here’s a link to the complete WSJ story:
http://online.wsj.com/article/SB120122452254515507.html
The best way to help the FDA to “raise the bar†is to accelerate 21st century regulatory science. And that means funding the Reagan/Udall Center. Everything else is just rhetoric.
