The FDA stands on two firm legs -- safety and efficacy. Now there's a hue and cry (from people who should know better) that the agency should embrace comparative effectiveness as a third measure. Wrong.
Do doctors need more and better information on how to get the right dose of the right drug to the right patient at the right time. Yes! But denying FDA approval to one drug because, in a large randomized controlled clinical trial, it may not be "as effective" as another is not only meaningless -- it's counterproductive. How can care be improved if physicians are denied access to new drugs that work? Hm.
What we DO need are more and better molecular diagnostics and more adaptive clinical trials to show what drugs work best in specific subpopulations. That's not comparative effectiveness, it's clinical effectiveness. And it's crucial to the advancement of 21st century medicine.
Here's the NPR story on the NEJM articles:
http://www.npr.org/templates/story/story.php?storyId=124516838
Watch for the issue of an FDA "third leg" to come up during the upcoming debate over PDUFA reauthorization. Watch "comparative" effectiveness morph into "cost" effectiveness. And remember -- what we need to discuss is "clinical" effectiveness.
Do doctors need more and better information on how to get the right dose of the right drug to the right patient at the right time. Yes! But denying FDA approval to one drug because, in a large randomized controlled clinical trial, it may not be "as effective" as another is not only meaningless -- it's counterproductive. How can care be improved if physicians are denied access to new drugs that work? Hm.
What we DO need are more and better molecular diagnostics and more adaptive clinical trials to show what drugs work best in specific subpopulations. That's not comparative effectiveness, it's clinical effectiveness. And it's crucial to the advancement of 21st century medicine.
Here's the NPR story on the NEJM articles:
http://www.npr.org/templates/story/story.php?storyId=124516838
Watch for the issue of an FDA "third leg" to come up during the upcoming debate over PDUFA reauthorization. Watch "comparative" effectiveness morph into "cost" effectiveness. And remember -- what we need to discuss is "clinical" effectiveness.
