The FDA has been pursuing the Critical Path Initiatve and developing a scientific foundation for personalized medicine with little money and lots of effort for nearly three years...as today's FDA Week notes:
"Deputy Commissioner for Operations Janet Woodcock said Monday FDA should not concern itself with determining which drug works better for a greater portion of the population. Instead, FDA needs to facilitate development of biomarkers that can tell physicians who will respond best to which drug. '
So you would think that the pols would pay attention to growing scientific evidence and support this trend and the Critical Path withh funding to promote the public health instead of underpowered one size fits all comparative effectiveness trials pushed by Tom Cruise Health Policy Scholar Marcia Angell
No such luck.
According to FDA Week...
"Rachel Sher, Waxman's health counsel, said Waxman believes federal funding should be allotted for comparative effectiveness studies, keeping in mind any studies by industry would be biased. "
Right and ALLHAT and CATIE were models of objectivity and have told us so much. Five years and $100s of millions of dollars later. Say goodbye to all new medicines.
Henry Waxman and Tom Cruise...perfect together.
"Deputy Commissioner for Operations Janet Woodcock said Monday FDA should not concern itself with determining which drug works better for a greater portion of the population. Instead, FDA needs to facilitate development of biomarkers that can tell physicians who will respond best to which drug. '
So you would think that the pols would pay attention to growing scientific evidence and support this trend and the Critical Path withh funding to promote the public health instead of underpowered one size fits all comparative effectiveness trials pushed by Tom Cruise Health Policy Scholar Marcia Angell
No such luck.
According to FDA Week...
"Rachel Sher, Waxman's health counsel, said Waxman believes federal funding should be allotted for comparative effectiveness studies, keeping in mind any studies by industry would be biased. "
Right and ALLHAT and CATIE were models of objectivity and have told us so much. Five years and $100s of millions of dollars later. Say goodbye to all new medicines.
Henry Waxman and Tom Cruise...perfect together.
