A sign that the FDA may be changing philosophy:
The goal was once to continuously expand the pharmacopeia of available drugs, as long as each drug was safe. But, apparently, not anymore. In voting 20-1 to reject Arcoxia, FDA’s advisers said that for certain ailments, we have enough medicines. This will ultimately deny patients needed choices and it reflects a dangerous way of looking at drug development, safety, and, more importantly, the practice of medicine. Science is leading us toward matching specific drugs to specific patients, a therapeutic process that requires more drug variety, not less. The FDA may now be moving in the opposite direction.
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Kevin:
Do you know that this drug is safe? Do you know what they compared it to? Do you know how weak that data set they brought to the table was? Do you think comparing a drug in a class known for increased cardio risk with a drug with increased cardio risk would make an analytically persuasive case for safety (rather than naproxen: equally as effective; 3x less cardio risk)?
Did you see who was actually on that panel, and did you happen to know that there were are large number of physicians who espouse the very same views on having options for their patients? Do you know who Scott Gottlieb is? Do you care about intellectual honesty as much as the good Mr. Gottlieb?
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