"Roche navigated through an important inflection point in the drug safety tempest last week, charting a course that other sponsors might use to overcome concerns that arise when drugs are a s s o c i a t e d with very rare, serious adverse effects.
The company deployed observational data to persuade FDAâ€™s Pediatric Advisory
Committee to recommend that the agency tone down c a u t i o n s about Tamiflu
oseltamivir, an antiviral drug that has been associated with troubling neuropsychiatric events. The Tamiflu story provided an opportunity to test the hypothesis that even in an era when FDA and its advisory committees are loathe to take risks, good data can reverse the slide into the precautionary abyss. It also concretely demonstrated how
difficult it can be to determine causality when apparent drug safety issues emerge."
The data showed that the link between psychiatric problems was linked with the flu and not the drug by following groups that had the flu alone as well as careful tracking of each of the handful of cases among the millions of Tamiflu users world wide."
As Usdin reports:
"During the discussion, committee chair Rappley argued ROG should not be punished
for responding to the advisory committeeâ€™s request for additional information
on Tamifluâ€™s safety. And several committee members said they were pleased by ROGâ€™s response. â€œThis is a case where the system worked. We asked for more information a couple of years ago and a year ago. I feel quite a bit more informed and reassured,â€ Newman said. â€œI am reassured by most of what I saw today. I think the system
worked,â€ Daum said."
Chalk one up for commonsense and science.