April 08, 2008
CDER's Woodcock says Vytorin criticism overblown
The press and the scientific community are “piling on” Vytorin unfairly, CDER director Janet Woodcock told the news site FDA Webview in an interview.
“I don't know to what extent we should wade into these scientific melees,” said Woodcock. “I believe people are piling on right now on one side of the argument. Independent reporters and media, if they really want to have some reasoned approach, ought to step back from that. But what we see right now is everybody just piling on to the same message.”
Woodcock compared Vytorin critics who have raised questions about the value of LDL lowering to scientists who deviate from the conventional wisdom on global warming. “You can always find some scientist who'd say, ‘Well, it isn't exactly like that,' But they didn't mean that the client wasn't getting warmer – they just had some little nit-pick with the current model,” Woodcock said, adding that “anyone who questions the lowering of LDL cholesterol overall is probably, like Bob Temple said, trying to kill the population.”
Temple, director of the FDA's Office of Medical Policy, and FDA Office of New Drugs Director John Jenkins had previously given interviews to the site downplaying the results of the Enhance trial due to its small size and reiterating the importance of LDL lowering.
Woodcock added: “What happens with these is that there is some little point that the scientists are arguing about, and then the media get on it, and they start throwing the baby out with the bathwater.”
Said Bernstein's Tim Anderson in an analyst note: “All of this is important because what FDA ends up doing with Enhance (we think not much) will have influence over what payers do with Vytorin, and related product Zetia, which in turn will have an impact on what physicians/patients do with the products.”
FDA Webview is published by James Dickinson, a regular contributor to MM&M.