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Friday, December 14, 2007

FDA Science

Does Dendreons cancer drug Provenge really work? After hundreds of millions of dollars spent on research and careful analysis from the MDs and PhDs of the medical science community, it's now up to the United States Congress to analyze the analyzers.

"two members of the FDA's advisory committee who opposed the drug's approval -- Howard Scher of the Memorial Sloan-Kettering Cancer Center and Maha Hussain of the University of Michigan -- had conflicts of interest.
"There is reason to believe that serious ethics rules were violated by two FDA advisory panel members in their decision, and that these violations played a role in the subsequent FDA decision to not approve Provenge at this time," said the letter, signed by Reps. Mike Michaud, D-Maine; Dan Burton, R-Ind.; and Tim Ryan, D-Ohio.
The congressmen said Scher was a lead investigator for a competing cancer drug..."

1 comment:

Aubrey Blumsohn said...

Good to see you back.

Yes the question is

- does it work?
- is there actual evidence that it works better than the harm it (might cause in the average recipient (or in recipients selected on the basis of some criterion)?

It may work, but there seems not much strong evince of that so far. That said, the FDA regularly approves drugs that don't work or where the evidence of long-term benefit is completely lacking (SSRI's or antipsychotic agents as prime examples).