
as the Obama administration already cowered to the demands of Big Pharma?
Forbes Magazine reports “How one company turned a rejection into a thumbs up, and what it could mean for the drug industry as a whole.”
The unexpected approval of iloperidone (Fanapt) a “me too” dangerous antipsychotic drug, that the agency itself had deemed “NOT APPROVABLE” in July 2008, raises serious questions about the Obama administration talk about applying comparative efficacy research (CER) standards to medical
treatments–in order to improve care and rein in expenditure for worthless, ineffective treatments.
See Douglas Bremner MD blog, Before You Take That Pill,
Vested Interests Move Against Putting Logic in Medical Decision Making:
orbes reports that even Jeffrey Lieberman, MD an influential schizophreniaFDA approved Vanda Pharmaceuticals’ bid to market iloperidone (Fanapt). researcher who, until the horrific findings of harm produced by the new antipsychotics, had been a prominent promoter of these drugs, said he was “amazed” that the
“The inference was that the FDA may be changing its policy and requiring superiority or distinctiveness for new drugs coming to a market that is already crowded. But the Fanapt approval would suggest the agency is still doing business as usual.”
The decision, Forbes notes, sends the signal that industry can look forward to dealing with “an easier FDA.
Vera Hassner Sharav
ALLIANCE FOR HUMAN RESEARCH PROTECTION
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