FDA Approves Another Dangerous Antipsychotic, Asenapine
At the July 30, 2009 FDA advisory committee hearing, the only formal presentations at the meeting were a summary of the safety and efficacy data by the sponsor.
At the July 30, 2009 FDA advisory committee hearing, the only formal presentations at the meeting were a summary of the safety and efficacy data by the sponsor.
But FDA says keep taking the "medicines."
The FDA’s expanded marketing approval process for antipsychotics, highly toxic drugs, is unaffected by evidence uncovered by the US Justice Department showing that the studies submitted by drug manufacturers were often flawed, if not fraudulent.
"The story’s pretty clear, and pretty embarrassing for the profession of psychiatry, which has allowed itself to be led by marketing," says Dr. Robert Rosenheck, Yale.
This is a result of public awareness–thanks to information uncovered during litigation, by Sen. Charles Grassley’s investigative team, by whistleblowers, and the press!
Evidence of harm has been linked to various vaccines challenging prevailing public recommendations.
AHRP proposes a multi-disciplinary team of independent scientists to review ALL of Dr. Joseph Biederman’s publications and supporting documents, including: research protocols, consent forms, and the original (of course, anonymized) data sets with associated code books for all pediatric studies.
The FDA expanded approval process for toxic drugs is unaffected by evidence uncovered by the US Justice Department showing the studies to be flawed, if not fraudulent.
FDA officials who continue to run its powerful center for drug evaluation (CDER) have once again shown bad faith by appointing financially compromised doctors to the Psychopharmacologic Drugs Advisory Committee (PDAC) advisory panel.
Why is FDA Silent? Seroquel Victim Asked Judge to Unseal Documents for FDA Advisory
"The committee’s concerns are part of a growing chorus of complaints about the increasing use of antipsychotic medicines in children and teenagers.