Public Testimonies at FDA-SSRI-Suicidality Hearings, Dec. 13, 2006

Only if one assumes that the FDA sees the drug industry as its client can some sense be made of December 13th meeting of the FDA’s Psychopharmacologic Drugs Advisory Committee in Silver Springs, Maryland.

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MEDIA ALERT: Drug Victim advocates and Expert Scientists and Physicians

Expert Scientists, Psychiatrists, a Primary Care Physician, a Leading Attorney, will shed light on FDA’s Review of selected data Re: Antidepressants and Adult Suicidality  One day prior to FDA’s  Advisory Committee Hearing, December 13.

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Science Refutes Claims of Drug Benefit: Antipsychotics Found Harmful_NEJM

"The drugs most commonly used to soothe agitation and aggression in people with Alzheimer’s disease are no more effective than placebos for most patients, and put them at risk of serious side effects, including confusion, sleepiness and Parkinson’s disease-like symptoms, researchers are reporting
today." Continue reading →

The FDA and Drug Safety: A Proposal for Sweeping Changes

A Special Article By Curt D. Furberg, MD, PhD; Arthur A. Levin, MPH; Peter A. Gross, MD; Robyn S. Shapiro, JD; Brian L. Strom, MD, MPH

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Hearing: Americans Denied Human Right to Say NO to Experimental Research Under FDA Rule

Tomorrow Hearing  FDA’s Emergency Research Rule–CNN News at 8:00 P.M will inform the public about how the FDA Rule impacts on American citizens who can be put at increased risk to test an experimental treatment without their knowledge or consent.

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FDA Suspends ADHD Drug Safety Study-Approves Risperdal for Autistic Children Without Public Hearing

Two actions by the FDA last week demonstrate where the agency’s priority lies—and that priority is NOT to protect public safety, NOT to protect children’s safety. FDA’s priority—as demonstrated by its actions—is approval of new drugs or approval for expanded even dubious uses of patented drugs.

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IOM Report Faults FDA Drug-Safety Process

A report by the Institute of Medicine is sharply critical of FDA’s drug safety monitoring system: "The report’s conclusions are striking and often damning – particularly when discussing the agency’s Center for Drug Evaluation and Research, known as C.D.E.R." 

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Antidepressants and Violence: Problems at the Interface of Medicine and Law_PLoS

Evidence of an association between violence and widely prescribed antidepressant drugs is the focus of this Infomail. Continue reading →