The Damaging Impact of PDUFA and Why It Should be Repealed

The re-prioritization of rapid approvals occurred at the expense of drug safety standards, Continue reading →

Role of Litigation in Defining Drug Risks_JAMA / BMJ

Documents uncovered during the course of litigation shed light on real risks of drug-induced harm that would not otherwise be known. Continue reading →

NEJM Vioxx Safety Correction / Consumers International Accuses Industry–Unscrupulous Marketing

Once again, the New England Journal of Medicine (July 13, 2006) has had to eat crow after it published false and misleading clinical trial findings.
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FDA Psychopharm Advisory Chair Acknowledges No Evidence for SSRI Chemical Imbalance Claims_CMAJ

"Biological psychiatrists have looked very closely for a serotonin imbalance or dysfunction in patients with depression or obsessive compulsive disorder and, to date, it has been elusive," says Dr. Wayne Goodman, Chair of the US Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee.


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