Dr. Margaret "Peggy" Hamburg, a former health commissioner in New York City, is the leading candidate to become FDA commissioner, the agency's top job, while Baltimore health chief Joshua Sharfstein is in line to become a deputy commissioner
“You’ve got an agency that quite frankly is either non-functional, or dysfunctional, or maybe all of the above. “Bet yourself a new hat or a fine dinner that you are going to have a scandal a month. They are running around like a lot of headless chickens.” said Rep. John Dingell.
Two prominent academic-psychiatrists–Jeffrey Bostic MD, director of school psychiatry, Harvard-Massachusetts General Hospital, and Charles Nemeroff MD, the former chairman of psychiatry at Emory–are featured in current government investigations.
"The corporate death penalty may be appropriate in cases involving recidivist violators, corporations that are deemed to be incapable of reform (i.e. inherently criminogenic)…"
The Washington Post suggests, the chance for success in overhauling US healthcare depends on President Obama's ability to keep the major–discordant–players on board.
U.S. Supreme Court has ruled against Wyeth (and by extension, the pharmaceutical industry) which claimed immunity from liability for its failure warn about adverse drug effects by invoking FDA preemption
Three years have elapsed since FDA medical officers reported the findings of their comprehensive review of clinical trial data at an FDA pediatric advisory committee hearing (March, 2006).
The unsealed documents reveal that AstraZeneca “buried” unfavorable studies that showed Seroquel posed a serious risk for diabetes.
Even a seemingly harmless topical ointment may pose unanticipated lethal risks which are undisclosed on the FDA-approved label.
A document filed in Federal District Court, Orlando Fla, by plaintiffs "in response to AstraZeneca’s motion to exclude evidence and argument about Dr. Macfadden’s personal relationships," sheds light on yet another facet of manipulation–sexual exploitation.
“Current users of typical and of atypical antipsychotic drugs had higher rates of sudden cardiac death than did nonusers of antipsychotic drugs.” NEJM 2009
Pharmaceutical companies willingly settle court cases for hundreds of millions of dollars–even billions of dollars–to keep the truth about their drugs under seal.
