A crooked doctor who faked data in a GlaxoSmithKline (GSK) study of the antidepressant Paxil in children pled guilty to criminal charges today, causing groans among GSK’s senior management as the company hopes to fend off a different criminal investigation into whether it manipulated clinical data on its diabetes drug, Avandia. She was sentenced to 13 months in prison.
At least a dozen major drug and device makers are under investigation by federal prosecutors and securities regulators in a broadening bribery inquiry into whether the companies made illegal payments to doctors and health officials in foreign countries. In previous investigations, federal officials have charged that some companies made these kinds of payments to encourage doctors abroad to order or prescribe their products.
Sixteen months after 7-year-old Gabriel Myers committed suicide while taking psychotropic drugs, the state of Florida has banned allowing any children in the state’s custody from participating in clinical drug trials.
Some critics insist too many foster parents, lacking the skill or patience to work with troubled children who arrive as strangers, are still too quick to see medication as the way to curb problem behavior or just keep foster children quiet, no matter the side effects. But whatever the truth of that, the study group recommended some good changes, and one made sense immediately, I thought: Ban the use of foster kids in drug trials.
For the past three years, the Chantix smoking cessation pill has caused a stir after being associated with suicidal behavior and vivid dreams. Consequently, the government banned the Pfizer drug for pilots and licenses wouldn’t be issued to truck drivers taking the med. The FDA subsequently imposed a risk management program and Pfizer added warnings.