Consistent overdosing of seven children in a clinical study conducted by Pfizer was described in a warning letter posted on the FDA's website. According to an article in Reuters, the drug in question was Geodon, a powerful second generation atypical used to treat schizophrenia and bipolar disorder. The market for children is being pursued actively by Pfizer, along with Astra Zeneca and Eli Lilly. The FDA tipped toward approval last spring. Previously the FDA accused Pfizer of misleading ads for Geodon.
Pfizer's poor management started with poor procedures for obtaining informed consent, a failure to titrate within study guidelines, and continuation of overdosing, in one case for as many as 22 days; side effects included weight gain, agitation, somnolence.
The letter comes one week after Pfizer released it's list of payments, amounting to $35 million for fees to doctors between July and December, 2009. An analysis of how the monies were divided, appears at John Mack's Pharma Marketing Blog.
