By Jim Edwards
April 21, 2010
The FDA’s letter to Pfizer (PFE) describing overdoses of the antipsychotic Geodon given to 13 children in clinical trials is merely the latest in a long history of controversies that have dogged the drug at virtually every stage of its existence. Among those controversies: Discredited doctors allegedly prepared research on Geodon for the FDA; Pfizer allegedly promoted the drug for unapproved uses in kids; and the company allegedly paid a non-profit mental health advocacy group to promote Geodon for kids.
Taken together, the string of incidents suggests a lack of management accountability. Like many large companies, Pfizer operates as a series of silos or divisions, with different managers for sales, marketing, R&D, and regulatory compliance. The fact that screwups have occurred across all these divisions illustrates the value of having one manager, or management team, with accountability for the entire product, from soup to nuts.
The FDA warned Pfizer that its trials of Geodon in children were improperly monitored, and that children got too much drug by mistake:
… dosing errors occurred and overdosing extended over several days for all seven pediatric subjects; in one case for as long as 22 days.
…a Pfizer internal document dated October 3, 2007 and entitled “Safety Information on Affected Subjects” refers to the overdosing of an additional six pediatric subjects in study (b)(4) at two different sites…
Read entire article: http://industry.bnet.com/pharma/10007813/kid-overdoses-in-antipsychotic-trial-caps-a-history-of-screwups-at-pfizer/
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