April 21st, 2010
FDA Warns Pfizer Over Geodon Trial Overdosing
By Ed Silverman
The drugmaker was cited for failing to properly monitor pediatric clinical trials in which at least 13 children with bipolar disorder experienced overdosing that led to restless legs, tremors, involuntary facial movements and skin petechiae, which results from bleeding under the skin. The FDA cited Pfizer in an April 9 warning letter that noted the problem was originally found during FDA reviews in 2005.
The FDA wrote that "Pfizer failed to properly ensure monitoring of the study referenced above. As a result of inadequate monitoring, widespread overdosing of study subjects at multiple study sites was neither detected nor corrected in a timely manner," according to the letter.
For instance, the FDA cited an internal Pfizer document dated Oct. 3, 2007 and entitled "Safety Information on Affected Subjects," whicd noted that an additional six pediatric subjects in the study at two different sites experienced overdosing. And these occurred in June, July and August 2007 - several months after Pfizer supposedly retrained study monitors on correct dosing procedures.
This is the sort of episode that bolsters criticism of the deal in which drugmakers were awarded patent extensions for agreeing to run pediatric trials. Moreover, this is also the same drugmaker that was fined $301 million for improperly marketing Geodon for unapproved uses; unapproved patients, including children, and for higher doses than approved by the FDA (see here). The unfortunate take-away message suggests a disregard for children, although Pfizer says it takes the situation seriously and maintains it has instituted new procedures to prevent a recurrence.
In its letter, the agency noted the inspection is part of its Bioresearch Monitoring Program, which includes inspections designed "to evaluate the conduct of research and to ensure that the rights, safety, and welfare of the human subjects of those studies have been protected." The Pfizer inspection was performed due to "significant violations found during inspections of several clinical investigators" involved in the trial.