The Pfizer Geodon Trial And Physician Mishaps
By Ed Silverman
April 28, 2010
Earlier this month, the FDA sent Pfizer a warning letter 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 a serious skin disorder.
This is a big problem for the drugmaker, since Pfizer hopes to receive an extra six months of marketing exclusivity in return for having conducted the pediatric trials. But the dosing scandal could prompt the FDA to request further trials, which would require so much additional time that exclusivity would likely be lost, since the basic Geodon patent expires in 2012. This would also delay pediatric approval, which would expand the possibilities for a drug that generated $1.1 billion in sales last year.
But who were some of the doctors involved? …
…there was Sohail Punjwani, who was cited for numerous instances in which the wrong dosage was given children. Punjwani ran one of three sites that were responsible for 40 patients receiving incorrect doses, or 16 percent of the kids involved, and half of them were given more than the maximum tolerated dose for the trial…
Punjwani has made headlines in Florida, where he is based, for treating 7-year-old Gabriel Myers, who hanged himself with a shower cord in a foster home. The boy’s death prompted a probe by a Department of Children & Families task force and proposed legislation before the Florida Senate. He did not respond to messages.
Note: The FDA warning letter to Pfizer states that informed consent was not obtained in these clinical trials. See letter here: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm208976.htm
The FDA warning letter to Punjwani can be found here: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm202862.htm