As the FDA's expert advisors prepare to hear arguments over the safety of GlaxoSmithKline's (NYSE: GSK) diabetes drug Avandia, one former agency staffer is preparing to testify in a liability suit involving the drug. And that testimony could be damaging not only in court, but also in GSK's ongoing fight to defend the still-popular drug.
Dr. Rosemary Johann-Liang, a former manager in the FDA's drug-safety unit, says in a deposition that GSK withheld data from a 2001 study showing Avandia might cause heart attacks, Bloomberg reports. GSK also withheld its internal researchers' opinion that Avandia could be linked to heart ailments, she adds. The FDA rejected her 2006 recommendation that Avandia get a black-box warning of the heart risks, and some officials leaked information about internal agency discussions of the potential warnings, Johann-Liang says.
GSK denies that it withheld any info on health risks, saying that the 2001 safety review concluded "there was no signal of an increased risk for heart attacks," spokeswoman Mary Anne Rhyne tells the news service. The FDA did add beefed-up warnings to Avandia in 2007, after a much-publicized study linked the drug with an increased risk of heart attacks.
The deposition comes in one of the liability suits GSK is fighting over Avandia; this suit alleges the company hid Avandia's health risks. But the deposition may also be considered by FDA's advisory panel in this week's meetings, sources tell Bloomberg.
- read the Bloomberg story