Avandia letter misleading, FDA tells Glaxo
pharmafile | August 24, 2010 | News story | Sales and Marketing | Avandia, GSK
GlaxoSmithKline’s travails over controversial diabetes drug Avandia show no sign of abating as members of a key regulatory panel accused the company of misleading doctors.
The FDA ordered GSK to send a letter to doctors involved in a key trial describing an FDA panel hearing in July at which experts discussed the drug.
The TIDE trial pits Avandia (rosiglitazone) against Takeda Pharmaceuticals’ Actos (pioglitazone) and the advisory committee recommended keeping Avandia on the market – a course the FDA may or may not follow.
But the New York Times has reported GSK’s letter made no mention of pleas by FDA medical officer Dr. David Graham to stop the trial on ethical grounds – leading Graham to say: “This summary is biased, misleading and not truthful.”
Panel member Dr. Clifford J. Rosen is quoted in the paper as saying: “This letter is really deceptive”, while another, Dr. Curt D. Furberg, said it was “very Avandia friendly”.
However, the article says another panel member, Dr. Sanjay Kaul, argued the letter “faithfully reflects the deliberations of the Avandia advisory meeting”.
In its US blog, GSK admits the FDA told the company that the letter did “not accurately capture the results on all the voting questions posed to the advisory committee panel at this meeting”.
“There is an overemphasis on the mortality findings that appears to dismiss the risk of ischemic cardiovascular events, particularly between rosiglitazone and pioglitazone. Consequently, this information does not fully inform participants of the potential risks of the different treatments in the TIDE trial.”
GSK is co-operating with the FDA on this, it says. The manufacturer already faces legal action over claims the drug raises the risk of heart attacks – and the US Senate Finance Committee has also claimed internal emails show GSK attempted to downplay scientific findings about its safety.
The company recorded a £252 million loss for Q2 this year – largely down to a £1.58 billion legal bill to settle three recent disputes, including litigation on Avandia, whose sales dropped £26 million during the quarter.
The European Medicines Agency expects to complete next month its own review into Avandia. The brand, contra-indicated in patients with various heart problems, is approved in combination with metformin (as Avandamet) and glimepiride (Avaglim).
Adam Hill
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