Greedy Trial Lawyer
Avandia Damage Control Falls Flat
Category: Gaming The System
GlaxoSmithKline had to do something. The safety of its drug, Avandia, had been called into question by a study reported in the New England Journal of Medicine recently.
So, the drug manufacturer released the results of its own study. Judge for yourself how successful the damage control effort has been.
Newest Avandia study not reassuring
By MARILYNN MARCHIONE, AP Medical WriterThe maker of the controversial diabetes pill Avandia pointed to early results of its own study Tuesday, saying they offered reassuring evidence the drug doesn't raise heart risks. However, outside experts called the results inconclusive at best and a sign of greater risk at worst.
The study compares Avandia with two other diabetes pills in nearly 4,500 people around the world. Drug maker GlaxoSmithKline PLC released results of the first few years of a six-year study showing similar rates of heart-related deaths and hospitalizations among those on Avandia versus those on the other drugs.
But some doctors said the results showed slightly more heart problems with Avandia - a bad sign even though the difference was so small that it could have occurred by chance alone. They also contend there are problems with the way the study was done.
"This study, which was designed to show the benefit of rosiglitazone (Avandia), if anything shows the opposite," said Dr. David Nathan, chief of diabetes care at Massachusetts General Hospital.
"It's not a study to show that there's not risk" from Avandia, said Michael Kutner, biostatistics chief at Emory University, who had no role in the study.
"It's a leap of faith" for the company now to say that these results suggest the drug is safe, he said.
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