Quoted from http://www.reuters.com/article/idUSTRE64A4NM20100511
U.S. group urges FDA to halt Glaxo's Avandia trial
Susan Heavey
Tue May 11, 2010 2:21pm EDT
WASHINGTON (Reuters) - An major trial of Avandia puts patients at risk and should be stopped, a U.S. advocacy group said on Tuesday, calling on regulators to immediately halt the global study of the controversial GlaxoSmithKline Plc diabetes drug.
The U.S. Food and Drug Administration asked the company in 2007 to conduct the trial to compare the drug's long-term heart effects with those of rival Actos by Takeda Pharmaceutical Co Ltd after other evidence suggested Avandia increased the risk of heart attack and chest pain.
Since then, even more data have linked Glaxo's drug to greater heart risks, the science-based consumer advocacy group Public Citizen said. Continuing to enroll patients in the trial -- which aims to study 16,000 worldwide through 2015 -- unnecessarily puts people with diabetes at risk, it added.
The trial, known as TIDE, is "exposing thousands of high-risk patients with diabetes to a drug with an unfavorable safety profile and no clinical advantage over its comparator," Public Citizen's Health Research Group Director Sidney Wolfe and Canadian researcher David Juurlink wrote in a letter to FDA Commissioner Margaret Hamburg.
"A wealth of data now suggests" that Avandia carries greater risks than Actos, the researchers said. Patients are also not adequately informed about the safety differences between the two medicines when deciding whether to participate in the trial, they added.
But FDA officials, who have said they are already taking a closer look at Avandia, are not likely to act so quickly.