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Independent experts urged US regulators Thursday to reduce restrictions on GlaxoSmithKline's controversial diabetes drug Avandia, banned in Europe over heart attack risk concerns, AFP reports. Thirteen members of the 26-member independent advisory panel convened by the Food and Drug Administration said strict US restrictions imposed in 2010 should be eased. Seven experts voted to lift them entirely, five to keep them and one said Avandia should be taken off the market. "I want to make sure the drug will be more available to patients who need it... but I don't know how to do it," said Nancy Geller, who heads the Office of Biostatistics Research of the National Heart, Lung, and Blood Institute. She voted to modify the restrictions. Other experts who voted similarly said a new analysis of clinical data was favorable for Avandia, although there is still uncertainty about whether the drug can raise the risk of a heart attack. The panel voted after two days of meetings on a new review of the GSK trial called RECORD, which confirmed the company's initial finding that Avandia does not raise cardiac risk more than other diabetes drugs. GSK, a British pharma giant, recently paid researchers at Duke University in North Carolina to carry out the new analysis of the data. The FDA is under no obligation to follow the recommendations of expert panels, though it usually does. Once a blockbuster drug for patients with type 2 diabetes, Avandia was approved in 1999 and soared to sales of $3 billion per year, but its use has declined dramatically in recent years. Critics have alleged flaws in the RECORD trial, and other research has pointed to a rise in heart attacks and strokes among patients using Avandia to control their blood sugar. Robert Ratner, chief scientific and medical officer for the American Diabetes Association, welcomed the FDA's evaluation process. The vote means it is "unlikely" that regulators will remove the drug from the market, Ratner said, adding that he did not foresee a new clinical trial as sought by several of the panel's experts. "In the current climate, with all the publicity surrounding Avandia... it would not be either ethical or feasible to do that," Ratner said. The Avandia controversy erupted after a 2007 study in the New England Journal of Medicine found that it raised the risk of heart attack by 43 percent. The lead author of that study, Steven Nissen of the Cleveland Clinic, has been outspoken against Avandia and told The Wall Street Journal this week that RECORD was "not conducted in a scientifically acceptable manner." He also said that the FDA denied his request to be part of the committee of experts reviewing the data. In 2010, the FDA slapped tight restrictions on use of Avandia, following the recommendations of independent experts who had concluded the drug significantly raised the risk of heart attacks. There are about 26 million diabetics in the United States, according to the American Diabetes Association. The disease is spreading quickly due to higher obesity rates.
Independent experts urged US regulators Thursday to reduce restrictions on GlaxoSmithKline's controversial diabetes drug Avandia, banned in Europe over heart attack risk concerns, AFP reports.
Thirteen members of the 26-member independent advisory panel convened by the Food and Drug Administration said strict US restrictions imposed in 2010 should be eased.
Seven experts voted to lift them entirely, five to keep them and one said Avandia should be taken off the market.
"I want to make sure the drug will be more available to patients who need it... but I don't know how to do it," said Nancy Geller, who heads the Office of Biostatistics Research of the National Heart, Lung, and Blood Institute.
She voted to modify the restrictions.
Other experts who voted similarly said a new analysis of clinical data was favorable for Avandia, although there is still uncertainty about whether the drug can raise the risk of a heart attack.
The panel voted after two days of meetings on a new review of the GSK trial called RECORD, which confirmed the company's initial finding that Avandia does not raise cardiac risk more than other diabetes drugs.
GSK, a British pharma giant, recently paid researchers at Duke University in North Carolina to carry out the new analysis of the data.
The FDA is under no obligation to follow the recommendations of expert panels, though it usually does.
Once a blockbuster drug for patients with type 2 diabetes, Avandia was approved in 1999 and soared to sales of $3 billion per year, but its use has declined dramatically in recent years.
Critics have alleged flaws in the RECORD trial, and other research has pointed to a rise in heart attacks and strokes among patients using Avandia to control their blood sugar.
Robert Ratner, chief scientific and medical officer for the American Diabetes Association, welcomed the FDA's evaluation process.
The vote means it is "unlikely" that regulators will remove the drug from the market, Ratner said, adding that he did not foresee a new clinical trial as sought by several of the panel's experts.
"In the current climate, with all the publicity surrounding Avandia... it would not be either ethical or feasible to do that," Ratner said.
The Avandia controversy erupted after a 2007 study in the New England Journal of Medicine found that it raised the risk of heart attack by 43 percent.
The lead author of that study, Steven Nissen of the Cleveland Clinic, has been outspoken against Avandia and told The Wall Street Journal this week that RECORD was "not conducted in a scientifically acceptable manner."
He also said that the FDA denied his request to be part of the committee of experts reviewing the data.
In 2010, the FDA slapped tight restrictions on use of Avandia, following the recommendations of independent experts who had concluded the drug significantly raised the risk of heart attacks.
There are about 26 million diabetics in the United States, according to the American Diabetes Association. The disease is spreading quickly due to higher obesity rates.
