Oh dear!
It looks like a wheel has fallen off the "glitazone bandwagon"!
GlaxoSmithKline, Europe's biggest drug-maker, was last night racing to shore up confidence in one of its most important medicines after a study in a respected US journal suggested that it dramatically increased the risks of having a heart attack.
The drug in question, Avandia, is taken by millions of Americans and others around the world who suffer from diabetes.
It contributed £414m to GSK's sales in the first three months of this year.
A study published by the New England Journal of Medicine (NEJM) yesterday analysed all the previously published data from studies of Avandia and calculated that taking the drug increases the chance of having a heart attack by 43 per cent.
The increase in the risk of having a fatal heart attack was even higher.
GSK immediately questioned the methodology of the study, which was conducted by Dr. Steven ("Drugslayer") Nissen, a cardiologist at the respected Cleveland Clinic in Ohio - but more than $10bn was wiped off the value of the company in afternoon trading in the US in the wake of the study.
Dr. David Nathan, chief of diabetes care at Massachusetts General Hospital, comments about the meta-analysis are most revealing:
"This analysis is just scratching the surface of what may be there. It needs to be taken seriously," said Nathan, who reviewed the paper for the medical journal and has no financial ties to any diabetes drugmakers.
The situation "reflects very badly on the FDA and on Glaxo," Nathan said. "It's the FDA's responsibility to be monitoring this stuff."
But wait! There's more:
The drug "represents a major failure of the drug-use and drug-approval processes in the United States," Drs. Bruce Psaty and Curt Furberg wrote in an editorial in the NEJM.
Psaty is with the University of Washington in Seattle and Furberg is with Wake Forest University.
When the drug was approved, evidence of its benefits were "at best mixed," wrote the two doctors. Both have been frequent critics of the FDA's failure to spot dangers in the drug approval process and its conduct involving Vioxx.
Sources: The Indy, Channel 7 Boston
It looks like a wheel has fallen off the "glitazone bandwagon"!
GlaxoSmithKline, Europe's biggest drug-maker, was last night racing to shore up confidence in one of its most important medicines after a study in a respected US journal suggested that it dramatically increased the risks of having a heart attack.
The drug in question, Avandia, is taken by millions of Americans and others around the world who suffer from diabetes.
It contributed £414m to GSK's sales in the first three months of this year.
A study published by the New England Journal of Medicine (NEJM) yesterday analysed all the previously published data from studies of Avandia and calculated that taking the drug increases the chance of having a heart attack by 43 per cent.
The increase in the risk of having a fatal heart attack was even higher.
GSK immediately questioned the methodology of the study, which was conducted by Dr. Steven ("Drugslayer") Nissen, a cardiologist at the respected Cleveland Clinic in Ohio - but more than $10bn was wiped off the value of the company in afternoon trading in the US in the wake of the study.
Dr. David Nathan, chief of diabetes care at Massachusetts General Hospital, comments about the meta-analysis are most revealing:
"This analysis is just scratching the surface of what may be there. It needs to be taken seriously," said Nathan, who reviewed the paper for the medical journal and has no financial ties to any diabetes drugmakers.
The situation "reflects very badly on the FDA and on Glaxo," Nathan said. "It's the FDA's responsibility to be monitoring this stuff."
But wait! There's more:
The drug "represents a major failure of the drug-use and drug-approval processes in the United States," Drs. Bruce Psaty and Curt Furberg wrote in an editorial in the NEJM.
Psaty is with the University of Washington in Seattle and Furberg is with Wake Forest University.
When the drug was approved, evidence of its benefits were "at best mixed," wrote the two doctors. Both have been frequent critics of the FDA's failure to spot dangers in the drug approval process and its conduct involving Vioxx.
Sources: The Indy, Channel 7 Boston
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