Quoted from http://www.nytimes.com/2010/07/22/business/22avandia.html
Glaxo Ordered to End Drug Trial Enrollment
By DUFF WILSON
Published: July 21, 2010
The Food and Drug Administration on Wednesday ordered GlaxoSmithKline to stop enrolling people in a controversial clinical trial comparing diabetes drugs.
The F.D.A. also ordered GlaxoSmithKline, the British pharmaceutical giant, to inform the 1,324 people already testing the drugs that its product Avandia may increase heart risks.
The company said it would comply, but maintained Avandia was a safe option for some people with Type 2 diabetes.
The F.D.A. notice said it was studying whether to take further action after most members of an advisory panel voted last week to withdraw Avandia from the market or severely restrict its use.
“This was the right thing for the F.D.A. to do now while we await the final decision,” Ruth R. Faden, a professor of bioethics at the Johns Hopkins Bloomberg School of Public Health, said on Wednesday.
“This was one of our main recommendations,” said Professor Faden, who was chairman of an Institute of Medicine group that recently offered the F.D.A. advice on ethical issues in studying the safety of approved drugs. “The key immediate action is to go to the people who are currently enrolled in the trial and let them know the new results so they can decide whether it affects their willingness to stay in the trial.”