Shining light on FDA and Glaxo

Dr. Weeks’ Comment: This would not have happened had not the internet shone light on the proceedings.


Glaxo Ordered to End Drug Trial Enrollment


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.”

Mary Anne Rhyne, a spokeswoman for GlaxoSmithKline, said the company would update investigators and ethics boards in the next week about new information from the F.D.A. review. She said a Canadian research institute would notify the patients, who live in 23 countries.

Dr. Hertzel C. Gerstein, the study’s principal investigator and a professor at McMaster University in Ontario, said new enrollment was stopped within 20 minutes of the F.D.A. action. He said information about the F.D.A. advisory vote was being distributed through doctors to people enrolled in the trial.

“This is being done as quickly as possible, “ Dr. Gerstein said.

He also said there was “nothing new scientifically” on the subject. The study’s 45 leaders met last week and determined it was important to continue the trial, he said.

Dr. Steven E. Nissen, a Cleveland Clinic cardiologist whose 2007 analysis led to the Avandia safety review, predicted the suspension of enrollment and new warnings would lead to abandoning the trial, which compares Avandia with Actos, a drug from Takeda Pharmaceuticals.

“There was really no other action they could take,” Dr. Nissen said. “Now the challenge is, if that trial is unethical, how can Avandia stay on the market?”

Also Wednesday, Glaxo reported a second-quarter loss of $464 million after a $2.4 billion charge for legal expenses, including $460 million to resolve more than 10,000 Avandia lawsuits.

Shares of Glaxo fell a penny, to $36.36.

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