Monday, June 11, 2007

Avandia Dangers Exposer Takes the Hit

This excerpt is from a report on the Weblo Do Fraga blog

A series of drug-safety scandals has led many on Capitol Hill to question whether the Food and Drug Administration has failed to strike the right balance between speed and safety. A clear sign of this imbalance, these critics say, is the increasing number of F.D.A. drug-safety officers who say they have been punished or ignored after uncovering dangers of popular medicines.
The latest to suffer this fate is Dr. Rosemary Johann-Liang, 42, who recommended more than a year ago that the diabetes drug Avandia carry the agency's strongest possible safety warning for its effects on the heart.

Dr. Johann-Liang spent Friday sadly winding down her nearly seven-year career at the F.D.A. She turned in her BlackBerry, laptop and office key, and she went to the agency library to make sure she had no overdue books. She wished her colleagues well.
A pediatrician and expert in infectious diseases, Dr. Johann-Liang joined the agency in December 2000 and rose through the ranks. For four years, she reviewed drug applications as a medical officer and then team leader.
Two years ago she became a deputy division director in the agency's office of surveillance and epidemiology, the group that examines the safety of already-marketed drugs.

In February 2006, one of her safety reviewers, Lanh Green, went to her with a problem. The agency's Office of New Drugs had asked Ms. Green to determine whether eye problems that sometimes resulted from taking Avandia and a similar drug, Actos, were a serious issue. But Ms. Green noted that visual deficits were just one part of a drug-induced swelling problem that could lead to weight gain, ankle swelling and, if left untreated, heart failure.
Alerts about some of these problems were scattered throughout the two drug's labels. Ms. Green suggested consolidating them and highlighting the heart risks with a boxed warning, the agency's most severe. After a week long review, Dr. Johann-Liang agreed.
There's no doubt these problems are caused by these drugs, and there's no doubt that patients are continuing to suffer bad outcomes, Dr. Johann-Liang said.
A week later, top officials from the new drug office walked by Dr. Johann-Liang's office and into the office of her boss, Dr. Mark Avigan, she said. Nearly an hour later, she said, the door opened, the officials left and Dr. Avigan called her in.

"Mark told me that they were upset with our recommendation," Dr. Johann-Liang recalled. "They decided to act like the review never happened."
Dr. Avigan took over the supervision of the safety review of Avandia and Actos and told Dr. Johann-Liang that she could no longer approve strong safety recommendations without his say-so, she said. Over the next year, she was increasingly excluded from crucial safety reviews and meetings, which contributed to her decision to leave the agency on Friday, she said.
In an interview, Dr. Avigan said that he did not intend to punish Dr. Johann-Liang.
"My view was simply that when there were conversations going on about important safety issues that were likely to garner a lot of attention, that I needed to be in the loop," he said.
On Wednesday, the F.D.A. commissioner, Andrew C. von Eschenbach, announced that the agency had asked for boxed warnings on Avandia and Actos, more than a year after Dr. Johann-Liang's recommendation.

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