On June 12, 2007, USA Today reported on a scientist from the U.S. Food and Drug Administration (FDA) who said her directors reprimanded her for recommending that Avandia get a “black box” warning about congestive heart failure.

Rosemary Johann-Liang, the former deputy director of the Division of Drug Risk Evaluation, said she recommended the Avandia warning on the suggestion of her staff. The FDA is investigating the validity of Johann-Liang’s claims.

In the meantime, the Senate Finance Committee is asking the FDA to make sure no scientist is reprimanded for raising safety questions.

“Those FDA employees dedicated to post-marketing surveillance…should be able to express their opinions in writing and independently without fear of retaliation, or reprimand or reprisal,” Sen. Chuck Grassley wrote in a letter dated June 4, 2007.

Johann-Liang said she wanted to be an advocate for drug safety, but oftentimes, her bosses did not want to hear about it.

“A lot of times the agency doesn’t want to hear that there are problems,” she said. “I think, in general, there is a culture of ‘The drug is always innocent.’”

Specifically Johann-Liang is warning people about Avandia, which she feels is a dangerous drug.

“People are continuing to be hurt,” she said. “Congestive heart failure is a very, very clear adverse reaction syndrome with Avandia.”

Source: Rita Rubin, USA Today, “FDA scientist says she was reprimanded for warning.” June 12, 2007.