Avandiagate: FDA Reviewer Walks The Plank
4 CommentsBy Ed Silverman // June 11th, 2007 // 8:13 am
Rosemany Johann-Liang, the FDA medical reviewer who was punished for pushing a black box warning for Avandia, left the agency Friday, becoming the latest in a string of staffers to feel the heat for refusing to back down on safety issues. Although motivated, in part, by family reasons, agency pressure convinced her to look for another job.
Background: Shortly after pushing for the Avandia black box warning, she says top officials from the FDA’s Office of New Drugs walked by her office and into the office of her boss, Mark Avigan. Nearly an hour later, the door opened, the officials left and Avigan called her in.
“Mark told me that they were upset with our recommendation,†the former deputy director of the Division of Drug Risk Evaluation, which is part of what used to be called the Office of Drug Safety tells The New York Times. “They decided to act like the review never happened.â€
“I really advocate for drug safety, and a lot of times the agency doesn’t want to hear that there are problems,” Johann-Liang tells USA Today. “I think, in general, there is a culture of ‘The drug is always innocent.’ ”
Avigan took over the supervision of the safety review of Avandia and Actos and told her she could no longer approve strong safety recommendations without his say-so, she tells the paper. An FDA spokeswoman tells the paper the agency is looking into whether Johann-Liang was reprimanded for her opinion. “We don’t know if that’s actually the case,” she says.
Part of the problem, she says, is that the Office of Surveillance and Epidemiology - formerly the Office of Drug Safety - can only recommend how to manage risks linked to drugs. The Office of New Drugs, the same office that approves drugs, decides whether to take action.
With Avandia, Johann-Liang says, “when we recommended this black box, they said they wanted to look at it further.” But the Office of New Drugs never got around to it, she says, because they were pressed to meet deadlines for acting on new drug applications.
She begins her new job today as chief medical officer in the vaccine injury compensation program at the federal Health Resources and Services Administration. Butl, she says, she might have tried to figure out how to stay at the FDA “if the agency had a vision of promoting and protecting public health.”
Laurie
Wouldn’t want to keep anyone around who might actually be CONCERNED about drug safety. Nah, just hide the information from the public and blame the patient in 10 years.
“if the agency had a vision of promoting and protecting public health.â€
Truer words could not be spoken.
Melody
“I think, in general, there is a culture of ‘The drug is always innocent.’ â€
Not only is “the drug always innocent,” Lilly actually changed the identification paradigm. What was once considered an “insulin reaction” where a diabetic experienced sweats, shakes, tremors, etc. if he had too much INSULIN in his system (or, alternatively, too little food), under the guise of PC has now been labeled a “hypoglycemic event.” Perhaps a more ’scientific’ description, and certainly not wrong–but it shifts any negative connotation away from the DRUG.
The DISEASE or the PATIENT is always to blame.
Hank
Every time you think it can’t get any worse, it gets worse. I assume Chuck Grassley all over this.
When are our Presidential candidates going to start talking about this (above a whisper?).
Laurie
“When are our Presidential candidates going to start talking about this (above a whisper?).”
When they stop taking Pharma’s campaign contributions. Until then, nothing will change.