FDA Drug Risk Evaluation employee reprimanded for mentioning dangers of diabetes drug

Wednesday, November 14, 2007 by: David Gutierrez

(NewsTarget) The former deputy director of the FDA's Division of Drug Risk Evaluation has said that she was verbally reprimanded by her superiors when she recommended that diabetes drug Avandia be labeled with a "black box" warning about congestive heart failure.

Rosemary Johann-Liang, who left her position on June 8, said that she followed her staff's recommendation in February 2006 and asked for the black box warning, the strongest warning that the FDA can issue for a medication without banning it. In response, Johann-Liang was scolded and told to check with her director before making any further major drug safety recommendations.

In response to new studies linking Avandia to increased risks of cardiovascular disease and congressional inquiries into the FDA's process for approving the drug, the agency is now asking for black box warnings on both Avandia and related drug Actos.

Johann-Liang has criticized the FDA for demanding a higher standard of proof that a drug is unsafe than it requires to prove a drug effective. For diabetes drugs, for example, the agency only requires proof that the drug lowers blood sugar, but none that it improves the quality or length of patients' lives. In contrast, the FDA is very resistant to hearing that there might be risks associated with a drug.

"I really advocate for drug safety, and a lot of times the agency doesn't want to hear that there are problems," Johann-Liang said. "I think, in general, there's a culture of 'the drug is always innocent.'"

This has led, she says, to serious safety problems, and "people are continuing to be hurt." Johann-Liang is concerned that patients taking Avandia may attribute congestive heart failure symptoms to their diabetes, and actually take more of the drug that is causing the problem.

"Despite existing warnings, these drugs [have continued to be] prescribed to patients with significant heart failure," said FDA Commissioner Andrew von Eschenbach.

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