Rosemary Johann-Liang, the former deputy director of the FDA’s Division of Drug Risk Evaluation says she was verbally castigated because she made the recommendation that Avandia, the billion-dollar diabetes drug, be labeled with a black box warning about congestive heart failure.
Ms. Johann-Liang left her position as deputy director with the FDA on June 8, saying that her staff had recommended to her in February 2006 that she designate a “black box warning” for Avandia, the strongest warning the FDA can issue for a medication, without actually banning it. In response to this, she was instead reprimanded, and told to first clear any future drug safety recommendations with her director.
Over a year later now, new studies are linking Avandia to increased risks of cardiovascular disease. Additionally, Congress is holding inquiries into the FDA’s process for approving the drug. As a direct consequence of the increased scientific and political pressure, the agency is finally asking for black box warnings on both Avandia and another related diabetes drug, Actos.
Johann-Liang has been critical of the FDA for requiring a much higher standard of proof that a drug is unsafe, than is actually needed to approve a drug for sale. With diabetes drugs, for instance, the FDA merely requires clinical studies that suggest the drug lowers blood sugar… but there’s no requirement that the drug actually improves the quality or length of patients’ lives. Yet when further research shows that a drug is unsafe, the FDA is highly resistant to assessing those risks. After all, doing so would be an implicit admission of an inadequate approval process in the first place.
“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 to serious safety issues, she states, and “people are continuing to be hurt.” Johann-Liang is alarmed that patients who are prescribed Avandia may blame their congestive heart failure symptoms on their diabetes — instead of identifying Avandia as the culprit — and actually take higher dosages of the very drug that is the underlying cause of the health problem in the first place.
Now, FDA Commissioner Andrew von Eschenbach has finally admitted: “Despite existing warnings, these drugs [have continued to be] prescribed to patients with significant heart failure.”
- Trevor K. Neuman