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Doctor: Glaxo withheld diabetes drug's risks from FDA

GlaxoSmithKline withheld from regulators a study showing its Avandia diabetes drug may cause heart attacks, a former FDA official said, according to two people familiar with her deposition in a lawsuit against the drugmaker.

Dr. Rosemary Johann-Liang, a former manager in the Food and Drug Administration's drug-safety unit, told lawyers suing Glaxo that the 2001 study found Avandia posed a greater heart-attack risk than rival medicines, the people said. Glaxo also didn't turn over an e-mail from researchers who concluded Avandia "strengthens the signals" of heart ailments, she testified in a pretrial deposition last month, according to the people.

Johann-Liang left the FDA in 2007 following her recommendation that London-based Glaxo add more information about health risks to Avandia's label, the people said. Johann-Liang stated that FDA officials provided the drugmaker with details of internal agency discussions about beefing up the warnings, according to the people, who also said she testified the leaks "should not have happened" and violated FDA policy.

Johann-Liang's deposition may be considered by an FDA advisory panel meeting next week in Washington to consider whether Avandia's ability to control blood-sugar levels outweighs a possible increase in heart attacks, strokes and deaths from cardiovascular disease, the people said.

While Glaxo officials contend no studies have proven that Avandia is dangerous, drug-safety advocates have called for the medicine's withdrawal. Actos, a similar diabetes drug sold by Tokyo-based Takeda Pharmaceutical Co., poses less of a heart-attack risk, researchers have found. Glaxo withheld a study on Actos from the FDA, Johann-Liang testified, according to the people.

A Glaxo spokeswoman declined to comment on the deposition. A spokeswoman for the FDA declined to comment beyond confirming that Johann-Liang isn't currently an FDA employee. Johann-Liang didn't return calls seeking comment.

Avandia was once the world's best-selling diabetes pill, generating annual revenue of $3 billion by 2006, including sales of a combination pill called Avandamet. Sales plunged after a 2007 report in the New England Journal of Medicine linked the drug to a 43 percent increased risk of heart attacks. That prompted U.S. and European regulators to order Glaxo to strengthen its warnings.


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