Avandia Heart Attack Study Data Concealed by Glaxo in 2001: FDA Reviewer

A former FDA employee says that GlaxoSmithKline knew as early as 2001 that the side effects of Avandia, a controversial diabetes medication, could increase the risk of heart problems, but failed to turn that research over to FDA.  

Dr. Rosemary Johann-Ling, has given a deposition as part of the ongoing Avandia litigation, during which she testifies that Glaxo failed to turn over key research that showed Avandia heart risks in 2001. Johann-Ling, a former drug safety manager at FDA, also testified that the FDA gave the company improper access to its internal decision-making process regarding the drug’s safety. Sources familiar with the deposition gave details to Bloomberg News.

Her testimony will likely be used as evidence in the first Avandia trials scheduled to begin in the federal multidistrict litigation (MDL) later this year. There are about 13,000 Avandia lawsuits consolidated and centralized for pretrial litigation in the U.S. District Court for the Eastern District of Pennsylvania, all involving similar allegations that the drug maker failed to adequately research their medication or warn users about the risk of serious side effects.

Johann-Ling’s deposition could also make an appearance at an FDA advisory committee meeting this week, at which time independent experts will decide whether to recommend that the FDA issue an Avandia recall. While the FDA is not bound by the committee’s decisions, it often heeds their recommendations.

Avandia (rosiglitazone) was first approved in the United States in 1998 to treat type 2 diabetes by helping control blood sugar levels. The drug has been used by millions of diabetics, but sales have plummeted in recent years following a May 2007 publication in the New England Journal of Medicine that identified an increased risk of heart attacks and congestive heart failure with Avandia.

Johann-Ling’s deposition appears to confirm some of the findings in a recent U.S. Senate report, which determined GlaxoSmithKline knew that Avandia caused heart problems, but failed to inform the U.S. drug regulators. The Senate report also revealed that some FDA drug safety reviewers have been calling for a recall for Avandia since 2007.

In 2006, Johann-Ling recommended that Avandia and Actos, a competing diabetes drug by Takeda Pharmaceuticals, be required to carry black box warnings about the risk of heart problems. Black box warnings are the most stringent label warnings the FDA can require.

Sources familiar with Johann-Ling’s deposition said that FDA officials were upset with Johann-Ling over the recommendation and refused to implement it for 17 months. Johann-Ling was also banned from making future recommendations, and was not invited to safety review meetings. Johann-Ling left the agency in June 2007 after working there for six years, one month after the Avandia study published by the New England Journal of Medicine.

GlaxoSmithKline officials dispute Johann-Ling’s version of events and say that the study she’s referring to was turned over to FDA and did not show an increased risk of heart attacks from Avandia.

Over the last two months, GlaxoSmithKline has reached Avandia settlements in about 5,700 of the Avandia lawsuits for undisclosed amounts. The first Avandia trial is now expected to begin in October 2010, unless additional settlements are reached.