Avandia Lawsuits: New Information Shows GlaxoSmithKline Hid Clinical Trial Data From FDA
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New information obtained from Senator Charles Grassley and the New York Times shows that GlaxoSmithKline (GSK) conducted secret studies on the effectiveness of it's multi-billion dollar diabetes drug, Avandia, in 1999. The results showed that Avandia use actually increased a patients' heart risks, but the company hid that information from the U.S. Food & Drug Administration (FDA). In fact, a GSK executive's internal memo was recently discovered by the New York Times which quotes him as saying, “ [This] data should not see the light of day to anyone outside of GSK.”
FDA To Meet About Avandia's Fate
The newly discovered information has caused the FDA to conduct a meeting on the fate of Avandia – which already contains a black box warning. It is not the first time the FDA has done so in response to charges that GSK hid clinical data. In 2007, an FDA panel was split on whether or not to pull the Type 2 diabetes drug from the market. In the end, it decided against that – even though numerous studies had already reported on dangerous Avandia side effects. However, the FDA may not give GSK the benefit of the doubt this time around based on the new information, which include:
- Hidden studies. GSK, then called SmithKlineBeecham, conducted a study on whether Avandia was safer to patients' hearts than Takeda Pharmaceutical's Actos, a leading diabetes drug already on the market. When the results of that study showed that it was not safer, the company hid the study and Avandia's side effects from the FDA and consumers.
- Corporate coverups. GSK executives spent the next ten plus years covering up the results of that study. Newly discovered information by the New York Times reveals that Dr. Martin Freed, a former corporate executive, wrote in an internal memo, “This was done for the U.S. business, way under the radar. Per senior management's request, [this] data should not see the light of day to anyone outside of GSK.”
- A history of similar behavior. In 2004, it was revealed that GSK hid data showing that its multi-billion dollar antidepressant drug, Paxil, increased suicidal behaviors in children and teenagers. At that time, the company agreed to make all of its clinical trial results public. However, they continued to hide the Avandia trial.
More Avandia Lawsuits Likely
Regardless of whether the FDA decides to withdraw Avandia from the market, the number of Avandia injury lawsuits is likely to increase as more evidence about what GSK knew, when it knew it and how it may have put profits over patients becomes public. If you've been injured by Avandia, contact an experienced Avandia injury lawyer to discuss your situation and evaluate your options.