India suspends TIDE as Takeda touts Actos
It's Day 2 after the Avandia vote, and the fallout continues. The FDA advisory panel voted Wednesday on the GlaxoSmithKline (NYSE: GSK)drug's safety, and while 12 members voted to withdraw it, more believed it should stay on the market, perhaps with stronger warnings and restrictions. The vote has spooked some, worried others and offered others a business opportunity.
- The Indian government has ordered GSK to suspend its TIDE research--designed to gauge the heart safety of Avandia versus rival drug Actos--because of recent studies suggesting an increased risk of cardiovascular troubles. Indian regulators wrote to Quintiles, the CRO running the TIDE trial in that country, asking it to put the research "on hold with immediate effect," a GSK spokesperson tells CBS News. The TIDE trial has 19 sites in India. Report
- Doctors are concerned that their Avandia patients might stop using the drug. Three expert groups--Endocrine Society, American Diabetes Association and the American Association of Clinical Endocrinologists--urged patients not to stop taking Avandia, saying that news about the controversial drug might be frightening, but it would be worse to suddenly stop taking it. Article
- Takeda Pharmaceuticals, which makes Avandia's direct rival Actos, has seized the day with a nationwide marketing campaign. The company is running ads in newspapers and magazines--154 in all--touting Actos' ability "to lower blood sugar without increasing your risk of having a heart attack or stroke." As Pharmalot reports, Takeda ran a similar campaign back in 2007, after the Avandia safety scandal first broke. News