PharmExec Blog

Avandia Trial in Trouble

GSK’s Avandia just won’t stay out of the news. Now comes a report from The Wall Street Journal that the FDA is considering dealing the beleaguered diabetes drug another blow by stopping one of its safety trials.

The TIDE trial, which received approval in 2007, pits Avandia (rosiglitazone) against Takeda’s Actos (pioglitazone), a drug that as yet hasn’t suffered from the same safety pitfalls. But with recent allegations of Avandia-research related misconduct from the Senate Finance Committee, and renewed unease about the drug’s safety profile, some researchers are wondering if the study places its subjects in harm’s way.

Glaxo has denied any suggestion of danger, and points to the study’s FDA-mandated structure and approval by ethics committees around the globe as proof of its safety and necessity. The company will have to wait until a July hearing to learn the fate of the trial—and possibly the drug itself, since further safety concerns in a study like this are inextricable from the drug’s safety profile, according to FDA’s principal deputy commissioner, Joshua Sharfstein.

But GSK can take some small comfort in the fact that it’s not alone: Pfizer received a warning letter just this week over one of its trials for antipsychotic Geodon (ziprasidone). The trial’s goal is to explore the drug’s use in bipolar children, but so far at least 13 of those subjects received enough medication to trigger an overdose, and the letter calls Pfizer out for failing to properly monitor the children. This comes after last year’s $2.3 billion settlement with the Department of Justice over illegal promotion of four drugs, including Geodon.

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