The embattled TIDE trial, which is evaluating the cardiovascular safety of rosiglitazone (Avandia), is having trouble enrolling participants in the United States, according to a story in the Wall Street Journal by Alicia Mundy. Two sites in the US have withdrawn from the trial. One, Wake Forest University Baptist Medical Center, had been unable to recruit a single patient into the trial, Mundy reports.
But TIDE may be in even murkier waters outside the US. According to a news article in BMJ by Janice Hopkins Tanne, consumer advocate Sidney Wolfe and David Juurlink, of Sunnybrook Health Sciences Centre in Toronto, wrote to the FDA requesting that TIDE be halted. The two were especially critical of the fact that new sites in TIDE were in developing countries. The Wall Street Journal story quotes Wolfe as saying that “it is ‘particularly troublesome’ that Glaxo had added so many sites in countries where patients may not be aware of the safety questions about Avandia.”
The BMJ story focuses on the incident, first reported on CardioBrief, in which GSK attempted to suppress an editorial by Steve Nissen that was highly critical of rosiglitazone. Tanne’s story offers a tasty tidbit for connoisseurs of corporate idiocy: despite written documentation showing that a GSK executive, Moncef Slaoui, in his own words, “urged the journal not to publish the online editorial in print,” a GSK spokeswoman hilariously told the BMJ:
“There was absolutely no attempt to suppress [Dr Nissen’s editorial]. As Glaxo’s chairman of research and development [Dr Slaoui] states in his letter, we saw inaccuracies and considered them serious enough to warrant correction before being repeated. We requested that the journal address these inaccuracies.”
Comment: So here’s my question for GSK: If you’re going to deny that you attempted to suppress the editorial, despite the written record of your own executive, how can you possibly expect anyone to believe anything else that you have to say about Avandia? By denying such an obvious and well-documented fact you destroy your own credibility.
Previous coverage of the Avandia controversy on CardioBrief:
- EHJ editors rebuffed GSK efforts to suppress Nissen editorial on rosiglitazone (April 30, 2010)
- Avandia again: Nissen and JAMA editors spin RECORD round and round(March 23, 2010)
- Avandia: a plaque on both your houses! (February 24, 2010)
- More Avandia action: Nissen secretly recorded GSK execs, FDA announces safety review (February 22, 2010)
- Senate releases Avandia report, GSK responds to attacks (February 20, 2010)
- NY Times: FDA and senate reports slam continued availability of Avandia (rosiglitazone) (February 20, 2010)
- BMJ study questions “whether ongoing use of rosiglitazone is justified in any circumstance” (August 18, 2009)
- Rosiglitazone goes on the RECORD, but is it a hit? (June 5, 2009)
- Senate investigation revealing new details in Avandia case, WSJ reports(January 14, 2009)