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Senate Finance Committee says GlaxoSmithKline withheld negative rosiglitazone data
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New evidence suggests that GlaxoSmithKline failed to publish studies that found serious cardiovascular risks associated with rosiglitazone in a timely manner and actively promoted the drug despite known safety concerns, according to a report released by the Senate Finance Committee.
Sen. Max Baucus, D-Mont., chairman of the Senate Finance Committee, and Sen. Chuck Grassley, R-Iowa, ranking member of the committee, uncovered documents showing that GlaxoSmithKline attempted to downplay scientific findings about the safety of rosiglitazone (Avandia) as far back as 2000. Additionally, the committee found that rosiglitazone was part of the drug manufacturer’s ghostwriting campaign.
Baucus and Grassley sent a letter and associated documents to the FDA this week as the agency began its advisory board meeting to examine health risks associated with rosiglitazone.
“Information is the most important tool the FDA has to protect American consumers, and the documents we uncovered in our investigation will help arm the FDA with the best information possible as it evaluates Avandia’s safety,” Baucus said in a press release, adding that the committee will continue to work with the FDA to ensure that health care professionals and patients have all the necessary information about rosiglitazone.
The recent findings are part of Baucus and Grassley’s ongoing inquiry into the safety of rosiglitazone. The finance leaders released a detailed report on rosiglitazone in February.
“What’s happened with this drug further makes the case about the need to strengthen the office within the FDA that monitors drug safety after a drug is on the market and being sold to patients. A lack of accountability damages public confidence and hope in new drugs,” Grassley said in a release.
GlaxoSmithKline released a response to the Senate Finance Committee’s allegations saying that the documents were taken out of context and are therefore “incomplete and misleading.”
The manufacturer added that it has been “diligent” in providing its safety data on rosiglitazone to the FDA, in publishing clinical trial data and in responding to all requests from the Senate Finance Committee since its inquiry began in 2007.
“Cherry-picking a handful of documents from more than 14 million pages of documents distorts the record and is misleading,” according to a statement.
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