GSK accused of Avandia cover-up
pharmafile | July 14, 2010 | News story | Sales and Marketing | Avandia, GlaxoSmithKline, diabetes
The ongoing battle over GlaxoSmithKline’s diabetes drug Avandia has taken another turn with US senators accusing the company of a cover-up stretching back a decade.
The manufacturer already faces legal action over claims the drug raises the risk of heart attacks – and the US Senate Finance Committee now says internal emails show GSK attempted to downplay scientific findings about the safety of Avandia as long ago as 2000.
It highlights a number of email exchanges between GSK executives, such as one from July 2001 which discussed whether to publish two GSK studies that found problems.
“Not a chance,” says the email. “These put Avnadia [sic] in quite a negative light when folks look at the response of the [Avandia] arm. It is a dificult [sic] story to tell and we would hope that these do not see the light of day. We have already published the better studies.”
GSK has given a robust response to the new accusations, presented this week at a public meeting to the US Food and Drug Administration (FDA), saying that they represent a “small subset” of a huge amount of legal paperwork.
“Cherry-picking a handful of documents from more than 14 million pages of documents distorts the record and is misleading,” the manufacturer insists.
“They include drafts and other documents taken out of context, which therefore are incomplete and misleading,” it adds in a statement.
“The documents do not offer new clinically relevant scientific information, and do not provide the full extent of GSK’s studies and evaluation of Avandia.”
The company is also keeping tightlipped over media reports that it is to pay up to $460m (£303m) to settle litigation arising from the use of Avandia.
The Committee began its investigation in 2007 and released its report on the drug in February this year. In its new submission to the FDA it also says executives were concerned about a GSK study of Takeda’s Actos (pioglitazone), called Study 175.
An email from a GSK employee said: “This was done for the US business, way under the radar and we lost in terms of LDL and Tgs [triglycerides] … Per Sr. Mgmt request, these data should not see the light of day to anyone outside of GSK.”
Another email discussed not wanting a head-to-head trial between Avandia and Actos because “the best result would be equivalence”.
The Committee says it is “concerned that Study 175 was not turned over to the FDA in a timely manner”, but GSK responds that it was an Actos-only study on LDL and triglycerides – “not a study on Avandia (rosiglitazone) and heart attack”.
The FDA’s hearing, during which the regulator may decide to pull the drug from the market, enters its second day today (Wednesday).
Meanwhile, in Europe regulatory advisors at the Committee for Medicinal Products for Human Use (CHMP) are to look at the benefit/risk profile of Avandia in a meeting next week.
Adam Hill
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