GSK 'settles Avandia claims' on first day of safety hearing
Wednesday 14 July 2010
Glaxosmithkline has agreed to pay up to $460m (£303m) to settle the majority of cases brought over its Avandia diabetes drug, which has been claimed to cause heart attacks and strokes, according to reports yesterday.
The drugs giant last night refused to comment on the reports, which came on the first day of a hearing into the safety of the treatment, held by the US Food and Drug Administration's scientific panel. During the proceedings in Washington yesterday, GSK was accused by the Senate Finance Committee of hiding negative trial data dating back as long as a decade ago.
"As far back as 2000, internal emails show that GSK executives sought to downplay scientific findings, which raise questions about the safety [of Avandia]," the committee said.
The panel was also reminded to "keep an open mind" on the drug's safety, however. Margaret Hamburg, the FDA commissioner, reminded her colleagues to "follow the science, wherever it leads, and the rest will fall into place".
GSK, Europe's biggest pharmaceutical company, has strenuously denied that it has hidden damaging data about Avandia, and that the drug is dangerous. Referring to news of a possible settlement, a spokeswoman last night said that the company never comments on ongoing litigation.
The company has settled some cases however, including a hearing that was scheduled for June. "We continue to prepare for trials later this year, and are fully prepared to defend any litigation because we are confident that when courts and juries look at actual clinical data, the manner in which we communicated with the FDA and physicians, and our openness in posting studies on our website, the facts will support our position," GSK said.
The group yesterday presented evidence in support of Avandia's safety on the first day of the long-awaited hearing. Lawyers representing thousands of patients who claim they suffered heart problems because of the drug are poring over documents released by the FDA last week.
These revealed that some FDA scientists are sceptical over the quality of a GSK study, called the Record study, which showed Avandia patients were no more likely to have heart problems than other diabetes sufferers. The trial "was inadequately designed and conducted to provide any reassurance", the FDA's Thomas Marciniak wrote. A different FDA scientist, however, came to an alternative conclusion, and GSK says it stands by the Record study and that a further five studies all concluded that Avandia was safe.
Avandia sales were worth $3bn in 2006, before an article written by Cleveland cardiologist Steven Nissen in the respected New England Journal of Medicine first cast doubts over its safety. In 2009, GSK made $1.2bn from Avandia sales.
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