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.
- 1 Five-year-old Iris Grace is raising awareness of autism through her extraordinary paintings
- 2 Car tax disc changes: Two days to go - and they affect you much more than just not displaying a piece of paper
- 3 The Simpsons death: Creator Al Jean would 'kill himself' before character like Homer or Lisa
- 4 British man raped while urinating in bushes at Oktoberfest beer festival in Germany
- 5 A teacher speaks out: 'I'm effectively being forced out of a career that I wanted to love'
Five-year-old Iris Grace is raising awareness of autism through her extraordinary paintings
Car tax disc changes: Two days to go - and they affect you much more than just not displaying a piece of paper
Isis an hour away from Baghdad - with no sign of Iraq army being able to make a successful counter-attack
British man raped while urinating in bushes at Oktoberfest beer festival in Germany
George Clooney and Amal Alamuddin wedding: The famous congratulate actor and human rights lawyer after Venice nuptials
Isis, we are told, is a 'clear and dangerous threat to our way of life'. I’m sorry, but I just don’t buy it
Exclusive: 'Putin's Russia has been my biggest regret,' says Nato's outgoing Secretary General
'Women, walk wherever you want' posters taken down in Stamford Hill following 'unacceptable' signs separating men and women
There’s no excuse for Dave Lee Travis’s behaviour, but we need to keep a sense of proportion
Mark Reckless becomes second Tory MP to defect to Ukip in a month
Should gay sex be illegal? 16% of Britons think so
- < Previous
- Next >
iJobs Money & Business
NEGOTIABLE: Austen Lloyd: TRUST ACCOUNTANT - KENTIf you are a Chartered Accou...
£18000 - £20000 per annum + OTE £30000: SThree: SThree are a global FTSE 250 b...
Highly Competitive Salary: Austen Lloyd: CITY - Law Costs Draftsperson - NICHE...
£300 - £330 per day: Ashdown Group: SQL Developer (Stored Procedures) Watford...