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Thursday, December 13, 2012

Demand £500m back for Tamiflu, urge MPs



Ministers should demand that the pharmaceutical firm Roche returns £500 million to the NHS if it is found to have sat on trials data showing the flu drug Tamiflu to be ineffective, say MPs.

The Swiss drugs giant has been accused of withholding key data on effectiveness of Tamiflu, which the NHS stockpiled in vast quantities in 2009 to protect against the swine flu threat.
Roche claims the drug reduces the risk of developing flu-related complications including bronchitis and pneumonia.
Because vaccines cannot be made quickly enough to protect against emerging strains like swine flu - which experts initially feared was deadly - the NHS purchased millions of doses of Tamiflu.
However, over the last year scientists have begun to challenge Roche’s claims. They have regularly asked it to publish all its clinical trials into the drug - it has carried out at least 123 - but at the moment some claim 60 per cent remain unpublished.
Scientists fear Roche has cherry-picked the most favourable trials to publish - and effectively hidden the rest.
Dr Sarah Wollaston, a Conservative MP and member of the Health Select Committee, wrote the letter.
It argues: “Without this information, UK regulators and doctors cannot properly assess the clinical benefit (if any) of Tamiflu.
“It could be that the previous government spent 0.5 per cent of the entire 2009 NHS budget on a drug which the manufacturers were aware was no better than a placebo.
"Without all the clinical trial data, we cannot draw firm conclusions, but it surely cannot be right for a pharmaceutical company to receive £500 million of taxpayers’ money if it withholds information about its own products.”
The letter continues: “In the event that your committee finds Roche has deliberately concealed evidence which shows Tamiflu to be simply a placebo with side effects, you might wish to consider a recommendation that the Government seeks repayment of the £500 million cost.”
The letter is signed by five other MPs, from the three main parties.
Speaking to The Daily Telegraph, Dr Wollaston said: “I’d like to see these Roche executives hauled up in front of the Public Accounts Committee and asked, ‘Where’s the data?’ “
Amazon, Starbucks and Google had been made to explain their tax avoidance schemes in front of the PAC, she said, so she could see no reason why Roche should not be subjected to similar scrutiny.
Dr Wollaston, a qualified GP, said Tamiflu was just one example of firms apparently concealing clinical trials data.
Mrs Hodge has yet to discuss the matter with other members of the Public Accounts Committee.
Roche denies it is concealing data. A spokesman said: "We stand behind the robustness and integrity of our data".
"Tamiflu is effective in reducing the severity and duration of symptoms in those infected with the flu and decreasing the risk of getting the flu," she went on, noting that these claims were supported by researchers including the Harvard School of Public Health.
She added: "Almost 80 per cent of Roche’s Tamiflu clinical data has been published as primary publications or made available to the scientific community on the web as complete Core Reports.
Of the remaining data, most come from studies that have recently been completed. Roche is working to make them publicly available."
She said: "Roche would cooperate with any requests from the Public Accounts Committee."  http://www.telegraph.co.uk/health/healthnews/9742581/Demand-500m-back-for-Tamiflu-urge-MPs.html