Sir David Davis signatory to letter calling for Tamiflu makers, Roche, to refund UK

As reported in the Financial Times;

“Roche, the Swiss pharmaceuticals group, is coming under pressure to reimburse £500m paid by the government for stockpiles of its blockbuster Tamiflu as debate intensifies over the drug’s efficacy.

A group of MPs led by David Davis has called on Margaret Hodge, chairman of the Commons public accounts committee, to launch an inquiry into wasteful spending on drugs, medical devices and implants not supported by full clinical trial data.

The action follows a long-running spat over the release of the full results of tests of Tamiflu by Roche, its manufacturer, to the Cochrane collaboration, a network of independent academics who assess the efficacy and safety of medicines.

In a campaign supported by the British Medical Journal, the researchers have called for comprehensive release of data and pointed out that US regulators authorised a narrow range of uses for the drug than in the UK, where Roche claims Tamiflu can reduce complications of flu, including bronchitis and pneumonia.

In a letter on Wednesday to Ms Hodge, Mr Davis wrote: “Roche has conducted over 123 clinical trials [of Tamiflu], of which at least 60 per cent remain unpublished … Without all the clinical trial data, we cannot draw firm conclusions, but it surely cannot be right for a pharmaceutical company to receive £500m of taxpayers’ money if it withholds information about its own products.”

The involvement of Mr Davis, himself a former chairman of the public accounts committee, will trigger concern at Roche, since the former Tory leadership contender is a renowned campaigner with a shrewd understanding of the media.

If the case is taken up by Ms Hodge, it would be even more problematic. She has established a reputation as a scourge of multinationals, most recently in her reports on the tax affairs of multinational companies, including Starbucks, Amazon and Google. It is understood Ms Hodge is considering the letter from MPs very seriously.

Roche said: “We stand behind the robustness and integrity of our data supporting the efficacy and safety of Tamiflu.

“Numerous clinical trials and real-life medical experiences have clearly demonstrated the clinically meaningful benefit for patients one year of age and older, for both the treatment and prevention of influenza. Roche has made full clinical study data available to health authorities around the world required for their review as part of the licensing process.”

The company stressed that published analysis by independent researchers had already supported its claims for Tamiflu, but that “in order to reach an amicable resolution” it planned to create an advisory board of outside experts to review all Tamiflu data.

The European Medicines Agency recently said that it planned to release in anonymised form all “raw data” on the effects in individual patients in all clinical trials of drugs on which it had made a decision.”

As reported in The Guardian;

“A senior cross-party group of MPs is calling for a parliamentary investigation to establish whether the NHS spent £500m on the Tamiflu drug without a proper assessment of its effectiveness.

The MPs, led by the former shadow home secretary David Davis and the Tory GP Sarah Wollaston, have asked the chair of the powerful commons public accounts committee, Margaret Hodge, to establish whether evidence about the drug was concealed.

Hodge, who recently shamed Starbucks into paying more tax, was asked to intervene after concerns were raised about the effectiveness of the anti-flu drug manufactured by the Swiss pharmaceutical group Roche. The Cochrane Collaboration, an academic group, has warned of “substantial problems” with trials of the drug which was stockpiled by governments around the world at a cost of billions of pounds during the 2009 flu pandemic.

In the letter to Hodge, written by Wollaston and signed by the Labour MP Valerie Vaz, the cross-party group wrote: “We are writing to you in your capacity as chair of the public accounts committee to ask if your committee would consider conducting an inquiry into the waste of NHS resources caused by the concealment of trial data for drugs, medical appliances and implants.”

The MPs pointed out that the last government spent £500m on the drug – 0.5% of the entire budget of the NHS – which may have been “no better than a placebo”. They added that Roche has conducted more than 123 clinical trials, of which at least 60% remain unpublished.

The letter to Hodge adds: “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 £500m cost.”

A spokeswoman for Roche insisted that many trials had shown that Tamiflu had a “clinically meaningful benefit for patients”. But the company announced it would establish a multi-party advisory board to review the “totality of Tamiflu data”.

The spokeswoman said: “We stand behind the robustness and integrity of our data supporting the efficacy and safety of Tamiflu. Numerous clinical trials and real-life medical experiences have clearly demonstrated the clinically meaningful benefit for patients one year of age and older, for both the treatment and prevention of influenza.

“Roche has made full clinical study data available to health authorities around the world required for their review as part of the licensing process. It is the role of global health authorities to review detailed information on medicines when assessing benefit and risk. Almost 80% 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.

“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. Analyses by global health authorities and independent groups of researchers, such as the Harvard School of Public Health, have supported these findings. After the 2009 H1N1 ‘swine flu’ pandemic a wealth of data has provided further assurance that Tamiflu is effective and well-tolerated and reduces the risk of complications.”

The Cochrane Collaboration highlighted its concerns about the drug in October. It wrote: “The authors have been unable to obtain the full set of clinical study reports or obtain verification of data from the manufacturer of [Tamiflu] oseltamivir (Roche) despite five requests between June 2010 and February 2011. No substantial comments were made by Roche on the protocol of our Cochrane Review which has been publicly available since December 2010. Based on our assessments of the documents we could obtain, we came to the conclusion that there were substantial problems with the design, conduct and availability of information from many of the trials.””

As reported in The Telegraph;

“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.

Now a group of MPs has written to Margaret Hodge, chairman of the Public Accounts Committee, urging her to press ministers to take action if Roche continues to refuse to publish full results.

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.””