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ABPI criticises Roche for withholding Tamiflu data from Cochrane reviewers

Tamiflu pack

Roche, manufacturer of Tamiflu, should have complied with a reasonable request for data, says the ABPI

The Association of the British Pharmaceutical Industry has criticised Roche following publication of a Cochrane review of the company’s anti-influenza drug Tamiflu (oseltamivir).

The review concluded that the antiviral provides small benefits on symptom relief, but there was little evidence that it reduces hospital admission or the risk of developing pneumonia. The review came after a four year battle to gain access to full clinical trial data from Roche.

Stephen Whitehead, the APBI’s chief executive, said there was no reason for the “game of cat and mouse” that went on between Roche and the Cochrane reviewers — after the latter requested data about the drug. 

Mr Whitehead told PJ Online that ABPI guidance instructs its members to comply with any “reasonable request” for data, adding that he thought the Cochrane request was reasonable. However, ABPI guidance is not enforceable for data dating back to before 2008 and Roche is no longer a member of the association, having left in December 2009. None the less, the company is still bound by the industry’s code of practice, an ABPI spokesman explained.

In contrast, GlaxoSmithKline, which is an ABPI member, co-operated with the Cochrane reviewers when GSK’s product Relenza (zanamivir) was also investigated, said Mr Whitehead, who questioned why Roche could not have behaved in the same manner. “It doesn’t help the image of the industry,” he told PJ Online.

Speaking at the ABPI’s annual conference in London on 10 April 2014, Mr Whitehead said it was disappointing that the controversy around Tamiflu had “coloured the day”. He pointed out that Tamiflu remains on the World Health Organization’s list of essential medicines. However, there could now be a question mark over whether it remains on the list, he told PJ Online.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.11137489

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