A leading researcher has suggested that European governments should sue the drug firm Roche and that doctors and others boycott the company’s products until it publishes missing data on Tamiflu.
Peter Gøtzsche, leader of the Nordic Cochrane Centre in Copenhagen, was responding to an open letter to Roche from BMJ Editor-in-chief, Dr Fiona Godlee.
The letter is part of the BMJ’s open data campaign, aimed at persuading Roche to honour the promise it made almost three years ago to make key Tamiflu trial data available for independent scrutiny.
Last week, Roche issued a “reactive statement” in response to Dr Godlee’s letter, saying it “does not accept or agree with the content of the letter regarding our transparency.”
The company said it had provided the Cochrane group with 3200 pages of information “enabling their questions to be answered” and that a further request for information was denied because the researchers “declined to sign a confidentiality agreement.”
However, the Cochrane researchers say they were never offered a confidentiality agreement at the time of the further request, and say they have “found misleading statements in each of the document’s four paragraphs.” The Cochrane researchers issued a letter to Roche last week - now posted on bmj.com/tamiflu - asking Roche to publicly correct the record.
Roche also says it “has made full clinical data…available to national health authorities,” but the Cochrane researchers say the European Medicines Agency has confirmed to them that it does not have some modules of the studies.
Gøtzsche comments came the same week as Dr Godlee and other campaigners met with health minster Lord Howe to discuss missing data, EU clinical trials regulations, and the role of regulators. Afterwards, MP Sarah Wollaston, who last month raised the issue in parliament, said she hoped to have a full day’s event to discuss further what could be done.
In his response, Gøtzsche said that he questioned “why European governments had not sued Roche to get the money they had spent on needlessly stockpiling Tamiflu. Roche has withheld data that purports to show that Tamiflu has dramatic effects. We all wonder why it is so difficult to get these data from Roche and why Roche has not published them if it is really true that they show these effects.”
He concludes: “European governments should sue Roche, which might have the effect that the hidden trial results come out in the open. Furthermore, I suggest we boycott Roche’s products until they publish missing Tamiflu data.”
The Cochrane researchers conclude: “We remain interested in conducting the most rigorous, independent assessment of Tamiflu that is possible, and remain interested in obtaining the full study reports promised in December 2009 and complete de-identified electronic patient level reports.”
Professor Peter Gøtzsche, Director, Nordic Cochrane Centre, Copenhagen, Denmark
Tel: +45 35 45 71 12; Mobile: +45 53 64 20 66
Peter Doshi, Postdoctoral Fellow, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
Tel (mobile): +1 617 407 3019
Tom Jefferson, Coordinator, Cochrane Acute Respiratory Infections Group, Rome, Italy
Tel (mobile): +39 329 202 5051
Fiona Godlee, Editor-in-Chief, BMJ, London, UK
Tel (via BMJ Group Press Office): +44 (0)20 7383 6529
Read all the correspondence here: bmj.com/tamiflu