Frustration is growing with one drug giant that has had three years to accurately report safety data and information concerning their flu treatment, Tamiflu, but has chosen to continually hide almost half of the information.
The British Medical Journal is also intensifying its efforts to help resolve a three year battle to gain access to the full data on oseltamivir (Tamiflu). In 2009, the Cochrane respiratory group, led by Tom Jefferson, was commissioned by the UK government to update its systematic review of neuraminidase inhibitors. Despite a public promise to release “full study reports” (internal company reports) for each trial, each of which can run to thousands of pages, Roche has stonewalled, variously pleading patient or commercial confidentiality, or claiming that sufficient data have already been provided.
In fact the Cochrane group has told The BMJ that about 60% of Roche’s data from phase III trials of oseltamivir have never been published. Although the European Medicines Agency (EMA) could have requested this data from Roche, it did not do so. Indeed the EMA’s unprecedented infringement proceedings launched against Roche last month suggest that even the manufacturer has never fully evaluated evidence it has collected on the drug’s adverse effects.
The anti-flu drug Tamiflu has been stockpiled by countries against the outbreak of a flu pandemic since 2004. The UK alone has spent £500m, which means that taxpayers in the United Kingdom and around the world have spent billions of dollars stockpiling a drug for which only the manufacturer has seen the complete evidence base.
What people want to know is, what has Roche got to hide?
According to The Independent, editor of The BMJ, Fiona Godlee, published an open letter to Sir John Bell, the Regius Professor of Medicine at Oxford University and a board member of Roche, in which she appeals to him to use his influence to persuade the company to release the data “for independent scrutiny”.
The two trials that have been published, she says, “were funded by Roche and authored by Roche employees and Roche-paid external experts” and “could not be relied on”.
There have now been 123 trials of Tamiflu but 60% of the patient data “remains unpublished”, she says. “I am appealing to you as an internationally-respected scientist and clinician and a leader of clinical research in the UK to bring your influence to bear,” she writes.
“In refusing to release these data of enormous public interest, you [the company’s directors] put Roche outside the circle of responsible pharmaceutical companies. Billions of pounds of public money have been spent on [Tamiflu] and yet the evidence on its effectiveness and safety remains hidden from appropriate and necessary independent scrutiny.”
Dr Godlee said, “Tamiflu was licensed over ten years ago and has been in widespread use since. Once a drug is licensed, it becomes a drug on which public money is spent and lives may be put at risk. Inevitably, if there is information we are not allowed to see, we wonder what is in there. There is a legitimate scientific question [about its safety and efficacy] which can only be answered by looking at the data. It is just shocking.”
A spokesman for Roche said, “Roche provided the Cochrane group with access to 3,200 pages of very detailed information, enabling their questions to be answered. Roche stands behind the robustness and integrity of our data supporting the efficacy and safety of Tamiflu.”