BMJ pushes Roche for raw data on Tamiflu trials

BMJ journal editor Fiona Godlee this week published an open letter to Roche, makers of the flu drug Tamiflu. Background provided by BMJ: Roche promised in 2009 to release full reports from clinical trials of oseltamivir in response to an investigation by the BMJ and the Cochrane Collaboration. In this open letter to John Bell, regius professor of medicine at Oxford University and a Roche board member, the BMJ’s editor in chief further urges the company to disclose the full data.

Excerpts of the letter (copy of letter pasted below):

Dear John

I am writing to you in your capacity as a member of the board of Roche. As you may be aware, the BMJ has been working with the Cochrane Collaboration in its efforts to get Roche to release the raw data on the effects of oseltamivir (Tamiflu) so that Cochrane can properly fulfil the UK government’s commission for a systematic review of neuraminidase inhibitors based on clinical study reports.

The Cochrane reviewers now know that there are at least 123 trials of oseltamivir and that most (60%) of the patient data from Roche’s phase III completed treatment trials remain unpublished. We have concerns on a number of fronts: the likely overstating of effectiveness and the apparent under-reporting of potentially serious adverse effects. Meanwhile, oseltamivir has just been added to the World Health Organization’s List of Essential Medicines, alongside aspirin and ? blockers.

On behalf of the Cochrane collaborators and public health decision makers around the world, I ask Roche to honour its publicly stated promise to make available the full clinical study reports. In order for the Cochrane collaborators to properly analyse these data they will need individual patient data in electronic format.

Oseltamivir has been a great commercial success for Roche. Billions of pounds of public money have been spent on it, and yet the evidence on its effectiveness and safety remains hidden from appropriate and necessary independent scrutiny. I am appealing to you, as an internationally respected scientist and clinician and a leader of clinical research in the United Kingdom, to bring your influence to bear on your colleagues on Roche’s board. As company directors, responsibility for Roche’s behaviour rests with you, as individuals and collectively. In refusing to release these data of enormous public interest, you put Roche outside the circle of responsible pharmaceutical companies. Releasing the data would do a great deal to restore confidence in the company and its board of directors.

The BMJ has launched a separate section of its website, the BMJ Open Data Campaign.

In a somewhat related note, the AP recently reported, “Roche probed for not reporting side effects.” Excerpt:

“Europe’s top drug regulator announced it is taking action against pharmaceutical giant Roche for allegedly failing to properly report the side effects of 19 drugs being used by U.S. patients. …

Eight of the drugs involved are used for the treatment of cancer, including breast cancer. They include Avastin, Herceptin, Tarceva, and Xeloda. The flu drug Tamiflu was also included in the list.”

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