BMJ Editor-in-Chief Fiona Godlee has called on Roche, manufacturers of Tamiflu (oseltamivir), to honor promises to release full clinical study reports on the effects of Tamiflu. In an open letter, published on the BMJ Web site and directed to Roche board member John Bell, Godlee points out that Roche publically promised to release the data in 2009 following the publication of a Cochrane review of neuraminidase inhibitors in healthy adults published in the BMJ.
The BMJ and the Cochrane Collaboration want the raw data so they can move forward with a systematic review, commissioned by the UK government.
Around 123 trials of Tamiflu are known to exist, and, of those, 60% of the patient data from Roche Phase 3 completed treatment trails remain unpublished, writes Godlee.
There are concerns that Roche’s failure to release the full data may indicate that the company overstated the effectiveness of the drug and that potentially serious adverse effects are being under reported.
“On behalf of the Cochrane collaborators and the public health decision makers around the world, I am asking Roche to honor its publicly stated promise to make available the full clinical study reports,” writes Godlee. She adds that releasing the data would help restore public confidence in the company and its board of directors.