The makers of Tamiflu (oseltamivir), Roche, should honor their promise made nearly three years ago and release trial data on Tamiflu for independent scrutiny, R. Fiona Godlee, BMJ Editor-in-Chief has urged.
Dr. Godlee wrote in an open letter to Professor Sir John Bell, company director “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.”
EMA (European Medicines Agency) has already initiated infringement proceedings against Roche to investigate failures in the reporting of safety data, which includes not releasing 80,000 reports on adverse drug reactions.
An open letter was also published in The Times (of London), urging pharmaceutical companies to “come clean” and release all clinical trial data on drugs that are currently used so that healthcare professionals have open access. Dr. Godlee, along with 27 others signed the letter.
British politicians are also beginning to apply pressure. Sarah Wollaston, a GP and Conservative MP (Member of Parliament), brought up the issue of missing data in Parliament. Norman Lamb, UK Health Minister has agreed to meet experts and talk about the issue of access to clinical trial data.
After a major investigation by the BMJ, in December 2009, Roche publicly pledged to release full clinical trial data on Tamiflu (oseltamivir), its antiviral medication. The BMJ investigation was carried out by Tom Jefferson and Peter Doshi from the Cochrane Collaboration.
According to the investigation, there is no compelling evidence demonstrating that Tamiflu prevents pneumonia, or other complications in healthy people. The authors expressed serious concern regarding access to drug data, the use of ghost writers in human trials, and the drug approval process.
The Cochrane investigators say they have received some further data from Roche, but as yet, not the full set as promised.
At least 123 clinical trials involving Tamiflu have been carried out, the Cochrane reviewers say. However, about 60% of patient data from Roche Phase 3 completed treatment trials have not yet been released.
The reviewers are concerned about “the likely overstating of effectiveness and the apparent under-reporting of potentially serious adverse effects.”
Tamiflu has made a lot of money for Roche. It is included in the WHO (World Health Organization) list of “essential medicines”.
Dr. Godlee urges Professor Bell:
“..to bring your influence to bear on your colleagues on Roche’s board. 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 your company and its board of directors.”
Professor Bell responded, saying he has referred the matter to Roche and awaits a response.
In an Accompanying Editorial, Dr. Godlee explains that the open correspondence “aims to hold specific individuals and organizations to account. Their actions are preventing independent scrutiny of the results of clinical trials and putting patients’ lives at risk. We also hope it will contribute to a sea change in the public mood.”
Last week, bmj.com asked who people thought is mainly at fault for denying access to negative clinical trial results. 569 respondents voted as follows:
- Pharma – 69%
- Regulators – 13.5%
- Legislators – 9%
The BMJ says it has plans to launch further campaigns urging more openness in clinical trial results.
Dr. Godlee’s open letter is published alongside correspondence by the Cochrane team with Roche, the CDC (Centers for Disease Control and Prevention, USA), and WHO, as part of an open data campaign urging Roche to provide doctors and patients access to complete data on Tamiflu.
Written by Christian Nordqvist