In the latest effort to force Roche to release clinical trial data on its Tamiflu flu medication, a researcher from the Nordic Cochrane Centre in Copenhagen is urging European governments to boycott Roche products and file lawsuits against the drugmaker until complete data is released.
The suggestion comes one week after the British Medical Journal, which published the missive from Peter Gotzsche, announced a new policy in which it will no longer publish studies unless “the relevant anonymised patient level data available (is made available) on reasonable request." The policy goes into effect in January 2013 (back story).
In explaining its decision, the influential pointed to a widely publicized episode last year in which researchers at the Cochrane Collaboration say they were stymied by Roche in their efforts to fully assess up-to-date efficacy information for the Tamiflu influenza treatment, an episode cited by BMJ (back story).
At issue has been concern over the extent to which Tamiflu is effective (read here) and a follow-up effort by the Cochrane Collaboration, which determined Tamiflu may not prevent complications from influenza in healthy adults, but reversed a previous finding the pill defended against and other deadly conditions linked to the disease.
In trying to undertake the review, Tom Jefferson, the lead author of the study, expressed concern that the European Medicines Agency, which approved Tamiflu, only saw some trial results and the FDA is believed not to have reviewed the largest ever trial of Tamiflu when the medicine was being considered for approval.
For its part, Roche has repeatedly rejected suggestions that its decisions are not transparent or fail to comply with legal requirements. In statements in January (see this) and again last month, the drugmaker maintains patient-level data is not disclosed due to legal and confidentiality restraints, although regulatory authorities do receive such data.
This response is what prompted BMJ to pursue its new policy and also prompted several researchers, including Tom Jefferson of the Cochrane Collaboration, to respond with a letter published in BMJ last week in which they maintained Roche issued several false statements, including the assertion that patient-level data is provided to regulators (read the Roche statement and their letter here).
Consequently, Gotzche wrote in BMJ today that he questions “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.”
“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 (see statement here).
Whether any governments would agree with the issue and the need for action is unclear, although many European governments have, of course, been trying to find ways to reduce their expenditures on prescription drugs. The call for a boycott may, perhaps, prompt some officials to take a closer look at the controversy as an excuse to pressure the drugmaker. But what do you think?
Should Governments Boycott Roche Over Unreleased Tamiflu Data?
- Yes (71%, 79 Votes)
- No (29%, 32 Votes)
Total Voters: 112