The tale of the drug Tamiflu (oseltamivir) just gets curiouser and curiouser.
On Monday, the journal BMJ released its latest correspondence in its open data campaign to get Tamiflu’s maker, the Switzerland-based Roche, to release “full study reports” (internal company reports) about the drug.
Tamiflu is, of course, the prescription antiviral drug that’s marketed to consumers as a way of shortening the duration of the flu when taken early in the illness. But the governments of many countries, including the United States, have spent billions of dollars stockpiling the drug for use in a pandemic. They did so on the claim that the drug can prevent flu-related hospitalizations and deaths.
A broken promise
Roche had promised to release its full reports on Tamiflu back in December 2009, after a team of experts for the independent and highly regarded Cochrane Collaboration published a paper in which the authors said that current data was insufficient to conclude that the drug did anything other than modestly shorten the course of the illness in otherwise healthy people.
In other words, there was no good evidence that it lowered the rate of hospitalizations or deaths — the endpoints for the drug that truly matter.
The Cochrane experts noted at the time that eight of the 10 randomized controlled trials on the effectiveness of Tamiflu had never been published. And the two trials that had been published were funded by Roche and written by its employees and experts with financial ties to the company.
Furthermore, the two published studies were themselves incomplete, omitting, for example, full reports of Tamiflu’s adverse effects.
After first agreeing to release the reports, Roche later reneged on that promise, claiming that it had concerns about the way Cochrane intended to analyze the data for effectiveness. In its latest correspondence, just published by BMJ, Roche announced that in order to create “an amicable resolution,” it intends to establish “a multi-party advisory board to review the totality of Tamiflu data.” Such an action, the company claims, will be “a sensible, fair and transparent way of addressing this public debate.”
The Cochrane reviewers interpret Roche’s latest suggestion regarding an advisory board as a step backward, not forward, in the efforts to resolve the uncertainties about Tamiflu’s effectiveness. Once again, they called for Roche to “honour your promise of three years ago and make public full clinical study reports in your possession.”
An ‘absurd’ situation
In an editorial written earlier this fall, BMJ editor-in-chief Dr. Fiona Godlee wrote about “the rank absurdity of the current situation” in which drug companies decide what clinical trial data the public gets to see.
“Why aren’t all clinical trial data routinely available for independent scrutiny once a regulatory decision has been made?” Godlee asks. “How have commercial companies been allowed to evaluate their own products and then to keep large and unknown amounts of the data secret even from the regulators? Why should it be up to the companies to decide who looks at the data and for what purpose? Why should it take legal action (as in the case of GlaxoSmithKline’s paroxetine and rosiglitazone), strong arm tactics by national licensing bodies (Pfizer’s reboxetine), and the exceptional tenacity of individual researchers and investigative journalists (Roche’s oseltamivir) to try to piece together the evidence on individual drugs?”
Earlier this month, Dr. Peter Gotzsche, director of the Nordic Cochrane Centre, which is part of the Cochrane Collaboration, published an open letter in which he suggested that European governments should sue Roche to force the company to release all its clinical trial data on Tamiflu and that physicians and others should boycott all Roche products until the company publishes that missing data.
BMJ has established a dedicated website to its ongoing Tamiflu open-data campaign. There you’ll find background articles, studies, editorials and correspondence regarding this curious case.
You have to wonder what exactly is in that unpublished data.