Roche ($RHHBY) is making a "fair and transparent" offer to critics at the Cochrane Collaboration: Let's set up an advisory board to review all the data on Tamiflu. As Reuters reports, the proposal is Roche's latest response to calls for open access to data on its flu-fighting drug.
That data has become the subject of a heated public debate, as Cochrane researchers took to the pages of the British Medical Journal. Some have even called for a Tamiflu boycott until Roche opens the books.
In the past, the company has said that it provided enough data necessary to the researchers' work. Roche has also questioned the researchers' methodology in analyzing Tamiflu's effectiveness. But now, the company has come up with a compromise. The advisory board, composed of academics and other experts, would decide how best to analyze the Tamiflu data. "We think that would be an appropriate, fair and transparent way of handling this debate," Roche pharma Chief Daniel O'Day told Reuters.
Cochrane researchers question Tamiflu's effectiveness--and they consider that question to be crucial, given the fact that governments around the world have stockpiled it in case of pandemic. Cochrane has been agitating for Roche to open its Tamiflu books for years. About three years ago, Roche said it would hand over the requested data, Cochrane says, but then reneged.
As part of its open data initiative, the BMJ recently published an open letter to one of Roche's board members, demanding full data on the influenza drug. The BMJ also posted years of correspondence between the Swiss drugmaker and Cochrane researchers as they haggled over access to Tamiflu documents.
Roche actually offers more access to information on its trials than many other pharma companies do. It has a dedicated website where all Roche-sponsored studies are available, either as peer-reviewed publications or in summary. Detailed trial reports are available on a password-protected site, the company says. But Roche has also been taken to task by regulators recently, for failing to properly pass along 80,000 reports of suspected adverse events, including some involving Tamiflu.
Inevitably, the latest Tamiflu news leads to questions about Roche's plans for overall access to trial data. GlaxoSmithKline ($GSK) recently said it would allow researchers to pore over its own patient-level study data, upon request. Roche says it handles such requests as well, but O'Day stopped short of promising full access.
"To what level data will be shared proactively and constantly is something we need to discuss," he told Reuters.
- read the Reuters news
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