GlaxoSmithKline encountered some stiff industry headwinds when it pledged to open up its data vault to outside investigators. But as of today it has a high-profile convert on its side. The biopharma giant Roche ($RHHBY) has agreed to follow in GSK's ($GSK) footsteps, saying that it will work with an independent group which will be charged with sorting out and approving requests for access to anonymized clinical trial data for all approved products. If regulators can't provide the data, says Roche, then the company will make it available.
"We understand and support calls for our industry to be more transparent about clinical trial data with the aim of meeting the best interests of patients and medicine," said Daniel O'Day, chief operating officer of Roche Pharma. "At the same time, we firmly believe that health authorities need to remain the gatekeeper for drug assessment and approval. We believe we have found a way in which patient data can be provided to third party researchers in a legitimate environment that ensures patient confidentiality and avoids the risk of publishing misleading results or giving rise to public health scares and consequences."
Significantly, Roche says it's also urging other companies to follow a path originally blazed by GSK, which has embraced transparency on data in order to counter critics who have lambasted the industry for remaining far too secretive about the data it makes available on approved drugs--even to the point of hiding badly needed information on drug safety.
In particular, Roche spelled out plans to unveil all the remaining data on Tamiflu. The company has been under intense pressure to open up on Tamiflu for the past two years, with the Cochrane group leadingthe charge. Today's move marks an abrupt change in approach for Roche,as well as its big subsidiary Genentech.
Four well-known scientists who specialize in influenza will look over the data, says Roche, "identify any unanswered questions and agree on a statistical analysis plan. Following an agreement, Roche will provide access to all requested Tamiflu clinical trial data for the analyses." The four scientists are: Professor Albert Osterhaus, Erasmus Medical Centre Rotterdam; Professor Menno De Jong, Academic Medical Centre Amsterdam; Professor Arnold Monto, University of Michigan and Professor Richard Whitley, University of Alabama.
The big question now is whether other companies, including the U.S.-based giants like Eli Lilly, Pfizer and Merck, will follow their European rivals. This is one trend that isn't going away anytime soon.
- here's the press release
- get the story from Reuters