The new year began with Sanofi ($SNY) and PhRMA trumpeting their commitment to sharing clinical trial data, but the self-congratulation was followed swiftly by fresh criticism of industry practices. Politicians in the U.K are the latest to chastise drugmakers for failing to share all their methods and results.
A U.K. committee of politicians made the criticisms after looking into the stockpiling of Roche's ($RHHBY) antiviral Tamiflu for use in a pandemic. The investigation dredged up longstanding questions about the effectiveness of Tamiflu and Roche's reluctance to share clinical trial data. After years of discussions Roche committed to sending all its Tamiflu trial data to health research group The Cochrane Collaboration in April, but U.K. politicians want to stop a similar situation from ever developing by opening up study results.
"The [U.K.] should ensure, both prospectively and retrospectively, that clinical trials are registered on an appropriate registry and that the full methods and results of all trials should be available for wider independent scrutiny, beyond the work undertaken by regulators during the licensing process," the committee recommended. If implemented, the proposals would give doctors access to the database of trial data and methods and mandate frequent audits to check if companies are withholding data.
GlaxoSmithKline ($GSK), Pfizer ($PFE) and now Sanofi have already committed to varying degrees of data transparency, but the committee thinks these fail to adequately address incomplete disclosure throughout medicine. The same criticism is leveled at proposed European legislation. Shortly before the holiday season, European politicians reached a provisional agreement to oblige companies to upload trial results to a public database. European politicians want to finalize the legislation by May.
Manufacturers and trade groups have already begun adopting self-imposed data sharing policies. On Jan. 1, PhRMA implemented the data sharing principles it developed with the European Federation of Pharmaceutical Industries and Associations (EFPIA). Sanofi--whose CEO Chris Viehbacher is the current head of EFPIA--committed to greater transparency on January 2. Neither initiative goes as far as the U.K. recommendations though. The fight over what data should be made public is far from over.
- here's the U.K. report (PDF)
- check out the EFPIA release
- read FierceBiotech's coverage