Roche’s plans to expand third-party access to its clinical-trial data have attracted further heavy criticism from the research community.
The latest broadside comes in a letter to the BMJ (part of the recently launched AllTrials transparency campaign) from Peter Doshi, postdoctoral fellow at Johns Hopkins University School of Medicine in the US and a Cochrane group researcher who has previously complained about the difficulty of securing access to reliable trial data on Roche’s antiviral Tamiflu (osteltamivir).
The company announced last week that it would work with “an independent body of recognised experts to evaluate and approve requests to access anonymised patient-level data” – a move Doshi characterises as “all talk and no action”.
Tamiflu pledge
Even back in 2009, he points out, Roche was promising publicly to share full clinical study reports (CSRs) for 10 treatment trials with Tamiflu, citing a commitment “to ensure transparency”.
Yet “despite our repeated requests for those data, Roche has yet to provide even a single full study report”, Doshi writes. And in its press release on the new transparency initiative, the company “offered no apologies for its broken promise”.
Rather, Roche has explained to Doshi and his colleagues that it “disagreed” with their analysis plan (provided in Dec 2010) for the flu treatment data, since this was “at odds with how Tamiflu has been reviewed and approved by regulatory authorities in over 80 countries”.
Own analysis
Roche “apparently does not understand the meaning of independent review”, Doshi says. “We are independent scientists, not regulators. Doing our own analysis, not dictated by others, is key to what makes us independent.”
It is “ironic” that the company stands by regulators’ analyses, Doshi adds. “With access to the very ten CSRs that Roche pledged to publicly share, FDA concluded over a decade ago that ‘Tamiflu has not been shown to prevent’ serious bacterial complications of influenza.”
The US Food and Drug Administration even required Roche to print this warning on the Tamiflu product labelling, Doshi notes. “But this did not stop Roche authors from publishing a paper in 2003, based on the same 10 trials, claiming the opposite.”
The company has now put together an advisory board and proposed that analysis of Tamiflu data should proceed under the board’s guidance, Doshi observes.
However, he says, “three of the four advisors selected to lead this group are not independent but have recent financial relationships with Roche”.
‘Unclear’ policy
It is “hard to react with enthusiasm” to the company’s plans for expanding access to its clinical-trial data, Doshi comments.
The policy is “unclear, containing conflicting statements about which data will be released, and the mechanisms for access appear restrictive”, he claims.
Rather than releasing patient-level data to third-party researchers, with no strings attached, Roche “apparently intends to grant researchers access to a ‘secure system’ and only ‘following agreement’. These conditions may render ‘independent’ analysis a hollow concept”.
The company’s pledge to release “full clinical study reports” may also be “meaningless, given the company’s stated intention to only release ‘edited’ CSRs”, Doshi suggests.
