In an effort to appease the growing clamor for Tamiflu clinical trial data, Roche has agreed to make available data from all 74 clinical trials for its treatment to a team of Cochrane Collaboration researchers. The move comes after the the drugmaker recently agreed to widen access more generally for clincal trial information for its medicines in response to increased pressure from academics and a widely publicized online petition (see this).
In an email sent to the researchers last week, Don MacLean, the life cycle leader for Tamiflu at Roche, wrote the Cochrane researchers about a proposal to provide the data in a staggered approach over the next few months. “In line with European Union law, each CSR [clinical study report] will be edited by Roche to ensure patient confidentiality and to protect legitimate commercial interests,” he wrote, according to BMJ, which first reported the development (read here).
The Cochrane researchers were cautious in welcoming the latest Roche move. "We will respond to Roche's offer in the next few days," Tom Jefferson, one of the Cochrane researchers, writes us. And as Sile Lane, director of campaigns at Sense about Science, which launched the AllTrials online campaign, tells BMJ, by acknowledging there are 74 trials and agreeing to publish the results, the drugmaker appears to have backpedaled from arguments in favor of secrecy.
As we wrote previously, the move comes after Roche found itself in a heated row with researchers at the Cochrane Collaboration, who two years ago complained they were repeatedly stymied in their efforts to fully assess up-to-date efficacy information for the influenza treatment. More recent attempts to obtain data prompted a response from the drugmaker that critics called stonewalling. Roche then responded with a compromise offer to form a multi-party advisory board for determining which data should be accessed, but that went nowhere.
The pressure mounted, though, after GlaxoSmithKline last fall agreed to make available patient-level data to independent researchers, a step that came after the drugmaker paid a $3 billion settlement to settle civil and criminal charges that included a failure to release trial data. That move, by the way, placed Glaxo seemingly at odds with industry trade groups in the US and the UK. PhRMA, in particular, lashed out at the idea of releasing case study reports containing patient level data, saying such a move would jeopardize propietary information. So far, by the way, Glaxo has provided the Cochrane researchers 30 redacted clinical study reports from Glaxo and are in the process of reviewing them, Jefferson adds.
Two monhts ago, Roche said that 71 of 74 completed trials were in the public domain either as a primary publication or secondary publication or on rochetrials.com, and arrangements are being made for the remaining three trials to be posted. The drugmaker also agreed to form a so-called Multi-party Group for Advice on Science, which will consist of four "renowned" scientists in the field of influenza to review Tamiflu data, "identify any unanswered questions and agree on a statistical analysis plan."
From there, Roche said an agreement will be formed for releasing data, but did not offer specifics concerning parties or substance. The scientists - Albert Osterhaus of Erasmus Medical Centre in Rotterdam, Menno De Jong of the Academic Medical Centre in Amsterdam, Arnold Monto of the University of Michigan and Richard Whitley of the University of Alabama - will invite independent experts and third parties to a meeting in June. But not all are independent. As recently as last fall, for instance, Osterhaus, Monto and Whitley were listed as scientific advisors or consultants to Roche, and Osterhaus has also been a grant recipient.