Critics skeptical about announcements by GSK and Roche to make available more clinical trial data

Prashant Reddy Thikkavarapu, CLB Student Fellow

Following in the footsteps of GSK’s decision to release all clinical trial data (which we blogged about here), Swiss pharmaceutical major Hoffman La’ Roche has announced that it too would make available more clinical trial data.

Unlike GSK which was probably motivated to release more clinical trial data after facing a $ 3 billion dollar fine, Roche’s reason was most likely the criticism it faced for not disclosing data from certain clinical trials regarding the safety and efficacy of Tamiflu or ‘oseltamivir’. Roche had made quite the killing in profits through the sale of its patented ‘oseltamivir’ when the World Health Organization declared a pandemic during the bird-flu crisis and approved Tamiflu as the preferred treatment. As a result of the alert declared by WHO most national governments had stocked up significantly on Tamiflu. There has however been an active campaign since 2009, by the Cochrane Collaboration (a public health group) and the British Medical Journal to access more data on the clinical trials of Tamiflu to examine whether the drug was actually as safe and effective as claimed by Roche. In response to the appeals by this campaign, Roche had agreed in 2009 to provide researchers with more information on the clinical trials but has allegedly not released any information in the last 3 years. Eventually in December, 2012 the British Parliament demanded that the government get Roche to refund the 500 million pounds spent on Tamiflu if Roche was not able to show that the drug was no better than a placebo. After a Parliamentary enquiry was announced in the U.K., Roche agreed to release more clinical trial data relating to Tamiflu and other drugs.

As expected, public health activists are skeptical about the mechanism announced by Roche to regulate the release of information. According to its press-release dated February 26, 2013 Roche has announced the following mechanism to release information: There will be “independent” bodies of recognizing experts who will deal requests for access to both patient data sets and clinical study reports, not already available with the European Medical Agency (EMA).

For access to patient data sets, the press release states “An independent body will assess the scientific validity of requests for anonymised patient-level data, with the requested data made available within a secure system following agreement.” With regard to clinical study reports, Roche has reserved the right to edit them in order to protect patient confidentiality and any possible intellectual property rights.

One reaction from the medical community, published in the BMJ, criticizes the policy on the grounds that “The policy is unclear, containing conflicting statements about which data will be released, and the mechanisms for access appear restrictive.  Rather than release 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.”

With specific reference to the already announced review process for the Tamiflu clinical trials, Peter Doshi, a post-doc at Johns Hopkins, has pointed out that “three of the four advisors selected to lead this group are not independent but have recent financial relationships with Roche.” In Roche’s defence the process announced by it requires these four advisors to select other independent experts and third parties to scrutinize the data.

Writing for Pharmalot, Carl Heneghan at the Centre for Evidence-Based Medicine at the University of Oxford and a member of the Cochrane Collaboration, reminds readers that Roche has been making such promises since 2009 to no avail and points to recent correspondence between the Cochrane Collaboration and Roche on the issue.

GSK has faced similar criticism in articles published in the BMJ and available here.

Roche reluctance to release more data appears to stem from the fear that competitors or activists may publish misleading studies on the basis of such data. In pertinent part, its press release states “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.”

The proof the pudding is in the eating and we should probably wait to see the results of the review process for Tamiflu, which will be the test case for Roche’s new policy.

The author is an LLM candidate at Stanford Law School and a student fellow at the CLB.