UK-based medical journal the BMJ has tapped into the growing momentum behind full disclosure for clinical trial results to step up its open-data campaign on a number of fronts.
While continuing to hold industry and regulators to account for selective reporting of clinical-trial outcomes, the journal has specifically pledged to publish, with effect from January 2013, studies of drugs and medical devices – whether industry-funded or not – only where there is a commitment “to make the relevant anonymised patient level data available on reasonable request”.
To date, the International Committee of Medical Journal Editors has “declined to take such a step”, notes an editorial by BMJ editor in chief Fiona Godlee.
The latest issue of the BMJ also features an open letter from Godlee to John Bell, regius professor of medicine at Oxford University and a member of Roche’s board of directors, putting pressure on the company to release the complete raw dataset on its antiviral oseltamivir (Tamiflu).
This is in line with the Cochrane Collaboration’s efforts – highlighted in previous issues of the BMJ – to obtain the full Tamiflu data for a systematic review of neuraminidase inhibitors.
In an unpublished response, Bell says he has referred the matter to Roche. Meanwhile, the BMJ has launched a dedicated website, www.bmj.com/tamiflu, including correspondence by e-mail and letter between Cochrane researcher Dr Tom Jefferson plus colleagues and Roche, as well as the World Health Organization and the US Centers for Disease Control and Prevention, over the unpublished Tamiflu data.
All of this comes as questions are being asked in the UK Parliament over clinical data transparency and Dr Ben Goldacre’s book Bad Pharma, which weighs into industry, regulators and others over selective data publication, continues to ride a wave of publicity.
Indeed, Godlee refers to Bad Pharma three times in her editorial, while Goldacre’s case rests substantially on transparency issues pursued in the BMJ, such as Tamiflu and the German meta-analysis of published and unpublished clinical trials with Pfizer’s antidepressant reboxetine (Edronax).
The BMJ’s latest efforts also catch Roche on the back foot, as the company negotiates the fall-out from last week’s revelation that the European Medicines Agency is investigating whether Roche failed to comply with legal obligations to report side effects associated with 19 of its medicines licensed for use in the European Union.
As far as Tamiflu is concerned, the company continues to insist the drug is safe and effective and that it has already provided the Cochrane group with 3,200 pages of highly detailed information addressing the researchers’ concerns.
In her editorial, Godlee contrasts Roche’s stance with GlaxoSmithKline’s announcement last month that it will allow access to anonymised patient-level data from its clinical trials, subject to review by an independent panel and the data request including a ‘reasonable scientific question’, a research protocol and a commitment from the researchers to publish their results.
While GSK’s initiative is very welcome, “what this apparently brave and benevolent action really serves to highlight is the rank absurdity of the current situation”, Godlee comments.
“Why aren’t all clinical trial data routinely available for independent scrutiny once a regulatory decision has been made?”, she asks. “How have commercial companies been allowed to evaluate their own products and then to keep large and unknown amounts of the data secret even from the regulators? Why should it be up to the companies to decide who looks at the data and for what purpose?”
In the meantime, and despite a “public promise” from Roche to release “full study reports” from its clinical trials with Tamiflu, the company has “stonewalled, variously pleading patient or commercial confidentiality, or claiming that sufficient data have already been provided”, Godlee says.
According to the Cochrane researchers, around 60% of Roche’s data from Phase III trials of oseltamivir have never been published. “This means that tax payers in the United Kingdom and around the world have spent billions of dollars stockpiling a drug for which no one except the manufacturer has seen the complete evidence base,” Godleee writes.
“Indeed,” she adds, “ the EMA’s unprecedented infringement proceedings launched against Roche last month suggest that even the manufacturer has never fully evaluated evidence it has collected on the drug’s adverse effects - What has Roche got to hide?”