BMJ to only publish trials with open data - NEWS - articles - Pharmaceutical Industry - PMLiVE

abernard102@gmail.com 2012-11-02

Summary:

The British Medical Journal has said from January 1, 2013, it will only publish clinical trials of drugs for which full data is openly available. The commitment follows increased efforts from the BMJ to get Roche to publish all available data on its flu drug Tamiflu (oseltamivir), which has drawn concerns about its true efficacy after the US Food and Drug Administration (FDA) concluded that the treatment had not been shown to reduce complications in people with influenza, despite being recommended by other organisations. The BMJ noted that Roche issued a public promise to release 'full study reports' concerning Tamiflu following a request from healthcare review group the Cochrane Collaboration, but has yet to provide access to this data. 'Roche has stonewalled, variously pleading patient or commercial confidentiality, or claiming that sufficient data have already been provided,' said BMJ editor Fiona Godlee, in her editorial announcing the journal’s commitment. Godlee also published an open letter to John Bell, regius professor of medicine at Oxford University and a Roche board member, claiming that evidence for Tamiflu was unreliable as the only two published trials investigating the effectiveness of the vaccine were funded by Roche, and a further eight studies were not accessible. She said: 'Oseltamivir has been a great commercial success for Roche. Billions of pounds of public money have been spent on it, and yet the evidence on its effectiveness and safety remains hidden from appropriate and necessary independent scrutiny. I am appealing to you, as an internationally respected scientist and clinician and a leader of clinical research in the UK, to bring your influence to bear on your colleagues on Roche’s board.' Not all pharma companies came under criticism from the BMJ, however, and Godlee praised GlaxoSmithKline’s recent decision to allow access to anonymised patient level data from its clinical trial through a panel which will assess requests. She qualified her statement with some reservations, however: 'Whether researchers will find it as easy to get past the panel as [GSK CEO Sir Andrew] Witty suggests we will have to wait and see. It will be particularly important to know how many requests are turned down and for what reasons.' In return, GSK put its support behind the BMJ’s decision to only publish studies where full data was accessible, saying such moves help medical research and improve understanding of medicines... The issue of intentionally concealed trial data has received a lot of attention recently due to the publication of Ben Goldacre’s book Bad Pharma, which describes several instances where pharma companies have been seen to hide data or use selected information to mislead doctors..."

Link:

http://www.pmlive.com/pharma_news/bmj_to_only_publish_trials_with_open_data_445004

From feeds:

Open Access Tracking Project (OATP) » abernard102@gmail.com

Tags:

oa.new oa.data oa.policies oa.comment oa.advocacy oa.biomedicine oa.clinical_trials oa.credibility oa.bmj oa.glaxosmithkline oa.roche oa.pharma

Date tagged:

11/02/2012, 13:50

Date published:

11/02/2012, 09:50