GSK pledge on trials transparency

GlaxoSmithKline (GSK) has announced a series of initiatives to make clinical trial data publically available that could set a precedent in an industry not known for its transparency. A first for a major pharmaceutical company, it plans to publish the results of all of its clinical trials – regardless of what the results say – in peer-reviewed scientific journals and enable researchers to access detailed patient data on its approved and discontinued medicines. The company will also make public about 200 promising leads for new medicines for tuberculosis (TB).

In the past, GSK stood accused of suppressing safety data in several high-profile cases. In July, the company agreed to pay $3 billion to settle charges in the US that it had marketed the antidepressants Paxil (paroxetine) and Wellbutrin (bupropion) for unapproved uses and had not disclosed clinical data related to the diabetes medicine Avandia (rosiglitazone) and the risk of heart attack. Ultimately, Avandia’s use was severely restricted.

But times are changing, according to GSK chief executive Andrew Witty. ‘There was a history in the industry of fear around collaboration, especially openness of information, and a mistaken judgment that actually by being more open and more transparent around data, somehow that would destroy the fundamental business model.’

Witty said GSK is already very transparent in the way in which its reports clinical trials. But he acknowledges that not everybody believes that. ‘We do publish every protocol on the web before it starts, so if you want to see any trial that we’re running, or are about to start, you can see it. Equally, we publish every set of results whether they are positive or negative.’

Faceless data

Starting from the beginning of the year, people will be able to apply to see raw data on trial patients. An independent panel of experts will review requests to ensure ‘scientific merit’. Witty stresses that all the data will be ‘anonymised’, making it impossible for any patient to be associated with any piece of data. The policy will apply to data from ‘this point forward’ and going back to 2007. Applications for data from before 2007 will be looked at on a case-by-case basis, according to a GSK spokesperson.

Meanwhile, the company will make available the results of a screen of more than two million compounds in its search for TB drugs. This follows its malaria initiative in 2010 when it placed all of its malaria drug leads in the public domain.

Industry observers, while welcoming the announcements in general, expressed some scepticism about their impact.

Fiona Godlee, editor-in-chief of the British Medical Journal, said: ‘GSK should be congratulated, although in some ways this is long overdue. It does represent a step change and puts GSK well ahead of other drug companies in terms of openness to independent scrutiny. We will have to wait and see how it turns out in practice and whether others will follow. Much will depend on how the independent panel works and in particular how it responds to requests for data from older trials on controversial drugs such as paroxetine and rosiglitazone.’

Ben Goldacre, author of Bad Pharma, a book that documents ‘ongoing problems’ in the industry, believes it’s a great initiative but warns that promises are not enough. Promises have been broken in the past ‘and we will only see if this promise is different in the decade to come’. He adds: ‘I hope [this transparency] happens at GSK, consistently, and I hope it is copied. But this one initiative does not address the ongoing problem of missing trial results throughout medicine, or the ongoing failure of the medical bodies, patient associations, ethics committees and universities to address this ongoing threat to patient care.

‘Positive step’

Catherine Elliott, head of clinical research support and ethics at the UK Medical Research Council, calls the move a ‘very positive step’, reflecting the potential value of data that underpins clinical trial results, whether published or unpublished. ‘It is likely that the real benefits will come once scientists have had the chance to consider what data is available and begin to submit research proposals,’ she says.

The Association of British Pharmaceutical Industry (ABPI) says GSK’s announcement demonstrates the pharmaceutical industry’s willingness to be more open and transparent. ‘The industry recognises a growing appetite from the public for more information and is responding to this in a number of different ways. Many companies, including GSK, already have dedicated areas of their websites to the publication of clinical trial results – both successful and unsuccessful.’

In a further move, GSK will double its funding for its Open Lab at Tres Cantos, Spain, awarding it an additional £5 million. Established in 2010, the lab allows independent researchers access to GSK resources to help them advance their own research projects into diseases that primarily affect the developing world. There are now 16 research projects in the portfolio.