News Analysis: GSK trials register raises PR stakes

GlaxoSmithKline last week unveiled plans to publish a database of its all clinical trials results. Ian Hall finds that a fundamental change in the way Big Pharma communicates on drug trials is just around the corner.

GlaxoSmithKline's decision to publish the results of its clinical trials, revealed last week, provided the drugs giant with the positive headlines it has been desperate for of late.

Its reputation has in the words of its European medical director, Alastair Benbow been 'under attack' over its anti-depressant Seroxat but suddenly it was on the PR front-foot talking of 'a new era of openness'.

GSK is accused of an alleged fraud by New York attorney-general Eliot Spitzer, who says it suppressed studies showing that Seroxat, marketed in the US as Paxil, increases suicidal tendencies in children.

'Sensible corporate strategy'

Given the media mauling engendered by the Seroxat controversy, some have viewed GSK's decision to set up its Clinical Trial Register (CTR) as a cynical PR stunt.

De Facto Communications CEO Richard Anderson is one who disagrees. He says: 'This is part of a very sensible corporate strategy. It is the right thing for GSK to do, even if the timing (of the announcement of the CTR) was unfortunate.'

The setting-up of the CTR - a website that will contain summaries of both the methodology and results of all GSK-funded trials of the medicines it has on the market - follows calls from patient groups and journals for pharma firms to be more transparent.

Axon Communications managing partner Ralph Sutton says the significance of GSK's move cannot be overstated: 'This issue is not just confined to GSK and the UK - the global industry is entering a new reality.'

One issue raised is how much data companies would be wise to disclose.

Companies will not want to provide rivals with certain information and there are concerns that doctors may prescribe products for unapproved (off-label) uses if they spot certain, previously unseen data.

'I don't believe we'll see a situation when all data is published,' says Sutton, adding: 'If all Phase I and II data is published there is a risk of confusion among all audiences. Patients may have their expectations raised about drugs that may never come to market.'

Biosector2 managing director Charlotte Ersboell says the public may lack the necessary context to understand what the data implies and what the rationale of the trial was.

'An initiative like this should be accompanied by an information campaign educating the public about how new drugs are researched and developed,' she says.

Ruder Finn UK deputy MD Pat Pearson concurs: 'There is a dilemma with publishing all data, which is perhaps most apparent where the mechanisms of disease are not totally understood and the actions of medicines can be misrepresented to non-professional audiences.'

Competitors, investors and analysts will be sure to log on to GSK's site.

Sante Communications managing director Liz Shanahan says: 'If anyone spots the tiniest glitch in your armory, rivals will be running off to the media to say "there's a huge problem with this product".'

But as Anderson points out, 'only a narrow group of patients will be able to understand (the data).'

So how groundbreaking is GSK's decision? Sutton says: 'Clinical trials registers will become the norm. The question is whether firms do this individually or as an industry.'

The Association of the British Pharmaceutical Industry, which has welcomed GSK's move, last year launched its own publicly accessible clinical trials database.

But the site, which is managed by the Centre for Medicines Research, is voluntary, with ABPI member companies merely 'encouraged' to register trials. Firms such as Schering, Novartis and Wyeth have so far provided data.

What do GSK's rivals make of its move? After all, Consumers' Association principal policy adviser Frances Blunden has called on them to follow suit.

AstraZeneca says the way in which it communicates its clinical trial data is 'regularly under review' and that it 'endeavours' to publish the results of clinical trials, adding that 'selective publication that would misrepresent the medical profile of an AZ product is not acceptable'.

Similarly, Pfizer says it is 'continuing to examine options for the transparency of clinical studies and the communication of results'.

Debate rages in US

The pressure on pharma firms to increase the transparency of their trials is as intense in the US, where a debate is ongoing as to how a government-run registry could function.

Merck, for example, has said it supports the formation of a national US database that would track late-stage trials from start to finish.

AZ dismisses GSK's CTR as 'nothing new', pointing out that companies including pre-merger Glaxo Wellcome have formed trial registries before.

But GW's registry was aimed at researchers and doctors, while the CTR will be publicly accessible.

Anderson will reserve full judgment on the CTR until it is up and running (GSK says it will launch within months), saying: 'We'll have to see how easy it is to access the data. GSK will be judged on the delivery of what will be an extensive and complex database.'

Fundamental change in the way Big Pharma communicates on drug trials is, it seems, just around the corner.

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