UK government cautious on trial transparency
pharmafile | June 4, 2013 | News story | Research and Development, Sales and Marketing | Goldacre, UK, alltrials, transparency
Two ministers with responsibility for life sciences in the UK struck a cautious note over clinical trial transparency at an official government hearing yesterday.
David Willetts, minister for science and universities and Earl Howe, minister for health, appeared before the House of Commons Science and Technology committee’s inquiry into clinical trials.
The main issue surrounded clinical trial transparency, with Earl Howe saying the government ‘supports the principles of disclosure’ but warned, very much in-line with pharma, that there needs to be practices in place to ensure that patient confidentiality is protected.
He said an independent and trusted intermediary – or ‘safe-haven’ – was being introduced to allow some data to be reviewed. He added that the publication of outcomes was already mandatory and this was already being done by Researchfish, a government-backed research database.
Willetts said that some pharma firms were going further and looking to publish data from the past. He paid particular praise to GlaxoSmithKline, who is doing this “quite energetically” and also commended the ABPI for its launch of a ‘transparency toolkit’ in March.
Willetts said that whilst admirable, neither he nor the government will force companies to publish past data, but rather ‘encourage’ them to do this, with the focus for the government very much on what the future for transparency will look like.
NICE data
But while supporting transparency, when questioned by the Committee’s chair Labour MP Andrew Miller, Earl Howe was adamant that he did not think NICE had ever been denied access to clinical trial data, or that negative data was buried by pharma.
This does not ring true with NICE it may appear, which in March signed the AllTrials register for greater clinical trial transparency. Its former chair Sir Michael Rawlins said shortly after the Institute’s signing that it was ‘unheard of’ that a body such as NICE should sign such a register, but he felt compelled to do so as evidence suggests only half of all clinical trials are published in the public domain.
“The rest are tucked away in the bottom drawers of the desks of academic investigators or in the vaults of pharmaceutical companies,” he said.
Both ministers said their overall aim was to increase the attractiveness of the UK for the life science industry, perhaps explaining their cautious note on transparency, and why they were stopping short of demanding full and open access to all data, as some quarters want.
Tamiflu
Clinical trial transparency has become a major issue in the UK, with the epicentre being very much Roche’s influenza drug Tamiflu.
The drug was stockpiled by the UK government over the past seven years at a cost of nearly £500 million to the taxpayer, but both the Cochrane Collaboration and the British Medical Journal have argued the drug may not be worth this investment.
They say that Roche has been withholding trial data from researchers and the public, with Cochrane spending nearly four years pursuing the Swiss firm for the missing information.
Roche has since promised to release a restricted and filtered series of data on the drug for Cochrane, but some MPs – such as Conservative MP Dr Sarah Wollaston – have criticised the move as being too limited and too late for taxpayers.
Earl Howe said the decision over Tamiflu and its stockpiling was made by the previous Labour government, so he could not comment on why this drug was deemed value for money.
He said, however, that the current stockpile was nearing the end of its clinical effectiveness, and would soon need to be replaced. This would not be his responsibility, he added, but would fall to junior health minister Anna Soubry – a situation that may create more tensions given that the complete set of data for Tamiflu remains outside the public realm.
AllTrials
The situation with Roche helped spark the AllTrials campaign which is run and supported by Sense about Science, Ben Goldacre and others who are lobbying hard for greater trial transparency.
It has been heavily involved in the meeting, having sent a number of formal questions to the committee in the run-up to yesterday’s meeting, hoping to steer the conversation toward trial transparency.
But the campaign itself was not mentioned by either minister or the committee members – transparency was, however, the biggest topic of discussion, taking up nearly three-quarters of the hour-long question time.
Pharma at odds with Europe
Early Howe made it clear that the UK was operating in an ‘EU context’ and said any changes to data transparency in Britain would mainly come from Europe.
And this committee meeting comes just days after a European parliamentary committee voted for new amendments to the Clinical Trial Directive, which aims to increase trial transparency by law across the continent.
The proposals would mean that clinical trials would have to be registered on a publicly accessible EU database, and their main findings reported within a year of the study ending.
The MEPs also backed amendments that say if pharma firms did not comply with these transparency provisions, it would result in sponsors being fined.
Earl Howe said the government had welcomed the amendments voted for last week, but was initially concerned that publication of full case study reports would be mandatory for every pharma product.
Instead of full CSRs however, the Directive will only require summaries, something that Howe and Willetts support, given the ‘unnecessary burden’ individual CSRs can be for pharma.
But problems still persist: the European Medicines Agency has had injunctions issued against it in two court cases brought by AbbVie and InterMune, who successfully challenged the Agency’s policy to give access to Clinical Study Reports it holds.
The firms argue that the data will be used by competitors to undermine their research and development efforts. Earl Howe said he was aware of these ‘legal issues’ but would not comment any further on what this means for transparency in Europe.
Ben Adams
Related Content
Addenbrooke’s hospital offers first self-service digital eye test
Addenbrooke’s Hospital, Cambridge, has become the first in the UK to deploy a digital self-testing …
Digital Control Room, a major pharma provider, wins King’s Award for Enterprise
Buckingham Palace has announced that Digital Control Room, a software platform that monitors companies’ online …
Deadly cancers are being financially left behind, new research claims
New research has revealed that some of the UK’s most deadly and prevalent cancers receive …
